{"change_dates":[],"dossier":{"amendments":[{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-231","justification":"The concept of Union authorisation is a positive step towards a harmonised European\nbiocidal products market, allowing for product authorisations to be valid throughout the 27\nMember States. The Council's approach - both by product type and in stages - is overly\nrestrictive. The possibility for products that are distributed widely across Europe to be\nauthorised at Union level is crucial in order to prevent pointless barriers to their placing on\nthe market.","location":[["Council position","Article 40"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:38"},"new":["A Union authorisation issued by the","Commission in accordance with this","Section shall be valid throughout the Union","unless otherwise specified. It shall confer","the same rights and obligations in each","Member State as a national authorisation."],"old":["A Union authorisation issued by the","Commission in accordance with this","Section shall be valid throughout the Union","unless otherwise specified. It shall confer","the same rights and obligations in each","Member State as a national authorisation.","For those categories of biocidal products","referred to in Article 41(1), the applicant","may apply for Union authorisation as an","alternative to applying for a national","authorisation and mutual recognition."],"orig_lang":"fr","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"231","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-232","justification":" The introduction of the concept of Union authorisation is a positive step towards a\n harmonised European biocidal products market, allowing for product authorisations to be\n valid throughout the EU-27 Member States. Product types should be brought forward for\n authorisation after a risk based evaluation process has been undertaken.","location":[["Council position","Article 40"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:38"},"new":["A Union authorisation issued by the","Commission in accordance with this","Section shall be valid throughout the Union","unless otherwise specified. It shall confer","the same rights and obligations in each","Member State as a national authorisation."],"old":["A Union authorisation issued by the","Commission in accordance with this","Section shall be valid throughout the Union","unless otherwise specified. It shall confer","","the same rights and obligations in each","Member State as a national authorisation.","For those categories of biocidal products","referred to in Article 41(1), the applicant","may apply for Union authorisation as an","alternative to applying for a national","authorisation and mutual recognition."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"232","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-233","justification":"The introduction of the concept of Union authorisation is a positive step towards a\nharmonised European biocidal products market, allowing for product authorisations to be\nvalid throughout the EU-27 Member States. Product types should be brought forward for\nauthorisation after a risk based evaluation process has been undertaken.","location":[[" Council position","Article 41"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:38"},"new":["1. A Union authorisation may be granted","to all categories of biocidal products with","the exception of biocidal products that","contain active substances that fall under","Article 5."],"old":["1. Applicants may apply for Union","authorisation for biocidal products which","have similar conditions of use across the","Union and which fall within the following","categories of biocidal products:","(a) biocidal products of product-types 6, 7,","9, 10, 12, 13 and 22; and","(b) with effect from 1 January 2020, all","other biocidal products except for those of","product-types 14, 15, 17, 20 and 21.","2. The Commission shall report to the","European Parliament and the Council on","the application of this Article by 31","December 2017. It shall, if appropriate,","accompany its report with relevant","proposals for adoption in accordance with","the ordinary legislative procedure."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"233","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-234","justification":"The concept of Union authorisation is a positive step towards a harmonised European\nbiocidal products market, allowing for product authorisations to be valid throughout the 27\nMember States. The Council's approach - both by product type and in stages - is overly\nrestrictive. The possibility for products that are distributed widely across Europe to be\nauthorised at Union level is crucial in order to prevent pointless barriers to their placing on\nthe market.","location":[["Council position","Article 41"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:38"},"new":["An application for Union authorisation","may be submitted for all categories of","biocidal products with the exception of","biocidal products that contain active","substances that fall under Article 5."],"old":["1. Applicants may apply for Union","authorisation for biocidal products which","have similar conditions of use across the","Union and which fall within the following","categories of biocidal products:","","","(a) biocidal products of product-types 6, 7,","9, 10, 12, 13 and 22; and","(b) with effect from 1 January 2020, all","other biocidal products except for those of","product types 14, 15, 17, 20 and 21.","2. The Commission shall report to the","European Parliament and the Council on","the application of this Article by 31","December 2017. It shall, if appropriate,","accompany its report with relevant","proposals for adoption in accordance with","the ordinary legislative procedure."],"orig_lang":"fr","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"234","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-235","justification":" The EP voted for a very limited scope of the Union authorisation (UA) in the first phase as of\n 2013. Council increased the scope by moving to certain product types (PTs). The rapporteur\n proposes to go way beyond the first reading. by adding PTs and by exchanging small ones for\n very big ones. As a true compromise, the larger scope of Council could be accepted, if\n substances that fall under Art.5 or 10, for which it is anyway impossible to find agreement at\n Union level, are excluded from the UA.","location":[[" Council position","Article 41 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:38"},"new":["1. Applicants may apply for Union","authorisation for biocidal products which","have similar conditions of use across the","Union and which fall within the following","categories of biocidal products, except any","product that contains active substances","that fall under Article 5 or 10:","Or. en","view to find a compromise with Council.)"],"old":["1. Applicants may apply for Union","authorisation for biocidal products which","have similar conditions of use across the","Union and which fall within the following","categories of biocidal products:","","","","(Partial reinstatement of amendment of am 359 from first reading in a modified way with a"],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"235","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-236","justification":"The amendment underlines what is meant by similar conditions of use. When an applicant\napplies for a Union Authorisation we need to be sure that the biocidal product has similar\nconditions of use across the Union in order to ensure that the evaluation covers all\ncircumstances and conditions. This will ensure a harmonised approach and fair completion","location":[[" Council position","Article 41 \u2013 paragraph 1 \u2013 subparagraphs 1a and 1b (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:38"},"new":["A product shall be considered a biocidal","product with similar use conditions if all","of the following criteria are met. The","biocidal product:","(i) has similar conditions of use across the","European Union, according to use","instructions,","(ii) does not require personal protective","equipment in conditions of use under","their normal and realistic worst case","condition of use according to Annex VI","and","(iii) does not contain any substances of","concern.","A Union authorisation may not be","granted for biocidal products that contain","active substances that fall under Article 5","or 10."],"old":[""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"236","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-237","justification":"Introduction of stage-by-stage Union authorisations. For the product groups chosen by the\nCouncil, with the exception of product-types 6 and 13, the applications can be submitted from\n2017 at the earliest, because on the basis of the review programme the decision on the\n\n inclusion of the active substance in Annex I will be taken from 2015 at the earliest. The\n proposed product-types are those which can take advantage of Community authorisation from\n 2013.","location":[["Council position","Article 41 \u2013 paragraph 1 \u2013 point a"]],"meps":[1929],"meta":{"created":"2019-07-03T05:28:39"},"new":["(a) biocidal products of product-types 1, 2,","3, 4, 5, 6, 8, 13, 18, 19; and"],"old":["(a) biocidal products of product-types 6, 7,","9, 10, 12, 13 and 22; and"],"orig_lang":"de","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"237","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-238","justification":" For those products not yet placed on the market and which provide an added benefit for the\n environment and human health compared to existing products, being the result of innovation\n and investment, the market access of these should be encouraged. The Union authorisation\n procedure should therefore be available as soon as 2017 to allow all EU consumers to benefit\n equally from innovation and research.","location":[[" Council position","Article 41 \u2013 paragraph 1 \u2013 point a"]],"meta":{"created":"2019-07-03T05:28:39"},"new":["(a) new biocidal products which have not","yet been placed on the market and which","provide additional benefits to the","environment and human health compared","to existing products and biocidal products","containing one or more new active","substances of product-types 1,2,3,4,5,6,8,","18,19; and"],"old":["(a) biocidal products of product-types 6, 7,","9, 10, 12, 13 and 22; and"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"238","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-239","justification":"The Council newly introduced the notion of \"similar conditions of use across the Union\". As\nthis is the precondition for qualifying for Union authorisation, a clear definition needs to be\nprovided before Union authorisation can be applied for.","location":[[" Council position","Article 41 \u2013 paragraph 2 a (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:39"},"new":["2 a. No later than 13 December 2013, the","Commission shall adopt delegated acts in","accordance with Article 82 a definition of","\"similar conditions of use across the","Union\"."],"old":["",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"239","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-240","justification":"This amendment is intended to improve consistency (both within the text and with other pieces\nof legislation) and to clarify the text.","location":[["Council position","Article 42 \u2013 paragraph 4 \u2013 subparagraph 3"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:39"},"new":["The evaluating competent authority shall","reject the application if the applicant fails","to submit the requested information within","the deadline and shall inform the applicant","accordingly. In such cases, part of the fee","paid in accordance with Article 79(1) and","(2) shall be reimbursed."],"old":["The evaluating competent authority shall","reject the application if the applicant fails","to submit the requested information within","the deadline and shall inform the applicant","accordingly. In such cases, part of the fee","paid in accordance with Article 79 shall be","reimbursed."],"orig_lang":"ro","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"240","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elisabetta Gardini, Sergio Berlato, Oreste Rossi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-241","location":[["Council position","Article 42 \u2013 paragraph 4a (new)"]],"meps":[58758,4746,97196],"meta":{"created":"2019-07-03T05:28:39"},"new":["4a. Where the Register for Biocidal","Products shows that a competent","authority is examining an application","relating to the same or a similar biocidal","product or has already authorised the","same or a similar biocidal product, the","Agency shall nominate the original","evaluating competent authority to","evaluate the application.","For products or families of products","already authorised, the original","evaluating competent authority shall","submit its evaluation report and its","evaluation conclusions to the Agency","within 90 days from the request of the","Agency."],"old":[""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"241","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-242","justification":" By minimising duplication of work, such provision will help both national competent\n authorities and applicants save time and resources thereby avoiding any unnecessary\n administrative burdens or delays in the placing on the market of biocidal products.","location":[[" Council position","Article 42 \u2013 paragraph 4 a (new)"]],"meta":{"created":"2019-07-03T05:28:39"},"new":["4 a. Where the Register for Biocidal","Products shows that a competent","authority is examining an application","relating to the same biocidal product or","has already authorised the same biocidal","product, that competent authority shall be","the evaluating competent authority."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"242","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-243","justification":"180 days is too long for the Agency to prepare and submit an opinion which is based on an\nalready available evaluation performed by the evaluating competent authority. 90 days would\nbe a more appropriate time frame.","location":[["Council position","Article 43 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meta":{"created":"2019-07-03T05:28:39"},"new":["Within 90 days of receipt of the","conclusions of the evaluation, the Agency","shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product."],"old":["Within 180 days of receipt of the","conclusions of the evaluation, the Agency","shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"243","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-244","justification":"The Summary of Biocidal Product Characteristics should be available in all the languages of\nthe EU for products, which will have access to all EU countries.","location":[["Council position","Article 43 \u2013 paragraph 3 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:39"},"new":["3 a. Within 30 days of the submission of","its opinion to the Commission, the Agency","shall transmit, in all the official","languages of the European Union, the","draft summary of the biocidal product","characteristics, as referred to in Article","21(2), as applicable;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"244","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-245","location":[[" Council position","Article 43 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[28156,96743,96741],"meta":{"created":"2019-07-03T05:28:39"},"new":["A Member State shall inform the","Commission if it decides to adjust certain","conditions of a Union authorisation","specifically for the territory of that","Member State or decides that a Union","authorisation shall not apply in the territory","of that Member State, provided that such a","decision can be justified on one or more of","the grounds referred to in Article 36(1).","Or. en","(Reinstatement of amendment 158 from first reading.)"],"old":["The Commission may, at the request of a","Member State, decide to adjust certain","conditions of a Union authorisation","specifically for the territory of that","Member State or decide that a Union","authorisation shall not apply in the territory","of that Member State, provided that such a","request can be justified on one or more of","the grounds referred to in Article 36(1).","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"245","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elisabetta Gardini, Sergio Berlato, Oreste Rossi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-246","location":[[" Council position","Article 44 \u2013 paragraph 2 \u2013 point a"]],"meps":[58758,4746,97196],"meta":{"created":"2019-07-03T05:28:39"},"new":["(a) without prejudice to Article 20 (1), all","relevant data required under Article 19","that has been generated since the initial","authorisation or, as appropriate, previous","renewal, or a letter of access to these data;"],"old":["(a) a list of all relevant data that it has","generated since the initial authorisation or,","as appropriate, previous renewal; and"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"246","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elisabetta Gardini, Sergio Berlato, Oreste Rossi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-247","location":[["Council position","Article 45 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[58758,4746,97196],"meta":{"created":"2019-07-03T05:28:40"},"new":["deleted"],"old":["The evaluating competent authority may","at any time require the applicant to submit","the data from the list referred to in Article","44(2)(a)."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"247","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-248","justification":"It needs to be clarified that an authorisation shall be cancelled when it fails to comply with\nthe requirements of relevant legislation for the protection of waters.","location":[["Council position","Article 47 \u2013 paragraph 1 \u2013 point a a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:40"},"new":["(a a) the authorisation fails to comply","with requirements of Directive","2008/56/EC establishing a framework for","community action in the field of marine","environmental policy, Directive","2006/118/EC on the protection of","groundwater against pollution and","deterioration, Directive 2000/60/EC","establishing a framework for Community","action in the field of water policy,","Directive 98/83/EC on groundwater and","Directive 2008/1/EC concerning","integrated pollution prevention and","control;","Or. en","(Reinstatement of amendment 163 from first reading.)"],"old":["","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"248","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-102","justification":"In line with the definition of a biocidal product, the Regulation should apply to in-situ\ngeneration of biocidal products, whether generated by mixing chemical precursors or by\nother means such as electrolysis. Fumigation is a hazardous activity in which biocidal\nproducts are often generated in situ. Deletion of the second sentence in Recital 9 also\nremoves the implication that biocides used for fumigation in industrial plants are outside\nscope.","location":[["Council position","Recital 9"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:39"},"new":["(9) This Regulation should apply to","biocidal products that, in the form in which","they are supplied to the user, consist of,","contain or generate one or more active","substances."],"old":["(9) This Regulation should apply to","biocidal products that, in the form in which","they are supplied to the user, consist of,","contain or generate one or more active","substances. It therefore should not apply","to devices within industrial plants that","generate biocidal products in situ."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Richard Seeber","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-249","location":[[" Council position","Article 50\u2013 paragraph 1"]],"meps":[28252],"meta":{"created":"2019-07-03T05:28:40"},"new":["In order to ensure a harmonised approach","to the cancellation and amendment of","authorisations, the Commission shall lay","down rules for the application of Articles","46 to 49, including a dispute settlement","mechanism, by means of implementing","acts. Those implementing acts shall be","adopted in accordance with the","examination procedure referred to in","Article 81(3)."],"old":["In order to ensure a harmonised approach","to the cancellation and amendment of","authorisations, the Commission shall lay","down rules for the application of Articles","46 to 49 by means of implementing acts.","Those implementing acts shall be adopted","in accordance with the examination","procedure referred to in Article 81(3)."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"249","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-250","justification":" In the assessment of technical equivalence, the Agency should have the possibility to ensure\n that applications are submitted according to the correct format. Applications not submitted\n according to the format or for which the required fee has not been paid, should be rejected.","location":[[" Council position","Article 53 \u2013 paragraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:40"},"new":["1. Where it is necessary to establish the","technical equivalence of active substances,","the person seeking to establish that","equivalence (\"the applicant\") shall submit","an application to the Agency in the correct","format and pay the applicable fee in","accordance with Article 79(1)."],"old":["1. Where it is necessary to establish the","technical equivalence of active substances,","the person seeking to establish that","equivalence (\u2018the applicant\u2019) shall submit","an application to the Agency and pay the","applicable fee."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"250","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-103","justification":" It should be clear that the physical devices / equipment generating an active substance in situ\n in itself is not included in the scope of this Regulation. If the present text is maintained all the\n machines/devices that are not within an industrial plant are defined as biocidal products and\n therefore have to be evaluated for any harmful effects on human or animal health or\n unacceptable effects or the environment.","location":[["Council position","Recital 9"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:40"},"new":["(9) This Regulation should apply to","biocidal products that, in the form in which","they are supplied to the user, consist of, or","contain one or more active substances or","precursors for one or more active","substances."],"old":["(9) This Regulation should apply to","biocidal products that, in the form in which","they are supplied to the user, consist of,","contain or generate one or more active","substances. It therefore should not apply","to devices within industrial plants that","generate biocidal products in situ."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-251","justification":"In the assessment of technical equivalence, the Agency should have the possibility to ensure\nthat applications are submitted according to the correct format. Applications not submitted\naccording to the format or for which the required fee has not been paid, should be rejected.","location":[["Council position","Article 53 \u2013 paragraph 2 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:40"},"new":["2 a. In the case where the Agency decides","that the application has not been","submitted in the correct format or that the","appropriate fee has not been paid it shall","reject the application and inform the","applicant accordingly."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"251","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-104","justification":" The Commission should review the approval of an active substance as soon as there are\n significant indications of non-compliance, not only when there are serious indications.","location":[[" Council position","Recital 13"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:40"},"new":["(13) The active substances in the Union list","should be regularly examined to take","account of developments in science and","technology. Where there are significant","indications that an active substance used in","biocidal products or treated articles does","not meet the requirements of this","Regulation, the Commission should be able","to review the approval of the active","substance.","Or. en","(To be coherent with parts of amendment 74 from first reading.)"],"old":["(13) The active substances in the Union list","should be regularly examined to take","account of developments in science and","technology. Where there are serious","indications that an active substance used in","biocidal products or treated articles does","not meet the requirements of this","Regulation, the Commission should be able","to review the approval of the active","substance.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-252","location":[["Council position","Article 54 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:40"},"new":["By way of derogation from Articles 17 and","18, a competent authority may permit, for a","period not exceeding four months, the","making available on the market or use of a","biocidal product which does not fulfil the","conditions for authorisation laid down in","this Regulation, for a limited and","controlled use, if such a measure is","necessary because of a danger to public","health or the environment which cannot be","contained by other means, and if all of the","following conditions are met:","(a) the active substances concerned are","approved for inclusion in Annex I or","evaluated according to Article 4 of this","Regulation and a full dossier is provided;","(b) if the relevant active substances fall","under Article 5(1) or 10(1), a mandatory","substitution plan is established and","implemented by the applicant or","competent authority in order to replace","the relevant substances with non-","hazardous chemical or non-chemical","alternatives within two years of the date of","approval; and","(c) the application of the product is","restricted to professional users who are","certified pursuant to the requirements for","an integrated pest management and the","use is appropriately monitored .","Or. en","(Reinstatement of amendment 175 from first reading.)"],"old":["By way of derogation from Articles 17 and","18, a competent authority may permit, for a","period not exceeding 270 days, the making","available on the market or use of a biocidal","product which does not fulfil the","conditions for authorisation laid down in","this Regulation, for a limited and","controlled use, if such a measure is","necessary because of a danger to public","health or the environment which cannot be","contained by other means.","","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"252","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-253","location":[[" Council position","Article 54 \u2013 paragraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:40"},"new":["deleted","Or. en","(Reinstatement of amendment 176 from first reading.)"],"old":["2. By way of derogation from point (a) of","Article 18(1) and until an active substance","is approved, competent authorities and the","Commission may authorise, for a period","not exceeding three years, a biocidal","product containing a new active","substance.","Such a provisional authorisation may be","issued only if, after dossiers have been","evaluated in accordance with Article 8,","the evaluating competent authority has","submitted a recommendation for approval","of the new active substance and the","competent authorities which received the","application for the provisional","","authorisation or, in the case of a","provisional Union authorisation, the","Agency, consider that the biocidal product","may be expected to comply with points (b),","(c) and (d) of Article 18(1) taking into","account the factors set out in Article","18(2).","The competent authorities or the","Commission shall enter the information","referred to in Article 29(4) in the Register","for Biocidal Products.","If the Commission decides not to approve","the new active substance, the competent","authorities which granted the provisional","authorisation or the Commission shall","cancel that authorisation.","Where a decision on the approval of the","new active substance has not yet been","adopted by the Commission when the","period of three years expires, the","competent authorities which granted the","provisional authorisation, or the","Commission, may extend the provisional","authorisation for a period not exceeding","one year, provided that there are good","reasons to believe that the active","substance will satisfy the requirements of","Article 4(1) or, where applicable, Article","5(2). Competent authorities which extend","the provisional authorisation shall inform","the other competent authorities and the","Commission of such action.","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"253","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-105","justification":"Products for wine processing as referred to in Commission Regulation (EC) No 606/2009 of\n10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC)\nNo 479/2008 as regards the categories of grapevine products, oenological practices and the\napplicable restrictions should be excluded from the scope of the regulation by analogy with\nprocessing aids.","location":[[" Council position","Recital 21"]],"meps":[1929],"meta":{"created":"2019-07-03T05:28:40"},"new":["(21) Processing aids are covered by","existing Union legislation, in particular","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition and Regulation (EC)","No 1333/2008 of the European Parliament","and of the Council of 16 December 2008","on food additives. Wine processing","products are covered by Commission","Regulation (EC) No 606/2009 of 10 July","2009 laying down certain detailed rules","for implementing Council Regulation","(EC) No 479/2008 as regards the","categories of grapevine products,","oenological practices and the applicable","restrictions1. Therefore, it is appropriate to","exclude them from the scope of this","Regulation.","___________","1","OJ. L 193, 24.7.2009, p. 1."],"old":["(21) Processing aids are covered by","existing Union legislation, in particular","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition and Regulation (EC)","No 1333/2008 of the European Parliament","and of the Council of 16 December 2008","on food additives. Therefore, it is","appropriate to exclude them from the scope","of this Regulation."],"orig_lang":"de","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"105","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-254","justification":" Experiments or tests on unauthorised biocidal products that belong to an existing biocidal\n product family requiring only minor changes should not be subject to the conditions laid\n down in this Article.","location":[["Council position","Article 55 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:40"},"new":["1. By way of derogation from Article 17,","an experiment or a test for the purposes of","research or development involving a new","biocidal product which cannot be deemed","to be a minor change to a product that has","already been authorised, or a non-","approved active substance intended","exclusively for use in a biocidal product","(\"experiment\" or \"test\") may take place","only under the conditions laid down in this","Article."],"old":["1. By way of derogation from Article 17,","an experiment or a test for the purposes of","research or development involving an","unauthorised biocidal product or a non-","approved active substance intended","exclusively for use in a biocidal product","(\"experiment\" or \"test\") may take place","only under the conditions laid down in this","Article."],"orig_lang":"fr","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"254","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-255","justification":"While it is important to maintain a record of the names and addresses of consumers, it is not\nfeasible to supply these details in advance, particularly given that this article concerns\nrelease into the environment rather than human health.","location":[[" Council position","Article 55 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:40"},"new":["2. Any person intending to carry out an","experiment or test that may involve, or","result in, release of the biocidal product","into the environment shall first notify the","relevant competent authority of the","Member State where the experiment or test","will occur. The notification shall include","the identity of the biocidal product or","active substance, labelling data and","quantities supplied. The person concerned","shall also compile a dossier containing all","available data on possible effects on","human or animal health or impact on the","environment. They shall make this","information available to the competent","authorities on request."],"old":["2. Any person intending to carry out an","experiment or test that may involve, or","result in, release of the biocidal product","into the environment shall first notify the","relevant competent authority of the","Member State where the experiment or test","will occur. The notification shall include","the information listed in the second","subparagraph of paragraph 1.","",""],"orig_lang":"fr","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"255","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-106","justification":" We do not support that a national authorisation granted in accordance with Chapter IVA \u2013\n the simplified authorisation procedure \u2013 can be placed on the market in all Member States\n without the need for mutual recognition. Instead we suggest that products authorised under\n the simplified procedure should have a Union authorisation with a lower fee.","location":[["Council position","Recital 28"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:40"},"new":["(28) To encourage the use of products with","a more favourable environmental or human","health profile, it is appropriate to provide","for simplified authorisation procedures for","such biocidal products."],"old":["(28) To encourage the use of products with","a more favourable environmental or human","","health profile, it is appropriate to provide","for simplified authorisation procedures for","such biocidal products. Once authorised in","at least one Member State, those products","should be allowed to be made available on","the market in all Member States without","the need for mutual recognition, under","certain conditions."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-256","justification":"While it is necessary to exclude from the scope of this chapter the abovementioned treated\narticles, this exclusion should apply in a general manner to all articles where the sole\ntreatment was fumigation or disinfection and where no residues are expected to remain\nregardless of the object of the treatment.","location":[["Council position","Article 57 \u2013 paragraph 1"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:40"},"new":["1. This Article shall apply exclusively to","treated articles within the meaning of","Article 3(1)(l) that are not biocidal","products within the meaning of Article","3(1)(a). It shall not apply to treated articles","where the sole treatment undertaken was","fumigation or disinfection and where no","residues are expected to remain from such","treatment."],"old":["1. This Article shall apply exclusively to","treated articles within the meaning of","Article 3(1)(l) that are not biocidal","products within the meaning of Article","3(1)(a). It shall not apply to treated articles","where the sole treatment undertaken was","the fumigation or disinfection of premises","or containers used for storage or","transport and where no residues are","expected to remain from such treatment."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"256","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jolanta Emilia Hibner, Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-107","justification":"Referring to Recital 29 of the Regulation, there is no category that can include denatonium\nbenzoate. Therefore, we propose to add one more group \u2018aversive agents\u2019. It is\na narrow group of substances used in cosmetics in very low concentrations, in which are not\nharmful to human and the environment.","location":[[" Council position","Recital 29"]],"meps":[96753,28299],"meta":{"created":"2019-07-03T05:28:40"},"new":["(29) To identify biocidal products which","are eligible for simplified authorisation","procedures, it is appropriate to establish a","specific list of the active substances that","those products may contain. That list","should, initially, contain substances","identified as presenting a low risk under","Regulation (EC) No 1907/2006 or","Directive 98/8/EC, substances identified as","food additives, pheromones and other","substances considered to have low toxicity,","such as weak acids, alcohols, aversive","agents and vegetable oils used in cosmetics","and food."],"old":["(29) To identify biocidal products which","are eligible for simplified authorisation","procedures, it is appropriate to establish a","specific list of the active substances that","those products may contain. That list","should, initially, contain substances","identified as presenting a low risk under","Regulation (EC) No 1907/2006 or","Directive 98/8/EC, substances identified as","food additives, pheromones and other","substances considered to have low toxicity,","such as weak acids, alcohols and vegetable","oils used in cosmetics and food."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"107","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-257","justification":" Member States or the Commission are allowed to prohibit or restrict the making available\n and use of biocidal product containing an active substance candidate for substitution (Article\n 22). There is also the need to make provisions to be able to do the same on treated articles.","location":[[" Council position","Article 57 \u2013 paragraph 2 a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:40"},"new":["2 a. Member States, or where appropriate","the Commission, may prohibit or restrict","the making available on the market or the","use of a treated article if an active","substance contained in the biocidal","product that it was treated with or","incorporates is a candidate for","substitution in accordance with Article","10(1)."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"257","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-258","justification":"The current wording remains unclear, e.g. in the case of non-biocidal products treated with\nin-can preservatives. Such preservatives, designed to avoid product deterioration and\nbacterial growth in non-biocidal products during storage may be seen as \u201cintended to be\nreleased\u201d when the non-biocidal product is used for non-biocidal purposes. The definition of\ntreated articles also covers substances and mixtures. Overlap with other legislation should be\navoided.","location":[[" Council position","Article 57 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:41"},"new":["3. Where, in order to exert a biocidal","effect with the exception of in-can","preservatives, the release of the active","substances contained in the biocidal","products with which a treated article was","treated or which it incorporates, is intended","or expected under normal or reasonably","foreseeable conditions of use, the person","responsible for the placing on the market of","that treated article shall ensure that the","label provides the following information:"],"old":["3. Where the release of the active","substances contained in the biocidal","products with which a treated article was","treated or which it incorporates, is intended","or expected under normal or reasonably","foreseeable conditions of use, the person","responsible for the placing on the market of","that treated article shall ensure that the","label provides the following information:"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"258","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rolandas Paksas","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-108","location":[["Council position","Recital 52"]],"meps":[96694],"meta":{"created":"2019-07-03T05:28:40"},"new":["(52) To enable consumers to make","informed choices, to facilitate enforcement","and to provide an overview of their use,","treated articles should be appropriately","labelled. Detailed labelling should take","place only where it is useful to the","consumer. All known information should","be kept in databanks and on the internet","and made available to consumers,","particularly when they need to call on the","aid of professionals (e.g. poison centres,","doctors etc.)"],"old":["(52) To enable consumers to make","informed choices, to facilitate enforcement","and to provide an overview of their use,","treated articles should be appropriately","labelled."],"orig_lang":"lt","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"108","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-259","justification":"Council has introduced two different bases for labelling - they hinge on whether the biocidal\nproduct is intended/expected to be released or not. However, especially the notion of an\n\"expectation\" is subjective and thus not a suitable basis for labelling. Any article that\ncontains an active substance with a hazard classification, that is a PBT, vPvB or an\nendocrine disrupter should be labelled. This also clarifies that only those articles that still\n\n contain a biocidal product need to be labelled.","location":[["Council position","Article 57 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:41"},"new":["3. Where the release of the active","substances contained in the biocidal","products with which a treated article was","treated or which it incorporates, is intended","under normal or reasonably foreseeable","conditions of use, or where the active","substance contained in the biocidal","product with which a treated article was","treated, or which it incorporates, is","classified or meets the criteria for","classification in accordance with","Regulation (EC) No 1272/2008, or meets","the criteria of Article 5(1)(d) or (e), the","person responsible for the placing on the","market of that treated article shall ensure","that the label provides the following","information:","Or. en","(Attempt to find a compromise between Council and Parliament.)"],"old":["3. Where the release of the active","substances contained in the biocidal","products with which a treated article was","treated or which it incorporates, is intended","or expected under normal or reasonably","foreseeable conditions of use, the person","responsible for the placing on the market of","that treated article shall ensure that the","label provides the following information:","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"259","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rolandas Paksas","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-109","location":[["Council position","Recital 62"]],"meps":[96694],"meta":{"created":"2019-07-03T05:28:40"},"new":["(62) The costs of the procedures associated","with the operation of this Regulation need","to be recovered from those making biocidal","products available on the market and those","seeking to do so in addition to those","supporting the approval of active","substances. To promote the smooth","operation of the internal market, it is","appropriate to establish certain common","principles applicable both to fees payable","to the Agency and to Member States'","competent authorities, including the need","to take into account, as appropriate, the","specific needs of SMEs. In particular, fees","should be as transparent as possible and","should reflect the various steps and","procedures needing to be taken in the","course of the assessment. They should","also be proportionate to the amount of","work required and should only be levied","where necessary."],"old":["(62) The costs of the procedures associated","with the operation of this Regulation need","to be recovered from those making biocidal","products available on the market and those","seeking to do so in addition to those","supporting the approval of active","substances. To promote the smooth","","operation of the internal market, it is","appropriate to establish certain common","principles applicable both to fees payable","to the Agency and to Member States'","competent authorities, including the need","to take into account, as appropriate, the","specific needs of SMEs."],"orig_lang":"lt","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"109","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-260","justification":" In light of the lack of knowledge about the effects of nanomaterials in biocidal products, any\n article that has been treated with a biocidal product that contains nanomaterials and still\n contains this nanomaterial should be explicitly labelled to allow for an informed consumer\n choice.","location":[[" Council position","Article 57 \u2013 paragraph 3 \u2013 point c a (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:41"},"new":["(c a) the name of all nanomaterials being","followed by the word \"nano\" in brackets;","Or. en","(Partial reinstatement of amendment 62 from first reading.)"],"old":["","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"260","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-110","justification":"It should be clear that the purpose of protecting both human and animal health and the\nenvironment is at an equal level as the purpose of the functioning of the internal market, and\nnot just an ancillary purpose.","location":[[" Council position","Article 1 \u2013 paragraph 1"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:40"},"new":["1. The purpose of this Regulation is to","ensure a high level of protection of both","human and animal health and the","environment and to improve the","functioning of the internal market through","the harmonisation of the rules on the","making available on the market and the use","of biocidal products. The provisions of this","Regulation are underpinned by the","precautionary principle, in order to ensure","that active substances or products placed","on the market do not have harmful effects","on humans, non-target species and the","environment. Special attention shall be","paid to protecting children, pregnant","women and the sick.","Or. en","(Reinstatement of amendment 341 from first reading.)"],"old":["1. The purpose of this Regulation is to","improve the functioning of the internal","market through the harmonisation of the","rules on the making available on the","market and the use of biocidal products,","whilst ensuring a high level of protection","of both human and animal health and the","environment. The provisions of this","Regulation are underpinned by the","precautionary principle, the aim of which","is to safeguard the health of humans,","animals and the environment.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-261","justification":"The current wording remains unclear, e.g. in the case of non-biocidal products treated with\nin-can preservatives. Such preservatives, designed to avoid product deterioration and\nbacterial growth in non-biocidal products during storage may be seen as \u201cintended to be\nreleased\u201d when the non-biocidal product is used for non-biocidal purposes. The definition of\ntreated articles also covers substances and mixtures. Overlap with other legislation should be\navoided.","location":[[" Council position","Article 57 \u2013 paragraph 3 \u2013 subparagraph 1a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:41"},"new":["Points (a) to (c) of subparagraph 1 shall","not apply where labelling requirements","for biocidal products or alternative means","to meet information requirements","concerning those active substances","already exist under sector-specific","legislation."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"261","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-111","location":[["Council position","Article 2 \u2013 paragraph 2 \u2013 introductory part"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:40"},"new":["2. This Regulation shall not apply to those","functions of biocidal products or treated","articles that are within the scope of the","following instruments for the purposes of","these instruments:"],"old":["2. Subject to any explicit provision to the","contrary in this Regulation or other Union","legislation, this Regulation shall not apply","to biocidal products or treated articles that","are within the scope of the following","instruments:"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"111","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-112","justification":" Materials and articles intended to come into contact with food, including any biocidal\n products linked to such materials, are already covered by Regulation (EC) No 1935/2004. In\n order to avoid duplication of assessment and legislation, and to avoid legal uncertainty\n concerning the interaction of two assessment systems, materials and articles intended to come\n into contact with food should be excluded from the scope of the regulation. Regulation (EC)\n No 1935/2004 guarantees a sufficient level of safety and, where there is a need to amend the\n rules governing materials and articles intended to come into contact with food, such\n amendments should be made by means of a revision of Regulation (EC) No 1935/2004, and\n not by extending the scope of this regulation on biocidal products.","location":[["Council position","Article 2 \u2013 paragraph 2 \u2013 point j a (new)"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:40"},"new":["j (a) Regulation (EC) No 1935/2004 of the","European Parliament and of the Council","of 27 October 2004 on materials and","articles intended to come into contact with","food1.","__________________","1","OJ L 338, 13.11.2004, p. 4."],"orig_lang":"fr","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-113","justification":" Food contact materials are already regulated by Regulation 1935/2004, including biocides.\n In order to avoid dual assessments and double legislation, as well as assuring legal certainty,\n food contact materials should be excluded from the scope of this regulation. Regulation\n 1935/2004 provides a sufficient level of safety, and should any changes be required to the\n rules governing food contact materials, these should be addressed through revision of\n Regulation 1935/2004, and not by extending the scope of the biocidal products regulation.","location":[[" Council position","Article 2 \u2013 paragraph 2 \u2013 point j a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:40"},"new":["(j a) Regulation (EC) No 1935/2004 of the","European Parliament and of the Council","of 27 October 2004 on materials and","articles intended to come into contact with","food. 1","__________________","1","OJ L 338, 13.11.2004, p. 4."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-114","justification":"New text from Council. There is a separate regulation for plant protection products. This\nregulation cannot replace it, otherwise there risks to be double standards in light of the\nslightly diverging provisions of the two regulations.","location":[["Council position","Article 2 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:41"},"new":["deleted"],"old":["Notwithstanding point (i), this Regulation","shall apply to biocidal products that are","intended to be used both as biocidal","products and plant protection products."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"114","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-262","justification":"This is no longer necessary if the amendment to Art. 57(3) by the same authors is adopted.","location":[["Council position","Article 57 \u2013 paragraph 4"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:41"},"new":["deleted","Or. en","(Linked to the amendment by the same authors to Art. 57(3))"],"old":["4. Where the release of the active","substances contained in the biocidal","products with which a treated article was","treated or which it incorporates, is not","intended or expected under normal or","reasonably foreseeable conditions of use,","the person responsible for the placing on","the market of the treated article shall","ensure that the label provides the","following information:","(a) a statement that the treated article was","treated with biocidal products; and","(b) the address of a website containing the","name of all active substances used for the","treatment, without prejudice to Article 24","of Regulation (EC) No 1272/2008.","The label of such a treated article shall","not lay claim to any biocidal property.","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"262","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-115","location":[["Council position","Article 2 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:41"},"new":["Notwithstanding point (i), this Regulation","shall apply to biocidal products that are to","be used both as biocidal product and for a","purpose within the scope of one of these","instruments."],"old":["Notwithstanding point (i), this Regulation","shall apply to biocidal products that are","intended to be used both as biocidal","products and plant protection products."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"115","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-116","justification":" Products for wine processing as referred to in Commission Regulation (EC) No 606/2009 of\n 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC)\n No 479/2008 as regards the categories of grapevine products, oenological practices and the\n applicable restrictions should be excluded from the scope of the regulation by analogy with\n processing aids.","location":[["Council position","Article 2 \u2013 paragraph 5 \u2013 point b"]],"meps":[1929],"meta":{"created":"2019-07-03T05:28:41"},"new":["b) processing aids and wine processing","products that are used as biocidal products."],"old":["(b) processing aids that are used as biocidal","products.",""],"orig_lang":"de","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"116","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-263","justification":" Overlap with other legislation should be avoided. For instance, the Detergents Regulation\n (EC) No 648/2004 requires in its Annex VII Part A labelling of ingredients used in detergents,\n in particular preservatives must be listed irrespective of their concentration with their INCI\n names (INCI: International Nomenclature Cosmetic Ingredients).","location":[[" Council position","Article 57 \u2013 paragraph 4 \u2013 subparagraph 2 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:41"},"new":["This paragraph shall not apply where","labelling requirements for biocidal","products or alternative means to meet","information requirements concerning","those active substances already exist","under sector-specific legislation."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"263","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Horst Schnellhardt","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-117","justification":" To secure effective animal disease control in the event of an outbreak or suspected outbreak\n of an animal disease it is crucial to have substances to combat the pathogen, which may in\n some cases also be dangerous to humans, available quickly and in sufficient quantities. Crisis\n planning documents list substances particularly suited to this purpose, such as caustic lime,\n sodium hydroxide, formaldehyde and various organic acids, which have proved their value\n over many decades in combating animal diseases.","location":[[" Council position","Article 2 \u2013 paragraph 8"]],"meps":[1930],"meta":{"created":"2019-07-03T05:28:41"},"new":["(8) Member States may allow for","exemptions from this Regulation in","specific cases for certain biocidal products,","on their own or in a treated article, where","necessary in the interests of defence or of","animal disease control."],"old":["(8) Member States may allow for","exemptions from this Regulation in","specific cases for certain biocidal products,","on their own or in a treated article, where","necessary in the interests of defence."],"orig_lang":"de","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"117","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-264","justification":"New text by the Council. The Commission should review the approval of an active substance\nas soon as there are significant indications of non-compliance, not only when there are\nserious indications.","location":[[" Council position","Article 57 \u2013 paragraph 7"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:41"},"new":["7. Where there are significant indications","that an active substance contained in a","biocidal product with which a treated","article is treated or which it incorporates","does not meet the conditions laid down in","Article 4(1), 5(2) or 24, the Commission","shall review the approval of that active","substance or its inclusion in Annex I in","accordance with Article 15(1) or 27(2).","Or. en"],"old":["7. Where there are serious indications that","an active substance contained in a biocidal","product with which a treated article is","treated or which it incorporates does not","meet the conditions laid down in Article","4(1), 5(2) or 24, the Commission shall","review the approval of that active","substance or its inclusion in Annex I in","accordance with Article 15(1) or 27(2).","","","(Amendment in line with part of amendment 74 of first reading in a modified form.)"],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"264","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-118","justification":"While \u2018primary\u2019 is relevant for articles because of the large variety of items having multiple\nfunctions, in the case of substances and mixtures, it is appropriate to delete the word\n\u2018primary\u2019. The wording \u2018primary intention\u2019 could introduce a loophole for certain types of\napplications, such as cleaning, disinfecting, etc.","location":[[" Council position","Article 3 \u2013 paragraph 1 \u2013 point a"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:41"},"new":["(a) 'biocidal product' means any substance,","mixture or article, in the form in which it is","supplied to the user, consisting of,","containing or generating one or more","active substances, with the intention,","except in the case of articles, where","primary intention is required, of","destroying, deterring, rendering harmless,","preventing the action of, or otherwise","exerting a controlling effect on, any","harmful organism by any means other than","mere physical or mechanical action;"],"old":["(a) \u2018biocidal product\u2019 means any substance,","mixture or article, in the form in which it is","supplied to the user, consisting of,","containing or generating one or more","active substances, with the primary","intention of destroying, deterring,","rendering harmless, preventing the action","of, or otherwise exerting a controlling","effect on, any harmful organism by any","means other than mere physical or","mechanical action;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"118","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-265","justification":"Since Article 59 extends data protection to data submitted under Directive 98/8/EC they\nshould benefit from the same level of protection in all respects.","location":[["Council position","Article 58 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:41"},"new":["1. Without prejudice to Articles 61 and 62,","data submitted for the purposes of","Directive 98/8/EC or of this Regulation","shall not be used by competent authorities","or the Agency for the benefit of a","subsequent applicant, except where:"],"old":["1. Without prejudice to Articles 61 and 62,","data submitted for the purposes of this","Regulation shall not be used by competent","authorities or the Agency for the benefit of","a subsequent applicant, except where:"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"265","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kathleen Van Brempt","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-119","justification":" The reference to \u2018primary intention\u2019 for all biocidal products could introduce a loophole for\n certain types of applications, in the sense that a number of products would fall outside the\n scope of the regulation. For example, a disinfecting product could be interpreted as having\n primarily a cleaning action, and only secondarily a disinfecting one. Splitting the definition\n into two parts avoids to extend the tension between \u2018primary \u2013 secondary function\u2019 to all\n biocidal products and limits it to treated articles.","location":[["Council position","Article 3 \u2013 paragraph 1 \u2013 point a"]],"meps":[5729],"meta":{"created":"2019-07-03T05:28:41"},"new":["(a) \u2018biocidal product\u2019 means any substance,","mixture or article, in the form in which it is","supplied to the user, consisting of,","containing or generating one or more","active substances, with the intention of","destroying, deterring, rendering harmless,","preventing the action of, or otherwise","exerting a controlling effect on, any","harmful organism by any means other than","mere physical or mechanical action;","A treated article that has a primary","biocidal function shall be considered as a","biocidal product."],"old":["(a) \u2018biocidal product\u2019 means any substance,","mixture or article, in the form in which it is","supplied to the user, consisting of,","containing or generating one or more","active substances, with the primary","intention of destroying, deterring,","rendering harmless, preventing the action","of, or otherwise exerting a controlling","effect on, any harmful organism by any","means other than mere physical or","mechanical action;",""],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"119","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-266","justification":" Point a) should include that the letter of access has to be submitted to the authorities in order\n to be used for the benefit of a subsequent applicant.","location":[["Council position","Article 58 \u2013 paragraph 1 \u2013 point a"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:41"},"new":["(a) the subsequent applicant has and","submits a letter of access; or"],"old":["(a) the subsequent applicant has a letter of","access; or"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"266","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-267","justification":" In order to ensure transparency of negotiations between prospective applicants and data\n owners and avoid free-ridership, the Agency shall determine whether technical equivalence\n can be established between the product of the data submitter (s) and of the prospective\n applicant or not. The data submitter (s) shall be informed of this equivalence before the\n prospective applicant is granted the possibility to request from the data owner the scientific\n and technical data.","location":[[" Council position","Article 61 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meta":{"created":"2019-07-03T05:28:41"},"new":["2. Any person intending to perform tests or","studies involving vertebrate animals or","non-vertebrate animals, (\"the prospective","applicant\"), shall submit a written request","to the Agency to determine whether such","tests or studies have already been","submitted to the Agency, or to a competent","authority in connection with a previous","application under this Regulation or","Directive 98/8/EC for an identical or","technically equivalent product. The","Agency shall verify whether such tests or","studies have already been submitted."],"old":["2. Any person intending to perform tests or","studies involving vertebrate animals or","non-vertebrate animals (\u2018the prospective","applicant\u2019) shall ask the Agency whether","such tests or studies have already been","submitted in connection with a previous","application under this Regulation or","Directive 98/8/EC. The competent","authority or the Agency shall verify","whether such tests or studies have already","been submitted."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"267","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-120","justification":" We find that all treated materials and articles that emit a biocide in order to control harmful\n organisms in their surroundings shall still be considered biocidal products.","location":[[" Council position","Article 3 \u2013 paragraph 1 \u2013 point a"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:41"},"new":["(a) 'biocidal products' means substances,","mixtures or articles, in the form in which","they are supplied to the user, consisting of,","containing or being the precursor for one","or more active substances, with the","intention of destroying, deterring,","rendering harmless, preventing the action","of, or otherwise exerting a controlling","effect on, any harmful organism by any","means other than mere physical or","mechanical action;"],"old":["(a) \u2018biocidal product\u2019 means any","substance, mixture or article, in the form","in which it is supplied to the user,","consisting of, containing or generating one","or more active substances, with the","primary intention of destroying, deterring,","rendering harmless, preventing the action","of, or otherwise exerting a controlling","effect on, any harmful organism by any","means other than mere physical or","mechanical action;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"120","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-268","justification":"In order to ensure transparency of negotiations between prospective applicants and data\nowners and avoid free-ridership, the Agency shall determine whether technical equivalence\ncan be established between the product of the data submitter (s) and of the prospective\napplicant or not. The data submitter (s) shall be informed of this equivalence before the\nprospective applicant is granted the possibility to request from the data owner the scientific\nand technical data.","location":[[" Council position","Article 61 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meta":{"created":"2019-07-03T05:28:41"},"new":["Where such tests or studies have already","been submitted to the Agency, or to a","competent authority in connection with a","previous application, under this Regulation","or Directive 98/8/EC, the Agency shall,","without delay, communicate the name and","contact details of the prospective applicant","as well as the outcome of the technical","equivalence verification to the data","submitter(s) and communicate the name","and contact details of the data","submitter(s) to the prospective applicant."],"old":["Where such tests or studies have already","been submitted in connection with a","previous application, under this Regulation","or Directive 98/8/EC, the competent","authority or the Agency shall, without","delay, communicate the name and contact","details of the data owner to the prospective","applicant."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"268","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-121","justification":"Where there is no harmonised classification, companies have to classify their substances\nthemselves. It is therefore important to also refer to \"meeting the criteria for classification\",\nand not just to the actual classification. This is the standard approach and had also been\nfollowed by the Commission in its proposal.","location":[["Council position","Article 3 \u2013 paragraph 1 \u2013 point (f) \u2013 subparagraph 2 \u2013 indent 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:41"},"new":["\u2013 a substance classified as dangerous or","meeting the criteria to be classified as","dangerous according to Directive","67/548/EEC, and present in the biocidal","product at a concentration leading the","product to be regarded as dangerous within","the meaning of Articles 5, 6 and 7 of","Directive 1999/45/EC, or","Or. en","(Reinstatement of the Commission text.)"],"old":["\u2013 a substance classified as dangerous","according to Directive 67/548/EEC, and","present in the biocidal product at a","concentration leading the product to be","regarded as dangerous within the meaning","of Articles 5, 6 and 7 of Directive","1999/45/EC, or","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"121","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-269","justification":" In order to ensure transparency of negotiations between prospective applicants and data\n owners and avoid free-ridership, the Agency shall determine whether technical equivalence\n can be established between the product of the data submitter (s) and of the prospective\n applicant or not. The data submitter (s) shall be informed of this equivalence before the\n prospective applicant is granted the possibility to request from the data owner the scientific\n and technical data.","location":[["Council position","Article 61 \u2013 paragraph 2 \u2013 subparagraph 3 \u2013 points a and b"]],"meta":{"created":"2019-07-03T05:28:41"},"new":["(a) shall, in the case of data involving tests","on vertebrate animals; and","(b) may, in the case of data not involving","tests on vertebrate animals, request from","the data owner(s),","all the scientific and technical data related","to the tests and studies concerned as well","as the right to refer to these data when","submitting applications within the","framework of this Regulation."],"old":["(a) shall, in the case of data involving tests","on vertebrate animals, request from the","data owner the right to refer to those tests","or studies; and","(b) may, in the case of data not involving","tests on vertebrate animals, request from","the data owner the right to refer to those","tests or studies.",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"269","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-270","justification":"R&D companies invest large amounts of resources (human and financial) on tests and studies\nto develop new and innovative products over many years. In order to boost innovation, these\ninvestments should be protected in the new regulation in order to avoid free ridership. An\nextension from 4 to 6 months as maximum period before the prospective applicant can obtain\nthe data will incentive R&D companies to keep investing and will still be a reasonable timing\nfor prospective applicants.","location":[[" Council position","Article 62 \u2013 paragraph 3"]],"meta":{"created":"2019-07-03T05:28:41"},"new":["3. Where no agreement is reached with","respect to tests and studies involving","vertebrate animals, the prospective","applicant shall inform the Agency and the","data owner(s) thereof at the earliest two","months after receipt, from the Agency, of","the name and address of the data","submitter(s). Within 120 days of being","informed, the Agency shall give the","prospective applicant permission to refer to","the requested tests and studies involving","vertebrate animals provided that the","prospective applicant demonstrates that it","has paid the data owner(s) for these tests","and studies a share of costs incurred, and","that every effort has been made to reach","an agreement on the sharing of these tests","and studies. The data owner(s) shall have","a claim on the prospective applicant for a","proportionate share of the cost incurred by","it, which shall be enforceable before the","national courts."],"old":["3. Where no such agreement is reached","within 60 days of a request made","according to Article 61(2) with respect to","data involving tests on vertebrate animals,","the prospective applicant shall, without","delay, inform the Agency, competent","authority and the data owner accordingly.","Within 60 days of being informed about","the failure to reach an agreement, the","Agency shall give the prospective applicant","the right to refer to those tests or studies.","Where the prospective applicant and data","owner cannot agree, national courts shall","decide on the proportionate share of the","cost that the prospective applicant shall","pay to the data owner."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"270","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-122","justification":" Where there is no harmonised classification, companies have to classify their substances\n themselves. It is therefore important to also refer to \"meeting the criteria for classification\",\n and not just to the actual classification. This is the standard approach and had also been\n followed by the Commission in its proposal.","location":[["Council position","Article 3 \u2013 paragraph 1 \u2013 point (f) \u2013 subparagraph 2 \u2013 indent 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:41"},"new":["\u2013 a substance classified as hazardous or","meeting the criteria for classification as","hazardous according to Regulation (EC)","No 1272/2008, and present in the biocidal","product at a concentration leading the","product to be regarded as hazardous within","the meaning of that Regulation;","Or. en","(Reinstatement of the Commission text.)"],"old":["\u2013 a substance classified as hazardous","according to Regulation (EC) No","1272/2008, and present in the biocidal","product at a concentration leading the","product to be regarded as hazardous within","the meaning of that Regulation;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"122","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-271","justification":" There are too many products on the market which are of poor quality. This amendment to the\n Council\u2019s text reinforces the possibility to secure an efficient control of the quality of\n products, as it is foreseen in other legislations. Furthermore, this provision will help to\n stimulate innovation with a view to have safer products on the market.","location":[["Council position","Article 64 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meta":{"created":"2019-07-03T05:28:41"},"new":["In order to facilitate such enforcement,","manufacturers of biocidal products placed","on the Union market shall maintain a","suitable system of quality control of the","manufacturing process. To that end they","shall establish and maintain, as a","minimum, appropriate documentation in","paper or electronic format with respect to:","(a) the input of the ingredients to be","added to the biocidal product to include","specifications, manufacturing formulae","and safety data sheets which are relevant","to compliance and the safety of the","biocidal product to be placed on the","market;","(b) the various manufacturing operations","performed which are relevant to","compliance and safety of the biocidal","product to be placed on the market and","allow its traceability; and","c) data concerning the results of the","quality control and batch identification.","A Member State does not need to","undertake a system of official controls","where a company holds an internationally","recognised quality assurance certificate","(e.g. ISO9001) that includes an audit to","verify, as a minimum, that all of the above","elements have been maintained.","Where necessary in order to ensure","uniform application of this paragraph, the","Commission may adopt implementing acts","in accordance with the procedure referred","to in Article 81(3)\"."],"old":["In order to facilitate such enforcement,","manufacturers of biocidal products placed","on the Union market shall maintain a","suitable system of quality control of the","manufacturing process without causing","disproportionate administrative burden to","economic operators and Member States.",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"271","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-272","location":[[" Council position","Article 64 \u2013 paragraph 3 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:41"},"new":["Every three years, from \u202647 , Member","States shall submit to the Commission a","report on the implementation of this","Regulation in their respective territories.","The implementation reports shall be","published annually on the relevant","website of the Commission. The report","shall include:","Or. en","(Reinstatement of amendment 199 from first reading.)"],"old":["Every three years, from \u202647 , Member","States shall submit to the Commission a","report on the implementation of this","Regulation in their respective territories.","The report shall include:","","","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"272","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-273","location":[["Council position","Article 64 \u2013 paragraph 3 \u2013 subparagraph 1 \u2013 point b"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:41"},"new":["(b) information on any poisonings and,","where available, occupational diseases","involving biocidal products, especially","regarding vulnerable groups, and the","actions undertaken to lower the risk of","future cases.","Or. en","(Reinstatement of amendment 200 from first reading.)"],"old":["(b) information on any poisonings and,","where available, occupational diseases","involving biocidal products.","","","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"273","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-123","justification":" Non-active substances that are a POP, PBT or vPvB should be considered a substance of\n concern.","location":[[" Council position","Article 3 \u2013 paragraph 1 \u2013 point (f) - subparagraph 2 \u2013 indent 2 a (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:41"},"new":["- a substance which fulfils the criteria for","being a POP under Regulation (EC) No","850/2004, or which fulfils the criteria for","being persistent, bio-accumulative and","toxic (PBT) or very persistent and very","bio-accumulative (vPvB) in accordance","with Annex XIII of Regulation (EC) No","1907/2006;","Or. en","(Reinstatement of amendment 99 from first reading.)"],"old":["","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"123","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-274","location":[["Council position","Article 64 \u2013 paragraph 3 \u2013 subparagraph 1 \u2013 point b"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:41"},"new":["(b) information on any poisonings,","especially regarding vulnerable groups,","and the actions taken to lower the risk of","future cases, and, where available,","occupational diseases involving biocidal","products.","Or. en","(Reinstatement of amendment 200 from first reading.)"],"old":["(b) information on any poisonings and,","where available, occupational diseases","involving biocidal products.","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"274","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-124","justification":"The change of the definition is made in order to bring it in accordance with Article 20(2)(e)\nand to underline that also the non-active substances should be evaluated and specified in a\nproduct family. With the wording in the Council common position an applicant can change\nany non active substance in a formulation and this might result in a significant higher risk to\nhuman health and the environment. If e.g. a change in the composition of a fixative in a wood\npreservative is made then this might result in a higher leaching rate of the active substances\nfrom the treated wood to the environment and therefore result in a higher environmental risk.","location":[[" Council position","Article 3 \u2013 paragraph 1 \u2013 point s"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:41"},"new":["(s) 'biocidal product family' means a group","of biocidal products having similar uses,","the active substances of which have the","same specifications or a change in the","quantities of one or more of the non-","active substances and presenting specified","variations in their composition which do","not adversely affect the level of risk or","significantly reduce the efficacy of the","products;"],"old":["(s) \u2018biocidal product family\u2019 means a group","of biocidal products having similar uses,","the active substances of which have the","","same specifications, and presenting","specified variations in their composition","which do not adversely affect the level of","risk or significantly reduce the efficacy of","the products;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"124","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-275","location":[[" Council position","Article 64 \u2013 paragraph 3 \u2013 subparagraph 1 \u2013 point b a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:41"},"new":["(b a) information on the impact on the","environment.","Or. en","(Reinstatement of amendment 201 from first reading.)"],"old":["","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"275","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-276","location":[[" Council position","Article 64 \u2013 paragraph 4"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:42"},"new":["4. The Commission shall draw up a report","on the implementation of this Regulation,","in particular Article 57, by 1 January 2020","and every three years thereafter. The","Commission shall submit the report to the","European Parliament and to the Council.","Or. en","(Partial reinstatement of amendment 350 from first reading.)"],"old":["4. The Commission shall draw up a report","on the implementation of this Regulation,","in particular Article 57, by 1 January 2020.","The Commission shall submit the report to","the European Parliament and to the","Council.","","","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"276","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-277","justification":"As the Council has newly introduced the reference to a horizontal definition of nano materials\nthe European Parliament has not been able to address this in 1st reading.","location":[[" Council position","Article 64 \u2013 paragraph 4 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:42"},"new":["4a. The Commission shall review the","suitability of the definition of","nanomaterial for biocides as defined in","Article 3 (aa) within two years of the entry","into force of this Regulation and shall","report to the European Parliament and","the Council."],"old":[""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"277","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso, Andres Perello Rodriguez, Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-125","justification":"In light of the many on-going researches and developments in the area of nanotechnology, the\ndefinition will need to be regularly reviewed to encompass latest EU and International\nscientific experience and acquired knowledge.","location":[["Council position","Article 3 \u2013 paragraph 1 \u2013 point aa"]],"meps":[4319,96989,4326],"meta":{"created":"2019-07-03T05:28:41"},"new":["(aa) \u2018nanomaterial\u2019 means nanomaterial as","defined in Commission Recommendation","20../\u2026/EC of \u2026 \u2026 \u2026 concerning the","definition of nanomaterials;","The Commission shall regularly review","and update the definition in light of latest","advances in technical and scientific","development."],"old":["(aa) \u2018nanomaterial\u2019 means nanomaterial as","defined in Commission Recommendation","20../\u2026/EC of \u2026 \u2026 \u2026 concerning the","definition of nanomaterials;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"125","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-278","location":[["Council position","Article 64 \u2013 paragraph 4 a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:42"},"new":["4 a. Not later than five years after the","entry into force of this Regulation, the","Commission shall draw up a report on the","impact of the spread of biocidal products","in the environment. The Commission","shall submit the report to the European","Parliament and the Council.","Or. en","(Reinstatement of amendment 204 from first reading.)"],"old":["","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"278","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-126","justification":" The definition of nanomaterials is an essential element of the regulation and thus needs to be\n adopted by the legislator. The discussions over the definition have been highly controversial\n within the Commission and the outcome is unclear. It is thus inappropriate to give the\n Commission a \"carte blanche\" for whatever definition they come up with.","location":[[" Council position","Article 3 \u2013 paragraph 1 \u2013 point aa"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:41"},"new":["(aa) \"nanomaterial\" means any","intentionally produced material that has","one or more dimensions of the order of","100 nm or less or is composed of discrete","functional parts, either internally or at the","surface, many of which have one or more","dimensions of the order of 100 nm or less,","including structures, agglomerates or","aggregates, which may have a size above","the order of 100 nm but retain properties","that are characteristic of the nanoscale.","Properties that are characteristic of the","nanoscale include:","(i) those related to the large specific","surface area of the materials considered;","and/or","(ii) specific physico-chemical properties","that are different from those of the non-","nanoform of the same material.","No later than six months after the","adoption of Recommendation 20../\u2026/EC","of \u2026 \u2026 concerning the definition of","nanomaterials , the Commission shall","make a legislative proposal to include the","definition in this Regulation.","Or. en","(Partial reinstatement of amendment 34 of first reading.)"],"old":["(aa) \u2018nanomaterial\u2019 means nanomaterial as","defined in Commission Recommendation","20../\u2026/EC of \u2026 \u2026 \u2026 concerning the","definition of nanomaterials;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"126","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-279","justification":" Nanomaterials fall within the scope of the Regulation. However, a proper assessment may\n well lack the necessary methods. There should be full transparency about how this Regulation\n deals with nanomaterials. As such, there should be a dedicated Commission report on the\n matter.","location":[["Council position","Article 64 \u2013 paragraph 4 a (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["4 a. At the latest two years after the entry","into force of this Regulation, the","Commission shall submit to the European","Parliament and Council a report on the","assessment of the risks to human health","and the environment presented by the use","of nanomaterials in biocidal products and","on specific measures to be taken with","regard to them.","Or. en","(Reinstatement of amendment 203 from first reading.)"],"old":["","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"279","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-127","justification":"The Council text is inexact, it is important to define \"major change\" more precisely.","location":[["Council position","Article 3 \u2013 paragraph 1 \u2013 point ad"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:41"},"new":["(ad) \u2018major change\u2019 means an amendment","of an existing authorisation requiring a full","or substantial re-evaluation of the risk","assessment of the biocidal product or","biocidal product family;"],"old":["(ad) \u2018major change\u2019 means an amendment","of an existing authorisation which is","neither an administrative change nor a","minor change;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"127","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-280","justification":" The precise use, function or application of a substance or mixture are confidential\n information and they should not be disclosed in order to protect commercial interests.","location":[[" Council position","Article 65 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point ba (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:42"},"new":["(ba) the precise use, function or","application of a substance or mixture;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"280","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-281","justification":"Name of active substances supplier and biocidal product\u2019s manufacturing site are\nconfidential business information that should not be disclosed in order to protect commercial\ninterests. The address of a biocidal product manufacturing site does not provide useful\ninformation to the public.","location":[[" Council position","Article 65 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point c a (new)"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["(c a) names and addresses of","manufacturers of the active substances,","including location of manufacturing sites;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"281","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-128","justification":" Active substances should continue to be included in an Annex to the Regulation. The\n approach proposed by Council would deprive Parliament of its control rights, which is not\n acceptable. Moreover, it is inconsistent with the analogous provision in Article 27 for the\n inclusion of active substances under the simplified procedure, which would continue to be\n adopted by way of delegated acts. Active substances that fall under Article 5 should have a\n shorter period for the inclusion in Annex I.","location":[["Council position","Article 4 \u2013 paragraph 1"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["1. An active substance shall be included in","Annex -I for an initial period not","exceeding 10 years if at least one biocidal","product containing that active substance","fulfils the conditions laid down in point (b)","of Article 18(1) taking into account the","factors set out in Article 18(2) and (5). An","active substance referred to in Article 5","may only be included in Annex I for an","initial period of 5 years.","(Note: This amendment applies throughout","the text. If adopted, reference to \"approval","of an active substance\" is to be replaced by","reference to \"inclusion of an active","substance in Annex -I\", reference to","\"approval\" by \"inclusion in Annex -I\",","reference to \"approved\" by \"included in","Annex -I\" etc. throughout the text.)","Or. en","(Reinstatement of amendment 39 from first reading.)"],"old":["1. An active substance shall be approved","for an initial period not exceeding 10 years","if at least one biocidal product containing","that active substance may be expected to","meet the criteria laid down in point (b) of","Article 18(1) taking into account the","factors set out in Article 18(2) and (5).","","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"128","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-282","justification":"Name of active substances supplier and biocidal product\u2019s manufacturing site are\nconfidential business information that should not be disclosed in order to protect commercial\ninterests. The address of a biocidal product manufacturing site does not provide useful\ninformation to the public.","location":[["Council position","Article 65 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point c b (new)"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["(c b) the location of a biocidal product","manufacturing site;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"282","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-129","justification":"It is not sufficient to refer to the candidate list of REACH to determine endocrine disrupters,\nas this is not a comprehensive scientific process, but one led by political priorities. So far,\nonly one substance has been proposed to be identified pursuant to Art. 57(f). Endocrine\ndisrupters should also be those that are identified on the basis of agreed test guidelines or\nother available information reviewed by the Agency in line with the provisions of the PPP\nregulation (Annex II, point 3.6.5).","location":[[" Council position","Article 5 \u2013 paragraph 1 \u2013 point d"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["(d) active substances which, on the basis","of the assessment of Union or","internationally agreed test guidelines or","other peer-reviewed scientific data and","information, including a review of the","scientific literature, reviewed by the","Agency, are considered as having","endocrine-disrupting properties that may","cause adverse effect in humans, or which","are identified in accordance with Articles","57(f) and 59(1) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties.","Or. en","(Reinstatement of part of amendment 44 from first reading.)"],"old":["(d) active substances identified in","accordance with Articles 57(f) and 59(1) of","Regulation (EC) No 1907/2006 as having","endocrine disrupting properties;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"129","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-283","justification":" This information is confidential and should not be disclosed in order to protect commercial\n interests.","location":[["Council position","Article 65 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point da (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:42"},"new":["(da) names and addresses of","manufacturers of the active substances,","including location of manufacturing sites;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"283","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-130","justification":"The amendment reinstates the Parliament's position in first reading and provides for more\nclarity. Risk mitigation measures are needed in order to protect human health, as well as the\nenvironment.","location":[["Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 introductory part"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["The active substances referred to in","paragraph 1 may be included in Annex I","only if at least one of the following","conditions is met:"],"old":["Without prejudice to Article 4(1), active","substances referred to in paragraph 1 of","this Article may be approved if it is shown","that at least one of the following conditions","is met:"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"130","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-284","justification":" This is a confidential information and it should not be disclosed in order to protect\n commercial interests.","location":[[" Council position","Article 65 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point db (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:42"},"new":["db) the location of a biocidal product's","manufacturing site."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"284","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-131","justification":" The term \"negligible exposure\" should be clearly defined to avoid any loopholes. The wording\n chosen here comes from the PPP regulation (Annex II, point 3.6.3).","location":[["Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["(a) the risk to humans or the environment","from exposure to the active substance in a","biocidal product, under realistic worst case","conditions of use, is negligible, meaning","that the product is used in closed systems","or under other conditions excluding","contact with humans;","Or. en","(Reinstatement of part of amendment 44 from first reading.)"],"old":["(a) the risk to humans or the environment","from exposure to the active substance in a","biocidal product, under realistic worst case","conditions of use, is negligible, in","particular where the product is used in","","closed systems or strictly controlled","conditions;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"131","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-285","location":[[" Council position","Article 65 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:42"},"new":["However, where urgent action is essential","to protect human health, safety or the","environment or for other reasons of","overriding public interest, the Agency or","the competent authorities shall disclose the","information referred to in this paragraph","with the exception of point (d)."],"old":["However, where urgent action is essential","to protect human health, safety or the","environment or for other reasons of","","overriding public interest, the Agency or","the competent authorities shall disclose the","information referred to in this paragraph."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"285","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-132","justification":" The amendment reinstates the Parliament's position in first reading and provides for more\n clarity. Risk mitigation measures are needed in order to protect human health, as well as the\n environment.","location":[[" Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["(a) the exposure of humans or to the","environment to the active substance in","question in a biocidal product, under","normal conditions of use, is negligible,","meaning that the product is used in closed","systems or under other conditions","excluding contact with humans;"],"old":["(a) the risk to humans or the environment","from exposure to the active substance in a","biocidal product, under realistic worst case","conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"132","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-133","justification":"The Council wording only suggests taking the availability of alternatives \"into account\". This\nis far too vague. It is unacceptable to grant a derogation for an active substance that should\nnormally be excluded from approval, when safer alternatives are available. Any such\nderogation should be subject to a number of conditions: risk mitigation, minimisation of\nexposure, substitution plan, and limitation of the use of the biocidal product to the Member\nState where the serious danger is.","location":[[" Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point b"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["(b) it is shown by evidence that the active","substance is necessary to prevent or","control a serious danger to public or animal","health or to the environment, to food and","feed safety, or to the public interest and","that there are no effective alternative","substances or technologies available.","The use of any biocidal product","containing active substances included in","Annex I pursuant to this paragraph shall","be subject to appropriate risk mitigation","measures to ensure that exposure of","humans and the environment is","minimised.","Member State authorising a biocidal","product containing an active substance","included in Annex I pursuant to this","paragraph shall draw up a substitution","plan concerning the control of the serious","danger by other means including non-","chemical methods, which are as effective","as the biocidal product concerned and","shall without delay transmit that plan to","the Commission. The use of the biocidal","product with the active substance","concerned shall be restricted to those","Member States where the serious danger","has to be prevented or, if it occurs,","controlled.","Or. en","Article 5(2)(c) and the last subparagraph - should be voted together.)"],"old":["(b) the active substance is essential to","prevent or to control a serious danger to","public or animal health or the environment;","or","","","","(Reinstatement of part of amendment 44 from first reading. Linked to the amendment deleting"],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"133","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-286","justification":"Name of active substances supplier and biocidal product\u2019s manufacturing site are\nconfidential business information that should not be disclosed in order to protect commercial\ninterests. The address of a biocidal product manufacturing site does not provide useful\ninformation to the public.","location":[["Council position","Article 65 \u2013 paragraph 3 \u2013 point a"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["(a) the name of the authorisation holder;"],"old":["(a) the name and address of the","authorisation holder;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"286","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-134","justification":" The amendment reinstates the Parliament's position in first reading and provides for more\n clarity. Risk mitigation measures are needed in order to protect human health, as well as the\n environment.","location":[[" Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point b"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["(b) it is shown by evidence that the active","substance is necessary to prevent or","control a serious danger to public or animal","health or to the environment, to food and","feed safety, or to the public interest and","that there are no effective alternative","substances or technologies available.","The use of any biocidal product","containing active substances included in","Annex I pursuant to this paragraph shall","be subject to appropriate risk mitigation","measures to ensure that exposure of","humans and the environment is","minimised."],"old":["(b) the active substance is essential to","prevent or to control a serious danger to","public or animal health or the environment;","or"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"134","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-287","justification":" Name of active substances supplier and biocidal product\u2019s manufacturing site are\n confidential business information that should not be disclosed in order to protect commercial\n interests. The address of a biocidal product manufacturing site does not provide useful\n information to the public.","location":[["Council position","Article 65 \u2013 paragraph 3 \u2013 point b"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["deleted"],"old":["(b) the name and address of the biocidal","product manufacturer;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"287","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-135","justification":"This clause is no longer necessary if the amendment to Article 5(2)(aa) is adopted. There\nshould always be an assessment whether there is no safer alternative available.","location":[[" Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point c"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["deleted","Or. en","Article 5(2)(b))"],"old":["(c) not approving the active substance","would cause disproportionate negative","impacts for society when compared with","the risk to human health or the","","environment arising from the use of the","substance.","","","","(Partial reinstatement of amendment 44 of first reading. Linked to the new amendment on"],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"135","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-288","justification":" This information falls under data protection.","location":[[" Council position","Article 65 \u2013 paragraph 3 \u2013 point c"]],"meps":[1929],"meta":{"created":"2019-07-03T05:28:42"},"new":["deleted"],"old":["(c) the name and address of the active","substance manufacturer;"],"orig_lang":"de","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"288","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-136","justification":"The amendment reinstates the Parliament's position in first reading and provides for more\nclarity. Risk mitigation measures are needed in order to protect human health, as well as the\nenvironment.","location":[["Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point c"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["deleted"],"old":["(c) not approving the active substance","would cause disproportionate negative","impacts for society when compared with","the risk to human health or the","environment arising from the use of the","substance."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"136","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-137","justification":" The Council wording only suggests to take the availability of alternatives \"into account\". This\n is far too vague, and could still allow a derogation for an active substance that should\n normally be excluded from approval despite the availability of safer alternatives.","location":[["Council position","Article 5 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["deleted","Or. en","Article 5(2)(b).)"],"old":["When deciding whether an active","substance may be approved in accordance","with the first subparagraph, the","availability of suitable and sufficient","alternative substances or technologies","shall also be taken into account.","","","","(Partial reinstatement of amendment 44 of first reading. Linked to the new amendment on"],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"137","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-289","location":[[" Council position","Article 65 \u2013 paragraph 4 \u2013 subparagraph 1a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:42"},"new":["Information accepted as confidential by a","competent authority or the Agency shall","be treated as confidential by other","competent authorities, the Agency and the","Commission."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"289","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-138","justification":" The date by which the Commission is to adopt scientific criteria for the determination of\n endocrine disrupting properties should be specified.","location":[[" Council position","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:42"},"new":["No later than 31 December 2013, the","Commission shall adopt delegated acts in","accordance with Article 82 specifying","scientific criteria for the determination of","endocrine disrupting properties."],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 82 specifying scientific criteria for","the determination of endocrine disrupting","properties."],"orig_lang":"fr","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"138","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-290","justification":"In the absence of a fee, requests for confidentiality are likely to be made on a routine basis\nusing up the resources of the national authorities and the Agency.","location":[["Council position","Article 65 \u2013 paragraph 4 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:42"},"new":["4 a. The request shall be accompanied by","a fee in accordance with Article 79(1). If","the fee is not paid, the request shall not be","considered."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"290","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-139","justification":"The Commission should not merely be empowered to adopt scientific criteria for endocrine\ndisrupters, but actually be obliged to do so. There should be a clear deadline for the\nCommission to do so.","location":[["Council position","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:42"},"new":["No later than 13 December 2013, the","Commission shall adopt delegated acts in","accordance with Article 82 specific","scientific criteria for the determination of","endocrine disrupting properties.","Or. en","(Partial reinstatement of amendment 44 of first reading.)"],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 82 specifying scientific criteria for","the determination of endocrine disrupting","properties.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"139","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elisabetta Gardini, Sergio Berlato, Oreste Rossi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-291","location":[["Council position","Article 66 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[58758,4746,97196],"meta":{"created":"2019-07-03T05:28:43"},"new":["The following information held by the","Agency or, as appropriate, the","Commission on active substances shall be","made, free of charge, publicly available in","a single database, in a structured format","on at least the relevant website of the","Commission:"],"old":["The following information held by the","Agency or the Commission on active","substances shall be made publicly and","easily available free of charge:"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"291","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-140","justification":"While it is important to establish at EU level criteria for the determination of endocrine\ndisrupting properties, the introduction of an interim definition may cause uncertainty and\nconfusion. It can lead to the exclusion of an active substance which could eventually be\napproved according to the final criteria adopted by the Commission. It is also needed to fix\nan appropriate deadline for the development of such criteria. The proposed date is in\n\n accordance with Regulation 1107/2009.","location":[["Council position","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["No later than 13 December 2013, the","Commission shall adopt delegated acts in","accordance with Article 82 specifying","scientific criteria for the determination of","endocrine disrupting properties."],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 82 specifying scientific criteria for","the determination of endocrine disrupting","properties."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"140","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-292","justification":" The word \"data\" is too generic and means studies doesn't refers directly to endpoints. It is\n necessary to clarify between the specific results of studies (endpoints) from the generic word\n data. The aim of the amendment is to underline the difference between \"end results\" and\n \"studies\".","location":[["Council position","Article 66 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point d"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:43"},"new":["(d) physicochemical endpoints and data on","pathways and environmental fate and","behaviour;"],"old":["(d) physicochemical data and data on","pathways and environmental fate and","behaviour;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"292","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-293","justification":" Also in this case \"endpoints\" is more clear than the word \"result\".","location":[[" Council position","Article 66 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point e"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:43"},"new":["(e) the endpoints of each toxicological and","ecotoxicological study;"],"old":["(e) the result of each toxicological and","ecotoxicological study;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"293","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-141","justification":" While it is important to establish at EU level criteria for the determination of endocrine\n disrupting properties, the introduction of an interim definition may cause uncertainty and\n confusion. It can lead to the exclusion of an active substance which could eventually be\n approved according to the final criteria adopted by the Commission. It is also needed to fix\n an appropriate deadline for the development of such criteria. The proposed date is in\n accordance with Regulation 1107/2009.","location":[[" Council position","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["deleted"],"old":["Pending the adoption of those criteria,","active substances that are classified in","accordance with the provisions of","Regulation (EC) No 1272/2008 as, or","meet the criteria to be classified as,","carcinogen category 2 and toxic for","reproduction category 2, shall be","considered as having endocrine-","disrupting properties."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"141","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-294","justification":"It is essential to establish a product list to inform consumers about biocidal products\nauthorised according to the new simplified authorization (which replaces the low risk\nprocedure).","location":[[" Council position","Article 66 \u2013 paragraph 2 a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:43"},"new":["2 a. Public access shall be granted free of","charge to an inventory containing details","of biocidal products authorised pursuant","to Article 25 and of the corresponding","manufacturers.","Or. en","(Reinstatement of amendment 211 from first reading.)"],"old":["","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"294","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-142","justification":"While it is important to establish at EU level criteria for the determination of endocrine\ndisrupting properties, the introduction of an interim definition may cause uncertainty and\nconfusion. It can lead to the exclusion of an active substance which could eventually be\napproved according to the final criteria adopted by the Commission. It is also needed to fix\nan appropriate deadline for the development of such criteria. The proposed date is in\naccordance with Regulation 1107/2009.","location":[[" Council position","Article 5 \u2013 paragraph 3 \u2013 subparagraph 3"]],"meta":{"created":"2019-07-03T05:28:42"},"new":["deleted"],"old":["Substances such as those that are","classified in accordance with the","provisions of Regulation (EC) No","1272/2008 as, or that meet the criteria to","be classified as, toxic for reproduction","","category 2 and that have toxic effects on","the endocrine organs, may be considered","as having endocrine-disrupting","properties."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"142","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-143","justification":"The Council wording is ambiguous. Such data waiving should only occur if all relevant\nexposure ban be ruled out.","location":[["Council position","Article 6 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:42"},"new":["(a) the data are not necessary as all","relevant exposure associated with the","proposed uses can be ruled out;","Or. en","(Reinstatement of amendment 47 of first reading.)"],"old":["(a) the data are not necessary owing to the","exposure associated with the proposed","uses;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"143","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-144","justification":" The Council text fails to take account of the fact that Article 79 has been modified so as to\n subdivide the fees into agency fees and evaluating authority fees. The aim of this amendment\n is to ensure a more consistent and coherent text.","location":[["Council position","Article 7 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:42"},"new":["Upon receipt of the fees payable under","Article 79(1) and (2), the Agency shall","accept the application and inform the","applicant and the evaluating competent","authority accordingly, indicating the exact","date of the acceptance of the application","and its unique identification code."],"old":["Upon receipt of the fees payable under","Article 79(1), the Agency shall accept the","application and inform the applicant and","the evaluating competent authority","accordingly, indicating the exact date of","the acceptance of the application and its","unique identification code."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"144","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-295","location":[["Council position","Article 66 \u2013 paragraph 2 b (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:43"},"new":["2 b. The Commission shall make available","on the internet a list of all active","substances available within the internal","market.","The persons responsible for the placing","on the market of biocidal products shall","make available on the internet a list of","such products. This website shall serve to","increase transparency for consumers and","to facilitate an easy and fast collection of","data on the properties and conditions of","use of these products.","Or. en","(Partial reinstatement of amendment 219 from first reading.)"],"old":["","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"295","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-145","justification":" The aim of this amendment is to clarify the text and ensure greater consistency (both within\n the text itself and with other legislative acts).","location":[[" Council position","Article 7 \u2013 paragraph 3 \u2013 subparagraph 2 a (new)"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:43"},"new":["As soon as possible after the agency has","accepted an application, the evaluating","competent authority shall inform the","applicant of the fees payable under Article","79(2). It shall reject the application if the","applicant fails to pay the fees within 60","days."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"145","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-296","justification":" \"Natural\" is an easily understood term and consumers should be able to identify products\n which contain natural rather than synthetic ingredients.","location":[[" Council position","Article 68 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:43"},"new":["In addition to compliance with paragraph","1, authorisation holders shall ensure that","labels are not misleading in respect of the","risks from the product to human health or","the environment or its efficacy and, in any","case, do not mention the indications \u2018low-","risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019, \u2018environmentally friendly\u2019,","\u2018animal friendly\u2019 or similar indications. In","addition, the label must show clearly and","indelibly the following information:"],"old":["In addition to compliance with paragraph","1, authorisation holders shall ensure that","labels are not misleading in respect of the","risks from the product to human health or","the environment or its efficacy and, in any","case, do not mention the indications \u2018low-","risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019, \u2018natural\u2019, \u2018environmentally","friendly\u2019, \u2018animal friendly\u2019 or similar","indications. In addition, the label must","show clearly and indelibly the following","information:"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"296","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-146","justification":"The aim of this amendment is to clarify the text and ensure greater consistency (both within\nthe text itself and with other legislative acts).","location":[["Council position","Article 7 \u2013 paragraph 4 \u2013 subparagraph 3"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:43"},"new":["The evaluating competent authority shall","reject the application if the applicant fails","to submit the requested information within","the deadline and shall inform the applicant","and the Agency accordingly. In such cases,","part of the fee paid in accordance with","Article 79(1) and (2) shall be reimbursed."],"old":["The evaluating competent authority shall","reject the application if the applicant fails","to submit the requested information within","the deadline and shall inform the applicant","and the Agency accordingly. In such cases,","part of the fee paid in accordance with","Article 79 shall be reimbursed."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"146","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Daciana Octavia S\u00e2rbu, Claudiu Ciprian T\u0103n\u0103sescu","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-147","location":[["Council position","Article 8 \u2013 paragraph 2"]],"meps":[33989,96847],"meta":{"created":"2019-07-03T05:28:43"},"new":["2. Where it appears that additional","information is necessary to carry out the","evaluation, the evaluating competent","authority shall ask the applicant to submit","such information within a specified time","limit, and shall inform the Agency","accordingly. Where such additional","information includes animal testing, the","applicant shall be advised by experts from","the Agency or competent authorities","regarding suitable alternative methods","and testing strategies to replace, reduce or","refine the use of vertebrate animals. As","specified in the second subparagraph of","Article 6(2), the evaluating competent","authority may, as appropriate, require the","applicant to provide sufficient data to","permit a determination of whether an","active substance meets the criteria referred","to in Article 5(1) or 10(1). The 365-day","period referred to in paragraph 1 of this","Article shall be suspended from the date of","issue of the request until the date the","information is received. The suspension","shall not exceed 180 days in total unless it","is justified by the nature of the data","requested or by exceptional circumstances."],"old":["2. Where it appears that additional","information is necessary to carry out the","evaluation, the evaluating competent","authority shall ask the applicant to submit","such information within a specified time","limit, and shall inform the Agency","accordingly. As specified in the second","subparagraph of Article 6(2), the","evaluating competent authority may, as","appropriate, require the applicant to","provide sufficient data to permit a","determination of whether an active","","","substance meets the criteria referred to in","Article 5(1) or 10(1). The 365-day period","referred to in paragraph 1 of this Article","shall be suspended from the date of issue","of the request until the date the information","is received. The suspension shall not","exceed 180 days in total unless it is","justified by the nature of the data requested","or by exceptional circumstances."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"147","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-297","justification":"Consumers and some market operators are increasingly demanding the possibility of taking\ninformed decisions in favour of purchasing products containing more natural substances. The\nindustry should therefore be authorised to provide information on the product's composition\nprovided that this does not mislead consumers and no inaccurate or unscientific statements\nare made concerning safety, environmental protection or performance.","location":[[" Council position","Article 68 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[2025,96908],"meta":{"created":"2019-07-03T05:28:43"},"new":["In addition to compliance with paragraph","1, authorisation holders shall ensure that","labels are not misleading in respect of the","risks from the product to human health or","the environment or its efficacy and, in any","case, do not mention the indications \"low-","risk biocidal product\", \"non-toxic\",","\"harmless\", \"environmentally friendly\",","\"animal friendly\" or similar indications. In","addition, the label must show clearly and","indelibly the following information:"],"old":["In addition to compliance with paragraph","1, authorisation holders shall ensure that","labels are not misleading in respect of the","risks from the product to human health or","the environment or its efficacy and, in any","case, do not mention the indications \"low-","risk biocidal product\", \"non-toxic\",","\"harmless\", \"natural\", \"environmentally","friendly\", \"animal friendly\" or similar","indications. In addition, the label must","show clearly and indelibly the following","information:"],"orig_lang":"fr","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"297","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-148","justification":"Cumulative effects to be considered should not be limited to the use of products with the same\nactive substance, but also include products with other substances with similar effects.","location":[[" Council position","Article 8 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["3. Where the evaluating competent","authority considers that there are concerns","with regard to the cumulative effects from","the use of biocidal products containing the","same active substance, or different","substances with similar or common effects","on the same endpoints, whether by the","same or different mechanism of action, it","shall document its concerns in accordance","with the requirements of the relevant parts","of Section II.3 of Annex XV to Regulation","(EC) No 1907/2006 and include this as part","of its conclusions.","Or. en","(Reinstatement of amendment 57 from first reading.)"],"old":["3. Where the evaluating competent","authority considers that there are concerns","with regard to the cumulative effects from","the use of biocidal products containing the","same active substance, it shall document its","concerns in accordance with the","requirements of the relevant parts of","Section II.3 of Annex XV to Regulation","(EC) No 1907/2006 and include this as part","of its conclusions.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"148","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-298","justification":"The impact of nanomaterials on health and the environment is largely unknown at present, yet\nthey may pose specific problems. Any user of a biocidal product should therefore be informed\nvia adequate labelling.","location":[["Council position","Article 68 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point aa (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:43"},"new":["(aa) whether the product contains","nanomaterials and any specific related","risks, and, following each reference to","nanomaterials, the word \"nano\" in","brackets;","Or. en","(Reinstatement of amendment 213 from first reading.)"],"old":["","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"298","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-299","location":[["Council position","Article 68 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point n a (new)"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:43"},"new":["(n a) the statement \u201cUse biocides safely.","Always read the label and product","information before use\u201d."],"old":[""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"299","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-149","justification":"Amendment of new text by Council, adding certain elements to am 17 by the rapporteur. The\n\n approval of active substances should be done by delegated act to ensure the control rights of\n Parliament. It should include the conditions and relevant dates of inclusion and expiry of\n inclusion. There should also be a decision in its own right if a substance is not included in\n Annex -I to have a record of all decisions.","location":[["Council position","Article 9 \u2013 paragraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["1. The Commission shall, on receipt of the","opinion of the Agency referred to in Article","8(4), adopt, by means of delegated acts in","accordance with Article 82, a decision on","the inclusion of the active substance in","Annex -I, including the conditions of the","inclusion, the dates of inclusion and of","expiry of inclusion, or on the non-","inclusion of the active substance in Annex","I."],"old":["1. The Commission shall, on receipt of the","opinion of the Agency referred to in Article","8(4), either:","(a) adopt an implementing Regulation","providing that an active substance is","approved, and under which conditions,","including the dates of approval and of","expiry of the approval; or","(b) n cases where the requirements of","Article 4(1) or, where applicable, Article","5(2), are not satisfied or where the","requisite information and data have not","been submitted within the prescribed","period, adopt an implementing decision","that an active substance is not approved.","Those implementing acts shall be adopted","in accordance with the examination","procedure referred to in Article 81(3)."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"149","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-300","justification":" \"Natural\" is an easily understood term and consumers should be able to identify products\n which contain natural rather than synthetic ingredients.","location":[[" Council position","Article 71 \u2013 paragraph 3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:43"},"new":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment or its efficacy. In any case,","the advertising of a biocidal product shall","not mention \u2018low-risk biocidal product\u2019,","\u2018non-toxic\u2019, \u2018harmless\u2019, \u2018environmentally","friendly\u2019, \u2018animal friendly\u2019 or any similar","indication."],"old":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment or its efficacy. In any case,","the advertising of a biocidal product shall","not mention \u2018low-risk biocidal product\u2019,","\u2018non-toxic\u2019, \u2018harmless\u2019, \u2018natural\u2019,","\u2018environmentally friendly\u2019, \u2018animal","friendly\u2019 or any similar indication."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"300","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-150","justification":" Active substances that are respiratory sensitisers should also be candidates for substitution.","location":[[" Council position","Article 10 \u2013 paragraph 1 \u2013 point a a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["(a a) it meets the criteria to be classified,","in accordance with Regulation (EC) No","1272/2008, as a respiratory sensitiser;","Or. en","(Reinstatement of amendment 65 of first reading.)"],"old":["","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"150","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-301","justification":"Consumers and some market operators are increasingly demanding the possibility of taking\ninformed decisions in favour of purchasing products containing more natural substances. The\nindustry should therefore be authorised to provide information on the product's composition\nprovided that this does not mislead consumers and no inaccurate or unscientific statements\nare made concerning safety, environmental protection or performance.","location":[[" Council position","Article 71 \u2013 paragraph 3"]],"meps":[2025,96908],"meta":{"created":"2019-07-03T05:28:43"},"new":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment or its efficacy. In any case,","the advertising of a biocidal product shall","not mention \"low-risk biocidal product\",","\"non toxic\", \"harmless\", \"environmentally","friendly\", \"animal friendly\" or any similar","indication."],"old":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","","","environment or its efficacy. In any case,","the advertising of a biocidal product shall","not mention \"low-risk biocidal product\",","\"non toxic\", \"harmless\", \"natural\",","\"environmentally friendly\", \"animal","friendly\" or any similar indication."],"orig_lang":"fr","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"301","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-151","justification":"This is a fall-back amendment to the amendment by the same authors to Article 5(1)(d). If a\ncomprehensive definition of endocrine disrupters is adopted in that Article, the content of this\namendment is covered by the reference to Art. 5(1) in Art. 10(1)(a). If endocrine disrupters\nare not properly covered under the exclusion criteria, they should be so at least as candidates\nfor substitution.","location":[[" Council position","Article 10 \u2013 paragraph 1 \u2013 point c a (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:43"},"new":["(c a) it is considered to have endocrine","disrupting properties that may cause","adverse effect on humans on the basis of","the assessment of Community or","internationally agreed test guidelines or","other available data","Or. en","(Reinstatement of the text of the Commission proposal.)"],"old":["","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"151","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elisabetta Gardini, Sergio Berlato, Oreste Rossi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-302","location":[["Council position","Article 75 \u2013 paragraph 1 \u2013 point j a (new)"]],"meps":[58758,4746,97196],"meta":{"created":"2019-07-03T05:28:43"},"new":["(j a) providing assistance to and","coordinating between Member States in","order to avoid the parallel assessment of","applications relating to the same or","similar biocidal products referred to in","Articles 28 (4) and 42 (5)."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"302","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-152","justification":"Reinstatement of first reading.","location":[["Council position","Article 10 \u2013 paragraph 1 \u2013 point d"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:43"},"new":["(d) there are reasons for concern linked to","the nature of the critical effects, in","particular developmental neurotoxic or","immunotoxic effects which, in","combination with the use patterns, amount","to use that could still cause concern, such","as high potential of risk to groundwater,","even with very restrictive risk management","measures;"],"old":["(d) there are reasons for concern linked to","the nature of the critical effects which, in","combination with the use patterns, amount","to use that could still cause concern, such","as high potential of risk to groundwater,","even with very restrictive risk management","measures;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"152","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-303","justification":" It should be clarified that also a submission fee is required for covering the related Agency\n services.","location":[["Council position","Article 79 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:43"},"new":["(a) the fees payable to the Agency,","including an annual and a submission fee;"],"old":["(a) the fees payable to the Agency,","","","including an annual fee;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"303","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Richard Seeber","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-304","location":[[" Council position","Article 79 \u2013 paragraph 1 \u2013 subparagraph 4"]],"meps":[28252],"meta":{"created":"2019-07-03T05:28:43"},"new":["The fees payable shall be set at such a level","as to ensure that the revenue derived from","the fees, when combined with other","sources of the Agency's and competent","authorities\u2019 revenue pursuant to this","Regulation, is sufficient to cover the cost","of the services delivered. The fees payable","shall be published by the Agency."],"old":["The fees payable to the Agency shall be set","at such a level as to ensure that the revenue","derived from the fees, when combined with","other sources of the Agency's revenue","pursuant to this Regulation, is sufficient to","cover the cost of the services delivered."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"304","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-153","justification":" Developmental neurotoxic or immunotoxic effects should be highlighted specifically, in line\n with the regulation on plant protection products.","location":[["Council position","Article 10 \u2013 paragraph 1 \u2013 point d"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["(d) there are reasons for concern linked to","the nature of the critical effects, in","particular developmental neurotoxic or","immunotoxic effects, which, in","combination with the use patterns, amount","to use that could still cause concern, such","as high potential of risk to groundwater,","even with very restrictive risk management","measures;","Or. en","(Reinstatement of the text of the Commission proposal.)"],"old":["(d) there are reasons for concern linked to","the nature of the critical effects which, in","combination with the use patterns, amount","to use that could still cause concern, such","","as high potential of risk to groundwater,","even with very restrictive risk management","measures;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"153","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-154","justification":" The level of non-active isomers or impurities is not directly related to the hazard or risk of the\n active substance, but rather depends on the manufacturing process. Therefore, it should not\n be part of the substitution criteria. Reinstating first reading Amendment 64.","location":[[" Council position","Article 10 \u2013 paragraph 1 \u2013 point e"]],"meps":[28247],"meta":{"created":"2019-07-03T05:28:43"},"new":["deleted"],"old":["(e) it contains a significant proportion of","non-active isomers or impurities."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"154","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-305","justification":"In absence of any justification an annual fee should not be applicable.","location":[[" Council position","Article 79 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meta":{"created":"2019-07-03T05:28:43"},"new":["(a) the fees payable to the Agency;"],"old":["(a) the fees payable to the Agency,","including an annual fee;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"305","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Andres Perello Rodriguez, Pilar Ayuso, Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-155","justification":"The proposed period of 90 days is a more appropriate timing for industry and other third\nparties to provide information on potential candidates for substitution.","location":[[" Council position","Article 10 \u2013 paragraph 3"]],"meps":[96989,4319,4326],"meta":{"created":"2019-07-03T05:28:43"},"new":["3. Prior to submitting its opinion on the","approval or renewal of the approval of an","active substance to the Commission, the","Agency shall make publicly available,","without prejudice to Articles 65 and 66,","information on potential candidates for","substitution during a period of no more","than 90 days, during which time interested","third parties may submit relevant","information, including information on","available substitutes. The Agency shall","take due account of the information","received when finalising its opinion."],"old":["3. Prior to submitting its opinion on the","","approval or renewal of the approval of an","active substance to the Commission, the","Agency shall make publicly available,","without prejudice to Articles 65 and 66,","information on potential candidates for","substitution during a period of no more","than 60 days, during which time interested","third parties may submit relevant","information, including information on","available substitutes. The Agency shall","take due account of the information","received when finalising its opinion."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"155","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-306","justification":"The deletion of certain parts is triggered by establishing a fee regulation that covers fees\npayable to both the Agency and the Member State, as proposed in Amendments 155 and 156.","location":[["Council position","Article 79 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:43"},"new":["3. The implementing Regulation referred","to in paragraph 1 concerning fees shall","respect the following principles:"],"old":["3. Both the implementing Regulation","referred to in paragraph 1 and Member","States' own rules concerning fees shall","respect the following principles:"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"306","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-156","location":[["Council position","Article 12 \u2013 paragraph 2"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:43"},"new":["2. In the light of scientific and technical","progress using agreed technical methods","and guidance documents available at the","time of application for renewal, the","conditions specified for the active","substance referred to in Article 4(3) shall","be reviewed and, where appropriate,","amended."],"old":["2. In the light of scientific and technical","progress, the conditions specified for the","active substance referred to in Article 4(3)","shall be reviewed and, where appropriate,","amended."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"156","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-307","justification":" While it is evident that the applicant has to pay for services delivered by the competent\n authorities and by the Agency, it is disproportionate to devolve all costs to the industry.","location":[["Council position","Article 79 \u2013 paragraph 3 \u2013 point a"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:43"},"new":["(a) fees shall be set at such a level as to","ensure that the revenue derived from the","fees is, in principle, sufficient to cover the","cost of the services delivered and shall not","exceed what is necessary to cover those","costs, The level should also reflect the","fact that (the funding of) the evaluation","and authorisation procedure shall not be","entirely financed by these fees;"],"old":["(a) fees shall be set at such a level as to","ensure that the revenue derived from the","fees is, in principle, sufficient to cover the","cost of the services delivered and shall not","exceed what is necessary to cover those","costs;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"307","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-157","justification":" The Council wording is ambiguous, it would also allow for a renewal for a period exceeding\n 15 years. Science is developing fast, and ad hoc reviews occur only very rarely. As such, a\n renewal should not exceed 10 years to ensure a proper reassessment every ten years at the\n latest.","location":[[" Council position","Article 12 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["3. Unless more strictly specified in the","decision to renew the approval of an active","substance, the renewal shall be for ten","years for all product-types to which the","approval applies.","Or. en","(Reinstatement of amendment 71 from first reading.)"],"old":["3. Unless otherwise specified in the","decision to renew the approval of an active","substance, the renewal shall be for fifteen","years for all product-types to which the","approval applies.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"157","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-308","justification":" SMEs could benefit from a specific fee payment system, e.g. by allowing them to spread the\n fee over several months or years.","location":[[" Council position","Article 79 \u2013 paragraph 3 \u2013 point c"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:44"},"new":["(c) the specific needs of small and medium","sized enterprises shall be taken into","account, with respect to a fee payment","system, as appropriate; this shall have no","bearing on the responsibility of the","relevant competent authority to carry out","a careful assessment in accordance with","the provisions of this Regulation;"],"old":["(c) the specific needs of SMEs shall be","taken into account, as appropriate;"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"308","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-309","justification":"Publication of the fee structure decided by the Agency and by Member States will allow\ncompanies to submit fee payment with their applications thereby shortening review times and\nminimising the risk that deadlines for payment will not be met.","location":[[" Council position","Article 79 \u2013 paragraph 3 \u2013 point f"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:44"},"new":["(f) the deadlines for the payment of fees","shall be fixed taking due account of the","deadlines of the procedures provided for in","this Regulation."],"old":["(f) as regards Member States' rules only,","the deadlines for the payment of fees to","competent authorities shall be fixed taking","due account of the deadlines of the","procedures provided for in this Regulation."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"309","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-158","location":[[" Council position","Article 14 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:43"},"new":["On the basis of an assessment of the","available information and the need to","review the conclusions of the initial","evaluation of the application for approval","or, as appropriate, the previous renewal,","the evaluating competent authority shall,","within 90 days of the Agency accepting an","application in accordance with Article","13(3), decide whether, in the light of","current scientific knowledge using agreed","technical methods and guidance","documents available at the time of","application for renewal, a full evaluation","of the application for renewal is necessary","taking account of all product types for","which renewal is requested."],"old":["On the basis of an assessment of the","available information and the need to","review the conclusions of the initial","evaluation of the application for approval","or, as appropriate, the previous renewal,","the evaluating competent authority shall,","within 90 days of the Agency accepting an","application in accordance with Article","13(3), decide whether, in the light of","current scientific knowledge, a full","evaluation of the application for renewal is","necessary taking account of all product-","types for which renewal is requested.","",""],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"158","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Andres Perello Rodriguez, Pilar Ayuso, Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-310","location":[["Council position","Article 88 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[96989,4319,4326],"meta":{"created":"2019-07-03T05:28:44"},"new":["To that effect, those wishing to apply for","the authorisation or mutual recognition in","parallel of biocidal products of that","product-type containing no active","substances other than approved existing","active substances shall submit applications","for authorisation or mutual recognition in","parallel to Member States' competent","authorities no later than the date of","approval of the active substance(s). In the","case of biocidal products containing more","than one active substance, applications for","authorisation shall be submitted no later","than the date of approval of the last active","substance for that product-type."],"old":["To that effect, those wishing to apply for","the authorisation or mutual recognition in","parallel of biocidal products of that","product-type containing no active","substances other than existing active","substances shall submit applications for","authorisation or mutual recognition in","parallel to Member States' competent","authorities no later than the date of","approval of the active substance(s). In the","case of biocidal products containing more","than one active substance, applications for","authorisation shall be submitted no later","than the date of approval of the last active","substance for that product-type."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"310","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-159","justification":"The aim of this amendment is to clarify the text and ensure greater consistency (both within\nthe text itself and with other legislative acts).","location":[["Council position","Article 14 \u2013 paragraph 2 \u2013 subparagraph 2 a (new)"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:43"},"new":["As soon as possible after the agency has","accepted an application, the evaluating","competent authority shall inform the","applicant of the fees payable under Article","79(2). It shall reject the application if the","applicant fails to pay the fees within 60","days."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"159","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Andres Perello Rodriguez, Pilar Ayuso, Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-311","justification":" In the absence of application for authorisation or mutual recognition in parallel, there should\n be no transitional period for biocidal products with the exception of existing stocks.","location":[["Council position","Article 88 \u2013 paragraph 3 \u2013 subparagraph 3 \u2013 point a"]],"meps":[96989,4319,4326],"meta":{"created":"2019-07-03T05:28:44"},"new":["(a) the biocidal product shall no longer be","made available on the market with effect","from the date of approval of the active","substance(s); and"],"old":["(a) the biocidal product shall no longer be","made available on the market with effect","from 180 days after the date of approval of","the active substance(s); and"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"311","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-160","justification":" Amendment of new text by Council, adding certain elements to am 20 by the rapporteur. The\n renewal of active substances should be done by delegated act to ensure the control rights of\n Parliament. It should include the conditions and relevant dates of inclusion and expiry of\n inclusion. There should also be a decision in its own right if the inclusion of a substance in\n Annex -I is not renewed to have a record of all decisions.","location":[["Council position","Article 14 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["4. The Commission shall, on receipt of the","opinion of the Agency, adopt, by means of","delegated acts in accordance with Article","82, a decision on the renewal of the","inclusion of the active substance in Annex","-I for one or more product-types, or of the","non-renewal of inclusion. In the event","that the inclusion is renewed, the decision","shall state the conditions of renewal and","the dates of renewal and of expiry of","inclusion."],"old":["4. The Commission shall, on receipt of the","opinion of the Agency, adopt:","","","(a) an implementing Regulation providing","that the approval of an active substance is","renewed for one or more product-types,","and under which conditions; or","(b) an implementing decision that the","approval of an active substance is not","renewed.","Those implementing acts shall be adopted","in accordance with the examination","procedure referred to in Article 81(3).","Article 9(2) shall apply."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"160","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-312","justification":" From Article 88(1), one can see that the new cut-off criteria of this Regulation should apply\n for future approval decisions. However, unless this subparagraph is deleted, the provisions of\n this new regulation, in particular the cut-off criteria and the provisions on candidates for\n substitution, will not apply for the evaluation of all existing substances for at least a decade,\n as the evaluation of existing active substances will still take many years. That makes a\n mockery of the whole regulation.","location":[[" Council position","Article 89 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:44"},"new":["deleted","(Amendment to achieve coherence with the","wording in Art. 88(1) third subparagraph.)"],"old":["Dossiers submitted for the purposes of","Directive 98/8/EC for which the","evaluation has not been completed by \u2026*","shall continue to be evaluated by the","competent authorities in accordance with","the provisions of Directive 98/8/EC and,","where relevant, Regulation (EC) No","1451/2007."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"312","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-161","justification":"The Commission should review the approval of an active substance as soon as there are\nsignificant indications of non-compliance, not only when there are serious indications. Non-\ncompliance with the relevant provisions of the water framework directive should also trigger\na review.","location":[[" Council position","Article 15 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["The Commission may review the approval","of an active substance for one or more","product-types at any time where there are","significant indications that any of the","conditions laid down in Article 4(1) or,","where relevant, Article 5(2) are no longer","met. The Commission may also review the","approval of an active substance for one or","more product-types at the request of a","Member State if there are indications that","the use of the active substance in biocidal","products or treated articles raises","significant concerns about the safety of","such biocidal products or treated articles.","The Commission may also review","inclusion where there are significant","indications that the objectives of Article","4(1)(a)(iv), Article 4(1)(b)(i) and Article","7(2) and (3) of Directive 2000/60/EC may","not be achieved.","Or. en","(Reinstatement of amendment 74 from first reading in a modified form.)"],"old":["The Commission may review the approval","of an active substance for one or more","product-types at any time where there are","serious indications that the conditions laid","down in Article 4(1) or, where relevant,","Article 5(2) are no longer met. The","Commission may also review the approval","of an active substance for one or more","product-types at the request of a Member","State if there are indications that the use of","the active substance in biocidal products or","treated articles raises serious concerns","","about the safety of such biocidal products","or treated articles.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"161","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-313","justification":"Mandatory sharing of non-vertebrate data should not be allowed as this would not be\nconsistent with other legislations (Regulation 1107/2009 on plant protection products,\nREACH) and would discriminate R&D investments.","location":[[" Council position","Article 95 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meta":{"created":"2019-07-03T05:28:44"},"new":["For the purposes of this paragraph and for","existing active substances listed in Annex","II to Regulation (EC) No. 1451/2007, the","provisions on data sharing, as laid down in","Articles 61, 62, and 63 shall apply to all","studies included in the dossier. The","relevant person shall be required to apply","for data sharing only for those data that it","does not already possess and that involves","tests on vertebrate animals only."],"old":["For the purposes of this paragraph and for","existing active substances listed in Annex","II to Regulation (EC) No 1451/2007, the","provisions on mandatory data sharing, as","laid down in Articles 61 and 62 of this","Regulation, shall apply to all toxicological","and ecotoxicological studies included in","the dossier. The relevant person shall be","required to apply for data sharing only for","those data that it does not already possess."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"313","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-162","justification":"Amendment to new text by the Council. While it is important to maintain an urgency\nprocedure, urgent decisions about renewals should be taken via delegated acts, not\nimplementing acts.","location":[["Council position","Article 15 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:43"},"new":["On duly justified imperative grounds of","urgency the Commission shall adopt","delegated acts in accordance with the","procedure referred to in Article 83."],"old":["On duly justified imperative grounds of","urgency the Commission shall adopt","immediately applicable implementing acts","in accordance with the procedure referred","to in Article 81(4)."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"162","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Jolanta Emilia Hibner, Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-314","justification":" We propose to include Tea tree oil into in Annex I. It was already included to Annex I of\n Commission Regulation (EC) No 1451/2007 of 4 December 2007. There are scientific\n justifications of antibacterial and antifungal activity in proposed concentration. Tea tree oil is\n effective in very low concentration, in which the substance is not harmful to human and the\n environment.","location":[["Council position","Annex I \u2013 Category 4 \u2013 Row 2a(new)"]],"meps":[96753,28299],"meta":{"created":"2019-07-03T05:28:44"},"new":["","EC number Name/group Restriction Comment","Natural oil Tea tree oil Maximum 68647-73-4"," concentration in"," products should be"," limited to 1%"],"old":["EC number Name/group Restriction Comment","","","",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"314","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jolanta Emilia Hibner, Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-315","justification":" We propose to include Garlic extract into in Annex I. It was already included into in Annex I\n and Annex II (product type 3,4,5,18,19) of Commission Regulation (EC) No 1451/2007of 4\n December 2007. Garlic extract can be used as a repellent even in 99.9 per cent, however, an\n antibacterial and antifungal activity is observed for concentration to 10 per cent. According\n to Directive 2008/127/EC this active substance was included to Directive 91/414/EEC and the\n long term exposure of human was set at 3g/kg b.w./day, which mean that this substance is not\n harmful to human.","location":[[" Council position","Annex I \u2013 Category 4 \u2013 Row 2b(new)"]],"meps":[96753,28299],"meta":{"created":"2019-07-03T05:28:44"},"new":[""," EC number Name/group Restriction Comment"," 232-371-1 Garlic extract"],"old":[" EC number Name/group Restriction Comment","","","",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"315","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-163","justification":" To enable biocidal products generated by an in situ device to be addressed in the Regulation\n (recital 9), they should be subject to a separate prohibition on making devices that generate\n biocidal products in situ available on the market, unless the biocidal product they generate is\n authorised. This is achieved by the proposed new Article 17(1a).","location":[[" Council position","Article 17 \u2013 paragraph 1 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:44"},"new":["1 a. In situ devices shall not be made","available on the market unless the","biocidal product that they generate is","authorised in accordance with this","Regulation and the in situ device complies","with any relevant conditions of that","authorisation."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"163","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jolanta Emilia Hibner, Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-316","justification":"We propose to include Citronella oil into in Annex I. It was already included to Annex I of\nCommission Regulation (EC) No 1451/2007 of 4 December 2007. There are scientific\njustifications of antifungal and repellent activity against ticks in proposed concentration.\nCitronella oil is effective in very low concentration, in which is not harmful to human and the\nenvironment.","location":[["Council position","Annex I \u2013 Category 4 \u2013 Row 2c (new)"]],"meps":[96753,28299],"meta":{"created":"2019-07-03T05:28:44"},"new":["","EC number Name/group Restriction Comment","Natural oil Citronella oil Maximum 8000-29-1"," concentration in"," products should be"," limited to 0.15%"],"old":["EC number Name/group Restriction Comment","","","",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"316","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-164","justification":" One important point of the modifications envisaged by the proposed regulation is the\n simplification and centralisation of applications. Therefore, the possibility to submit all\n applications (both national and Union authorisations) directly to the Agency should be\n\nmaintained. Partial reinstatement of first reading Amendment 81.","location":[[" Council position","Article 17 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28247],"meta":{"created":"2019-07-03T05:28:44"},"new":["Applications for authorisation shall be","submitted to the Agency."],"old":["Applications for national authorisation in","a Member State shall be submitted to the","competent authority of that Member State","(\u2018the receiving competent authority\u2019)."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"164","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Jolanta Emilia Hibner, Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-317","justification":" We propose to include denatonium benzoate (Bitrex) to Annex I. It was already included to\n Annex I of Commission Regulation (EC) No 1451/2007 of 4 December 2007. Based on a\n discussion between EU Member States Bitrex has been approved as an active substance in\n biocidal products using as a repellent against pet animals (e.g. dogs, cats). It is also\n commonly use as aversive agent in rodenticides and important for their safe use. Denatonium\n benzoate is used in products in very low concentration, in which is not harmful to human and\n the environment.","location":[["Council position","Annex I \u2013 Category 7 \u2013 Row 4a (new)"]],"meps":[96753,28299],"meta":{"created":"2019-07-03T05:28:44"},"new":[""," EC number Name/group Restriction"," 223-095-2 Denatonium benzoate Maximum concentration in"," products should be limited"," to 500 ppm (0.050%)."],"old":["EC number Name/group Restriction","","","",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"317","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-318","justification":"methodology for both exposure estimates and hazard identification of nanomaterials needs to\nbe further developed and validated. As such, existing methods for bulk chemicals cannot be\nassumed to provide relevant data. Until the validity of standard test methods has been\nassessed for nanomaterials, a special justification has to be given for the use of these tests for\nthe assessment of nanomaterials.","location":[[" Council position","Annex II \u2013 point 5"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:44"},"new":["5. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Commission","Regulation (EC) No 440/2008 of 30 May","2008 laying down test methods pursuant to","Regulation (EC) No 1907/2006 of the","European Parliament and of the Council on","the Registration, Evaluation, Authorisation","and Restriction of Chemicals (REACH)66 .","Methods listed in Annex I do not cover","nanomaterials, except where specifically","mentioned. However, if a method is","inappropriate or not described, other","methods shall be used which are","scientifically satisfactory and the validity","of which must be justified in the","application.","Or. en","(Reinstatement of amendment 346 from first reading)"],"old":["5. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Commission","Regulation (EC) No 440/2008 of 30 May","2008 laying down test methods pursuant to","Regulation (EC) No 1907/2006 of the","European Parliament and of the Council on","the Registration, Evaluation, Authorisation","and Restriction of Chemicals (REACH)66 .","However, if a method is inappropriate or","not described, other methods shall be used","which are, whenever possible,","internationally recognised and must be","justified in the application.","","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"318","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-165","justification":"In the new regulation there is the possibility to change the composition of the biocidal\nproducts within a product family and therefore it is appropriate that the Competent Authority\ndo have the possibility to refuse a product if they do not consider that the product is covered\nby the risk assessment performed for the product family.","location":[["Council position","Article 17 \u2013 paragraph 6"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:44"},"new":["6. The authorisation holder shall submit an","application to each competent authority","that has granted a national authorisation for","a biocidal product family of each product","within the biocidal product family before","placing it on the market, except where a","particular product is explicitly identified in","the authorisation or the variation in","composition concerns only pigments,","perfumes and dyes within the permitted","variations. The notification shall indicate","the exact composition, trade name and","suffix to the authorisation number. In the","case of a Union authorisation, the","authorisation holder shall notify the","Agency and the Commission."],"old":["6. The authorisation holder shall notify","each competent authority that has granted a","national authorisation for a biocidal","product family of each product within the","biocidal product family before placing it on","the market, except where a particular","product is explicitly identified in the","authorisation or the variation in","composition concerns only pigments,","perfumes and dyes within the permitted","variations. The notification shall indicate","the exact composition, trade name and","suffix to the authorisation number. In the","case of a Union authorisation, the","authorisation holder shall notify the","Agency and the Commission."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"165","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-319","justification":"Additional information is important at both active substance level (Annex II) and for the\nBiocidal Product (Annex III) in order to allow for a proper cumulative risk assessment for\nbiocidal products where relevant.","location":[["Council position","Annex II \u2013 Title 1 \u2013 7.5. \u2013 Column 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:44"},"new":["7.5. Likely tonnage to be placed on the","market per year and where relevant, for","the envisaged major use categories."],"old":["7.5. Likely tonnage to be placed on the","market per year"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"319","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-166","justification":" The notification should be made at least 30 days in advance to allow a real market\n monitoring. The notification of products belonging to a biocidal product family aims to know\n all products that are placed on the market, as well as their exact composition. The\n notification of each product within the biocidal product family is therefore needed.","location":[["Council position","Article 17 \u2013 paragraph 6"]],"meps":[97076],"meta":{"created":"2019-07-03T05:28:44"},"new":["6. The authorisation holder shall notify","each competent authority that has granted a","national authorisation for a biocidal","product family of each product within the","biocidal product family at least 30 days","before placing it on the market. The","notification shall indicate the exact","composition, trade name and suffix to the","authorisation number. In the case of a","Union authorisation, the authorisation","holder shall notify the Agency and the","Commission."],"old":["6. The authorisation holder shall notify","each competent authority that has granted a","national authorisation for a biocidal","product family of each product within the","biocidal product family before placing it on","the market, except where a particular","product is explicitly identified in the","authorisation or the variation in","composition concerns only pigments,","perfumes and dyes within the permitted","variations. The notification shall indicate","the exact composition, trade name and","suffix to the authorisation number. In the","case of a Union authorisation, the","authorisation holder shall notify the","Agency and the Commission."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"166","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-320","justification":" Acute toxicity studies can sometimes lead to morbidity or mortality in animal specimens.\n Requiring such studies by more than one exposure route (i.e. oral + skin + inhalation) should\n be the exception rather than the rule. This is especially true for dermal (skin) testing, which\n has been shown in several independent analyses to add nothing of value for classification\n purposes in more than 98% biocides and other substances examined.","meps":[96956],"meta":{"created":"2019-07-03T05:28:44"},"new":["8.7. Acute toxicity","In addition to the oral route (8.7.1), for","substances other than gases, the","information mentioned under 8.7.2 to 8.7.3","may be provided for other routes.","\u2013 The choice for the second route will","depend on the nature of the substance and","the likely route of human exposure.","\u2013 Gases and volatile liquids should be","administered by the inhalation route","\u2013 If the only route of exposure is the oral","route, then information for only that route","need be provided. If dermal or inhalation","route is the only route available then an","oral test may be considered. Before a new","dermal acute toxicity study is carried out,","an in vitro dermal penetration study","(OECD 428) should be conducted to","assess the likely magnitude and rate of","dermal bioavailability.","\u2013 There may be exceptional circumstances","where all routes of exposure are deemed","necessary."],"old":["8.7. Acute toxicity","In addition to the oral route (8.7.1), for","substances other than gases, the","information mentioned under 8.7.2 to 8.7.3","shall be provided for at least one other","route.","\u2013 The choice for the second route will","depend on the nature of the substance and","the likely route of human exposure.","\u2013 Gases and volatile liquids should be","administered by the inhalation route","\u2013 If the only route of exposure is the oral","route, then information for only that route","need be provided. If dermal or inhalation","route is the only route available then an","oral test may be considered.","\u2013 There may be specific circumstances","where all routes of exposure are deemed","necessary."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"320","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-167","justification":"Nanomaterials can have very different characteristics to the same substances in normal form.\nThe risks posed by nanomaterials in biocidal products must therefore be investigated\nseparately.","location":[[" Council position","Article 18 \u2013 paragraph 1 \u2013 point e a (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:44"},"new":["(e a) where nanomaterials are used in that","product, the risk to the environment and","to health has been assessed separately","Or. en","(Reinstatement of amendment 88 from first reading.)"],"old":["","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"167","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-321","justification":"Same scientific justification as for Amendment 328. This amendment refines the triggers for\nacute (lethal dose) testing by the skin route and introduces an intelligent testing strategy to\nprevent unnecessary animal use.","meps":[96956],"meta":{"created":"2019-07-03T05:28:44"},"new":["8.7.3. By dermal route","Testing by the dermal route may be","indicated if:","\u2013 inhalation of the substance is unlikely;","\u2013 skin contact in production and/or use is","likely;","\u2013 the physicochemical and toxicological","properties suggest potential for a","significant rate of absorption through the","skin; and","\u2013 the oral LD50 is 300 mg/kg or less;","\u2013 the results of an in vitro dermal","penetration study (OECD 428)","demonstrate high dermal bioavailability."],"old":["8.7.3. By dermal route","Testing by the dermal route is","appropriate if:","","\u2013 inhalation of the substance is unlikely;","or","\u2013 skin contact in production and/or use is","likely; or","\u2013 the physicochemical and toxicological","properties suggest potential for a","significant rate of absorption through the","skin."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"321","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Holger Krahmer, Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-168","justification":"This Amendment would ensure the alignment to provisions for the Chemical Safety Report\nthreshold under the REACH regulation. Reinstating first reading Amendment 9.","location":[["Council position","Article 18 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[28247,1929],"meta":{"created":"2019-07-03T05:28:44"},"new":["(b a) The evaluation of the compliance of","the biocidal product with the criteria set","out in points (b) and (c) of paragraph 1","shall not take into account a substance","contained in the biocidal product if it is","present in a preparation at a","concentration lower than any of the","concentrations mentioned in points (a) to","(f) of Article 14(2) of Regulation (EC) No","1907/2006;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"168","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-322","justification":" A repeated dose toxicity study by the dermal route should not be carried out if the results of\n an in vitro dermal absorption study are 1) not available and 2) do not demonstrate higher\n absorption via the skin vs. the oral route.","location":[["Council position","Annex II \u2013 Title 1 \u2013 8.9. Repeated dose toxicity \u2013 Column 1 \u2013 point(iii)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:28:45"},"new":["8.9 Repeated dose toxicity","(iii) dermal toxicity is recognised for","structurally related substances and for","example is observed at lower doses than in","the oral toxicity test and dermal absorption","is comparable or higher than oral","absorption"],"old":["8.9 Repeated dose toxicity","(iii) dermal toxicity is recognised for","structurally related substances and for","example is observed at lower doses than in","the oral toxicity test or dermal absorption","is comparable or higher than oral","","absorption"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"322","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-169","justification":" It is important to differentiate cumulative effects (same substance in different products and\n uses) from synergistic effects (different substances in one mixture).","location":[["Council position","Article 18 \u2013 paragraph 2 \u2013 point d"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:44"},"new":["(d) cumulative effects."],"old":["(d) cumulative and synergistic effects."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"169","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-323","justification":" Long-term general toxicity studies are costly in both economic and animal welfare terms and\n can often be avoided by extrapolating the results from a 90-day study data using conservative\n statistical techniques (i.e. dividing the \u201cno effect level\u201d from a 90 day study by 10, which\n assumes that humans could be up to 10-times more sensitive to long-term vs. short-term\n exposure). In practice, this approach usually leads to more conservative and health-protective\n risk assessments than can be achieved with animal testing.","location":[[" Council position","Annex II \u2013 Title 1 \u2013 8.9.3. Long-term repeated dose toxicity (\u2265 12 months) \u2013 Column 3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["8.9.3. The long-term toxicity study (\u2265 12","months) does not need to be conducted if:","\u2013 Long-term exposure can be excluded and","no effects have been seen at limit dose in","the 90-day study, or","\u2013 if the application of an uncertainty","factor of up to ten-fold would be","sufficiently protective for risk assessment","purposes, or","\u2013 a combined long-term repeated","dose/carcinogencity study (section 8.11.1)","is undertaken."],"old":["8.9.3. The long-term toxicity study (\u2265 12","months) does not need to be conducted if:","\u2013 Long-term exposure can be excluded and","no effects have been seen at limit dose in","the 90-day study or","\u2013 a combined long-term repeated","dose/carcinogencity study (section 8.11.1)","is undertaken."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"323","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-170","justification":" It is important to differentiate cumulative effects (same substance in different products and\n uses) from synergistic effects (different substances in one mixture).","location":[[" Council position","Article 18 \u2013 paragraph 2 \u2013 point d a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:44"},"new":["(d a) synergistic effects."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"170","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-324","justification":"Testing on a second species (i.e. dogs) should be the exception rather than the rule. The first\nof the proposed triggers for further studies is not appropriate and should be deleted.","location":[["Council position","Annex II \u2013 Title 1 \u2013 8.9.4. Further repeat dose studies \u2013 Column 1\u2013 paragraph 1 \u2013 introductory part and indent 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["8.9.4. Further repeat dose studies","Further repeat dose studies including","testing on a second species (non-rodent),","studies of longer duration or through a","different route of exposure may be","undertaken in case of:"],"old":["8.9.4. Further repeat dose studies","Further repeat dose studies including","testing on a second species (non-rodent),","studies of longer duration or through a","different route of exposure shall be","undertaken in case of:","\u2013 no other information on toxicity for a","second non-rodent species is provided for;","or"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"324","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-171","justification":"Amendment to new text by the Council. The same conditions as adopted in first reading for\nthe derogations from the cut-off criteria for active substances should apply in analogy for any\nderogations from the cut-offs for biocidal products. There should be no derogation for\ngeneral use for products authorised for professional use only.","location":[[" Council position","Article 18 \u2013 paragraph 5"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:44"},"new":["5. Notwithstanding paragraphs 1 and 4, a","biocidal product may be authorised when","the conditions laid down in paragraph","1(b)(iii) and (iv) are not fully met, where it","is shown by evidence that the biocidal","product is necessary to prevent or control","a serious danger to public or animal health","or to the environment, to food and feed or","to the public interest and that there are no","effective alternative products or","technologies available.","The use of any biocidal product authorised","pursuant to this paragraph shall be","subject to appropriate risk mitigation","measures to ensure that exposure of","humans and the environment is","minimised.","A Member State authorising a biocidal","product authorised pursuant to this","paragraph shall draw up a substitution","plan concerning the control of the serious","danger by other means including non-","chemical methods, which are as effective","as the biocidal product concerned and","shall without delay transmit that plan to","the Commission. The use of any biocidal","product authorised pursuant to this","paragraph shall be restricted to those","Member States where the serious danger","has to be prevented or, if it occurs,","controlled."],"old":["5. Notwithstanding paragraphs 1 and 4, a","biocidal product may be authorised when","the conditions laid down in paragraph","1(b)(iii) and (iv) are not fully met, or may","be authorised for making available on the","market for use by the general public when","the criteria referred to in paragraph 4(c)","are met, where not authorising the","biocidal product would result in","disproportionate negative impacts for","society when compared to the risks to","human or animal health or to the","environment arising from the use of the","biocidal product under the conditions laid","","down in the authorisation."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"171","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sirpa Pietik\u00e4inen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-325","location":[["Council position","Annex II \u2013 Title 1 \u2013 8.10.2 \u2013 Column 1"]],"meps":[40599],"meta":{"created":"2019-07-03T05:28:45"},"new":["8.10.2. Two-generation reproductive","toxicity study, rat, oral route of","administration is the preferred route.","If another reproductive toxicity test is used","justification shall be provided. Now that an","extended one-generation reproductive","toxicity study has been adopted at OECD","level it should be considered as an","alternative approach to the multi-","generation study."],"old":["8.10.2. Two-generation reproductive","toxicity study, rat, oral route of","administration is the preferred route.","If another reproductive toxicity test is used","justification shall be provided."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"325","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-172","location":[["Council position","Article 19 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:44"},"new":["1. An application for authorisation shall","contain the following documents:"],"old":["1. The applicant for an authorisation shall","submit the following documents together","with the application:"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"172","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-326","location":[[" Council position","Annex II \u2013 Title 1 \u2013 8.11.2. Carcinogenicity testing in a second species \u2013 Column 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["Delete"],"old":["8.11.2. Carcinogenicity testing in a second","species","\u2013 A second carcinogenicity study should","normally be conducted using the mouse","as test species.","\u2013 For evaluation of consumer safety of","active substances that may end up in food","or feed, it is necessary to conduct toxicity","studies by the oral route."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"326","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-173","justification":" According to Art. 21 (1), the authorisation includes also stipulates the terms and conditions\n relating to the placing on the market and use of the biocidal product. The latter circumscribes\n the authorisation of the product that should be used in compliance with it. The terms and\n conditions of the authorisation should be drafted and submitted by the applicant and should\n be handled by the competent authorities together with the summary of product characteristics\n during the whole procedure.","location":[[" Council position","Article 19 \u2013 paragraph 1 \u2013 point a \u2013 point i"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:44"},"new":["(i) a dossier or a letter of access to a","dossier for the biocidal product satisfying","the requirements set out in Annex III;"],"old":["(i) a dossier or letter of access for the","biocidal product satisfying the","requirements set out in Annex III;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"173","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-327","justification":"The explosive growth of computing power and computational biology has made available a\nwide range of new tools for studying the effects of chemicals on cells, tissues and organisms\nin a rapid and cost-efficient manner. As companies begin to incorporate these tools and tests\ninto their in-house product stewardship programmes, these data should be submitted in\nparallel to maximise the availability of mechanistic data to support regulation, and to build\nconfidence in the use of new methods to replace or reduce animal use.","location":[[" Council position","Annex II \u2013 Title 1 \u2013 8.13. \u2013 Column 1 \u2013 paragraph 1a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:45"},"new":["Other available data: Available data from","emerging methods and models, including","toxicity pathway-based risk assessment, in","vitro and \u2018omic (genomic, proteomic,","metabolomic, etc.) studies, systems","biology, computational toxicology,","bioinformatics, and high-throughput","screening shall be submitted in parallel."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"327","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-174","justification":" According to Art. 21 (1), the authorisation includes also stipulates the terms and conditions\n relating to the placing on the market and use of the biocidal product. The latter circumscribes\n the authorisation of the product that should be used in compliance with it. The terms and\n conditions of the authorisation should be drafted and submitted by the applicant and should\n\nbe handled by the competent authorities together with the summary of product characteristics\nduring the whole procedure.","location":[[" Council position","Article 19 \u2013 paragraph 1 \u2013 point a \u2013 point ii a (new)"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:44"},"new":["(ii a) a proposal for the terms and","conditions of the authorisation referred to","in Article 21 (1);"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"174","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-328","justification":"The explosive growth of computing power and computational biology has made available a\nwide range of new tools for studying the effects of chemicals on cells, tissues and organisms\nin a rapid and cost-efficient manner. As companies begin to incorporate these tools and tests\ninto their in-house product stewardship programmes, these data should be submitted in\nparallel to maximise the availability of mechanistic data to support regulation, and to build\nconfidence in the use of new methods to replace or reduce animal use.","location":[["Council position","Annex II \u2013 Title 1 \u2013 8.13 \u2013 Column 1 \u2013 paragraph 1a(new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:28:45"},"new":["Other available data","Available data from emerging methods","and models, including toxicity pathway-","based risk assessment, in vitro and \u2018omic","(genomic, proteomic, metabolomic, etc.)","studies, systems biology, computational","toxicology, bioinformatics, and high-","throughput screening shall be submitted","in parallel."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"328","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Jolanta Emilia Hibner, Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-175","justification":"In case of products containing both the active substances approved and listed in Annex I,\nsubmitting of data required in Annex II for active substances listed in Annex I should not be\nrequired, because these active substances are regarded as not posing the risk and is\nimpossible, because such data do not exist, as being not required for inclusion of these\nsubstances into Annex I. The amendment is necessary for legal certainty, that biocidal\nproducts authorized according to Chapters VI, VII and VIII may contain also active\nsubstances included into Annex I.","location":[["Council position","Article 19 \u2013 paragraph 1 \u2013 point a \u2013 point iii"]],"meps":[96753,28299],"meta":{"created":"2019-07-03T05:28:44"},"new":["(iii) a dossier or a letter of access for the","biocidal product satisfying the","requirements set out in Annex II for each","active substance in the biocidal product,","other than active substances listed in","Annex I;"],"old":["(iii) a dossier or a letter of access for the","biocidal product satisfying the","requirements set out in Annex II for each","active substance in the biocidal product;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"175","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-329","meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["8.13.3. Endocrine-mediated toxicity","If there is any evidence from in vitro,","repeat dose or reproduction toxicity","studies, that the active substance may","exhibit endocrine-mediated toxic","properties then additional information or","specific studies may be required:"],"old":["8.13.3. Endocrine disruption","If there is any evidence from in vitro,","repeat dose or reproduction toxicity","studies, that the active substance may have","endocrine disrupting properties then","additional information or specific studies","shall be required:"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"329","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-176","justification":" This sub point concerns active substances that could be included in low-risk biocidal\n products. It is in line with Article 95.","location":[["Council position","Article 19 \u2013 paragraph 1 \u2013 point a \u2013 point iii a (new)"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:45"},"new":["(iii a) a dossier or a letter of access to a","dossier satisfying the requirements set out","in Annex II if the active substance is","listed in category 6 of Annex I;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"176","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-177","location":[[" Council position","Article 19 \u2013 paragraph 1 \u2013 point b \u2013 point i a (new)"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:45"},"new":["(i a) a proposal for the terms and","conditions of the authorisation referred to","in Article 21 (1);"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"177","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-330","location":[[" Council position","Annex II \u2013 Title 1 \u2013 8.13.4. \u2013 Column 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["8.13.4. Immunotoxicity","If there is any evidence, from skin","sensitisation, repeat dose or reproduction","toxicity studies, that the active substance","may have immunotoxicity properties then","additional information or specific studies","may be required:","\u2013 to elucidate the mode/mechanism of","action","\u2013 provide sufficient evidence for relevant","adverse effects in humans"],"old":["8.13.4. Immunotoxicity including","developmental immunotoxicity","If there is any evidence, from skin","sensitisation, repeat dose or reproduction","toxicity studies, that the active substance","may have immunotoxicity properties then","additional information or specific studies","shall be required:","\u2013 to elucidate the mode/mechanism of","action","\u2013 provide sufficient evidence for relevant","adverse effects in humans"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"330","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-178","justification":"Products authorised at the level of the Union will have access to the markets of all Member\nStates. It is therefore important that the summary of product characteristics is available in all\nofficial languages. The costs of providing such translations should be borne by the applicant.","location":[[" Council position","Article 19 \u2013 paragraph 2 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:45"},"new":["2 a. For applications for Union","authorisations submitted under Article 42,","the summary of the characteristics of the","biocidal product referred to in point (ii) of","paragraph(1)(a) of this Article shall be","provided in one official language of the","Union accepted by the evaluating","competent authority at the time of","application. The Agency shall transmit","that summary to the Commission in all","official languages within 30 days of the","submission of the opinion referred to in","Article 43(3)."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"178","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Holger Krahmer, Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-179","justification":"This Amendment would ensure the alignment to provisions for the Chemical Safety report\nthreshold under the REACH Regulation. Partial reinstatement of first reading Amendment\n117","location":[["Council position","Article 21 \u2013 paragraph 2 \u2013 point e"]],"meps":[28247,1929],"meta":{"created":"2019-07-03T05:28:45"},"new":["(e) qualitative and quantitative composition","in terms of the active substances and non-","active substances, taking account of the","concentration limits in Article 18(2b) and","in so far as this information is required","for proper use of the biocidal product;"],"old":["(e) qualitative and quantitative composition","in terms of the active substances and non-","active substances, knowledge of which is","essential for proper use of biocidal","products; and in the case of a biocidal","product family, the quantitative","composition shall indicate a minimum","and maximum percentage for each active","and non-active substance, where the","minimum percentage indicated for certain","substances may be 0 %;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"179","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Sirpa Pietik\u00e4inen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-331","meps":[40599],"meta":{"created":"2019-07-03T05:28:45"},"new":["Delete"],"old":["9.1.11. Amphibian metamorphosis assay -","ADS"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"331","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-180","justification":" This information is covered by data protection law.","location":[["Council position","Article 21 \u2013 paragraph 2 \u2013 point g"]],"meps":[1929],"meta":{"created":"2019-07-03T05:28:45"},"new":["deleted"],"old":["(g) manufacturers of the active substances","(names and addresses including location","of manufacturing sites);"],"orig_lang":"de","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"180","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-332","justification":"Because it is standard to use rodent and other mammalian data developed for human health\nassessments in environmental toxicology assessments aimed at protecting wild mammals, this\nshould be stated explicitly to avoid unnecessary additional animal testing. The language of\nthe proposed amendment is derived from proposed new EU data requirements for plant\nprotection products.","location":[["Council position","Annex II \u2013 Title 1 \u2013 9.9. \u2013 Column 3 (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["Data are derived from the mammalian","toxicological assessment. The most","sensitive relevant mammalian long-term","toxicological endpoint (NOAEL)","expressed as mg test compound/kg bw/day","shall be reported."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"332","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-181","justification":" Name of active substances supplier is confidential business information that should not be\n disclosed in order to protect commercial interests.","location":[[" Council position","Article 21 \u2013 paragraph 2 \u2013 point g"]],"meta":{"created":"2019-07-03T05:28:45"},"new":["deleted"],"old":["(g) manufacturers of the active substances","(names and addresses including location","of manufacturing sites);"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"181","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-333","justification":" Adaptation of certain standard information requirements for microbial biocides through the\n addition of qualifying sentence to the introductory text.","location":[["Council position","Annex II \u2013 Title 2 \u2013 7. Effects on human and animal health \u2013 Column 3 (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["Information requirements in this section","may be adapted as appropriate in","accordance with the specifications of Title","1 of this Annex."],"old":[""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"333","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-182","justification":"The request for comparative assessment should take into account first of all \u2013 as a rule, not as\nan exception \u2013 sufficient experience of use. The request for comparative assessment should\naccordingly be restricted to the renewal of authorisations for products containing an active\nsubstance identified as a candidate for substitution in accordance with Article 9.","location":[[" Council position","Article 22 \u2013 paragraph 1"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:45"},"new":["1. The receiving competent authority or, in","the case of an evaluation of an application","for a Union authorisation, the evaluating","competent authority, shall perform a","comparative assessment as part of the","renewal pursuant to this Regulation of","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 10(1). Comparative","assessment shall be carried out on all","biocidal products used for the same","purpose provided that sufficient (at least","five years\u2019) experience of their use exists."],"old":["1. The receiving competent authority or, in","the case of an evaluation of an application","for a Union authorisation, the evaluating","","competent authority, shall perform a","comparative assessment as part of the","evaluation of an application for","authorisation or for renewal of","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 10(1)."],"orig_lang":"fr","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"182","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-183","justification":"Comparative assessment should concentrate on biocidal products with an identified risk and\nfor which alternatives are needed.","location":[["Council position","Article 22 \u2013 paragraph 1 a (new)"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:45"},"new":["1 a. By derogation from paragraph 1,","comparative assessment shall not be","carried out on biocidal products which","have been shown to be safe in use."],"orig_lang":"fr","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"183","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-334","justification":" Acute toxicity studies can sometimes lead to morbidity or mortality in animal specimens.\n Requiring such studies by more than one exposure route (i.e. oral + inhalatory +\n intraperitoneal/subcutaneous) should be the exception rather than the rule. Accordingly,\n acute pulmonary toxicity should at most be a second-tier data requirement.","location":[[" Council position","Annex II \u2013 Title 2 \u2013 7.2.2.2. Acute inhalatory toxicity\u2013 Column 2 (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["ADS"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"334","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-184","justification":" The request for comparative assessment should take into account first of all \u2013 as a rule, not as\n an exception \u2013 sufficient experience of use. The request for comparative assessment should\n accordingly be restricted to the renewal of authorisations for products containing an active\n substance identified as a candidate for substitution in accordance with Article 9.","location":[[" Council position","Article 22 \u2013 paragraph 2"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:45"},"new":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of renewal of a Union authorisation,","also to the Commission."],"old":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of evaluation of an application for a","Union authorisation, also to the","Commission."],"orig_lang":"fr","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"184","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-335","justification":"Acute toxicity studies involve literally poisoning animals to death, making them among the\nmost severe and ethically objectionable type of toxicity test. Requiring such studies by more\nthan one exposure route (i.e. oral + pulmonary + intraperitoneal/subcutaneous) should be the\nexception rather than the rule. Accordingly, acute pulmonary toxicity should at most be a\nsecond-tier data requirement. Accordingly, an acute injection study should at most be a\nsecond-tier data requirement.","location":[[" Council position","Annex II \u2013 Title 2\u2013 7.2.2.3. Intraperitoneal/subcutaneous single dose \u2013 Column 2 (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["ADS"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"335","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-185","justification":"The request for comparative assessment should take into account first of all \u2013 as a rule, not as\nan exception \u2013 sufficient experience of use. The request for comparative assessment should\naccordingly be restricted to the renewal of authorisations for products containing an active\nsubstance identified as a candidate for substitution in accordance with Article 9.","location":[[" Council position","Article 22 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:45"},"new":["3. The receiving competent authority or, in","the case of a decision on the renewal of a","Union authorisation, the Commission shall","prohibit or restrict the making available on","the market or the use of a biocidal product","containing an active substance that is a","candidate for substitution where the","comparative assessment in accordance with","Annex VI (\u2018comparative assessment\u2019)","demonstrates that both of the following","criteria are met:"],"old":["3. The receiving competent authority or, in","the case of a decision on an application for","a Union authorisation, the Commission","shall prohibit or restrict the making","available on the market or the use of a","biocidal product containing an active","substance that is a candidate for","substitution where the comparative","assessment in accordance with Annex VI","(\u2018comparative assessment\u2019) demonstrates","that both of the following criteria are met:"],"orig_lang":"fr","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"185","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-186","justification":"The request for comparative assessment should take into account first of all \u2013 as a rule, not as\nan exception \u2013 sufficient experience of use. The request for comparative assessment should\naccordingly be restricted to the renewal of authorisations for products containing an active\nsubstance identified as a candidate for substitution in accordance with Article 9.","location":[["Council position","Article 22 \u2013 paragraph 3 \u2013 point a"]],"meps":[2025],"meta":{"created":"2019-07-03T05:28:45"},"new":["(a) for the uses specified in the application,","other authorised biocidal products already","exist which present a significantly lower","overall risk for human and animal health","and the environment, are sufficiently","effective and present no other significant","economic or practical disadvantages;"],"old":["(a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention","method already exists which presents a","significantly lower overall risk for human","and animal health and the environment, is","sufficiently effective and presents no other","significant economic or","practical disadvantages;"],"orig_lang":"fr","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"186","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-336","justification":"The Commission has expressed support in principle for the adaptation of certain standard\ninformation requirements for microbial biocides through the addition of qualifying sentence\nto the introductory text.","location":[["Council position","Annex II \u2013 Title 2 \u2013 8. Effects on non-target organisms \u2013 Column 3 (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["Information requirements in this section","may be adapted as appropriate in","accordance with the specifications of Title","1 of this Annex."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"336","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-187","justification":" It is important that Member States follow the same methodology in comparative assessments.","location":[["Council position","Article 22 \u2013 paragraph 3 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:45"},"new":["3 a. The Commission shall, on the basis of","paragraph 3, be empowered to adopt","delegate acts in accordance with Article","82 defining the criteria and algorithms to","be used in comparative assessments to","ensure that there is a uniform application","throughout the Union.","Or. en","(Partial reinstatement of amendment 124 from first reading.)"],"old":["","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"187","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-188","justification":" This Amendment makes the text more precise. Reinstatement of first reading Amendment 126","location":[[" Council position","Article 22 \u2013 paragraph 6"]],"meps":[28247],"meta":{"created":"2019-07-03T05:28:45"},"new":["6. Notwithstanding Article 17(4), and","without prejudice to paragraph 4 of this","Article, an authorisation for a biocidal","product containing an active substance that","is a candidate for substitution shall be","granted for periods not exceeding five","years and renewed for a periods not","exceeding five years."],"old":["6. Notwithstanding Article 17(4), and","without prejudice to paragraph 4 of this","Article, an authorisation for a biocidal","product containing an active substance that","is a candidate for substitution shall be","granted for a period not exceeding five","years and renewed for a period not","exceeding five years."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"188","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-337","justification":" The relevant scientific committee of the Commission concluded that the knowledge on the\n methodology for both exposure estimates and hazard identification of nanomaterials needs to\n be further developed and validated. As such, existing methods for bulk chemicals cannot be\n assumed to provide relevant data. Until the validity of standard test methods has been\n assessed for nanomaterials, a special justification has to be given for the use of these tests for\n the assessment of nanomaterials.","location":[["Council position","Annex III \u2013 point 5"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:45"},"new":["5. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Regulation","(EC) No 440/2008. Methods listed in","Annex I do not cover nanomaterials,","except where specifically mentioned.","However, if a method is inappropriate or","not described, other methods shall be used","which are scientifically satisfactory and","the validity of which must be justified in","the application","Or. en","(Reinstatement of amendment 293 from first reading.)"],"old":["5. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Regulation","(EC) No 440/2008. However, if a method","is inappropriate or not described, other","","methods shall be used which are, whenever","possible, internationally recognised and","scientifically appropriate and must be","justified in the application.","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"337","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-189","justification":"It is more appropriate to refer to Chapter VIII, which regulates the cancellation, review and\namendment of authorisations.","location":[[" Council position","Article 22 \u2013 paragraph 7"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:45"},"new":["7. Where it is decided not to authorise or to","restrict the use of a biocidal product","pursuant to paragraph 3, the cancellation or","amendment of the authorisation shall take","effect in accordance with the provisions of","Chapter VIII."],"old":["7. Where it is decided not to authorise or to","restrict the use of a biocidal product","pursuant to paragraph 3, that cancellation","or amendment of the authorisation shall","take effect five years after that decision.","However, where the approval of the active","substance which is a candidate for","substitution expires on an earlier date, the","cancellation of the authorisation shall","take effect on that earlier date."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"189","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-190","justification":" It is unacceptable to allow a biocidal product to stay on the market for another five years\n when better alternatives are available. The same timeline as agreed in the PPP regulation\n should apply.","location":[["Council position","Article 22 \u2013 paragraph 7"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:45"},"new":["7. Where it is decided not to authorise or to","restrict the use of a biocidal product","pursuant to paragraph 3, that cancellation","or amendment of the authorisation shall","take effect three years after that decision.","However, where the approval of the active","substance which is a candidate for","substitution expires on an earlier date, the","cancellation of the authorisation shall take","effect on that earlier date.","Or. en","(Reinstatement of amendment 128 from first reading.)"],"old":["7. Where it is decided not to authorise or to","restrict the use of a biocidal product","pursuant to paragraph 3, that cancellation","or amendment of the authorisation shall","take effect five years after that decision.","However, where the approval of the active","substance which is a candidate for","substitution expires on an earlier date, the","cancellation of the authorisation shall take","effect on that earlier date.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"190","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer, Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-338","justification":"This Amendment would ensure the alignment to provisions for the Chemical Safety Report\nthreshold under the REACH Regulation.","location":[[" Council position","Annex III - Title 1 - point 2.3 - Column 1"]],"meps":[28247,1929],"meta":{"created":"2019-07-03T05:28:45"},"new":["2.3. Detailed quantitative and qualitative","information on the composition of the","biocidal product, e.g. active substance(s),","impurities, adjutants, inert components,","taking account of the concentrations","referred to in Article 18(2)(ba)","Or. en","(Reinstatement of amendment 296 from first reading.)"],"old":["2.3. Complete quantitative (g/kg, g/l or %","w/w (v/v)) composition of the biocidal","product, i.e. declaration of all active","substances and co-formulants (substance","or mixture according to Article 3 of","Regulation (EC) No 1907/2006), which","are intentionally added to the biocidal","product (formulation) as well as detailed","quantitative and qualitative information","on the composition of the active","substance(s) contained. For co-","formulants, a safety data sheet in","compliance with Article 31 of Regulation","(EC) No 1907/2006 has to be provided. In","addition, all relevant information on","individual ingredients, their function and,","in case of a reaction mixture, the final","","","composition of the biocidal product shall","be given.","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"338","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-191","justification":" There is neither a currently agreed scientific definition for the concept of cumulative or\n synergistic effects, nor an agreed methodology. These definitions and methodologies need to\n be adopted by the Commission via technical guidance notes, prior to entry into force of the\n Regulation.","location":[[" Council position","Article 23"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:45"},"new":["The Commission shall draw up technical","guidance notes to facilitate the","implementation of this Chapter and, in","particular, Articles 18(2)(d) and (da), 21(2)","and 22(3)."],"old":["The Commission shall draw up technical","guidance notes to facilitate the","implementation of this Chapter and, in","particular, Articles 21(2) and 22(3)."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"191","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-339","justification":"Additional information is important at both active substance level (Annex II) and for the\nBiocidal Product (Annex III) in order to allow for a proper cumulative risk assessment for\nbiocidal products where relevant.","location":[["Council position","Annex III \u2013 Title 1 \u2013 7.5. \u2013 Column 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:46"},"new":["7.5 Likely tonnage to be placed on the","market per year and where relevant, for","different use categories."],"old":["7.5 Likely tonnage to be placed on the","market per year"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"339","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-192","justification":"In light of the current lack of appropriate risk assessment of nanomaterials, they should not\nqualify for the simplified authorisation procedure.","location":[[" Council position","Article 24 \u2013 paragraph 1 \u2013 point b a (new)"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:45"},"new":["(b a) the biocidal product does not contain","a nanomaterial;","Or. en","(Reinstatement of amendment 103 of first reading.)"],"old":["","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"192","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-340","justification":"\n Acute toxicity studies can sometimes lead to morbidity or mortality in animal specimens. This\n is especially true for dermal (skin) testing, which has been shown in several independent\n analyses to add nothing of value for classification purposes in more than 98% biocides and\n other substances examined. Classification of biocidal products for acute dermal toxicity\n should therefore be based on direct \u201cread-across\u201d from the oral classification.","location":[["Council position","Annex III \u2013 Title 1 \u2013 8.5.3. Acute toxicity \u2013 by dermal route \u2013 Column 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["delete"],"old":["8.5.3. By dermal route"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"340","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-193","justification":"The aim of this amendment is to clarify the text and ensure greater consistency (both within\nthe text itself and with other legislative acts).","location":[["Council position","Article 25 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:45"},"new":["The evaluating competent authority shall","inform the applicant of the fees payable","under Article 79(2) and shall reject the","application if the applicant fails to pay the","fees within 60 days. It shall inform the","applicant accordingly."],"old":["The evaluating competent authority shall","inform the applicant of the fees payable","under Article 79 and shall reject the","application if the applicant fails to pay the","fees within 30 days. It shall inform the","applicant accordingly."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"193","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-341","justification":" Testing of the finished product/formulation should not normally be needed due to the\n extensive data requirements for individual formulants and accepted \u201cclassification by\n calculation\u201d approaches. If and when required, such testing can normally be limited to the\n acute exposure scenario.","location":[[" Council position","Annex III \u2013 Title 1 \u2013 9.1. Testing of biocide formulations \u2013 Column 1 \u2013 indent 2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["- Where valid information on the","components is not available or where","synergistic effects may be expected, testing","of components and/or the biocidal product","itself may be necessary. Vertebrate animal","testing should be restricted to acute","studies."],"old":["- Where valid data on the components is","not available or where synergistic effects","may be expected then testing of","components and/or the biocidal product","itself may be necessary."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"341","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-194","justification":" The aim of this amendment is to clarify the text and ensure greater consistency (both within\n the text itself and with other legislative acts).","location":[["Council position","Article 25 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:46"},"new":["Upon receipt of the fees payable under","Article 79(2), the evaluating competent","authority shall accept the application and","inform the applicant accordingly."],"old":["Upon receipt of the fees payable under","Article 79, the evaluating competent","authority shall accept the application and","inform the applicant accordingly."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"194","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-342","justification":"Testing of the finished product/formulation should not normally be needed due to the\nextensive data requirements for individual formulants and accepted \u201cclassification by\ncalculation\u201d approaches. If and when required, such testing can normally be limited to the\nacute exposure scenario.","meps":[96741],"meta":{"created":"2019-07-03T05:28:46"},"new":["9.2. Further Ecotoxicological studies","Further studies chosen from among the","endpoints referred to in Annex II, Section 9","for relevant components of the biocidal","product or the biocidal product itself may","be required if the data on the active","substance cannot give sufficient","information and if there are indications of","risk due to specific properties of the","biocidal product. Vertebrate animal testing","should be restricted to acute studies."],"old":["9.2. Further Ecotoxicological studies","Further studies chosen from among the","endpoints referred to in Annex II, Section 9","for relevant components of the biocidal","product or the biocidal product itself may","be required if the data on the active","substance cannot give sufficient","information and if there are indications of","risk due to specific properties of the","biocidal product"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"342","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-195","location":[[" Council position","Article 26 \u2013 paragraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:46"},"new":["1. If an authorisation holder wishes to","place the biocidal product on the market in","other Member States they shall apply for","an Union authorisation to the Agency.","The application shall contain the","evaluation and authorisation already given","in one Member State, including the","confirmation according to article 41 that","the biocidal product would have similar","conditions of use across the Union.","On receipt of an application for","authorisation for a product already","authorised according to Article 25, the","Agency shall prepare an opinion","on the authorisation of the biocidal","product and submit it to the Commission.","The opinion","shall contain at least the following","elements:","(a) a statement on whether the conditions","laid down in Article 24 are fulfilled","b) where relevant, details of any terms","or conditions which should be imposed on","the placing on the market or use of the","biocidal product;","(c) the final assessment report on the","biocidal product"],"old":["1. A biocidal product authorised in","accordance with Article 25 may be made","available on the market in all Member","States without the need for mutual","recognition. However, the authorisation","holder shall notify each Member State","before placing the biocidal product on the","market within the territory of that","Member State and shall use the official","language or languages of that Member","State in the product's labelling, unless that","Member State provides otherwise."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"195","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-343","justification":"\nAcute toxicity studies can sometimes lead to morbidity or mortality in animal specimens. This\nis especially true for dermal (skin) testing, which has been shown in several independent\nanalyses to add nothing of value for classification purposes in more than 98% biocides and\nother substances examined. Classification of biocidal products for acute dermal toxicity\nshould therefore be based on direct \u201cread-across\u201d from the oral classification.","location":[["Council position","Annex III \u2013 Title 2 \u2013 8.5.3. Acute toxicity \u2013 by dermal route \u2013 Column 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["delete"],"old":["Dermal"],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"343","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-196","location":[["Council position","Article 26 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:46"},"new":["On receipt of the opinion of the Agency,","the Commission shall adopt a decision on","the Union authorisation of the biocidal","product in accordance with the","examination procedure referred to in","Article 81(3). As soon as the Commission","has granted a Union authorisation, it shall","enter the information referred to in","Article 29(4) in the Register for Biocidal","Products.","A Member State shall inform the","Commission if it decides that the Union","authorisation is adjusted to the different","circumstances in that Member State in","accordance with the grounds laid down in","Article 36(1)."],"old":["Where a Member State other than that of","the evaluating competent authority","considers that a biocidal product","authorised in accordance with Article 25","has not been notified or labelled in","accordance with paragraph 1 of this","Article or does not meet the requirements","of Article 24, it may refer that matter to","the coordination group established in","accordance with Article 34(1). Article","34(3) and Article 35 shall apply mutatis","mutandis."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"196","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-344","justification":" Annex III sets out the requirements for biocidal products, including chemical products (Title\n 1) and micro-organisms (Title 2). The data requirement 8.7 appears in both titles. If the data\n requirement 8.7 in Title 1 is amended (Amendment 96), the same amendment needs to be\n made to the corresponding data requirement 8.7 in Title 2 to ensure consistency.","location":[[" Council position","Annex III \u2013 Title 2 \u2013 8.7. \u2013 Column 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:28:46"},"new":["8.7. Available toxicological data relating","to:","\u2013 co-formulants (i.e. substance(s) of","concern), or","\u2013 a mixture that a substance(s) of concern","is a component of.","If insufficient data are available for a","coformulant(s) and cannot be inferred","through read-across or other accepted","non-testing approaches, targeted acute","test(s) described in Annex II, shall be","carried out for the substance(s) of concern","or a mixture that a substance(s) of concern","is a component of."],"old":["8.7. Available toxicological data relating","to:","","- co-formulants (i.e. substance(s) of","concern), or","","- a mixture that a substance(s) of concern is","a component of","","If no data is available, then the","appropriate test(s) described in Annex II,","shall be carried out for the co-formulants","(i.e. substance(s) of concern) or a mixture","that a substance(s) of concern is a","component of"],"orig_lang":"de","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"344","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-197","justification":" We do not support that a national authorisation granted in accordance with the simplified\n authorisation procedure \u2013 can be placed on the market in all Member States without the need\n for mutual recognition. Instead we suggest that products authorised under the simplified\n procedure should have a Union authorisation with a lower fee.","location":[["Council position","Article 26 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:46"},"new":["deleted"],"old":["Where a Member State has valid reasons","to consider that a biocidal product","authorised in accordance with Article 25","does not meet the criteria laid down in","Article 24 and a decision pursuant to","","Articles 34 and 35 has not yet been taken,","that Member State may provisionally","restrict or prohibit the use or sale of that","product on its territory."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"197","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-345","justification":"Identical to Rapporteur\u2019s Amendment 96 addressing an identical point in Annex III, Title 1\n(chemicals vs. micro-organisms). For consistency the same language should be used in Title\n2.","meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["8.7. Available toxicological data relating","to:","\u2013 co-formulants (i.e. substance(s) of","concern), or","\u2013 a mixture that a substance(s) of concern","is a component of","\u2013 if insufficient data are available for a co-","formulant(s) and cannot be inferred","through read-across or other accepted","non-testing approaches, targeted test(s)","described in Annex II, shall be carried out","for the substance(s) of concern or a mixture","that a substance(s) of concern is a","component of. Vertebrate animal testing","should be restricted to acute studies."],"old":["8.7. Available toxicological data relating","to:","\u2013 co-formulants (i.e. substance(s) of","concern), or","\u2013 a mixture that a substance(s) of concern","is a component of","\u2013 If no data is available, then the","appropriate test(s) described in Annex II,","shall be carried out for the co-formulants","(i.e. substance(s) of concern) or a mixture","that a substance(s) of concern is a","component of."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"345","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jolanta Emilia Hibner, Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-198","justification":" This amendment will allow to put into Annex I commonly used food additive substances (e.g.\n acidic acid), which do not comply with the exclusion criteria listed in Art. 27/2 (e.g. skin\n corrosivity). Acetic acid and propionic acid could be therefore placed, with proposed\n restrictions, as category 1 Annex I substances.","location":[[" Council position","Article 27 \u2013 paragraph 1 a (new)"]],"meps":[96753,28299],"meta":{"created":"2019-07-03T05:28:46"},"new":["1 a. Without prejudice to paragraph 1,","active substances fulfilling the criteria","laid down in paragraph 2 of this Article","may be included in Annex I if they are","authorised as food additives in","accordance with Regulation (EC) No","1333/2008"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"198","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-346","justification":" Testing of the finished product/formulation should not normally be needed due to the\n extensive data requirements for individual formulants and accepted \u201cclassification by\n calculation\u201d approaches. If and when required, such testing can normally be limited to the\n acute exposure scenario.","location":[["Council position","Annex III \u2013 Title 2 \u2013 9.2. Testing of biocide formulations \u2013 Column 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["9.2. Further ecotoxicological studies","Further studies chosen from among the","endpoints referred to in Annex II, Section","8, Micro- Organisms for relevant","components of the biocidal product or the","biocidal product itself may be required if","the data on the active substance cannot","give sufficient information and if there are","indications of risk due to specific","properties of the biocidal product.","Vertebrate animal testing should be","restricted to acute studies."],"old":["9.2. Further ecotoxicological studies","Further studies chosen from among the","endpoints referred to in Annex II, Section","8, Micro- Organisms for relevant","components of the biocidal product or the","biocidal product itself may be required if","the data on the active substance cannot","give sufficient information and if there are","indications of risk due to specific","properties of the biocidal product.",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"346","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-199","justification":"References made to Article 19 and 20 make the text more precise. In order to obtain data\nprotection, it is required that the data is actually submitted. The possibility to submit a letter\nof access should be included in this provision for cases when the data owner is different from\nthe applicant wishing to seek a renewal.","location":[["Council position","Article 30 \u2013 paragraph 3 \u2013 point a"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:46"},"new":["(a) without prejudice to Article 20 (1), all","relevant data required under Article 19","that has generated since the initial","authorisation or, as appropriate, previous","renewal, or a letter of access to such data;","and"],"old":["(a) a list to all relevant data that it has","generated since the initial authorisation or,","as appropriate, previous renewal; and"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"199","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-347","location":[[" Council position","Annex V \u2013 Main group 1: Disinfectants \u2013 product-type 6 \u2013 paragraph 2"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:46"},"new":["Products used as preservatives for the","storage or use of rodenticide, insecticide or","other baits."],"old":["Products used as preservatives for the","storage or use of rodenticide or insecticide","baits."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"347","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-200","justification":"The aim of this amendment is to clarify the text and ensure greater consistency (both within\nthe text itself and with other legislative acts).","location":[["Council position","Article 30 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:46"},"new":["The receiving competent authority shall","inform the applicant of the fees payable","under Article 79(2) and shall reject the","application if the applicant fails to pay the","fees within 60 days. It shall inform the","applicant accordingly."],"old":["The receiving competent authority shall","inform the applicant of the fees payable","under Article 79 and shall reject the","application if the applicant fails to pay the","fees within 30 days. It shall inform the","applicant accordingly."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"200","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-348","location":[[" Council position","Annex V \u2013 Main Groups 2: Preservatives \u2013 Product type 9 \u2013 paragraph 1"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:46"},"new":["Products used for the preservation of","fibrous or polymerised materials, such as","leather, rubber or paper or textile products","by the control of fibrous/polymerised","material destroying or disfiguring","organisms, including insects."],"old":["Products used for the preservation of","fibrous or polymerised materials, such as","leather, rubber or paper or textile products","by the control of microbiological","deterioration."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"348","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-201","justification":" The aim of this amendment is to clarify the text and ensure greater consistency (both within\n the text itself and with other legislative acts).","location":[[" Council position","Article 30 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[38595],"meta":{"created":"2019-07-03T05:28:46"},"new":["Upon receipt of the fees payable under","Article 79(2), the receiving competent","authority shall accept the application and","inform the applicant accordingly,","indicating the date of the acceptance."],"old":["Upon receipt of the fees payable under","Article 79, the receiving competent","authority shall accept the application and","inform the applicant accordingly,","indicating the date of the acceptance."],"orig_lang":"ro","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"201","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-349","justification":"Additional and readily available methods, capable of determining weight of nano-sized\nparticles, should be used where suitable validated methodologies are not available for\nevaluating numbers of small particles in certain product types according to the definition for\nnanomaterials, as per Recommendation 20../\u2026/EC. Developments regarding the definition of\n\n nanomaterial to be introduced in Commission Recommendation 20../\u2026/EC of \u2026and its\n requirements are new and could not be addressed by the European Parliament in 1st reading.","location":[["Council position","Annex VI \u2013 Introduction \u2013 point 2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["2. The principles set out in this Annex can","be applied in their entirety to the evaluation","of biocidal products comprised of chemical","substances. For biocidal products","containing micro-organisms, these","principles should be further developed in","technical guidance taking into account","practical experience gained, and be applied","taking into account the nature of the","product and the latest scientific","information. In the case of biocidal","products containing nanomaterials the","principles set out in this Annex will also","need to be adapted and elaborated in","technical guidance to take account of the","latest scientific information. The guidance,","for substances falling under","Recommendation 20../\u2026/EC of \u2026 shall","not apply where these substances contain:","- less than 10 wt-% of nano-objects","OR","- less than 50 wt-% of aggregates","/agglomerates consisting of nano-objects","OR","- have not been intentionally","manufactured at the nanoscale in order to","take advantage of their specific nano","qualities"],"old":["2. The principles set out in this Annex can","be applied in their entirety to the evaluation","of biocidal products comprised of chemical","substances. For biocidal products","containing micro-organisms, these","principles should be further developed in","technical guidance taking into account","practical experience gained, and be applied","taking into account the nature of the","product and the latest scientific","information. In the case of biocidal","products containing nanomaterials the","principles set out in this Annex will also","need to be adapted and elaborated in","technical guidance to take account of the","latest scientific information."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"349","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-350","justification":"Amends new provision introduced by Council. This approach is in line with ECHA Guidance\nDocument for \u201cidentification and naming of substances under REACH\u201d (June 2007).\nFurthermore, in line with the approach of Regulation (EC) No 1223/2009 of 30 November\n2009 on cosmetic products (article 2.1 (k)), only those substances which are intentionally\nmanufactured to benefit from nanomaterial properties should fall under the requirements\nassociated with the definition.","location":[[" Council position","Annex VI \u2013 Introduction \u2013 point 2"]],"meps":[28247],"meta":{"created":"2019-07-03T05:28:46"},"new":["2. The principles set out in this Annex can","be applied in their entirety to the evaluation","of biocidal products comprised of chemical","substances. For biocidal products","containing micro-organisms, these","principles should be further developed in","technical guidance taking into account","practical experience gained, and be applied","taking into account the nature of the","product and the latest scientific","information. In the case of biocidal","products containing nanomaterials the","principles set out in this Annex will also","need to be adapted and elaborated in","technical guidance to take account of the","latest scientific information. The guidance,","for substances falling under","Recommendation 20../\u2026/EC of \u2026 with","regard to specific requirements under this","Regulation relating to their nature as","nanomaterials shall not apply where these","substances contain:","- less than 10 wt-% of nano-objects","or","- less than 50 wt-% of aggregates","/agglomerates consisting of nano-objects","or","- have not been intentionally","manufactured at the nanoscale in order to","take advantage of their specific nano","qualities"],"old":["2. The principles set out in this Annex can","be applied in their entirety to the evaluation","of biocidal products comprised of chemical","substances. For biocidal products","containing micro-organisms, these","principles should be further developed in","technical guidance taking into account","practical experience gained, and be applied","taking into account the nature of the","product and the latest scientific","information. In the case of biocidal","products containing nanomaterials the","principles set out in this Annex will also","need to be adapted and elaborated in","technical guidance to take account of the","latest scientific information."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"350","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-202","location":[[" Council position","Article 30 \u2013 paragraph 5 \u2013 subparagraph 1"]],"meps":[96603],"meta":{"created":"2019-07-03T05:28:46"},"new":["On the basis of an assessment of the","available information and the need to","review the conclusions of the initial","evaluation of the application for","authorisation or, as appropriate, the","previous renewal, the receiving competent","authority shall, within 90 days of accepting","an application in accordance with","paragraph 4, decide whether, in the light of","current scientific knowledge using agreed","technical methods and guidance","documents available at the time of","application for renewal, a full evaluation","of the application for renewal is necessary","taking account of all product types for","which renewal is requested."],"old":["On the basis of an assessment of the","available information and the need to","review the conclusions of the initial","evaluation of the application for","authorisation or, as appropriate, the","previous renewal, the receiving competent","authority shall, within 90 days of accepting","an application in accordance with","paragraph 4, decide whether, in the light of","current scientific knowledge, a full","evaluation of the application for renewal is","necessary taking account of all product","types for which renewal is requested.","",""],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"202","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso, Cristina Guti\u00e9rrez-Cortines, Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-351","justification":" Available methods, capable of measuring weight of nano-sized particles as indicated by\n ECHA Guidance Document for identification and naming of substances, should be used\n where suitable validated methodologies are not available for evaluating numbers of small\n particles in products according to the definition for nanomaterials. As in Regulation\n N\u00b01223/2009, only substances which are intentionally manufactured to be nanomaterials\n should fall under the requirements associated with the definition","location":[["Council position","Annex VI \u2013 Introduction \u2013 point 2"]],"meps":[4319,4326,96989],"meta":{"created":"2019-07-03T05:28:46"},"new":["2. The principles set out in this Annex can","be applied in their entirety to the evaluation","of biocidal products comprised of chemical","substances. For biocidal products","containing micro-organisms, these","principles should be further developed in","technical guidance taking into account","practical experience gained, and be applied","taking into account the nature of the","product and the latest scientific","information. In the case of biocidal","products containing nanomaterials the","principles set out in this Annex will also","need to be adapted and elaborated in","technical guidance to take account of the","latest scientific information. The guidance,","for substances falling under","Recommendation 20../.../EC of ... with","regard to specific requirements under this","Regulation relating to their nature as","nanomaterials shall not apply where these","substances contain:","-less than 10 w-% of nano-objects as","defined by ISO,","or","-have not been intentionally","manufactured at the nanoscale in order to","take advantage of their specific nano","qualities."],"old":["2. The principles set out in this Annex can","be applied in their entirety to the evaluation","of biocidal products comprised of chemical","substances. For biocidal products","containing micro-organisms, these","principles should be further developed in","technical guidance taking into account","practical experience gained, and be applied","taking into account the nature of the","product and the latest scientific","information. In the case of biocidal","products containing nanomaterials the","principles set out in this Annex will also","need to be adapted and elaborated in","technical guidance to take account of the","latest scientific information.",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"351","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-203","justification":"The possibility to submit application for mutual recognition in sequence in English facilitates\nthe handling of these demands in each Member State concerned, as the Parliament proposed\nit in first reading Art. 32 (3).","location":[["Council position","Article 32 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meta":{"created":"2019-07-03T05:28:46"},"new":["(a) a translation of the national","authorisation granted by the reference","Member State, into English or one of the","official languages of the Member State","concerned; and"],"old":["(a) a translation of the national","authorisation granted by the reference","Member State, into such official languages","of the Member State concerned as it may","require; and"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"203","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-352","justification":"At present, there is no single agreed scientific definition for the concepts of cumulative and\nsynergistic effects, neither is there a common, agreed method of analysis. The Commission\nshould adopt these definitions and methodologies by way of technical guidance notes, before\nthe regulation's entry into force.","location":[[" Council position","Annex VI\u2013 Introduction \u2013 point 3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["3. In order to ensure a high and harmonised","level of protection of human and animal","health and of the environment, any risks","arising from the use of a biocidal product","shall be identified. To achieve this, a risk","assessment shall be carried out to","determine the acceptability or otherwise of","any risks that are identified. This is done","by carrying out an assessment of the risks","associated with the relevant individual","components of the biocidal product taking","into account any cumulative and","synergistic effects.","Scientific definitions and methodologies","for the assessment of cumulative or","synergistic effects will be based on the","technical guidance notes provided by the","Commission as foreseen in Article 23."],"old":["3. In order to ensure a high and harmonised","level of protection of human and animal","health and of the environment, any risks","arising from the use of a biocidal product","shall be identified. To achieve this, a risk","assessment shall be carried out to","determine the acceptability or otherwise of","any risks that are identified. This is done","by carrying out an assessment of the risks","associated with the relevant individual","components of the biocidal product taking","into account any cumulative and","synergistic effects."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"352","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-204","justification":" According to Article 21(1), the authorisation includes not only the summary of biocidal\n product characteristics, but it stipulates also the terms and conditions relating to the placing\n on the market and use of the biocidal products in question. A single authorisation number\n should facilitate the administrative management of applications for mutual recognition.","location":[["Council position","Article 32 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:46"},"new":["Within 90 days of validating the","application, and subject to Articles 34, 35","and 36, the Member States concerned shall","agree on the summary of biocidal product","characteristics together with the terms and","conditions of the authorisation; shall","authorise the biocidal product accordingly","and shall record their agreement in the","Register for Biocidal Products.","A single authorisation number shall be","used in all Member States concerned."],"old":["Within 90 days of validating the","application, and subject to Articles 34, 35","and 36, the Member States concerned shall","agree on the summary of biocidal product","characteristics and shall record their","agreement in the Register for Biocidal","Products.","",""],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"204","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-353","justification":"At present, there is no single agreed scientific definition for the concepts of cumulative and\nsynergistic effects, neither is there a common, agreed method of analysis. The Commission\nshould adopt these definitions and methodologies by way of technical guidance notes, before\nthe regulation's entry into force.","location":[["Council position","Annex VI \u2013 Assessment \u2013 point 15"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:46"},"new":["15. In carrying out the assessment, the","possibility of cumulative or synergistic","effects shall also be taken into account.","Scientific definitions and methodologies","for the assessment of cumulative or","synergistic effects will be based on the","technical guidance notes provided by the","Commission as foreseen in Article 23."],"old":["15. In carrying out the assessment, the","possibility of cumulative or synergistic","effects shall also be taken into account."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"353","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Romana Jordan Cizelj","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-205","justification":"Consistency between Regulation 1107/2009 and this one is essential. Given that the\nprovisions on zonal authorisation in Regulation 1107/2009 on PPP exclude the possibility for\none Member State to delay the authorisation procedure in the other Member States once the\nDraft Inclusion by the Rapporteur has been finalised, the same principle should apply within\nthe Biocides Regulation. This will allow avoiding unnecessary delays which could jeopardise\nthe benefits of the mutual recognition process.","location":[[" Council position","Article 32 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meta":{"created":"2019-07-03T05:28:46"},"new":["Within 90 days of validating the","application, and subject to Articles 34,35","and 36, the Member States concerned shall","agree on the summary of biocidal product","characteristics included in the national","authorisation granted by the reference","Member State and shall record their","agreement in the Register for Biocidal","Products.","Without prejudice to Articles 34, 35, and","36, if agreement is not reached within the","90 day period referred to in the second","subparagraph, each Member State which","agrees to the biocidal product","characteristics referred to in the first","subparagraph may register its agreement","in the Register of Biocidal Products and","authorise the product in conformity with","the summary of biocidal product","characteristics to which it agreed."],"old":["Within 90 days of validating the","application, and subject to Articles 34, 35","and 36, the Member States concerned shall","agree on the summary of biocidal product","characteristics and shall record their","agreement in the Register for Biocidal","Products."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"205","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-354","justification":" In order to ensure proper consideration of potentially PBT and vPvB substances. The\n exclusion criteria in Article 5 give some security that the active substances do not have such\n properties; however this also applies for coformulants in biocidal products especially\n because the concentration of these substances normally exist in much higher concentrations\n compared to the active substances.","location":[["Council position","Annex VI \u2013 Assessment \u2013 point 47 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:46"},"new":["47 a. The evaluating body shall conclude","that the biocidal product does not comply","with criterion (iv) under point (b) of","Article 18(1) if it contains any substance","of concern or of relevant metabolites or","breakdown or reaction products fulfilling","the criteria for being PBT or vPvB in","accordance with Annex XIII of","Regulation (EC) No 1907/2006, or have","endocrine-disrupting properties unless it","is scientifically demonstrated that under","relevant field conditions there is no","unacceptable effect."],"old":["",""],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"354","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-355","justification":"At present, there is no single agreed scientific definition for the concepts of cumulative and\nsynergistic effects, neither is there a common, agreed method of analysis. The Commission\nshould adopt these definitions and methodologies by way of technical guidance notes, before\nthe regulation's entry into force.","location":[[" Council position","Annex VI \u2013 Assessment \u2013 point 52"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:47"},"new":["52. In each of the areas where risk","assessments have been carried out, the","evaluating body shall combine the results","for the active substance together with the","results for any substance of concern to","produce an overall assessment for the","biocidal product itself. This shall also take","account of any cumulative or synergistic","effects.","Scientific definitions and methodologies","for the assessment of cumulative or","synergistic effects will be based on the","technical guidance notes provided by the","Commission as foreseen in Article 23."],"old":["52. In each of the areas where risk","assessments have been carried out, the","evaluating body shall combine the results","for the active substance together with the","results for any substance of concern to","produce an overall assessment for the","biocidal product itself. This shall also take","account of any cumulative or synergistic","effects."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"355","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Miroslav Ouzk\u00fd","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-206","justification":"According to Art. 21 (1), the authorisation includes also stipulates the terms and conditions\nrelating to the placing on the market and use of the bioc. product in question. The latter\ncircumscribes the authorisation of the product which should be used in compliance with it.\nTherefore, in case of mutual recognition, the Member States concerned should agree not only\non the summary of bioc. product characteristics, but also on the terms and conditions of\nauthorisation.","location":[["Council position","Article 32 \u2013 paragraph 3"]],"meps":[23705],"meta":{"created":"2019-07-03T05:28:47"},"new":["3. The procedure shall be closed after all","the Member States concerned have agreed","on the summary of biocidal product","characteristics together with the terms and","conditions of the authorisation, and","recorded their agreement in the Register","for Biocidal Products."],"old":["3. The procedure shall be closed after all","the Member States concerned have agreed","on the summary of biocidal product","characteristics and recorded their","agreement in the Register for Biocidal","Products."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"206","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-356","justification":"The requirements for personal protective equipment must be determined by the biocidal\nproduct risk assessment, and not be ascertained from precautionary statements derived from\nthe product classification under either the Dangerous Preparations Directive or the\nClassification, Labelling and Packaging Regulation, as these are solely hazard-based\nassessments.","location":[["Council position","Annex VI \u2013 Conclusions \u2013 point 62"]],"meps":[96956],"meta":{"created":"2019-07-03T05:28:47"},"new":["62. If for non-professional users the","wearing of personal protective equipment","would be the only possible method for","reducing exposure to an acceptable level","for this population as a result of the","biocidal product risk assessment, the","product shall not normally be considered","as complying with criterion (iii) under","point (b) of Article 18(1) for this","population."],"old":["62. If for non-professional users the","wearing of personal protective equipment","would be the only possible method for","reducing exposure to an acceptable level","for this population the product shall not","normally be considered as complying with","criterion (iii) under point (b) of Article","18(1) for this population."],"orig_lang":"en","peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"356","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Romana Jordan Cizelj","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-207","justification":" Consistency between Regulation 1107/2009 and this one is essential. Given that the\n provisions on zonal authorisation in Regulation 1107/2009 on PPP exclude the possibility for\n one Member State to delay the authorisation procedure in the other Member States once the\n Draft Inclusion by the Rapporteur has been finalised, the same principle should apply within\n the Biocides Regulation. This will allow avoiding unnecessary delays which could jeopardise\n the benefits of the mutual recognition process.","location":[["Council position","Article 32 \u2013 paragraph 3"]],"meta":{"created":"2019-07-03T05:28:47"},"new":["3. The procedure referred to in the second","subparagraph shall be closed after all the","Member States concerned have agreed on","the summary of biocidal product","characteristics included in the national","authorisation granted by the reference","Member State and recorded their","agreement in the Register for Biocidal","Products."],"old":["3. The procedure shall be closed after all","the Member States concerned have agreed","on the summary of biocidal product","characteristics and recorded their","agreement in the Register for Biocidal","Products."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"207","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-357","location":[["Council position","Annex VI \u2013 Conclusion \u2013 point 68 \u2013 introductory part"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:47"},"new":["68. The evaluating body shall conclude that","the biocidal product does not comply with","criterion (iv) under point (b) of Article","18(1) if the foreseeable concentration of","the active substance or a substance of","concern or of relevant metabolites,","breakdown or reaction products to be","expected in groundwater or surface water","or its sediments after use of the biocidal","product under the proposed conditions of","use:","Or. en","(Reinstatement of amendment 328 from first reading)"],"old":["68. The evaluating body shall conclude that","the biocidal product does not comply with","criterion (iv) under point (b) of Article","18(1) if the foreseeable concentration of","the active substance or a substance of","concern or of relevant metabolites,","breakdown or reaction products to be","expected in surface water or its sediments","after use of the biocidal product under the","proposed conditions of use:","","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"357","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Romana Jordan Cizelj","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-208","justification":" Consistency between Regulation 1107/2009 and this one is essential. Given that the\n provisions on zonal authorisation in Regulation 1107/2009 on PPP exclude the possibility for\n\none Member State to delay the authorisation procedure in the other Member States once the\nDraft Inclusion by the Rapporteur has been finalised, the same principle should apply within\nthe Biocides Regulation. This will allow avoiding unnecessary delays which could jeopardise\nthe benefits of the mutual recognition process.","location":[[" Council position","Article 32 \u2013 paragraph 4"]],"meta":{"created":"2019-07-03T05:28:47"},"new":["4. Within 30 days of closure of the","procedure referred to in paragraph 3","Member States concerned shall authorise","the biocidal product in conformity with the","agreed summary of biocidal product","characteristics."],"old":["4. Within 30 days of closure of the","procedure, each of the Member States","concerned shall authorise the biocidal","product in conformity with the agreed","summary of biocidal product","characteristics."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"208","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-209","justification":"Since the terms and conditions of authorisation constitute an important part of the\nauthorisation, it should be proposed and added to the application by the applicant.","location":[["Council position","Article 33 \u2013 paragraph 2 \u2013 point c a (new)"]],"meta":{"created":"2019-07-03T05:28:47"},"new":["(c a) the proposed terms and conditions of","the authorisation referred to in Article 21","(1) in English."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"209","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-14T00:00:00","id":"PE472.203-358","location":[[" Council position","Annex VI \u2013 Conclusion \u2013 point 68 \u2013 indent 1 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:47"},"new":["\u2013 risks non-achievement of the objectives","or standards fixed by:","\u2013 Directive 98/83/EC, or","\u2013 Directive 2000/60/EC, or","\u2013 Directive 2006/118/EC, or","\u2013 Directives 2008/56/EC, or","\u2013 Directive 2008/105/EC, or","\u2013 international agreements containing","important obligations on the protection of","marine waters from pollution, or","Or. en","(Reinstatement of amendment 329 from first reading.)"],"old":["","",""],"peid":"PE472.203v01-00","reference":"2009/0076(COD)","seq":"358","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.203+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Romana Jordan Cizelj","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-210","justification":" Consistency between Regulation 1107/2009 and this one is essential. Given that the\n provisions on zonal authorisation in Regulation 1107/2009 on PPP exclude the possibility for\n one Member State to delay the authorisation procedure in the other Member States once the\n Draft Inclusion by the Rapporteur has been finalised, the same principle should apply within\n the Biocides Regulation. This will allow avoiding unnecessary delays which could jeopardise\n the benefits of the mutual recognition process.","location":[["Council position","Article 33 \u2013 paragraph 5 a (new)"]],"meta":{"created":"2019-07-03T05:28:47"},"new":["5 a. Without prejudice to Articles 34, 35,","and 36, if agreement is not reached within","the 90 day period referred to in paragraph","5 each Member State which agrees to the","summary biocidal product characteristics","referred to in paragraph 4 may register its","agreement and authorise the product in","conformity with the summary of biocidal","product characteristics to which it agreed."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"210","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-211","location":[[" Council position","Article 33 \u2013 paragraph 6"]],"meps":[96890],"meta":{"created":"2019-07-03T05:28:47"},"new":["6. The procedure shall be closed after all","the Member States concerned have agreed","the summary of biocidal product","characteristics together with the terms and","conditions of the authorisation, and","recorded their agreement in the Register","for Biocidal Products.","A single authorisation number shall be","used in all the Member States concerned."],"old":["6. The procedure shall be closed after all","the Member States concerned have agreed","the summary of biocidal product","characteristics and recorded their","agreement in the Register for Biocidal","Products."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"211","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Romana Jordan Cizelj","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-212","justification":"Consistency between Regulation 1107/2009 and this one is essential. Given that the\nprovisions on zonal authorisation in Regulation 1107/2009 on PPP exclude the possibility for\none Member State to delay the authorisation procedure in the other Member States once the\nDraft Inclusion by the Rapporteur has been finalised, the same principle should apply within\nthe Biocides Regulation. This will allow avoiding unnecessary delays which could jeopardise\nthe benefits of the mutual recognition process.","location":[[" Council position","Article 33 \u2013 paragraph 7"]],"meta":{"created":"2019-07-03T05:28:47"},"new":["7. Within 30 days of closure of the","procedure, each of the remaining Member","States concerned shall authorise the","biocidal product in conformity with the","agreed summary of biocidal product","characteristics."],"old":["7. Within 30 days of closure of the","procedure, the reference Member State","and each of the Member States concerned","shall authorise the biocidal product in","conformity with the agreed summary of","biocidal product characteristics."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"212","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-213","location":[["Council position","Article 36 \u2013 title"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:47"},"new":["Derogations"],"old":["Derogations from mutual recognition"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"213","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-214","location":[["Council position","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:47"},"new":["By way of derogation from Articles 26,","31(2) and 41(1), any of the Member States","concerned may refuse to grant an","authorisation or to adjust the terms and","conditions of the authorisation to be","granted, provided that such a measure can","be justified on grounds of:"],"old":["By way of derogation from Article 31(2),","any of the Member States concerned may","propose to refuse to grant an authorisation","or to adjust the terms and conditions of the","authorisation to be granted, provided that","such a measure can be justified on grounds","of:"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"214","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-215","justification":" Member States should be allowed to derogate from mutual recognition in justified cases, and\n not just make a proposal to do so..","location":[[" Council position","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:47"},"new":["By way of derogation from Article 31(2),","any of the Member States concerned may","refuse to grant an authorisation or adjust","the terms and conditions of the","authorisation to be granted, provided that","such a measure can be justified on grounds","of:","Or. en","(Amendment to be coherent with amendment 342 from first reading.)"],"old":["By way of derogation from Article 31(2),","any of the Member States concerned may","propose to refuse to grant an authorisation","or to adjust the terms and conditions of the","authorisation to be granted, provided that","such a measure can be justified on grounds","of:","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"215","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-216","justification":" It should be clarified that the protection of vulnerable groups is included amongst the\n grounds to derogate from mutual recognition.","location":[[" Council position","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:47"},"new":["(c) the protection of health and life of","humans, particularly of vulnerable","groups, or of animals or plants;","Or. en","(Partial reinstatement of amendment 343 from first reading)"],"old":["(c) the protection of health and life of","humans, animals or plants;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"216","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Esther de Lange, Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-217","justification":"Member States should be able to request a derogation from the Commission to allow national\npolicies that relate to the implementation of other Union legislation, such as national policies\nthat ensure drinking water quality to continue to exist.","location":[["Council position","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point e a (new)"]],"meps":[38398,1929],"meta":{"created":"2019-07-03T05:28:48"},"new":["(e a) implementation of other Union","legislation, and in particular Directive","98/83/EC."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"217","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-218","justification":"Member States should be allowed to derogate from mutual recognition so as to safeguard\nnational implementation of Union legislation. This is particular relevant for the Drinking\nWater Directive 98/83/EC, for which different national conditions may result in stricter\nnational laws to comply with Union legislation.","location":[["Council position","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point e a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:28:48"},"new":["(e a) implementation of other relevant","Union legislation, and in particular","Directive 98/83/EC."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"218","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-219","location":[[" Council position","Article 36 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:48"},"new":["Any of the Member States concerned may,","in particular, in accordance with the first","subparagraph refuse to grant an","authorisation or to adjust the terms and","conditions of the authorisation to be","granted for a biocidal product containing","an active substance to which Article 5(2) or","10(1) applies."],"old":["Any of the Member States concerned may,","in particular, propose in accordance with","the first subparagraph to refuse to grant an","authorisation or to adjust the terms and","conditions of the authorisation to be","granted for a biocidal product containing","an active substance to which Article 5(2) or","10(1) applies."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"219","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-220","justification":" Member States should always be allowed to deviate from mutual recognition for substances\n covered by Article 5 or 10(1).","location":[[" Council position","Article 36 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:48"},"new":["Any of the Member States concerned may,","in particular, in accordance with the first","subparagraph, refuse to grant an","authorisation or adjust the terms and","conditions of the authorisation to be","granted for a biocidal product containing","an active substance to which Article 5(2) or","10(1) applies.","Or. en","(Amendment to be coherent with amendment 342 from first reading.)"],"old":["Any of the Member States concerned may,","in particular, propose in accordance with","the first subparagraph to refuse to grant an","authorisation or to adjust the terms and","conditions of the authorisation to be","granted for a biocidal product containing","an active substance to which Article 5(2) or","10(1) applies.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"220","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-221","location":[["Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:48"},"new":["The Member State concerned shall without","delay inform the other Member States and","the Commission of any decision taken in","this respects and its justification."],"old":["The Member State concerned shall","communicate to the applicant a detailed","statement of the grounds for seeking a","derogation pursuant to paragraph 1 and","shall seek to reach an agreement with the","applicant on the proposed derogation."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"221","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-222","location":[["Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 introductory part"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted"],"old":["If the Member State concerned is unable","to reach agreement with the applicant or","receives no reply from the applicant","within 60 days of that communication it","shall inform the Commission. In that","case, the Commission:","(a) may ask the Agency for an opinion on","scientific or technical questions raised by","the applicant or the Member State","concerned;","(b) shall adopt a decision on the","derogation in accordance with the","examination procedure referred to in","Article 81(3)."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"222","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-223","justification":" While it is acceptable to try to reach an agreement on national derogation with the applicant,\n in case no such agreement is found, the Member State should be free to derogate from mutual\n recognition as long as it provides a proper justification on the basis of the grounds listed in\n the first paragraph of this Article.","location":[[" Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 introductory part"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:48"},"new":["If the Member State concerned is unable to","reach agreement with the applicant or","receives no reply from the applicant within","60 days of that communication it shall","without delay inform other Member States","and the Commission of any decision taken","in this respect and its justification.","Or. en","paragraph)"],"old":["If the Member State concerned is unable to","reach agreement with the applicant or","receives no reply from the applicant within","60 days of that communication it shall","inform the Commission. In that case, the","Commission:","","","","(Reinstatement of amendment 342 from first reading. Linked to the deletion of the rest of this"],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"223","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-224","justification":"A Member State should be free to derogate from mutual recognition as long as it provides a\nproper justification on the basis of the grounds listed in the first paragraph of this Article. As\nsuch, there is no need for the Commission to ask the Agency for an opinion.","location":[[" Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted","Or. en","(Reinstatement of amendment 342 from first reading.)"],"old":["(a) may ask the Agency for an opinion on","scientific or technical questions raised by","the applicant or the Member State","concerned;","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"224","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-225","location":[["Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted"],"old":["(a) may ask the Agency for an opinion on","scientific or technical questions raised by","the applicant or the Member State","concerned;"],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"225","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-226","justification":"A Member State should be free to derogate from mutual recognition as long as it provides a\nproper justification on the basis of the grounds listed in the first paragraph of this Article. As\nsuch, there is no need for a Commission on this matter.","location":[["Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted","Or. en","(Reinstatement of amendment 342 from first reading)"],"old":["(b) shall adopt a decision on the","derogation in accordance with the","examination procedure referred to in","Article 81(3).","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"226","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-227","location":[[" Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted"],"old":["(b) shall adopt a decision on the","derogation in accordance with the","examination procedure referred to in","Article 81(3)."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"227","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage, Mich\u00e8le Rivasi, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-228","justification":" A Member State should be free to derogate from mutual recognition as long as it provides a\n proper justification on the basis of the grounds listed in the first paragraph of this Article. In\n that case, there is no need for this clause.","location":[[" Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[28156,97076,96743,96741],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted","Or. en","(Reinstatement of amendment 342 from first reading)"],"old":["The Commission's decision shall be","addressed to the Member State concerned","and the Commission shall inform the","applicant thereof.","","",""],"peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"228","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-229","location":[["Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted"],"old":["The Commission's decision shall be","addressed to the Member State concerned","and the Commission shall inform the","applicant thereof."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"229","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2011-09-13T00:00:00","id":"PE472.199-230","justification":"Member States should have the possibility to refuse to grant an authorisation/ adjust the\ncontain conditions without a say from the Commission. Such a decision shall be justified\naccording to the grounds referred to paragraph 1","location":[["Council position","Article 36 \u2013 paragraph 2 \u2013 subparagraph 4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:28:48"},"new":["deleted"],"old":["The Member State concerned shall take","necessary measures to comply with the","Commission's decision within 30 days of","its notification."],"orig_lang":"en","peid":"PE472.199v01-00","reference":"2009/0076(COD)","seq":"230","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-472.199+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-103","location":[["Proposal for a regulation","Citation 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:31"},"new":["Having regard to the Treaty on the","Functioning of the EU, and in particular","Article 114, 192 and 168 thereof,"],"old":["Having regard to the Treaty establishing","the European Community, and in","particular Article 95 thereof,"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-104","justification":" Guarantees to ensure a high level of protection for human health and the environment and to\n implement the prevention approach. It is necessary to protect vulnerable groups (pregnant\n women, infants). As well, the Biocidal Products Directive 98/8/EC has introduced a risk\n management approach for the benefit of human and animal health and for the environment\n instead of emphasizing the increase of the free movement of any kind of biocidal products by\n supporting product innovation and promoting healthy biocidal products. This is also of\n special benefit for SMEs.","location":[["Proposal for a regulation","Recital 3"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:31"},"new":["(3) The purpose of this Regulation is first","to ensure a high level of protection of","both human and animal health and the","environment from any harmful or","unacceptable effects linked with the use of","biocides and secondly to promote the","internal market of low-risk biocidal","products within the Community. Particular","attention should be paid to the protection","of vulnerable groups of the population,","including pregnant women, infants and","children. The precautionary principle","should be applied and this Regulation","should ensure that industry demonstrates","that substances or products produced or","placed on the market do not have any","harmful effect on human or animal","health or any unacceptable effects on the","environment."],"old":["(3) The purpose of this Regulation is to","increase the free movement of biocidal","products within the Community. In order","to remove as far as possible obstacles to","trade in biocidal products stemming from","the different levels of protection in the","Member States, harmonised rules should","be laid down for the approval of active","substances and the placing on the market","and use of biocidal products, including","the rules on the mutual recognition of","authorisations and on parallel trade."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-105","location":[[" Proposal for a regulation","Recital 3"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:31"},"new":["(3) The purpose of this Regulation is to","increase the free movement of biocidal","products within the Community and to","ensure a high level of protection of both","human and animal health and the","environment. Particular attention should","be paid to the protection of vulnerable","groups of the population, including","pregnant women, infants and children.","The Precautionary principle should be","applied to this regulation in order to","ensure that substances or products","produced or placed on the market do not","have any harmful effect on human or","animal health or any unacceptable effects","on the environment. In order to remove as","far as possible obstacles to trade in biocidal","products rules should be laid down for the","approval of active substances and the","placing on the market and use of biocidal","products, including the rules on the mutual","recognition of authorisations and on","parallel trade."],"old":["(3) The purpose of this Regulation is to","increase the free movement of biocidal","products within the Community. In order to","remove as far as possible obstacles to trade","in biocidal products stemming from the","different levels of protection in the","Member States, harmonised rules should","be laid down for the approval of active","substances and the placing on the market","and use of biocidal products, including the","rules on the mutual recognition of","authorisations and on parallel trade."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"105","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-106","justification":"The possibilities for derogation from the exclusion criteria need to be strictly limited. The text\nproposed here is in line with what was adopted for plant protection products.","location":[["Proposal for a regulation","Recital 10"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:31"},"new":["(10) With view to achieving a high level of","environmental and human health","protection, active substances with the worst","hazard profiles should not be approved for","use in biocidal products except in","exceptional and very specific situations.","These should include situations when the","approval is justified because of a negligible","exposure of humans to the substance or a","serious danger to public that cannot be","contained by any other means in that","Member State. This should be subject to","appropriate risk mitigation measures to","minimize any exposure and to the","submission of a substitution plan."],"old":["(10) With view to achieving a high level of","environmental and human health","protection, active substances with the worst","hazard profiles should not be approved for","use in biocidal products except in specific","situations. These should include situations","when the approval is justified because of a","negligible exposure of humans to the","substance, public health reasons or","disproportionate negative impacts of a","possible non-inclusion provided no","alternatives exist."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-107","justification":" An active substance that has not been authorised for plant protection products should only be\n used as a biocide in very exceptional cases.","location":[["Proposal for a regulation","Recital 11"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:31"},"new":["(11) In order to prevent the use of active","substances with the worst hazard profiles,","in particular when their use is not","authorised under Regulation (EC) No","XXX/2009 of the European Parliament and","of the Council of ..... 2009 concerning the","placing of plant protection products on the","market and repealing Council Directives","79/117/EEC and 91/414/EEC, it is","appropriate to restrict their approval to","situations when the exposure of humans to","the substance is negligible or the substance","is necessary to combat a serious danger to","public that cannot be contained by any","other means in that Member State."],"old":["(11) In order to prevent the use of active","substances with the worst hazard profiles,","in particular when their use is not","authorised under Regulation (EC) No","XXX/2009 of the European Parliament and","of the Council of ..... 2009 concerning the","placing of plant protection products on the","","market and repealing Council Directives","79/117/EEC and 91/414/EEC, it is","appropriate to restrict their approval to","situations when the exposure of humans to","the substance is negligible or the substance","is necessary for public health reasons."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"107","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-108","justification":" Producers of products of based on natural plant extracts which do not pose any particular\n risk for human health often have limited resources and are thus not in a position to cover the\n administrative costs of the substance assessment procedure.","location":[[" Proposal for a regulation","Recital 12 a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:31"},"new":["12a. A simplified assessment procedure","should be set up for substances consisting","of natural plant extracts whose","toxicological profile does not pose a risk","for human health."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"108","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-109","justification":"The renewal period for substances that are candidates for substitution should be the same as\nin the PPP regulation.","location":[[" Proposal for a regulation","Recital 13"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:31"},"new":["(13) Active substances can, on basis of","their intrinsic hazardous properties, be","designated as candidates for substitution","with other active substances, whenever","such substances considered as efficient","towards the targeted harmful organisms","become available in sufficient variety to","avoid the development of resistances","amongst harmful organisms. In order to","allow for a regular examination of","substances identified as candidates for","substitution, the inclusion period for these","substances should not exceed five years,","and in the case of renewal, not exceed","seven years. Furthermore, the","identification of substances which are","considered as candidates for substitution","should be considered as a first step of a","comparative assessment."],"old":["(13) Active substances can, on basis of","their intrinsic hazardous properties, be","designated as candidates for substitution","with other active substances, whenever","such substances considered as efficient","towards the targeted harmful organisms","become available in sufficient variety to","avoid the development of resistances","amongst harmful organisms. In order to","allow for a regular examination of","substances identified as candidates for","substitution, the inclusion period for these","substances should not, even in the case of","renewal, exceed ten years. Furthermore,","the identification of substances which are","considered as candidates for substitution","should be considered as a first step of a","comparative assessment."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"109","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-110","justification":" Products which are candidates for substitution should be reviewed regularly.","location":[["Proposal for a regulation","Recital 13"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:31"},"new":["(13) Active substances can, on basis of","their intrinsic hazardous properties, be","designated as candidates for substitution","with other active substances, whenever","such substances considered as efficient","towards the targeted harmful organisms","become available in sufficient variety to","avoid the development of resistances","amongst harmful organisms. In order to","allow for a regular examination of","substances identified as candidates for","substitution, the inclusion period for these","substances should not, even in the case of","renewal, exceed five years. Furthermore,","the identification of substances which are","considered as candidates for substitution","should be considered as a first step of a","comparative assessment."],"old":["(13) Active substances can, on basis of","their intrinsic hazardous properties, be","designated as candidates for substitution","with other active substances, whenever","such substances considered as efficient","towards the targeted harmful organisms","become available in sufficient variety to","avoid the development of resistances","","amongst harmful organisms. In order to","allow for a regular examination of","substances identified as candidates for","substitution, the inclusion period for these","substances should not, even in the case of","renewal, exceed ten years. Furthermore,","the identification of substances which are","considered as candidates for substitution","should be considered as a first step of a","comparative assessment."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-111","justification":"The risk to the environment and to human health has its source not so much in the active\nsubstance given the low quantities used in each product but rather in the product itself and in\nits use. Comparing only those products containing a substance classified as a candidate for\nsubstitution will have little relevance. There are very few new actives found every year, which\ncan hardly replace old ones and the candidates for substitution will remain on the market for\na longer period than expected. In order to stimulate innovation it is essential to favour only\nthe safest products on the market.","location":[[" Proposal for a regulation","Recital 14"]],"meta":{"created":"2019-07-03T05:29:31"},"new":["(14) In course of the authorisation or","renewal of biocidal product authorisations,","it should be possible to compare two or","more biocidal products with regard to risks","posed by them and benefits accrued","through their use. As a result of such a","comparative assessment, any biocidal","product could be replaced with others that","present significantly less risk to health or to","the environment and where there are no","significant adverse economic or practical","impacts. Appropriate phase-out periods","should be foreseen in such cases."],"old":["(14) In course of the authorisation or","renewal of biocidal product authorisations,","it should be possible to compare two or","more biocidal products with regard to risks","posed by them and benefits accrued","through their use. As a result of such a","comparative assessment, authorised","biocidal products containing active","substances indicated as candidates for","substitution could be replaced with others","that present significantly less risk to health","or to the environment and where there are","no significant adverse economic or","practical impacts. Appropriate phase-out","periods should be foreseen in such cases."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"111","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Glenis Willmott","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-112","justification":"It is necessary to retain product type 20 given that these biocidal products are not\npreservatives but disinfectants. For instance, products used to disinfect feed from human\npathogens such as Salmonella do not meet the requirements of the feed additives regulations.\nIndeed, the products do not \u2018favourably affect the feed\u2019 nor enhance its performance nor do\nthey have a preservative action. They intend to avoid Salmonella contamination of eggs and\npoultry and pig meat and therefore must be considered as disinfectant agents with their sole\npurpose being to protect human health","location":[["Proposal for a regulation","Recital 20"]],"meta":{"created":"2019-07-03T05:29:32"},"new":["deleted"],"old":["(20) As products used for the preservation","of food or feedstocks by the control of","harmful organisms, previously covered by","product type 20, are covered by Council","Directive 89/107/EEC and Regulation","(EC) No 1831/2003 of the European","Parliament and of the Council, it is not","appropriate to maintain this product type."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-113","justification":" It is necessary to keep former Directive 98/8\u2019s biocidal product type 20 (\u2018Preservatives for\n food or feedstocks\u2019), but its definition needs to be amended, given that these biocidal products\n are not preservatives but disinfectants (as a consequence, the older definition led to\n confusion). For instance, products used to disinfect feed from human pathogens such as\n Salmonella do not meet the requirements of the feed additives regulations. Indeed, the\n products do not \u2018favourably affect the feed\u2019 nor enhance its performance.","location":[["Proposal for a regulation","Recital 20"]],"meta":{"created":"2019-07-03T05:29:32"},"new":["deleted"],"old":["(20) As products used for the preservation","of food or feedstocks by the control of","harmful organisms, previously covered by","product type 20, are covered by Council","Directive 89/107/EEC and Regulation","(EC) No 1831/2003 of the European","Parliament and of the Council, it is not","appropriate to maintain this product type."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-114","justification":" It is necessary to keep biocidal product type 20 (\u2018Preservatives for food or feedstocks\u2019) but its\n definition needs to be amended, since these biocidal products are not preservatives but\n\ndisinfectants. For instance, products used to disinfect feed from human pathogens such as\nSalmonella do not meet the requirements of the feed additives regulations. Neither do they act\nas preservatives to prevent animal feed from deteriorating. These products must be therefore\nconsidered as disinfectant agents.","location":[[" Proposal for a regulation","Recital 20"]],"meps":[4319],"meta":{"created":"2019-07-03T05:29:32"},"new":["deleted"],"old":["(20) As products used for the preservation","of food or feedstocks by the control of","harmful organisms, previously covered by","product type 20, are covered by Council","Directive 89/107/EEC and Regulation","(EC) No 1831/2003 of the European","Parliament and of the Council, it is not","appropriate to maintain this product type."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"114","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-115","justification":"International authorisations cannot be automatically seen as fulfilling the requirements of EU\nlaw.","location":[["Proposal for a regulation","Recital 21"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:32"},"new":["(21) As the International Convention for","the Control and Management of Ships'","Ballast Water and Sediments provides for","an effective assessment of the risks posed","by ballast water management systems, the","final approval and subsequent type","approval of such systems should be","considered for the product authorisation","required under this Regulation."],"old":["(21) As the International Convention for","the Control and Management of Ships'","Ballast Water and Sediments provides for","an effective assessment of the risks posed","by ballast water management systems, the","final approval and subsequent type","approval of such systems should be","considered equivalent to the product","authorisation required under this","Regulation."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"115","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-116","justification":" Low-risk products should be primarily products with intrinsic low-risk properties. In order to\n judge this the active substances contained therein should be in all cases approved for use.","location":[["Proposal for a regulation","Recital 26"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:32"},"new":["deleted"],"old":["(26) In order to encourage the use of low-","risk biocidal products with more","favourable environmental or human","health profile compared to other biocidal","products, it should be allowed to authorise","low-risk biocidal products without prior","","approval of the active substances","contained therein."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"116","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-117","justification":" The sustainable use of biocides will be achieved by acknowledging the need for preventive\n measures as a first course.","location":[[" Proposal for a regulation","Recital 33 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:32"},"new":["33a. Infestation with harmful organisms","should be avoided by means of suitable","deterrents to banish or repel these","organisms. In addition, other","precautionary steps should be taken, e.g.","proper warehousing of goods, compliance","with hygiene standards and immediate","disposal of waste. Only if these measures","have no effect should further steps be","taken. Biocidal products that pose lower","risks for humans, animals and the","environment should always be used prior","to other products where those lower risk","products provide an effective remedy in","particular situations. Biocidal products","that are intended to harm, kill or destroy","animals that are capable of experiencing","pain and distress should be applied as a","last resort."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"117","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-118","justification":"In order to find an appropriate balance between free trade of goods and a safe market then\nthis article on parallel trade should be limited to identical products based on the same\nspecification and content of active substances and co-formulants.","location":[["Proposal for a regulation","Recital 45"]],"meta":{"created":"2019-07-03T05:29:32"},"new":["(45) In view of the benefits for the internal","market and for the consumer, it is desirable","to establish harmonised rules for parallel","trade of identical biocidal products that are","authorised in different Member States."],"old":["(45) In view of the benefits for the internal","market and for the consumer, it is desirable","to establish harmonised rules for parallel","trade of substantially identical biocidal","products that are authorised in different","Member States."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"118","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-119","justification":"Parallel trade should be confined to products which have the same specifications and contain\n\n the same active substances and co-formulants.","location":[["Proposal for a regulation","Recital 45"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:32"},"new":["(45) In view of the benefits for the internal","market and for the consumer, it is desirable","to establish harmonised rules for parallel","trade of identical biocidal products which","are authorised in different Member States."],"old":["(45) In view of the benefits for the internal","market and for the consumer, it is desirable","to establish harmonised rules for parallel","trade of substantially identical biocidal","products that are authorised in different","Member States."],"orig_lang":"t","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"119","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-120","location":[[" Proposal for a regulation","Recital 54"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:33"},"new":["(54) It is necessary to provide for the","effective communication of information on","risks resulting from biocidal products and","risk management measures as it forms an","essential part of the system established by","this Regulation. While facilitating access to","information, competent authorities, the","Agency and the Commission should","respect the principle of confidentiality and","avoid any disclosure of information which","could be harmful for the commercial","interests of the person concerned, except","where this is necessary for the protection","of human health and the environment."],"old":["(54) It is necessary to provide for the","effective communication of information on","risks resulting from biocidal products and","risk management measures as it forms an","essential part of the system established by","this Regulation. While facilitating access to","information, competent authorities, the","Agency and the Commission should","respect the principle of confidentiality and","avoid any disclosure of information which","could be harmful for the commercial","interests of the person concerned."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"120","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-121","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[[" Proposal for a regulation","Recital 60"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:33"},"new":["deleted","OJ L 184, 17.7.1999, p. 23."],"old":["(60) The measures necessary for the","implementation of this Regulation should","be adopted in accordance with Council","Decision 1999/468/EC of 28 June 1999","laying down the procedures for the","exercise of implementing powers","conferred on the Commission15 .","__________________________________","","15"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"121","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-122","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[["Proposal for a regulation","Recital 61"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:33"},"new":["deleted"],"old":["(61) In particular, the Commission should","be empowered to adopt measures to decide","on the application to include the active","substance in Annex I or to renew or","review the inclusion, to specify the","procedures related to the renewal and","review of an inclusion of an active","substance in Annex I, to extend the","provisions on Community authorisations","to other categories of biocidal products, to","specify the criteria and procedures related","to a cancellation of an authorisation or","amendments of the terms and conditions","of an authorisation, including a dispute","settlement mechanism, to specify the","overall applicable maximum quantities of","active substances or biocidal products that","may be released during experiments and","the minimum data to be submitted, to","establish a harmonised structure of fees","and other rules concerning the payment","of fees and charges to the competent","authorities and the Agency, to adapt the","Annexes to scientific and technical","progress, to carry out the work","programme and to specify the related","rights and obligations of the competent","authorities and the participants in the","programme and to extend the duration of","the work programme for a determined","period. Since those measures are of","","general scope and are designed to amend","non-essential elements of this Regulation,","inter alia, by supplementing this","Regulation with new non-essential","elements, they must be adopted in","accordance with the regulatory procedure","with scrutiny provided for in Article 5a of","Decision 1999/468/EC."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"122","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-123","justification":"Nanosilver is currently the main use of nanomaterials. The lack of knowledge about\nnanomaterials needs to be addressed.","location":[[" Proposal for a regulation","Recital 61 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:33"},"new":["61a. There is scientific uncertainty about","the safety of nanomaterials for human","health and the environment; for example","the EU Scientific Committee on Emerging","and Newly Identified Health Risks","(SCENIHR ) identified some specific","health hazards as well as toxic effects on","environmental organisms for some","nanomaterials. SCENIHR furthermore","found a general lack of high-quality","exposure data for both humans and the","environment, concluding that the","knowledge on the methodology for both","exposure estimates and hazard","identification needs to be further","developed, validated and standardized.","More and more biocidal products contain","nanosilver."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"123","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-124","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Recital 62"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:33"},"new":["deleted"],"old":["(62) When, on imperative grounds of","urgency, the normal time limits for the","regulatory procedure with scrutiny cannot","be complied with, the Commission should","be able to apply the urgency procedure","provided for in Article 5a(6) of Decision","1999/468/EC for the adoption of decisions","to amend the inclusion of an active","substance in Annex I or to remove it from","that Annex on basis of Article 13."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"124","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-125","justification":" To provide for transitional measures until the new rules on implementing acts are adopted.","location":[["Proposal for a regulation","Recital 62 a (new)"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:33"},"new":["62a. According to Article 291 TFEU,","rules and general principles concerning","mechanisms for control, by Member","States, of the Commission's exercise of","implementing powers are to be laid down","in advance by a regulation adopted in","accordance with the ordinary legislative","procedure. Pending the adoption of that","new regulation, and given the necessity to","adopt as soon as possible this Regulation,","control by Member States should be","exercised in accordance with the","provisions of Council Decision","1999/468/EC of 28 June 1999 laying","down the procedures for the exercise of","implementing powers conferred on the","Commission, insofar as those provisions","remain compatible with the amended","Treaties. References to those provisions","should nevertheless be replaced with","references to the rules and principles set","out in the new regulation as soon as that","regulation enters into force."],"old":["",""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"125","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-126","justification":"Food contact materials should not be within the scope of the Proposal as this would lead to\ndouble regulation and assessment. Food contact materials are already regulated by the Food\nContact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\nto the rules governing food contact materials, they should be addressed through a revision of\nthe food contact legislation, not by extending the scope of the BPR.","location":[[" Proposal for a regulation","Recital 66"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:33"},"new":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","to be prepared to apply the rules","concerning in situ generated active","substances and treated articles and","materials."],"old":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","to be prepared to apply the rules","concerning in situ generated active","substances, treated articles and materials","and food contact materials."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"126","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-127","justification":"Food contact materials are already governed by Regulation (EC) No 1935/2004. This\nRegulation may not cover all aspects of assessment of materials and their use. However, new\nrestrictions should be introduced through a review of the legislation specific to food contact\nmaterials and in the Biocidal Products Regulation in order to avoid duplication of rules and\nassessments.","location":[["Proposal for a regulation","Recital 66"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:33"},"new":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","to be prepared to apply the rules","concerning in situ generated active","substances, and treated articles and","materials."],"old":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","to be prepared to apply the rules","concerning in situ generated active","substances, treated articles and materials","and food contact materials."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"127","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-128","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 subparagraph 1 a"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["1a. The purpose of this Regulation is to","ensure a high level of protection of both","human and animal health and the","environment. The provisions of this","Regulation are underpinned by the","precautionary principle in order to ensure","that active substances or products placed","on the market do not have harmful effects","on human or animal health or the","environment. Member States shall not be","prevented from applying the","precautionary principle when there is","scientific uncertainty as to the risks with","regard to human or animal health or the","environment posed by the biocide","products to be authorised in their","territory."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"128","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-129","justification":" Food contact materials are already governed by Regulation (EC) No 1935/2004. This\n Regulation may not cover all aspects of assessment of materials and their use. However, new\n restrictions should be introduced through a review of the legislation specific to food contact\n\nmaterials and in the Biocidal Products Regulation in order to avoid duplication of rules and\nassessments.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point p a (new)"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:34"},"new":["pa. Regulation (EC) No 1935/2004 of the","European Parliament and of the Council","of 27 October 2004 on materials and","articles intended to come into contact with","food1;","1","OJ L 338, 13.11.2004, p. 4."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"129","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-130","justification":"Food contact materials should not be within the scope of the Proposal as this would lead to\ndouble regulation and assessment. Food contact materials are already regulated by the Food\nContact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\nto the rules governing food contact materials, they should be addressed through a revision of\nthe food contact legislation, not by extending the scope of the BPR.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point p a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["pa. Regulation (EC) No 1935/2004 of the","European Parliament and of the Council","of 27 October 2004 on materials and","articles intended to come into contact with","food and repealing Directives 80/590/EEC","and 89/109/EEC;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"130","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-131","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point p a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["pa. Council Directive 98/83/EC of 3","November 1998 on the quality of water","intended for human consumption;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"131","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-132","justification":" International authorisations should not be automatically carried over into the EU.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 8"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:34"},"new":["8. The data provided for biocidal products","which obtained the final approval under the","International Convention for the Control","and Management of Ships' Ballast Water","and Sediments shall be considered when","deciding about authorisations of such","products pursuant to this Regulation.","Articles 38 and 57 shall apply accordingly."],"old":["8. Biocidal products which obtained the","final approval under the International","Convention for the Control and","Management of Ships' Ballast Water and","Sediments shall be considered as","authorised under Chapter VII of this","Regulation. Articles 38 and 57 shall apply","accordingly."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"132","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-133","justification":"It would seem appropriate to highlight the fact that children are more vulnerable to harmful\nproducts than adults, on whom the proposal for a regulation is basing tolerance criteria.\nChildren often find themselves in places which have been sprayed with biocidal products and\npesticides, and show reactions - immediately or in the longer term - which are directly or\nindirectly attributable to the harmful substances.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point f"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:34"},"new":["(f) 'substance of concern' means","any substance, other than the active","substance, which has an inherent capacity","to cause an adverse effect, immediately or","in the more distant future on humans,","especially children, animals or the","environment and is present or is produced","in a biocidal product in sufficient","concentration to present risks of such an","effect;"],"old":["(f) 'substance of concern' means","","any substance, other than the active","substance, which has an inherent capacity","to cause an adverse effect on humans,","animals or the environment and is present","or is produced in a biocidal product in","sufficient concentration to present risks of","such an effect;"],"orig_lang":"t","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"133","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-134","justification":"It would seem appropriate to highlight the fact that children are more vulnerable to harmful\nproducts than adults, on whom the proposal for a regulation is basing tolerance criteria.\nChildren often find themselves in places which have been sprayed with biocidal products and\npesticides, and show reactions - immediately or in the longer term - which are directly or\nindirectly attributable to the harmful substances.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point g"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:34"},"new":["(g) 'harmful organism' means","organisms, including pathogenic agents,","which have an unwanted presence or a","detrimental effect immediately or in the","more distant future on humans, especially","children, human activities or the products","they use or produce, or on animals or the","environment;"],"old":["(g) 'harmful organism' means","","organisms, including pathogenic agents,","which have an unwanted presence or a","detrimental effect on humans, their","activities or the products they use or","produce, or on animals or the environment;"],"orig_lang":"t","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"134","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-135","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point h"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["(h) \u2018residues\u2019 means","substances present in or on plants or","products of plant origin, edible animal","products, water resources drinking water","or elsewhere in the environment and","resulting from the use of a biocidal","product, including their metabolites,","breakdown or reaction products;"],"old":["(h) \u2018residues\u2019 means","substances present in or on plants or","products of plant origin, edible animal","products, drinking water or elsewhere in","the environment and resulting from the use","of a biocidal product, including their","metabolites, breakdown or reaction","products;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"135","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-136","justification":" Not just the 'first supply', but 'any supply' should be deemed to be placing on the market, as in\n other chemicals legislation (see REACH). Derogations should only be admitted when, for\n example, a craftsman is commissioned by a client to paint a fa\u00e7ade with a substance that\n contains an authorised biocidal product. This clarification is necessary.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point i"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:34"},"new":["(i) 'placing on the market' means","the supply of a biocidal product to third","parties, whether in return for payment or","free of charge, or the making available of","a biocidal product to third parties.","Importation shall be deemed to be placing","on the market. No supply to third parties","is involved, for example, when in the","course of a commercial activity treated","materials or products are individually","manufactured and then incorporated by","the manufacturer."],"old":["(i) 'placing on the market' means","the first supply of a biocidal product for","distribution or for use on the Community","market in the course of a commercial","activity, whether in return for payment or","free of charge;"],"orig_lang":"e","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"136","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-137","justification":"The Commission's definition of \u2018placing on the market\u2019 is far more narrow than the definition\nin the current Biocide directive. The proposed change would bring the new Biocide\nRegulation in line with REACH, whereby downstream sale will also be limited.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point i"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["(i) \u2018placing on the market\u2019 means","supplying or making available biocidal","products, whether in return for payment or","free of charge, to a third party, import","shall be deemed to be placing on the","market;"],"old":["(i) \u2018placing on the market\u2019 means","","the first supply of a biocidal product for","distribution or for use on the Community","market in the course of a commercial","activity, whether in return for payment or","free of charge;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"137","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-227","justification":"Adaptation to the same author's amendment to Article 3(i). As with REACH, not just the 'first\nsupply', but 'any supply' should be a 'placing on the market', so as to ensure that the health\nand environmental regulations apply at every stage. The application for authorisation is of\ncourse necessary only for the initial placing on the market.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:33"},"new":["2. Application for authorisation shall be","made by, or on behalf of, the person who","shall be responsible for the initial placing","on the market of a biocidal product in a","particular Member State or in the","Community."],"old":["2. Application for authorisation shall be","made by, or on behalf of, the person who","shall be responsible for the placing on the","market of a biocidal product in a particular","Member State or in the Community."],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"227","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-228","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:33"},"new":["2. Application for authorisation shall be","made by, or on behalf of, the person","holding the authorisation. The person","may be, but is not necessarily, the person","responsible for the placing on the market of","a biocidal product in a particular Member","State or in the Community."],"old":["2. Application for authorisation shall be","made by, or on behalf of, the person who","shall be responsible for the placing on the","market of a biocidal product in a particular","Member State or in the Community."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"228","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Esther De Lange","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-138","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point k"]],"meps":[38398],"meta":{"created":"2019-07-03T05:29:34"},"new":["(k) \u2018treated material or article\u2019 means","i) any substance, mixture, material or","article which was treated with or","incorporates one or more biocidal products","with the intention to protect the substance,","mixture, material or article from","deterioration caused by harmful organisms,","or","ii) any substance, mixture, material or","article, which was treated with or","incorporates one or more biocidal","products with the intention to destroy,","deter, render harmless, prevent the action","of, or otherwise exert a controlling effect","on any harmful organism, provided that","the substance, mixture, material or article","has a function of its own;"],"old":["(k) \u2018treated material or article\u2019 means","","any substance, mixture, material or article","which was treated with or incorporates one","or more biocidal products with the","intention to protect the substance, mixture,","material or article from deterioration","caused by harmful organisms;",""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"138","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-229","justification":" The person responsible for placing an authorised product on the market is not always the\n holder of the authorisation. The industry needs this flexibility in the supply chain. The\n regulation should make it clear that, where the applicant wishes to obtain authorisation for a\n frame formulation, he must submit a single application for authorisation to cover all products\n to be included in the formulation.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:33"},"new":["2. Application for authorisation shall be","made by, or on behalf of, the person who","will be the holder of the authorisation.","The person may be, but is not necessarily,","the person responsible for the placing on","the market of a biocidal product in a","particular Member State or in the","Community."],"old":["2. Application for authorisation shall be","made by, or on behalf of, the person who","shall be responsible for the placing on the","market of a biocidal product in a particular","Member State or in the Community."],"orig_lang":"r","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"229","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-139","justification":" The term 'external effect' is not defined in the regulation on biocidal products itself, but in the\n 'Manual of Decisions'.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point k a (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:34"},"new":["ka. 'External biocidal effect' means","the effect of applications whereby the","incorporated biocidal product is intended","to be released under normal conditions of","use which can reasonably be foreseen."],"orig_lang":"e","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"139","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-230","justification":"The industry needs more flexibility in the supply chain. In fact it is not uncommon that a\nproduct is imported in one country and placed on the market under the responsibility of a\ndistributor which is not the holder of the authorisation or, in case of multinational companies,\nthat each individual sister company is responsible for placing the product on the market in\ntheir own country. The provision that the holder of the authorisation and the person\nresponsible for placing the product on the market are the same would create a very rigid and\nunpractical framework for Industry to work with.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:33"},"new":["2. Application for authorisation shall be","made by, or on behalf of, the person who","will be the holder of the authorisation.","This person may be, but is not necessarily,","the person responsible for the placing on","the market of a biocidal product in a","particular Member State or in the","Community."],"old":["2. Application for authorisation shall be","made by, or on behalf of, the person who","shall be responsible for the placing on the","market of a biocidal product in a particular","Member State or in the Community."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"230","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-140","justification":"This brings the frame formulation in accordance with Directive 98/8/EC. Underlining that the\nframe-formulations only apply for low-risk products will encourage sustainable product\ninnovation and an appropriate risk-management.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point p"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["(p) \u2018frame formulation\u2019 means","a group of low-risk biocidal products","having similar uses and presenting limited","variations in their composition with regard","to a reference biocidal product belonging","to that group which contains the same","active substances of the same","specifications where such permitted","variations do not adversely affect the level","of risk or the efficacy of these products;","where the variation is a reduction in the","percentage of the active substance and/or","a change in percentage composition of","one or more of the non-active substances;"],"old":["(p) \u2018frame formulation\u2019 means","","a group of biocidal products having","similar uses and presenting limited","variations in their composition with regard","to a reference biocidal product belonging","to that group which contains the same","active substances of the same","specifications where such permitted","","variations do not adversely affect the level","of risk or the efficacy of these products;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"140","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-477","justification":"Nanomaterials are used due to their different or enhanced properties as compared to\nsubstances in bulk form. Due to their miniscule size and the resulting increase of relative\nsurface area, they may pose new risks. Thus, they require an assessment in their own right.\nAn inclusion of a substance in Annex I must not count for nanomaterials, unless specifically\nmentioned, otherwise nanomaterials would be given a \"free-ride\". The wording proposed\nhere is taken from the cosmetics regulation, which also has a positive list approach for\ncertain substances (preamble to Annexes II to VI).","location":[["Proposal for a regulation","Annex I - introductory paragraph (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:33"},"new":["Substances listed in Annex I do not cover","nanomaterials, except where specifically","mentioned."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"477","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-231","justification":"The industry needs this flexibility in the supply chain. The text should explicitly specify that in\ncase the applicant would like to have an authorisation granted for a frame formulation, then\none single application is to be made to cover all products intended to be part of the frame.\nSuch a clarification does not currently appear in the text.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 3 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:33"},"new":["A single application for authorisation may","be made by the applicant for a group of","products intended to be authorised under","a frame formulation."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"231","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-478","justification":" Difenacoum is a highly problematic substance on all accounts (toxicity, persistence,\n bioaccumulation, teratogenicity, effects on non-target organisms, effects on human health,\n suffering of target organisms). It should only be used when it has been proven that it is\n necessary to control a serious danger to public health that cannot be controlled otherwise.\n The risk mitigation measures should be made legally binding. Only professionals should be\n allowed to use it subject to strict criteria.","location":[["Proposal for a regulation","Annex I -difenacoum - 9th row - 8th column"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:33"},"new":["In view of the fact that the active substance","characteristics meet the criteria for","classification as toxic to reproduction","category 1A and render it potentially","persistent, liable to bioaccumulate and","toxic, or very persistent and very liable to","bioaccumulate, the active substance shall","be considered a candidate for substitution","in accordance with Article 9.","In view of the risks identified for the","aquatic compartments, the fact that the","active substance is very toxic to birds and","mammals, the risks for infant poisoning,","the problem of resistance formation and","the pain and prolonged suffering it causes","in target animals, authorisations are","subject to the following condition:","A serious danger to public health is","proven that cannot be controlled by any","other means.","The following risk mitigation measures","shall be taken:","(1) The nominal concentration of the active","substance in the products shall not exceed","75 mg/kg and only ready-for-use products","shall be authorised.","(2) Products shall contain an aversive agent","and, where appropriate, a dye.","(3) Products shall not be used as tracking","powder.","(4) Primary as well as secondary exposure","of humans, non-target animals and the","environment shall be minimised by","applying all appropriate and available risk","mitigation measures. These include,","amongst others, that the use shall be","restricted to professional use only, that an","upper limit to the package size shall be set","and that only tamper resistant and secured","bait boxes shall be used."],"old":["In view of the fact that the active substance","characteristics render it potentially","persistent, liable to bioaccumulate and","toxic, or very persistent and very liable to","bioaccumulate, the active substance shall","be considered a candidate for substitution","in accordance with Article 9.","Authorisations are subject to the following","","","conditions:","","(1) The nominal concentration of the active","substance in the products shall not exceed","75 mg/kg and only ready-for-use products","shall be authorised.","","(2) Products shall contain an aversive agent","and, where appropriate, a dye.","(3) Products shall not be used as tracking","powder.","(4) Primary as well as secondary exposure","of humans, non-target animals and the","environment are minimised, by","considering and applying all appropriate","and available risk mitigation measures.","These include, amongst others, the","restriction to professional use only, setting","an upper limit to the package size and","laying down obligations to use tamper","resistant and secured bait boxes."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"478","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-141","justification":"Food contact materials are already governed by Regulation (EC) No 1935/2004. This\nRegulation may not cover all aspects of assessment of materials and their use. However, new\nrestrictions should be introduced through a review of the legislation specific to food contact\nmaterials and in the Biocidal Products Regulation in order to avoid duplication of rules and\nassessments.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point s"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:34"},"new":["deleted"],"old":["(s) 'food contact materials' means","any material and article intended to come","into contact with food which are covered","by Regulation (EC) No 1935/20044343;","_________________________________","","43","OJ L 338, 13.11.2004, p. 4."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"141","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-232","justification":" The person responsible for placing an authorised product on the market is not always the\n holder of the authorisation. The industry needs this flexibility in the supply chain. The\n regulation should make it clear that, where the applicant wishes to obtain authorisation for a\n frame formulation, he must submit a single application for authorisation to cover all products\n to be included in the formulation.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 3 a (new)"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:33"},"new":["A single application for authorisation","may be made by the applicant for a group","of products to be authorised in the context","of a frame formulation."],"orig_lang":"r","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"232","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-479","justification":"Threshold of Toxicological Concern is a \u201cweight of evidence\u201d risk assessment approach used\nin the safety assessment of food-contact materials, and other substances of unknown toxicity\nbut with demonstrably low human risk. When combined with known information and\npredicted behaviour, the approach bins chemicals into classes, with their own acceptable\nhuman exposure limits. If exposure is below these very low levels, toxicity testing may be\navoided. A project is currently under by the International Life Sciences Institute on\ndeveloping a TTC approach for some biocidal products.","location":[["Proposal for a regulation","Annex II \u2013 heading 1 \u2013 point 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:33"},"new":["1. Dossiers on active substances shall","contain the information needed to establish","that exposure is below the Threshold of","Toxicological Concern (TTC), or where","relevant, to establish the Acceptable Daily","Intake (ADI), Acceptable Operator","Exposure Level (AOEL), Predicted","Environmental Concentration (PEC) and","Predicted No-Effect Concentration","(PNEC)."],"old":["1. Dossiers on active substances shall","contain the information needed to","establish, where relevant, Acceptable Daily","Intake (ADI), Acceptable Operator","Exposure Level (AOEL), Predicted","Environmental Concentration (PEC) and","Predicted No-Effect Concentration","(PNEC)."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"479","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-142","justification":" Food contact materials should not be within the scope of the Proposal as this would lead to\n double regulation and assessment. Food contact materials are already regulated by the Food\n Contact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\n to the rules governing food contact materials, they should be addressed through a revision of\n the food contact legislation, not by extending the scope of the BPR.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point s"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["deleted","OJ L 338, 13.11.2004, p. 4"],"old":["(s) \u2018food contact materials\u2019 means","any material and article intended to come","into contact with food which are covered","by Regulation (EC) No 1935/200443 ;","________________________________","","43"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"142","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-233","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5 \u2013 subparagraph 2 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:33"},"new":["Mandatory measures shall be established","and implemented with a Framework","Directive for Community action in order","to achieve the sustainable professional","use of biocides including the introduction","of National Action Plans, integrated pest","management, risk reduction measures","and the promotion of alternatives.","Two years after the adoption of this","Regulation, the Commission shall submit","a proposal to the European Parliament","and the Council."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"233","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-480","justification":" Threshold of Toxicological Concern is a \u201cweight of evidence\u201d risk assessment approach used\n extensively in the safety assessment of food additives, flavourings, food-contact materials, and\n other substances of unknown toxicity but with demonstrably low human exposure. When\n combined with known structural information and predicted metabolism or other behaviour,\n the approach bins chemicals into classes, each of which has its own acceptable human\n exposure limits. If exposure is below these very low levels, toxicity testing may be avoided.","location":[["Proposal for a regulation","Annex II \u2013 heading 1 \u2013 point 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["(1) Dossiers on active substances shall","contain the information needed to establish","that exposure is below the Threshold of","Toxicological Concern (TTC), or where","relevant, to establish the Acceptable Daily","Intake (ADI), Acceptable Operator","Exposure Level (AOEL), Predicted","Environmental Concentration (PEC) and","Predicted No-Effect Concentration","(PNEC)."],"old":["(1) Dossiers on active substances shall","contain the information needed to","establish, where relevant, Acceptable Daily","Intake (ADI), Acceptable Operator","Exposure Level (AOEL), Predicted","Environmental Concentration (PEC) and","Predicted No-Effect Concentration","","(PNEC)."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"480","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-234","justification":"Article 15 should be extended by a new Paragraph 1 to include regulations on the sustainable\nuse of biocides.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5 a (new)"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:33"},"new":["5a. Infestation with harmful organisms is","to be avoided by suitable measures of","deterrence to banish or repel these","organisms. In addition, other","precautionary steps have to be taken, e.g.","proper warehousing of goods, compliance","with hygiene standards and immediate","disposal of waste. Only after these","measures show no effect, further steps","should be taken. Biocidal products that","pose low risks for humans, animals and","the environment should always be used","prior to others. Biocidal products that are","intended to harm, kill or destroy animals","that are capable of experiencing pain and","distress should only be applied as a last","resort."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"234","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-143","justification":"The regulation should include a definition of vulnerable groups, in line with regulation\n1107/2009 and the REACH legislation.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["ua. \u2018Vulnerable Groups\u2019 means","persons needing specific consideration","when assessing the acute and chronic","health effects of biocide products. These","include pregnant and nursing women, the","unborn, infants and children, the elderly","and workers and residents subject to high","biocide exposure over the long term;"],"old":[""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"143","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-481","justification":" The original phrasing of Paragraph 4 of Annex II is not clear enough and will hinder the use\n of alternatives to animal experimentation that are mentioned in Annex IV","location":[[" Proposal for a regulation","Annex II \u2013 heading 1 \u2013 point 4"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["4. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Council","Regulation (EC) No 440/2008. However, if","a method is inappropriate or not described,","other methods shall be used which are","scientifically appropriate and must be","justified in the application."],"old":["4. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Council","Regulation (EC) No 440/2008. However, if","a method is inappropriate or not described,","other methods shall be used which are,","whenever possible, internationally","recognised and must be justified in the","application."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"481","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-235","justification":"Ensures a consistent protection of the environment and human health. It is necessary to\ncomply with all relevant Community standards for the protection of the environment. This is\nalso ensured with the Biocidal Products Directive 98/8/EC. In addition, the protection of\n\n vulnerable groups \u2013 like it is prescribed according to Regulation (EC) 1107/2009 concerning\n provisions on plant protection products - and combination effects should be taken into\n consideration.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint i"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:33"},"new":["i) it is necessary and sufficiently effective;"],"old":["i) it is sufficiently effective;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"235","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-144","justification":"This regulation should include a definition of vulnerable groups, in line with regulation\n1107/2009 on phytopharmaceutical products and regulation REACH 1907/2006.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u a (new)"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:35"},"new":["ua. \u2018vulnerable groups\u2019 means","persons needing specific consideration","when assessing the acute and chronic","health effects of biocide products. These","include inter alia pregnant and nursing","women, infants and children, and the","elderly ;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"144","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-482","justification":"The original phrasing of Paragraph 4 of Annex II is not clear enough and will hinder the use\nof alternatives to animal experimentation that are mentioned in Annex IV","location":[[" Proposal for a regulation","Annex II \u2013 heading 1 \u2013 paragraph 4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["(4) Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Council","Regulation (EC) No 440/2008. However, if","a method is inappropriate or not described,","other methods shall be used which are","scientifically appropriate and must be","justified in the application."],"old":["(4) Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Council","Regulation (EC) No 440/2008. However, if","a method is inappropriate or not described,","other methods shall be used which are,","whenever possible, internationally","recognised and must be justified in the","application."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"482","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-236","justification":" Ensures a consistent protection of the environment and human health. It is necessary to\n comply with all relevant Community standards for the protection of the environment. This is\n also ensured with the Biocidal Products Directive 98/8/EC. In addition, the protection of\n vulnerable groups \u2013 like it is prescribed according to Regulation (EC) 1107/2009 concerning\n provisions on plant protection products - and combination effects should be taken into\n consideration.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint ii"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:33"},"new":["ii) it has no real or potential effects on the","target organisms, in particular unacceptable","resistance or cross-resistance or","unnecessary suffering and pain for","vertebrates;"],"old":["ii) it has no unacceptable effects on the","target organisms, in particular unacceptable","resistance or cross-resistance or","unnecessary suffering and pain for","vertebrates;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"236","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-145","justification":" It is necessary to define the type of variations that can be made to an existing authorised\n biocidal product.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 points u a - u c (new)"]],"meta":{"created":"2019-07-03T05:29:35"},"new":["ua. 'Administrative change' means","a variation to an existing authorisation of","a purely administrative nature, which","does not involve a re-assessment of the","risk for public health or the environment","or the efficacy of the product.","ub. 'Minor change' means","a variation to an existing authorisation","which cannot be deemed to be an","administrative variation as it requires a","limited re-assessment of the risk for","public health or the environment and/or","of the efficacy of the product. The","variation should not adversely affect the","level of risk for public health or the","environment and the efficacy of the","product.","uc. 'Major change' means","a variation to an existing authorisation","which cannot be deemed to be an","administrative change or a minor change","and which requires a full re-assessment of","the risk for public health or the","environment and/or of the efficacy of the","product;"],"old":[""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"145","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-483","justification":" The neccessity of advise from 3Rs experts has to be made articulate. Applicants have to be\n supported in the design of intelligent testing strategies to avoid unneccessary or duplicate\n testing and to minimise animal experimentation","location":[["Proposal for a regulation","Annex II \u2013 title 1 - paragraph 4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["Before new tests are carried out to","determine the properties listed in this","Annex, all available in vitro data, in vivo","data, historical human data, data from valid","(Q)SARs and data from structurally related","substances (read-across approach) shall be","assessed first. In vivo testing with","corrosive substances at concentration/dose","levels causing corrosivity shall be avoided.","Prior to testing, further guidance on","intelligent testing strategies should be","sought from experts in alternatives to","animal experimentation in addition to this","Annex."],"old":["Before new tests are carried out to","determine the properties listed in this","Annex, all available in vitro data, in vivo","data, historical human data, data from valid","(Q)SARs and data from structurally related","substances (read-across approach) shall be","assessed first. In vivo testing with","corrosive substances at concentration/dose","levels causing corrosivity shall be avoided.","Prior to testing, further guidance on testing","strategies should be consulted in addition","to this Annex."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"483","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-237","justification":"It is unacceptable to speak of \"unacceptable\" effects when speaking about human health. In\nthe context of the authorisation of plant protection products, the term \"unacceptable\" was\nonly used in the context of environmental effects. The wording from the PPP regulation\nshould be used here, all the more that it also includes cumulative and synergistic effects.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint iii"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:34"},"new":["iii) it shall have no immediate or delayed","harmful effect on human health itself or","as a result of its residues, including that of","vulnerable groups, or animal health,","directly or through drinking water (taking","into account substances resulting from","water treatment), food, feed or air, or","consequences in the workplace or through","other indirect effects, taking into account","known cumulative and synergistic effects","where the scientific methods accepted by","the Agency to assess such effects are","available; or on groundwater;"],"old":["iii) it has no unacceptable effects itself or","as a result of its residues, directly or","indirectly, on human or animal health;",""],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"237","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-146","justification":"The Commission is currently developing a new horizontal definition of nanomaterials with the\nsupport of the Scientific Committee on Emerging and Newly Identified Health Risks\n(SCENIHR). SCENIHR has already proposed in an opinion in 2009 to extend the current\ndefinition based on physical size by the addition of a limit of the specific surface area. This\nshould be reflected in the proposal for a new nanomaterial definition the current situation as\nit stands.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u a (new)"]],"meps":[4319],"meta":{"created":"2019-07-03T05:29:35"},"new":["ua. Nanomaterials are defined as","intentionally manufactured, solid,","particulate substances, either in powder","form or as dispersions or as aerosols,","consisting of nano-objects and their","aggregates and agglomerates,","(i) Which contain, when measured by","standardized and recognized methods, at","least 10 wt.-% of nano-objects,","(ii) Or which have, when measured by","appropriate methods, a volume specific","surface area larger than 6 x 1/100 nm.","Nano-objects are discrete particles with","one, two or three external dimensions","between approximately 1 nm and 100 nm;"],"old":["","",""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"146","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-484","justification":" The neccessity of advise from experts has to be made articulate. Applicants have to be\n supported in the design of intelligent testing strategies to avoid unneccessary or duplicate\n testing and to minimise animal experimentation.","location":[[" Proposal for a regulation","Annex II \u2013 title 1 - paragraph 4"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["Before new tests are carried out to","determine the properties listed in this","Annex, all available in vitro data, in vivo","data, historical human data, data from valid","(Q)SARs and data from structurally related","substances (read-across approach) shall be","assessed first. In vivo testing with","corrosive substances at concentration/dose","levels causing corrosivity shall be avoided.","Prior to testing, further guidance on","intelligent testing strategies should be","sought from experts in alternatives to","animal experimentation in addition to this","Annex."],"old":["Before new tests are carried out to","determine the properties listed in this","Annex, all available in vitro data, in vivo","data, historical human data, data from valid","(Q)SARs and data from structurally related","substances (read-across approach) shall be","assessed first. In vivo testing with","corrosive substances at concentration/dose","levels causing corrosivity shall be avoided.","Prior to testing, further guidance on testing","strategies should be consulted in addition","to this Annex."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"484","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-238","justification":"Ensures a consistent protection of the environment and human health. It is necessary to\ncomply with all relevant Community standards for the protection of the environment. This is\nalso ensured with the Biocidal Products Directive 98/8/EC. In addition, the protection of\nvulnerable groups \u2013 like it is prescribed according to Regulation (EC) 1107/2009 concerning\nprovisions on plant protection products - and combination effects should be taken into\nconsideration.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint iii"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:34"},"new":["iii) it has no real or potential adverse","effects itself or as a result of its metabolites","and residues, directly or indirectly, on the","health of humans, particularly of","vulnerable groups, or animal health;"],"old":["iii) it has no unacceptable effects itself or","as a result of its residues, directly or","indirectly, on human or animal health;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"238","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-485","justification":"The European Commission has accepted two in vitro methods for the testing of skin irritation\non July 23rd, 2009: The \u201cEpiDerm SIT\u201d and the \u201cSkinEthic RHE\u201d assays. Consequently, the\nin vivo tests for skin irritation are no longer necessary and should be deleted from the data\nrequirements in Annex II. The first adaptation to technical progress of Regulation (EC) No\n440/2008 included a new test guideline for in vitro dermal irritation that can replace the in\nvivo method for the purposes of this Regulation. Consequently, the in vivo method is no\nlonger necessary and should be deleted.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.1.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["deleted"],"old":["6.1.1. The study does not need to be","conducted if:","\u2013 the substance is classified as corrosive","to the skin or as a skin irritant; or","\u2013 the substance is a strong acid (pH < 2,0)","or base (pH > 11,5); or","\u2013 the substance is flammable in air at","room temperature; or","\u2013 the substance is classified as very toxic","in contact with skin; or","\u2013 an acute toxicity study by the dermal","route does not indicate skin irritation up","to the limit dose level (2 000 mg/kg body","weight)."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"485","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-147","justification":"It is necessary to define the type of variations that can be made to an existing authorised\nbiocidal product.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["ua. 'Administrative change' means","a variation to an existing authorisation of","a purely administrative nature, which","does not involve a re-assessment of the","risk for public health or the environment","or the efficacy of the product."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"147","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-239","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint iii"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:34"},"new":["iii) it has no immediate or delayed","unacceptable effects itself or as a result of","its residues, directly or indirectly, on","human or animal health, taking into","account vulnerable groups;"],"old":["iii) it has no unacceptable effects itself or","as a result of its residues, directly or","indirectly, on human or animal health;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"239","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-148","justification":" It is necessary to define the type of variations that can be made to an existing authorised\n biocidal product.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u b (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["ub. 'Minor change' means","a variation to an existing authorisation","which cannot be deemed to be an","administrative variation as it requires a","limited re-assessment of the risk for","public health or the environment and/or","of the efficacy of the product. The","variation should not adversely affect the","level of risk for public health or the","environment and the efficacy of the","product."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"148","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-486","justification":" On September 7th 2009, the OECD officially adopted adopted two alternative methods as Health\n Effects Test Guidelines for the assesment of severe eye irritation. The new test guidelines have\n been designated Test Guidelines TG 437: Bovine corneal opacity and permeability (BCOP) and\n TG 438: Isolated chicken-eye assay (ICE). Consequently, the in vivo test for eye irritation should\n be deleted from the data requirements in Annex II","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.2.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["deleted"],"old":["6.2.1. The study does not need to be","conducted if:","","\u2013 the substance is classified as irritating to","eyes with risk of serious damage to eyes;","or","\u2013 the substance is classified as corrosive","to the skin and provided that the applicant","classified the substance as eye irritant; or","\u2013 the substance is a strong acid (pH < 2,0)","or base (pH > 11,5); or","\u2013 the substance is flammable in air at","room temperature."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"486","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-149","justification":"It is necessary to define the type of variations that can be made to an existing authorised\nbiocidal product.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u c (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["uc. 'Major change' means","a variation to an existing authorisation","which cannot be deemed to be an","administrative change or a minor change."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"149","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-240","justification":" Ensures a consistent protection of the environment and human health. It is necessary to\n comply with all relevant Community standards for the protection of the environment. This is\n also ensured with the Biocidal Products Directive 98/8/EC. In addition, the protection of\n vulnerable groups \u2013 like it is prescribed according to Regulation (EC) 1107/2009 concerning\n provisions on plant protection products - and combination effects should be taken into\n consideration.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint iv \u2013 introductory part"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:34"},"new":["iv) it has no real or potential adverse","effects itself, or as a result of its residues,","on the environment having particular","regard to the following considerations:"],"old":["iv) it has no unacceptable effects itself, or","as a result of its residues, on the","environment having particular regard to the","following considerations:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"240","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-487","justification":"As a measure to reduce the number of animals used a reduced version of the Murine The\nLocal Lymph Node Assay (rLLNA) should be performed to distinguish between skin\nsensitisers and non-sensitisers. Compare also the associated ECVAM Scientific Advisory\nCommittee (ESAC) statement of September 27th, 2007.","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 6.3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.3. The assessment of this endpoint shall","comprise the following consecutive steps:","(1) an assessment of the available human,","animal and alternative data,","(2) In vivo testing.","Step 2 does not need to be conducted if:","\u2013 the available information indicates that","the substance should be classified for skin","sensitisation or corrosivity; or","\u2013 the substance is a strong acid (pH < 2,0)","or base (pH > 11,5); or","\u2013 the substance is flammable in air at room","temperature.","The reduced Murine Local Lymph Node","Assay (rLLNA) is the first-choice method","for in vivo testing as a screening test to","distinguish between sensitisers and non-","sensitisers. The full LLNA should be","performed when it is known that an","assessment of sensitisation potency is","required. Only in exceptional","circumstances should another test be used.","Justification for the use of another test shall","be provided."],"old":["6.3. The assessment of this endpoint shall","comprise the following consecutive steps:","(1) an assessment of the available human,","animal and alternative data,","(2) In vivo testing.","Step 2 does not need to be conducted if:","\u2013 the available information indicates that","the substance should be classified for skin","sensitisation or corrosivity; or","\u2013 the substance is a strong acid (pH < 2,0)","or base (pH > 11,5); or","\u2013 the substance is flammable in air at room","temperature.","The Murine Local Lymph Node Assay","(LLNA) is the first-choice method for in","","vivo testing. Only in exceptional","circumstances should another test be used.","Justification for the use of another test shall","be provided."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"487","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-241","justification":"Ensures a consistent protection of the environment and human health. It is necessary to\ncomply with all relevant Community standards for the protection of the environment. This is\nalso ensured with the Biocidal Products Directive 98/8/EC. In addition, the protection of\nvulnerable groups \u2013 like it is prescribed according to Regulation (EC) 1107/2009 concerning\nprovisions on plant protection products - and combination effects should be taken into\nconsideration.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint iv \u2013 indent 1"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:34"},"new":["- its fate and distribution in the","environment including long-distance","distribution;"],"old":["- its fate and distribution in the","environment;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"241","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-150","justification":"Substances that fall under the exclusion criteria should only be included in Annex I for a\nmaximum period of 5 years. This is in line with the PPP regulation.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:35"},"new":["1. An active substance shall be included in","Annex I for an initial period not exceeding","10 years if the biocidal products containing","that active substance fulfil the conditions","laid down in point (b) of Article 16(1). An","active substance referred to in Article (5)","may only be included in Annex I for an","initial period of 5 years."],"old":["1. An active substance shall be included in","Annex I for an initial period not exceeding","10 years if the biocidal products containing","that active substance fulfil the conditions","laid down in point (b) of Article 16(1)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"150","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-488","justification":"Tier I studies examine a variety of different modes of mutagenic/genotoxic action, which must\nbe examined together, as part of a \u201cweight-of-evidence\u201d approach, in order for the complete\npicture to become clear.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.4"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.4. Appropriate in vivo mutagenicity","studies shall be considered in case of a","positive result in any of the genotoxicity","studies in Tier 1.","For new substances, it is advisable to","assess the parameters of an in-vivo","micronucleus test as part of a 28- or 90-","day repeated dose toxicity study."],"old":["6.4. Appropriate in vivo mutagenicity","studies shall be considered in case of a","positive result in any of the genotoxicity","studies in Tier 1."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"488","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-151","justification":" It is sufficient for the active substance to be contained in a single biocidal product for it to be\n included in Annex I.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:35"},"new":["1. An active substance shall be included in","Annex I for an initial period not exceeding","10 years if at least one of the biocidal","products containing that active substance","fulfils the conditions laid down in point (b)","of Article 16(1)."],"old":["1. An active substance shall be included in","Annex I for an initial period not exceeding","10 years if the biocidal products containing","that active substance fulfil the conditions","laid down in point (b) of Article 16(1)."],"orig_lang":"t","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"151","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-242","justification":"To be in line with the wording adopted for PPP.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b \u2013 subpoint iv \u2013 indent 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:34"},"new":["- contamination of surface waters","(including estuarial and seawater),","groundwater and drinking water, air and","soil taking into account locations distant","from its use following long-range","environmental transportation;"],"old":["- contamination of surface waters","(including estuarial and seawater),","groundwater and drinking water, air and","soil;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"242","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-489","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 6.4.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.4.1 Further mutagenicity studies shall be","considered in case of a positive result.","Such a study does not need to be","conducted in the case of antimicrobial","substances or formulations."],"old":["6.4.1 Further mutagenicity studies shall be","considered in case of a positive result."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"489","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-152","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 2 a (new)"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:35"},"new":["2a. Active substances as such or in","biocidal products may only be placed on","the market in the Union for use in","biocidal products if they have been","included in Annex I in accordance with","the provisions of this Regulation."],"orig_lang":"e","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"152","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-490","justification":" It has to be clarified that the applicant should not have conducted the in vivo studies himself\n or that they were conducted by his order.","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 6.4.3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.4.3. The study does not need to be","conducted if adequate data from a reliable","in vivo mammalian gene mutation test are","available elsewhere."],"old":["6.4.3. The study does not usually need to","be conducted if adequate data from a","reliable in vivo mammalian gene mutation","test are available."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"490","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-243","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point c"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["c) the nature, the quantity and the technical","equivalence of active substances in the","biocidal product and, where appropriate,","any toxicologically or ecotoxicologically","significant impurities and non-active","substances, and its metabolites and","residues of toxicological or environmental","significance, which result from uses to be","authorised, should be determined","according to the relevant requirements in","Annexes II and III;"],"old":["c) the nature, the quantity and the technical","equivalence of active substances in the","biocidal product and, where appropriate,","any toxicologically or ecotoxicologically","significant impurities and non-active","substances, and its residues of","toxicological or environmental","significance, which result from uses to be","authorised, can be determined according to","the relevant requirements in Annexes II","and III;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"243","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-153","location":[[" Proposal for a regulation","Article 4 - paragraph 2 b (new)"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:35"},"new":["2b. Unless otherwise provided in this","Regulation, all manufacturers of an","active substance shall submit to the","Agency an application for inclusion in","Annex I."],"orig_lang":"de","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"153","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-491","justification":"In the pharmaceutical sector, it is becoming increasingly common to incorporate\nmicronucleus assays into 28- or 90-day general toxicity studies in rats as a means of\nefficiently gathering mutagenicity data without a stand-alone in vivo study. According to this\napproach, micronucleus induction is determined through collection of peripheral blood at\nseveral time-Sections throughout a study, as well as from bone marrow collection at\ntermination.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.4.4 - subparagraph 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.4.4. If there is a positive result in any of","the in vitro genotoxicity studies in Tier I","and there are no results available from an","in vivo study already, an appropriate in","vivo somatic cell genotoxicity study shall","be proposed by the applicant. For new","substances, it should be possible to assess","the parameters of an in-vivo micronucleus","test as part of a 28- or 90-day repeated","dose toxicity study."],"old":["6.4.4. If there is a positive result in any of","the in vitro genotoxicity studies in Tier I","and there are no results available from an","in vivo study already, an appropriate in","vivo somatic cell genotoxicity study shall","be proposed by the applicant."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"491","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-244","justification":" Ensures a consistent protection of the environment and human health. It is necessary to\n comply with all relevant Community standards for the protection of the environment. This is\n also ensured with the Biocidal Products Directive 98/8/EC. In addition, the protection of\n vulnerable groups \u2013 like it is prescribed according to Regulation (EC) 1107/2009 concerning\n provisions on plant protection products - and combination effects should be taken into\n consideration.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 2 \u2013 point a"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:34"},"new":["a) all normal conditions or other realistic","scenarios like accidents under which the","biocidal product may be used;"],"old":["a) all normal conditions under which the","biocidal product may be used;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"244","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-154","justification":"The conditions for inclusion in Annex I should be made more stringent and clearer.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 4"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:35"},"new":["4. Maximum residue limits shall be","established with respect to active","substances included in Annex I in","accordance with Regulation (EC) No","396/2005 of the European Parliament and","of the Council [and Council Regulation","(EEC) No 2377/90]."],"old":["4. Where appropriate, maximum residue","limits shall be established with respect to","active substances included in Annex I in","accordance with Regulation (EC) No","396/2005 of the European Parliament and","of the Council [and Council Regulation","(EEC) No 2377/90]."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"154","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-492","justification":" Multi-route studies for acute toxicity should not be required or encouraged. Two recent\n retrospective data analyses examining the concordance among regulatory classifications\n for acute oral, dermal and inhalation toxicity for several hundred agrochemical and\n biocidal active substances and nearly 2,000 industrial chemicals have revealed that\n dermal studies do not add value above and beyond oral data for hazard classification\n purposes in more than 99% of cases. Data requirements should be revised to reflect these\n new findings.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.5"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.5. The study/ies do(es) not generally","need to be conducted if:","- the substance is classified as corrosive to","the skin."],"old":["6.5. The study/ies do(es) not generally","need to be conducted if:","","- the substance is classified as corrosive to","the skin.","","In addition to the oral route (6.5.1.), for","substances other than gases, the","","information mentioned under 5.6.2. to","6.5.3. shall be provided for at least one","other route. The choice for the second","route will depend on the nature of the","substance and the likely route of human","exposure. If there is only one route of","exposure, information for only route need","be provided."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"492","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-155","justification":" Only if manufacturers are obliged to comply with the same data requirements in Annex II will\n fair treatment be possible.","location":[["Proposal for a regulation","Article 4 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:35"},"new":["4a. 1. Active substances as such or in","biocidal products may only be placed on","the market in the Union for use in","biocidal products if they have been","included in Annex I in accordance with","the provisions of this Regulation.","2. Unless otherwise provided in this","Regulation, all manufacturers of an","active substance, as such or in a biocidal","product, shall submit to the Agency an","application for inclusion in Annex I."],"orig_lang":"e","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"155","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-245","justification":"Ensures a consistent protection of the environment and human health. It is necessary to\ncomply with all relevant Community standards for the protection of the environment. This is\nalso ensured with the Biocidal Products Directive 98/8/EC. In addition, the protection of\nvulnerable groups \u2013 like it is prescribed according to Regulation (EC) 1107/2009 concerning\nprovisions on plant protection products - and combination effects should be taken into\nconsideration.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:34"},"new":["ca) cumulative or synergistic effects."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"245","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-493","justification":"The method for the assesment of acute toxicity has to be specified to minimise the number of\nanimals used. In the Council Regulation (EC) No 440/2008, both the Acute Toxic Class\nMethod and the Fixed Dose Method are suggested. The Acute Toxic Class Method uses less\nanimals than the Fixed Dose Method and should therefore be the method of choice.","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 6.5.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.5.1. The study need not be conducted if a","study on acute toxicity by the inhalation","route (6.5.2) is available.","The Acute Toxic Class Method is the first-","choice method for in-vivo testing. Only in","exceptional circumstances should another","test be used, in which case a justification","shall be provided."],"old":["6.5.1. The study need not be conducted if a","study on acute toxicity by the inhalation","route (6.5.2) is available.","",""],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"493","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-156","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1"]],"meps":[28156,97076],"meta":{"created":"2019-07-03T05:29:35"},"new":["deleted"],"old":["1. Notwithstanding Article 4(1), active","substances referred to in paragraph 2","shall be included in Annex I only if at","least one of the following conditions is","met:","a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;","b) it is shown that the active substance is","necessary to control a serious danger to","public health;","c) it is shown that not including the active","substance in Annex I would cause","disproportionate negative impacts when","compared with the risk to human health","or the environment arising from the use","of the substance and that there are no","suitable alternative substances or","technologies.","Point (c) shall not apply to active","substances for product types 4 and 14 to","19."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"156","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-246","justification":"The Commission's proposal does not guarantee any kind of evaluation on EU-level of low risk\n\n active substances. It is completely unclear what active substances a low-risk product can\n contain. In order to categorise anything as a low-risk product, it is crucial to know what it\n contains. Therefore, the active substances of a low risk product should as a very minimum be\n evaluated on an EU-level and be included on annex I in order for the product to be\n recognized as a low-risk product.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 3"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["3. An authorisation to place a low-risk","biocidal product on the market can only be","granted if the active substances are","evaluated as low-risk active substances","and included in Annex I (or a separate","annex) in accordance with Article 4 and","Article 5, further the authorisation shall","be subject to compliance with the","requirements of points (a), (b), (c) and (d)","of paragraph 1."],"old":["3. An authorisation to place a low-risk","biocidal product on the market shall be","subject to compliance with the","requirements of points (b), (c) and (d) of","paragraph 1."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"246","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-494","justification":"Testing via multiple exposure routes should not be necessary if hazard classification is the\nprimary objective. Revision of data requirements to forego redundant testing could markedly\nreduce costs and animal use. In cases where inhalation represents the primary human\nexposure scenario, the OECD Acute Toxic Class animal reduction test guideline should be\nused in lieu of the classical lethal poisoning method.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.5.2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.5.2. Testing by the inhalation route is","appropriate only if this constitutes the","primary route of human exposure taking","into account the vapour pressure of the","substance and/or the possibility of","exposure to aerosols, particles or droplets","of an inhalable size. The Acute Toxic","Class Method is the first-choice method","for in-vivo testing. Only in exceptional","circumstances should the classic \u201clethal","concentration\u201d (LC50) test be used.","Justification for the use of another test","shall be provided."],"old":["6.5.2. Testing by the inhalation route is","appropriate if exposure of humans via","inhalation is likely taking into account the","vapour pressure of the substance and/or the","possibility of exposure to aerosols,","particles or droplets of an inhalable size."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"494","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-495","justification":" This data requirement should be deleted on the basis of the aforementioned analysis, which\n found dermal classifications to be concordant with or less severe than oral classifications in\n over 99% of cases. Dermal classifications can therefore be based on direct read-across from\n oral data.","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 6.5.3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:34"},"new":["deleted"],"old":["6.5.3. Testing by the dermal route is","appropriate if:","","(1) inhalation of the substance is unlikely;","and","","(2) skin contact in production and/or use","is likely; and","","(3) the physiochemical and toxicological","properties suggest potential for a","significant rate of absorption through the","skin."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"495","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-157","justification":"It is necessary to prevent the use of active substances with the worst hazard profiles and\nwhich have adverse effects for health and the environment, particularly for vulnerable groups\nand biodiversity. the application of exemptions should be clearly restricted to defined\nconditions.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:35"},"new":["1. Notwithstanding Article 4(1), active","substances referred to in paragraph 2 shall","be included in Annex I only if all of the","following conditions are met:"],"old":["1. Notwithstanding Article 4(1), active","substances referred to in paragraph 2 shall","be included in Annex I only if at least one","of the following conditions is met:"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"157","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-247","justification":" Because of the health hazards of these substances, they should not be allowed in the hands of\n the general public","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 5 \u2013 point b a (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:34"},"new":["ba) considered to have endocrine","disrupting properties."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"247","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-158","justification":"It is necessary to prevent the use of active substances with the worst hazard profiles and\nwhich have adverse effects for health and the environment, particularly for vulnerable groups\nand biodiversity. The application of exemptions should be clearly restricted to defined\nconditions.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:35"},"new":["a) the exposure of humans to that active","substance in a biocidal product, under","realistic and all worst-case conditions of","use, is negligible, in particular where the","product is used in closed systems or strictly","controlled conditions;"],"old":["a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"158","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-496","justification":"It is only necessary with either a 28- or 90-day study. No significant new knowledge is\nprovided by using both. Endpoint-combining is a generally accepted practice for improving\ntesting efficiency and should be encouraged as a means of minimising the conduct of stand-\nalone neurotoxicity and other \u201cspecial\u201d studies.","location":[[" Proposal for a regulation","Annex II -title 1 - table - section 6.6.1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.6.1. The short-term toxicity study (28","days) does not need to be conducted if:","\u2013 a reliable sub-chronic (90 days) or","chronic toxicity study is available or","planned, provided that an appropriate","species, dosage, solvent and route of","administration were or are to be used; or","\u2013 where a substance undergoes immediate","disintegration and there are sufficient data","on the cleavage products; or","\u2013 relevant human exposure can be","excluded in accordance with Annex IV","section 3.","Testing shall be conducted via the oral","route unless:","(1) the primary route of human exposure","will be dermal, and one of the following","conditions is met:","- the physicochemical and toxicological","properties, including an in-vitro dermal","penetration study (i.e. OECD TG 428),","indicate that dermal bioavailability will be","substantial; or","- significant dermal toxicity or dermal","penetration is recognised for structurally","related substances.","(2) the primary route of human exposure","will be inhalation, taking into account the","vapour pressure of the substance and","likely frequency, magnitude and duration","of exposure to aerosols, particles or","droplets of an inhalable size.","Testing shall only be carried out via one","exposure route. Estimates of toxicity via","other routes shall be based upon","pharmacokinetic modelling.","The sub-chronic toxicity study (90 days)","(Tier II, section 6.6.2) shall be proposed by","the applicant in lieu of a 28-day study if:","the frequency and duration of human","exposure indicates that a study of > 1","month and < 12 months is appropriate and","available data indicate that the kinetics or","other properties of a substance or its","metabolites are such that adverse effects","could go undetected in a short-term","toxicity study","For substances related on a molecular","level to known organ-specific toxicants","(e.g. neurotoxicity), additional relevant","parameters should ideally be examined in","the context of a 28-day or 90-day study in","lieu of a stand-alone, e.g. neurotoxicity","study. Further stand-alone studies should","be limited to exceptional circumstances."],"old":["6.6.1. The short-term toxicity study (28","days) does not need to be conducted if:","","\u2013 a reliable sub-chronic (90 days) or","chronic toxicity study is available,","provided that an appropriate species,","","","dosage, solvent and route of administration","were used; or","","\u2013 where a substance undergoes immediate","disintegration and there are sufficient data","on the cleavage products; or","","\u2013 relevant human exposure can be","excluded in accordance with Annex IV","section 3","","The appropriate route shall be chosen on","the following basis:","","Testing by the dermal route is appropriate","if:","","(1) inhalation of the substance is unlikely;","and","","","","(2) skin contact in production and/or use","is likely; and","","(3) the physicochemical and toxicological","properties suggest potential for a","significant rate of absorption through the","skin.","","Testing by the inhalation route is","appropriate if exposure of humans via","inhalation is likely taking into account the","vapour pressure of the substance and/or","the possibility of exposure to aerosols,","particles or droplets of an inhalable size.","","The sub-chronic toxicity study (90 days)","(Tier II, section 6.6.2) shall be proposed by","the applicant if: the frequency and duration","of human exposure indicates that a longer","term study is appropriate; and one of the","following conditions is met:","","\u2013 other available data indicate that the","substance may have a dangerous property","that cannot be detected in a short-term","toxicity study; or","","\u2013 appropriately designed toxicokinetic","studies reveal accumulation of the","substance or its metabolites in certain","tissues or organs which would possibly","remain undetected in a short term toxicity","study but which are liable to result in","adverse effects after prolonged exposure.","","Further studies shall be proposed by the","applicant or may be required in case of:","","\u2013 failure to identify a NOAEL in the 28 or","the 90 days study, unless the reason for","the failure to identify a NOAEL is","absence of adverse toxic effects; or","","\u2013 toxicity of particular concern (e.g.","serious/severe effects); or","","\u2013 indications of an effect for which the","available evidence is inadequate for","toxicological and/or risk characterisation.","In such cases it may also be more","appropriate to perform specific","toxicological studies that are designed to","investigate these effects (e.g.","","immunotoxicity, neurotoxicity); or","","\u2013 the route of exposure used in the initial","repeated dose study was inappropriate in","relation to the expected route of human","exposure and route-to-route extrapolation","cannot be made; or","","\u2013 particular concern regarding exposure","(e.g. use in consumer products leading to","exposure levels which are close to the","dose levels at which toxicity to humans","may be expected); or","","\u2013 effects shown in substances with a clear","relationship in molecular structure with","the substance being studied, were not","detected in the 28 or the 90 days study."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"496","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-248","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 5 \u2013 point b a (new)"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:34"},"new":["ba) developmental neurotoxic or","immunotoxic effects."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"248","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-159","justification":" A serious management of the risk can reduce the exposure of users whether professionals or\n non-professionals and ultimately protect the environment and the health of users. A tiny\n quantity of an active substance even classified as CMR1 in a bait station, for instance, would\n pose no risk to human health given that the product is adequately designed to prevent any\n misuse. It is therefore the product and its use which will determine whether there is a risk\n given that, in this case, the active substance is in very low quantity.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meta":{"created":"2019-07-03T05:29:36"},"new":["a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible or","properly managed through sustainable","use measures and taking into account the","intrinsic properties of the active","substance, in particular where the product","is used in closed systems or strictly","controlled conditions;"],"old":["a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"159","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-160","justification":"Wording in line with the regulation on plant protection products (\u2018PPP regulation\u2019).\nNegligible exposure should be clearly defined. This is not the case in the Commission\nproposal, which only gives a possible example of negligible exposure. Negligible exposure\nshould be defined as only being uses which exclude contact with humans and where there are\nno residues.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:36"},"new":["a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, that","is, the product is used in closed systems or","in other conditions excluding contact with","humans and where residues of the active","substance do not exceed the limit of","detection;"],"old":["a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;",""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"160","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-249","justification":"The Commission's proposal does not guarantee any kind of evaluation on EU-level of low risk\nactive substances. It is completely unclear what active substances a low-risk product can\ncontain. In order to categorise anything as a low-risk product, it is crucial to know what it\ncontains. Therefore, the active substances of a low risk product should as a very minimum be\nevaluated on an EU-level and be included on annex I in order for the product to be\nrecognized as a low-risk product.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 - introductory part"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["1. A biocidal product shall be considered a","low-risk biocidal product if the active","substances therein are included in Annex","I and if both the following conditions are","fulfilled:"],"old":["1. A biocidal product shall be considered a","low-risk biocidal product if both the","following conditions are fulfilled:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"249","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-497","justification":" It is only necessary with either a 28- or 90-day study. No significant new knowledge is\n provided by using both. Endpoint-combining is a generally accepted practice for improving\n testing efficiency and should be encouraged as a means of minimising the conduct of stand-\n alone neurotoxicity and other \u201cspecial\u201d studies.","location":[["Proposal for a regulation","Annex II -title 1 - table - section 6.6.2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:34"},"new":["6.6.2. The sub-chronic toxicity study (90","days) does not need to be conducted if:","\u2013 a reliable short-term toxicity study (28","days) is available showing severe toxicity","effects according to the criteria for","classifying the substance as R48, for which","the observed NOAEL-28 days, with the","application of an appropriate uncertainty","factor, allows the extrapolation towards the","NOAEL-90 days for the same route of","exposure; or","\u2013 a reliable chronic toxicity study is","available, provided that an appropriate","species and route of administration were","used; or","\u2013 a substance undergoes immediate","disintegration and there are sufficient data","on the cleavage products (both for systemic","effects and effects at the site of uptake); or","\u2013 the substance is unreactive, insoluble and","not inhalable and there is no evidence of","absorption and no evidence of toxicity in a","28-day \"limit test\", particularly if such a","pattern is coupled with limited human","exposure.","Testing shall be conducted via the oral","route unless:","(1) the primary route of human exposure","will be dermal, and one of the following","conditions is met:","- the physicochemical and toxicological","properties, including an in-vitro dermal","penetration study (i.e. OECD TG 428),","indicate that dermal bioavailability will be","substantial; or","- significant dermal toxicity or dermal","penetration is recognised for structurally","related substances.","(2) the primary route of human exposure","will be inhalation, taking into account the","vapour pressure of the substance and the","likely frequency, magnitude and duration","of exposure to aerosols, particles or","droplets of an inhalable size.","Testing shall be carried out via one","exposure route. Estimates of toxicity via","other routes shall be based upon","pharmacokinetic modelling.","For substances related on a molecular","level to known organ-specific toxicants","(e.g. neurotoxicity), additional relevant","parameters should ideally be examined in","the context of a 28-day or 90-day study in","lieu of a standalone, e.g. neurotoxicity","study. Further standalone studies should","be limited to exceptional circumstances."],"old":["6.6.2. The sub-chronic toxicity study (90","days) does not need to be conducted if:","","\u2013 a reliable short-term toxicity study (28","days) is available showing severe toxicity","effects according to the criteria for","classifying the substance as R48, for which","the observed NOAEL-28 days, with the","application of an appropriate uncertainty","factor, allows the extrapolation towards the","","","NOAEL-90 days for the same route of","exposure; or","","\u2013 a reliable chronic toxicity study is","available, provided that an appropriate","species and route of administration were","used; or","","\u2013 a substance undergoes immediate","disintegration and there are sufficient data","on the cleavage products (both for systemic","effects and effects at the site of uptake); or","","\u2013 the substance is unreactive, insoluble and","not inhalable and there is no evidence of","absorption and no evidence of toxicity in a","28-day \"limit test\", particularly if such a","pattern is coupled with limited human","exposure.","","The appropriate route shall be chosen on","the following basis:","","Testing by the dermal route is appropriate","if:","","(1) skin contact in production and/or use","is likely; and","","","","(2) the physicochemical properties suggest","a significant rate of absorption through","the skin; and","","(3) one of the following conditions is met:","","","\u2013 toxicity is observed in the acute dermal","toxicity test at lower doses than in the oral","toxicity test; or","","\u2013 systemic effects or other evidence of","absorption is observed in skin and/or eye","irritation studies; or","","\u2013 in vitro tests indicate significant dermal","absorption; or","","\u2013 significant dermal toxicity or dermal","penetration is recognised for structurally","related substances.","","Testing by the inhalation route is","appropriate if:","","\u2013 exposure of humans via inhalation is","likely taking into account the vapour","pressure of the substance and/or the","possibility of exposure to aerosols,","particles or droplets of an inhalable size.","","Further studies shall be proposed by the","applicant or may be required in case of:","","\u2013 failure to identify a NOAEL in the 90","days study unless the reason for the","failure to identify a NOAEL is absence of","adverse toxic effects; or","","\u2013 toxicity of particular concern (e.g.","serious/severe effects); or","","\u2013 indications of an effect for which the","available evidence is inadequate for","toxicological and/or risk characterisation.","In such cases it may also be more","","appropriate to perform specific","toxicological studies that are designed to","investigate these effects (e.g.","immunotoxicity, neurotoxicity); or","","\u2013 particular concern regarding exposure","(e.g. use in consumer products leading to","exposure levels which are close to the","dose levels at which toxicity to humans","may be expected)."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"497","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-161","justification":"Wording in line with the PPP regulation. It must be proven that the serious danger to public\nhealth cannot be controlled by any other means, including non-chemical methods, and\nappropriate risk mitigation measures need to be taken.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point b"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:36"},"new":["b) it is shown on the basis of documented","evidence included in the application of an","active substance that that the active","substance is necessary to control a serious","danger to public health which cannot be","contained by other available means","including non-chemical methods."],"old":["b) it is shown that the active substance is","necessary to control a serious danger to","public health;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"161","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-162","justification":" It is necessary to prevent the use of active substances with the worst hazard profiles and\n which have adverse effects for health and the environment, particularly for vulnerable groups\n and biodiversity. The application of exemptions should be clearly restricted to defined\n conditions.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point b"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:36"},"new":["b) it is proven by the applicant on the","basis of documented evidence that the","active substance is necessary to control a","serious danger to public health which","cannot be contained by any other","available means, including non-chemical","means;"],"old":["b) it is shown that the active substance is","necessary to control a serious danger to","public health;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"162","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-250","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 - introductory part"]],"meta":{"created":"2019-07-03T05:29:35"},"new":["1. A biocidal product shall be considered a","low-risk biocidal product if one or both of","the following conditions are fulfilled:"],"old":["1. A biocidal product shall be considered a","low-risk biocidal product if both the","following conditions are fulfilled:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"250","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-163","justification":" The negative impacts that may be disproportionate are not defined - so this creates a gaping\n loophole for all kinds of derogations, e.g. those motivated by economic interests. No such\n derogation exists for the analogous PPP regulation. The clause of the non-existence of\n\nsuitable alternatives or technologies is better addressed in the modification of the previous\npoint.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["c) it is shown that not including the active","substance in Annex I would cause","disproportionate negative impacts when","compared with the risk to human health","or the environment arising from the use","of the substance and that there are no","suitable alternative substances or","technologies."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"163","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-498","justification":"Long-term toxicity studies are costly in both economic and animal welfare terms and can\ngenerally be avoided through the use of appropriate statistical techniques (e.g. extrapolation\nfrom shorter-term studies). In exceptional cases where empirical data are considered\nnecessary, testing should only be carried out in a single species, and where cancer risk is also\na consideration, a combined chronic toxicity-carcinogenicity study should be required in lieu\nof separate, standalone studies for these two endpoints.","location":[[" Proposal for a regulation","Annex II -title 1 - table - section 6.6.3"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["6.6.3. A long-term repeated dose toxicity","study (\u226512 months) may be proposed by the","applicant or required only if:","- the frequency, magnitude and duration of","human exposure, indicate that a chronic","risk assessment is appropriate; and","- if the application of an appropriate","uncertainty factor would not be","sufficiently protective for risk assessment","purposes.","If carcinogenicity data are also required","and not already available, long-term","repeated dose and carcinogenicity studies","should be carried out using the OECD TG","453 combination study protocol."],"old":["6.6.3. A long-term repeated toxicity study","(\u226512 months) may be proposed by the","applicant or required if the frequency and","duration of human exposure indicates that","a longer term study is appropriate and one","of the following conditions is met:","- serious or severe toxicity effects of","particular concern when observed in the","28-day or 90-day study for which the","available evidence is inadequate for","toxicological evaluation or risk","characterisation; or","- effects shown in substances with a clear","relationship in molecular structure with","","the substance being studied were not","detected in the 28-day or 90-day study; or","- the substance may have a dangerous","property that cannot be detected in a 90-","day study."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"498","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-164","justification":"It is necessary to prevent the use of active substances with the worst hazard profiles and\nwhich have adverse effects for health and the environment, particularly for vulnerable groups\nand biodiversity. The application of exemptions should be clearly restricted to defined\nconditions.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:36"},"new":["c) with a comparative assessment it is","shown that there are no chemical or non-","chemical alternative substances or","technologies for the purpose concerned","and which present significantly lower risk","and harm for human or animal health or","the environment;"],"old":["c) it is shown that not including the active","substance in Annex I would cause","disproportionate negative impacts when","compared with the risk to human health or","the environment arising from the use of","the substance and that there are no","suitable alternative substances or","technologies."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"164","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-251","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 - point b a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["ba) the cumulative effects of both active","substances and non-active substances are","taken into consideration and defined as","low-risk."],"old":[""],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"251","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-499","justification":" Unnecessary repetition of measures articulated in 6.6.2., 6.6.3. and 6.7.","location":[["Proposal for a regulation","Annex II -title 1 - table - section 6.6.4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["deleted"],"old":["6.6.4. Further studies shall be proposed by","the applicant or may be required in case","of:","","- toxicity of particular concern (e.g.","serious/severe effects); or","","- indications of an effect for which the","available evidence is inadequate for","toxicological evaluation and/or risk","characterisation. In such cases it may also","be more appropriate to perform specific","toxicological studies that are designed to","investigate these effects (e.g.","immunotoxicity, neurotoxicity); or","","- particular concern regarding exposure","","(e.g. use in consumer products leading to","exposure levels which are close to the","dose levels at which toxicity is observed).","","If a substance is known to have an","adverse effect on fertility, meeting the","criteria for classification as Repr Cat 1A","or 1B: May damage fertility (H360F), and","the available data are adequate to support","a robust risk assessment, then no further","testing for fertility will be necessary.","However, testing for developmental","toxicity must be considered."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"499","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Esther De Lange","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-165","justification":" Regulating biocidal products only on the basis of the properties of their active substances\n without taking into account their actual use and exposure undermines the principle of science\n based decision-making.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c a (new)"]],"meps":[38398],"meta":{"created":"2019-07-03T05:29:36"},"new":["ca. the evaluation of intrinsic hazards,","under prescribed conditions of use,","demonstrates risks to be acceptable in","accordance with the criteria laid down in","evaluation dossiers for biocidal products","referred to in Annex IV."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"165","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-252","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 introductory part"]],"meta":{"created":"2019-07-03T05:29:35"},"new":["However, specific sustainable use","measures with appropriate technologies to","control the use are necessary should a","biocidal product meet at least two of the","following conditions:"],"old":["However, a biocidal product shall not be","considered a low-risk biocidal product if at","least one of the following conditions is","present:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"252","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-166","justification":" It is necessary to prevent the use of active substances with the worst hazard profiles and\n which have adverse effects for health and the environment, particularly for vulnerable groups\n and biodiversity. The application of exemptions should be clearly restricted to defined\n conditions.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c a (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:36"},"new":["ca. the use of the active substance is","subject to risk mitigation measures to","ensure that exposure to humans and the","environment is minimised and regularly","monitored;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"166","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-500","justification":"A tangible example of adverse reproductive effects from a non-generational study type was\nneeded. The example provided illustrates the fact that adverse effects on male fertility can\noften be detected in a 90-day repeated dose study, which is less expensive and consumes\nmany times fewer animals than a specific reproductive toxicity study.","location":[[" Proposal for a regulation","Annex II -title 1 - table - section 6.7"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["6.7. The studies need not be conducted if:","\u2013 the substance is known to be a genotoxic","carcinogen and appropriate risk","management measures are implemented; or","\u2013 the substance is known to be a germ cell","mutagen and appropriate risk management","measures are implemented; or","- the substance is of low toxicological","activity (no evidence of toxicity seen in","any of the tests available), it can be proven","from toxicokinetic data that no systemic","absorption occurs via relevant routes of","exposure (e.g. plasma/blood concentrations","below detection limit using a sensitive","method and absence of the substance and","of metabolites of the substance in urine,","bile or exhaled air) and there is no or no","significant human exposure.","If a substance is known to have an adverse","effect on fertility (e.g. based on testes","pathology data or sperm parameters from","90-day repeated dose studies) meeting the","criteria for classification as Repr Cat 1A or","1B: May damage fertility (H360F), and the","available data are adequate to support a","robust risk assessment, then no further","testing for fertility will be necessary.","However, testing for pre-natal","development toxicity must be considered.","If a substance is known to cause","development toxicity, meeting the criteria","for classification as Repr Cat 1A or 1B:","May damage the unborn child (H360D),","and the available data are adequate to","support a robust risk assessment, then no","further testing for development toxicity","will be necessary. However, testing for","effects on fertility must be considered."],"old":["6.7. The studies need not be conducted if:","\u2013 the substance is known to be a genotoxic","carcinogen and appropriate risk","management measures are implemented; or","\u2013 the substance is known to be a germ cell","mutagen and appropriate risk management","measures are implemented; or","\u2013 the substance is of low toxicological","activity (no evidence of toxicity seen in","any of the tests available), it can be proven","from toxicokinetic data that no systemic","absorption occurs via relevant routes of","exposure (e.g. plasma/blood concentrations","below detection limit using a sensitive","method and absence of the substance and","of metabolites of the substance in urine,","bile or exhaled air) and there is no or no","","significant human exposure.","If a substance is known to have an adverse","effect on fertility, meeting the criteria for","classification as Repr Cat 1A or 1B: May","damage fertility (H360F), and the available","data are adequate to support a robust risk","assessment, then no further testing for","fertility will be necessary. However, testing","for development toxicity must be","considered.","If a substance is known to cause","development toxicity, meeting the criteria","for classification as Repr Cat 1A or 1B:","May damage the unborn child (H360D),","and the available data are adequate to","support a robust risk assessment, then no","further testing for development toxicity","will be necessary. However, testing for","effects on fertility must be considered."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"500","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-167","justification":"It is necessary to prevent the use of active substances with the worst hazard profiles and\nwhich have adverse effects for health and the environment, particularly for vulnerable groups\nand biodiversity. The application of exemptions should be clearly restricted to defined\nconditions.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c b (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:36"},"new":["cb. a substitution plan on how to control","the serious danger by other means,","including non-chemical methods, is","presented by the applicant."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"167","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-501","justification":"Minor technical edits; refer to justification for Section 6.7.3 for additional discussion.","location":[["Proposal for a regulation","Annex II -title 1 - table - section 6.7.1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["6.7.1. This study does not need to be","conducted if:","\u2013 the substance is known to be a genotoxic","carcinogen and appropriate risk","management measures are implemented; or","\u2013 the substance is known to be a germ cell","mutagen and appropriate risk management","measures are implemented; or","\u2013there is no significant human exposure","in accordance with Annex IV section 3; or","\u2013 a pre-natal developmental toxicity study","(Tier II, 6.7.2) or a one- or two-generation","reproductive toxicity study (Tier II, section","6.7.3) is available.","If a substance is known to have an adverse","effect on fertility, meeting the criteria for","classification as Repr Cat 1A or 1B: May","damage fertility (H360F), and the available","data are adequate to support a robust risk","assessment, then no further testing for","fertility will be necessary. However, testing","for pre-natal development toxicity must be","considered.","If a substance is known to cause","developmental toxicity, meeting the criteria","for classification as Repr Cat 1A or 1B:","May damage the unborn child (H360D),","and the available data are adequate to","support a robust risk assessment, then no","further testing for developmental toxicity","will be necessary. However, testing for","effects on fertility must be considered.","In cases where there are serious concerns","about the potential for adverse effects on","fertility or development, an enhanced one-","generation reproductive toxicity study,","with or without a pre-natal developmental","toxicity module (Tier II, section 6.7.3),","may be proposed by the applicant instead","of the screening study."],"old":["6.7.1. This study does not need to be","conducted if:","","\u2013 the substance is known to be a genotoxic","carcinogen and appropriate risk","","","management measures are implemented; or","","\u2013 the substance is known to be a germ cell","mutagen and appropriate risk management","measures are implemented; or","","\u2013 relevant human exposure can be","excluded in accordance with Annex IV","section 3; or","","\u2013 a pre-natal developmental toxicity study","(Tier II, 6.7.2) or a two-generation","reproductive toxicity study (Tier II, section","6.7.3) is available.","If a substance is known to have an adverse","effect on fertility, meeting the criteria for","classification as Repr Cat 1A or 1B: May","damage fertility (H360F), and the available","data are adequate to support a robust risk","assessment, then no further testing for","fertility will be necessary. However, testing","for development toxicity must be","considered.","","If a substance is known to cause","developmental toxicity, meeting the criteria","for classification as Repr Cat 1A or 1B:","May damage the unborn child (H360D),","and the available data are adequate to","support a robust risk assessment, then no","further testing for developmental toxicity","will be necessary. However, testing for","effects on fertility must be considered.","","In cases where there are serious concerns","about the potential for adverse effects on","fertility or development, either a pre-natal","developmental toxicity study (Tier II,","section 6.7.2) or a two generation","reproductive toxicity study (Tier II, section","6.7.3) may be proposed by the applicant","instead of the screening study."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"501","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-253","justification":" In order to be accurate I propose to re-phrase","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point a"]],"meps":[38595],"meta":{"created":"2019-07-03T05:29:35"},"new":["a) it releases one / more chemical","substances during normal use or it","contains one or more active substances","which fulfil the criteria for being persistent,","bio-accumulative and toxic (PBT) or very","persistent and very bio-accumulative","(vPvB) in accordance with Annex XIII of","Regulation (EC) No 1907/2006;"],"old":["a) it contains one or more active substances","which fulfil the criteria for being persistent,","bio-accumulative and toxic (PBT) or very","persistent and very bio-accumulative","(vPvB) in accordance with Annex XIII of","Regulation (EC) No 1907/2006;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"253","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-168","justification":"There is no scientific nor ecological or health reason to exclude PT 4 and PT 14-19 from the\nderogation. Indeed, the risk to human health could be highly disproportionate if some actives\nare not included only because they fall in certain product type categories. The 2009\nCommission\u2019s White Paper on Adaptation to Climate Change alerted about the spread of new\nserious infectious vector-borne transmissible human and animal diseases such as malaria,\ndue to climate change. Insecticides are paramount to combat these diseases.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["Point (c) shall not apply to active","substances for product types 4 and 14 to","19."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"168","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-254","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point a"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["a) it contains one or more substances which","fulfil the criteria for being a POP,","persistent, bio-accumulative and toxic","(PBT, vP) or very persistent and very bio-","accumulative (vPvB) in accordance with","Annex XIII of Regulation (EC) No","1907/2006;"],"old":["a) it contains one or more active substances","which fulfil the criteria for being persistent,","bio-accumulative and toxic (PBT) or very","persistent and very bio-accumulative","(vPvB) in accordance with Annex XIII of","Regulation (EC) No 1907/2006;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"254","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-502","justification":"A retrospective review of substances in the EU New Chemicals Database reveals that fewer\nthan 5% of substances tested in developmental toxicity studies are classified as harmful to\ndevelopment. Given the low prevalence of this effect, it follows that the likelihood of a \u201cfalse\nnegative\u201d result by testing in a single species is equally low. On the other hand, routine\ntesting in a second species can inflate the rate of false positive findings, severely detracting\nfrom the specificity of a testing strategy. As such, testing in a second species should be neither\nrequired nor encouraged..","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.7.2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["6.7.2. The study shall be performed on one","species only, ideally in combination with","an enhanced one-generation reproductive","toxicity study (Tier II, section 6.7.3)."],"old":["6.7.2. The study shall be initially","performed on one species. A decision on","the need to perform a study at this","tonnage level or the next on a second","species should be based on the outcome of","the first test and all other relevant","available data."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"502","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-255","justification":"In order to be accurate I propose to re-phrase","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point b"]],"meps":[38595],"meta":{"created":"2019-07-03T05:29:35"},"new":["b) it releases one / more chemical","substances during normal use or it","contains one or more active substances","qualified as endocrine disrupters;"],"old":["b) it contains one or more active substances","qualified as endocrine disrupters;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"255","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-169","justification":" There are no scientific grounds for discriminating against product types (e.g. PT4 and 14-19).\n These products are rodenticides, acaricides, molluscicides and disinfectants, and are for\n disinfection against rats and insects. Exclusion should be decided on the basis of a risk\n analysis (a combination of hazardousness and exposure). If it is scientifically proven that the\n risks are well controlled, the active substances should be authorised.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["Point (c) shall not apply to active","substances for product types 4 and 14 to","19."],"orig_lang":"t","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"169","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-256","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point b"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["b) it contains any substance qualified as","endocrine disrupters;"],"old":["b) it contains one or more active","substances qualified as endocrine","disrupters;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"256","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-503","justification":" Routine conduct of multigenerational studies should not be required or encouraged.\n Recent retrospective data analyses examining more than 350 two-generation studies have\n revealed that in approximately 99% of cases, breeding a second generation contributed\n nothing to either the regulatory classification or risk assessment that could not be gleaned\n from first generation data. Data requirements should be revised to reflect this important\n innovation.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.7.3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["6.7.3. Enhanced one-generation","reproductive toxicity study, one species,","male and female, most appropriate route of","administration, having regard to the likely","route of human exposure."],"old":["6.7.3. Two-generation reproductive toxicity","","study, one species, male and female, most","appropriate route of administration, having","regard to the likely route of human","exposure, unless already provided as part","of Tier 1 requirements"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"503","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-170","justification":" There are no scientific justifications to the exclusion of product types 4 and 14 to 19 from the\n derogation of article 5 - paragraph 1 - point c. This exemption from the derogation would\n result in the removal of essential products in the area of food and feed disinfection and pest\n control.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["Point (c) shall not apply to active","substances for product types 4 and 14 to","19."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"170","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Rovana Plumb","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-257","justification":" In order to be accurate I propose to re-phrase","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c \u2013 introductory part"]],"meps":[38595],"meta":{"created":"2019-07-03T05:29:35"},"new":["c) it releases one / more chemical","substances during normal use or it","contains one or more active substances","which have been classified in accordance","with Regulation (EC) No 1272/2008 as or","which meets the criteria to be classified as","one of the following:"],"old":["c) it contains one or more active substances","which have been classified in accordance","with Regulation (EC) No 1272/2008 as or","which meets the criteria to be classified as","one of the following:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"257","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-504","justification":" Reference to the conduct of a two-generation study in a second species was an error\n introduced in an early draft of REACH. It has since been corrected, and should not be\n perpetuated in the Biocidal Products Regulation.","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 6.7.3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["deleted"],"old":["6.7.3. The study shall be initially","performed on one species. A decision on","the need to perform a study at this","tonnage level or the next on a second","species should be based on the outcome of","the first test and all other relevant","available data."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"504","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-258","justification":"Definition in line with the regulation on PPP which stipulates that a low-risk product must\nnot contain a substance of concern (Art. 47(1)(b)).","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c \u2013 introductory part"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:35"},"new":["c) it contains one or more active substances","which are a substance of concern or","which have been classified in accordance","with Regulation (EC) No 1272/2008 as or","which meets the criteria to be classified as","one of the following:"],"old":["c) it contains one or more active substances","which have been classified in accordance","with Regulation (EC) No 1272/2008 as or","which meets the criteria to be classified as","","one of the following:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"258","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-171","justification":"It is necessary to prevent the use of active substances with the worst hazard profiles and\nwhich have adverse effects for health and the environment, particularly for vulnerable groups\nand biodiversity. The application of exemptions should be clearly restricted to defined\nconditions.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:36"},"new":["2. The use of the biocidal product with the","active substance concerned shall be","restricted to those Member States where","the relevant harmful organisms or serious","danger occur. The application of such","products shall be limited to professional","users."],"old":["Point (c) shall not apply to active","substances for product types 4 and 14 to","19.",""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"171","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-259","justification":"It must be ensured that biocidal products of low-risk are of low-hazard.","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c \u2013 subpoint vi a (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:35"},"new":["via) explosive;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"259","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-172","justification":"It is necessary to prevent the use of active substances with the worst hazard profiles and\nwhich have adverse effects for health and the environment, particularly for vulnerable groups\nand biodiversity. The application of exemptions should be clearly restricted to defined\nconditions.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 2 a (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:36"},"new":["2a. The active substance shall only be","included in Annex I once, for a period not","exceeding five years."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"172","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-505","justification":"An OECD test guideline for in vitro dermal irritation has been available since 2004 and is\ncapable of fully replacing the in vivo method for the purposes of the Biocidal Products\nRegulation. Consequently, these data requirements should specifically cite the in vitro method\nas the only necessary or acceptable approach for fulfilling this endpoint.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.8.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["6.8.1. In-vitro dermal absorption study"],"old":["6.8.1. Dermal absorption study"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"505","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-260","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c \u2013 subpoint vi a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["via) corrosive;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"260","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-506","justification":" Carcinogenicity studies are costly in both economic and animal welfare terms and can\n generally be avoided through the use of analysis of mutagenicity/genotoxicity data ( it is\n generally accepted that substances that are not genotoxic in vivo are not genotoxic\n carcinogens). Where empirical data is considered necessary, testing should only be carried\n out in a single species and where chronic toxicity is also a consideration, a combined\n carcinogenicity-chronic toxicity study should be required in lieu of separate, standalone\n studies for these two endpoints.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 6.9"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["6.9. A carcinogenicity study may be","proposed by the applicant or may be","required if:","- the substance has a widespread dispersive","use or there is evidence of frequent or","long-term human exposure; and","- the substance is classified as mutagen","category 2 or there is evidence from the","repeated dose study(ies) that the substance","is able to induce hyperplasia and/or pre-","neoplastic lesions.","If the substance is classified as mutagen","category 1A or 1B, the default presumption","would be that a genotoxic mechanism for","carcinogenicity is likely. In these cases, a","carcinogenicity test will normally not be","required.","If long-term toxicity data are also","required and not already available,","carcinogenicity and long-term repeated","dose studies should be carried out using","the OECD TG 453 combination study","protocol."],"old":["6.9. A carcinogenicity study may be","proposed by the applicant or may be","required if:","","- the substance has a widespread dispersive","use or there is evidence of frequent or","long-term human exposure; and","","- the substance is classified as mutagen","category 2 or there is evidence from the","repeated dose study(ies) that the substance","is able to induce hyperplasia and/or pre-","neoplastic lesions.","","If the substance is classified as mutagen","category 1A or 1B, the default presumption","would be that a genotoxic mechanism for","carcinogenicity is likely. In these cases, a","carcinogenicity test will normally not be","","required.",""],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"506","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-173","justification":" This is identical to the provisions of the PPP regulation. There should be no derogation\n possible for know carcinogens or for possible carcinogens without a threshold, nor for\n substances that are known to be toxic to reproduction.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 2 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:36"},"new":["2a. The derogations shall not apply to","active substances which are or have to be","classified in accordance with Regulation","(EC) No 1272/2008, as carcinogenic","category 1A, carcinogenic category 1B","without a threshold, or toxic for","reproduction category 1A."],"old":["",""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"173","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-261","justification":" It must be ensured that biocidal products of low-risk are of low-hazard.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c \u2013 subpoint vi b (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:35"},"new":["vib)corrosive;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"261","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-262","justification":" It must be ensured that biocidal products of low-risk are of low-hazard.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c \u2013 subpoint vi c(new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:35"},"new":["vic) very toxic or toxic."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"262","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-174","justification":"Provisions in line with the provisions of the PPP regulation, with the additional specification\nthat the use of products containing substances that fall under the exclusion criteria shall be\nlimited to professional users.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 subparagraph 2 b (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:36"},"new":["2b. The use of any biocidal product","containing active substance included in","Annex I pursuant to this paragraph shall","be subject to appropriate risk mitigation","measures to ensure that exposure of","humans and the environment is","minimised. In any case, the application of","such products shall be limited to","professional users.","A Member State authorising a biocidal","product containing an active substance","included in Annex I pursuant to this","paragraph shall draw up a phasing out","plan concerning the control of the serious","danger by other means, including non-","chemical methods, and shall without","delay transmit that plan to the","Commission."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"174","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-507","justification":"The requirement for aquatic toxicity testing should be exposure-driven rather than absolute,\nparticularly with respect to testing on vertebrate animals.","location":[[" Proposal for a regulation","Annex II - title 1 - table- section 7.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["7.1. Requirements for aquatic toxicity","testing on vertebrate animals may be","waived if the use profile for a substance","does not indicate significant potential for","exposure to the aquatic environment.","Long-term toxicity testing shall be","proposed by the applicant if the assessment","performed under Tier I indicates the need","to investigate further the effects on aquatic","organisms. The choice of the appropriate","test(s) depends on the results of the","assessment performed under Tier I."],"old":["7.1. Long-term toxicity testing shall be","proposed by the applicant if the assessment","performed under Tier I indicates the need","to investigate further the effects on aquatic","organisms. The choice of the appropriate","test(s) depends on the results of the","assessment performed under Tier I."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"507","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-263","justification":"Based on current knowledge or lack thereof, a biocidal product containing nanomaterials\ndisqualifies as low-risk.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:35"},"new":["ca) it contains a nanomaterial."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"263","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-175","justification":" It is not sufficient to refer to Art. 57(f) of REACH to determine endocrine disrupters. The\n identification of substances of very high concern under REACH is very slow. Not a single\n substance has yet even been proposed to be identified based on Art. 57(f). And the hurdle is\n very high: scientific evidence of \u2018probable [!] serious effects\u2019. Endocrine disrupters should\n also be identified based on agreed test guidelines or other available information (as in the\n PPP regulation). Specific criteria for endocrine disrupting chemicals should be developed at\n the same time as in the PPP regulation.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point d"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:36"},"new":["d) active substances which, on the basis of","the assessment of Community or","internationally agreed test guidelines or","other available data and information,","including a review of the scientific","literature, reviewed by the Agency, as","having endocrine disrupting properties","may cause adverse effect in humans, or","identified under Article 57(f) of Regulation","(EC) No 1907/2006 as having endocrine","disrupting properties.","Until 13 December 2013, the Commission","shall, by means of delegated acts in","accordance with Article 72, adopt","measures on specific scientific criteria for","determining endocrine-disrupting","properties. Pending the adoption of these","criteria, substances that are or have to be","classified, in accordance with the","provisions of Regulation (EC) No","1272/2008, as carcinogenic category 2","and toxic for reproduction category 2,","shall be considered to have endocrine-","disrupting properties. In addition,","substances such as those that are or have","to be classified, in accordance with the","provisions of Regulation (EC) No","1272/2008, as toxic for reproduction","category 2 and which have toxic effects on","the endocrine organs, may be considered","to have such endocrine disrupting","properties."],"old":["d) active substances identified under","Article 57(f) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"175","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-508","justification":"The ECVAM-validated \u201cthreshold approach\u201d addresses fish toxicity by initially using a\nsingle- concentration test (limit test) requiring less fish compared to the full acute fish toxicity\nstudy. The selection of a single concentration is based on the derivation of a threshold\nconcentration from algae and daphnia toxicity data (Section 7.1.1.). Fish toxicity is then\ntested at the threshold concentration. If no deaths are seen in the limit test, the threshold\nconcentration can be used as a surrogate to the \u201clethal concentration\u201d (LC50) value in the\nfurther hazard or risk assessment.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 7.1.3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["7.1.3. Short-term toxicity testing on fish:","threshold approach."],"old":["7.1.3. Short-term toxicity testing on fish:","The applicant may consider long-term","toxicity testing instead of short-term."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"508","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Esther De Lange","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-264","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 points c a - c c (new)"]],"meps":[38398],"meta":{"created":"2019-07-03T05:29:36"},"new":["ca) the product is explosive;","cb) the product is highly flammable;","cc) the product is self-igniting at","application temperature."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"264","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-176","justification":" A consultant commissioned by the European Commission shall release, in April 2011, its final\n report on how to address endocrine disruptors. It would be premature to already draw\n conclusions as to which active substance should be assimilated to endocrine disruptors. There\n are very few actives being evaluated and very few new actives are being developed,\n assimilating, for instance, CMRs2 as ED would have dramatic consequences and would\n prevent the authorities from fighting efficiently public health threats.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point d"]],"meta":{"created":"2019-07-03T05:29:37"},"new":["d) active substances identified under","Article 57(f) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties.","Given the current scientific uncertainty as","to the criteria necessary to determine the","endocrine disrupting properties, the","European Commission shall, at the latest","by 14 December 2013, propose a draft","addressing the latter."],"old":["d) active substances identified under","Article 57(f) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"176","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-509","justification":" Currently no conditions are set for triggering Tier II studies; however, reasonable conditions\n include use profile/exposure and physical-chemical properties.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 7.1.6"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["7.1.6. Long-term toxicity testing on fish, if","indicated by substance use profile and/or","physical-chemical properties","The information shall be provided for one","of the sections 7.1.6.1, 7.1.6.2 or 7.1.6.3."],"old":["7.1.6. Long-term toxicity testing on fish,","(unless already provided as part of Tier I","requirements)","","The information shall be provided for one","of the sections 7.1.6.1, 7.1.6.2 or 7.1.6.3."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"509","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-265","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["ca) Product is classified or is to be","classified in any category according to","Regulation (EC) 1272/2008;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"265","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-177","justification":"So far no criteria have been developed to identify endocrine disrupting substances. The\nCommission is currently working on a horizontal definition which will apply to a number of\nEU legislative texts referring to endocrine disruption e.g. the REACH and plant protection\nregulations. It is the purpose of this amendment to align the biocides legislation to this\nongoing process. The Commissions approach should be consistent with international\ndevelopments in particular with the OECD framework.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point d"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:37"},"new":["d) active substances identified under","Article 57(f) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties. Until 30 June 2015, the","Commission shall, by means of delegated","acts in accordance Articles XY, adopt","measures on specific scientific criteria for","determining endocrine-disrupting","properties."],"old":["d) active substances identified under","Article 57(f) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"177","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-510","justification":" It is not clear what study is envisioned by this data requirement. The only non-aquatic species\n commonly subject to acute ecotoxicological studies are birds, and a separate avian data\n requirements section is included elsewhere. If additional specificity is not provided, including\n reference to an accepted EU or international test guideline, this requirement should be\n deleted.","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 7.4.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:35"},"new":["deleted"],"old":["7.4.1. Acute toxicity test on one other,","non-aquatic, non-target organism"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"510","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-266","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c b (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["cb) it contains any substance of concern."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"266","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-267","justification":" The intrinsic characteristics of an active substance, alone, should not determine its suitability\n for low risk products since the risks may come more from the exposure to the product than\n from the hazard of the active substance. Given that some biocides are used by non-\n professionals, it is important to guarantee the safety of these products through better\n information and precautions regarding their use. Finally, industry needs to be encouraged to\n focus its research and innovation efforts towards developing low risk products.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 a (new)"]],"meta":{"created":"2019-07-03T05:29:36"},"new":["1a. The applicant for an authorisation","shall in the circumstances identified","above provide the competent authorities","with:","(i) a specific point of sale information","(ii) a specific advice and/or the provision","on the use of protective equipments","(iii) provide a brochure on the risks,","benefits and responsible use of the","product","(iv) an annual report on incidents, if any"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"267","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-178","justification":" In order to comply with the Water Framework Directive as outlined by the EP Rapporteur in\n her AM 11.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point d a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["da) substances on the list of priority","hazardous substances for water policy","annexed to Directive 2000/60/EC."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"178","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-511","justification":"The measures necessary to protect man, animals and the environment should also include\nidentification of the substances relevant for drinking water and for water policy in general.","location":[[" Proposal for a regulation","Annex II -title 1 - table - section 8.1 - introductory part"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:35"},"new":["8.1. Identification of any substances falling","within the scope of List I or List II of the","Annex to Directive 80/68/EEC on the","protection of groundwater against pollution","caused by certain dangerous substances,","Annex I Part B to Directive 98/83/EC on","the quality of water intended for human","consumption, or Annex X to Directive","2000/60/EC establishing a framework for","Community action in the field of water","policy."],"old":["8.1. Identification of any substances falling","within the scope of List I or List II of the","Annex to Directive 80/68/EEC on the","protection of groundwater against pollution","caused by certain dangerous substances.","",""],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"511","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-268","justification":"A product cannot fall into a low-risk product category if it does not fulfil the criteria given in\nthe articles above","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["2. Notwithstanding paragraph 1, a","biocidal product shall be considered a","low-risk biocidal product if the active","substances in the biocidal product are","contained in such way that only a","negligible exposure can take place under","normal conditions of use and the product","is handled under strictly controlled","conditions during all other stages of its","lifecycle."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"268","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-179","justification":" Scientific studies have shown the adverse effects of neurotoxic substances on the development\n of children's\u2019 nervous system. In line with the precautionary principle and the goal of\n ensuring a high level of protection of human health and the environment, substances which\n have developmental neurotoxic or immunotoxic effects should not be authorized.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point d a (new)"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:37"},"new":["da) active substances which have","developmental neurotoxic or immunotoxic","effects."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"179","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-512","justification":"The requirement for avian testing should be exposure-driven rather than absolute,\nparticularly given the interest in minimising testing on vertebrate animals.","location":[["Proposal for a regulation","Annex II -title 1 - table - section 11.1 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:35"},"new":["11.1a. Avian toxicity data shall not be","required unless the use profile for a","substance indicates significant potential","for exposure or harmful effects to birds."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"512","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-269","justification":" The determination \u201cnegligible\u201d is far too vague as being appropriate criteria to support the\n protection of human health and the environment.","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 2"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["2. Notwithstanding paragraph 1, a","biocidal product shall be considered a","low-risk biocidal product if the active","substances in the biocidal product are","contained in such way that only a","negligible exposure can take place under","normal conditions of use and the product","is handled under strictly controlled","conditions during all other stages of its","lifecycle."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"269","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-180","justification":" In order to ensure a high level of health and environment protection, active substances with\n nanomaterial should not be authorized.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point d a (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:37"},"new":["da) Active substances containing","nanomaterials."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"180","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-513","justification":" According to REACH technical guidance, \u201cfew (if any) scenarios are likely to lead to acute\n poisoning risks for birds\u201d, and \u201cevidence from pesticides suggests that chronic effects cannot\n be reliably extrapolated or inferred from acute toxicity data.\u201d Accordingly, this data\n requirement will contribute little or nothing to an environmental risk assessment and should\n therefore be deleted.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 11.1.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["11.1.1. Acute oral toxicity - this need not","be done if an avian species was selected","for study in section 7.4.1"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"513","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-270","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:36"},"new":["2. Notwithstanding paragraph 1, a biocidal","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible exposure can","take place under normal conditions of use,","that is, the product is used in closed","systems or in other conditions excluding","contact with humans, where residues of","the active substance do not exceed the","limit of detection, and the product is","handled under strictly controlled conditions","during all other stages of its lifecycle."],"old":["2. Notwithstanding paragraph 1, a biocidal","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible exposure can","take place under normal conditions of use","and the product is handled under strictly","controlled conditions during all other","stages of its lifecycle."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"270","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-181","justification":"Residues of the active substance can be more harmful that the active substance itself and\nshould therefore be explicitly addressed in the application.","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:37"},"new":["a) a dossier for the active substance and its","residues satisfying the requirements set out","in Annex II;"],"old":["a) a dossier for the active substance","satisfying the requirements set out in","Annex II;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"181","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-514","justification":" Avian dietary toxicity testing, where indicated by use profile and other considerations, should\n be strictly limited to a single species.","location":[[" Proposal for a regulation","Annex II - title 1 - table - section 11.1.2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:36"},"new":["11.1.2. Short-term toxicity - eight-day","dietary study in one species"],"old":["11.1.2. Short-term toxicity - eight-day","dietary study in at least one species (other","than chickens)"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"514","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Esther De Lange","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-271","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 2"]],"meps":[38398],"meta":{"created":"2019-07-03T05:29:36"},"new":["2. Notwithstanding paragraph 1, a biocidal","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible exposure can","take place under normal conditions of use","and the product is handled under strictly","controlled conditions during all other","stages of its lifecycle and the under 17.1","(d) mentioned risks can be mitigated when","following the intended use."],"old":["2. Notwithstanding paragraph 1, a biocidal","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible exposure can","","take place under normal conditions of use","and the product is handled under strictly","controlled conditions during all other","stages of its lifecycle."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"271","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-182","justification":"Biocides are very widely used in construction products and building materials. In order to\nintegrate environmental and health aspects, information on the emission of biocides under\nspecial circumstances should be available like realistic emission scenarios describing the\nleaching properties of biocides. This becomes particularly relevant in light of the current\nrevision of the construction product directive.","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point b a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["ba) a dossier for emission scenarios of","biocides based on Annex II, 1 and Annex","III, 1"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"182","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-515","justification":"Reference:\nREACH technical guidance: http://guidance.echa.europa.eu/docs/guidance_document/\ninformation_requirements_r7c_en.pdf?vers=20_08_08","location":[[" Proposal for a regulation","Annex II -title 1 - table - section 11.1.3 a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["11.1.3 This test is not required if the","dietary toxicity study (section 11.1.2)","shows that the LC50 is above 2,000","mg/kg."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"515","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-272","justification":"The intrinsic characteristics of an active substance, alone, should not determine its suitability\nfor low risk products since the risks may come more from the exposure to the product than\nfrom the hazard of the active substance. Given that some biocides are used by non-\nprofessionals, it is important to guarantee the safety of these products through better\ninformation and precautions regarding their use. Finally, industry needs to be encouraged to\nfocus its research and innovation efforts towards developing low risk products.","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 2"]],"meta":{"created":"2019-07-03T05:29:36"},"new":["2. Notwithstanding paragraph 1, a biocidal","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible or managed","exposure through sustainable use","measures can take place under prescribed","conditions of use and the product is","handled under strictly controlled conditions","during all other stages of its lifecycle."],"old":["2. Notwithstanding paragraph 1, a biocidal","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible exposure can","take place under normal conditions of use","and the product is handled under strictly","controlled conditions during all other","stages of its lifecycle."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"272","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-183","justification":" This information should only be waived if there is no relevant exposure.","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point a"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:37"},"new":["a) the information is not necessary as the","relevant exposure can be excluded with","the proposed uses;"],"old":["a) the information is not necessary owing","to the exposure associated with the","proposed uses;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"183","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-516","justification":"This section duplicates section 7.1. and should be deleted.","location":[["Proposal for a regulation","Annex II - title 1 - table - section 11.2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["11.2. Effects on aquatic organisms","11.2.1. Prolonged toxicity to an","appropriate species of fish","11.2.2. Effects on reproduction and","growth rate on an appropriate species of","fish","11.2.3. Bioaccumulation in an","appropriate species of fish","11.2.4. Daphnia magna reproduction and","growth rate"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"516","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-273","justification":" It is necessary to base the evaluation of low-risk substances and products on sufficient data","location":[["Proposal for a regulation","Article 18 \u2013 paragraph 1 \u2013 point c"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["c) a dossier or a letter of access to a dossier","satisfying the requirements set out in","Annex II for each active substance in the","biocidal product;"],"old":["c) for other than low-risk biocidal","products, a dossier or a letter of access to a","dossier satisfying the requirements set out","in Annex II for each active substance in the","biocidal product;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"273","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-184","justification":" This is very vague and a potential loophole that is not justified.","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point b"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["b) it is not scientifically necessary to","supply the information;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"184","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-274","justification":" It is necessary with sufficient data to evaluate if an active substance and a product is of low\n risk","location":[[" Proposal for a regulation","Article 18 \u2013 paragraph 1 \u2013 point d"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["d) for low-risk biocidal products, a dossier","or letter of access for the biocidal product","satisfying the requirements set out in","Annex III."],"old":["d) for low-risk biocidal products, any","relevant information in support of the","conclusion that the biocidal product is to","be considered a low-risk biocidal product."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"274","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-517","justification":" Unless specific data requirements are provided, together with rules for adaptation, this\n section should be deleted.","location":[[" Proposal for a regulation","Annex II -title 1 - table - section 12"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["12. Classification and labelling"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"517","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-185","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point c"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["c) it is not technically possible to supply","the information."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"185","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-518","justification":"The ECVAM-validated \u201creduced\u201d Local Lymph Node Assay (rLLNA) should be the default\napproach for distinguishing between skin sensitisers and non-sensitisers. Reference: \u2022\n ECVAM validation statement: http://ecvam.jrc.it/publication/ESAC26_statement_\nrLLNA_20070525_C.pdf It is problematic that this section does not (i) include rules for\nadaptation of in vivo data requirements, or (ii) identify accepted EU or international test\nguidelines for fulfilling data requirements, which are particularly critical in the case of\nmicrobial agents.","location":[[" Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.2.1 \u2013 paragraph 1(new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["The assessment of this endpoint shall","comprise the following consecutive steps:","(1) an assessment of the available human,","animal and alternative data,","(2) In-vivo testing.","The reduced Murine Local Lymph Node","Assay (rLLNA) is the first-choice method","for in vivo testing as a screening test to","distinguish between sensitisers and non","sensitisers. The full LLNA should be","performed when it is known that an","assessment of sensitisation potency is","required. Only in exceptional","circumstances should another test be","used, in which case a justification shall be","provided."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"518","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-275","justification":"It is critical that in the case of applications involving subsequent mutual recognition\nprocedures the application and all related documents are accepted in English by the receiving\ncompetent authority. This is very important in order to avoid time-consuming and expensive\ntranslation procedures for the same documentation in several European languages.","location":[[" Proposal for a regulation","Article 18 \u2013 paragraph 3"]],"meta":{"created":"2019-07-03T05:29:36"},"new":["3. The receiving competent authority may","require that applications for the sole","purpose of a national authorisation be","submitted in one or more of the official","languages of the Member State where that","competent authority is situated.","Applications for a national authorisation","which involve a mutual recognition","procedure may be submitted to the","competent authority in English, including","the documents referred to in paragraph 1."],"old":["3. The receiving competent authority may","require that applications for a national","authorisation be submitted in one or more","of the official languages of the Member","State where that competent authority is","situated."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"275","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-519","justification":"As discussed above under Section 6.5.1., testing via multiple exposure routes should not be\nnecessary if hazard classification is the primary objective. Revision of data requirements to\nforego redundant testing could markedly reduce costs and animal use. It is problematic that\nthis section does not (i) include rules for adaptation of in vivo data requirements, or (ii)\nidentify accepted EU or international test guidelines for fulfilling data requirements, which\nare particularly critical in the case of microbial agents.","location":[["Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.2.2 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["Testing shall be conducted via the oral","route unless the primary route of human","exposure is expected to be inhalation.","Testing shall be carried out via only a","single exposure route."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"519","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-276","location":[["Proposal for a regulation","Article 19 \u2013 paragraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["1. Notwithstanding Article 18, the","applicant need not provide data required","under that Article if any of the following","grounds applies:","a) the information is not necessary owing","to the exposure associated with the","proposed uses;","b) it is not scientifically necessary to","supply the information;","c) it is not technically possible to supply","the information."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"276","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-186","justification":"This is unclear and thus a potential loophole that is not justified.","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point c"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["c) it is not technically possible to supply","the information."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"186","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-520","justification":" As discussed above, testing via multiple exposure routes should not be necessary if hazard\n classification is the primary objective. Revision of data requirements to forego redundant\n testing could markedly reduce costs and animal use. It is problematic that this section does\n not (i) include rules for adaptation of in vivo data requirements, or (ii) identify accepted EU\n or international test guidelines for fulfilling data requirements, which are particularly critical\n in the case of microbial agents.","location":[["Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.2.2.2 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["Testing by the inhalation route is","appropriate only if this constitutes the","primary route of human exposure."],"old":[""],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"520","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-277","location":[[" Proposal for a regulation","Article 19 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["2. The applicant may propose to adapt the","data required under Article 18 in","accordance with Annex IV. The","justification for the proposed adaptations","to the data requirements shall be clearly","stated in the application with reference to","the specific rules in Annex IV."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"277","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-521","justification":" Neither i.p. nor s.c. injection are relevant routes of exposure. Consequently, the value of such\n studies for human risk assessment is dubious, and this data requirement should be deleted. It\n is problematic that this section does not (i) include rules for adaptation of in vivo data\n requirements, or (ii) identify accepted EU or international test guidelines for fulfilling data\n requirements, which are particularly critical in the case of microbial agents.","location":[[" Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.2.2.3"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["5.2.2.3. Intraperitoneal/subcutaneous","single dose"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"521","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-278","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[[" Proposal for a regulation","Article 19 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:36"},"new":["3. In order to define what constitutes","adequate justification to adapt the data","required under Article 18 on the ground","referred to in paragraph 1(a), the","Commission shall adapt the criteria by","means of delegated acts in accordance","with Article 71 a and subject to the","conditions of Articles 71 b and 71 c."],"old":["3. The Commission shall adopt the","measures designed to set the criteria","defining what constitutes adequate","justification to adapt the data required","under Article 18 on the ground referred to","in paragraph 1(a)."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"278","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-187","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:37"},"new":["4. In order to define what constitutes","adequate justification to adapt the data","required under paragraph 1 on the ground","referred to in paragraph 2(a), the","Commission shall adapt the criteria by","means of delegated acts in accordance","with Article 71 a and subject to the","conditions of Articles 71 b and 71 c."],"old":["4. The Commission shall adopt the","measures designed to set the criteria","defining what constitutes adequate","justification to adapt the data required","under paragraph 1 on the ground referred","to in paragraph 2(a)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"187","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-522","justification":"Testing via multiple exposure routes should not be necessary or encouraged. It is problematic\nthat this section does not (i) include rules for adaptation of in vivo data requirements, or (ii)\nidentify accepted EU or international test guidelines for fulfilling data requirements, which\nare particularly critical in the case of microbial agents.","location":[[" Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.2.5 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["Testing shall be conducted via the oral","route unless the primary route of","exposure is expected to be inhalation.","Testing shall be carried out via only a","single exposure route."],"old":[""],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"522","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-279","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Article 19 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:36"},"new":["deleted"],"old":["Those measures designed to amend non-","essential elements of this Regulation by","supplementing it shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"279","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-523","justification":"Testing via multiple exposure routes should not be necessary or encouraged. It is problematic\nthat this section does not (i) include rules for adaptation of in vivo data requirements, or (ii)\nidentify accepted EU or international test guidelines for fulfilling data requirements, which\nare particularly critical in the case of microbial agents.","location":[["Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.2.5.1 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["Testing by the inhalation route is","appropriate only if this constitutes the","primary route of human exposure."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"523","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-280","location":[["Proposal for a regulation","Article 20 \u2013 paragraph 2 \u2013 point o a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["oa) analytical methods including recovery","rates and the limits of determination","(LOD) for toxicologically and","ecotoxicologically relevant components of","biocidal products and/or residues hereof."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"280","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-188","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[33989],"meta":{"created":"2019-07-03T05:29:37"},"new":["4. The Commission shall adopt and","publish transparent criteria and guidance","for defining what constitutes adequate","justification to adapt the data required","under paragraph 1 on the grounds referred","to in paragraph 2(a), also in accordance","with the objective that testing on","vertebrate animals for the purposes of this","Regulation shall be undertaken only as a","last resort."],"old":["4. The Commission shall adopt the","measures designed to set the criteria","defining what constitutes adequate","justification to adapt the data required","under paragraph 1 on the ground referred","to in paragraph 2(a)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"188","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-524","justification":" This should be a conditional Tier II requirement. It is problematic that this section does not\n (i) include rules for adaptation of in vivo data requirements, or (ii) identify accepted EU or\n international test guidelines for fulfilling data requirements, which are particularly critical in\n the case of microbial agents.","location":[["Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.3 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["Testing may be waived if there is no","evidence of specific toxicity in earlier","studies."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"524","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-281","justification":" A new paragraph is needed to specify that in case of an authorised frame a single\n authorisation number will be provided for all products belonging to that frame. No such\n clarification currently exists in the BPR proposal.","location":[["Proposal for a regulation","Article 20 \u2013 paragraph 2 a (new)"]],"meta":{"created":"2019-07-03T05:29:36"},"new":["2a. In the case of a frame formulation,","one single authorisation number will be","provided for all biocidal products which","belong to that frame."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"281","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-189","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["Those measures designed to amend non-","essential elements of this Regulation by","supplementing it shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"189","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-282","justification":" Paragraph 3(b) should be fully consistent with Article 16(6), i.e. '\u2026in the case of a frame\n formulation, a reduction in the percentage of the active substance in the reference biocidal\n product may be allowed'. The content of the authorisation should therefore reflect this\n possibility.","location":[[" Proposal for a regulation","Article 20 \u2013 paragraph 3 \u2013 point b"]],"meps":[97294,96908],"meta":{"created":"2019-07-03T05:29:37"},"new":["b) the permitted alteration of the","composition of this reference biocidal","product expressed as a reduction in the","percentage of the active substance(s)","and/or as an alteration in the percentage","of the non-active substances contained in","the biocidal products which are considered","to belong to that frame formulation;"],"old":["b) the permitted alteration of the","composition of this reference biocidal","product expressed in percentage of the","non-active substances contained in the","biocidal products which are considered to","belong to that frame formulation;"],"orig_lang":"r","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"282","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-190","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 4 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:37"},"new":["4a. Scientific peer-reviewed open","literature on the active substance and its","relevant metabolites dealing with side-","effects on health, the environment and","non-target species and published within","the last 10 years before the date of","submission of the dossier shall be added","by the applicant to the dossier."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"190","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-525","justification":" In the pharmaceutical sector, it is becoming increasingly common to incorporate\n micronucleus assays into 28- or 90-day general toxicity studies in rats as a means of\n efficiently gathering mutagenicity data without a stand-alone in vivo study. This section\n should include (i) rules for adaptation of in vivo data requirements, or (ii) identify accepted\n EU or international test guidelines for fulfilling data requirements, which are particularly\n critical in the case of microbial agents.","location":[[" Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.4 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["For new substances, it should be possible","to assess the parameters of an in-vivo","micronucleus test as part of a repeated","exposure study."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"525","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-191","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[33989],"meta":{"created":"2019-07-03T05:29:37"},"new":["2. If, when the dossiers are evaluated, it","appears that additional information is","necessary to carry out the evaluation, the","evaluating competent authority shall ask","the applicant to submit such information","within a specified time limit, and shall","inform the Agency thereof. Where such","additional information includes animal","testing, the applicant shall be advised by","experts from the Agency or competent","authorities regarding suitable alternative","methods and testing strategies to replace,","reduce or refine the use of vertebrate","animals."],"old":["2. If, when the dossiers are evaluated, it","appears that additional information is","necessary to carry out the evaluation, the","evaluating competent authority shall ask","the applicant to submit such information","within a specified time limit, and shall","inform the Agency thereof.",""],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"191","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-283","justification":"Paragraph 3b should be fully coherent with Article 16.6, i.e. that \u201c\u2026in the case of a frame\nformulation, a reduction in the percentage of the active substance in the reference biocidal\nproduct may be allowed\u201d. Hence the authorisation content should reflect also this possibility.","location":[["Proposal for a regulation","Article 20 \u2013 paragraph 3 \u2013 point b"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:37"},"new":["b) the permitted alteration of the","composition of this reference biocidal","product expressed as reduction in the","percentage of the active substance(s)","and/or as alteration in the percentage of","the non-active substances contained in the","biocidal products which are considered to","belong to that frame formulation;"],"old":["b) the permitted alteration of the","composition of this reference biocidal","product expressed in percentage of the","non-active substances contained in the","biocidal products which are considered to","belong to that frame formulation;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"283","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-526","justification":"This should be a conditional Tier II requirement. It is problematic that this section does not\n(i) include rules for adaptation of in vivo data requirements, or (ii) identify accepted EU or\ninternational test guidelines for fulfilling data requirements, which are particularly critical in\nthe case of microbial agents.","location":[[" Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 5.5 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["Testing may be waived if there is no","evidence of genotoxicity in somatic cell","studies."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"526","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-527","justification":"Avian dietary toxicity testing, where indicated by use profile and other considerations, should\nbe strictly limited to a single species. Reference: \u2022 REACH technical guidance:\nhttp://guidance.echa.europa.eu/docs/guidance_document/\ninformation_requirements_r7c_en.pdf?vers=20_08_08 It is problematic that this section does\nnot (i) include rules for adaptation of in vivo data requirements, or (ii) identify accepted EU\nor international test guidelines for fulfilling data requirements, which are particularly critical\nin the case of microbial agents.","location":[["Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 8.1 \u2013 paragraphs 1 and 2(new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["An avian dietary toxicity study in a single","species may be proposed where a","substance use profile indicates the","potential for significant exposure to birds.","An avian reproduction study is not","generally required, and is not appropriate","if the dietary toxicity study (section 8.1.1.)","shows that the LC50 is above 5,000","mg/kg."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"527","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-192","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:38"},"new":["3. If the evaluating competent authority","considers that there are concerns with","regard to the cumulative effects from the","use of biocidal products containing the","same active substance, or different","substances with similar or common effects","on the same endpoints, whether by the","same or different mechanism of action, it","shall document its concerns in accordance","with the requirements of the relevant parts","of Section II.3 of Annex XV to Regulation","(EC) No 1907/2006 and include this as part","of its conclusions."],"old":["3. If the evaluating competent authority","considers that there are concerns with","regard to the cumulative effects from the","use of biocidal products containing the","same active substance, it shall document its","concerns in accordance with the","requirements of the relevant parts of","Section II.3 of Annex XV to Regulation","(EC) No 1907/2006 and include this as part","of its conclusions."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"192","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-284","justification":" Paragraph 3b should be fully coherent with Article 16.6, i.e. that \u201c\u2026in the case of a frame\n formulation, a reduction in the percentage of the active substance in the reference biocidal\n product may be allowed\u201d. Hence the authorisation content should reflect also this possibility.","location":[["Proposal for a regulation","Article 20 \u2013 paragraph 3 \u2013 point b"]],"meta":{"created":"2019-07-03T05:29:37"},"new":["b) the permitted alteration of the","composition of this reference biocidal","product expressed as reduction in the","percentage of the active substance(s)","and/or as alteration in the percentage of","the non-active substances contained in the","biocidal products which are considered to","belong to that frame formulation;"],"old":["b) the permitted alteration of the","composition of this reference biocidal","product expressed in percentage of the","non-active substances contained in the","biocidal products which are considered to","belong to that frame formulation;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"284","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-285","justification":" A new paragraph is needed to specify that in case of an authorised frame a single\n authorisation number will be provided for all products belonging to that frame. No such\n clarification currently exists in the BPR proposal.","location":[[" Proposal for a regulation","Article 20 \u2013 paragraph 3 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:37"},"new":["3a. In the case of a frame formulation,","one single authorisation number will be","provided for all biocidal products which","belong to that frame."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"285","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-193","justification":"It should be clarified that the opinion by the Agency is done with regard to the conclusions by\nthe evaluating competent authority.","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:38"},"new":["4. Within nine months after the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the inclusion of","the active substance in Annex I having","regard to the conclusions of the","evaluating competent authority."],"old":["4. Within nine months after the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the inclusion of","the active substance in Annex I."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"193","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-528","justification":" The requirement for aquatic toxicity testing should be exposure-driven rather than absolute,\n particularly with respect to testing on vertebrate animals. It is problematic that Annex II, Title\n 2, does not (i) include rules for adaptation of in vivo data requirements, or (ii) identify\n accepted EU or international test guidelines for fulfilling data requirements, which are\n particularly critical in the case of microbial agents.","location":[["Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 8.2.1 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:36"},"new":["Requirements for aquatic toxicity testing","on vertebrate animals may be waived if","the use profile for a substance does not","indicate significant potential for exposure","to the aquatic environment."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"528","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-286","justification":"The aim is to provide a clearer definition of how the comparative assessment should be\ncarried out. One element to be taken into consideration is the need for sufficient experience in\nthe use of the product. This should be the rule and not the exception.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:37"},"new":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation, within the meaning of this","Regulation, of an application for a renewal","of an authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1). The comparative","assessment must be carried out for all","biocidal products having the same","purpose, when sufficient experience has","been gained in their use and they have","been in use for at least five years."],"old":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product","containing an active substance that is a","","candidate for substitution in accordance","with Article 9(1)."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"286","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-194","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 5"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:38"},"new":["5. In order to keep the list of authorised","active substances updated, on receipt of","the opinion of the Agency, the Commission","shall adopt, by means of delegated acts in","accordance with Article 71 a and subject","to the conditions of Articles 71 b and 71 c,","a decision to include the active substance","in Annex I. If the Commission decides to","include the substance in Annex I, the","name of the applicants shall be given."],"old":["5. On receipt of the opinion of the Agency,","the Commission shall adopt a decision on","the application to include the active","substance in Annex I. That decision,","designed to amend non-essential elements","of this Regulation by supplementing it,","shall be adopted in accordance with the","regulatory procedure with scrutiny","referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"194","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-287","justification":"The risk to the environment and to human health has its source not so much in the active\nsubstance given the low quantities used in each product but rather in the product itself and in\nits use. Comparing only those products containing a substance classified as a candidate for\n\n substitution will have little relevance. There are very few new actives found every year, which\n can hardly replace old ones and the candidates for substitution will remain on the market for\n a longer period than expected. In order to stimulate innovation it is essential to favour only\n the safest products on the market.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 1"]],"meta":{"created":"2019-07-03T05:29:37"},"new":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product.","Comparative assessment shall be applied","to all biocidal products for the same","purpose when there is sufficient","experience, and a minimum of three","years, in use."],"old":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1)."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"287","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-529","justification":" Unless a reference is provided to accepted EU or international test guidelines to address this\n data requirement, it should be deleted.","location":[[" Proposal for a regulation","Annex II \u2013 title 2 \u2013 point 8.7.2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["8.7.2. Mammals"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"529","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-530","justification":"Threshold of Toxicological Concern is a \u201cweight of evidence\u201d risk assessment approach used\nextensively in the safety assessment of food additives, flavourings, food-contact materials, and\nother substances of unknown toxicity but with demonstrably low human exposure. When\ncombined with known structural information and predicted metabolism or other behaviour,\nthe approach bins chemicals into classes, each of which has its own acceptable human\nexposure limits. If exposure is below these very low levels, toxicity testing may be avoided.","location":[[" Proposal for a regulation","Annex III \u2013 heading 1 \u2013 paragraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["1. Dossiers on biocidal products shall","contain the information needed to establish","that exposure is below the Threshold of","Toxicological Concern (TTC), or where","relevant, to establish Acceptable Daily","Intake (ADI), Acceptable Operator","Exposure Level (AOEL), Predicted","Environmental Concentration (PEC), and","Predicted No-Effect Concentration","(PNEC)."],"old":["1. Dossiers on product shall contain the","","information needed to establish, where","relevant, Acceptable Daily Intake (ADI),","Acceptable Operator Exposure Level","(AOEL), Predicted Environmental","Concentration (PEC) and Predicted No-","Effect Concentration (PNEC)."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"530","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-195","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point a"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["a) its acceptable daily intake, acute","reference dose or acceptable operator","exposure level is significantly lower than","","those of the majority of the active","substances included in Annex I for the","same product type;"],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"195","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-288","justification":" An application for comparative assessment should, as the rule and not the exception, take\n account of experience from use of the product in practice. An application for comparative\n assessment should therefore be confined to the renewal of authorisations for those products\n which contain active substances that have been identified as candidates for substitution in\n accordance with Article 9.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:37"},"new":["1. 1. The receiving competent authority or,","in the case of evaluation of an application","for a Community authorisation, the","evaluating competent authority shall","perform a comparative assessment for a","renewal, subject to this Regulation, of an","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1).","Comparative assessment shall be applied","to all biocidal products for the same","purpose when there is sufficient","experience, and a minimum of five years,","in use."],"old":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1)."],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"288","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-531","justification":" Nanomaterials are used due to their different or enhanced properties as compared to\n substances in bulk form. Due to their miniscule size and the resulting increase of relative\n surface area, they may pose new risks. The relevant scientific committee of the Commission\n concluded that the knowledge on the methodology for both exposure estimates and hazard\n identification needs to be further developed, validated and standardized for nanomaterials. As\n such, existing methods for bulk chemicals cannot be assumed to provide relevant data, unless\n clearly specified","location":[["Proposal for a regulation","Annex III - point 5"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:37"},"new":["Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Council","Regulation (EC) No 440/2008. Methods","listed in Annex I do not cover","nanomaterials, except where specifically","mentioned. However, if a method is","inappropriate or not described, other","methods shall be used which are, whenever","possible, internationally recognised and the","validity of which must be justified in the","application."],"old":["Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Council","Regulation (EC) No 440/2008. However, if","a method is inappropriate or not described,","other methods shall be used which are,","whenever possible, internationally","recognised and must be justified in the","application."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"531","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-196","justification":" This can often be mitigated by changes in the use of the product or by use of personal\n protective equipment and engineering controls.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point a"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["a) its acceptable daily intake, acute","reference dose or acceptable operator","exposure level is significantly lower than","those of the majority of the active","substances included in Annex I for the","same product type;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"196","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-532","justification":" The original phrasing of Paragraph 5 of Annex III is not clear enough and will hinder the use\n of alternatives to animal experimentation that are mentioned in Annex IV","location":[[" Proposal for a regulation","Annex III \u2013 heading 1 \u2013 paragraph 5"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["5. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Council","Regulation (EC) No 440/2008. However, if","a method is inappropriate or not described,","other methods shall be used which are","scientifically satisfactory and must be","justified in the application."],"old":["5. Tests submitted for the purpose of","authorisation shall be conducted according","to the methods described in Regulation","(EC) No 440/2008. However, if a method","is inappropriate or not described, other","methods shall be used which are, whenever","possible, internationally recognised and","must be justified in the application."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"532","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-289","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product","containing an active substance or non-","active substance that is a candidate for","substitution in accordance with Article","9(1)."],"old":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1)."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"289","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-533","justification":"It is unacceptable that data requirements for inclusion of an active substance in Annex I and\nfor authorisation of a biocidal product result in duplicate testing or the repetition of tests,\nespecially if they include animal experimentation. Non-active substances in a biocidal\nproduct formulation will be regulated under REACH. This provision should therefore be\ndeleted in order to prevent confusion or potential duplicative vertebrate testing","location":[[" Proposal for a regulation","Annex III \u2013 heading 1 \u2013 paragraph 7"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["7. Where testing is done, a detailed","description (specification) of the material","used and its impurities must be provided."],"old":["7. Where testing is done, a detailed","description (specification) of the material","used and its impurities must be provided.","","Where necessary, data as established in","Annex II shall be required for all the","toxicologically/eco-toxicologically","relevant chemical components of the","biocidal product, in particular if the","components are substances of concern as","defined in Article 3."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"533","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-197","justification":"The criteria for identifying candidates for substitution should be aligned with the REACH\nRegulation authorisation criteria. As ECHA will have the task of examining whether an active\nsubstance meets the criteria, harmonisation between the two regulations is advisable.\nSubstances which do not pose a risk to human health or the environment as regards their\nplanned uses should not be considered as candidates for substitution.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point b"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:38"},"new":["b) it is considered as a persistent, bio-","accumulative and toxic substance in","accordance with the criteria set out in","Annex XIII of Regulation (EC) No","1907/2006;","(The justification given below also applies","to amendments relating to Article 9(1)(c),","(d) and (f), and (2)."],"old":["b) it meets two of the criteria to be","considered as a persistent, bio-","accumulative and toxic substance as set out","in Annex XIII of Regulation (EC) No","1907/2006;","",""],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"197","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-534","location":[["Proposal for a regulation","Annex III \u2013 heading 1 \u2013 paragraph 8"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["8. Where test data exist that have been","generated before ... [OJ: insert the date","referred to in the first subparagraph of","Article 85] by methods other than those","laid down in Regulation (EC) No","440/2008, the adequacy of such data for","the purposes of this Regulation and the","need to conduct new tests according to the","Regulation (EC) No 440/2008 must be","decided by the competent authority of the","Member State concerned in agreement","with the ECHA, on a case-by-case basis,","taking into account, among other factors,","the need to minimise testing on vertebrate","animals."],"old":["8. Where test data exist that have been","generated before ... [OJ: insert the date","referred to in the first subparagraph of","Article 85] by methods other than those","laid down in Regulation (EC) No","440/2008, the adequacy of such data for","the purposes of this Regulation and the","need to conduct new tests according to the","Regulation (EC) No 440/2008 must be","decided by the competent authority of the","Member State, on a case-by-case basis,","taking into account, among other factors,","the need to minimise testing on vertebrate","animals."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"534","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-290","justification":"An application for comparative assessment should, as the rule and not the exception, take\naccount of experience from use of the product in practice. An application for comparative\n\n\n assessment should therefore be confined to the renewal of authorisations for those products\n which contain active substances that have been identified as candidates for substitution in\n accordance with Article 9.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:37"},"new":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of renewal of a Community","authorisation, also to the Commission."],"old":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of evaluation of an application for a","Community authorisation, also to the","Commission."],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"290","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-535","justification":" Standard stability tests that are based on the measurements and quantification of the active\n substance are not appropriate for products containing readily decomposable active\n substances, such as sodium hypochlorite. These substances are known to decompose beyond\n accepted guidelines (FAO, WHO limits). Therefore, in such cases, it is more appropriate that\n the stability and the shelf-life is determined by other means, such as extrapolating the\n analytical data of the active substance from product aging experiments until reaching the\n efficacy threshold.","location":[[" Proposal for a regulation","Annex III \u2013 title 1 \u2013point 3.7"]],"meta":{"created":"2019-07-03T05:29:37"},"new":["3.7. Storage stability - stability and shelf-","life. Effects of light, temperature and","humidity on technical characteristics of the","biocidal product; reactivity towards","container material","Storage stability and shelf life will be","generally determined based on the","stability of the active substance. In the","case of readily decomposable active","substances, the storage stability and the","shelf life may be determined by other valid","scientific means, such as extrapolating","the analytical data of the active substance","from product aging experiments until","reaching the efficacy threshold."],"old":["3.7. Storage stability - stability and shelf-","life. Effects of light, temperature and","humidity on technical characteristics of the","biocidal product; reactivity towards","container material"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"535","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-198","justification":"For reasons of consistency between the two regulations, the criteria for identifying candidates\nof substitution are aligned with the criteria for substances to be authorised under Regulation\n(EC) No 1907/2006 (REACH) (Article 57). Since the Agency (ECHA) will own the task of\nexamining if an active substance fulfils any of the criteria, consistency between the two\nregulations is advisable.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point b"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:38"},"new":["b) substances which are persistent,","bioaccumulative and toxic in accordance","with the criteria set out in Annex XIII of","Regulation (EC) No 1907/2006;"],"old":["b) it meets two of the criteria to be","considered as a persistent, bio-","accumulative and toxic substance as set","out in Annex XIII of Regulation (EC) No","1907/2006;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"198","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-291","justification":" The results of the comparative assessment should be forwarded to the Commission only in the\n case of a renewal of a Community authorisation.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:37"},"new":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of renewal of an application for a","Community authorisation, also to the","Commission."],"old":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of evaluation of an application for a","Community authorisation, also to the","Commission."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"291","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-536","justification":"Annex II of Directive 1999/45/EC y provides for \u201cclassification by calculation\u201d as an\nalternative to redundant in vivo testing for formulated preparations comprised of well\ncharacterised active substances and other ingredients. This approach should be promoted\nunder the Biocidal Products Regulation. Research shows that dermal studies do not add value\nabove and beyond oral data for hazard classification purposes in more than 99% of cases.\nHence, data requirements should be revised to reflect these new findings.","location":[[" Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 6.1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["For studies of Sections 6.1.1 to 6.1.3,","classification by calculation should be the","default approach. Only in exceptional","cases should additional in-vivo testing be","considered, and in such cases, only the","single most relevant exposure route","should be tested. Gases and volatile liquids","should be administered by the inhalation","route."],"old":["For studies of Sections 6.1.1 to 6.1.3,","biocidal products other than gases shall","","be administered via at least two routes,","one of which should be the oral route. The","choice of the second route will depend on","the nature of the product and the likely","route of human exposure. Gases and","volatile liquids should be administered by","the inhalation route"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"536","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-199","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point b"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["b) it meets one of the criteria to be","considered as a persistent, bio-","accumulative and toxic substance as set out","in Annex XIII of Regulation (EC) No","1907/2006;"],"old":["b) it meets two of the criteria to be","considered as a persistent, bio-","accumulative and toxic substance as set out","in Annex XIII of Regulation (EC) No","1907/2006;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"199","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-292","justification":"The comparison should focus on biocidal products for which there is an identified risk and\nwhere alternatives are needed. No comparative assessment should be carried out on biocidal\nproducts whose use has been shown to be safe.","location":[[" Proposal for a regulation","Article 21, paragraph 2 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:37"},"new":["2a. By way of derogation from paragraph","1, a comparative assessment shall not be","required for biocidal products whose use","has been shown to be safe."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"292","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-537","justification":"This data requirement should be deleted on the basis of the aforementioned analysis, which\nfound dermal classifications to be concordant with or less severe than oral classifications in\nover 99% of cases. Dermal classifications can therefore be based on direct read-across from\noral data.","location":[["Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 6.1.2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["6.1.2. Dermal"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"537","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-293","justification":"An application for comparative assessment should, as the rule and not the exception, take\naccount of experience from use of the product in practice. An application for comparative\nassessment should therefore be confined to the renewal of authorisations for those products\nwhich contain active substances that have been identified as candidates for substitution in\naccordance with Article 9.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:37"},"new":["3. The receiving competent authority or, in","the case of a decision on a renewal of a","Community authorisation, the Commission","shall prohibit or restrict the placing on the","market or use of a biocidal product","containing an active substance that is a","candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:"],"old":["3. The receiving competent authority or, in","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product containing an active substance that","is a candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:"],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"293","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-200","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point c"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:38"},"new":["c) it is considered as a persistent, bio-","accumulative and toxic substance in","accordance with the criteria set out in","Annex XIII of Regulation (EC) No","1907/2006;"],"old":["c) there are reasons for concern linked to","the nature of the critical effects, in","particular developmental neurotoxic or","immunotoxic effects, which, in","combination with the use patterns,","amount to use that could still cause","concern, even with very restrictive risk","management measures;"],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"200","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-538","justification":" Annex II of Directive 1999/45/EC y provides for \u201cclassification by calculation\u201d as an\n alternative to redundant in vivo testing for formulated preparations comprised of well\n characterised active substances and other ingredients. This approach should be promoted\n under the Biocidal Products Regulation. Research shows that dermal studies do not add value\n above and beyond oral data for hazard classification purposes in more than 99% of cases.\n Hence, data requirements should be revised to reflect these new findings.","location":[["Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 6.1.3 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["Testing by the inhalation route is","appropriate only if (i) classification by","calculation is not feasible and (ii) this","constitutes the primary route of human","exposure, taking into account the vapour","pressure of the substance and the","possibility of exposure to aerosols,","particles or droplets of an inhalable size.","The Acute Toxic Class Method is the first-","choice method for in-vivo testing. Only in","exceptional circumstances should the","classic \u201clethal concentration\u201d (LC50) test","be used. Justification for the use of","another test shall be provided."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"538","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-201","justification":"For reasons of consistency between the two regulations, the criteria for identifying candidates\nof substitution are aligned with the criteria for substances to be authorised under Regulation\n(EC) No 1907/2006 (REACH) (Article 57). Since the Agency (ECHA) will own the task of\nexamining if an active substance fulfils any of the criteria, consistency between the two\nregulations is advisable.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point c"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:38"},"new":["c) substances which are very persistent","and very bioaccumulative in accordance","with the criteria set out in Annex XIII of","Regulation (EC) No 1907/2006;"],"old":["c) there are reasons for concern linked to","the nature of the critical effects, in","particular developmental neurotoxic or","immunotoxic effects, which, in","combination with the use patterns,","amount to use that could still cause","concern, even with very restrictive risk","","management measures;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"201","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-294","justification":" Comparative assessment should be confined to authorisation renewal cases.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:37"},"new":["3. The receiving competent authority or, in","the case of a decision on a renewal of a","Community authorisation, the Commission","shall prohibit or restrict the placing on the","market or use of a biocidal product","containing an active substance that is a","candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:"],"old":["3. The receiving competent authority or, in","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product containing an active substance that","is a candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:"],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"294","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-539","justification":"This requirement should be deleted, as it would lead to unnecessary use of vertebrate animals\nin lethal/distressing studies with limited or no public health value beyond what can be\ngleaned from other acute test data.","location":[[" Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 6.1.4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["6.1.4. For biocidal products that are","intended to be authorised for use with","other biocidal products, the mixture of","products, where possible, shall be tested","for acute dermal toxicity and skin and eye","irritation, as appropriate"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"539","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-295","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 introductory part"]],"meta":{"created":"2019-07-03T05:29:38"},"new":["3. The receiving competent authority or, in","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product where the comparative assessment","weighing up the risks and benefits in","accordance with Annex VI demonstrates","that all the following criteria are met:"],"old":["3. The receiving competent authority or, in","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product containing an active substance","that is a candidate for substitution where","the comparative assessment weighing up","the risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"295","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-202","justification":"Considering water resources protection by analogy to the regulation concerning the placing\nof plant protection products on the market (1107/2009) Annex II, 4, 3rd indent.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point c"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:38"},"new":["c) there are reasons for concern linked to","the nature of the critical effects, in","particular developmental neurotoxic or","immunotoxic effects, which, in","combination with the use patterns, amount","to use that could still cause concern, e.g.","high potential of risk to groundwater,","even with very restrictive risk management","measures;"],"old":["c) there are reasons for concern linked to","the nature of the critical effects, in","particular developmental neurotoxic or","immunotoxic effects, which, in","combination with the use patterns, amount","to use that could still cause concern, even","with very restrictive risk management","measures;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"202","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-540","justification":"Annex II of Directive 1999/45/EC expressly provides for \u201cclassification by calculation\u201d as an\nalternative to redundant in vivo testing for formulated preparations comprised of well\ncharacterised active substances and other ingredients. This approach should be more\nstrongly promoted under the Biocidal Products Regulation. References: \u2022 Directive\n1999/45/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=\nCELEX:31999L0045:EN:HTML","location":[["Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 6.2 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["Classification by calculation should be the","default approach."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"540","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-296","justification":"An application for comparative assessment should, as the rule and not the exception, take\naccount of experience from use of the product in practice. An application for comparative\nassessment should therefore be confined to the renewal of authorisations for those products\nwhich contain active substances that have been identified as candidates for substitution in\naccordance with Article 9.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 point a"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:38"},"new":["a) for the uses specified in the application,","other authorised biocidal products or a","non-chemical control or prevention method","already exist which present significantly","lower risk for human or animal health or","the environment and which prove equally","effective and involve no significant","increase in the risks for any other","parameter;"],"old":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower risk for human or animal health or","the environment;"],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"296","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-203","justification":" Non-active isomers do not pose a danger to health or the environment. There is therefore no\n need to include them among substances that are candidates for substitution.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point d"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["d) it contains a significant proportion of","non-active isomers;"],"orig_lang":"t","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"203","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-297","justification":" It would seem appropriate to highlight the fact that children are more vulnerable to harmful\n products than adults, on whom the proposal for a regulation is basing tolerance criteria.\n Children often find themselves in places which have been sprayed with biocidal products and\n pesticides, and show reactions - immediately or in the longer term - which are directly or\n indirectly attributable to the harmful substances.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 point a"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:38"},"new":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower risk immediately or in the more","distant future for the health of human","beings, especially children, or animals or","for the environment;"],"old":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower risk for human or animal health or","the environment;"],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"297","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-541","justification":"Annex II of Directive 1999/45/EC expressly provides for \u201cclassification by calculation\u201d as an\nalternative to redundant in vivo testing for formulated preparations comprised of well\n\n characterised active substances and other ingredients. This approach should be more\n strongly promoted under the Biocidal Products Regulation. References: \u2022 Directive\n 1999/45/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=\n CELEX:31999L0045:EN:HTML It is problematic that this title does not include rules for\n adaptation of in vivo data requirements.","location":[["Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 6.3 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["Classification by calculation should be the","default approach."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"541","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-204","justification":" For reasons of consistency between the two regulations, the criteria for identifying candidates\n of substitution are aligned with the criteria for substances to be authorised under Regulation\n (EC) No 1907/2006 (REACH) (Article 57). Since the Agency (ECHA) will own the task of\n examining if an active substance fulfils any of the criteria, consistency between the two\n regulations is advisable.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point d"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["d) it contains a significant proportion of","non-active isomers;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"204","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-298","justification":" The use of a comparative assessment should be confined to the renewal of authorisations of\n those biocidal products which contain active substances which are candidates for substitution\n in accordance with Article 9 of the Regulation.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 point a"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:38"},"new":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower risk for human or animal health or","the environment and which proves equally","effective and involves no significant","increase in the risks for any other","parameter;"],"old":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower risk for human or animal health or","the environment;"],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"298","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-205","location":[[" Proposal for a regulation","Article 9 - paragraph 1 - point d"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["d) it contains a significant proportion of","","","non-active isomers;"],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"205","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-542","justification":" An OECD test guideline for in vitro dermal irritation has been available since 2004 and is\n capable of fully replacing the in vivo method for the purposes of the Biocidal Products\n Regulation. Consequently, these data requirements should specifically cite the in vitro method\n as the only necessary or acceptable approach for fulfilling this end Section.","location":[[" Proposal for a regulation","Annex III- title 1 - section 6.4"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:37"},"new":["(6.4) Information on in-vitro dermal","absorption"],"old":["(6.4) Information on dermal absorption"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"542","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-299","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 point a"]],"meta":{"created":"2019-07-03T05:29:38"},"new":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower or reduced risk for human or animal","health or the environment;"],"old":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower risk for human or animal health or","the environment;"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"299","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-206","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point e"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["e) it is classified or meets the criteria to be","classified, in accordance with Regulation","(EC) No 1272/2008, as respiratory","sensitizers, carcinogen category 1A or 1B,","mutagen category 1A or 1B or toxic for","reproduction category 1A or 1B;"],"old":["e) it is classified or meets the criteria to be","classified, in accordance with Regulation","(EC) No 1272/2008, as carcinogen","category 1A or 1B, mutagen category 1A","or 1B or toxic for reproduction category","1A or 1B;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"206","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-543","justification":" The requirement being referenced currently lacks any description of the specific data being\n sought, rules for adaptation, or rationale for why a \u201cclassification by calculation\u201d approach\n would not suffice based on Annex II data for the active substance.","location":[[" Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 9.2.1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["9.2.1. Where relevant all the information","required in Annex II, Section 12"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"543","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-207","justification":" For reasons of consistency between the two regulations, the criteria for identifying candidates\n of substitution are aligned with the criteria for substances to be authorised under Regulation\n (EC) No 1907/2006 (REACH) (Article 57). Since the Agency (ECHA) will own the task of\n examining if an active substance fulfils any of the criteria, consistency between the two\n regulations is advisable.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point f"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:39"},"new":["f) substances \u2014 such as those having","endocrine disrupting properties or those","having persistent, bioaccumulative and","toxic properties or very persistent and very","bioaccumulative properties, which do not","fulfil the criteria of points (b) or (c) \u2014 for","which there is scientific evidence of","probable serious effects to human health","or the environment which give rise to an","equivalent level of concern to those of","other substances listed in points (b), (c) or","(e) and which are identified on a case-by-","case basis in accordance with the","procedure set out in Article 59 of","Regulation (EC) No 1907/2006;"],"old":["f) it is considered to have endocrine","disrupting properties that may cause","adverse effect on humans on the basis of","the assessment of Community or","internationally agreed test guidelines or","other available data."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"207","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-300","justification":"An application for comparative assessment should, as the rule and not the exception, take\naccount of experience from use of the product in practice. An application for comparative\nassessment should therefore be confined to the renewal of authorisations for those products\nwhich contain active substances that have been identified as candidates for substitution in\naccordance with Article 9.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 point b"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:38"},"new":["b) the biocidal products referred to in point","(a) do not present significant economic or","practical disadvantages;"],"old":["b) the biocidal product or non-chemical","control or prevention method referred to","in point (a) does not present significant","economic or practical disadvantages;"],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"300","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-544","justification":"\nAccording to REACH technical guidance, \u201cfew (if any) scenarios are likely to lead to acute\npoisoning risks for birds\u201d, and \u201cevidence from pesticides suggests that chronic effects cannot\nbe reliably extrapolated or inferred from acute toxicity data.\u201d Accordingly, this data\nrequirement will contribute little or nothing to an environmental risk assessment and should\ntherefore be deleted.","location":[["Proposal for a regulation","Annex III - title 1 - section 9.3.1.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["9.3.1.1. Acute oral toxicity, if not already","done in accordance with Annex II,","Section 7"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"544","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-208","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point f"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:39"},"new":["f) it is a substance, such as those with","endocrine disrupting properties or","persistent, bioaccumulative and toxic","properties or very persistent, very","bioaccumulative properties which do not","comply with the criteria referred to in","points (b) and (c) \u2013 for which scientific","evidence exists of possible serious effects","on public health or the environment","giving rise to a level of concern equivalent","to that applicable to other substances","referred to in points (b) and (c)."],"old":["f) it is considered to have endocrine","disrupting properties that may cause","adverse effect on humans on the basis of","the assessment of Community or","internationally agreed test guidelines or","other available data."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"208","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-301","justification":" It is not appropriate to carry out comparative assessments between biocidal products and\n non-chemical control measures which have not been subject to the same efficiency and risk\n assessments.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 point b"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:38"},"new":["b) the biocidal product referred to in point","(a) does not present significant economic","or practical disadvantages;"],"old":["b) the biocidal product or non-chemical","","control or prevention method referred to","in point (a) does not present significant","economic or practical disadvantages;"],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"301","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-545","justification":"Unless a reference is provided to accepted EU or international test guidelines to address this\ndata requirement, it should be deleted. It is problematic that this section does not include\nrules for adaptation of in vivo data requirements.","location":[["Proposal for a regulation","Annex III \u2013 title 1 \u2013 point 9.3.3.1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["deleted"],"old":["9.3.3.1. Toxicity to terrestrial vertebrates","other than birds"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"545","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-209","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point f"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["f) it is considered to have endocrine","disrupting properties that may cause","adverse effect on humans or the","environment on the basis of the assessment","of Community or internationally agreed","test guidelines or other available data."],"old":["f) it is considered to have endocrine","disrupting properties that may cause","adverse effect on humans on the basis of","","the assessment of Community or","internationally agreed test guidelines or","other available data."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"209","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-302","justification":" An application for comparative assessment should, as the rule and not the exception, take\n account of experience from use of the product in practice. An application for comparative\n assessment should therefore be confined to the renewal of authorisations for those products\n\nwhich contain active substances that have been identified as candidates for substitution in\naccordance with Article 9.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 3 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:38"},"new":["3a. The Commission shall, on the basis of","paragraph 3, adopt implementing","measures laying down the procedure","necessary for the definition of an","application for comparative assessment of","biocidal products. These measures shall","define the criteria and algorithms to be","used in a comparative assessment to","ensure that there is a uniform application","throughout the Community.","Those measures designed to amend non-","essential elements of this Regulation by","supplementing it shall be adopted in","accordance with the regulatory procedure","without scrutiny referred to in","Article 72(3)."],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"302","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-546","justification":" Annex II of Directive 1999/45/EC y provides for \u201cclassification by calculation\u201d as an\n alternative to redundant in vivo testing for formulated preparations comprised of well\n characterised active substances and other ingredients. This approach should be promoted\n under the Biocidal Products Regulation. Research shows that dermal studies do not add value\n above and beyond oral data for hazard classification purposes in more than 99% of cases.\n Hence, data requirements should be revised to reflect these new findings.","location":[[" Proposal for a regulation","Annex III \u2013 title 2 \u2013 point 6.1.1 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:37"},"new":["Classification by calculation should be the","default approach. Only in exceptional","cases should additional in-vivo testing be","considered, and in such cases, only the","single most relevant exposure route","should be tested."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"546","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-210","justification":"In compliance with the substitution principle, a new Subparagraph g) should be added to\nArticle 9, 1 This would also account for equal treatment of biocidal products that are already\nauthorised and new active substances.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point f a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:39"},"new":["fa) for the uses specified in the dossier of","the active substance, an alternative","authorised biocidal product or a non-","chemical control or prevention method","already exists which presents significantly","lower risk for human or animal health or","the environment;"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"210","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-547","justification":" Annex II of Directive 1999/45/EC y provides for \u201cclassification by calculation\u201d as an\n alternative to redundant in vivo testing for formulated preparations comprised of well\n characterised active substances and other ingredients. This approach should be promoted\n\nunder the Biocidal Products Regulation. Research shows that dermal studies do not add value\nabove and beyond oral data for hazard classification purposes in more than 99% of cases.\nHence, data requirements should be revised to reflect these new findings.","location":[[" Proposal for a regulation","Annex III \u2013 title 2 \u2013 point 6.1.2 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["Testing by the inhalation route is","appropriate only if (i) classification by","calculation is not feasible and (ii) this","constitutes the primary route of human","exposure."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"547","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-303","justification":"An application for comparative assessment should, as the rule and not the exception, take\naccount of experience from use of the product in practice. An application for comparative\nassessment should therefore be confined to the renewal of authorisations for those products\nwhich contain active substances that have been identified as candidates for substitution in\naccordance with Article 9.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 4"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["4. By way of derogation from paragraph","1, a biocidal product containing an active","substance that is a candidate for","substitution shall be authorised without","comparative assessment in cases where it","is necessary to acquire experience first","through using that product in practice."],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"303","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-548","justification":"Annex II of Directive 1999/45/EC expressly provides for \u201cclassification by calculation\u201d as an\nalternative to redundant in vivo testing for formulated preparations comprised of well\ncharacterised active substances and other ingredients. This approach should be more\nstrongly promoted under the Biocidal Products Regulation. References: \u2022 Directive\n1999/45/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=\nCELEX:31999L0045:EN:HTML It is problematic that this section does not include rules for\nadaptation of in vivo data requirements.","location":[["Proposal for a regulation","Annex III \u2013 title 2 \u2013 point 6.2.1 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["Classification by calculation should be the","default approach."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"548","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-211","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 2"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:39"},"new":["2. When preparing an opinion on the","inclusion or renewal of the inclusion of an","active substance in Annex I, the Agency","shall examine whether the active substance","fulfils any of the criteria listed in paragraph","1 and whether exposure is not adequately","controlled, bearing in mind the intrinsic","hazards of the substance, and shall","address the matter in its opinion."],"old":["2. When preparing an opinion on the","inclusion or renewal of the inclusion of an","active substance in Annex I, the Agency","shall examine whether the active substance","fulfils any of the criteria listed in paragraph","1 and address the matter in its opinion.",""],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"211","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-304","justification":" When a substance is classified as a candidate for substitution it is established that there are\n health and environmental hazards associated with it. Products with candidates for\n substitution should therefore always undergo comparative assessment before being placed on\n the market.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 4"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["4. By way of derogation from paragraph","1, a biocidal product containing an active","substance that is a candidate for","substitution shall be authorised without","comparative assessment in cases where it","is necessary to acquire experience first","through using that product in practice."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"304","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-212","justification":" Substitution plans should be carried out in order to encourage a sustainable production and\n marketing of products where substances of concern are substituted with less hazardous\n substances. In addition, the establishment of substitution plans promotes product innovation.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be renewed for a","period not exceeding five years.","Member states shall establish and","implement a substitution plan in order to","ensure that the application of the active","substance concerned will be phased out","within the authorisation period and that","the active substance can be replaced with","sound chemical or non-chemical","alternatives."],"old":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be renewed for a","period not exceeding ten years."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"212","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-549","justification":"Annex II of Directive 1999/45/EC expressly provides for \u201cclassification by calculation\u201d as an\nalternative to redundant in vivo testing for formulated preparations comprised of well\ncharacterised active substances and other ingredients. This approach should be more\n\n strongly promoted under the Biocidal Products Regulation. References: \u2022 Directive\n 1999/45/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=\n CELEX:31999L0045:EN:HTML It is problematic that this section does not include rules for\n adaptation of in vivo data requirements.","location":[["Proposal for a regulation","Annex III \u2013 title 2 \u2013 point 6.2.2 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["Classification by calculation should be the","default approach."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"549","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-305","justification":" In the interests of uniform application of the comparative assessment of biocidal products, the\n Commission should draw up implementing measures.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 4"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:38"},"new":["4. The Commission shall adopt","implementing measures which specify the","procedure required to define the","application for comparative assessment","for biocidal products in accordance with","the provisions of paragraph 3. These","measures shall define the criteria and","algorithms to be used for a comparative","assessment so as to ensure uniform","application throughout the Community.","These measures shall be adopted in","accordance with the procedures laid down","in Article 72(3)."],"old":["4. By way of derogation from paragraph","1, a biocidal product containing an active","substance that is a candidate for","substitution shall be authorised without","comparative assessment in cases where it","is necessary to acquire experience first","through using that product in practice."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"305","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-213","justification":"Active substances that are considered as candidates for substitution in accordance with\nparagraph 1 should not included in Annex I for more than five years.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 4"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:39"},"new":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be renewed for a","period not exceeding five years."],"old":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be renewed for a","period not exceeding ten years."],"orig_lang":"r","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"213","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-306","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["4. 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By way of derogation from paragraph 1,","a biocidal product containing an active","substance that is a candidate for","substitution shall be authorised without","comparative assessment in cases where it is","necessary to acquire experience first","through using that product in practice."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"306","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-550","justification":" Annex II of Directive 1999/45/EC expressly provides for \u201cclassification by calculation\u201d as an\n alternative to redundant in vivo testing for formulated preparations comprised of well\n characterised active substances and other ingredients. This approach should be more\n strongly promoted under the Biocidal Products Regulation. References: \u2022 Directive\n 1999/45/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=\n CELEX:31999L0045:EN:HTML It is problematic that this section does not include rules for\n adaptation of in vivo data requirements.","location":[[" Proposal for a regulation","Annex III \u2013 title 2 \u2013 point 6.2.3 \u2013 paragraph 1 (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["Classification by calculation should be the","default approach."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"550","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-214","justification":"The inclusion period for substances that are candidates for substitution should be the same as\nin the PPP regulation.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be granted or","renewed for a period not exceeding seven","years."],"old":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be renewed for a","period not exceeding ten years."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"214","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-307","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 5 \u2013 subparagraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:38"},"new":["In order to specify the procedures related","to comparative assessments involving","questions of Community interest, the","Commission shall adapt the criteria by","means of delegated acts in accordance","with Article 71 a and subject to the","conditions of Articles 71 b and 71 c."],"old":["The Commission shall adopt","implementing rules specifying the","procedures related to comparative","assessments involving questions of","Community interest. Those rules, designed","to amend non-essential elements of this","Regulation by supplementing it, shall be","adopted in accordance with the regulatory","procedure with scrutiny referred to in","Article 72(4)."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"307","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-551","justification":" Unnecessary for formulated product. Annex II of Directive 1999/45/EC expressly provides\n\n\nfor \u201cclassification by calculation\u201d as an alternative to redundant in vivo testing for\nformulated preparations comprised of well characterised active substances and other\ningredients. This approach should be more strongly promoted under the Biocidal Products\nRegulation.","location":[[" Proposal for a regulation","Annex III - title 2 - section 9.1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["9.1. Effects on birds"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"551","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-215","justification":" As long as essential and viable biocidal products exist based on active substances that are\n candidates for substitution, the renewal of its Annex I inclusion should be allowed, and not be\n limited to a one-off renewal period of maximum ten years.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 4"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:39"},"new":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be renewed for","periods not exceeding ten years."],"old":["4. By way of derogation from Article","10(3), the inclusion of an active substance","in Annex I that is considered as a candidate","for substitution shall be renewed for a","period not exceeding ten years."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"215","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-308","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 6 - subparagraph 1a (new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["Member States shall establish and","implement a substitution plan in order to","ensure that the application of the relevant","biocidal product will be phased out within","the authorisation period and that the","relevant active substance or product can","be replaced with chemical or non-","chemical sound alternatives."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"308","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-552","justification":"Annex II of Directive 1999/45/EC expressly provides for \u201cclassification by calculation\u201d as\nan alternative to redundant in vivo testing for formulated preparations comprised of well\ncharacterised active substances and other ingredients. This approach should be more\nstrongly promoted under the Biocidal Products Regulation.","location":[["Proposal for a regulation","Annex III - title 2 - section 9.2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["9.2. Effects on aquatic organisms"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"552","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-216","location":[[" Proposal for a regulation","Article 10 \u2013 paragraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["1. The Commission shall renew the","inclusion of an active substance in Annex I","if the active substance still complies with","the requirements referred to in Article 4","and Article 5."],"old":["1. 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Mammals"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"553","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-217","justification":"Renewals should not be for an unlimited period of time. The same provisions were adopted in\nthe PPP regulation.","location":[[" Proposal for a regulation","Article 10 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["3. Unless otherwise specified in the","decision to renew the inclusion of an active","substance in Annex I, the renewal shall be","for a period not exceeding 15 years. The","renewal of approval of substances covered","by Article 5 shall be for a period not","exceeding five years."],"old":["3. 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The proposed introduction of possibilities for data waiving contradicts efforts for\n the protection of human health and environment.","location":[[" Proposal for a regulation","Annex IV \u2013 title"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["GENERAL RULES FOR THE","ADAPTATION OF THE DATA","REQUIREMENTS"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"554","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-310","justification":"It is unacceptable to allow a biocidal product to stay on the market for another five years\nwhen better alternatives are available. The same timeline as agreed in the PPP regulation\nshould apply.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 7"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["7. Where it is decided not to authorise or to","restrict the use of a biocidal product","pursuant to paragraph 3, that cancellation","or amendment of the authorisation shall","take effect three years after the decision or","at the end of the inclusion period of the","candidate for substitution, whichever is the","earlier."],"old":["7. Where it is decided not to authorise or to","restrict the use of a biocidal product","pursuant to paragraph 3, that cancellation","or amendment of the authorisation shall","take effect five years after the decision or","at the end of the inclusion period of the","candidate for substitution, whichever is the","earlier."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"310","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-218","justification":"Indefinite authorisations of new active substances will limit the incentive to conduct new\nresearch and provide new scientific data. In line with the current directive on biocides as well\nas the pesticides/plant protection legislation, there is a need for review of the active\nsubstances on a regular basis.","location":[["Proposal for a regulation","Article 10 \u2013 paragraph 3"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["3. Unless stricter specified in the decision","to renew the inclusion of an active","substance in Annex I, the renewal may be","renewed for a period not exceeding 10","years."],"old":["3. Unless otherwise specified in the","decision to renew the inclusion of an active","substance in Annex I, the renewal shall be","for an unlimited period of time."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"218","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-555","justification":" It is essential to provide the necessary data set for the evaluation and authorisation of active\n ingredients in order to protect the human health and the environment and to avoid a\n deterioration of the current standards etstablished with the Biocidal Products Directive\n 98/8/EC. The proposed introduction of possibilities for data waiving contradicts efforts for\n\nthe protection of human health and environment.","location":[[" Proposal for a regulation","Annex IV \u2013 introductory paragraph"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["The applicant may propose to adapt the","data requirements set out in Annexes II","and III according to the general rules set","out in this Annex. The reasons for such","adaptations to the data requirements must","be clearly stated under the appropriate","heading of the dossier referring to the","specific rule(s) of this Annex."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"555","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-311","justification":"An application for comparative assessment should, as the rule and not the exception, take\naccount of experience from use of the product in practice. An application for comparative\nassessment should therefore be confined to the renewal of authorisations for those products\n\n which contain active substances that have been identified as candidates for substitution in\n accordance with Article 9.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 7 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:39"},"new":["7a. By way of derogation from","paragraph 1, a comparative assessment","shall not be required for biocidal products","whose use has been shown to be safe."],"orig_lang":"e","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"311","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-556","justification":"Annex II of Directive 1999/45/EC expressly provides for \u201cclassification by calculation\u201d as an\nalternative to redundant in vivo testing for formulated preparations comprised of well\ncharacterised active substances and other ingredients. This approach should be more\nstrongly promoted under the Biocidal Products Regulation. References: \u2022 Directive\n\n\n 1999/45/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=\n CELEX:31999L0045:EN:HTML","location":[["Proposal for a regulation","Annex IV \u2013 point 1.1.3 a (new)(new)"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["1.1.3a. Calculation methods for the","evaluation of health hazards of","preparations","Data requirements for preparations may","generally be waived in favour of the","calculation approach specified in Annex","II to Directive 1999/45/EC, which is","applicable to all preparations and which","takes into consideration all the health","hazards of substances contained in the","preparation. Guidance is specifically","provided for the following categories of","adverse health effects:","- acute lethal effects","- non-lethal irreversible effects after a","single exposure","- severe effects after repeated or","prolonged exposure","- corrosive or irritant effects","- sensitising effects","- carcinogenic effects","- mutagenic effects","- reprotoxic effects"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"556","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-219","justification":" In order to ensure an appropriate protection of consumers and environment the approval of\n an active substance shall be regularly reviewed. Provisions favouring an unlimited approval\n results in a weakening of the current Community standards for the authorisation of active\n substances and contradicts the approaches of other chemical laws like the Regulation on\n Plant Protection Products.","location":[["Proposal for a regulation","Article 10 \u2013 paragraph 3"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:39"},"new":["3. Unless stricter specified in the decision","to renew the inclusion of an active","substance in Annex I, the renewal shall be","not exceeding a maximum period of 5","years."],"old":["3. Unless otherwise specified in the","decision to renew the inclusion of an active","substance in Annex I, the renewal shall be","for an unlimited period of time."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"219","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-312","justification":" Given the fact that, before being included in Annex I to the regulation, active substances used\n in biocidal products are already subject to lengthy assessment, it is felt that the period of\n twelve months provided for in the proposal for a regulation is too long for the authorisation\n of a biocidal product based on authorised active substances.","location":[[" Proposal for a regulation","Article 23 \u2013 paragraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:39"},"new":["1. The receiving competent authority shall,","within six months after the validation","referred to in Article 22, decide on the","application in accordance with Article 16."],"old":["1. The receiving competent authority shall,","within twelve months after the validation","referred to in Article 22, decide on the","application in accordance with Article 16."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"312","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Kartika Tamara Liotard, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-557","justification":" Some toxicity tests (e.g. acute studies) are used exclusively for classification and labelling\n purposes and not for risk assessment; thus, it is important to accommodate these different\n regulatory purposes with the term \u201cand/or\u201d.","location":[[" Proposal for a regulation","Annex IV \u2013 point 1.4 \u2013 paragraph 2 \u2013 point 2"]],"meps":[28182,96741],"meta":{"created":"2019-07-03T05:29:38"},"new":["(2) results are adequate for the purpose of","classification and labelling and/or risk","assessment; and"],"old":["(2) results are adequate for the purpose of","classification and labelling and risk","assessment; and"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"557","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-313","justification":"12 months would be a more appropriate length of time for the renewal of an authorisation.","location":[[" Proposal for a regulation","Article 24 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:39"},"new":["1. The authorisation holder or his","representative shall submit an application","for renewal of a national authorisation to","the receiving competent authority at least","12 months before the expiry date of the","authorisation."],"old":["1. The authorisation holder or its","representative shall submit an application","for renewal of a national authorisation to","the receiving competent authority at least","18 months before the expiry date of the","authorisation."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"313","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-558","justification":" Some toxicity tests (e.g. acute studies) are used exclusively for classification and labelling\n purposes and not for risk assessment; thus, it is important to accommodate these different\n regulatory purposes with the term \u201cand/or\u201d.","location":[[" Proposal for a regulation","Annex IV \u2013 point 1.4 \u2013 paragraph 2 \u2013 point 2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["(2) results are adequate for the purpose of","classification and/or labelling and risk","assessment; and"],"old":["(2) results are adequate for the purpose of","classification and labelling and risk","assessment; and"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"558","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-220","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 5"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:39"},"new":["5. In order to keep the list of authorised","active substances updated, at the end of","the period referred to in paragraph 3 or on","receipt of the opinion of the Agency, the","Commission shall adopt, by means of","delegated acts in accordance with Article","71 a and subject to the conditions of","Articles 71 b and 71 c, a decision","concerning a renewal of the inclusion of","the active substance in Annex I. If the","Commission decides to renew the","inclusion of an active substance in Annex","I, the name of the applicants shall be","mentioned."],"old":["5. At the end of the period referred to in","paragraph 3 or on receipt of the opinion of","the Agency, the Commission shall adopt a","decision concerning a renewal of the","inclusion of the active substance in Annex","I. That decision, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"220","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-314","justification":"In the case of a mutual recognition procedure, a single authorisation number should be used\nin all Member States. The Commission should be responsible for adopting implementing\nmeasures to introduce a single number.","location":[["Proposal for a regulation","Article 25 \u2013 paragraph 5"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:39"},"new":["5. 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The receiving competent authority shall","authorise the biocidal product concerned","under the same conditions as the reference","competent authority."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"314","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-559","justification":"Some toxicity tests (e.g. acute studies) are used exclusively for classification and labelling\npurposes and not for risk assessment; thus, it is important to accommodate these different\nregulatory purposes with the term \u201cand/or\u201d.","location":[["Proposal for a regulation","Annex IV \u2013 point 1.5 \u2013 paragraph 3 \u2013 indent 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:38"},"new":["\u2013 be adequate for the purpose of","classification and labelling and/or risk","assessment,"],"old":["\u2013 be adequate for the purpose of","classification and labelling and risk","assessment,"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"559","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Esther De Lange","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-315","location":[["Proposal for a regulation","Article 25 \u2013 paragraph 5"]],"meps":[38398],"meta":{"created":"2019-07-03T05:29:39"},"new":["5. The receiving competent authority shall","authorise the biocidal product concerned","under the same conditions as the reference","competent authority, unless specific","national circumstances justify a deviation","according to article 29."],"old":["5. The receiving competent authority shall","","authorise the biocidal product concerned","under the same conditions as the reference","competent authority."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"315","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-221","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:39"},"new":["1. 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A period of three months is thought to be adequate to enable the Commission to draw\n up a proposal for a decision to refuse to recognise or to restrict the authorisation.","location":[[" Proposal for a regulation","Article 27 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:39"},"new":["The Commission shall, after consultation","with the applicant, adopt a decision on","whether the grounds set out by the","competent authority justify refusal to","recognise, or restriction of, the national","authorisation in accordance with the","procedure referred to in Article 72(3).","Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. 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The proposed introduction of possibilities for data waiving contradicts efforts for\n the protection of human health and environment.","location":[["Proposal for a regulation","Annex IV \u2013 point 2"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["2. TESTING IS TECHNICALLY NOT","POSSIBLE","Testing for a specific endpoint may be","omitted, if it is technically not possible to","conduct the study as a consequence of the","properties of the substance: e.g. very","volatile, highly reactive or unstable","substances cannot be used, mixing of the","substance with water may cause danger of","fire or explosion or the radio-labelling of","the substance required in certain studies","may not be possible. 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Three months is an adequate period of time for the\n Commission to make a proposal for a decision setting out the grounds for refusing to\n recognise authorisations or recognising them with restrictions.","location":[["Proposal for a regulation","Article 28 \u2013 paragraph 9 \u2013 subparagraph 3 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:39"},"new":["Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. 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The proposed introduction of possibilities for data waiving contradicts efforts for\nthe protection of human health and environment.","location":[[" Proposal for a regulation","Annex IV \u2013 point 3"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:38"},"new":["deleted"],"old":["3. PRODUCT-TAILORED EXPOSURE-","DRIVEN TESTING","3.1. Testing in accordance with sections 6","and 7 of Annexes II and III may be","omitted based on exposure considerations.","3.2. In all cases, adequate justification","and documentation shall be provided. The","","justification shall be based on an","exposure assessment in accordance with","the Technical Notes for Guidance."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"562","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-223","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[[" Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:40"},"new":["deleted"],"old":["That decision, designed to amend non-","essential elements of this Regulation,","shall be adopted in accordance with the","regulatory procedure with scrutiny","referred to in Article 72(4). On imperative","grounds of urgency, the Commission may","have recourse to the urgency procedure","referred to in Article 72(5)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"223","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-319","justification":" In line with the PPP regulation, Member States should also be allowed to adjust the uses of\n the biocides (Article 58(2)(d)) and the categories of users (Article 58(2)(k)).","location":[[" Proposal for a regulation","Article 29 \u2013 paragraph 1 \u2013 subparagraph 1 - introductory part"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["1. The competent authority that has","received an application for mutual","recognition in accordance with Articles 25","or 28 may, within two months from the","receipt of the application, propose to the","applicant that certain conditions referred to","in points (d) (e), (f), (h), (j), (k) and (l) of","Article 58(2) in the authorisation be","adjusted to local circumstances, so that","conditions for issue of an authorisation laid","down in Article 16 are satisfied, and shall","inform the Commission thereof, if it","establishes that, in its territory, one of the","following conditions is met:"],"old":["1. The competent authority that has","received an application for mutual","recognition in accordance with Articles 25","or 28 may, within two months from the","receipt of the application, propose to the","applicant that certain conditions referred to","in points (e), (f), (h), (j) and (l) of Article","58(2) in the authorisation be adjusted to","local circumstances, so that conditions for","issue of an authorisation laid down in","Article 16 are satisfied, and shall inform","the Commission thereof, if it establishes","that, in its territory, one of the following","conditions is met:"],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"319","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-563","justification":"The catalogue of product groups must also cover biocidal products used in the textiles sector.","location":[["Proposal for a regulation","Annex V \u2013 Product-type 9"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:38"},"new":["Products used for the preservation of","fibrous or polymerised materials, such as","leather, rubber or paper or textile products","and rubber by the control of","microbiological deterioration.","These include products which inhibit","surface build-ups of microorganisms (e.g.","pathogenic or odour-generating germs)","and thus curb or prevent the creation of","odours and/or have other uses."],"old":["Products used for the preservation of","fibrous or polymerised materials, such as","leather, rubber or paper or textile products","and rubber by the control of","microbiological deterioration."],"orig_lang":"e","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"563","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-320","justification":"Member States should be allowed to adjust to local circumstances whenever the climate or\nthe breeding period differs significantly. This is even more strict than the PPP regulation,\nwhich allows for national adjustments without any conditions (see Article 36(3) of the PPP\nregulation).","location":[[" Proposal for a regulation","Article 29 \u2013 paragraph 1 \u2013 point c"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["c) the relevant circumstances of use, in","particular the climate or the breeding","period of the target species, differ","significantly from those in the Member","State where the initial evaluation was","carried out or the Member State where the","initial national authorisation was issued,"],"old":["c) the relevant circumstances of use, in","particular the climate or the breeding","period of the target species, differ","significantly from those in the Member","State where the initial evaluation was","carried out or the Member State where the","initial national authorisation was issued,","and an unchanged national authorisation","may therefore present unacceptable risks","to humans or to the environment."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"320","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-564","justification":" It is necessary to keep biocidal product type 20 (\u2018Preservatives for food or feedstocks\u2019) but its\n definition needs to be amended, since these biocidal products are not preservatives but\n disinfectants. For instance, products used to disinfect feed from human pathogens such as\n Salmonella do not meet the requirements of the feed additives regulations. Neither do they act\n as preservatives to prevent animal feed from deteriorating. These products must be therefore\n considered as disinfectant agents.","location":[["Proposal for a regulation","Annex V \u2013 Product-type 20"]],"meps":[4319],"meta":{"created":"2019-07-03T05:29:38"},"new":["Product-type 20: -Food and feed","disinfectants","Products used for the disinfection of food","or feedstocks by the control of harmful","organisms."],"old":["Product-type 20: -"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"564","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-224","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[[" Proposal for a regulation","Article 14 \u2013 title"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:40"},"new":["Detailed procedures for renewal and","review"],"old":["Implementing measures"],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"224","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-321","justification":"In the PPP regulation, there are no conditions for the adjustment of authorisations to local\ncircumstances. As such, it should be possible for Member States to adjust in general in case\nthey consider that an unchanged national authorisation would present harmful effects on\nhuman health or unacceptable effects on the environment.","location":[["Proposal for a regulation","Article 29 \u2013 paragraph 1 \u2013 point c a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["ca) an unchanged national authorisation","may present harmful effects on human","health or unacceptable effects on the","environment."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"321","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Glenis Willmott","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-565","justification":" It is necessary to retain product type 20 given that these biocidal products are not\n preservatives but disinfectants. For instance, products used to disinfect feed from human\n pathogens such as Salmonella do not meet the requirements of the feed additives regulations.\n Indeed, the products do not \u2018favourably affect the feed\u2019 nor enhance its performance nor do\n they have a preservative action. They intend to avoid Salmonella contamination of eggs and\n poultry and pig meat and therefore must be considered as disinfectant agents with their sole\n purpose being to protect human health.","location":[[" Proposal for a regulation","Annex V \u2013 Product-type 20"]],"meta":{"created":"2019-07-03T05:29:39"},"new":["Product-type 20: -Food and feed","disinfectants","Products used for the disinfection of food","or feedstocks by the control of harmful","organisms."],"old":["Product-type 20: -"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"565","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-322","justification":" When dealing with an application under the mutual recognition procedure, a Member State\n should have the option of refusing authorisation if there are substantiated reasons for fearing\n that a biocide presents risks for humans and the environment in the Member State concerned\n because of specific national circumstances such as climatic conditions or hydromorphology.\n This is similar to the provision in the regulation on the market authorisation for plant\n protection products.","location":[[" Proposal for a regulation","Article 29 \u2013 paragraph 1 a (new)"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:39"},"new":["1a. Where the concerns of a Member","State relating to human or animal health","or the environment cannot be dispelled by","the establishment of the risk mitigation","measures referred to in paragraph 1, a","Member State may refuse authorisation of","a biocide in its territory if, due to specific","environmental or use-related","circumstances, it has substantiated","reasons to assume that the biocide in","question still poses an unacceptable risk","to human or animal health or the","environment."],"orig_lang":"l","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"322","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-566","justification":"It is necessary to keep former Directive 98/8\u2019s biocidal product type 20 (\u2018Preservatives for\nfood or feedstocks\u2019), but its definition needs to be amended, given that these biocidal products\nare not preservatives but disinfectants (as a consequence, the older definition led to\nconfusion). For instance, products used to disinfect feed from human pathogens such as\nSalmonella do not meet the requirements of the feed additives regulations. Indeed, the\nproducts do not \u2018favourably affect the feed\u2019 nor enhance its performance.","location":[["Proposal for a regulation","Annex V \u2013 Product-type 20"]],"meta":{"created":"2019-07-03T05:29:39"},"new":["Product-type 20: Food and feed","disinfectants","Products used for the disinfection of food","or feedstocks by the control of harmful","organisms."],"old":["Product-type 20: -"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"566","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-225","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Article 14 \u2013 paragraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:40"},"new":["In order to ensure the smooth functioning","of the renewal and review procedures, the","Commission may adopt further detailed","measures by means of delegated acts in","accordance with Article 71 a and subject","to the conditions of Articles 71 b and 71 c."],"old":["The Commission may adopt detailed","measures for the implementation of","Articles 10 to 13 of this Regulation","specifying the procedures related to the","renewal and review of an inclusion of an","active substance in Annex I."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"225","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-323","justification":"Additional measures to reduce the risk to humans and the environment with regard to the use\nof biocides, in the light of specific circumstances in a Member State.","location":[[" Proposal for a regulation","Article 29 \u2013 paragraph 1 b (new)"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:39"},"new":["1b. Subject to Community law,","appropriate conditions may be imposed","with respect to the requirements referred","to in Article 15 and other risk mitigation","measures deriving from specific","conditions of use."],"old":[""],"orig_lang":"l","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"323","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-567","justification":" The consideration of cumulative, combination and synergistic effects needs to be included\n explicitly in the common principles for the evaluation of dossiers.","location":[["Proposal for a regulation","Annex VI - introduction - point 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["2. In order to ensure a high and harmonised","level of protection of human and animal","health and of the environment, any risks","arising from the use of a biocidal product","shall be identified. To achieve this, a risk","assessment shall be carried out to","determine the acceptability or otherwise of","any risks identified during the proposed","normal use of the biocidal product. This is","done by carrying out an assessment of the","risks associated with the relevant","individual components of the biocidal","product, taking due account of","cumulative, combination and synergistic","effects."],"old":["2. In order to ensure a high and harmonised","level of protection of human and animal","health and of the environment, any risks","arising from the use of a biocidal product","shall be identified. To achieve this, a risk","assessment shall be carried out to","determine the acceptability or otherwise of","any risks identified during the proposed","normal use of the biocidal product. This is","done by carrying out an assessment of the","risks associated with the relevant","individual components of the biocidal","product.",""],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"567","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-324","justification":"Adjustments to local circumstances by the competent authorities should be respected. It is\nagainst the subsidiarity principle to grant the Commission the power to decide on adjustments\nto local circumstances.","location":[["Proposal for a regulation","Article 29 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["deleted"],"old":["The Commission shall adopt a decision on","the proposed adjustment of the conditions","of the national authorisation to local","circumstances in accordance with the","procedure referred to in Article 72(3). The","competent authority of the concerned","Member State shall without delay adopt","all appropriate measures to comply with","that decision."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"324","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-18T00:00:00","id":"PE439.902-226","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[["Proposal for a regulation","Article 14 \u2013 paragraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:40"},"new":["deleted"],"old":["Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.902v01-00","reference":"2009/0076(COD)","seq":"226","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.902+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-325","location":[["Proposal for a regulation","Article 29 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:40"},"new":["The Commission shall, after consultation","with the applicant, adopt a decision on the","proposed adjustment of the conditions of","the national authorisation to local","circumstances in accordance with the","procedure referred to in Article 72(3). 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The","competent authority of the concerned","Member State shall without delay adopt all","appropriate measures to comply with that","decision."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"325","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-568","justification":" The consideration of cumulative, combination and synergistic effects needs to be included\n explicitly in the common principles for the evaluation of dossiers.","location":[[" Proposal for a regulation","Annex VI - introduction - point 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["3. A risk assessment on the active","substance or substances present in the","biocidal product is always required. This","will already have been carried out for the","purpose of the inclusion of the active","substance into Annex I. This risk","assessment shall entail hazard","identification, and, as appropriate, dose","(concentration) - response (effect)","assessment, exposure assessment and risk","characterisation, taking due account of","cumulative, combination and synergistic","effects. Where a quantitative risk","assessment cannot be made a qualitative","assessment shall be produced."],"old":["3. A risk assessment on the active","substance or substances present in the","biocidal product is always required. This","will already have been carried out for the","purpose of the inclusion of the active","substance into Annex I. This risk","assessment shall entail hazard","identification, and, as appropriate, dose","(concentration) - response (effect)","assessment, exposure assessment and risk","characterisation. Where a quantitative risk","assessment cannot be made a qualitative","assessment shall be produced."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"568","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-326","justification":" The regulation should set out the time period for the resolution of disputes between Member\n States. Three months is an adequate period of time for the Commission to make a proposal for\n a decision setting out the grounds for recognising or not recognising authorisations.","location":[[" Proposal for a regulation","Article 29 \u2013 paragraph 2 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:40"},"new":["(2a) Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. Should the","Commission ask the Agency for an","opinion under the procedure set out in","Article 30, the three-month period shall be","suspended until the Agency has forwarded","its opinion."],"orig_lang":"t","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"326","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Kartika Tamara Liotard, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-569","justification":"It is not acceptable to require risk assessments for other substances than the active substances\nin a biocidal product. This would lead to a duplication of testing procedures, including\nanimal experimentation, as all chemical ingredients also have to be assessed within the scope\nof the REACH regulation. All available data for non-active substance ingredients rather has\nto be included in dossiers.","location":[["Proposal for a regulation","Annex VI \u2013 introduction \u2013 point 4"]],"meps":[28182,96741],"meta":{"created":"2019-07-03T05:29:39"},"new":["deleted"],"old":["4. Additional risk assessments shall be","carried out, in the same manner as","described above, on any other substance","of concern present in the biocidal product","where relevant for the use of the biocidal","product."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"569","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-570","justification":"It is not acceptable to require risk assessments for other substances than the active substances\nin a biocidal product. This would lead to a duplication of testing procedures, including\nanimal experimentation, as all chemical ingredients also have to be assessed within the scope\n\n of the REACH regulation. All available data for non-active substance ingredients rather has\n to be included in dossiers.","location":[["Proposal for a regulation","Annex VI \u2013 introduction \u2013 point 4"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["deleted"],"old":["4. Additional risk assessments shall be","carried out, in the same manner as","described above, on any other substance","of concern present in the biocidal product","where relevant for the use of the biocidal","product."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"570","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-327","justification":"Member States should be allowed to refuse mutual recognition for substances that fall under\nthe exclusion criteria and for substances that are candidates for substitution.","location":[["Proposal for a regulation","Article 31 \u2013 title"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:40"},"new":["Derogation regarding certain active","substances or product-types","Or.en","((Linked to the amendment of Article 31.) )"],"old":["Derogation regarding certain product-","types","","",""],"peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"327","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Kartika Tamara Liotard, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-571","justification":" It is not acceptable to require risk assessments for other substances than the active substances\n in a biocidal product. This would lead to a duplication of testing procedures, including\n animal experimentation, as all chemical ingredients also have to be assessed within the scope\n of the REACH regulation. All available data for non-active substance ingredients rather has\n to be included in dossiers.","location":[[" Proposal for a regulation","Annex VI \u2013 evaluation \u2013 point 14"]],"meps":[28182,96741],"meta":{"created":"2019-07-03T05:29:39"},"new":["14. A risk assessment on the active","substance present in the biocidal product","shall always be carried out. If there are, in","addition, any substances of concern present","in the biocidal product then all available","data shall be included in the dossier for","authorisation of a biocidal product for","each of these. 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The risk assessment shall cover the","proposed normal use of the biocidal","product together with a realistic worst-case","scenario including any relevant production","and disposal issue either of the biocidal","product itself or any material treated with","it."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"571","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-572","justification":"See also Comment to Annex VI, Introduction, 4","location":[[" Proposal for a regulation","Annex VI \u2013 evaluation \u2013 point 14"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["14. A risk assessment on the active","substance present in the biocidal product","shall always be carried out. If there are, in","addition, any substances of concern present","in the biocidal product then all available","data shall be included in the dossier for","authorisation of a biocidal product for","each of these. The data shall cover the","proposed normal use of the biocidal","product together with a realistic worst-case","scenario including any relevant production","and disposal issue either of the biocidal","product itself or any material treated with","it."],"old":["14. A risk assessment on the active","","substance present in the biocidal product","shall always be carried out. If there are, in","addition, any substances of concern present","in the biocidal product then a risk","assessment shall be carried out for each of","these. The risk assessment shall cover the","proposed normal use of the biocidal","product together with a realistic worst-case","scenario including any relevant production","and disposal issue either of the biocidal","product itself or any material treated with","it."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"572","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-328","justification":" Member States should be allowed to refuse mutual recognition for substances that fall under\n the exclusion criteria and for substances that are candidates for substitution.","location":[["Proposal for a regulation","Article 31"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:40"},"new":["By way of derogation from Articles 25","and 28, competent authorities of Member","States may refuse mutual recognition of","national authorisations granted for active","substances referred to in Article 5 and 9","and for product types 15, 17 and 23 of","Annex V provided that such a refusal can","be justified on grounds of the protection of","health of humans, animals or plants, the","protection of national treasures possessing","artistic, historic or archaeological value, or","the protection of industrial and commercial","property. Competent authorities of Member","States shall without delay inform each","other and the Commission of any decision","taken in this respect and shall indicate the","reasons thereof."],"old":["By way of derogation from Articles 25","and 28, competent authorities of Member","States may refuse mutual recognition of","national authorisations granted for product","types 15, 17 and 23 of Annex V provided","that such a refusal can be justified on","grounds of the protection of health of","humans, animals or plants, the protection","of national treasures possessing artistic,","historic or archaeological value, or the","protection of industrial and commercial","property. Competent authorities of Member","States shall without delay inform each","other and the Commission of any decision","taken in this respect and shall indicate the","reasons thereof."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"328","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Csaba S\u00e1ndor Tabajdi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-329","justification":" Ensures the principles of subsidiarity and precautionary. Competent authorities on national\n and regional level should have sufficient room for manoeuvre, particularly in order to protect\n their vulnerable citizens and the environment. It is necessary to comply with Article 193 of the\n newly adopted EU-Treaty. Besides, the current provisions of the Biocidal Products Directive\n 98/8/EC allows competent authorities to adjust relevant requirements or conditions of\n authorisation for the protection of the environment.","location":[[" Proposal for a regulation","Article 31"]],"meps":[23808],"meta":{"created":"2019-07-03T05:29:40"},"new":["By way of derogation from Articles 25 -","29, competent authorities of Member","States may refuse mutual recognition of","national authorisations granted for product","types 15, 17 and 23 of Annex V provided","that such a refusal can be justified on","grounds of the protection of health of","humans, particularly of vulnerable","groups, the protection of health of animals","or plants, the protection of environment","national treasures possessing artistic,","historic or archaeological value, or the","protection of industrial and commercial","property. Competent authorities of Member","States shall without delay inform each","other and the Commission of any decision","taken in this respect and shall indicate the","reasons thereof."],"old":["By way of derogation from Articles 25","and 28, competent authorities of Member","States may refuse mutual recognition of","national authorisations granted for product","types 15, 17 and 23 of Annex V provided","that such a refusal can be justified on","grounds of the protection of health of","humans, animals or plants, the protection","of national treasures possessing artistic,","historic or archaeological value, or the","protection of industrial and commercial","property. Competent authorities of Member","States shall without delay inform each","other and the Commission of any decision","taken in this respect and shall indicate the","reasons thereof."],"orig_lang":"n","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"329","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-573","justification":" The consideration of cumulative, combination and synergistic effects needs to be included\n explicitly in the common principles for the evaluation of dossiers.","location":[["Proposal for a regulation","Annex VI - evaluation - point 15"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["15. For each active substance and each","substance of concern present in the","biocidal product, the risk assessment shall","entail a hazard identification and the","establishment of appropriate no-observed-","adverse-effect levels (NOAEL), where","possible. It shall also include, as","appropriate, a dose (concentration) -","response (effect) assessment, together with","an exposure assessment and a risk","characterisation, taking due account of","cumulative, combination and synergistic","effects."],"old":["15. For each active substance and each","substance of concern present in the","biocidal product, the risk assessment shall","entail a hazard identification and the","establishment of appropriate no-observed-","adverse-effect levels (NOAEL), where","possible. It shall also include, as","appropriate, a dose (concentration) -","response (effect) assessment, together with","an exposure assessment and a risk","characterisation."],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"573","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.904-330","location":[["Proposal for a regulation","Article 31"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:40"},"new":["By way of derogation from Article 25-29,","competent authorities of Member States","may refuse mutual recognition of national","authorisations granted for product types 15,","17 and 23 of Annex V provided that such a","refusal can be justified on grounds of the","protection of health of humans,","environment, animals or plants, the","protection of national treasures possessing","artistic, historic or archaeological value, or","the protection of industrial and commercial","property. Competent authorities of Member","States shall without delay inform each","other and the Commission of any decision","taken in this respect and shall indicate the","reasons thereof."],"old":["By way of derogation from Articles 25 and","28, competent authorities of Member","States may refuse mutual recognition of","national authorisations granted for product","types 15, 17 and 23 of Annex V provided","that such a refusal can be justified on","grounds of the protection of health of","humans, animals or plants, the protection","of national treasures possessing artistic,","historic or archaeological value, or the","protection of industrial and commercial","property. Competent authorities of Member","States shall without delay inform each","other and the Commission of any decision","taken in this respect and shall indicate the","reasons thereof."],"orig_lang":"en","peid":"PE439.904v02-00","reference":"2009/0076(COD)","seq":"330","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.904+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-574","location":[[" Proposal for a regulation","Annex VI \u2013 evaluation \u2013 point 20 \u2013 indent 9 a (new)"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:39"},"new":["\u2013 \u2013 immunotoxicity"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"574","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Kartika Tamara Liotard, Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-575","location":[[" Proposal for a regulation","Annex VI \u2013 evaluation \u2013 point 47"]],"meps":[28182,96741],"meta":{"created":"2019-07-03T05:29:39"},"new":["47. Data shall be submitted to and","evaluated by the competent authorities to","assess whether the biocidal product does","not cause unnecessary suffering and pain","in its effect on target vertebrates. This shall","include an evaluation of the mechanism by","which the effect is obtained and the","observed effects on the behaviour and","health of the target vertebrates; where the","intended effect is to kill the target","vertebrate the time necessary to obtain the","death of the target vertebrate and the","conditions under which death occurs shall","be evaluated. These findings shall for","each authorised biocidal product be made","publicly available on the Agency website."],"old":["47. Data shall be submitted to and","evaluated by the competent authorities to","assess whether the biocidal product does","not cause unnecessary suffering in its","effect on target vertebrates. This shall","include an evaluation of the mechanism by","which the effect is obtained and the","observed effects on the behaviour and","health of the target vertebrates; where the","intended effect is to kill the target","vertebrate the time necessary to obtain the","death of the target vertebrate and the","conditions under which death occurs shall","be evaluated."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"575","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-576","location":[["Proposal for a regulation","Annex VI \u2013 evaluation \u2013 point 47"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:39"},"new":["47. Data shall be submitted to and","evaluated by the competent authorities to","assess whether the biocidal product does","not cause unnecessary suffering and pain","in its effect on target vertebrates. This shall","include an evaluation of the mechanism by","which the effect is obtained and the","observed effects on the behaviour and","health of the target vertebrates; where the","intended effect is to kill the target","vertebrate the time necessary to obtain the","death of the target vertebrate and the","conditions under which death occurs shall","be evaluated. Those findings shall for","each authorised biocidal product be made","publicly available on the Agency website."],"old":["47. Data shall be submitted to and","evaluated by the competent authorities to","assess whether the biocidal product does","not cause unnecessary suffering in its","effect on target vertebrates. This shall","include an evaluation of the mechanism by","which the effect is obtained and the","observed effects on the behaviour and","health of the target vertebrates; where the","intended effect is to kill the target","vertebrate the time necessary to obtain the","death of the target vertebrate and the","conditions under which death occurs shall","be evaluated."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"576","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-577","justification":"The consideration of cumulative, combination and synergistic effects needs to be considered in\nthe decision-making process.","location":[["Proposal for a regulation","Annex VI- decision making - point 59 - indent 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:39"},"new":["- the nature and severity of the effect,","taking due account of cumulative,","combination and synergistic effects"],"old":["- the nature and severity of the effect,"],"orig_lang":"en","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"577","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-578","justification":" Ensures to comply with the standards of Community provisions and international agreements\n for the protection of waters.","location":[[" Proposal for a regulation","Annex VI \u2013 decision making \u2013 point 77 \u2013 introductory part"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:39"},"new":["77. The competent authorities or the","Commission shall not authorise a biocidal","product if the foreseeable concentration of","the active substance or a substance of","concern or of relevant metabolites,","breakdown or reaction products to be","expected in groundwater or surface water","or its sediments after use of the biocidal","product under the proposed conditions of","use:"],"old":["77. The competent authorities or the","Commission shall not authorise a biocidal","product if the foreseeable concentration of","the active substance or a substance of","concern or of relevant metabolites,","breakdown or reaction products to be","expected in surface water or its sediments","after use of the biocidal product under the","proposed conditions of use:"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"578","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":" Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-579","justification":"Ensures to comply with the standards of Community provisions and international agreements\nfor the protection of waters.","location":[[" Proposal for a regulation","Annex VI \u2013 decision making \u2013 point 77 \u2013 indent 2 a (new)"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:39"},"new":["\u2013 \u2013 risk a non-achievement of the","objectives or standards fixed by:","\u2013 Directive 98/83/EC, or","\u2013Directive 2000/60/EC or","\u2013Directive 2006/118/EC or","\u2013Directives 2008/56/EC, or","\u2013Directive 2008/105/EC, or","- international agreements containing","important obligations on the protection of","marine waters from pollution or"],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"579","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Sabine Wils","changes":{},"committee":["ENVI"],"date":"2010-04-08T00:00:00","id":"PE439.930-580","justification":"Ensures to comply with the standards of Community provisions and international agreements\nfor the protection of waters.","location":[["Proposal for a regulation","Annex VI \u2013 decision making \u2013 point 77 \u2013 last part"]],"meps":[96741],"meta":{"created":"2019-07-03T05:29:39"},"new":["deleted"],"old":["unless it is scientifically demonstrated that","under relevant field conditions this","concentration is not exceeded."],"orig_lang":"n","peid":"PE439.930v03-00","reference":"2009/0076(COD)","seq":"580","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.930+03+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-331","location":[["Proposal for a regulation","Article 32 - paragraph 1a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:41"},"new":["A Community authorisation may not be","granted for biocidal products that contain","active substances that fall under Article 5","or 9."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"331","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-332","justification":"Most Member States do not currently have an authorisation system of biocides. It is therefore\nrational to consider that it is more appropriate to move the authorisation procedure directly\nat the EU level to ensure that all EU citizens are equal with respect to human health and\n\n environment protection. Moreover, most existing active substances will have then been\n evaluated. Finally, the biocides industry needs to be incentivised to innovate. This requires a\n simplified procedure with shorter deadlines as a sign of Better Regulation.","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 1"]],"meta":{"created":"2019-07-03T05:29:41"},"new":["1. The Community authorisation may be","granted to all biocidal products with","substantially similar patterns and","conditions of use.","A Community authorization requires the","adoption of sustainable use measures","whenever it is appropriate to ensure the","same level of human health and","environment protection across the EU.","These measures could vary depending on","the Product Type."],"old":["1. The Community authorisation may be","granted to the following categories of","biocidal products:","","(a) biocidal products containing one or","more new active substances;","(b) low-risk biocidal products."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"332","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-333","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 point a"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:41"},"new":["deleted"],"old":["a) biocidal products containing one or","more new active substances;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"333","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-334","justification":" Acceptance by the Community of the product categories which can be used everywhere should\n be subject to the same restrictions and conditions throughout the Community. This means that\n no exceptions should be possible in particular regions or Member States, so that it is only\n possible either to place the product on the market or not to do so. Any necessary exceptions\n on environmental grounds or on account of concern for people or animals are therefore\n impossible.","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 point a"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:41"},"new":["deleted"],"old":["(a) biocidal products containing one or","more new active substances;"],"orig_lang":"l","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"334","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-335","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 point a"]],"meta":{"created":"2019-07-03T05:29:42"},"new":["deleted"],"old":["a) biocidal products containing one or","more new active substances;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"335","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-336","justification":"A Community authorisation for biocidal products containing new active substances should\nonly be granted if there is a need for such a product in all Member States, and if there are\nnon-chemical alternatives. If a Community authorisation was possible for any new active\nsubstances, or even for all active substances, the drive towards more low-risk products would\nbe lost.","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 point a"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:42"},"new":["a) biocidal products containing one or","more new active substances, provided","there is a need for such a product in all","Member States, and that there are no","non-chemical alternatives;"],"old":["a) biocidal products containing one or","more new active substances;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"336","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-337","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 point b"]],"meta":{"created":"2019-07-03T05:29:42"},"new":["deleted"],"old":["b) low-risk biocidal products."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"337","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-338","justification":" One of the key objectives of the Union authorisation system is to ensure consistent product\n safety assessments, equal standards of consumer protection, and harmonised implementation\n of the requirements within all Member States. Biocidal products, which are used in a similar\n way across the European Union, should benefit from the Union authorisation scheme. These\n products are used in domestic or in professional settings as a pragmatic and cost effective\n means to promote and protect public health, thereby reducing the burden of infectious\n diseases within the EU. These products have simple and clear use instructions.","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 point b a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:42"},"new":["b a) biocidal products designed to be used","by consumers in domestic settings, or by","professional users, according to","conditions and instructions of use which","are similar within the European Union,","and which meet the criteria listed in","Article 33 a (new)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"338","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-339","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:42"},"new":["deleted"],"old":["2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","Those measures, designed to amend non-","","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"339","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-340","justification":"Most Member States do not currently have an authorisation system of biocides. It is therefore\nrational to consider that it is more appropriate to move the authorisation procedure directly\nat the EU level to ensure that all EU citizens are equal with respect to human health and\nenvironment protection. Moreover, most existing active substances will have then been\nevaluated. Finally, the biocides industry needs to be incentivised to innovate. This requires a\nsimplified procedure with shorter deadlines as a sign of Better Regulation.","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 2"]],"meta":{"created":"2019-07-03T05:29:42"},"new":["deleted"],"old":["2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"340","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-341","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:42"},"new":["deleted"],"old":["2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"341","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-342","justification":"Acceptance by the Community of the product categories which can be used everywhere should\nbe subject to the same restrictions and conditions throughout the Community. This means that\nno exceptions should be possible in particular regions or Member States, so that it is only\npossible either to place the product on the market or not to do so. Any necessary exceptions\non environmental grounds or on account of concern for people or animals are therefore\nimpossible.","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 2"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:42"},"new":["deleted"],"old":["2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted","according to the regulatory procedure","","","with scrutiny referred to in Article 72(4)."],"orig_lang":"l","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"342","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-343","justification":"The extension of the Community procedure to other categories of product is a substantial\nmodification to this Regulation. It must be based on the ordinary legislative procedure, with\ndue regard for the powers of the European Parliament and of the Council.","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:42"},"new":["2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the Community","authorisations, the Commission may","propose that the European Parliament","and the Council add other categories of","biocidal products in paragraph 1 of this","Article. The European Parliament and the","Council shall act pursuant to Article 294","of the Treaty."],"old":["2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the Community","authorisations, the Commission may add","other categories of biocidal products in","paragraph 1 of this Article."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"343","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-344","justification":" The extension of the Community procedure to other categories of product is a substantial\n modification to this Regulation. It must be based on the ordinary legislative procedure, with\n due regard for the powers of the European Parliament and of the Council.","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:42"},"new":["deleted"],"old":["Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted","according to the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"344","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-345","justification":"The criteria are based on the targeted and consistent application and use, of these type of\nproducts across the EU (number of Member States to be specified), as well as their positive\ncontribution to human and animal safety protection. Annex VI lays down the principles for the\nevaluation of dossiers for biocidal products to ensure a harmonised high level of protection\nfor humans and the environment. This involves detailed risk assessment of products during\ntheir use. Should a risk be identified, personal protective equipment would need to be\nspecified. Absence of PPE is therefore an indication of limited risk.","location":[[" Proposal for a regulation","Article 33 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:42"},"new":["In accordance with article 33 paragraph 1","point b a(new), a product shall be","considered a biocidal product with similar","use conditions if all of the following","criteria are met. The biocidal product:","(i) has similar conditions of use across the","European Union, according to use","instructions;","(ii) is already placed on the market in at","least [x] Member States or is intended to","be placed on the market in at least (x)","Member States within two years after the","authorisation has been granted;","(iii) does not require personal protective","equipment in conditions of use according","to Annex VI, and when used under their","normal and reasonably foreseeable","conditions of use, meets the requirements","in Article 16(1).","In order to define or adapt the number of","Member States mentioned in paragraph","(ii), the Commission may adopt a","delegated act in accordance with Article","72a."],"old":["",""],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"345","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-346","justification":"There is no need to give the Agency nine months to prepare and submit its opinion on the\nauthorisation of a biocidal product: this time-frame is too long, especially since the opinion\nwill be based on a pre-existing evaluation by the evaluating competent authority.","location":[["Proposal for a regulation","Article 35 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:42"},"new":["3. Within three months from the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product.","Or.. it"],"old":["3. Within nine months from the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product.",""],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"346","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-347","location":[[" Proposal for a regulation","Article 35 - paragraph 4 - subparagraph 2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:42"},"new":["The Member State shall notify the","Commission if it restrict or prohibit the","Community authorisation for a biocidal","product of the product-types 15, 17 or 23","of Annex V in the territory of that","Member State. This must be justified on","grounds of the protection of either","(a) health of humans, particularly","vulnerable groups, or","(b) environment, particularly vulnerable","ecosystems, or","(c) animals, or","(d) plants, or","(e) national treasures possessing artistic,","historic or archaeological value, or","(f) the protection of industrial and","commercial property."],"old":["The Commission may, on the request of a","Member State, decide that the Community","authorisation shall not apply in the","territory of that Member State for a","biocidal product of the product-types 15,","17 or 23 of Annex V provided that such a","request can be justified on grounds of the","protection of health of humans, animals or","plants, the protection of national treasures","possessing artistic, historic or","archaeological value, or the protection of","industrial and commercial property."],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"347","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-348","location":[[" Proposal for a regulation","Article 35 - paragraph 4 - subparagraph 3"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:42"},"new":["The Member States shall inform the","Commission if it is decided that the","Community authorisation should be","adjusted to the different local","circumstances in that Member State in","accordance with Article 29."],"old":["The Commission may, on the request of a","","Member State, decide that certain","conditions of the Community authorisation","should be adjusted to the different local","circumstances in that Member State in","accordance with Article 29."],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"348","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-349","justification":"When applications are made using the Community authorisation procedure, a Member State\nshould be able to refuse authorisation if there are well-founded reasons to fear that the\napplication of a biocidal product will present risks to people and the environment in the\nMember State in question due to specific national circumstances in the Member State, such as\nclimate or hydromorphology. This is analogous to the provision in the Regulation concerning\nmarket authorisation for plant protection products.","location":[["Proposal for a regulation","Article 35 \u2013 paragraph 4 \u2013 subparagraph 3 a (new)"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:43"},"new":["If the concern felt by a Member State on","grounds of human or animal health or the","environment cannot be overcome by the","risk mitigation measures referred to in the","third paragraph, a Member State may","refuse to authorise a biocidal product","within its territory if that Member State,","due to specific circumstances relating to","the environment or use, has well-founded","reasons to assume that the biocidal","product in question still presents an","unacceptable risk to human or animal","health or the environment."],"orig_lang":"l","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"349","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-350","justification":" Additional measures to mitigate the risks to people and the environment arising from use of\n biocides on the basis of the specific circumstances in a Member State.","location":[[" Proposal for a regulation","Article 35 \u2013 paragraph 4 a (new)"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:43"},"new":["4a. Appropriate conditions may be laid","down by Community law regarding","compliance with the requirements","referred to in Article 15 and other risk","mitigation measures based on specific","circumstances of use."],"orig_lang":"l","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"350","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-351","justification":"This paragraph becomes superfluous if the amendment to Article 33 is adopted","location":[[" Proposal for a regulation","Article 35 \u2013 paragraph 5"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:43"},"new":["deleted"],"old":["5. If the decision referred to in paragraph","4 refuses to grant a Community","authorisation to a biocidal product","because it does not fulfil the criteria for a","low-risk biocidal product in accordance","with Article 17, the applicant may apply, if","relevant, for a Community authorisation","in accordance with point (a) of Article","33(1) or a national authorisation in","accordance with Chapter V."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"351","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-352","location":[["Proposal for a regulation","Article 35 - paragraph 5"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:43"},"new":["(5) If the decision referred to in paragraph","4 refuses to grant a Community","authorisation to a biocidal product because","it does not fulfil the criteria for a low-risk","biocidal product in accordance with Article","17, the applicant may apply, if relevant, for","a national authorisation in accordance with","Chapter V."],"old":["(5) If the decision referred to in paragraph","4 refuses to grant a Community","authorisation to a biocidal product because","it does not fulfil the criteria for a low-risk","biocidal product in accordance with Article","17, the applicant may apply, if relevant, for","a Community authorisation in accordance","with point (a) of Article 33(1) or a national","authorisation in accordance with Chapter","V."],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"352","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-353","justification":"Unless there is new data to evaluate, 18 months is not necessary to renew an authorisation of\n\n a product. 12 months would be a more appropriate time frame.","location":[["Proposal for a regulation","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:43"},"new":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 12 months before","the expiry date of the authorisation."],"old":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 18 months before","the expiry date of the authorisation."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"353","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-354","justification":" 12 months would be a more appropriate length of time for the renewal of an authorisation.","location":[[" Proposal for a regulation","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:43"},"new":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 12 months before","the expiry date of the authorisation.","Or.. it"],"old":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 18 months before","the expiry date of the authorisation.",""],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"354","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-355","location":[[" Proposal for a regulation","Article 38 \u2013 paragraph 1 \u2013 point a"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:43"},"new":["a) new knowledge or information on the","effects of the active substance or biocidal","product for humans or the environment,","especially those regarding vulnerable","groups;"],"old":["a) new knowledge or information on the","effects of the active substance or biocidal","product for humans or the environment;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"355","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-356","location":[["Proposal for a regulation","Article 39 - paragraph 1 - point a"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:43"},"new":["(a) the requirements referred to in Article","16 are not satisfied or pursuant to","Community standards for the protection","of human health and the environment,","particularly established in accordance","with Directive 2008/56/EC, Directive","2006/118/EC, Directive 2000/60/EC,","Directives 98/83/EC and 96/61/EC;"],"old":["(a) the requirements referred to in Article","16 are not satisfied;"],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"356","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-357","justification":"Analogous to the rapporteur's Amendment 39. In addition to revision of the inclusion of an\nactive substance in Annex I, an indication (from practical measurements) that the aims of the\nWater Framework Directive are jeopardised must also be grounds for cancelling or\namending the authorisation of a biocidal product.","location":[["Proposal for a regulation","Article 39 \u2013 paragraph 1 \u2013 point d a (new)"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:43"},"new":["(da) there are indications that the","objectives of Article 4(1)(a)(iv) and (b)(i)","and Article 7(2) and (3) of Directive","2000/60/EC of the European Parliament","and of the Council of 23 October 2000","establishing a framework for Community","action in the field of water policy may not","be achieved."],"orig_lang":"l","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"357","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-358","justification":" The legislative text should clearly outline the main principles which shall be applied when\n amending authorisations, although the details of the procedures can be specified in the\n implementing measures. In particular, it is necessary to specify the types of changes that can\n be made to existing product authorisations.","location":[[" Proposal for a regulation","Article 41 \u2013 paragraph 2 a (new)"]],"meta":{"created":"2019-07-03T05:29:43"},"new":["2a) An amendment to an existing","authorisation should fall under one of the","following categories of changes","a) 'Administrative change'","b) 'Minor change'","c) 'Major change'","as defined in Article 3 (u a)new, (u b)new","and (u c)new."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"358","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-359","justification":"The legislative text should clearly outline the main principles which shall be applied when\namending authorisations, although the details of the procedures can be specified in the\nimplementing measures. In particular, it is necessary to specify the types of changes that can\nbe made to existing product authorisations.","location":[[" Proposal for a regulation","Article 41 \u2013 paragraph 2 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:43"},"new":["2 a. An amendment to an existing","authorisation should fall under one of the","following categories of changes;","a) 'Administrative change'","b) 'Minor change'","c) 'Major change'","as defined in Article 3 (a) new, (b) new","and (c) new."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"359","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-360","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Article 42 \u2013 title"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:43"},"new":["Detailed procedures on cancellation and","amendments"],"old":["Implementing measures"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"360","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-361","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[["Proposal for a regulation","Article 42 \u2013 paragraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:43"},"new":["In order to ensure the smooth","functioning of the cancellation and","amendment procedures, the Commission","shall adopt further detailed measures","specifying the criteria and procedures","related to a cancellation of an authorisation","or amendments of the terms and conditions","of an authorisation under Articles 39 to 41,","including a dispute settlement mechanism","by means of delegated acts in accordance","with Article 71 a and subject to the","conditions of Articles 71 b and 71 c."],"old":["The Commission shall adopt","implementing measures specifying the","criteria and procedures related to a","cancellation of an authorisation or","amendments of the terms and conditions of","an authorisation under Articles 39 to 41,","including a dispute settlement mechanism.","",""],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"361","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-362","justification":" The legislative text should clearly outline the main principles which shall be applied when\n amending authorisations, although the details of the procedures can be specified in the\n implementing measures. In particular, it is necessary to specify that different types of\n amendment procedures should be applied depending on the degree and significance of the\n\nforeseen changes (administrative, minor or major) to the biocidal product (compared to the\noriginal authorisation).","location":[[" Proposal for a regulation","Article 42 \u2013 paragraph 1 a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:43"},"new":["The criteria and the procedures referred","to in paragraph 1 of this Article shall be","based on, but not limited to, the following","principles:","(a) a simplified notification procedure","shall be applied for administrative","changes to the authorisation;","(b) a reduced evaluation period shall be","established for minor changes to the","authorisation;","(c) in the case of major changes the","evaluation period should be proportionate","to the extent of the proposed change."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"362","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-363","justification":"The text should clearly outline the main principles which shall be applied when amending\nauthorisations. In particular, it is necessary to specify that different types of amendment\nprocedures should be applied depending on the degree and significance of the foreseen\nchanges (administrative, minor or major) to the biocidal product (compared to the original\nauthorisation). The simplified evaluation procedure would allow minor changes to be made\nwithout requiring a burdensome and time-consuming administrative procedure by the\nCompetent Authority.","location":[["Proposal for a regulation","Article 42 \u2013 paragraph 1 a (new)"]],"meta":{"created":"2019-07-03T05:29:43"},"new":["1a. The criteria and the procedures","referred to in paragraph 1 of this Article","shall be based on, but not limited to, the","following principles:","(a) a simplified notification procedure","shall be applied for administrative","changes to the authorisation;","(b) a reduced evaluation period shall be","established for minor changes to the","authorisation;","(c) in the case of major changes the","evaluation period should be proportionate","to the extent of the proposed change."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"363","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-364","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[["Proposal for a regulation","Article 42 \u2013 paragraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:43"},"new":["deleted"],"old":["Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"364","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-365","justification":" In order to find an appropriate balance between free trade of goods and a safe market then\n this article on parallel trade should be limited to identical products based on the same\n specification and content of active substances and co-formulants.","location":[[" Proposal for a regulation","Article 44 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["1. A competent authority of a Member","State (hereinafter referred to as 'Member","State of introduction') may grant a parallel","trade permit for a biocidal product that is","authorised in another Member State","(hereinafter referred to as 'Member State of","origin') to be placed on the market and","used in the Member State of introduction,","if it determines that the biocidal product is","identical in composition to a biocidal","product already authorised in that Member","State (hereinafter referred to as 'the","reference product')."],"old":["1. A competent authority of a Member","State (hereinafter referred to as 'Member","State of introduction') may grant a parallel","trade permit for a biocidal product that is","authorised in another Member State","(hereinafter referred to as 'Member State of","origin') to be placed on the market and","used in the Member State of introduction,","if it determines that the biocidal product is","substantially identical in composition to a","biocidal product already authorised in that","Member State (hereinafter referred to as","'the reference product')."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"365","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-366","justification":"In order to find an appropriate balance between free trade of goods and a safe market then\nthis article on parallel trade should be limited to identical products based on the same\nspecification and content of active substances and co-formulants.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["The application shall be accompanied by","all the information necessary to","demonstrate that the biocidal product is","identical to the reference product as","defined in paragraph 3."],"old":["The application shall be accompanied by","all the information necessary to","demonstrate that the biocidal product is","substantially identical to the reference","product as defined in paragraph 3."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"366","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-367","justification":" In order to find an appropriate balance between free trade of goods and a safe market then\n this article on parallel trade should be limited to identical products based on the same\n specification and content of active substances and co-formulants.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["2. A parallel trade permit shall be granted","within two months from submission of an","application. The competent authority of the","Member State of introduction may request","from the competent authority of the","Member State of origin additional","information necessary to determine","whether the product is identical to the","reference product. The competent authority","of the Member State of origin shall provide","the requested information within one","month of receiving the request."],"old":["2. A parallel trade permit shall be granted","within two months from submission of an","application. The competent authority of the","Member State of introduction may request","from the competent authority of the","Member State of origin additional","information necessary to determine","whether the product is substantially","identical to the reference product. The","competent authority of the Member State","of origin shall provide the requested","information within one month of receiving","the request."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"367","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-368","justification":" In order to find an appropriate balance between free trade of goods and a safe market then\n this article on parallel trade should be limited to identical products based on the same\n specification and content of active substances and co-formulants.","location":[[" Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["3. A biocidal product shall be considered","as identical to the reference product if all","of the following conditions are met:"],"old":["3. A biocidal product shall be considered","as substantially identical to the reference","product if one of the following conditions","is met:"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"368","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-369","justification":"The conditions need to be cumulative.","location":[[" Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:44"},"new":["3. A biocidal product shall be considered","as substantially identical to the reference","product if all of the following conditions","are met:"],"old":["3. A biocidal product shall be considered","as substantially identical to the reference","product if one of the following conditions","is met:"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"369","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-370","justification":"In order to find an appropriate balance between free trade of goods and a safe market then\nthis article on parallel trade should be limited to identical products based on the same\nspecification and content of active substances and co-formulants.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 point a"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["a) it has been manufactured by the same","company or by an associated undertaking","or under licence in accordance with the","same manufacturing process;"],"old":["a) the source of the active substances it","contains is the same in terms of","manufacturer and location of the","production plant;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"370","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-371","justification":"In order to find an appropriate balance between free trade of goods and a safe market then\n\n this article on parallel trade should be limited to identical products based on the same\n specification and content of active substances and co-formulants.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 point b"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["b) it is identical with regard to the","specification and content of the active","substances and in the type of formulation;"],"old":["b) it is either the same or similar with","regard to the non-active substances present","and the type of formulation;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"371","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-372","justification":" It is not sufficient that the product is the same or similar with regard to the non-active\n substances. This also needs to be the case for the active substance.","location":[[" Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 point b"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:44"},"new":["b) it is either the same or similar with","regard to the active and non-active","substances present and the type of","formulation;"],"old":["b) it is either the same or similar with","regard to the non-active substances present","and the type of formulation;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"372","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-373","justification":"It would seem appropriate to highlight the fact that children are more vulnerable to harmful\nproducts than adults, on whom the proposal for a regulation is basing tolerance criteria.\nChildren are often to be found - unbehknown to themselves - in places which have been\nsprayed with biocidal products and pesticides, and show reactions \u2013 immediately or in the\nlonger term \u2013 which are directly or indirectly attributable to the harmful substances.","location":[[" Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 point c"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:44"},"new":["(c) it is either the same or equivalent in","terms of the potential adverse impact,","whether occurring immediately or with a","time lag, on the safety of the product with","regard to human health, with particular","reference to children, animal health, or the","environment.","Or.. it"],"old":["(c) it is either the same or equivalent in","terms of the potential adverse impact on","the safety of the product with regard to","human or animal health or the","environment.",""],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"373","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-374","justification":"In order to find an appropriate balance between free trade of goods and a safe market then\nthis article on parallel trade should be limited to identical products based on the same\nspecification and content of active substances and co-formulants.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 point c"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["c) it is either the same or equivalent with","regard to the co-formulants present and","the packaging size, material or form, in","terms of the potential adverse impact on","the safety of the product with regard to","human or animal health or the","environment."],"old":["c) it is either the same or equivalent in","terms of the potential adverse impact on","the safety of the product with regard to","human or animal health or the","environment."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"374","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-375","justification":" The application for a parallel trade licence must also contain information relating to the\n letter of access, as indicated in Article 50.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 4 \u2013 point c"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["(c) name and address of the authorisation","holder in the Member State of origin and a","letter of access in accordance with Article","50 from the authorisation holder;"],"old":["(c) name and address of the authorisation","holder in the Member State of origin;"],"orig_lang":"it","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"375","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-376","location":[[" Proposal for a regulation","Article 45 - paragraph 1 - subparagraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:44"},"new":["(1) By way of derogation from Articles 15","and 16, a competent authority may","authorise for a period not exceeding four","months, the placing on the market of a","biocidal product not complying with the","provisions of this Regulation for a limited","and controlled use if all of the following","conditions are met:","(a) such a measure is necessary because of","a danger to public health or the","environment which cannot be contained by","other means and","(b) the active substances concerned are","approved for inclusion into Annex I or","evaluated according to Article 4 of this","Regulation and a full dossier is provided","(c) if the relevant active substances are","classified as cut-off substances or","candidates for substitution, a mandatory","substitution plan is established and","implemented by the applicant or","competent authority in order to replace","the relevant substances with non-","hazardous chemical or non-chemical","alternatives within 2 years after approval","and","(d) the application of the product is","restricted to professional users who are","certified pursuant to the requirements for","an integrated pest management and the","use is appropriately monitored ."],"old":["(1) By way of derogation from Articles 15","and 16, a competent authority may","authorise for a period not exceeding nine","months, the placing on the market of a","biocidal product not complying with the","provisions of this Regulation for a limited","and controlled use if such a measure is","necessary because of a danger to public","health or the environment which cannot be","contained by other means.",""],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"376","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-377","justification":"The risk posed by an active substance that is authorised under \"Derogation from the\nrequirements\" has to be controlled as far as possible.","location":[["Proposal for a regulation","Article 45 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:44"},"new":["1. By way of derogation from Articles 15","and 16, a competent authority may","authorise for a period not exceeding nine","months, the placing on the market of a","biocidal product not complying with the","provisions of this Regulation for a limited","and controlled use if such a measure is","necessary because of a danger to public","health or the environment which cannot be","contained by other means that pose a lower","risk."],"old":["1. By way of derogation from Articles 15","and 16, a competent authority may","authorise for a period not exceeding nine","months, the placing on the market of a","biocidal product not complying with the","provisions of this Regulation for a limited","and controlled use if such a measure is","necessary because of a danger to public","health or the environment which cannot be","contained by other means."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"377","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-378","location":[["Proposal for a regulation","Article 45 - paragraph 2"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:44"},"new":["deleted"],"old":["(2) By way of derogation from point (a)","Article 16(1) and until an active substance","","is listed in Annex I, competent authorities","and the Commission may authorise, for a","period not exceeding three years, the","placing on the market of a biocidal","product containing a new active substance","not listed in Annex I.","Such an authorisation may be issued only","if, after dossiers have been evaluated in","accordance with Article 8, the evaluating","competent authority has submitted a","recommendation for inclusion of the new","active substance in Annex I and the","competent authority which received the","application for the provisional","authorisation or in case of Community","authorisation, the Agency, considers that","the biocidal product may be expected to","comply with points (c) and (d) of Articles","16(1).","The competent authorities or the","Commission shall enter the information","on the authorisation referred to in Article","23(5) in the Community Register of","Biocidal Products.","If the Commission decides not to include","an active substance in Annex I, the","competent authority which granted an","authorisation referred to in the first","subparagraph or the Commission shall","cancel that authorisation.","Where a decision on the inclusion of an","active substance in Annex I has not yet","been adopted by the Commission when","the period of three years expires, the","competent authority which granted a","provisional authorisation, or the","Commission, may extend the provisional","authorisation for a period not exceeding","one year, provided there are good reasons","to believe that the active substance will","satisfy the requirements of Article 4.","Competent authorities which extended the","provisional authorisation shall inform the","other competent authorities and, where","appropriate, the Commission of such","action."],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"378","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-379","justification":"The requirement for a national authorization constitutes a significant barrier to innovation,\nas it implies a very long waiting period before the test can be carried out. It is proposed\ninstead, whilst maintaining the need for a prior evaluation by the competent authority, that a\n30-day period is set to for it to assess if the proposed test/experiment raises any concerns, and\nto issue its opinion. Finally, when a test is carried out in a single Member State, notifying the\nCommission and the other Competent Authorities serves no clear purpose and provides no\nbenefit.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:44"},"new":["In the case of scientific research and","development, including product and","process-oriented research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data and quantities","supplied, and shall compile a dossier","containing all available data on possible","effects on human or animal health or","impact on the environment. The persons","concerned shall, if requested, make this","information available to the competent","authority."],"old":["In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data, quantities","supplied and the names and addresses of","those persons receiving the biocidal","product or active substance, and shall","compile a dossier containing all available","data on possible effects on human or","animal health or impact on the","environment. The persons concerned shall,","if requested, make this information","available to the competent authority."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"379","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-380","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:44"},"new":["In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data, quantities","supplied and the names and addresses of","those persons receiving the biocidal","product or active substance, and shall","compile a dossier containing all available","data on possible immediate or long-term","effects on human health, with particular","reference to children, animal health, or the","impact on the environment. The persons","concerned shall, if requested, make this","information available to the competent","authority.","Or. it","Justification."],"old":["In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data, quantities","supplied and the names and addresses of","those persons receiving the biocidal","product or active substance, and shall","compile a dossier containing all available","data on possible effects on human or","animal health or impact on the","environment. The persons concerned shall,","if requested, make this information","available to the competent authority.","","","","","It would seem appropriate to highlight the fact that children are more vulnerable to harmful","products than adults, on whom the proposal for a regulation is basing tolerance criteria.","Children are often to be found - unbeknown to themselves - in places which have been","sprayed with biocidal products and pesticides, and show reactions \u2013 immediately or in the","longer term \u2013 which are directly or indirectly attributable to the harmful substances."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"380","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-381","justification":"According to the proposal, in order to proceed with an experiment or test for the purposes of\nR&D, an unauthorised biocidal product which may involve release of the product into the\nenvironment requires a national authorisation before the test/experiment can be done. This\nclearly constitutes a significant barrier to innovation, as it implies a very long waiting period\nbefore the test can be carried out. Thus, whilst maintaining the need for a prior evaluation by\nthe competent authority, a 30 day period should be set to assess if the proposed\ntest/experiment raises any concerns.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:44"},"new":["In the case of scientific research and","development, including product and","process-oriented research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data and quantities","supplied, and shall compile a dossier","containing all available data on possible","effects on human or animal health or","impact on the environment. The persons","concerned shall, if requested, make this","information available to the competent","authority."],"old":["In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data, quantities","supplied and the names and addresses of","those persons receiving the biocidal","product or active substance, and shall","compile a dossier containing all available","data on possible effects on human or","animal health or impact on the","environment. The persons concerned shall,","if requested, make this information","available to the competent authority."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"381","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-382","justification":" Under the Commission proposal, a test on an unauthorised biocidal product for research and\n development purposes which involved the release of the product into the environment would\n require prior national authorisation. The time required in order to obtain it could hamper\n innovation. It is proposed instead that a fifteen-day period be set to allow the authority to\n assess whether the proposed test gives rise to any concern and to deliver its opinion.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:45"},"new":["In the case of scientific research and","development comprising research and","development performed on products and","processes, the person who intends to carry","out the experiment or the test shall notify","the competent authority prior to the start.","The person shall draw up and maintain","written records detailing the identity of the","biocidal product or active substance,","labelling data and quantities supplied, and","shall compile a dossier containing all","available data on possible effects on human","or animal health or impact on the","environment. The persons concerned shall,","if requested, make this information","available to the competent authority."],"old":["In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data, quantities","supplied and the names and addresses of","those persons receiving the biocidal","product or active substance, and shall","compile a dossier containing all available","data on possible effects on human or","animal health or impact on the","environment. The persons concerned shall,","if requested, make this information","available to the competent authority."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"382","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-383","justification":"In the Commission\u2019s proposal, in order to proceed with an experiment or test for the purposes\nof research and development, an unauthorised biocidal product which may involve release of\nthe product into to the environment requires a national authorisation before the\ntest/experiment can be done. This clearly constitutes a significant barrier to innovation, as it\nimplies a very long waiting period before the test can be carried out. It is proposed instead,\nwhilst maintaining the need for a prior evaluation by the competent authority, that a 15-day\nperiod is set to for it to assess if the proposed test/experiment raises any concerns, and to\nissue its opinion.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:45"},"new":["deleted"],"old":["In the case of product and process-","oriented research and development, the","person who intends to carry out the","experiment or the test shall, prior to the","placing of the biocidal product or the","active substance on the market, notify the","information required in the second","subparagraph to the competent authority","of the Member State where the placing on","the market occurs."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"383","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-384","justification":"According to the proposal, in order to proceed with an experiment or test for the purposes of\nR&D, an unauthorised biocidal product which may involve release of the product into the\nenvironment requires a national authorisation before the test/experiment can be done. This\nclearly constitutes a significant barrier to innovation, as it implies a very long waiting period\nbefore the test can be carried out. Thus, whilst maintaining the need for a prior evaluation by\nthe competent authority, a 30 day period should be set to assess if the proposed\ntest/experiment raises any concerns.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:45"},"new":["deleted"],"old":["In the case of product and process-","oriented research and development, the","person who intends to carry out the","experiment or the test shall, prior to the","placing of the biocidal product or the","active substance on the market, notify the","information required in the second","subparagraph to the competent authority","of the Member State where the placing on","the market occurs."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"384","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-385","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:45"},"new":["deleted"],"old":["In the case of product and process-","oriented research and development, the","person who intends to carry out the","experiment or the test shall, prior to the","placing of the biocidal product or the","active substance on the market, notify the","information required in the second","subparagraph to the competent authority","of the Member State where the placing on","the market occurs."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"385","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-386","justification":"Under the Commission proposal, a test on an unauthorised biocidal product for research and\ndevelopment purposes which involved the release of the product into the environment would\nrequire prior national authorisation. The time required in order to obtain it could hamper\ninnovation. It is proposed instead that a fifteen-day period be set to allow the authority to\nassess whether the proposed test gives rise to any concern and to deliver its opinion.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 2"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:45"},"new":["2. An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and delivered a","favourable opinion for this purpose which","may impose further conditions. In the","absence of an opinion from the competent","authority delivered within 30 days after","notification of the information required in","paragraph 1, the biocidal product or","active substance should be placed on the","market for the purposes of the notified","experiment or test."],"old":["2. An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and issued a","national authorisation for this purpose","which limits the quantities to be used and","the areas to be treated and which may","impose further conditions. The competent","authority shall without delay inform the","Commission and other competent","authorities about the issued national","","authorisation."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"386","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-387","justification":"The requirement for a national authorization constitutes a significant barrier to innovation,\n\n as it implies a very long waiting period before the test can be carried out. It is proposed\n instead, whilst maintaining the need for a prior evaluation by the competent authority, that a\n 30-day period is set to for it to assess if the proposed test/experiment raises any concerns, and\n to issue its opinion. Finally, when a test is carried out in a single Member State, notifying the\n Commission and the other Competent Authorities serves no clear purpose and provides no\n benefit.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:45"},"new":["(2) An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and issued a","positive opinion for this purpose and which","may impose further conditions. In the","absence of an opinion from the competent","authority within 30 days of the notification","of the information required in paragraph","1, the biocidal product or active substance","may be placed on the market for the","purpose of the notified experiment or test."],"old":["(2) An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and issued a","national authorisation for this purpose","which limits the quantities to be used and","the areas to be treated and which may","impose further conditions. The competent","authority shall without delay inform the","Commission and other competent","authorities about the issued national","authorisation."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"387","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-388","justification":" According to the proposal, in order to proceed with an experiment or test for the purposes of\n R&D, an unauthorised biocidal product which may involve release of the product into the\n environment requires a national authorisation before the test/experiment can be done. This\n clearly constitutes a significant barrier to innovation, as it implies a very long waiting period\n before the test can be carried out. Thus, whilst maintaining the need for a prior evaluation by\n the competent authority, a 30 day period should be set to assess if the proposed\n test/experiment raises any concerns.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 2"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:45"},"new":["2. An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and issued a","positive opinion for this purpose which","may impose further conditions. In the","absence of an opinion from the competent","authority within 30 days of the notification","of the information required in paragraph","1, the biocidal product or active substance","may be placed on the market for the","purpose of the notified experiment or test."],"old":["2. An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and issued a","national authorisation for this purpose","which limits the quantities to be used and","the areas to be treated and which may","impose further conditions. The competent","authority shall without delay inform the","Commission and other competent","authorities about the issued national","authorisation."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"388","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-389","justification":"The rules on conducting tests/experiments on the territory of a Member State, other than the\none on whose market the biocidal products shall be placed, should be same as those in\nparagraph one of the same article.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:45"},"new":["3. Where any experiment or test takes","place in a Member State other than the","Member State where placing on the market","of the biocidal product occurs, the","applicant shall notify the competent","authority of the Member State in the","territory of which the experiments or tests","are to be conducted. The applicant shall","draw up and maintain written records","detailing the identity of the biocidal","product or active substance, labelling data","and quantities supplied, and shall compile","a dossier containing all available data on","possible effects on human or animal","health or impact on the environment. The","applicant shall, if requested, make this","information available to the competent","authority."],"old":["3. Where any experiment or test takes","place in a Member State other than the","Member State where placing on the market","of the biocidal product occurs, the","applicant shall obtain experiment or test","authorisation from the competent","authority of the Member State in the","territory of which the experiments or tests","are to be conducted."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"389","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-390","justification":" It would seem appropriate to highlight the fact that children are more vulnerable to harmful\n products than adults, on whom the proposal for a regulation is basing tolerance criteria.\n Children are often to be found - unbeknown to themselves - in places which have been\n sprayed with biocidal products and pesticides, and show reactions \u2013 immediately or in the\n longer term \u2013 which are directly or indirectly attributable to the harmful substances.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:45"},"new":["If the proposed experiments or tests","referred to in paragraphs 1 and 2 may have","harmful effects, whether occurring","immediately or with a time lag, on human","health, in particular as regards children,","or animal health or any unacceptable","adverse effect on the environment,","humans, or animals, the competent","authority of the Member State concerned","may prohibit them or allow them subject to","such conditions as it considers necessary to","prevent those consequences. The","competent authority shall without delay","inform the Commission and other","competent authorities about such measures."],"old":["If the proposed experiments or tests","","referred to in paragraphs 1 and 2 may have","harmful effects on human or animal health","or any unacceptable adverse effect on the","environment, the competent authority of","the Member State concerned may prohibit","them or allow them subject to such","conditions as it considers necessary to","prevent those consequences. The","competent authority shall without delay","inform the Commission and other","competent authorities about such measures."],"orig_lang":"it","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"390","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-391","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:45"},"new":["4. In order to encourage the research and","development in active substances and","biocidal products, the Commission shall","adopt, by means of delegated acts in","accordance with Article 71 a and subject","to the conditions of Articles 71 b and 71 c,","measures to specify the overall applicable","maximum quantities of active substances","or biocidal products that may be released","during experiments and the minimum data","to be submitted in accordance with","paragraph 2."],"old":["4. The Commission shall adopt measures to","specify the overall applicable maximum","quantities of active substances or biocidal","products that may be released during","experiments and the minimum data to be","submitted in accordance with paragraph 2."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"391","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-392","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:45"},"new":["deleted"],"old":["Those measures designed to amend non-","essential elements of this Regulation by","supplementing it shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"392","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-393","justification":" It is necessary to ensure that only active substances which are on the Annex I positive list are\n used in treated articles and materials. Many articles are manufactured outside the EU and\n therefore the non-active components of the biocidal product will not have been authorised in\n the EU. Since these non-active components are not intended to be released under normal or\n reasonable foreseeable conditions of use, there is no reason to make the approval of the\n entire formulated biocidal product a legal requirement for treated articles entering the EU.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 1"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:45"},"new":["1. Treated materials or articles that","incorporate one or more active substances","shall not be placed on the market unless the","active substance(s) used for treating the","materials or articles are listed in Annex I","(the positive list for active substances) and","from a source supported by the named","applicant listed alongside the Annex I","inclusion for that active substance.","authorised for this use in the Community or","in at least one Member State."],"old":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or articles are authorised for this","use in the Community or in at least one","Member State.","",""],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"393","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-394","justification":" Some biocidal products unauthorised in the EU are readily used in non-EU countries: cross-\n contamination of articles cannot therefore be entirely ruled out. A general threshold for these\n\nbiocidal products must be set, with the possibility for the Biocidal Products Committee to set\ndifferent ones, if necessary.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 1"]],"meta":{"created":"2019-07-03T05:29:45"},"new":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or the articles are authorised for","this use in the Community or in at least one","Member State or the biocidal product is","present in those articles in a","concentration of less than 0.01% weight","by weight. Where appropriate, the","Biocidal Products Committee may","propose different thresholds for specific","biocidal product(s) or groups of biocidal","products."],"old":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or articles are authorised for this","use in the Community or in at least one","Member State."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"394","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-395","justification":"Some biocidal products unauthorised in the EU are readily used in non-EU countries: cross-\ncontamination of articles cannot therefore be entirely ruled out. A general threshold for these\nbiocidal products must be set.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 1"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:45"},"new":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or the articles are authorised for","this use in the Community or in at least one","Member State, or the biocidal product is","present in those articles in transit in a","concentration of less than 0.01% weight","by weight."],"old":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or articles are authorised for this","use in the Community or in at least one","Member State."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"395","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Esther De Lange","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-396","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 1"]],"meps":[38398],"meta":{"created":"2019-07-03T05:29:45"},"new":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","active substances used for treating the","materials or articles are authorised for this","use in the Community."],"old":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or articles are authorised for this","use in the Community or in at least one","","Member State."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"396","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-397","justification":" The labelling provisions for treated articles and materials should not lead to requirements for\n unnecessary information and should not overlap with existing requirements under sectoral\n legislation. Existing sectoral legislation and their information requirements (e.g. labelling,)\n should always be taken into consideration. E.g, under the Detergent Regulation, the INCI\n name of the preservative must be labelled on products for the general public and reported in\n the SDS for Institutional and Industrial products. Additional labelling requirements are\n therefore unnecessary.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:45"},"new":["a) the name, using wherever possible","common nomenclature (e.g. INCI) of all","active substances that were used to treat the","article or materials or that were","incorporated in the articles or materials,","where relevant and for all active","substances which are intended to be","released under normal or foreseeable","conditions of use from the treated article","or material, unless labelling requirements","or alternative means to meet information","requirements already exist under sector-","specific legislation;"],"old":["a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"397","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-398","justification":"As consumers may not necessarily be familiar with the names of biocides, the label should\nclearly indicate that the articles have been treated with biocides before listing the names of\nthe active substances. Nanomaterials should be labelled as such, as already adopted for\ncosmetics.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:46"},"new":["a) the words \"treated with biocides\",","followed by the name of all active","substances that were used to treat the","article or materials or that were","incorporated in the articles or materials;","the names of all nanomaterials shall be","followed by the word \"nano\" in brackets;"],"old":["a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"398","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-399","justification":" The labelling provisions for treated articles and materials should not lead to requirements for\n unnecessary information and should not overlap with existing requirements under sectoral\n legislation. Existing sectoral legislation and their information requirements (e.g. labelling,\n Safety Data Sheets) should always be taken into consideration. For example under the\n Detergent Regulation, the INCI name of the preservative must be labelled on products for the\n general public and reported in the SDS for Institutional and Industrial products. Hence any\n additional labelling requirements are unnecessary.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a"]],"meta":{"created":"2019-07-03T05:29:46"},"new":["a) the name, using wherever possible","common nomenclature (e.g. INCI) of all","active substances that were used to treat the","article or materials or that were","incorporated in the articles or materials,","where relevant and for all active","substances which are intended to be","released under normal or foreseeable","conditions of use from the treated article","or material, unless labelling requirements","or alternative means to meet information","requirements already exist under sector-","specific legislation;"],"old":["a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"399","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-400","justification":" The labelling of treated products must explicitly indicate that the product has been treated\n with biocidal products. This information is essential for consumers.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:46"},"new":["(aa) the indication 'treated with biocidal","products';"],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"400","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-401","justification":"These labelling requirements should only concern articles that have been treated with a\nbiocidal product which might come into contact with humans and the environment, as only\nthese might really prove hazardous.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point b"]],"meta":{"created":"2019-07-03T05:29:46"},"new":["b) where relevant, the biocidal property","attributed to treated articles or materials if","the biocidal product is intended to come","into direct contact with humans and the","environment;"],"old":["b) where relevant, the biocidal property","attributed to treated articles or materials;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"401","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-402","justification":"More stringent rules should apply to products which have an external biocidal effect. In this\nrespect the wording of Article 47 needs to be clarified.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point b"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:46"},"new":["b) the biocidal properties attributed to","treated materials or products if the","biocidal product is intended to be released","under normal conditions of use which can","reasonably be foreseen;"],"old":["b) where relevant, the biocidal property","attributed to treated articles or materials;"],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"402","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-403","justification":"Additional hazard and precautionary statements set out in the authorisation for the biocidal\n\n product would be misleading information to be put on the label of the treated material. The\n material does not have to be dealt with in the same way as the biocidal product that was used\n in the treated material and so the hazard and precautionary statements are not relevant for\n the treated material itself.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point b"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:46"},"new":["b) where relevant, the biocidal property","attributed to treated articles;"],"old":["b) where relevant, the biocidal property","attributed to treated articles or materials;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"403","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-404","justification":" The inclusion of the authorisation number does not have any consumer safety benefits. On the\n contrary, a long list of authorisation numbers would arise as it is not uncommon to have\n multiple suppliers of one active substance. This would create confusion among consumer. For\n the purposes of enforcement by competent authorities, the authorisation number can be\n obtained through other means.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point c"]],"meta":{"created":"2019-07-03T05:29:46"},"new":["deleted"],"old":["c) the authorisation number of all","biocidal products that were used for the","treatment or were incorporated in the","articles or materials;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"404","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-405","justification":"The authorisation number does not serve to inform consumers about the product.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point c"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:46"},"new":["deleted"],"old":["(c) the authorisation number of all","biocidal products that were used for the","treatment or were incorporated in the","articles or materials;"],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"405","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-406","justification":"The inclusion on the product label of the biocidal product's authorisation number used to\ntreat the article will disclose the recipient/supplier relationship and will, in addition, clearly\nlimit the flexibility of a formulator to switch from one supplier to another, as each change\nwould require an artwork change. Also, the inclusion of the authorisation number does not\nhave any consumer safety benefits. On the contrary, a long list of authorisation numbers\nwould arise as it is not uncommon to have multiple suppliers of one active substance. This\nwould create confusion among consumer.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:46"},"new":["d) only for treated articles and where","relevant, any hazard statement or","precautionary statement set out in the","authorisation for the biocidal product ."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"406","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-407","justification":" More stringent rules should apply to products which have an external biocidal effect. In this\n respect the wording of Article 47 needs to be clarified.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:46"},"new":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product if the biocidal product","is intended to be released under normal","conditions of use which can reasonably be","foreseen."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"407","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-408","justification":" These labelling requirements should only concern articles that have been treated with a\n biocidal product which might come into contact with humans and the environment, as only\n these might really prove hazardous.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meta":{"created":"2019-07-03T05:29:46"},"new":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product if the biocidal product","is intended to come into direct contact","with humans and the environment."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"408","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-409","justification":"Information on the biocidal product and the biocidal active substance is not relevant to\nconsumers from the safety point of view where the active substance is not intended to be\nreleased by the treated article or material.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:46"},"new":["(d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product where relevant, and","for all active substances intended to be","released by the article or material treated","in normal or foreseeable conditions of","use."],"old":["(d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product.","",""],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"409","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-410","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:46"},"new":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product, especially regarding","vulnerable groups."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"410","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-411","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:46"},"new":["The labelling shall be clearly visible, easily","legible, appropriately durable, and printed","on the article or material."],"old":["The labelling shall be clearly visible, easily","legible and appropriately durable."],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"411","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-412","justification":" In the case of specially produced items or items produced in very small series, particularly in\n the construction sector, other forms of labelling can easily be negotiated with the customer.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:46"},"new":["Where this is necessary because of the size","or the function of the treated article or","material, the labelling shall be printed on","the packaging, on the instructions for use","or on the warranty of the treated article or","material. In the case of treated materials","or articles which are not produced as part","of a series, but rather designed and","manufactured to meet a specific order, the","manufacturer may agree other methods of","providing the relevant information with","the customer."],"old":["Where this is necessary because of the size","or the function of the treated article or","material, the labelling shall be printed on","the packaging, on the instructions for use","or on the warranty of the treated article or","material."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"412","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-413","justification":"The labelling must be clear, legible and readily accessible for the consumer.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:46"},"new":["The labelling shall be printed on the","packaging, on the instructions for use and","on the warranty of the treated article or","material."],"old":["Where this is necessary because of the","size or the function of the treated article","or material, the labelling shall be printed","on the packaging, on the instructions for","use or on the warranty of the treated article","or material."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"413","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-414","justification":"Any person placing articles or materials treated with biocides on the market should also have\na letter of certification listing all the biocides which have been used in the articles and\nmaterials.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2- subparagrah 3 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:46"},"new":["The person responsible for placing treated","articles or materials on the market shall","have a letter of certification issued by the","authorisation holder in respect of all","biocidal products which have been used","for the treatment or which have been","inserted into the articles or materials."],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"414","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-415","justification":" The Commission proposal would open the door to free-riding because, having obtained a\n letter of access, a company could easily switch to a different supplier. Information owners\n and/or participants would not then be in a position to recoup their costs. As rule, letters of\n access are issued free of charge in connection with supply agreements. Providing for the\n revocation of letters of access if agreements are broken is a means of protecting information\n owners\u2019 investments.","location":[["Proposal for a regulation","Article 50 \u2013 paragraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:47"},"new":["2. Revocation of a letter of access prior to","its expiry date shall invalidate the","authorisation drawn up on the basis of the","letter of access in question with immediate","effect, unless another letter of access for","an equivalent active substance is","submitted by the holder of the","authorisation within four months."],"old":["2. Revocation of a letter of access prior to","its expiry date shall not affect the validity","of the authorisation issued on the basis of","the letter of access in question."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"415","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-416","location":[[" Proposal for a regulation","Article 50 \u2013 paragraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:47"},"new":["2. Revocation of a letter of access prior to","its expiry date shall invalidate the","authorisation issued on the basis of the","letter of access in question, unless another","letter of access for an equivalent active","substance is provided by the authorisation","holder within four months.","Or. it","Justification."],"old":["2. Revocation of a letter of access prior to","its expiry date shall not affect the validity","of the authorisation issued on the basis of","the letter of access in question.","","","","","Letters of access are generally provided free of charge and are linked to supply agreements.","The option of revoking letters of access should agreements be violated, e.g. with alternative","supplies, is intended to protect a data owner\u2019s investments. To protect users, the product","authorisation may remain valid for a permitted period in order to allow time to obtain a new","letter of access."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"416","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-417","justification":"The regulation is aiming for a sustainable approach emphasising product safety and\ncompatibility in terms of human and animal health and the environment.","location":[[" Proposal for a regulation","Article 51 \u2013 paragraph 1"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:47"},"new":["1. Given that animal testing should be","avoided, testing on vertebrate animals for","the purposes of this Regulation shall be","undertaken only as a last resort where no","alternative solution can be employed","without producing an impact on humans","or animals. Testing on vertebrate animals","shall not be repeated for the purposes of","this Regulation."],"old":["1. In order to avoid animal testing, testing","on vertebrate animals for the purposes of","this Regulation shall be undertaken only as","a last resort. Testing on vertebrate animals","shall not be repeated for the purposes of","this Regulation."],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"417","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-418","justification":" Data owners and prospective applicants have a long history of negotiating successfully on\n data compensation terms. National courts have little experience in this regards, precisely\n because these matters are resolved in most cases directly by the parties. Recognised\n independent arbitration bodies would be better suited to resolving discussions in the\n situations where agreement cannot be reached.","location":[["Proposal for a regulation","Article 52 \u2013 paragraph 3"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:47"},"new":["3. Where no such agreement is reached two","months after the request was made","according to Article 51(2), both the owner","of the information and the prospective","applicant shall without delay inform the","Agency and the owner of the information","thereof. Within two months of being","informed about the failure to reach an","agreement, the Agency shall give the","prospective applicant the right to refer to","the tests or studies involving tests on","vertebrate animals. Both the owner of the","information and the prospective applicant","will submit to legally binding abitration.","The arbitration will be carried out under","the rules of a recognised independent","arbitration institute decided by the owner","of the information after consulting with","the prospective applicant. An arbitration","shall be started and concluded promptly","and in any event be concluded within 6","months of the parties informing the","Agency of their failure to reach an","agreement. An arbitration shall decide on","the proportionate share of all the costs","associated with the generation and use of","the information that the prospective","applicant shall pay to the data owner."],"old":["3. Where no such agreement is reached two","months after the request was made","according to Article 51(2), the prospective","applicant shall without delay inform the","Agency and the owner of the information","thereof. Within two months of being","informed about the failure to reach an","agreement, the Agency shall give the","prospective applicant the right to refer to","the tests or studies involving tests on","vertebrate animals. National courts shall","decide on the proportionate share of the","cost that the prospective applicant shall pay","to the data owner.",""],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"418","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-419","justification":" Member states shall develop sustainable measures for the use phase.","location":[[" Proposal for a regulation","Article 54 \u2013 paragraph 2 a (new)"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:47"},"new":["2 a. Within 4 years after entry into force","of this Regulation action plans shall be","established and implemented at national","level in order to support the sustainable","use of biocidal products. Action plans","shall be reviewed every three years."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"419","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Csaba S\u00e1ndor Tabajdi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-420","justification":"Implementation reports should be up to date as much as possible and best practices should be\ndisseminated on a regular basis among member states.","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[23808],"meta":{"created":"2019-07-03T05:29:47"},"new":["3. Every year, starting in 2013, competent","authorities shall submit to the Commission","a report on the implementation of this","Regulation in their respective territories.","The implementation reports shall be","annually published on the relevant","website of the Commission. The report","shall include:"],"old":["3. Every three years, starting in 2013,","competent authorities shall submit to the","Commission a report on the","implementation of this Regulation in their","respective territories. The report shall","include:"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"420","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Csaba S\u00e1ndor Tabajdi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-421","justification":"Best practices should be disseminated among member states.","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 3 \u2013 point b"]],"meps":[23808],"meta":{"created":"2019-07-03T05:29:47"},"new":["b) information on any poisonings involving","biocidal products, and the actions","undertaken to lower the risk of future","cases."],"old":["b) information on any poisonings involving","biocidal products."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"421","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-422","location":[[" Proposal for a regulation","Article 54 \u2013 paragraph 3 \u2013 point b"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:47"},"new":["b) information on any poisonings involving","biocidal products, especially regarding","vulnerable groups."],"old":["b) information on any poisonings involving","biocidal products."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"422","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-423","justification":" Substances incorporating nanomaterials fall within the scope of the Regulation. However, the\n impact of these substances on health and the environment is largely unknown at present. It is\n imperative to initiate without delay research to asses their impact in order to be able to\n consider specific measures if appropriate.","location":[[" Proposal for a regulation","Article 54 \u2013 paragraph 4 a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:47"},"new":["4a. Two years, at the latest, after the entry","into force of this Regulation, the","Commission shall submit a report on the","assessment of the risks to human health","and the environment presented by the use","of nanomaterials in biocidal products and","on specific measures which should be","taken with regard to them."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"423","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-424","justification":"Many biocidal products are not used in closed systems but released into the environment, for\nexample in effluent. Insufficient data are available in this field. A thorough study of their\nenvironmental impact is needed.","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 4 b (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:47"},"new":["4b. Within five years after the entry into","force of this Regulation, the Commission","shall draw up a report on the impact of","the spread of biocidal products in the","environment. The Commission shall","submit the report to the European","Parliament and the Council."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"424","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-425","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 4 c (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:47"},"new":["4c. Within two years after the entry into","force of this Regulation, the Commission","shall propose a revision of the Regulation","so as to establish a simplified evaluation","procedure for substances consisting of","natural plant extracts whose toxicological","profile does not give grounds for concern","about human health."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"425","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-426","location":[[" Proposal for a regulation","Article 55 \u2013 paragraph 2 \u2013 introductory part"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:47"},"new":["2. Disclosure of the following information","shall be deemed to undermine the","protection of the commercial interests of","the person concerned and may not be","disclosed publicly:"],"old":["2. Disclosure of the following information","shall be deemed to undermine the","protection of the commercial interests of","the concerned person:"],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"426","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-427","location":[[" Proposal for a regulation","Article 55 - paragraph 2 - point b"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:47"},"new":["deleted"],"old":["(b) the precise use, function or application","of a substance or mixture;"],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"427","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-428","justification":"The information to be treated as confidential, because it is commercially sensitive, should\nalso include the date of issue of an authorisation and the expiry date, the stated doses and\nalso instructions for use, and the location of the site where a biocidal product is\nmanufactured.","location":[[" Proposal for a regulation","Article 55 \u2013 paragraph 2 \u2013 points d a - d d (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:48"},"new":["(da) manufacturers of the active","substances (names and addresses","including location of manufacturing","sites);","(db) the location of a biocidal product\u2019s","manufacturing site;","(dc) the date of issue of an authorisation","and the expiry date;","(dd) doses and instructions for use."],"old":["",""],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"428","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-429","justification":"It is essential to ensure transparency in urgent cases to protect health, the safety of persons or\nthe environment.","location":[["Proposal for a regulation","Article 55 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:48"},"new":["However, where urgent action is essential","to protect human health, safety or the","environment, the Agency or the competent","authorities shall take the necessary","measures to disclose the information","referred to in this paragraph."],"old":["However, where urgent action is essential","to protect human health, safety or the","environment, the Agency or the competent","authorities may disclose the information","referred to in this paragraph."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"429","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Csaba S\u00e1ndor Tabajdi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-430","justification":" Information on biocidal products shall be published in structured, researchable way on the\n internet, first of all on the website of the Commission dealing with biocidal products.","location":[["Proposal for a regulation","Article 56 \u2013 paragraph 1 \u2013 introductionory part"]],"meps":[23808],"meta":{"created":"2019-07-03T05:29:48"},"new":["1. The following information held by the","competent authorities, the Agency or, as","appropriate, the Commission on active","substances shall be made, free of charge,","publicly available in a single database, in","a structured format at least on the","relevant website of the Commission:"],"old":["1. The following information held by the","competent authorities, the Agency or, as","","appropriate, the Commission on active","substances shall be made, free of charge,","publicly available:"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"430","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Csaba S\u00e1ndor Tabajdi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-431","justification":" A reference on the classification of certain biocidal substances according to the community\n legislation in force is necessary.","location":[[" Proposal for a regulation","Article 56 \u2013 paragraph 1 \u2013 point d a (new)"]],"meps":[23808],"meta":{"created":"2019-07-03T05:29:48"},"new":["(da) a clear reference if the active","substance qualifies as persistent, bio-","accumulative and toxic (PBT) or very","persistent and very bioaccumulative","(vPvB) in accordance with Annex XIII of","Regulation (EC) No. 1907/2006 or as","endocrine disrupter or if it has been","classified in accordance with Regulation","(EC) No 1272/2008 as one of the","following: carcinogenic; mutagenic;","neurotoxic; immunotoxic; toxic to","reproduction; sensitising."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"431","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Judith A. Merkies","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-432","justification":"In order to make clear that there should be also analytical methods available to analyse\nwaters and drinking water.","location":[["Proposal for a regulation","Article 56 \u2013 paragraph 1 \u2013 point h"]],"meps":[96910],"meta":{"created":"2019-07-03T05:29:48"},"new":["h) analytical methods if requested in","accordance with Annex II or III to this","Regulation which make it possible to","detect a dangerous substance when","discharged into the environment (including","water resources and drinking waters) as","well as to determine the direct exposure of","humans."],"old":["h) analytical methods if requested in","accordance with Annex II or III to this","Regulation which make it possible to","detect a dangerous substance when","discharged into the environment as well as","to determine the direct exposure of","humans."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"432","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-433","justification":"Final users must be able to distinguish between low-risk and high-risk biocidal products and\nmake purchasing decisions accordingly.","location":[["Proposal for a regulation","Article 56 \u2013 paragraph 3 a (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:48"},"new":["3a. Public access shall be granted free of","charge to an inventory containing details","of biocidal products authorised pursuant","to Article 16(3) and of the corresponding","manufacturers."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"433","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-434","justification":" This approach has also been incorporated in the regulation concerning the placing of plant\n protection products on the market (1107/2009): Article 67 Record-keeping, par 1-3 and\n should be also part of the new biocide regulation","location":[[" Proposal for a regulation","Article 57 - paragraph 1"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:48"},"new":["(1) Producers, importers and professional","users of biocidal products shall keep","records of the biocidal products they use,","containing the name of the biocide, the","time and the dose of application, the area","and the articles and materials where the","biocide was used, for at least three years.","They shall make the relevant information","contained in these records available to the","competent authority on request. Third","parties such as the drinking water","industry, retailers or residents, may","request access to this information by","addressing the competent authority.","Producers of biocidal products shall","undertake post-authorisation monitoring","on request of the competent authorities.","They shall notify the competent","authorities of the relevant results."],"old":["(1) Producers, importers and professional","users of biocidal products shall keep","records of the biocidal products they","produce, place on the market or use for at","least three years. They shall make","available the relevant information","contained in these records to the competent","authority on request."],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"434","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-435","justification":"The period for which records are kept must be sufficiently long to enable the competent\nauthority to perform checks. The proposed period of ten years is the same as provided for by\nthe REACH Regulation.","location":[[" Proposal for a regulation","Article 57 \u2013 paragraph 1"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:48"},"new":["1. Producers, importers and professional","users of biocidal products shall keep","records of the biocidal products they","produce, place on the market or use for at","least ten years. They shall make available","the relevant information contained in these","records to the competent authority on","request."],"old":["1. Producers, importers and professional","users of biocidal products shall keep","records of the biocidal products they","produce, place on the market or use for at","least three years. They shall make","available the relevant information","contained in these records to the competent","authority on request."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"435","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-436","location":[["Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 introductory part"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:48"},"new":["2. Labels shall not be misleading and, in","any case, shall not mention the indications","\u2018non-toxic\u2019, \u2018harmless\u2019 or similar","indications. In addition, the label must","show clearly and indelibly the following","information:","Or.it","Justification."],"old":["2. Labels shall not be misleading and, in","any case, shall not mention the indications","\u2018low-risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019 or similar indications. In","addition, the label must show clearly and","indelibly the following information:","","","","","A low-risk biocidal product can be identified as such on the label."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"436","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-437","justification":" Final users must be able to distinguish between low-risk and high-risk biocidal products and\n make purchasing decisions accordingly.","location":[[" Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 introductory part"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:48"},"new":["2. Labels shall not be misleading and, in","any case, shall not mention the indications","\u2018non-toxic\u2019, \u2018harmless\u2019 or similar","indications. The description 'low-risk","biocidal product' shall be reserved for","products authorised pursuant to Article","16(3). In addition, the label must show","clearly and indelibly the following","information:"],"old":["2. Labels shall not be misleading and, in","any case, shall not mention the indications","\u2018low-risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019 or similar indications. In","addition, the label must show clearly and","indelibly the following information:"],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"437","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-438","justification":" The impact of nanomaterials on health and the environment is largely unknown at present.\n Consumers must be informed correctly.","location":[[" Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:48"},"new":["(ba) where appropriate, whether the","product contains nanomaterials and any","specific risks;"],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"438","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-439","justification":"Nanomaterials in biocidal products need to be clearly labelled as such.","location":[["Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:48"},"new":["(ca) all nanomaterials followed by the","word \"nano\" in brackets;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"439","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-440","justification":"The dose rate expressed in metric units is not comprehensible to non-professional users and is\ntherefore difficult for them to understand. Instead, the dose rate should be expressed on the\nlabel in a manner that is meaningful and comprehensible to the end user.","location":[["Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 point e"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:48"},"new":["(e) directions for use and the dose rate,","expressed in a manner that is meaningful","and comprehensible to users, for each use","provided for under the terms of the","authorisation;"],"old":["(e) directions for use and the dose rate,","expressed in metric units, for each use","provided for under the terms of the","authorisation;"],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"440","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-441","justification":" Better guidance on the labels of biocidal products for vulnerable groups should be provided","location":[[" Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 point g"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:48"},"new":["g) if accompanied by a leaflet, the sentence","\"Read attached instructions before use\"","and where applicable warnings for","vulnerable groups;"],"old":["g) if accompanied by a leaflet, the sentence","\"Read attached instructions before use\";"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"441","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-442","justification":" Final users must be able to distinguish between low-risk and high-risk biocidal products and\n make purchasing decisions accordingly.","location":[[" Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 point m a (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:48"},"new":["(ma) where appropriate, the description","'low-risk biocidal product' for products","authorised pursuant to Article 16(3)."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"442","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-443","justification":"Both consumers and those acting on behalf of supervisory authorities must be able to gain\naccess to the information in their mother tongue.","location":[[" Proposal for a regulation","Article 58 \u2013 paragraph 3"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:48"},"new":["3. Biocidal products placed on the market","of the territories of the Member States","shall be labelled in the national language","or languages of the country where they are","marketed."],"old":["3. Member States may require that","biocidal products placed on the market of","their territories are labelled in their","national language or languages."],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"443","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-444","justification":"The proper functioning of the Community Register for Biocidal Products throughout the EU\nrequires that detailed measure related to the running of the Register are established by\ndelegated acts.","location":[["Proposal for a regulation","Article 60 \u2013 paragraph 5"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:49"},"new":["5. In order to ensure the proper","functioning of the Community Register","for Biocidal Products, The Commission","may adopt, by means of delegated acts in","accordance with Article 71 a and subject","to the conditions of Articles 71 b and 71 c,","detailed rules on the types of information","to be entered in the Register and the","procedures related to it."],"old":["5. The Commission may adopt detailed","rules on the types of information to be","entered in the Community Register for","Biocidal Products and the procedures","related to it, in accordance with the","procedure referred to in Article 72(2)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"444","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-445","justification":" A low-risk biocidal product can be identified as such in advertisements.","location":[[" Proposal for a regulation","Article 62 \u2013 paragraph 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:49"},"new":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment. In any case, the advertising","of a biocidal product shall not mention","\u2018non-toxic\u2019, \u2018harmless\u2019 or any similar","indication."],"old":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment. In any case, the advertising","of a biocidal product shall not mention","\u2018low-risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019 or any similar indication."],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"445","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-446","justification":"Final users must be able to distinguish between low-risk and high-risk biocidal products and\nmake purchasing decisions accordingly.","location":[[" Proposal for a regulation","Article 62 \u2013 paragraph 3"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:49"},"new":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment. In any case, the advertising","of a biocidal product shall not mention","\u2018low-risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019 or any similar indication.","Advertising employing the description","'low-risk biocidal product' shall be","permissible only for products authorised","pursuant to Article 16(3)."],"old":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment. In any case, the advertising","of a biocidal product shall not mention","\u2018low-risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019 or any similar indication."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"446","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-447","location":[["Proposal for a regulation","Article 65 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point f a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:49"},"new":["(fa) where appropriate, proposals for","thresholds for specific biocidal product(s)","or groups of biocidal products in articles","in transit.","Or.enJustification"],"old":["","","Some biocidal products unauthorised in the EU are readily used in non-EU countries: cross-","contamination of articles cannot therefore be entirely ruled out. The Agency must be able, if","necessary, to depart form the general 0,01% threshold for treated articles in transit cited in","article 47, paragraph 1."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"447","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Fr\u00e9d\u00e9rique Ries, Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-448","location":[["Proposal for a regulation","Article 66 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[4253,97076],"meta":{"created":"2019-07-03T05:29:49"},"new":["(ia) providing guidance and tools for the","use phase, particularly:","- measures for integrated pest","management, for specified vermin,","- monitoring biocidal product use","- best practice of biocidal product use to","limit use of such products to the minimum","necessary dose,","- pest management in sensitive areas like","schools, workplaces, kindergartens, public","spaces, lake, canal and river sides,","geriatric care centres,","- technical equipment for of biocidal","product application and its inspection."],"old":[""],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"448","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-449","justification":" Fees should reflect the work required and the fact that it has been performed in an\n appropriate and efficient manner. An annual fee is therefore not acceptable without a\n justification, and fees should only be charged when they are genuinely necessary.","location":[[" Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point a"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:49"},"new":["a) a reduced fee shall be set for small and","medium-sized enterprises within the","meaning of Recommendation 2003/361/EC","concerning the definition of micro, small","and medium-sized enterprises; this shall","have no bearing on the responsibility of","the relevant competent authority to carry","out a careful assessment in accordance","with the provisions of this Regulation;"],"old":["a) a reduced fee shall be set for small and","medium-sized enterprises within the","meaning of Recommendation 2003/361/EC","concerning the definition of micro, small","and medium-sized enterprises;"],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"449","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-450","justification":"\nIn absence of any justification an annual fee should not be applicable and full consultation\nprogramme should be conducted before such measures are introduced. It is accepted that the\nCommission and Member States must be able to cover their costs, but the fees should not be a\nbarrier to trade purely on economic grounds as biocidal products are key in all areas of\npublic health.","location":[[" Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point a"]],"meta":{"created":"2019-07-03T05:29:49"},"new":["a) a reduced fee shall be set for small and","medium-sized enterprises within the","meaning of Recommendation 2003/361/EC","concerning the definition of micro, small","and medium-sized enterprises. This shall","in no way alter the responsibility of the","evaluating competent authority to conduct","a thorough evaluation according to this","Regulation;"],"old":["a) a reduced fee shall be set for small and","medium-sized enterprises within the","","meaning of Recommendation 2003/361/EC","concerning the definition of micro, small","and medium-sized enterprises;"],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"450","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-451","justification":"The fee structure may make it possible to provide incentives for production of low-risk\nproducts.","location":[["Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:49"},"new":["(ba) the fee structure shall take into","account the fact that the product","submitted for authorisation complies with","the criteria for a low-risk product;"],"orig_lang":"r","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"451","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-452","justification":" Fees should reflect the work required and the fact that it has been performed in an\n appropriate and efficient manner. An annual fee is therefore not acceptable without a\n justification, and fees should only be charged when they are genuinely necessary.","location":[["Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point d"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:49"},"new":["deleted"],"old":["d) an annual fee shall be paid by persons","placing biocidal products on the market;","and"],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"452","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-453","justification":" The requirement to pay an annual fee cannot be laid down from the outset. The fee should\n apply only when genuinely necessary.","location":[[" Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point d"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:49"},"new":["(d) the fee shall be payable only when it is","genuinely necessary;"],"old":["(d) an annual fee shall be paid by persons","placing biocidal products on the market;"],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"453","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-454","location":[[" Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point d"]],"meta":{"created":"2019-07-03T05:29:49"},"new":["d) the fee shall only be charged when","effectively needed.","Or.enJustification"],"old":["d) an annual fee shall be paid by persons","placing biocidal products on the market;","","and","","","","In absence of any justification an annual fee should not be applicable and full consultation","programme should be conducted before such measures are introduced. It is accepted that the","Commission and Member States must be able to cover their costs, but the fees should not be a","barrier to trade purely on economic grounds as biocidal products are key in all areas of","public health."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"454","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-455","justification":"Fees should reflect the work required and the fact that it has been performed in an\nappropriate and efficient manner. An annual fee is therefore not acceptable without a\njustification, and fees should only be charged when they are genuinely necessary.","location":[["Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point e"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:49"},"new":["e) fees shall be charged only when","genuinely necessary. The structure and","amount of the fees shall take account of the","work required by this Regulation to be","carried out by the Agency and the","competent authorities and shall be fixed at","such level as to ensure that the revenue","derived from the fees when combined with","other sources of the Agency's revenue","pursuant to this Regulation is sufficient to","cover the cost of the services delivered."],"old":["e) the structure and amount of the fees","shall take account of the work required by","this Regulation to be carried out by the","Agency and the competent authorities and","shall be fixed at such level as to ensure that","the revenue derived from the fees when","combined with other sources of the","Agency's revenue pursuant to this","Regulation is sufficient to cover the cost of","the services delivered."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"455","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-456","justification":" The range of fees must reflect the fees currently charged in Europe:","location":[["Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point e a (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:49"},"new":["(ea) fees may not exceed EUR 45 000."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"456","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-457","justification":"Pursuant to Article 290 TFEU, detailed provisions on the delegation of powers have to be set\nout in the Regulation.","location":[[" Proposal for a regulation","Article 71 a (new)"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:49"},"new":["Article 71a","Exercise of the delegation","1. The powers to adopt delegated acts","referred to in Articles 6(4), 8(5), 12(5),","13(1), 14, 19(3), 21(5), 42, 46(4), 60(5),","70(1), 73 and 77(1) shall be conferred on","the Commission for a period of 5 years","following the entry into force of this","Directive. The Commission shall make a","report in respect of the delegated powers","at the latest 6 months before the end of","the 5 year period. The delegation of","powers shall be automatically extended","for periods of an identical duration,","unless the European Parliament and the","Council revokes it in accordance with","Article 71b.","2. As soon as it adopts a delegated act, the","Commission shall notify it simultaneously","to the European Parliament and to the","Council","3. The powers to adopt delegated acts are","conferred on the Commission subject to","the conditions laid down in Articles 71b","and 71c."],"old":["",""],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"457","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-458","justification":" Pursuant to Article 290 TFEU, detailed provisions on the delegation of powers have to be set\n out in the Regulation.","location":[["Proposal for a regulation","Article 71 b (new)"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:49"},"new":["Article 71b","Revocation of the delegation","1. The delegation of powers referred to in","Articles 6(4), 8(5), 12(5), 13(1), 14, 19(3),","21(5), 42, 46(4), 60(5), 70(1), 73 and 77(1)","may be revoked at any time by the","European Parliament or by the Council.","2.The institution which has commenced","an internal procedure for deciding","whether to revoke the delegation of","powers shall endeavour to inform the","other institution and the Commission","within a reasonable time before the final","decision is taken, indicating the delegated","powers which could be subject to","revocation and possible reasons for a","revocation.","3. The decision of revocation shall put an","end to the delegation of the powers","specified in that decision. It shall take","effect immediately or at a later date","specified therein. It shall not affect the","validity of the delegated acts already in","force. It shall be published in the Official","Journal of the European Union."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"458","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-459","justification":" Pursuant to Article 290 TFEU , detailed provisions on the delegation of powers have to be set\n out in the Regulation.","location":[[" Proposal for a regulation","Article 71 c (new)"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:49"},"new":["Article 71c","Objections to delegated acts","1. The European Parliament or the","Council may object to a delegated act","within a period of three months from the","date of notification.","At the initiative of the European","Parliament or the Council this period","shall be extended by one month.","2. If, on expiry of that period, neither the","European Parliament nor the Council has","objected to the delegated act it shall be","published in the Official Journal of the","European Union and shall enter into","force at the date stated therein.","3. If the European Parliament or the","Council objects to a delegated act, it shall","not enter into force. The institution which","objects shall state the reasons for","objecting to the delegated act."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"459","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-460","justification":"Due to the alignment of the comitology regime to the new system of delegated acts pursuant to\nArticle 290 TFEU, the regulatory procedure with scrutiny will not apply for the\nimplementation of the Regulation.","location":[["Proposal for a regulation","Article 72 \u2013 paragraph 5"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:49"},"new":["deleted"],"old":["5. Where reference is made to this","paragraph, Article 5a (1), (2), (4) and (6),","and Article 7 of Decision 1999/468/EC","shall apply, having regard to the","provisions of Article 8 thereof."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"460","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-461","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n\n 290 TFEU.","location":[["Proposal for a regulation","Article 73 \u2013 paragraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:50"},"new":["In order to take account of technical","progress, the Commission may adapt, by","means of delegated acts in accordance","with Article 71 a and subject to the","conditions of Articles 71 b and 71 c, the","Annexes to scientific and technical","progress."],"old":["The Commission may adapt the Annexes","to scientific and technical progress."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"461","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-462","location":[[" Proposal for a regulation","Article 73 \u2013 paragraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:50"},"new":["The Commission shall adapt the Annexes","to scientific and technical progress."],"old":["The Commission may adapt the Annexes","to scientific and technical progress."],"orig_lang":"e","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"462","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-463","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[[" Proposal for a regulation","Article 73 \u2013 paragraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:50"},"new":["deleted"],"old":["Those measures, designed to amend non-","essential elements of this Regulation,","shall be adopted in accordance with the","regulatory procedure with scrutiny","referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"463","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Tiziano Motti","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-464","justification":"It would seem appropriate to highlight the fact that children are more vulnerable to harmful\nproducts than adults, on whom the proposal for a regulation is basing tolerance criteria.\nChildren are often to be found - unbeknown to themselves - in places which have been\nsprayed with biocidal products and pesticides, and show reactions \u2013 immediately or in the\nlonger term \u2013 which are directly or indirectly attributable to the harmful substances.","location":[[" Proposal for a regulation","Article 76 \u2013 paragraph 1"]],"meps":[96760],"meta":{"created":"2019-07-03T05:29:50"},"new":["Where, on the basis of new evidence, a","Member State has justifiable grounds to","consider that a biocidal product, although","satisfying the requirements of this","Regulation, constitutes a serious immediate","or long-term risk to human health, in","particular as regards children, or animal","health or to the environment, it may take","appropriate provisional measures. The","Member State shall without delay inform","the Commission and the other Member","States thereof and give reasons for its","decision based on the new evidence."],"old":["Where, based on new evidence, a Member","State has justifiable grounds to consider","that a biocidal product, although satisfying","the requirements of this Regulation,","constitutes a serious risk to human or","animal health or to the environment, it may","take appropriate provisional measures. The","Member State shall without delay inform","the Commission and the other Member","States thereof and give reasons for its","decision based on the new evidence."],"orig_lang":"t","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"464","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Csaba S\u00e1ndor Tabajdi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-465","justification":" Ensures the implementation of the subsidiarity principle and the precautionary principle.\n Member states have to implement secondary European law like the Water Framework\n Directive. Considering the newly adopted Regulation on Plant Protection Products member\n states have appropriate rooms for manoeuvre in order to protect their citizens and vulnerable\n ecosystems.","location":[["Proposal for a regulation","Article 76 \u2013 paragraph 1"]],"meps":[23808],"meta":{"created":"2019-07-03T05:29:50"},"new":["Where, based on new evidence, a Member","State has justifiable grounds to consider","that a biocidal product, although satisfying","the requirements of this Regulation,","constitutes a serious risk to human or","animal health or to the environment,","particularly to vulnerable groups and to","risk a failure of achieving the quality","standards of Directive 2000/60/EC it may","take appropriate provisional measures. The","Member State shall without delay inform","the Commission and the other Member","States thereof and give reasons for its","decision."],"old":["Where, based on new evidence, a Member","State has justifiable grounds to consider","that a biocidal product, although satisfying","the requirements of this Regulation,","constitutes a serious risk to human or","animal health or to the environment, it may","take appropriate provisional measures. The","Member State shall without delay inform","the Commission and the other Member","States thereof and give reasons for its","","decision based on the new evidence."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"465","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Csaba S\u00e1ndor Tabajdi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-466","justification":" According to Article 193 of the newly adopted EU-Treaty member states can maintain or\n introduce more stringent protective measures for the improvement of the quality of the\n environment and the protection of human health.","location":[[" Proposal for a regulation","Article 76 \u2013 paragraph 2"]],"meps":[23808],"meta":{"created":"2019-07-03T05:29:50"},"new":["deleted"],"old":["The Commission shall, in accordance","with the procedure referred to in Article","72(3), either authorise the provisional","measure for a time period defined in the","decision or require the Member State to","revoke the provisional measure."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"466","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-467","justification":"To align the comitology regime to the new system of delegated acts in accordance with Article\n290 TFEU.","location":[[" Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:50"},"new":["1.The Commission shall carry on with the","work programme for the systematic","examination of all existing active","substances commenced in accordance with","Article 16(2) of Directive 98/8/EC and","achieve it by 14 May 2014. In order to","ensure the smooth transition, the","Commission may adopt, by means of","delegated acts in accordance with Article","71 a and subject to the conditions of","Articles 71 b and 71 c, implementing rules","to carry out the work programme and to","specify the related rights and obligations of","the competent authorities and the","participants in the programme; and,","depending upon the progress of the work","programme, a decision to extend the","duration of the work programme for a","determined period."],"old":["1. The Commission shall carry on with the","work programme for the systematic","examination of all existing active","substances commenced in accordance with","Article 16(2) of Directive 98/8/EC and","achieve it by 14 May 2014. The","Commission may adopt implementing","rules to carry out the work programme and","to specify the related rights and obligations","of the competent authorities and the","participants in the programme. Those","measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"467","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-468","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[["Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:50"},"new":["deleted"],"old":["Depending upon the progress of the work","programme, the Commission may extend","the duration of the work programme for a","determined period. That measure,","designed to amend non-essential elements","of this Regulation by supplementing it,","shall be adopted in accordance with the","regulatory procedure with scrutiny","","referred to in Article 72(4)."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"468","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-469","justification":" To align the comitology regime to the new system of delegated acts in accordance with Article\n 290 TFEU.","location":[[" Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[1929],"meta":{"created":"2019-07-03T05:29:50"},"new":["In order to progress with the work","programme, the Commission shall decide,","by means of delegated acts in accordance","with Article 71 a and subject to the","conditions of Articles 71 b and 71 c, that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and data","have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex I","of this Regulation. The decision shall","specify the date on which the inclusion in","Annex I becomes effective."],"old":["During the work programme, the","Commission shall decide pursuant to the","procedure laid down in Article 72(4) that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and data","have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex I","of this Regulation. The decision shall","specify the date on which the inclusion in","Annex I becomes effective."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"469","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Mario Pirillo","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-470","justification":"The legislative text should clearly state the timelines applicable. Two years have previously\nbeen agreed upon by the Competent Authorities","location":[["Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:29:50"},"new":["During the work programme, the","Commission shall decide pursuant to the","procedure laid down in Article 72(4) that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and data","have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex I","of this Regulation. The decision shall","specify the date on which the inclusion in","Annex I becomes effective, which is two","years after the decision."],"old":["During the work programme, the","Commission shall decide pursuant to the","procedure laid down in Article 72(4) that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and data","have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex I","of this Regulation. The decision shall","specify the date on which the inclusion in","Annex I becomes effective."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"470","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-471","justification":" Timings for disposal, storage and use of existing stocks of biocidal products should be\n consistent throughout the article.","location":[["Proposal for a regulation","Article 77 \u2013 paragraph 4"]],"meta":{"created":"2019-07-03T05:29:50"},"new":["4. Biocidal products for which the","competent authority of the Member State","has rejected an application for","authorisation submitted under paragraph 3","or has decided not to grant authorisation,","shall no longer be placed on the market","with effect from six months after such a","rejection or a decision. Disposal, storage","and use of existing stocks of biocidal","products for which the competent","authority of the Member State has","rejected an application for authorisation","submitted under paragraph 3 or has","decided not to grant authorisation are","allowed until eighteen months after the","date on which the inclusion becomes","effective."],"old":["4. Biocidal products for which the","competent authority of the Member State","has rejected an application for","authorisation submitted under paragraph 3","or has decided not to grant authorisation,","shall no longer be placed on the market","with effect from six months after such a","","rejection or a decision."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"471","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-472","location":[[" Proposal for a regulation","Article 81"]],"meps":[28156],"meta":{"created":"2019-07-03T05:29:50"},"new":["By way of derogation from Article 47,","treated articles and materials that","incorporate biocidal products which are not","authorised in the Community or in at least","one Member State and which were","available on the market on ... [OJ: insert","the date referred to in the first","subparagraph of Article 85] may, until the","date of a decision granting authorisation to","these biocidal products, continue to be","placed on the market if the application for","authorisation is submitted at the latest by 1","January 2013. In the case of a refusal to","grant an authorisation to place a biocidal","product on the market, treated articles and","materials that incorporate such biocidal","product shall no longer be placed on the","market within six months after such","decision."],"old":["By way of derogation from Article 47,","treated articles and materials that","incorporate biocidal products which are not","authorised in the Community or in at least","one Member State and which were","available on the market on ... [OJ: insert","the date referred to in the first","subparagraph of Article 85] may, until the","date of a decision granting authorisation to","these biocidal products, continue to be","placed on the market if the application for","authorisation is submitted at the latest by 1","January 2017. In the case of a refusal to","grant an authorisation to place a biocidal","product on the market, treated articles and","materials that incorporate such biocidal","product shall no longer be placed on the","market within six months after such","decision."],"orig_lang":"en","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"472","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-473","location":[["Proposal for a regulation","Article 81"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:50"},"new":["By way of derogation from Article 47,","treated articles and materials that","incorporate biocidal products which are not","authorised in the Community or in at least","one Member State and which were","available on the market on ... [OJ: insert","the date referred to in the first","subparagraph of Article 85] may, until the","date of a decision granting authorisation to","these biocidal products, continue to be","placed on the market if the application for","authorisation is submitted at the latest by 1","January 2017. In the case of a refusal to","grant an authorisation to place a biocidal","product on the market, treated articles and","materials that incorporate such biocidal","product shall no longer be placed on the","market within 12 months after such","decision.","Or.deJustification"],"old":["By way of derogation from Article 47,","treated articles and materials that","incorporate biocidal products which are not","authorised in the Community or in at least","one Member State and which were","available on the market on ... [OJ: insert","the date referred to in the first","subparagraph of Article 85] may, until the","date of a decision granting authorisation to","these biocidal products, continue to be","placed on the market if the application for","authorisation is submitted at the latest by 1","January 2017. In the case of a refusal to","grant an authorisation to place a biocidal","product on the market, treated articles and","materials that incorporate such biocidal","product shall no longer be placed on the","market within six months after such","decision.","","","The deadline must be extended to take account of importers' business cycles. Traders order","goods up to 18 months before they appear on the shelves. A 12-month deadline would","guarantee importers the legal security they need."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"473","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-474","location":[["Proposal for a regulation","Article 81 - paragraph 1a (new)"]],"meta":{"created":"2019-07-03T05:29:51"},"new":["Disposal, storage and use of existing","stocks of biocidal products which are not","authorised for the relevant use by the","competent authority or the Commission","are allowed until twelve months after the","date of the decision referred to in the first","subparagraph of Article 80 or twelve","months after the date referred to in the","second subparagraph of the same Article,","whichever is the later.","Or.enJustification"],"old":["","","The addition of this paragraph taken from Article 80 ensures consistent measures for the new","products which will fall under the scope of the Biocidal Products Regulation."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"474","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Catherine Soullie, Fran\u00e7oise Grosset\u00eate, Gaston Franco","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-475","location":[[" Proposal for a regulation","Article 82"]],"meps":[97294,2025,96908],"meta":{"created":"2019-07-03T05:29:51"},"new":["Article 82 deleted","Or.frJustification"],"old":["Transitional measures concerning food","contact materials","1. Applications for the authorisation of","biocidal products which are food contact","materials and which were available on the","market on [OJ: insert the date referred to","in the first subparagraph of Article 85]","shall be submitted at the latest 1 January","2017.","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was submitted in accordance with","paragraph 1 may continue to be placed on","the market until the date of the decision","granting the authorisation or refusing to","","grant the authorisation. In case of a","refusal to grant an authorisation to place","such biocidal product on the market, such","biocidal product shall no longer be placed","on the market within six months after","such decision.","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was not submitted in accordance with","paragraph 1 may continue to be placed on","the market until six months after the date","referred to in paragraph 1.","2. Disposal, storage and use of existing","stocks of biocidal products which are not","authorised for the relevant use by the","competent authority or the Commission is","allowed until twelve months after the date","of the decision referred to in the second","subparagraph of paragraph 1 or twelve","months after the date referred to in the","third subparagraph of paragraph 1,","whichever is the later.","","","Food contact materials are already regulated by Regulation (EC) No 1935/2004. That","Regulation perhaps does not cover all aspects of the evaluation of such materials and their","use, but fresh restrictions must be introduced by revising the legislation specifically dealing","with food contact materials and [not?] in the Regulation on biocidal products, in order to","avoid any duplication of regulation and evaluations."],"peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"475","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Julie Girling","changes":{},"committee":["ENVI"],"date":"2010-03-19T00:00:00","id":"PE439.891-476","justification":" Food contact materials should not be within the scope of the Proposal as this would lead to\n double regulation and assessment. Food contact materials are already regulated by the Food\n Contact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\n\nto the rules governing food contact materials, they should be addressed through a revision of\nthe food contact legislation, not by extending the scope of the BPR.","location":[["Proposal for a regulation","Article 82"]],"meps":[96956],"meta":{"created":"2019-07-03T05:29:51"},"new":["Article 82 deleted"],"old":["Transitional measures concerning food","contact materials","1. Applications for the authorisation of","","biocidal products which are food contact","materials and which were available on the","market on [OJ: insert the date referred to","in the first subparagraph of Article 85]","shall be submitted at the latest 1 January","2017.","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was submitted in accordance with","paragraph 1 may continue to be placed on","the market until the date of the decision","granting the authorisation or refusing to","grant the authorisation. In case of a","refusal to grant an authorisation to place","such biocidal product on the market, such","biocidal product shall no longer be placed","on the market within six months after","such decision.","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was not submitted in accordance with","paragraph 1 may continue to be placed on","the market until six months after the date","referred to in paragraph 1.","2. Disposal, storage and use of existing","stocks of biocidal products which are not","authorised for the relevant use by the","competent authority or the Commission is","allowed until twelve months after the date","of the decision referred to in the second","subparagraph of paragraph 1 or twelve","months after the date referred to in the","third subparagraph of paragraph 1,","whichever is the later."],"orig_lang":"n","peid":"PE439.891v01-00","reference":"2009/0076(COD)","seq":"476","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.891+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bill Newton Dunn","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-44","justification":"It is necessary to keep biocidal product type 20 (\u2018Preservatives for food or feedstocks\u2019) but its\ndefinition needs to be amended, since these biocidal products are not preservatives but\ndisinfectants. For instance, products used to disinfect feed from human pathogens such as\nSalmonella do not meet the requirements of the feed additives regulations. Neither do they act\nas preservatives to prevent animal feed from deteriorating. These products must be therefore\nconsidered as disinfectant agents.","location":[["Proposal for a regulation","Recital 20"]],"meps":[1394],"meta":{"created":"2019-07-03T05:34:40"},"new":["deleted"],"old":["(20) As products used for the preservation","of food or feedstocks by the control of","harmful organisms, previously covered by","product type 20, are covered by Council","Directive 89/107/EEC and Regulation","(EC) No 1831/2003 of the European","Parliament and of the Council, it is not","appropriate to maintain this product type."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"44","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-45","justification":" To avoid pointless duplication of effort.","location":[["Proposal for a regulation","Recital 21 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:40"},"new":["(21a) As the WHO Pesticide Evaluation","Scheme (WHOPES) constitutes a system","for effective testing and evaluation of the","impact of insecticides on public health,","compliance with the final","recommendations approved under that","scheme should be regarded as equivalent","to the product authorisation required by","this Regulation."],"old":[""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"45","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-46","location":[[" Proposal for a regulation","Recital 22"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:40"},"new":["deleted"],"old":["(22) To take account of the specific nature","of some biocidal products and the low","level of risk associated with their proposed","use, and to encourage the development of","biocidal products containing new active","substances, it is appropriate to provide for","a Community authorisation of those","products."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-47","location":[[" Proposal for a regulation","Recital 24"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:40"},"new":["(24) In order to facilitate access to the","internal market and to avoid the additional","costs and time involved in obtaining","separate national authorisations in separate","Member States, the Commission has","decided to introduce a Community","authorisation procedure for all biocidal","products."],"old":["(24) In order to facilitate access to the","internal market and to avoid the additional","costs and time involved in obtaining","separate national authorisations in separate","Member States, the Commission, taking","into account the experience with the","provisions on Community authorisations,","may decide to extend the scope of the","Community authorisation procedure to","","","other biocidal products."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"47","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-48","justification":"Parallel trade should be confined to identical products which have the same specifications\nand contain the same active substances and co-formulants.","location":[["Proposal for a regulation","Recital 45"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:41"},"new":["(45) In view of the benefits for the internal","market and for the consumer, it is desirable","to establish harmonised rules for parallel","trade of identical biocidal products that are","authorised in different Member States."],"old":["(45) In view of the benefits for the internal","market and for the consumer, it is desirable","to establish harmonised rules for parallel","trade of substantially identical biocidal","products that are authorised in different","Member States."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-49","justification":" Those who have undertaken investment under the existing legislation must not be excluded.","location":[["Proposal for a regulation","Recital 48"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(48) Applicants that have invested in","supporting the inclusion of an active","substance in Annex I or in the authorisation","of a biocidal product in accordance with","the provisions of this Regulation and/or","those of Directive 98/8/EC should be able","to recover part of their investment by","receiving equitable compensation","whenever use of proprietary information","which they submitted in support of such","inclusions or authorisations is made for the","benefit of subsequent applicants."],"old":["(48) Applicants that have invested in","supporting the inclusion of an active","substance in Annex I or in the authorisation","of a biocidal product in accordance with","the provisions of this Regulation should be","able to recover part of their investment by","receiving equitable compensation","whenever use of proprietary information","which they submitted in support of such","inclusions or authorisations is made for the","","benefit of subsequent applicants."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-50","justification":" In the interests of clarity.","location":[[" Proposal for a regulation","Recital 49"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(49) In view of ensuring that all proprietary","information submitted in support of an","inclusion of an active substance in Annex I","or an authorisation of a biocidal product is","protected from the moment of its","submission and to prevent situations where","some information is without protection, the","provision on information protection","periods should also apply to information","submitted for the purposes of Directive","98/8/EC."],"old":["(49) In view of ensuring that all proprietary","information submitted in support of an","inclusion of an active substance or an","authorisation of a biocidal product is","protected from the moment of its","submission and to prevent situations where","some information is without protection, the","provision on information protection","periods should also apply to information","submitted for the purposes of Directive","98/8/EC."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-51","justification":"Sharing of data applies not only to product data but also to data on the active substance.","location":[[" Proposal for a regulation","Recital 51"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:41"},"new":["(51) It is essential to minimise the number","of tests on vertebrates and to ensure that","testing of a biocidal product and/or a","biocidal active substance contained in","biocidal products is made dependent on","the purpose and use of a product.","Applicants should share, and not duplicate,","vertebrate animal studies in exchange for","equitable compensation. In absence of an","agreement on sharing of vertebrate animal","studies between the data owner and the","prospective applicant, the Agency should","allow the use of the studies by the","prospective applicant without prejudice to","the decision on the compensation made by","national courts. A Community register","listing the contact details of the owners of","such studies should be established and put","at the disposal of all authorities to inform","prospective applicants. These applications","will not apply to those animal tests, such","as efficacy tests, where no additional","suffering is anticipated over and above","that caused by normal rearing practices."],"old":["(51) It is essential to minimise the number","","of tests on animals and to ensure that","testing should be made dependent on the","purpose and use of a product. Applicants","should share, and not duplicate, vertebrate","animal studies in exchange for equitable","compensation. In absence of an agreement","on sharing of vertebrate animal studies","between the data owner and the","prospective applicant, the Agency should","allow the use of the studies by the","prospective applicant without prejudice to","the decision on the compensation made by","national courts. A Community register","listing the contact details of the owners of","such studies should be established and put","at the disposal of all authorities to inform","prospective applicants."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-52","location":[["Proposal for a regulation","Recital 61"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(61) In particular, the Commission should","be empowered to adopt measures to decide","on the application to include the active","substance in Annex I or to renew or review","the inclusion, to specify the procedures","related to the renewal and review of an","inclusion of an active substance in Annex","I, to specify the criteria and procedures","related to a cancellation of an authorisation","or amendments of the terms and conditions","of an authorisation, including a dispute","settlement mechanism, to specify the","overall applicable maximum quantities of","active substances or biocidal products that","may be released during experiments and","the minimum data to be submitted, to","establish a harmonised structure of fees","and other rules concerning the payment of","fees and charges to the competent","authorities and the Agency, to adapt the","Annexes to scientific and technical","progress, to carry out the work programme","and to specify the related rights and","obligations of the competent authorities","and the participants in the programme and","to extend the duration of the work","programme for a determined period. Since","those measures are of general scope and","are designed to amend non-essential","elements of this Regulation, inter alia, by","supplementing this Regulation with new","non-essential elements, they must be","adopted in accordance with the regulatory","procedure with scrutiny provided for in","Article 5a of Decision 1999/468/EC."],"old":["(61) In particular, the Commission should","be empowered to adopt measures to decide","on the application to include the active","substance in Annex I or to renew or review","the inclusion, to specify the procedures","related to the renewal and review of an","inclusion of an active substance in Annex","","","I, to extend the provisions on Community","authorisations to other categories of","biocidal products, to specify the criteria","and procedures related to a cancellation of","an authorisation or amendments of the","terms and conditions of an authorisation,","including a dispute settlement mechanism,","to specify the overall applicable maximum","quantities of active substances or biocidal","products that may be released during","experiments and the minimum data to be","submitted, to establish a harmonised","structure of fees and other rules concerning","the payment of fees and charges to the","competent authorities and the Agency, to","adapt the Annexes to scientific and","technical progress, to carry out the work","programme and to specify the related rights","and obligations of the competent","authorities and the participants in the","programme and to extend the duration of","the work programme for a determined","period. Since those measures are of general","scope and are designed to amend non-","essential elements of this Regulation, inter","alia, by supplementing this Regulation with","new non-essential elements, they must be","adopted in accordance with the regulatory","procedure with scrutiny provided for in","Article 5a of Decision 1999/468/EC."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-53","justification":"Food contact materials are already governed by Regulation (EC) No 1935/2004. Such\nmaterials should not fall within the scope of the proposal, as that would result in duplication\nof evaluation and regulation. If gaps in the legislation are discovered, they should be\nremedied by amending the Regulation on food contact materials.","location":[[" Proposal for a regulation","Recital 66"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","to be prepared to apply the rules","concerning in situ generated active","substances, treated articles and materials."],"old":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","","to be prepared to apply the rules","concerning in situ generated active","substances, treated articles and materials","and food contact materials."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-54","justification":"Food contact materials are already governed by Regulation (EC) No 1935/2004. Such\nmaterials should not fall within the scope of the proposal, as that would result in duplication\nof evaluation and regulation. If gaps in the legislation are discovered, they should be\nremedied by amending the Regulation on food contact materials.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point p a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(pa) Regulation (EC) No 1935/2004 of the","European Parliament and of the Council","of 27 October 2004 on materials and","articles intended to come into contact with","food and repealing Directives 80/590/EEC","and 89/109/EEC."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-55","justification":" Aimed at avoiding an unnecessary duplication of effort.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 8 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(8a) Biocidal products for Product Type","18 manufactured in accordance with the","Final Recommendations approved under","the WHO Pesticide Evaluation Scheme","(WHOPES) shall be considered to be","authorised within the meaning of Chapter","VII of this Regulation. Articles 38 and 57","shall apply accordingly."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-56","justification":"The definition is already to be found in Directive 98/8/EC, and should be incorporated in the\nnew Regulation in the interests of clarity.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point f \u2013 subparagraph 2 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:41"},"new":["Unless there are other grounds for","concern, such a substance should","normally be a substance classified as","hazardous pursuant to Council Directive","67/548/EEC of 27 June 1967 and be","present in the biocidal product in a","concentration such as to require it to be","regarded as hazardous within the","meaning of Directive 1999/45/EC or","Regulation (EC) No 1272/2008."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-57","justification":"This amendment extends the definition of treated articles and materials to include both\narticles such as paints which have been preserved and articles with an external effect, such as\nmosquito nets. The evaluation is thus a chemical one.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point k"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:41"},"new":["(k) 'treated material or article' means","any substance, mixture, material or article","which was treated with or incorporates one","or more biocidal products with the","intention to produce the biocidal effect","which is their purpose;"],"old":["(k) 'treated material or article' means","any substance, mixture, material or article","which was treated with or incorporates one","or more biocidal products with the","intention to protect the substance, mixture,","material or article from deterioration","caused by harmful organisms;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"57","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-58","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point n"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(n) 'authorisation' means","national authorisation or Community","authorisation or primary authorisation or","duplicate authorisation or additional","authorisation;"],"old":["(n) 'authorisation' means","national authorisation or Community","authorisation;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"58","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-59","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point n a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(na) 'duplicate authorisation' means","an administrative act by which, for the","benefit of the holder of a primary","authorisation, a Member State or the","Commission authorises the placing on the","market and the use of the same biocidal","product under a different name;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"59","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-60","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point n b (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(nb) 'additional authorisation' means","an administrative act by which a Member","State or the Commission authorises the","placing on the market and the use, under","a different name, of a biocidal product","based on a primary authorisation and on","approval by the holder of the primary","authorisation;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"60","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-61","justification":"It is important to establish that the risk potential must not be greater than that of the\nreference biocidal product and that the efficacy on the target organisms is consistent with the\nproduct label.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point p"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:41"},"new":["(p) 'frame formulation' means","a group of biocidal products having similar","uses and presenting variations in their","composition with regard to a reference","biocidal product belonging to that group","which contains the same active substances","of the same specifications, provided that,","irrespective of these variations, the level","of risk does not exceed that attached to the","reference biocidal products and the","efficacy on the target organism","corresponds to what is indicated on the","label of the product;"],"old":["(p) 'frame formulation' means","a group of biocidal products having similar","uses and presenting limited variations in","their composition with regard to a","reference biocidal product belonging to","that group which contains the same active","substances of the same specifications","where such permitted variations do not","adversely affect the level of risk or the","efficacy of these products;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"61","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-62","justification":" It is felt necessary to clarify the definition of 'letter of access'.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point q"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:41"},"new":["(q) 'letter of access' means","an original document, signed by the owner","or owners of information or their","representative, which states that the","information may be used by the designated","competent authorities, the European","Chemicals Agency, or the Commission for","the purpose of evaluating an active","substance or granting an authorisation to a","third party;"],"old":["(q) 'letter of access' means","","an original document, signed by the owner","or owners of information, which states that","the information may be used by the","competent authorities, the European","Chemicals Agency, or the Commission for","","","the purpose of evaluating an active","substance or granting an authorisation;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"62","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-63","justification":" Food contact materials are already governed by Regulation (EC) No 1935/2004. Such\n materials should not fall within the scope of the proposal, as that would result in duplication\n of evaluation and regulation. If gaps in the legislation are discovered, they should be\n remedied by amending the Regulation on food contact materials.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point s"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["deleted"],"old":["(s) 'food contact materials' means","any material and article intended to come","into contact with food which are covered","by Regulation (EC) No 1935/2004;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"63","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-64","justification":"It is necessary to define the types of variations that can be made to an existing authorised\nbiocidal product.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(ua) 'administrative (or formal) variation'","means","a variation to an existing authorisation of","a purely administrative (or formal)","nature, which does not require a re-","assessment of the risk to public health or","the environment or the efficacy of the","product."],"old":["","",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"64","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-65","justification":"It is necessary to define the types of variations that can be made to an existing authorised\nbiocidal product.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u b (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:41"},"new":["(ub) 'limited variation' means","a variation to an existing authorisation","which is not deemed to be an","administrative variation, in that it","requires a fresh partial assessment of the","risk to public health or the environment","and/or of the efficacy of the product. The","variation must not aggravate the level of","risk to public health or the environment","or the efficacy of the product."],"old":[""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"65","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-66","justification":" It is necessary to define the types of variations that can be made to an existing authorised\n biocidal product.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u c (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["(uc) 'major (or substantial) variation'","means","a variation to an existing authorisation","which is not deemed to be an","administrative variation or a limited","variation."],"old":[""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"66","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-67","justification":"In view of the new wording of Article 83, it is necessary to define 'manufacturer'. In fact the\ndefinition is in line with the provisions of Commission Regulation (EC) No 1896/2000 of 7\nSeptember 2000 on the first phase of the programme referred to in Article 16(2) of Directive\n98/8/EC of the European Parliament and of the Council on biocidal products.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point u d (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["(ud) 'manufacturer' means:","- with reference to an active substance","produced within Community territory or","placed on the market, the person who","manufactures that active substance or a","person resident in the Community who is","designated by the manufacturer as his","sole representative for the purposes of the","present Regulation,","- with reference to an active substance","produced outside Community territory,","the person resident in the Community","who is designated by the manufacturer of","the active substance as his sole","representative for the purposes of the","present Regulation or, if no such person","has been designated, the person who","imports the active substance in question","into the Community,","- with reference to an active substance","produced outside Community territory,","the person resident in the Community","who is designated by the manufacturer of","the active substance as his sole","representative for the purposes of the","present Regulation or, if no such person","has been designated, the person who","imports the biocidal product in question","into the Community,"],"old":[""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"67","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-68","justification":"These procedures are necessary in order to avoid duplication of tests on vertebrate animals\nand to comply with requests for Annex II information. The 'obligation to provide information'\nunder the REACH Regulation is made mutual, as the Agency will have the requisite\ninfrastructure and expertise to adopt this procedure.","location":[["Proposal for a regulation","Article 3 a (new \u2013 first Article of Chapter II)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["Article 3a","1. Any prospective applicant for inclusion","of an active substance in Annex I shall","inquire of the Agency whether","- an application for inclusion of the same","substance in Annex I has already been","submitted or","- the same substance is included in Annex","I or","- the same substance is registered","pursuant to Regulation (EC) No","1907/2006.","2. Any prospective applicant shall forward","the following information to the Agency","with the application:","(a) its identity as specified in section 1 of","Annex VI to Regulation (EC) No","1907/2006, with the exception of Nos 1.2","and 1.3;","(b) the identity of the substance as","specified in section 2 of Annex VI to","Regulation (EC) No 1907/2006;","(c) which requests for information will","require new studies involving vertebrate","animals which it will have to perform;","(d) which requests for information will","require other new studies which it will","have to perform.","3. If the same substance is not included in","Annex I or not registered pursuant to","Regulation (EC) No 1907/2006, the","Agency shall inform the prospective","applicant accordingly.","4. If an application for inclusion of the","same active substance in Annex I has","already been submitted; if the same active","substance is already included in Annex I","or if it has been registered pursuant to","Regulation (EC) No 1907/2006, the","Agency shall inform the prospective","applicant, without delay, of the name and","address of the previous applicants and","registrants and the study summaries or","robust study summaries of the","information, as the case may be, already","supplied.","5. The Agency shall at the same time","inform the previous applicant or","registrant of the name and address of the","prospective applicant for inclusion in","Annex I. The available studies of","vertebrate animals shall be shared with","the prospective applicant in accordance","with Chapter XI of this Regulation."],"old":[""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"68","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-69","justification":"At the time of entry in Annex I, the dossier must be submitted for at least one representative\nbiocidal product whose active substance meets the conditions laid down. The proposed\nchange is considered to reflect the concept of entry in Annex I more satisfactorily.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["1. An active substance shall be included in","Annex I for an initial period not exceeding","10 years if at least one of the biocidal","products containing that active substance","fulfils the conditions laid down in point (b)","of Article 16(1)."],"old":["1. An active substance shall be included in","Annex I for an initial period not exceeding","10 years if the biocidal products containing","that active substance fulfil the conditions","laid down in point (b) of Article 16(1)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"69","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-70","justification":" It is important to link the chemical substance described in Annex I to the data which have\n supported its inclusion in the annex. In addition, the isomeric composition is important for the\n purpose of distinguishing chemical identity.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 3 - introductory part"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["3. An active substance and a statement of","the reference source for the determination","of technical equivalence shall, where","appropriate, be included in Annex I","together with any of the following","conditions:"],"old":["3. An active substance shall, where","appropriate, be included in Annex I","together with any of the following","","","conditions:"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"70","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-71","justification":" It is important to link the chemical substance described in Annex I to the data which have\n supported its inclusion in the annex. In addition, the isomeric composition is important for the\n purpose of distinguishing chemical identity.","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 3 \u2013 point f a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["(fa) indication of the chemical identity as","regards stereoisomers."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"71","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-72","justification":" The formulation proposed by the Commission was not clear. The substances excluded must be\n clearly identified. It is also imperative to insert the exclusion of active substances which fulfil\n the criteria for classification as Persistent, Bioaccumulative and Toxic substances (PBT) or\n as very Persistent and very Bioaccumulative (vPvB), and those which are persistent organic\n pollutants. Lastly, Article 45 already provides for derogations which permit biocidal products\n\nto be placed on the market although they do not comply with the provisions of the present\nregulation.","location":[["Proposal for a regulation","Article 5"]],"meps":[97076],"meta":{"created":"2019-07-03T05:34:42"},"new":["1. Notwithstanding Article 4(1), the","following active substances shall not be","included in Annex I:","(a) active substances which have been","classified in accordance with Regulation","(EC) No 1272/2008 as, or which meet the","criteria to be classified as, carcinogens","category 1A or 1B;","(b) active substances which have been","classified in accordance with Regulation","(EC) No 1272/2008 as, or which meet the","criteria to be classified as, mutagens","category 1A or 1B;","(c) active substances which have been","classified in accordance with Regulation","(EC) No 1272/2008 as, or which meet the","criteria to be classified as, toxic for","reproduction category 1A or 1B;","(d) active substances identified under","Article 57(f) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties;","(e) active substances which meet the","criteria for classification as substances","persistent, bioaccumulative and toxic","(PBT), or very persistent and very","bioaccumulative (vPvB) pursuant to","Annex XIII to Regulation (EC) No","1907/2006;","(f) active substances which are persistent","organic pollutants as referred to in","Regulation (EC) No 850/2004 of the","European Parliament and of the Council","of 29 April 2004 on persistent organic","pollutants .1","1","OJ L 158, 30.4.2004, p. 7."],"old":["1. Notwithstanding Article 4(1), active","substances referred to in paragraph 2 shall","be included in Annex I only if at least one","of the following conditions is met:","(a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;","(b) it is shown that the active substance is","necessary to control a serious danger to","public health;","(c) it is shown that not including the","active substance in Annex I would cause","disproportionate negative impacts when","compared with the risk to human health","or the environment arising from the use","of the substance and that there are no","suitable alternative substances or","technologies.","Point (c) shall not apply to active","substances for product types 4 and 14 to","19.","","","","","","2. The following active substances shall","be included in Annex I where at least one","of the conditions set out in paragraph 1 is","met:","","(a) active substances which have been","classified in accordance with Regulation","(EC) No 1272/2008 as, or which meets the","criteria to be classified as, carcinogen","category 1A or 1B;","","(b) active substances which have been","classified in accordance with Regulation","(EC) No 1272/2008 as, or which meet the","criteria to be classified as, mutagen","category 1A or 1B;","","(c) active substances which have been","classified in accordance with Regulation","(EC) No 1272/2008 as, or which meet the","criteria to be classified as, toxic for","reproduction category 1A or 1B;","","(d) active substances identified under","Article 57(f) of Regulation (EC) No","1907/2006 as having endocrine disrupting","properties."],"orig_lang":"fr","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"72","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-73","justification":"There are no scientific grounds for discriminating against product types (e.g. PT4 and 14-19).\nThese products are rodenticides, acaricides, molluscicides, disinfectants, piscicides and\ninsecticides and are beneficial, in particular, to people in Southern Europe, where it is vital to\ncombat rat or insect infestations for hygiene reasons. Exclusion should be decided on the\nbasis of a risk analysis (a combination of hazardousness and exposure). If it is scientifically\nproven that the risks are well controlled, the active substances should be authorised.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 point a"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:42"},"new":["(a) the exposure of humans to that active","substance in a biocidal product, under","prescribed conditions of use, is negligible","or adequately controlled, taking account","of the intrinsic hazards presented by the","substance, in particular where the product","is used in closed systems or strictly","controlled conditions;"],"old":["(a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"73","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-74","justification":" There are no scientific grounds for discriminating against product types (e.g. PT4 and 14-19).\n These products are rodenticides, acaricides, molluscicides, disinfectants, piscicides and\n insecticides and are beneficial, in particular, to people in Southern Europe, where it is vital to\n combat rat or insect infestations for hygiene reasons. Exclusion should be decided on the\n basis of a risk analysis (a combination of hazardousness and exposure). If it is scientifically\n proven that the risks are well controlled, the active substances should be authorised.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 - subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:42"},"new":["deleted"],"old":["Point (c) shall not apply to active","substances for product types 4 and 14 to","19."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"74","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-75","justification":" At present no criteria exist for approval of endocrine-disrupters, and it is necessary to draft\n them. These criteria should be adopted in accordance with Regulation (EC) No 1107/2009 on\n the placing on the market of plant protection products, which entered into force on 24\n November 2009.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 subparagraph 1 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:42"},"new":["Implementing measures shall be applied","which specify the scientific criteria for","determining the endocrine-disrupting","properties adopted by the Regulation of","the European Parliament and of the","Council on placing plant protection","products on the market."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"75","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-76","justification":"Applicants may not be in legitimate possession of all the data in support of the application.","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 1 \u2013 point a"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["(a) a dossier for the active substance","satisfying the requirements set out in","Annex II or a letter of access;"],"old":["(a) a dossier for the active substance","satisfying the requirements set out in","Annex II;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"76","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-77","justification":"Applicants may not be in legitimate possession of all the data in support of the application.","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 1 \u2013 point b"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["(b) a dossier or a letter of access for at","least one representative biocidal product","that contains the active substance satisfying","the requirements set out in Annex III."],"old":["(b) a dossier for at least one representative","biocidal product that contains the active","substance satisfying the requirements set","out in Annex III."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"77","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-78","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 1 \u2013 subparagraph 1 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["The Agency shall assign a reference","number to each application, which shall","be used for all correspondence","concerning the application until the","substance is included in Annex I, and a","submission date, which shall be the date","of receipt by the Agency."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"78","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-79","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["Within three weeks after the receipt of an","application, the Agency shall validate the","application if it complies with the","following requirements:"],"old":["Within two months after the receipt of an","application, the Agency shall validate the","application if it complies with the","following requirements:"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"79","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-80","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 4 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:42"},"new":["4a. Within two months after the receipt of","an application, the Agency shall register","each part of the information in the dossier","with a unique identifying code."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"80","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-81","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 5 \u2013 subparagraph 1 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:42"},"new":["When the Commission decides to include","the active substance in Annex I, the","name(s) of the applicant(s) shall be","indicated."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"81","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-82","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 5 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:42"},"new":["5a. With the decision to include the active","substance in Annex I, the Agency shall","assign to the substance in question a","specific registration number for the","substance and for the applicant. The","Agency shall without delay inform the","applicant of the number and the date of","registration. This registration number","shall be used in all further","correspondence regarding the active","substance and for product authorisation","as referred to in Chapter IV of this","Regulation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"82","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-83","justification":" The criteria for identifying active substances which are candidates for substitution are\n aligned with the criteria for substances subject to authorisation as referred to in Regulation\n (EC) No 1907/2006 for reasons of harmonisation between the two regulations - see Article 57\n of Regulation (EC) No 1907/2006. As the Agency (ECHA) will have the task of examining\n whether an active substance meets the criteria, harmonisation between the two regulations is\n advisable.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["1. An active substance fulfilling at least","one of the following criteria shall be","considered a candidate for substitution in","accordance with the procedure referred to","in paragraph 2:","(a) substances which are persistent,","bioaccumulative and toxic in accordance","with the criteria set out in Annex XIII of","Regulation (EC) No 1907/2006;","(b) substances which are very persistent","and very bioaccumulative in accordance","with the criteria set out in Annex XIII of","Regulation (EC) No 1907/2006;","(c) substances which meet the criteria to","be classified, in accordance with","Regulation (EC) No 1272/2008, as","category 1A or 1B carcinogens, category","1A or 1B mutagens or toxic for","reproduction category 1A or 1B;","(d) substances \u2013 such as those with","endocrine disrupting properties or","persistent, bioaccumulative and toxic","properties or very persistent and very","bioaccumulative properties which do not","comply with the criteria referred to in","point (b) or (c) \u2013 for which scientific","evidence exists of probable serious effects","on public health or the environment","giving rise to a level of concern equivalent","to that applicable to the substances","referred to in point (b) or (c)."],"old":["1. An active substance fulfilling at least","one of the following criteria shall be","considered a candidate for substitution in","accordance with the procedure referred to","in paragraph 2:","(a) its acceptable daily intake, acute","reference dose or acceptable operator","exposure level is significantly lower than","those of the majority of the active","substances included in Annex I for the","same product type;","(b) it meets two of the criteria to be","","considered as a persistent, bio-","accumulative and toxic substance as set","out in Annex XIII of Regulation (EC) No","1907/2006;","(c) there are reasons for concern linked to","the nature of the critical effects, in","particular developmental neurotoxic or","immunotoxic effects, which, in","combination with the use patterns,","amount to use that could still cause","concern, even with very restrictive risk","management measures;","(d) it contains a significant proportion of","non-active isomers;","(e) it is classified or meets the criteria to be","classified, in accordance with Regulation","(EC) No 1272/2008, as carcinogen","category 1A or 1B, mutagen category 1A","or 1B or toxic for reproduction category","1A or 1B;","(f) it is considered to have endocrine","disrupting properties that may cause","adverse effect on humans on the basis of","the assessment of Community or","internationally agreed test guidelines or","other available data."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"83","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-84","justification":"Non-active isomers are substances which are not dangerous either to health or to the\nenvironment, and it is therefore unnecessary to include them among the candidates for\nsubstitution.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point d"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:43"},"new":["deleted"],"old":["(d) it contains a significant proportion of","non-active isomers;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"84","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-85","justification":"The criteria for identifying active substances which are candidates for substitution are\naligned with the criteria for substances subject to authorisation as referred to in Regulation\n(EC) No 1907/2006 for reasons of harmonisation between the two regulations - see Article 57\nof Regulation (EC) No 1907/2006. As the Agency (ECHA) will have the task of examining\n\n whether an active substance meets the criteria, harmonisation between the two regulations is\n advisable.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["2. When preparing an opinion on the","inclusion or renewal of the inclusion of an","active substance in Annex I, the Agency","shall examine whether the active substance","fulfils any of the criteria listed in paragraph","1 and, if exposure is not adequately","controlled, bearing in mind the intrinsic","hazards of the substance, shall address the","matter in its opinion."],"old":["2. When preparing an opinion on the","inclusion or renewal of the inclusion of an","active substance in Annex I, the Agency","shall examine whether the active substance","fulfils any of the criteria listed in paragraph","1 and address the matter in its opinion."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"85","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-87","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:43"},"new":["2. Application for authorisation shall be","made by, or on behalf of, the person","holding the authorisation, who may or","may not be the person responsible for the","placing on the market of a biocidal product","in a particular Member State or in the","Community."],"old":["2. Application for authorisation shall be","made by, or on behalf of, the person who","shall be responsible for the placing on the","market of a biocidal product in a particular","Member State or in the Community."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"87","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-86","justification":"Including the active substance in Annex I, together with the name of the applicant firm, is an\nappropriate and effective means of preventing free-riding, since it enables the firm which\nsupported the substance to be identified quickly and thereby reducing the administrative\nburden.","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 5"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:43"},"new":["5. At the end of the period referred to in","paragraph 3 or on receipt of the opinion of","the Agency, the Commission shall adopt a","decision concerning a renewal of the","inclusion of the active substance in Annex","I. That decision, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4). If","the Commission decides to renew the","inclusion of the active substance in Annex","I, mention should be made of the name of","the applicant(s)."],"old":["5. At the end of the period referred to in","paragraph 3 or on receipt of the opinion of","the Agency, the Commission shall adopt a","decision concerning a renewal of the","inclusion of the active substance in Annex","I. That decision, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"86","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-88","justification":"ECHA should carry out the initial validation of all applications throughout the Community,\nso that the evaluating competent authorities can concentrate on the actual evaluation of\napplications. Currently, where evaluating competent authorities consider both the\nadministrative and the scientific aspects of applications, there have been inconsistencies in\ntheir approach. The possibility of choosing the evaluating competent authority is an\nadvantage for small and medium-sized enterprises in particular, since they are able to work\nwith their national authorities.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["deleted"],"old":["Application for national authorisation in","a Member State shall be submitted to the","competent authority of that Member State","(hereinafter referred to as 'the receiving","competent authority')."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"88","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-89","justification":" The ECHA should carry out the initial validation of all applications throughout the\n Community, so that the evaluating competent authorities can concentrate on the actual\n evaluation of applications. Currently, where evaluating competent authorities consider both\n the administrative and the scientific aspects of applications, there have been inconsistencies\n in their approach. The possibility of choosing the evaluating competent authority is an\n advantage for small and medium-sized enterprises in particular, since they are able to work\n with their national authorities.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["Application for authorisation shall be","submitted to the Agency.","The applicant may, in agreement with a","Member State, have his application","validated by that Member State and must","identify the evaluating competent","authority in the application itself, as laid","down in Article 22."],"old":["Application for Community authorisation","shall be submitted to the Agency.","",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"89","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-90","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 3 a (new)"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:43"},"new":["An applicant seeking authorisation for a","group of products as part of a frame","formulation may submit a single","application for authorisation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"90","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-91","justification":"Contributes to promote a safe and proper use of biocides and clarifies techniques for an\nintegrated pest management. In addition, it shall support innovation and research. This is\nnecessary as the current implementation report has recorded 15.600 poisoning and other\nrelevant incidents between 2003 and 2005 in the EU. A Commission report (2009) has\nhighlighted the need for appropriate and coordinated measures for the use phase.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5 \u2013 subparagraphs 2 a and 2 b (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:34:43"},"new":["Mandatory measures shall be established","and implemented by means of a","Framework Directive for Union action in","order to achieve the sustainable use of","biocides including integrated pest","management and risk reduction","measures.","The Commission shall submit a proposal","to the European Parliament and Council","not later than two years after this","Regulation is adopted."],"old":[""],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"91","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-92","justification":"Contributes to promote a safe and proper use of biocides and clarifies techniques for an\nintegrated pest management. In addition, it shall support innovation and research. This is\nnecessary as the current implementation report has recorded 15.600 poisoning and other\nrelevant incidents between 2003 and 2005 in the EU. A Commission report (2009) has\nhighlighted the need for appropriate and coordinated measures for the use phase.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5 \u2013 subparagraph 2 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:34:43"},"new":["The Commission shall submit a proposal","to the European Parliament and Council","not later than two years after this","Regulation is adopted."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"92","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-93","justification":" In the interests of consistency with the evaluation procedure described in Article 8(5a).","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point a"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["a) the active substances included therein","are listed in Annex I, a registration","number is assigned to them in accordance","with Article 8, paragraph 5a, and any","conditions included in that Annex together","with those active substances are complied","with;"],"old":["a) the active substances included therein","are listed in Annex I and any conditions","included in that Annex together with those","active substances are complied with;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"93","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-94","justification":"The term \u2018nature\u2019 has not been clearly defined. 'Chemical identity' seems a better way of\ndescribing the active substance.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point c"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["c) the chemical identity, the quantity and","the technical equivalence of active","substances in the biocidal product and,","where appropriate, any toxicologically or","ecotoxicologically significant impurities","and non-active substances, and its residues","of toxicological or environmental","significance, which result from uses to be","authorised, can be determined according to","the relevant requirements in Annexes II","and III;"],"old":["c) the nature, the quantity and the","technical equivalence of active substances","in the biocidal product and, where","appropriate, any toxicologically or","ecotoxicologically significant impurities","and non-active substances, and its residues","of toxicological or environmental","significance, which result from uses to be","authorised, can be determined according to","the relevant requirements in Annexes II","and III;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"94","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-95","justification":"The aim is to prevent unnecessary animal testing, while also complying with the REACH\nrequirement regarding Chemical Safety Report thresholds.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2 \u2013 subparagraph 2 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["The evaluation of the compliance of the","biocidal products with the criteria set out","in point (b) of paragraph 1 should be","based as far as possible on existing","information on the substances of concern","contained in the biocidal product in order","to keep tests on animals to a minimum. In","particular, use should be made of the","provisions of Directive 1999/45/EC or","Regulation (EC) No 1272/2008 on","identifying the danger posed by biocidal","products and consequent risk assessment."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"95","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-96","justification":" The aim is to prevent unnecessary animal testing while also complying with the REACH\n requirement regarding Chemical Safety Report thresholds.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2 \u2013 subparagraphs 2a and 2 b (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:43"},"new":["The evaluation of the compliance of the","biocidal products with the criteria set out","in point (b) of paragraph 1 should be","based as far as possible on existing","information on the substances of concern","contained in the biocidal product in order","to keep tests on animals to a minimum. In","particular, use should be made of the","provisions of Directive 1999/45/EC or","Regulation (EC) No 1272/2008 on","identifying the danger posed by biocidal","products and consequent risk evaluation.","The evaluation of the compliance of the","biocidal product with the criteria set out","in point (b) and the requirements set out","in point (c) of paragraph 1 shall not take","into account a substance contained in the","biocidal product if it is present in a","preparation at a concentration lower than","any of the following:","(a) the applicable concentrations laid","down in Article 3(3) of Directive","1999/45/EC;","(b) the concentration limit values given in","Annex I to Directive 67/548/EEC;","(c) the concentration limit values given in","Part B of Annex II to Directive","1999/45/EC;","(d) the concentration limit values given in","Part B of Annex III to Directive","1999/45/EC;","(e) the concentration limit given in an","agreed entry in the classification and","labelling inventory established under Title","V of Regulation (EC) No 1272/2008;","(f) 0.1% weight by weight (w/w), if the","substance meets the criteria in Annex","XIII to Regulation (EC) No 1907/2006."],"old":[""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"96","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-97","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 6"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["6. In the case of a frame formulation, the","following variations are permitted in","respect of one or more reference biocidal","products:","(a) elimination of an active substance in","respect of a reference biocidal product","with at least two active substances;","(b) reduction in the percentage of the","active substances;","(c) elimination of one or more non-active","substances;","(d) variation in the percentage","composition of one or more non-active","substances;","(e) replacement of one or more non-active","substances."],"old":["6. In the case of a frame formulation, a","reduction in the percentage of the active","substance in the reference biocidal","product may be allowed, and/or an","alteration in percentage composition of","one or more non-active substances,","and/or the replacement of one or more","non-active substances by others","presenting the same or lower risk."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"97","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-98","justification":" The aim is to ensure uniform implementation of the Regulation within Community territory.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 6 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["6a. In accordance with the procedure laid","down in Article 72(2), the Commission","shall provide scientific and technical","guidance for the authorisation of","products, particularly as regards uniform","requirements for data, evaluation","procedures and decisions by the Member","States."],"old":[""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"98","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-99","justification":" It must be ensured that active substances applied in biocidal products are of low-hazard and\n of low-risk.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 point c a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:34:44"},"new":["(ca) it contains active substances which","are not included in Annex I of this","Regulation."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"99","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-100","location":[[" Proposal for a regulation","Article 18 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["1. The applicant for a primary","authorisation shall submit the following","documents together with the application:"],"old":["1. The applicant for an authorisation shall","submit the following documents together","with the application:"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"100","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-101","location":[["Proposal for a regulation","Article 18 \u2013 paragraph 2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["2. The application for primary","authorisation shall be accompanied by the","fees payable under Article 70."],"old":["2. The application for authorisation shall be","accompanied by the fees payable under","Article 70."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"101","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-102","justification":"Once all applications are sent to and validated by the ECHA, the Agency will be the only\nreceiving competent authority. One official language should suffice.","location":[["Proposal for a regulation","Article 18 \u2013 paragraph 3"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["3. The Agency may require that","applications for a national authorisation be","submitted in one of the official languages","of the Member State where that competent","authority is situated."],"old":["3. The receiving competent authority may","require that applications for a national","authorisation be submitted in one or more","of the official languages of the Member","State where that competent authority is","situated."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-103","justification":" This amendment recognises that assistance and guidelines from the Commission can be\n particularly important for SME, which may not have the appropriate resources and\n experience to adapt to the Regulation.","location":[[" Proposal for a regulation","Article 18 \u2013 paragraph 5 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["5a. In accordance with the procedure laid","down in Article 72(2), the Commission","shall provide a standard technical and","legal guide and, in particular, assistance","with authorisation applications in","accordance with Articles 18, 19 and 20,","particularly for SME."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-104","justification":" This amendment is necessary to avoid disseminating confidential data; in point (g), provided\n\nthe manufacturer of the substance is authorised through registration in Annex I, the location\nof the manufacturing site should remain confidential and should not form part of the biocidal\nproduct authorisation.","location":[[" Proposal for a regulation","Article 20 \u2013 paragraph 2 - point e"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["e) qualitative and quantitative composition","in terms of the active substances and non-","active substances, taking into","consideration the concentration limit","values given in Article 16, in so far as","knowledge of these is essential for proper","use of the biocidal product;"],"old":["e) qualitative and quantitative composition","in terms of the active substances and non-","active substances, knowledge of which is","essential for proper use of the biocidal","product;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-105","justification":"In the interests of consistency with the evaluation procedure set out in Article 8(5a).","location":[["Proposal for a regulation","Article 20 \u2013 paragraph 2 \u2013 point g"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["g) manufacturers of the active substances","(names and addresses including location of","manufacturing sites) and registration","number of the active substance, in","accordance with Article 8(5a);"],"old":["g) manufacturers of the active substances","(names and addresses including location of","manufacturing sites);"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"105","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-106","justification":"Reference biocidal products are not necessarily defined by the highest concentration. In\naddition, further to the amendments to Articles 3(1)(p) and 16(6), more than one reference\n\n\n biocidal product may be permitted. The list of accepted variations within a frame formulation\n is already clearly set out in Article 16(6). Reference to this article will ensure a consistent\n approach.","location":[["Proposal for a regulation","Article 20 \u2013 paragraph 3 \u2013 point a"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["a) the reference biocidal product within the","group of products comprising the frame","formulation;"],"old":["a) the reference biocidal product within the","group of products comprising the frame","formulation that has the highest allowed","concentration of the active substances;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-107","justification":" Reference biocidal products are not necessarily defined by the highest concentration. In\n addition, further to the amendments to Articles 3(1)(p) and 16(6), more than one reference\n biocidal product may be permitted. The list of accepted variations within a frame formulation\n is already clearly set out in Article 16(6). Reference to this article will ensure a consistent\n approach.","location":[[" Proposal for a regulation","Article 20 \u2013 paragraph 3 \u2013 point b"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["b) the variations permitted in accordance","with Article 16(6)."],"old":["b) the permitted alteration of the","composition of this reference biocidal","product expressed in percentage of the","non-active substances contained in the","biocidal products which are considered to","belong to that frame formulation;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"107","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-108","justification":"Reference biocidal products are not necessarily defined by the highest concentration. In\naddition, further to the amendments to Articles 3(1)(p) and 16(6), more than one reference\nbiocidal product may be permitted. The list of accepted variations within a frame formulation\nis already clearly set out in Article 16(6). Reference to this article will ensure a consistent\napproach.","location":[[" Proposal for a regulation","Article 20 \u2013 paragraph 3 \u2013 point c"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["deleted"],"old":["c) the non-active substances that may be","substituted in the authorised biocidal","products belonging to that frame","formulation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"108","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-109","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:44"},"new":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment for the renewal, in","accordance with this regulation, of an","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1). A comparative","assessment shall be required for all","biocidal products having the same","purpose when sufficient experience has","been gained in their use and they have","been in use for at least five years."],"old":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"109","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-110","justification":" The aim is to provide a clearer definition of how the comparative assessment should be\n carried out. One element to be taken into consideration is the need for sufficient experience in\n the use of the product. This should be the rule and not the exception.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:45"},"new":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for a renewal","of an authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1). The comparative","assessment must be carried out for all","biocidal products having the same","purpose, when sufficient experience has","been gained in their use and they have","been in use for at least five years."],"old":["1. The receiving competent authority or, in","the case of evaluation of an application for","a Community authorisation, the evaluating","","competent authority shall perform a","comparative assessment as part of the","evaluation of an application for an","authorisation or a renewal of an","authorisation of a biocidal product","containing an active substance that is a","candidate for substitution in accordance","with Article 9(1)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-111","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 1 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["1a. By way of derogation from paragraph","1, a comparative assessment shall not be","required for biocidal products whose use","has been shown to be safe."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"111","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-112","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of a renewal of a Community","authorisation, also to the Commission."],"old":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of evaluation of an application for a","Community authorisation, also to the","Commission."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-113","justification":"The results of the comparative assessment should be forwarded to the Commission only in the\ncase of a renewal of a Community authorisation.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:45"},"new":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of renewal of an application for a","Community authorisation, also to the","Commission."],"old":["2. The results of the comparative","assessment shall be forwarded, without","delay, to the competent authorities of other","Member States and the Agency and, in the","case of evaluation of an application for a","Community authorisation, also to the","Commission."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-114","justification":" The comparative assessment should focus on biocidal products where there is an identified\n risk and a need for alternatives. It is not needed for biocidal products whose use has been\n shown to be safe.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 2 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:45"},"new":["2a. By way of derogation from paragraph","1, a comparative assessment shall not be","required for biocidal products whose use","has been shown to be safe."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"114","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-115","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 3"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["3. The receiving competent authority or, in","the case of a decision on a renewal of a","Community authorisation, the Commission","shall prohibit or restrict the placing on the","market or use of a biocidal product","containing an active substance that is a","candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:","(a) for the uses specified in the application,","other authorised biocidal products already","exist which present significantly lower risk","for human or animal health or the","environment and which prove equally","effective and involve no significant","increase in the risks for any other","parameter;","(b) the biocidal products referred to in","point (a) do not present significant","economic or practical disadvantages;","(c) the chemical diversity of the active","substances is adequate to minimise the","occurrence of resistance in the target","harmful organism."],"old":["3. The receiving competent authority or, in","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product containing an active substance that","is a candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:","(a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention","method already exists which presents","significantly lower risk for human or","","animal health or the environment;","(b) the biocidal product or non-chemical","control or prevention method referred to","in point (a) does not present significant","economic or practical disadvantages;","(c) the chemical diversity of the active","substances is adequate to minimise the","occurrence of resistance in the target","harmful organism."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"115","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-116","justification":" The use of a comparative assessment should be confined to the renewal of authorisations of\n those biocidal products which contain active substances which are candidates for substitution\n in accordance with Article 9 of the Regulation. It is not appropriate to carry out comparative\n assessments between biocidal products and non-chemical control measures which have not\n been subject to the same efficiency and risk assessments.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:45"},"new":["3. The receiving competent authority or, in","the case of a decision on a renewal of a","Community authorisation, the Commission","shall prohibit or restrict the placing on the","market or use of a biocidal product","containing an active substance that is a","candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:","a) for the uses specified in the application,","another authorised biocidal product already","exists which presents significantly lower","risk for human or animal health or the","environment and which proves equally","effective and involves no significant","increase in the risks for any other","parameter;","b) the biocidal product referred to in point","(a) does not present significant economic","or practical disadvantages;","c) the chemical diversity of the active","substances is adequate to minimise the","occurrence of resistance in the target","harmful organism."],"old":["3. The receiving competent authority or, in","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product containing an active substance that","is a candidate for substitution where the","comparative assessment weighing up the","risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:","a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention","method already exists which presents","significantly lower risk for human or","animal health or the environment;","b) the biocidal product or non-chemical","control or prevention method referred to","in point (a) does not present significant","","economic or practical disadvantages;","c) the chemical diversity of the active","substances is adequate to minimise the","occurrence of resistance in the target","harmful organism."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"116","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-117","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 3 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["3a. The Commission shall adopt the","measures and procedures required to","define how a comparative assessment","should be carried out for biocidal","products in accordance with paragraph 3.","These measures shall define the criteria","and algorithms to be used for a","comparative assessment so as to ensure","uniform application throughout the","Community."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"117","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-118","justification":"In the interests of uniform application of the comparative assessment of biocidal products, the\nCommission should draw up implementing measures.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 4"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:45"},"new":["4. The Commission shall adopt","implementing measures which specify the","procedure required to define the","application for comparative assessment","for biocidal products in accordance with","the provisions of paragraph 3. These","measures shall define the criteria and","algorithms to be used for the comparative","assessments so as to ensure uniform","application throughout the Community.","These measures shall be adopted in","accordance with the procedures laid down","in Article 72(3)."],"old":["4. By way of derogation from paragraph","1, a biocidal product containing an active","substance that is a candidate for","substitution shall be authorised without","comparative assessment in cases where it","is necessary to acquire experience first","through using that product in practice."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"118","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-119","justification":"The ECHA should perform the initial validation of all applications throughout the\nCommunity, so that the evaluating competent authorities can concentrate on the actual\nassessment of applications. Currently, where evaluating competent authorities consider both\nthe administrative and scientific aspects of applications, there have been inconsistencies in\ntheir approach. The Agency must abide by the same deadlines as those laid down under\nREACH (Article 20) for validating the application.","location":[["Proposal for a regulation","Article 21 a (new) \u2013 to be inserted at the end of Chapter IV"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["Article 21a","1. The person responsible for the placing","of a biocidal product on the market, or his","representative, shall submit an application","for a national authorisation or an","application for a Community","authorisation to the Agency and inform","the Agency of the name of the competent","authority of the Member State of his","choice which shall be responsible for the","evaluation of the application (hereinafter","referred to as 'the evaluating competent","authority').","The Agency shall, within three weeks","after the receipt of the application, notify","the evaluating competent authority that","the application is available in the Agency","database.","2. Within three weeks after the receipt of","an application, the Agency shall validate","the application if it complies with the","following requirements:","a) the information referred to in Article","18 has been submitted;","(b) it is accompanied by the fees payable","under Article 70.","The validation shall not include an","assessment of the quality or the adequacy","of any data or justifications for the","adaptation of data requirements","submitted.","3. If the Agency considers that the","application is incomplete, it shall inform","the applicant as to what additional","information is required for the validation","of the application and shall set a","reasonable time limit for the submission","of that information.","The Agency shall, within three weeks","from the receipt of the additional","information, determine whether the","additional information submitted is","sufficient to validate the application.","The Agency shall reject the application if","the applicant fails to submit the","information required within the deadline","and inform the applicant and the","evaluating competent authority thereof.","In such cases a part of the fee paid to the","Agency in accordance with Article 70","shall be reimbursed.","4. An appeal may be brought, in","accordance with Article 67, against","Agency decisions under the third","subparagraph of paragraph 3.","5. If the Agency, on the basis of the","validation made pursuant to paragraph 2,","considers that the application is complete,","it shall without delay inform the applicant","and the evaluating competent authority","thereof."],"old":["","","",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"119","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-120","justification":" In accordance with new Article 22, the submission and validation of applications for national\n and Community authorisations are to be governed by the same rules. Article 22 of the\n original proposal is therefore superfluous.","location":[["Proposal for a regulation","Article 22"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["Article 22 deleted"],"old":["","Submission and validation of application","1. Within one month after the receipt of","an application for a national","authorisation referred to in Article 15, the","receiving competent authority shall","validate the application if it complies with","the following requirements:","a) the information referred to in Article","18 has been submitted;","b) it is accompanied by the fees payable","under Article 70.","","","The validation shall not include an","assessment of the quality or the adequacy","of any data or justifications for the","adaptation of data requirements","submitted.","2. If the receiving competent authority","considers that the application is","incomplete, it shall inform the applicant","as to what additional information is","required for the validation of the","application and shall set a reasonable","time limit for the submission of that","information.","The receiving competent authority shall,","within one month from the receipt of the","additional information, determine","whether the additional information","submitted is sufficient to validate the","application.","The receiving competent authority shall","reject the application if the applicant fails","to submit the requested information","within the deadline and inform the","applicant thereof.","3. If the receiving competent authority, on","basis of the validation made pursuant to","paragraph 1, considers that the","application is complete, it shall without","delay inform the applicant thereof."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"120","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-121","justification":"Given the fact that, before being included in Annex I to the regulation, active substances used\nin biocidal products are already subject to lengthy assessment, it is felt that the period of\ntwelve months provided for in the proposal for a regulation is too long for the authorisation\nof a biocidal product based on authorised active substances.","location":[["Proposal for a regulation","Articolo 23 \u2013 paragraph 1"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:45"},"new":["1. The receiving competent authority shall,","within six months after the validation","referred to in Article 22, decide on the","application in accordance with Article 16."],"old":["1. The receiving competent authority shall,","within twelve months after the validation","referred to in Article 22, decide on the","application in accordance with Article 16."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"121","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-122","justification":"The active substances used in biocidal products will already have been fully assessed prior to\ninclusion in Annex I to the regulation. It is therefore unnecessary to provide for such a long\nperiod of assessment for the authorisation of a biocidal product based on authorised active\nsubstances.","location":[["Proposal for a regulation","Article 23 \u2013 paragraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["1. The receiving competent authority shall,","within six months after the validation","referred to in Article 22, decide on the","application in accordance with Article 16."],"old":["1. The receiving competent authority shall,","within twelve months after the validation","referred to in Article 22, decide on the","application in accordance with Article 16."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"122","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-123","justification":" To avoid unnecessary duplication of effort.","location":[[" Proposal for a regulation","Article 23 \u2013 paragraph 2 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["2a. If the ingredients contained in the","biocidal product have already been","registered for use in biocidal products in","accordance with Regulation No","1907/2006, the evaluating competent","authority shall not carry out a further","assessment."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"123","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-124","justification":" Unless there are new data to be assessed, eighteen months are not required to renew a\n product authorisation. A twelve month period is more appropriate.","location":[[" Proposal for a regulation","Article 24 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:45"},"new":["1. The authorisation holder or his","representative shall submit an application","for renewal of a national authorisation to","the receiving competent authority at least","twelve months before the expiry date of the","authorisation."],"old":["1. The authorisation holder or his","representative shall submit an application","for renewal of a national authorisation to","the receiving competent authority at least","eighteen months before the expiry date of","the authorisation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"124","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-125","justification":"It is felt that twelve months is a sufficient period for submitting an application for renewal of\nan authorisation.","location":[["Proposal for a regulation","Article 24 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["1. The authorisation holder or his","representative shall submit an application","for renewal of a national authorisation to","the receiving competent authority at least","twelve months before the expiry date of the","authorisation."],"old":["1. The authorisation holder or his","representative shall submit an application","for renewal of a national authorisation to","the receiving competent authority at least","eighteen months before the expiry date of","the authorisation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"125","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-126","justification":"In the case of a mutual recognition procedure, a single authorisation number should be used\nin all Member States. The Commission should be responsible for adopting implementing\nmeasures to introduce a single number.","location":[["Proposal for a regulation","Article 25 \u2013 paragraph 5 \u2013 subparagraph 1 a (new)"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["In the event of mutual recognition, a","single authorisation number shall be used","in all Member States involved."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"126","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-127","justification":" In the case of a mutual recognition procedure, a single authorisation number should be used\n in all Member States. The Commission should be responsible for adopting implementing\n measures to introduce a single number.","location":[[" Proposal for a regulation","Article 25 \u2013 paragraph 5 a (new)"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["5a. In the case of mutual recognition","procedures, the Commission shall adopt","implementing measures laying down the","criteria and procedures for assigning a","single authorisation number in all","Member States concerned."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"127","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-128","justification":" Provision is needed in the regulation for a deadline for settling disputes between Member\n States. A period of three months is thought to be adequate to enable the Commission to draw\n\nup a proposal for a decision to refuse to recognise or to restrict the authorisation.","location":[[" Proposal for a regulation","Article 27 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["After consulting the applicant, the","Commission shall adopt a decision on","whether the grounds set out by the","competent authority justify refusal to","recognise, or restriction of, the national","authorisation in accordance with the","procedure referred to in Article 72(3)."],"old":["The Commission shall adopt a decision on","whether the grounds set out by the","competent authority justify refusal to","recognise, or restriction of, the national","authorisation in accordance with the","procedure referred to in Article 72(3)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"128","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-129","justification":"The legislative text must clearly establish the time limit needed to have an efficient procedure\nfor resolving disputes between Member States. Three months constitutes appropriate timing\nfor the Commission to make a proposal for a decision supporting the refusal to recognise, or\nrestriction of, authorisation.","location":[["Proposal for a regulation","Article 27 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:46"},"new":["The Commission shall, after consultation","with the applicant, adopt a decision on","whether the grounds set out by the","competent authority justify refusal to","recognise, or restriction of, the national","authorisation in accordance with the","procedure referred to in Article 72(3)."],"old":["The Commission shall adopt a decision on","whether the grounds set out by the","competent authority justify refusal to","recognise, or restriction of, the national","authorisation in accordance with the","procedure referred to in Article 72(3)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"129","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-130","justification":" The regulation should set out the time period for the resolution of disputes between Member\n States. Three months would seem to be appropriate timing time for the Commission to draw\n up a proposal for a decision on the refusal, or restriction, of authorisation.","location":[["Proposal for a regulation","Article 27 \u2013 paragraph 1 \u2013 subparagraph 2 a (new)"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. Should the","Commission ask the Agency for an","opinion under the procedure set out in","Article 30, the three-month period shall be","suspended until the Agency has forwarded","its opinion."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"130","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-131","justification":" The legislative text must clearly establish the time limit needed to have an efficient procedure\n for resolving disputes between Member States. Three months constitutes appropriate timing\n for the Commission to make a proposal for a decision supporting the refusal to recognise, or\n restriction of, authorisation.","location":[[" Proposal for a regulation","Article 27 \u2013 paragraph 1 \u2013 subparagraph 2 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:46"},"new":["Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. Should the","Commission ask the Agency for an","opinion under the procedure set out in","Article 30, the three-month period shall be","suspended until the Agency has forwarded","its opinion."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"131","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-132","justification":"The legislative text must clearly establish the time limit needed to have an efficient procedure\nfor resolving disputes between Member States. Three months constitutes appropriate timing\nfor the Commission to make a proposal for a decision supporting the refusal to recognise, or\nrestriction of, authorisation.","location":[[" Proposal for a regulation","Article 28 \u2013 paragraph 9 \u2013 subparagraph 2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:46"},"new":["The Commission shall, after consultation","with the applicant, adopt a decision on","whether the grounds set out by the","competent authority justify refusal to","recognise, or restriction of, the national","authorisation in accordance with the","procedure referred to in Article 72(3)."],"old":["The Commission shall adopt a decision on","","","whether the grounds set out by the","competent authority justify refusal to","recognise, or restriction of, the national","authorisation in accordance with the","procedure referred to in Article 72(3)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"132","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-133","justification":"The legislative text must clearly establish the time limit needed to have an efficient procedure\nfor resolving disputes between Member States. Three months constitutes appropriate timing\nfor the Commission to make a proposal for a decision supporting the refusal to recognise, or\nrestriction of, authorisation.","location":[["Proposal for a regulation","Article 28 \u2013 paragraph 9 \u2013 subparagraph 3 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:46"},"new":["Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. Should the","Commission ask the Agency for an","opinion under the procedure set out in","Article 30, the three-month period shall be","suspended until the Agency has forwarded","its opinion."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"133","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-134","justification":" The regulation should set out the time period for the resolution of disputes between Member\n States. Three months would seem to be appropriate timing time for the Commission to draw\n up a proposal for a decision on the refusal, or restriction, of authorisation.","location":[[" Proposal for a regulation","Article 29 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["The Commission shall, after consultation","with the applicant, adopt a decision on the","proposed adjustment of the conditions of","the national authorisation to local","circumstances in accordance with the","procedure referred to in Article 72(3). The","competent authority of the concerned","Member State shall without delay adopt all","appropriate measures to comply with that","decision."],"old":["The Commission shall adopt a decision on","the proposed adjustment of the conditions","of the national authorisation to local","circumstances in accordance with the","procedure referred to in Article 72(3). The","competent authority of the concerned","Member State shall without delay adopt all","appropriate measures to comply with that","decision."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"134","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-135","justification":"The legislative text must clearly establish the time limit needed to have an efficient procedure\nfor resolving disagreements between Member States. Three months constitutes appropriate\ntiming for the Commission to make a proposal for a decision supporting the refusal to\nrecognise, or restriction of, authorisation.","location":[[" Proposal for a regulation","Article 29 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:46"},"new":["The Commission shall, after consultation","with the applicant, adopt a decision on the","proposed adjustment of the conditions of","the national authorisation to local","circumstances in accordance with the","procedure referred to in Article 72(3). The","competent authority of the concerned","Member State shall without delay adopt all","appropriate measures to comply with that","decision."],"old":["The Commission shall adopt a decision on","the proposed adjustment of the conditions","of the national authorisation to local","circumstances in accordance with the","procedure referred to in Article 72(3). The","competent authority of the concerned","Member State shall without delay adopt all","appropriate measures to comply with that","decision."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"135","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-136","location":[["Proposal for a regulation","Article 29 \u2013 paragraph 2 \u2013 subparagraph 2 a (new)"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. Should the","Commission ask the Agency for an","opinion under the procedure set out in","Article 30, the three-month period shall be","suspended until the Agency has forwarded","its opinion.","Or. it","Justification."],"old":["","","","","The regulation should set out the time period for the resolution of disputes between Member","States. Three months would seem to be appropriate timing time for the Commission to draw","up a proposal for a decision on the refusal, or restriction, of authorisation."],"peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"136","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-137","justification":" The legislative text must clearly establish the time limit needed to have an efficient procedure\n for resolving disagreements between Member States. Three months constitutes appropriate\n timing for the Commission to make a proposal for a decision supporting the refusal to\n recognise, or restriction of, authorisation.","location":[["Proposal for a regulation","Article 29 \u2013 paragraph 2 \u2013 subparagraph 2 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:46"},"new":["Within three months of receiving the","notification, the Commission shall make a","proposal for a decision. Should the","Commission ask the Agency for an","opinion under the procedure set out in","Article 30, the three-month period shall be","suspended until the Agency has forwarded","its opinion."],"old":["",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"137","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-138","justification":" The Community authorisation should be open to all product categories and products\n containing existing active substances. On the one hand, this will markedly reduce the\n administrative burden both on the applicant and on the Member State. On the other hand, this\n extension in scope should not overburden the system, since the number of active substances\n included in Annex I will gradually diminish as the review programme proceeds. The ECHA\n should conduct the initial validation on all applications.","location":[[" Proposal for a regulation","Article 33"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:46"},"new":["The Community authorisation may be","granted to all biocidal products for which","the use and conditions are substantially","similar."],"old":["1. The Community authorisation may be","granted to the following categories of","biocidal products:","(a) biocidal products containing one or","more new active substances;","b) low-risk biocidal products.","2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","","with scrutiny referred to in Article 72(4)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"138","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-139","justification":" A centralised authorisation system has clear benefits for the functioning of the internal\n market by ensuring consistent assessments and a harmonised implementation of the\n requirements in all Member States, driving best practices and same standards of consumer\n protection across Europe. The Community authorisation procedure should therefore extend to\n all product categories instead of only a small minority of products (low risk biocidal products\n and products with new active substances).","location":[[" Proposal for a regulation","Article 33"]],"meps":[28155],"meta":{"created":"2019-07-03T05:34:46"},"new":["The Community authorisation may be granted","to any category of biocidal products."],"old":["1. The Community authorisation may be","granted to the following categories of biocidal","products:","(a) biocidal products containing one or more","new active substances;","(b) low-risk biocidal products.","2. Following the report of the Commission on","the implementation of this Regulation","referred to in Article 54(4) and in light of the","experience gained with the Community","authorisations, the Commission may add","other categories of biocidal products in","paragraph 1 of this Article.","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"139","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-140","justification":" Introduction of the Community authorisation constitutes a step towards European\n harmonisation of the market in biocidal products. A centralised authorisation system has\n clear benefits for the functioning of the internal market. The Community authorisation should\n be equivalent to the national authorisation procedure. It should remain possible for\n companies placing products on the market in a single or limited number of Member States to\n apply for authorisation directly to a Member State.","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:47"},"new":["1. The Community authorisation may be","granted to all categories of biocidal","products:"],"old":["1. The Community authorisation may be","granted to the following categories of","biocidal products:"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"140","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-141","justification":"Introduction of the Community authorisation constitutes a step towards European\nharmonisation of the market in biocidal products. A centralised authorisation system has\nclear benefits for the functioning of the internal market. The Community authorisation should\nbe equivalent to the national authorisation procedure. It should remain possible for\ncompanies placing products on the market in a single or limited number of Member States to\napply for authorisation directly to a Member State.","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 2"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:47"},"new":["deleted"],"old":["2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"141","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-142","justification":"Under the new Article 22, the submission and validation of applications for national and\nCommunity authorisations are governed by the same rules. This renders superfluous Article\n22 of the original proposal.","location":[["Proposal for a regulation","Article 34"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["Article 34 Deleted"],"old":["","Submission and validation of application","","1. The person responsible for the placing","of a biocidal product on the market, or his","representative, shall submit an application","for a Community authorisation to the","Agency and inform the Agency of the","name of the competent authority of the","Member State of his choice which shall be","responsible for the evaluation of the","application (hereinafter referred to as 'the","evaluating competent authority').","","The Agency shall, within one month after","the receipt of the application, notify the","","evaluating competent authority that the","application is available in the Agency","database.","","2. Within two months after the receipt of","an application, the Agency shall validate","the application if it complies with the","following requirements:","","a) the information referred to in Article","18 has been submitted;","","b) it is accompanied by the fees payable","under Article 70.","","The validation shall not include an","assessment of the quality or the adequacy","of any data or justifications for the","adaptation of data requirements","submitted.","","3. If the Agency considers that the","application is incomplete, it shall inform","the applicant as to what additional","information is required for the validation","of the application and shall set a","reasonable time limit for the submission","of that information.","","The Agency shall, within two months","from the receipt of the additional","information, determine whether the","additional information submitted is","sufficient to validate the application.","","The Agency shall reject the application if","the applicant fails to complete his","application within the deadline and","inform the applicant and the evaluating","competent authority thereof. In such","cases a part of the fee paid to the Agency","in accordance with Article 70 shall be","reimbursed.","","4. An appeal may be brought, in","accordance with Article 67, against","Agency decisions under the third","subparagraph of paragraph 3.","","","5. If the Agency, on basis of the validation","made pursuant to paragraph 2, considers","that the application is complete, it shall","without delay inform the applicant and","the evaluating competent authority","thereof."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"142","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-143","justification":"Aims to avoid an unnecessary duplication of effort.","location":[["Proposal for a regulation","Article 35 \u2013 paragraph 1 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["1a. Should the ingredients contained in","the biocidal product have already been","registered, in conformity with Regulation","No 1907/2006, for use in biocidal","products, the evaluating competent","authority shall not duplicate that","evaluation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"143","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-144","justification":" Nine months is too long a period for the Agency to prepare and submit an opinion based on\n an already-available evaluation conducted by the evaluating competent authority. Three\n months is a more appropriate length of time.","location":[[" Proposal for a regulation","Article 35 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["3. Within three months from the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product."],"old":["3. Within nine months from the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"144","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-145","justification":" The nine months granted the Agency to prepare and submit to the Commission an opinion on\n the authorisation is too long. Three months is a more appropriate length of time, not least\n because the Agency\u2019s opinion is drawn up on the basis of an evaluation already conducted by\n the evaluating competent authority.","location":[[" Proposal for a regulation","Article 35 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:47"},"new":["3. Within three months from the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product."],"old":["3. Within nine months from the receipt of","the conclusions of the evaluation, the","Agency shall prepare and submit to the","Commission an opinion on the","authorisation of the biocidal product."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"145","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-146","justification":"This paragraph requires deletion as Community authorisation is being requested for all types\nof biocide.","location":[["Proposal for a regulation","Article 35 \u2013 paragraph 5"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:47"},"new":["deleted"],"old":["5. If the decision referred to in","paragraph 4 refuses to grant a","Community authorisation to a biocidal","product because it does not fulfil the","criteria for a low-risk biocidal product in","accordance with Article 17, the applicant","may apply, if relevant, for a Community","authorisation in accordance with point (a)","of Article 33(1) or a national","authorisation in accordance with Chapter","V."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"146","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-147","justification":" This paragraph becomes superfluous if the amendment to Article 33 is adopted.","location":[["Proposal for a regulation","Article 35 \u2013 paragraph 5"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["deleted"],"old":["5. If the decision referred to in paragraph","4 refuses to grant a Community","authorisation to a biocidal product","because it does not fulfil the criteria for a","low-risk biocidal product in accordance","with Article 17, the applicant may apply, if","relevant, for a Community authorisation","in accordance with point (a) of Article","33(1) or a national authorisation in","","accordance with Chapter V."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"147","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-148","justification":" 12 months would be a more appropriate length of time for the renewal of an authorisation.","location":[[" Proposal for a regulation","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:47"},"new":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 12 months before the","expiry date of the authorisation."],"old":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 18 months before the","expiry date of the authorisation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"148","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-149","justification":"Unless there is new data to evaluate, 18 months is unnecessarily long for the renewal of a\nproduct authorisation. 12 months is a more appropriate length of time.","location":[[" Proposal for a regulation","Article 36 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 12 months before the","expiry date of the authorisation."],"old":["1. The authorisation holder or his","representative shall submit an application","for renewal of a Community authorisation","to the Agency at least 18 months before the","expiry date of the authorisation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"149","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-150","location":[["Proposal for a regulation","Chapter VIIa (new) \u2013 Article 37a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["CHAPTER VIIa","Article 37a","(1) Holders of, or applicants for, a","primary authorisation may submit to the","Agency a request for a duplicate","authorisation for the same biocidal","product.","(2) Applicants for a duplicate","authorisation must forward the following","items and information with their","application:","(a) the authorisation number for the","primary authorisation or, in the case of","an application for primary authorisation,","the application number;","(b) the qualitative and quantitative","composition in terms of active substances","and non-active substances, taking into","account the concentration limits given in","Article 16, insofar as knowledge of this is","essential for appropriate use of the","biocidal product;","(c) the application doses and instructions","for use;","(d) categories of users;","(3) The Agency shall validate the","application on the basis of the rules laid","down in Article 22.","(4) If the Agency considers the","application to be complete, on the basis of","the validation under paragraph 3, it shall","inform forthwith the applicant, the","evaluating competent authority granting","the primary authorisation or, in the case","of duplication of a Community","authorisation, the Commission.","(5) In the case of existing primary","authorisations, the evaluating competent","authority or, in the case of duplication of","a Community authorisation, the","Commission, shall decide on the","application within one month of the","validation. In the case of pending","applications for authorisation, the","evaluating competent authority or, in the","case of duplication of a Community","authorisation, the Commission, must","decide on the application within one","month of the granting of the primary","authorisation.","(6) Should additional information appear","to be required to enable the identity of the","biocidal product to be established, the","evaluating competent authority or, in the","case of duplication of a Community","authorisation, the Commission, shall","request that information from the","applicant. The one-month period referred","to in paragraph 5 shall be suspended from","the date of issue of the request until the","date the information is received.","(7) As soon as the evaluating competent","authority or, in the case of duplication of","a Community authorisation, the","Commission, has authorised the","duplication of a primary authorisation, it","shall assign to it a specific authorisation","number and record the administrative act","in the Community Register of Biocidal","Products.","(8) Notwithstanding the information","submitted pursuant to paragraph 2, in the","case of duplicate authorisations the terms","and conditions for the placing on the","market and use of the biocidal product","agreed in the primary authorisation must","be applied."],"old":["","","",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"150","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-151","location":[["Proposal for a regulation","Article 37b (new \u2013 second article in the new Chapter VIIa)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["Article 37b","(1) An additional authorisation may be","granted on the basis of a primary","authorisation.","(2) Applicants wishing to apply for an","additional authorisation must send the","application for authorisation to the","Agency.","(3) Applicants for an additional","authorisation must forward the following","items and information with their","application:","(a) the authorisation number for the","primary authorisation or, in the case of a","pending application, the application","number;","(b) the name and address of the applicant;","(c) written approval from the holder of the","authorisation;","(d) the qualitative and quantitative","composition in terms of active substances","and non-active substances, taking into","account the concentration limits given in","Article 16, insofar as knowledge of this is","essential for appropriate use of the","biocidal product;","(e) the application doses and instructions","for use;","(f) categories of users;","(4) The Agency shall validate the","application on the basis of the rules laid","down in Article 22.","(5) If the Agency considers the","application to be complete, on the basis of","the validation under paragraph 4, it shall","inform forthwith the applicant, the","evaluating competent authority granting","the primary authorisation or, in the case","of duplication of a Community","authorisation, the Commission.","(6) In the case of existing primary","authorisations, the evaluating competent","authority or, in the case of addition of a","Community authorisation, the","Commission, shall decide on the","application within one month of the","validation. In the case of pending","applications for authorisation, the","evaluating competent authority or, in the","case of addition of a Community","authorisation, the Commission, must","decide on the application within one","month of the granting of the primary","authorisation.","(7) Should additional information appear","to be required to enable the identity of the","biocidal product to be established, the","evaluating competent authority or, in the","case of addition of a Community","authorisation, the Commission, shall","request that information from the","applicant. The one-month period referred","to in paragraph 5 shall be suspended from","the date of issue of the request until the","date the information is received.","(8) As soon as the evaluating competent","authority or, in case of addition of a","Community authorisation, the","Commission, has authorised the addition","of a primary authorisation, it shall assign","to it a specific authorisation number and","record the administrative act in the","Community Register of Biocidal Products.","(9) Notwithstanding the information","submitted pursuant to paragraph 3, in the","case of additional authorisations the","terms and conditions for the placing on","the market and use of the biocidal product","agreed in the primary authorisation must","be applied."],"old":["","","","",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"151","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-152","justification":"Notification of any change in the origin of an active substance used in a biocidal product is\nbeing requested as this can have an impact on the safety of the product.","location":[["Proposal for a regulation","Article 38 \u2013 paragraph 1 \u2013 point c a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["(ca) changes in the origin or composition","of the active substance."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"152","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-153","location":[["Proposal for a regulation","Article 39 - paragraph 3 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:47"},"new":["3a. The cancellation or amendment of a","primary authorisation shall apply to","duplicate and additional authorisations","based on that authorisation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"153","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-154","location":[[" Proposal for a regulation","Article 40 - paragraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:48"},"new":["The competent authority that has granted","an authorisation shall cancel the","authorisation at the request of its holder,","who shall state the reasons for such request","If such a request concerns a duplicate or","additional Community authorisation, it","shall be submitted to the Agency."],"old":["The competent authority that has granted","the national authorisation or in case of","Community authorisation, the","Commission, shall cancel the authorisation","at the request of its holder, who shall state","the reasons for such request. If such a","request concerns a Community","authorisation, it shall be submitted to the","Agency."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"154","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-155","location":[[" Proposal for a regulation","Article 41 - paragraph 2 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:48"},"new":["2a. The amendment of a primary","authorisation at the request of the holder","of the primary authorisation shall apply to","duplicate and additional authorisations","based on that authorisation."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"155","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-156","location":[["Proposal for a regulation","Article 42 \u2013 paragraph 1 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:48"},"new":["The criteria and procedures referred to in","the first paragraph of this article shall be","based, non-exclusively, on the following","principles for which a simplified","notification procedure has been","requested:","(a) administrative changes to the","authorisation;","(b) changes to the biocidal product within","the range permitted under an existing","authorised frame formulation;","(c) placing on the market of a new","biocidal product within the limits of an","existing authorised frame formulation;","(d) changes in a biocidal product which","do not adversely alter the level of the risk","or efficacy of the product."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"156","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-157","justification":" Parallel trade should be confined to identical products which have the same specifications\n and contain the same active substances and co-formulants.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:48"},"new":["The application shall be accompanied by","all the information necessary to","demonstrate that the biocidal product is","identical to the reference product as","defined in paragraph 3."],"old":["The application shall be accompanied by","all the information necessary to","demonstrate that the biocidal product is","substantially identical to the reference","product as defined in paragraph 3."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"157","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-158","justification":" Parallel trade should be confined to identical products which have the same specifications\n and contain the same active substances and co-formulants.","location":[[" Proposal for a regulation","Article 44 \u2013 paragraph 3"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:48"},"new":["3. A biocidal product shall be considered","as identical to the reference product if all","the following conditions are met:","a) it has been manufactured by the same","company or one of its associate","companies or under licence, following the","same production process;","b) it is the same with regard to the","specifications, the active substances","present and the type of formulation;","c) it is either the same or equivalent, as","regards the co-formulants it contains and","the format, materials and form of its","packaging, in terms of the potential","adverse impact on the safety of the product","with regard to human or animal health or","the environment."],"old":["3. A biocidal product shall be considered","as substantially identical to the reference","product if one of the following conditions","is met:","","a) the source of the active substances it","contains is the same in terms of","manufacturer and location of the","production plant;","","b) it is either the same or similar with","regard to the non-active substances present","and the type of formulation;","","c) it is either the same or equivalent in","terms of the potential adverse impact on","the safety of the product with regard to","human or animal health or the","environment."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"158","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-159","justification":"The application for a parallel trade licence must also contain the number of registrations for\nthe active substances.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 4 \u2013 point a a new"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:48"},"new":["aa) the number of registrations of the","active substances contained in the product","and a letter of access in accordance with","Article 50 from the relevant applicant","under Chapter II of this Regulation;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"159","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-160","justification":"The application for a parallel trade licence must also contain information relating to the\nletter of access, as indicated in Article 50.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 4 \u2013 point c"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:48"},"new":["c) name and address of the authorisation","holder in the Member State of origin and a","letter of access in accordance with Article","50 from the holder of the authorisation"],"old":["c) name and address of the authorisation","holder in the Member State of origin"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"160","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-161","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:48"},"new":["1. By way of derogation from Article 15,","an experiment or a test for the purposes of","research or development, including","product- and process-oriented research","and development activities, involving the","placing on the market of an unauthorised","biocidal product or an active substance","intended exclusively for use in a biocidal","product may only take place in the case of","scientific research and development or in","the case of product and process-oriented","research and development, and under the","conditions laid down in the second and","third subparagraphs.","In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data and quantities","supplied, and shall compile a dossier","containing all available data on possible","effects on human or animal health or","impact on the environment. The persons","concerned shall, if requested, make this","information available to the competent","authority."],"old":["1. By way of derogation from Article 15,","an experiment or a test for the purposes of","research or development involving the","placing on the market of an unauthorised","biocidal product or an active substance","intended exclusively for use in a biocidal","product may only take place in the case of","scientific research and development or in","the case of product and process-oriented","research and development, and under the","conditions laid down in the second and","third subparagraphs.","In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data, quantities","supplied and the names and addresses of","those persons receiving the biocidal","product or active substance, and shall","compile a dossier containing all available","data on possible effects on human or","animal health or impact on the","environment. The persons concerned shall,","if requested, make this information","available to the competent authority.","In the case of product and process-","oriented research and development, the","person who intends to carry out the","experiment or the test shall, prior to the","placing of the biocidal product or the","active substance on the market, notify the","information required in the second","subparagraph to the competent authority","","of the Member State where the placing on","the market occurs."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"161","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-162","justification":"The biocidal product is intended to protect and improve the properties of the treated article.\nIn many cases, the treated article is not intended to release an active biocidal product.\nInformation on the biocidal product and the biocidal active substance does not provide\nappropriate safety information for consumers in cases where the active substance or biocidal\nproduct is not intended to be released by the treated article or material.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:48"},"new":["a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials, if significant, and of the active","principles intended for release by the","article or material treated, under normal","and foreseeable conditions of use;"],"old":["a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"162","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-163","justification":" The labelling provisions for treated articles and materials should not lead to requirements for\n unnecessary information and should not overlap with existing requirements under sectoral\n legislation. Existing sectoral legislation and their information requirements (e.g. labelling,\n Safety Data Sheets) should always be taken into consideration. For example under the\n Detergent Regulation, the INCI name of the preservative must be labelled on products for the\n general public and reported in the SDS for Institutional and Industrial products. Hence any\n additional labelling requirements are unnecessary.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a"]],"meps":[28155],"meta":{"created":"2019-07-03T05:34:48"},"new":["(a) the name, using wherever possible","common nomenclature (e.g. INCI), of all","active substances that were used to treat the","article or materials or that were incorporated","in the articles or materials, where relevant,","and of all active substances which are","intended to be released under normal or","foreseeable conditions of use from the","treated article or material, unless labelling","requirements or alternative means to meet","information requirements already exist","under sector-specific legislation;"],"old":["(a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials;",""],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"163","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-164","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:48"},"new":["a) the name, using wherever possible a","common nomenclature (e.g. INCI), of all","active substances that were used to treat the","article or materials or that were","incorporated in the articles or materials","where relevant, and of all active","substances intended to be released by the","article or material treated in normal or","foreseeable conditions of use, unless this","is already required under labelling rules","or alternative ways of satisfying","information requirements already existing","in specific sectoral legislation;"],"old":["a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"164","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-165","justification":"The labelling provisions for treated articles and materials should not lead to requirements for\nunnecessary information and should not overlap with existing requirements under sectoral\nlegislation. Existing sectoral legislation and their information requirements (e.g. labelling,\nSafety Data Sheets) should always be taken into consideration. For example under the\nDetergent Regulation, the INCI name of the preservative must be labelled on products for the\ngeneral public and reported in the SDS for Institutional and Industrial products. Hence any\nadditional labelling requirements are unnecessary.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point b"]],"meps":[28155],"meta":{"created":"2019-07-03T05:34:48"},"new":["(b) where relevant, the biocidal property","attributed to treated articles;"],"old":["(b) where relevant, the biocidal property","attributed to treated articles or materials;"],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"165","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-166","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point b"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:48"},"new":["b) where relevant, the biocidal property","attributed to treated articles;"],"old":["b) where relevant, the biocidal property","attributed to treated articles or materials;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"166","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-167","justification":" The labelling provisions for treated articles and materials should not lead to requirements for\n unnecessary information and should not overlap with existing requirements under sectoral\n legislation. Existing sectoral legislation and their information requirements (e.g. labelling,\n Safety Data Sheets) should always be taken into consideration. For example under the\n Detergent Regulation, the INCI name of the preservative must be labelled on products for the\n general public and reported in the SDS for Institutional and Industrial products. Hence any\n additional labelling requirements are unnecessary.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point c"]],"meps":[28155],"meta":{"created":"2019-07-03T05:34:48"},"new":["deleted"],"old":["(c) the authorisation number of all biocidal","products that were used for the treatment or","were incorporated in the articles or","materials;"],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"167","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-168","meps":[36392],"meta":{"created":"2019-07-03T05:34:48"},"new":["deleted"],"old":["c) the authorisation number of all","biocidal products that were used for the","treatment or were incorporated in the","articles or materials;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"168","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-169","justification":"The biocidal product is intended to protect and improve the properties of the treated article.\nIn many cases, the treated article is not intended to release an active biocidal product.\nInformation on the biocidal product and the biocidal active substance does not provide\nsuitable safety information for consumers where the active substance or biocidal product is\nnot intended to be released by the treated article or material.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point c"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:49"},"new":["deleted"],"old":["c) the authorisation number of all","","","biocidal products that were used for the","treatment or were incorporated in the","articles or materials;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"169","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-170","justification":"The biocidal product is intended to protect and improve the properties of the treated article.\nIn many cases, the treated article is not intended to release an active biocidal product.\nInformation on the biocidal product and the biocidal active substance does not provide\nsuitable safety information for consumers where the active substance or biocidal product is\nnot intended to be released by the treated article or material.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:49"},"new":["(d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product where relevant, and","for all active substances intended to be","released by the article or material treated","in normal or foreseeable conditions of","use."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"170","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-171","justification":" The biocidal product is intended to protect and improve the properties of the treated article.\n In many cases, the treated article is not intended to release an active biocidal product.\n Information on the biocidal product and the biocidal active substance does not provide\n suitable safety information for consumers where the active substance or biocidal product is\n not intended to be released by the treated article or material.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 subparagraphs 2 and 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:49"},"new":["The labelling shall be clearly visible, easily","legible, appropriately durable and printed","on the article or material, on the","packaging, on the instructions for use or on","the warranty of the treated article or","material."],"old":["The labelling shall be clearly visible, easily","legible and appropriately durable.","Where this is necessary because of the","size or the function of the treated article","or material, the labelling shall be printed","on the packaging, on the instructions for","use or on the warranty of the treated article","or material."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"171","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-172","justification":"The labelling provisions for treated articles and materials should not lead to requirements for\nunnecessary information and should not overlap with existing requirements under sectoral\nlegislation. Existing sectoral legislation and their information requirements (e.g. labelling,\nSafety Data Sheets) should always be taken into consideration. For example under the\nDetergent Regulation, the INCI name of the preservative must be labelled on products for the\ngeneral public and reported in the SDS for Institutional and Industrial products. Hence any\nadditional labelling requirements are unnecessary.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[28155],"meta":{"created":"2019-07-03T05:34:49"},"new":["(d) only for treated articles and where","relevant, any hazard statement or","precautionary statement set out in the","authorisation for the biocidal product."],"old":["(d) any hazard statement or precautionary","statement set out in the authorisation for the","biocidal product."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"172","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-173","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:49"},"new":["d) solely in the case of treated articles","and where appropriate, any hazard","statement or precautionary statement set","out in the authorisation for the biocidal","product."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"173","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sajjad Karim","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-174","justification":" It should be clarified that treated articles and materials, as with other products, should\n always be labelled in the national language or languages of the Member State on whose\n market the product is placed. (The rapporteur has amended his proposed Amendment 37 of\n his draft opinion to take account of Member States with more than one national language.)","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28481],"meta":{"created":"2019-07-03T05:34:49"},"new":["The labelling shall be clearly visible, easily","legible, appropriately durable and in the","national language or languages of the","Member State on whose market the","treated article or material is to be placed."],"old":["The labelling shall be clearly visible, easily","legible and appropriately durable."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"174","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-175","justification":" Any person placing articles or materials treated with biocides on the market should also have\n a letter of certification listing all the biocides which have been used in the articles and\n materials.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 a (new)"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:49"},"new":["2a. The person responsible for placing","treated articles or materials on the market","shall have a letter of certification issued","by the holder of the authorisation in","respect of all biocidal products that have","been used for the treatment or that have","been inserted into the articles or","materials."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"175","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-176","justification":"The first applicant is not necessarily the data owner. Provision should also be made for cases\nin which a second applicant or company is or becomes joint owner of data as a result of the\nsharing or joint compilation of the data.","location":[[" Proposal for a regulation","Article 48 \u2013 paragraph 1 \u2013 point a"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:49"},"new":["a) the subsequent applicant has written","agreement in the form of a letter of access","in accordance with the requirements of","Article 50,"],"old":["a) the subsequent applicant has written","agreement in the form of a letter of access","from the first applicant that he can use","that information,"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"176","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-177","justification":"The first applicant is not necessarily the data owner. Provision should also be made for cases\nin which a second applicant or company is or becomes joint owner of data as a result of the\nsharing or joint compilation of the data.","location":[["Proposal for a regulation","Article 48 \u2013 paragraph 1 \u2013 point b a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:49"},"new":["(ba) the subsequent applicant is also an","owner of the data."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"177","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-178","justification":" The Register should contain every element of information and documents in the list. A\n numerical identification is preferable for every document sent in order to avoid any confusion\n wherever titles or corrections of studies with similar names are sent. There should also be a\n link to the data owner to ensure that ownership rights are respected.","location":[["Proposal for a regulation","Article 48 \u2013 paragraph 4"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:49"},"new":["4. Every element of information in the list","referred to in paragraph 2, identified by a","unique code, shall be entered by the","Agency in the Biocides Data Sharing","Register, including all the identifying","details and linked to the identity of the","first applicant and data owner(s)."],"old":["4. The list referred to in paragraph 2 shall","be entered by the Agency in the Biocides","Data Sharing Register."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"178","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-179","justification":" Directive 98/8/EC did not clearly lay down data protection requirements. The date of\n submission of the dossier may not be the date of submission of all the information. This is why\n each submission should be assigned a date.","location":[[" Proposal for a regulation","Article 49 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:49"},"new":["An individual date of submission shall be","assigned to each document, as identified","by the unique code under Article 48(4)."],"old":["Information protected under Directive","98/8/EC or under this Article or for which","the protection period expired under","Directive 98/8/EC or under this Article","shall not be protected again."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"179","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-180","justification":"Although this article is an improvement on BPD provisions on data protection, there is no\nreason to distinguish between new and existing data. National legislative arrangements only\ncover a small fraction of the BPD market. Where such arrangements exist, some Member\nStates have not in fact applied them. Moreover, the removal of this distinction would bring the\nBPD provisions closer into line with REACH.","location":[[" Proposal for a regulation","Article 49 \u2013 paragraph 4"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:49"},"new":["deleted"],"old":["4. By way of derogation from the first","subparagraph of paragraph 2, the","protection period for information","submitted to a Member State under","","","national systems or practices for the","approval of biocidal products, before it","was submitted for the purposes of","Directive 98/8/EC or of this Regulation,","shall end at the expiry of any remaining","period provided for under national rules","or on 14 May 2014, whichever is the","earlier, unless this information has been","generated after 14 May 2000."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"180","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-181","justification":"Letters of access are generally provided free of charge and are linked to supply agreements.\nThe option of revoking letters of access should agreements be violated, e.g. with alternative\nsupplies, is intended to protect a data owner's investments. As a means of protecting users,\nprovision is made for a period within which it is possible to validate the product authorisation\nin order to obtain a new letter of access.","location":[["Proposal for a regulation","Article 50 \u2013 paragraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:50"},"new":["2. Revocation of a letter of access prior to","its expiry date shall invalidate the","authorisation issued on the basis of the","letter of access in question, unless another","letter of access for an equivalent active","substance is provided by the holder of the","authorisation within four months ."],"old":["2. Revocation of a letter of access prior to","its expiry date shall not affect the validity","of the authorisation issued on the basis of","the letter of access in question."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"181","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-182","justification":" Before studies give rise to the sharing of data, appropriate checks should be carried out on\n technical equivalence. Otherwise, there is no way of establishing whether the data available\n are applicable to the subsequent applicant.","location":[[" Proposal for a regulation","Article 51 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:50"},"new":["Where those tests or studies have already","been submitted in connection with a","previous application, the competent","authority or the Agency shall without delay","assess whether they are technically","equivalent in the light of the reference","source. If the assessment confirms the","fact, the competent authority of the","Agency shall communicate the name and","contact details of the owner of the","information to the prospective applicant."],"old":["Where those tests or studies have already","been submitted in connection with a","previous application, the competent","authority or the Agency shall without delay","communicate the name and contact details","of the owner of the information to the","prospective applicant."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"182","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-183","justification":"Should it be possible to reach an agreement between the two parties, i.e. between the owner\nand the potential applicant, they should inform the Agency thereof. To ensure that the\ncompulsory sharing of data is conducted in a harmonised manner at EU level, the\nCommission should set up an arbitration body. The compilation and use of the information\nmay include the preparation of studies, expenditure for the application for authorisation and\nexperts.","location":[[" Proposal for a regulation","Article 52 \u2013 paragraph 3"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:50"},"new":["3. Where no such agreement is reached two","months after the request was made","according to Article 51(2), either the","owner of the information or the","prospective applicant shall without delay","inform the Agency thereof. Within two","months of being informed about the failure","to reach an agreement, the Agency shall","give the prospective applicant the right to","refer to the tests or studies involving tests","on vertebrate animals. An arbitration body","shall decide on the proportionate share of","the all the costs relating to the compilation","and use of the information that the","prospective applicant shall pay to the data","owner."],"old":["3. Where no such agreement is reached two","months after the request was made","according to Article 51(2), the prospective","applicant shall without delay inform the","Agency and the owner of the information","thereof. Within two months of being","informed about the failure to reach an","agreement, the Agency shall give the","","prospective applicant the right to refer to","the tests or studies involving tests on","vertebrate animals. National courts shall","decide on the proportionate share of the","cost that the prospective applicant shall pay","to the data owner."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"183","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-184","justification":" If an applicant wishes to share data, the similarity and technical equivalence must be\n demonstrated even if the data protection period has not ended.","location":[["Proposal for a regulation","Article 53 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[96890],"meta":{"created":"2019-07-03T05:34:50"},"new":["1. In the case of a biocidal product which","has already been authorised in accordance","with Articles 15, 25 or 28, and where all","periods of protection of information","according to Article 49 have expired, the","receiving competent authority or the","Agency may agree that a subsequent","applicant for authorisation may refer to","data provided by the first applicant and, if","the information protection periods under","Article 49 have not ended, the competent","authority or the Agency may agree that a","subsequent applicant for authorisation","may share the data provided by the first","applicant in accordance with Article 52, in","so far as the subsequent applicant can","provide evidence that the biocidal product","is similar to and its active substances are","technically equivalent to the one formerly","authorised, including degree of purity and","nature of impurities."],"old":["1. In the case of a biocidal product which","has already been authorised in accordance","with Articles 15, 25 or 28, and where all","periods of protection of information","according to Article 49 have expired, the","receiving competent authority or the","Agency may agree that a subsequent","applicant for authorisation may refer to","data provided by the first applicant in so","far as the subsequent applicant can provide","evidence that the biocidal product is","similar to and its active substances are","technically equivalent to the one formerly","authorised, including degree of purity and","nature of impurities.","",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"184","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-185","justification":" Biocidal products which include nanomaterials are covered by the Regulation. But the impact\n of these substances on health and the environment is largely unknown at present. It is vital to\n initiate research without delay in order to assess this impact so that any specific measures\n which may be necessary can be considered.","location":[[" Proposal for a regulation","Article 54 \u2013 paragraph 4 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:34:50"},"new":["4a. No later than 2 years after the entry","into force of this regulation, the","Commission shall submit a report on the","assessment of the risks to human health","and the environment presented by nano-","active and nano-biocidal substances and","on the specific measures which should, if","appropriate, be taken with regard to them."],"orig_lang":"fr","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"185","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-186","justification":"Biocidal products which include nanomaterials are covered by the Regulation. But the impact\nof these substances on health and the environment is largely unknown at present. It is vital to\ninitiate research without delay in order to assess this impact so that any specific measures\nwhich may be necessary can be considered.","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 4 a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:34:50"},"new":["4a. No later than 2 years after the entry","into force of this regulation, the","Commission shall submit a report on the","assessment of the risks to human health","and the environment presented by nano-","active and nano-biocidal substances and","on the specific measures which should, if","appropriate, be taken with regard to them."],"orig_lang":"fr","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"186","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-187","justification":" (dc) Information to be considered confidential because it is commercially sensitive should\n also include the date of issue of an authorisation and the expiry date, doses, instructions for\n use and the location of the manufacturing site of a biocidal product or active substance.","location":[["Proposal for a regulation","Article 55 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:50"},"new":["2. Disclosure of the following information","shall be deemed to undermine the","protection of the commercial interests of","the concerned person and may not be","disclosed publicly:","a) details of the full composition of a","biocidal product;","b) the precise use, function or application","of a substance or mixture;","c) the precise tonnage of the substance or","mixture manufactured or placed on the","market;","d) links between a manufacturer of an","active substance and the person responsible","for the placing of a biocidal product on the","market or between the person responsible","for the placing of a biocidal product on the","market and the distributors of the product;","(da) manufacturers of the active","substances (names and addresses","including location of manufacturing","sites);","(db) the location of a biocidal product's","manufacturing site;","(dc) the date of issue of an authorisation","and the expiry date;","(dd) doses and instructions for use."],"old":["2. Disclosure of the following information","shall be deemed to undermine the","protection of the commercial interests of","the concerned person:","a) details of the full composition of a","biocidal product;","b) the precise use, function or application","of a substance or mixture;","","c) the precise tonnage of the substance or","mixture manufactured or placed on the","market;","d) links between a manufacturer of an","active substance and the person responsible","for the placing of a biocidal product on the","market or between the person responsible","for the placing of a biocidal product on the","market and the distributors of the product."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"187","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-188","justification":"This article should apply not just to active substances but also to biocidal products.","location":[[" Proposal for a regulation","Articolo 55 \u2013 paragrafo 3"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:50"},"new":["3. Any person submitting information","related to an active substance or a biocidal","product to the Agency or a competent","authority for the purposes of this","Regulation can request that the information","in Article 56(2) shall not be made available","including a justification as to why the","disclosure of the information could be","harmful for his or any other concerned","party's commercial interests."],"old":["3. Any person submitting information","related to an active substance to the","Agency or a competent authority for the","purposes of this Regulation can request","that the information in Article 56(2) shall","not be made available including a","justification as to why the disclosure of the","information could be harmful for his or any","other concerned party's commercial","","interests."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"188","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-189","justification":"Information on R&D should remain confidential.","location":[["Proposal for a regulation","Article 56 \u2013 paragraph 2 \u2013 point e"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:50"},"new":["deleted"],"old":["e) subject to Article 24 of Regulation (EC)","No 1272/2008, the name in the IUPAC","nomenclature for active substances","referred to in paragraph 1(a) of this","Article that are only used as one or more","of the following:","","i) in scientific research and development;","","ii) in product and process orientated","research and development."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"189","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-190","justification":" Anyone who places low-risk products on the market should be encouraged and should be\n allowed to publicise it appropriately.","location":[["Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 introductory part"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:50"},"new":["2. Labels shall not be misleading and, in","any case, shall not mention the indications","\u2018non-toxic\u2019, \u2018harmless\u2019 or similar","indications. In addition, the label must","show clearly and indelibly the following","information:"],"old":["2. Labels shall not be misleading and, in","","any case, shall not mention the indications","\u2018low-risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019 or similar indications. In","addition, the label must show clearly and","indelibly the following information:"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"190","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-191","justification":" The dose rate expressed in metric units is not comprehensible for non-professional users and\n is therefore difficult for users to understand. Instead, the dose rate should be expressed on the\n label in a manner that is meaningful and comprehensible to the end user.","location":[[" Proposal for a regulation","Article 58 \u2013 paragraph 2 \u2013 point e"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:50"},"new":["e) directions for use and the dose rate,","expressed in a manner that is meaningful","and comprehensible to users, for each use","provided for under the terms of the","authorisation;"],"old":["e) directions for use and the dose rate,","expressed in metric units, for each use","provided for under the terms of the","authorisation;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"191","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sajjad Karim","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-192","justification":"Products in general should always be labelled in the national language or languages of the\nMember State on whose market the product is placed. (The rapporteur has amended his\nproposed Amendment 39 of his draft opinion to take account of Member States with more\nthan one national language.)","location":[["Proposal for a regulation","Article 58 \u2013 paragraph 3"]],"meps":[28481],"meta":{"created":"2019-07-03T05:34:50"},"new":["3. Member States shall require that","biocidal products placed on the market of","their territories are labelled in their national","language or languages."],"old":["3. Member States may require that biocidal","products placed on the market of their","territories are labelled in their national","language or languages."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"192","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-193","justification":"Biocidal products which include nanomaterials are covered by the Regulation. But the impact\nof these substances on health and the environment is largely unknown at present. Consumers\nmust be informed correctly.","location":[["Proposal for a regulation","Article 58 \u2013 paragraph 3 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:34:50"},"new":["3a. Biocidal products which include","nanomaterials or which have been","manufactured by means of the","nanotechnology shall be clearly labelled","as such."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"193","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-194","justification":" Biocidal products which include nanomaterials are covered by the Regulation. But the impact\n of these substances on health and the environment is largely unknown at present. Consumers\n must be informed correctly.","location":[[" Proposal for a regulation","Article 58 \u2013 paragraph 3 a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:34:50"},"new":["3a. Biocidal products which include","nanomaterials or which have been","manufactured by means of the","nanotechnology shall be clearly labelled","as such."],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"194","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-195","justification":" Anyone who places low-risk products on the market should be encouraged and should be\n allowed to publicise it appropriately.","location":[[" Proposal for a regulation","Article 62 \u2013 paragraph 3"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:50"},"new":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment. In any case, the advertising","of a biocidal product shall not mention","\u2018non-toxic\u2019, \u2018harmless\u2019 or any similar","indication."],"old":["3. Advertisements for biocidal products","shall not refer to the product in a manner","which is misleading in respect of the risks","from the product to human health or the","environment. In any case, the advertising","of a biocidal product shall not mention","\u2018low-risk biocidal product\u2019, \u2018non-toxic\u2019,","\u2018harmless\u2019 or any similar indication."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"195","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-196","justification":"Fees should correspond to the work requested. An arbitrary annual fee is therefore not\nacceptable and fees should be paid only when they are actually necessary.","location":[["Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point a"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["a) a reduced fee shall be set for small and","medium-sized enterprises within the","meaning of Recommendation 2003/361/EC","concerning the definition of micro, small","and medium-sized enterprises; this in no","way alters the responsibility of the","evaluating competent authority for","carrying out an accurate evaluation","within the meaning of the Regulation;"],"old":["a) a reduced fee shall be set for small and","medium-sized enterprises within the","meaning of Recommendation 2003/361/EC","concerning the definition of micro, small","and medium-sized enterprises;"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"196","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-197","justification":" Fees should correspond to the work requested. An arbitrary annual fee is therefore not\n acceptable and fees should be paid only when they are actually necessary.","location":[["Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point d"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["d) the fee shall be applied only when it is","actually necessary and the structure and","amount of the fees shall take account of","the work required by this Regulation to be","carried out by the Agency and the","competent authorities and shall be fixed","at such level as to ensure that the revenue","derived from the fees when combined with","other sources of the Agency's revenue","pursuant to this Regulation is sufficient to","cover the cost of the services delivered."],"old":["d) an annual fee shall be paid by persons","placing biocidal products on the market;","and","",""],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"197","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-198","justification":" Le tariffe dovrebbero essere riferite al lavoro richiesto. An arbitrary annual fee is therefore\n not acceptable and fees should be paid only when they are actually necessary.","location":[[" Proposal for a regulation","Article 70 \u2013 paragraph 2 \u2013 point e"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["soppresso"],"old":["e) the structure and amount of the fees","shall take account of the work required by","this Regulation to be carried out by the","Agency and the competent authorities and","shall be fixed at such level as to ensure","that the revenue derived from the fees","when combined with other sources of the","Agency's revenue pursuant to this","Regulation is sufficient to cover the cost","of the services delivered."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"198","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-199","location":[[" Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["1. The Commission shall carry on with the","work programme for the systematic","examination of all existing active","substances commenced in accordance with","Article 16(2) of Directive 98/8/EC and","achieve it by 31 December 2018. The","Commission may adopt implementing","rules to carry out the work programme and","to specify the related rights and obligations","of the competent authorities and the","participants in the programme. Those","measures, designed to amend non-essential","elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"old":["1. The Commission shall carry on with the","","","work programme for the systematic","examination of all existing active","substances commenced in accordance with","Article 16(2) of Directive 98/8/EC and","achieve it by 14 May 2014. The","Commission may adopt implementing","rules to carry out the work programme and","to specify the related rights and obligations","of the competent authorities and the","participants in the programme. Those","measures, designed to amend non-essential","elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"199","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-200","location":[["Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["deleted"],"old":["During the work programme, the","Commission shall decide pursuant to the","procedure laid down in Article 72(4) that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and","data have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex","I of this Regulation. The decision shall","specify the date on which the inclusion in","Annex I becomes effective."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"200","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mario Pirillo, Edit Herczog","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-201","justification":" The period of time within which the Commission decision is to become effective should be\n specified as of now.","location":[[" Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meps":[96890,28155],"meta":{"created":"2019-07-03T05:34:51"},"new":["During the work programme, the","Commission shall decide pursuant to the","procedure laid down in Article 72(4) that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and data","have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex I","of this Regulation. The decision shall","specify the date on which the inclusion in","Annex I becomes effective, which shall be","two years after the decision."],"old":["During the work programme, the","Commission shall decide pursuant to the","procedure laid down in Article 72(4) that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and data","have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex I","of this Regulation. The decision shall","specify the date on which the inclusion in","Annex I becomes effective."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"201","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-202","justification":"The aim is to shorten the deadlines since downstream users should be aware of their\nobligations and of the state of revision of active substances.","location":[[" Proposal for a regulation","Article 77 \u2013 paragraph 3 \u2013 subparagraph 3"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["Biocidal products, for which an application","for a product authorisation has not been","submitted in accordance with the second","subparagraph, shall no longer be placed on","the market with effect from the date on","which the inclusion becomes effective.","Disposal, storage and use of existing stocks","of biocidal products for which an","application for authorisation has not been","submitted in accordance with the second","subparagraph are allowed until six months","after the date on which the inclusion","becomes effective."],"old":["Biocidal products, for which an application","for a product authorisation has not been","submitted in accordance with the second","subparagraph, shall no longer be placed on","the market with effect from six months","after the date on which the inclusion","becomes effective. Disposal, storage and","","use of existing stocks of biocidal products","for which an application for authorisation","has not been submitted in accordance with","the second subparagraph are allowed until","eighteen months after the date on which","the inclusion becomes effective."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"202","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-203","justification":" Food contact materials are already governed by Regulation (EC) No 1935/2004. Such\n materials should not fall within the scope of the proposal, as that would result in duplication\n of evaluation and regulation. If gaps in the legislation are discovered, they should be\n remedied by amending the Regulation on food contact materials.","location":[["Proposal for a regulation","Article 82"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["Article 82 deleted","contact materials"],"old":["","Transitional measures concerning food","","1. Applications for the authorisation of","biocidal products which are food contact","materials and which were available on the","market on [OJ: insert the date referred to","in the first subparagraph of Article 85]","shall be submitted at the latest 1 January","2017.","","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was submitted in accordance with","paragraph 1 may continue to be placed on","the market until the date of the decision","granting the authorisation or refusing to","grant the authorisation. In case of a","refusal to grant an authorisation to place","","","such biocidal product on the market, such","biocidal product shall no longer be placed","on the market within six months after","such decision.","","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was not submitted in accordance with","paragraph 1 may continue to be placed on","the market until six months after the date","referred to in paragraph 1.","2. Disposal, storage and use of existing","stocks of biocidal products which are not","authorised for the relevant use by the","competent authority or the Commission is","allowed until twelve months after the date","of the decision referred to in the second","subparagraph of paragraph 1 or twelve","months after the date referred to in the","third subparagraph of paragraph 1,","whichever is the later."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"203","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-204","justification":"Only companies which contribute to the system should be authorised to manufacture and\nmarket active substances for use in biocidal products. This is the best way to deal with the\nproblem of free riders, through appropriate supervision of the market in active substances.\nMember States should be required to establish what biocidal products exist on the market and\nwhether the manufacturer of the active substance has submitted a file under Annex I, and take\nappropriate action.","location":[["Proposal for a regulation","Article 83 \u2013 paragraph -1 (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["From 1 January 2014 all manufacturers","of an existing active substance placed on","the market for use in biocidal products","shall submit to the Agency a request to","include the substance in Annex I.","Competent authorities shall carry out","official controls in accordance with","Article 54(1)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"204","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-205","justification":"Only companies which contribute to the system should be authorised to manufacture and\n\n market active substances for use in biocidal products. The is the best way to deal with the\n problem of free riders, through appropriate supervision of the market in active substances.\n Member States should be required to establish what biocidal products exist on the market and\n whether the manufacturer of the active substance has submitted a file under Annex I, and take\n appropriate action.","location":[["Proposal for a regulation","Article 83 \u2013 paragraph 2 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["Competent authorities shall take the","necessary measures in accordance with","Article 54(2)."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"205","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-206","justification":" To bring the provision into line with the amendments to Article 16(2a) and (2b)(new).","location":[[" Proposal for a regulation","Annex III \u2013 Title 1 \u2013 point 2.2"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["2.2. Detailed quantitative and qualitative","information on the composition of the","biocidal product, e.g. active substance(s),","impurities, adjutants, inert components,","taking into account the concentration","limits laid down in Article 16"],"old":["2.2. Detailed quantitative and qualitative","information on the composition of the","biocidal product, e.g. active substance(s),","impurities, adjutants, inert components"],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"206","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Aldo Patriciello","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-207","justification":"To avoid unnecessary animal tests.","location":[[" Proposal for a regulation","Annex III - paragraph 1 a (new)"]],"meps":[36392],"meta":{"created":"2019-07-03T05:34:51"},"new":["1a. The information shall, as far as","possible, be taken from existing data in","order to minimise animal tests. The","provisions of Directive 1999/45/EC and","Regulation (EC) No 1272/2008 shall, in","particular, be applied."],"orig_lang":"it","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"207","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bill Newton Dunn","changes":{},"committee":["ITRE"],"date":"2010-02-25T00:00:00","id":"PE439.127-208","justification":"It is necessary to keep biocidal product type 20 (\u2018Preservatives for food or feedstocks\u2019) but its\ndefinition needs to be amended since these products are not preservatives but disinfectants.\nFor example, products used to disinfect feed from human pathogens such as Salmonella do\nnot meet the requirements of the feed additives regulations. Neither do they act as\npreservatives to prevent feed from deteriorating. These products must be therefore considered\nas disinfectant agents.","location":[["Proposal for a regulation","Annex V \u2013 Main Group 4 \u2013 Product type 20"]],"meps":[1394],"meta":{"created":"2019-07-03T05:34:51"},"new":["Product-type 20: Food and feed","disinfectants","Products used for the disinfection of food","or feedstocks and for the control of","harmful organisms."],"old":["Product-type 20: -"],"orig_lang":"en","peid":"PE439.127v01-00","reference":"2009/0076(COD)","seq":"208","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.127+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-101","justification":"The risk to the environment and to human health has its source not so much in the active\nsubstance given the low quantities used in each product but rather in the product itself and in\nits use. Comparing only those products containing a substance classified as a candidate for\nsubstitution will have little relevance. There are very few new actives found every year, which\ncan hardly replace old ones and the candidates for substitution will remain on the market for\na longer period than expected. In order to stimulate innovation it is essential to favour only\nthe safest products on the market.","location":[["Proposal for a regulation","Recital 14"]],"meta":{"created":"2019-07-03T05:38:17"},"new":["(14) In course of the authorisation or","renewal of biocidal product authorisations,","it should be possible to compare two or","more biocidal products with regard to risks","posed by them and benefits accrued","through their use. As a result of such a","comparative assessment, any biocidal","product could be replaced with others that","present significantly less risk to health or to","the environment and where there are no","significant adverse economic or practical","impacts. Appropriate phase-out periods","should be foreseen in such cases."],"old":["(14) In course of the authorisation or","renewal of biocidal product authorisations,","it should be possible to compare two or","more biocidal products with regard to risks","posed by them and benefits accrued","through their use. As a result of such a","comparative assessment, authorised","biocidal products containing active","substances indicated as candidates for","substitution could be replaced with others","that present significantly less risk to health","or to the environment and where there are","no significant adverse economic or","practical impacts. Appropriate phase-out","periods should be foreseen in such cases."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"101","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Emma McClarkin, Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-102","justification":" It is necessary to keep former Directive 98/80/EC\u2019s biocidal product type 20 (\u2018Preservatives\n for food or feedstocks\u2019), but its definition needs to be amended, given that these biocidal\n products are not preservatives but disinfectants (as a consequence, the older definition led to\n confusion). For instance, products used to disinfect feed from human pathogens such as\n Salmonella do not meet the requirements of the feed additives regulations. Indeed, the\n products do not \u2018favourably affect the feed\u2019 nor enhance its performance.","location":[["Proposal for a regulation","Recital 20"]],"meps":[96919],"meta":{"created":"2019-07-03T05:38:17"},"new":["deleted"],"old":["(20) As products used for the preservation","of food or feedstocks by the control of","harmful organisms, previously covered by","","product type 20, are covered by Council","Directive 89/107/EEC and Regulation","(EC) No 1831/2003 of the European","Parliament and of the Council, it is not","appropriate to maintain this product type."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-103","location":[[" Proposal for a regulation","Recital 22"]],"meta":{"created":"2019-07-03T05:38:17"},"new":["deleted"],"old":["(22) To take account of the specific nature","of some biocidal products and the low","level of risk associated with their proposed","use, and to encourage the development of","biocidal products containing new active","substances, it is appropriate to provide for","a Community authorisation of those","products."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-104","location":[[" Proposal for a regulation","Recital 24"]],"meta":{"created":"2019-07-03T05:38:17"},"new":["(24) In order to facilitate access to the","internal market and to avoid the additional","costs and time involved in obtaining","separate national authorisations in separate","Member States, the Commission decided to","introduce a Community authorisation","procedure for all biocidal products."],"old":["(24) In order to facilitate access to the","","","internal market and to avoid the additional","costs and time involved in obtaining","separate national authorisations in separate","Member States, the Commission, taking","into account the experience with the","provisions on Community authorisations,","may decide to extend the scope of the","Community authorisation procedure to","other biocidal products."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-105","location":[["Proposal for a regulation","Recital 61"]],"meta":{"created":"2019-07-03T05:38:17"},"new":["(61) In particular, the Commission should","be empowered to adopt measures to decide","on the application to include the active","substance in Annex I or to renew or review","the inclusion, to specify the procedures","related to the renewal and review of an","inclusion of an active substance in Annex","I, to specify the criteria and procedures","related to a cancellation of an authorisation","or amendments of the terms and conditions","of an authorisation, including a dispute","settlement mechanism, to specify the","overall applicable maximum quantities of","active substances or biocidal products that","may be released during experiments and","the minimum data to be submitted, to","establish a harmonised structure of fees","and other rules concerning the payment of","fees and charges to the competent","authorities and the Agency, to adapt the","Annexes to scientific and technical","progress, to carry out the work programme","and to specify the related rights and","obligations of the competent authorities","and the participants in the programme and","to extend the duration of the work","programme for a determined period. Since","those measures are of general scope and","are designed to amend non-essential","elements of this Regulation, inter alia, by","supplementing this Regulation with new","non-essential elements, they must be","adopted in accordance with the regulatory","procedure with scrutiny provided for in","Article 5a of Decision 1999/468/EC."],"old":["(61) In particular, the Commission should","be empowered to adopt measures to decide","on the application to include the active","substance in Annex I or to renew or review","the inclusion, to specify the procedures","related to the renewal and review of an","inclusion of an active substance in Annex","I, to extend the provisions on Community","authorisations to other categories of","biocidal products, to specify the criteria","and procedures related to a cancellation of","an authorisation or amendments of the","terms and conditions of an authorisation,","including a dispute settlement mechanism,","to specify the overall applicable maximum","quantities of active substances or biocidal","products that may be released during","experiments and the minimum data to be","submitted, to establish a harmonised","structure of fees and other rules concerning","the payment of fees and charges to the","competent authorities and the Agency, to","adapt the Annexes to scientific and","technical progress, to carry out the work","programme and to specify the related rights","and obligations of the competent","authorities and the participants in the","","programme and to extend the duration of","the work programme for a determined","period. Since those measures are of general","scope and are designed to amend non-","essential elements of this Regulation, inter","alia, by supplementing this Regulation with","new non-essential elements, they must be","adopted in accordance with the regulatory","procedure with scrutiny provided for in","Article 5a of Decision 1999/468/EC."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"105","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-106","justification":" Food contact materials should not be within the scope of the Proposal as this would lead to\n double regulation and assessment. Food contact materials are already regulated by the Food\n Contact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\n to the rules governing food contact materials, they should be addressed through a revision of\n the food contact legislation, not by extending the scope of the BPR.","location":[[" Proposal for a regulation","Recital 66"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:17"},"new":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","to be prepared to apply the rules","concerning in situ generated active","substances and treated articles and","materials."],"old":["(66) Taking into consideration that some","products were not previously covered by","the Community legislation in the field of","biocidal products, it is appropriate to allow","for a transitional period for the companies","to be prepared to apply the rules","concerning in situ generated active","substances, treated articles and materials","and food contact materials."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-107","location":[["Proposal for a regulation","Article 1 a (new)"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:17"},"new":["Article 1a","Precautionary principle","This Regulation is based on the","precautionary principle."],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"107","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-108","location":[["Proposal for a regulation","Article 1 b (new)"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:18"},"new":["Article 1b","Aim of the Regulation","The aim of this Regulation shall be a high","level of health and environmental","protection. Special attention shall be paid","to protecting children, pregnant women","and the sick."],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"108","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-109","justification":" Food contact materials should not be within the scope of the Proposal as this would lead to\n double regulation and assessment. Food contact materials are already regulated by the Food\n Contact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\n to the rules governing food contact materials, they should be addressed through a revision of\n the food contact legislation, not by extending the scope of the BPR.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point p a (new)"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:18"},"new":["pa) Regulation (EC) No 1935/2004 of the","European Parliament and of the Council","of 27 October 2004 on materials and","articles intended to come into contact with","food and repealing Directives 80/590/EEC","and 89/109/EEC;"],"old":[""],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"109","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Amalia Sartori","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-110","justification":" This amendment broadens the definition of treated articles and materials to include both\n articles such as paints and varnishes, which contain preserving agents, and articles with\n external effects, such as mosquito nets, which contain a biocidal product. The assessment is\n thus a chemical one.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point k"]],"meps":[4423],"meta":{"created":"2019-07-03T05:38:18"},"new":["(k) 'treated material or article' means","any substance, mixture, material or article","which was treated with or incorporates one","or more biocidal products with the","intention that it should perform the","biocidal function for which it is intended;"],"old":["(k)'treated material or article' means","any substance, mixture, material or article","which was treated with or incorporates one","or more biocidal products with the","intention to protect the substance, mixture,","material or article from deterioration","caused by harmful organisms;"],"orig_lang":"it","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-111","justification":"Food contact materials should not be within the scope of the Proposal as this would lead to\ndouble regulation and assessment. Food contact materials are already regulated by the Food\nContact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\nto the rules governing food contact materials, they should be addressed through a revision of\nthe food contact legislation, not by extending the scope of the BPR.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 \u2013 point s"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:18"},"new":["deleted"],"old":["s) \"food contact materials' means","any material and article intended to come","into contact with food which are covered","by Regulation (EC) No 1935/200443 ;","43","OJ L 338, 13.11.2004, p. 4"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"111","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-112","justification":"A serious management of the risk can reduce the exposure of users whether professionals or\nnon-professionals and ultimately protect the environment and the health of users. A tiny\nquantity of an active substance even classified as CMR1 in a bait station, for instance, would\npose no risk to human health given that the product is adequately designed to prevent any\nmisuse. It is therefore the product and its use which will determine whether there is a risk\n\n given that, in this case, the active substance is in very low quantity.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1 \u2013 point a"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible or","properly managed through sustainable","use measures and taking into account the","intrinsic properties of the active","substance, in particular where the product","is used in closed systems or strictly","controlled conditions;"],"old":["a) the exposure of humans to that active","substance in a biocidal product, under","normal conditions of use, is negligible, in","particular where the product is used in","closed systems or strictly controlled","conditions;"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-113","justification":" Steps must be taken to ensure that certain Member States are not required to deal with a\n plethora of applications, thereby guaranteeing a balanced division of tasks among the\n Member States.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:18"},"new":["1. The applicant shall submit an application","to include an active substance in Annex I,","or to make subsequent amendments to the","conditions of inclusion of an active","substance, to the European Chemicals","Agency (hereinafter referred to as 'the","Agency'). The Agency shall indicate the","name of the competent authority of the","Member State that it has chosen to","evaluate the application. That competent","authority (hereinafter referred to as 'the","evaluating competent authority') shall be","responsible for the evaluation of the","application."],"old":["1. The applicant shall submit an application","to include an active substance in Annex I,","or to make subsequent amendments to the","conditions of inclusion of an active","substance, to the European Chemicals","Agency (hereinafter referred to as 'the","Agency') and inform it of the name of the","competent authority of the Member State","that he chooses to evaluate his application.","That competent authority (hereinafter","referred to as 'the evaluating competent","authority') shall be responsible for the","evaluation of the application."],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-114","location":[[" Proposal for a regulation","Article 10 \u2013 paragraph 3"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:18"},"new":["3. Unless otherwise specified in the","decision to renew the inclusion of an active","substance in Annex I, the renewal of the","inclusion shall be reviewed after 10 years."],"old":["3. Unless otherwise specified in the","decision to renew the inclusion of an active","substance in Annex I, the renewal shall be","","","for an unlimited period of time."],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"114","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-115","justification":"The industry needs more flexibility in the supply chain. In fact it is not uncommon that a\nproduct is imported in one country and placed on the market under the responsibility of a\ndistributor which is not the holder of the authorisation or, in case of multinational companies,\nthat each individual sister company is responsible for placing the product on the market in\ntheir own country. The provision that the holder of the authorisation and the person\nresponsible for placing the product on the market are the same would create a very rigid and\nunpractical framework for industry to work with.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["2. Application for authorisation shall be","made by, or on behalf of, the person who","will be the holder of the authorisation.","This person may be, but is not necessarily,","the person responsible for the placing on","the market of a biocidal product in a","particular Member State or in the","Community."],"old":["2. Application for authorisation shall be","made by, or on behalf of, the person who","shall be responsible for the placing on the","market of a biocidal product in a particular","Member State or in the Community."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"115","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-116","justification":" The intrinsic characteristics of an active substance, alone, should not determine its suitability\n for low risk products since the risks may come more from the exposure to the product than\n from the hazard of the active substance. Given that some biocides are used by non-\n professionals, it is important to guarantee the safety of these products through better\n information and precautions regarding their use. Finally, industry needs to be encouraged to\n focus its research and innovation efforts towards developing low risk products.","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 introductory part"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["1. A biocidal product shall be considered a","low-risk biocidal product if at least one of","the following conditions are fulfilled:"],"old":["1. A biocidal product shall be considered a","low-risk biocidal product if both the","following conditions are fulfilled:"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"116","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-117","justification":" The intrinsic characteristics of an active substance, alone, should not determine its suitability\n for low risk products since the risks may come more from the exposure to the product than\n from the hazard of the active substance. Given that some biocides are used by non-\n professionals, it is important to guarantee the safety of these products through better\n information and precautions regarding their use. Finally, industry needs to be encouraged to\n focus its research and innovation efforts towards developing low risk products.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1 \u2013 subparagraph 2 \u2013 introductory part"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["However, specific sustainable use","measures with appropriate technologies to","control the use are necessary if a biocidal","product meets at least two of the following","conditions:"],"old":["However, a biocidal product shall not be","considered a low-risk biocidal product if at","least one of the following conditions is","present:"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"117","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-118","justification":"The intrinsic characteristics of an active substance, alone, should not determine its suitability\nfor low risk products since the risks may come more from the exposure to the product than\nfrom the hazard of the active substance. Given that some biocides are used by non-\nprofessionals, it is important to guarantee the safety of these products through better\ninformation and precautions regarding their use. Finally, industry needs to be encouraged to\nfocus its research and innovation efforts towards developing low risk products.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 2"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["2. Notwithstanding paragraph 1, a biocidal","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible or managed","exposure through sustainable use","measures can take place under prescribed","conditions of use and the product is","handled under strictly controlled conditions","during all other stages of its lifecycle."],"old":["2. Notwithstanding paragraph 1, a biocidal","","product shall be considered a low-risk","biocidal product if the active substances in","the biocidal product are contained in such","way that only a negligible exposure can","take place under normal conditions of use","and the product is handled under strictly","controlled conditions during all other","stages of its lifecycle."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"118","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-119","justification":"The intrinsic characteristics of an active substance, alone, should not determine its suitability\n\n for low risk products since the risks may come more from the exposure to the product than\n from the hazard of the active substance. Given that some biocides are used by non-\n professionals, it is important to guarantee the safety of these products through better\n information and precautions regarding their use. Finally, industry needs to be encouraged to\n focus its research and innovation efforts towards developing low risk products.","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 2 a (new)"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["2a. The applicant for an authorisation","shall, in the circumstances defined in","paragraphs 1 and 2, provide the","competent authorities with:","(i) information on specific points of sale","(ii) specific instructions on the use of","protective equipment","(iii) a brochure on the risks, benefits and","responsible use of the product","(iv) an annual report on incidents, if any."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"119","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-120","justification":" It is critical that in the case of applications involving subsequent mutual recognition\n procedures the application and all related documents are accepted in English by the receiving\n competent authority. This is very important in order to avoid time-consuming and expensive\n translation procedures for the same documentation in several European languages.","location":[[" Proposal for a regulation","Article 18 \u2013 paragraph 3"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["3. The receiving competent authority may","require that applications for the sole","purpose of a national authorisation be","submitted in one or more of the official","languages of the Member State where that","competent authority is situated.","Applications for a national authorisation","which involve a mutual recognition","procedure may be submitted, along with","the documents referred to in paragraph 1,","to the competent authority in English."],"old":["3. The receiving competent authority may","require that applications for a national","authorisation be submitted in one or more","of the official languages of the Member","State where that competent authority is","situated."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"120","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-121","justification":"The risk to the environment and to human health has its source not so much in the active\nsubstance given the low quantities used in each product but rather in the product itself and in\nits use. There are very few new actives found every year, which can hardly replace old ones\nand the candidates for substitution will remain on the market for a longer period than\nexpected. In order to stimulate innovation it is essential to favour only the safest products on\nthe market.","location":[[" Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 introductory part"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["3. The receiving competent authority, or in","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product where the comparative assessment","weighing up the risks and benefits in","accordance with Annex VI demonstrates","that all the following criteria are met:"],"old":["3. The receiving competent authority or, in","","","the case of a decision on an application for","a Community authorisation, the","Commission shall prohibit or restrict the","placing on the market or use of a biocidal","product containing an active substance","that is a candidate for substitution where","the comparative assessment weighing up","the risks and benefits in accordance with","Annex VI demonstrates that all the","following criteria are met:"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"121","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-122","justification":"The risk to the environment and to human health has its source not so much in the active\nsubstance given the low quantities used in each product but rather in the product itself and in\nits use. There are very few new actives found every year, which can hardly replace old ones\nand the candidates for substitution will remain on the market for a longer period than\nexpected. In order to stimulate innovation it is essential to favour only the safest products on\n\n the market.","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 3 \u2013 point a"]],"meta":{"created":"2019-07-03T05:38:18"},"new":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower or reduced risk for human or animal","health or the environment;"],"old":["a) for the uses specified in the application,","another authorised biocidal product or a","non-chemical control or prevention method","already exists which presents significantly","lower risk for human or animal health or","the environment;"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"122","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-123","location":[[" Proposal for a regulation","Article 28"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:18"},"new":["Article deleted"],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"123","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" J\u00fcrgen Creutzmann","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-124","justification":"A centralised authorisation system has clear benefits for the functioning of the internal\nmarket by ensuring consistent assessments and a harmonised implementation of the\nrequirements in all Member States, driving best practices and same standards of consumer\nprotection across Europe. The Community authorisation procedure should therefore extend to\nall product categories. However, the possibility to apply for product authorisation directly to\nMember States for companies marketing products in a single or limited number of Member\nStates should be kept.","location":[[" Proposal for a regulation","Article 33"]],"meps":[96873],"meta":{"created":"2019-07-03T05:38:19"},"new":["1. The Community authorisation may be","granted to all categories of biocidal","products."],"old":["1. The Community authorisation may be","granted to the following categories of","biocidal products:","a) biocidal products containing one or","more new active substances;","b) low-risk biocidal products.","2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"124","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-125","justification":" Most Member States do not currently have an authorisation system of biocides. It is therefore\n more appropriate to move the authorisation procedure directly at the EU level to ensure that\n all EU citizens are equal with respect to human health and environment protection.\n Moreover, most existing active substances will have then been evaluated. Finally, the biocides\n industry needs to be incentivised to innovate. This requires a simplified procedure with\n shorter deadlines as a sign of Better Regulation.","location":[["Proposal for a regulation","Article 33"]],"meta":{"created":"2019-07-03T05:38:19"},"new":["1. The Community authorisation may be","granted to all biocidal products with","substantially similar patterns and","conditions of use.","A Community authorisation requires the","adoption of sustainable use measures","whenever it is appropriate to ensure the","same level of human health and","environmental protection across the","Union. Those measures may vary","depending on the product type."],"old":["1. The Community authorisation may be","granted to the following categories of","biocidal products:","a) biocidal products containing one or","more new active substances;","b) low-risk biocidal products.","2. Following the report of the Commission","on the implementation of this Regulation","referred to in Article 54(4) and in light of","the experience gained with the","Community authorisations, the","Commission may add other categories of","biocidal products in paragraph 1 of this","Article.","Those measures, designed to amend non-","essential elements of this Regulation by","supplementing it, shall be adopted in","accordance with the regulatory procedure","with scrutiny referred to in Article 72(4)."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"125","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox, Amalia Sartori","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-126","justification":" One of the key objectives of the Union authorisation system is to ensure consistent product\n safety assessments, equal standards of consumer protection and harmonised implementation\n of the requirements within all Member States. Biocidal products, which are used in a similar\n way across the EU, should benefit from the Union authorisation scheme. These products are\n used in domestic or in professional settings as a pragmatic and cost effective means to protect\n public health, thereby reducing the burden of infectious diseases. These products have simple\n and clear use instructions.","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 point b a (new)"]],"meps":[96957,4423],"meta":{"created":"2019-07-03T05:38:19"},"new":["ba) biocidal products designed to be used","by consumers in domestic settings, or by","professional users, according to","conditions and instructions of use which","are similar within the European Union,","and which meet the criteria listed in","Article 33 a."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"126","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox, Amalia Sartori","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-127","justification":"The criteria are based on the targeted and consistent application and use of those types of\nproducts across the EU (number of Member States to be specified), as well as their positive\ncontribution to human and animal safety protection. Annex VI lays down the principles for the\nevaluation of dossiers for biocidal products to ensure a harmonised high level of protection\nfor humans and the environment. This involves detailed risk assessment of products during\ntheir use. Should a risk be identified, personal protective equipment would need to be\nspecified. Absence of PPE is therefore an indication of limited risk.","location":[[" Proposal for a regulation","Article 33 a (new)"]],"meps":[96957,4423],"meta":{"created":"2019-07-03T05:38:19"},"new":["In accordance with point (ba) of Article","33(1), a product shall be considered a","biocidal product with similar use","conditions if all of the following criteria","are met:","(i) it has similar conditions of use across","the European Union, according to use","instructions;","(ii) it is already placed or is intended to be","placed on the market in at least [...]","Member States within two years of the","authorisation being granted;","(iii) it does not require personal protective","equipment in conditions of use according","to Annex VI, and when used under","normal and reasonably foreseeable","conditions of use, meets the requirements","in Article 16(1).","In order to define or adapt the number of","Member States referred to in point (ii), the","Commission shall adopt delegated acts in","accordance with Article [....]."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"127","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-128","justification":" This paragraph becomes superfluous if the amendment to Article 33 is adopted.","location":[["Proposal for a regulation","Article 35 \u2013 paragraph 5"]],"meta":{"created":"2019-07-03T05:38:19"},"new":["deleted"],"old":["5. If the decision referred to in paragraph","4 refuses to grant a Community","authorisation to a biocidal product","because it does not fulfil the criteria for a","low-risk biocidal product in accordance","with Article 17, the applicant may apply, if","relevant, for a Community authorisation","in accordance with point (a) of Article","33(1) or a national authorisation in","accordance with Chapter V."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"128","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-129","justification":" The legislative text should clearly outline the main principles which shall be applied when\n amending authorisations, although the details of the procedures can be specified in the\n implementing measures. In particular, it is necessary to specify the types of changes that can\n be made to existing product authorisations.","location":[[" Proposal for a regulation","Article 41 \u2013 paragraph 2 \u2013 subparagraph 1 a (new)"]],"meta":{"created":"2019-07-03T05:38:19"},"new":["An amendment to an existing","authorisation should fall under one of the","following categories referred to in points","(ua), (ub) and (uc) of Article 3:","a) Administrative change,","b) Minor change or","c) Major change."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"129","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-130","justification":"In order to find an appropriate balance between free trade of goods and a safe market, this\narticle on parallel trade should be limited to identical products based on the same\nspecification and content of active substances and co-formulants.","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 2"]],"meta":{"created":"2019-07-03T05:38:19"},"new":["2. A parallel trade permit shall be granted","within two months from submission of an","application. The competent authority of the","Member State of introduction may request","from the competent authority of the","Member State of origin additional","information necessary to determine","whether the product is identical to the","reference product. The competent authority","of the Member State of origin shall provide","the requested information within one","month of receiving the request."],"old":["2. A parallel trade permit shall be granted","within two months from submission of an","application. The competent authority of the","Member State of introduction may request","from the competent authority of the","Member State of origin additional","information necessary to determine","whether the product is substantially","identical to the reference product. The","competent authority of the Member State","of origin shall provide the requested","information within one month of receiving","the request."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"130","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-131","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:19"},"new":["3. A biocidal product shall be considered","as substantially identical to the reference","product if the following conditions are","met:"],"old":["3. A biocidal product shall be considered","as substantially identical to the reference","product if one of the following conditions","is met:"],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"131","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-132","justification":" The requirement for a national authorization constitutes a significant barrier to innovation,\n as it implies a very long waiting period before the test can be carried out. It is proposed\n instead, whilst maintaining the need for a prior evaluation by the competent authority, that a\n 30-day period is set to for it to assess if the proposed test/experiment raises any concerns, and\n to issue its opinion. Finally, when a test is carried out in a single Member State, notifying the\n Commission and the other Competent Authorities serves no clear purpose and provides no\n benefit.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:19"},"new":["In the case of scientific research and","development, including product and","process-oriented research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data and quantities","supplied, and shall compile a dossier","containing all available data on possible","effects on human or animal health or","impact on the environment. The persons","concerned shall, if requested, make this","information available to the competent","authority."],"old":["In the case of scientific research and","development, the person who intends to","carry out the experiment or the test shall","notify the competent authority prior to the","start. The person shall draw up and","maintain written records detailing the","identity of the biocidal product or active","substance, labelling data, quantities","supplied and the names and addresses of","those persons receiving the biocidal","product or active substance, and shall","compile a dossier containing all available","data on possible effects on human or","animal health or impact on the","environment. The persons concerned shall,","if requested, make this information","available to the competent authority."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"132","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi, Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-133","justification":"The requirement for a national authorization constitutes a significant barrier to innovation,\nas it implies a very long waiting period before the test can be carried out. It is proposed\ninstead, whilst maintaining the need for a prior evaluation by the competent authority, that a\n30-day period is set to for it to assess if the proposed test/experiment raises any concerns, and\nto issue its opinion. Finally, when a test is carried out in a single Member State, notifying the\nCommission and the other Competent Authorities serves no clear purpose and provides no\nbenefit.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:19"},"new":["deleted"],"old":["In the case of product and process-","oriented research and development, the","person who intends to carry out the","experiment or the test shall, prior to the","placing of the biocidal product or the","active substance on the market, notify the","information required in the second","subparagraph to the competent authority","of the Member State where the placing on","the market occurs."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"133","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-134","justification":" The requirement for a national authorization constitutes a significant barrier to innovation,\n as it implies a very long waiting period before the test can be carried out. It is proposed\n instead, whilst maintaining the need for a prior evaluation by the competent authority, that a\n 30-day period is set to for it to assess if the proposed test/experiment raises any concerns, and\n to issue its opinion. Finally, when a test is carried out in a single Member State, notifying the\n Commission and the other Competent Authorities serves no clear purpose and provides no\n benefit.","location":[["Proposal for a regulation","Article 46 \u2013 paragraph 2"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:19"},"new":["2. An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and issued a","positive opinion for this purpose which","may impose further conditions. In the","absence of an opinion from the competent","authority within 30 days of the notification","of the information required in paragraph","1, the biocidal product or active substance","may be placed on the market for the","purpose of the notified experiment or test."],"old":["2. An unauthorised biocidal product or an","active substance for exclusive use in a","biocidal product shall not be placed on the","market for the purpose of any experiment","or test which may involve, or result in,","release of the biocidal product into the","environment unless the competent","authority has assessed the data submitted","by the person interested in the placing of","such product on the market and issued a","national authorisation for this purpose","which limits the quantities to be used and","","the areas to be treated and which may","impose further conditions. The competent","authority shall without delay inform the","Commission and other competent","authorities about the issued national","authorisation."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"134","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox, Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-135","justification":"The rules on conducting tests/experiments on the territory of a Member State, other than the\none on whose market the biocidal products shall be placed, should be same as those in\nparagraph one of the same article.","location":[[" Proposal for a regulation","Article 46 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:19"},"new":["3. Where any experiment or test takes","place in a Member State other than the","Member State where placing on the market","of the biocidal product occurs, the","applicant shall notify the competent","authority of the Member State in the","territory of which the experiments or tests","are to be conducted. The applicant shall","draw up and maintain written records","detailing the identity of the biocidal","product or active substance, labelling data","and quantities supplied, and shall compile","a dossier containing all available data on","possible effects on human or animal","health or impact on the environment. The","applicant shall, if requested, make this","information available to the competent","authority."],"old":["3. Where any experiment or test takes","place in a Member State other than the","Member State where placing on the market","of the biocidal product occurs, the","applicant shall obtain experiment or test","authorisation from the competent","authority of the Member State in the","territory of which the experiments or tests","are to be conducted."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"135","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-136","justification":"Some biocidal products unauthorised in the EU are readily used in non-EU countries: cross-\ncontamination of articles cannot therefore be entirely ruled out. A general threshold for these\nbiocidal products must be set, with the possibility for the Biocidal Products Committee to set\ndifferent ones, if necessary.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 1"]],"meta":{"created":"2019-07-03T05:38:19"},"new":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or the articles are authorised for","this use in the Community or in at least one","Member State, or the biocidal product is","present in those articles in a","concentration of less than 0,01% by","weight. Where appropriate, the Biocidal","Products Committee may propose","different thresholds for specific biocidal","products or groups of biocidal products."],"old":["1. Treated materials or articles that","incorporate one or more biocidal products","shall not be placed on the market unless the","biocidal product(s) used for treating the","materials or articles are authorised for this","use in the Community or in at least one","Member State."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"136","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-137","justification":" The labelling provisions for treated articles and materials should not lead to requirements for\n unnecessary information and should not overlap with existing requirements under sectoral\n legislation. Existing sectoral legislation and their information requirements (e.g. labelling,\n Safety Data Sheets) should always be taken into consideration. For example under the\n Detergent Regulation, the INCI name of the preservative must be labelled on products for the\n general public and reported in the SDS. Hence any additional labelling requirements are\n unnecessary.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point a"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:19"},"new":["a) the name, using wherever possible","common nomenclature (e.g. INCI) of all","active substances that were used to treat the","article or materials or that were","incorporated in the articles or materials,","where relevant and for all active","substances which are intended to be","released under normal or foreseeable","conditions of use from the treated article","or material, unless labelling requirements","or alternative means to meet information","requirements already exist under sector-","specific legislation."],"old":["a) the name of all active substances that","were used to treat the article or materials or","that were incorporated in the articles or","materials;"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"137","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-138","justification":"These labelling requirements should only concern articles that have been treated with a\nbiocidal product which might come into contact with humans and the environment, as only\nthese might really prove hazardous.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point b"]],"meta":{"created":"2019-07-03T05:38:20"},"new":["b) where relevant, the biocidal property","attributed to treated articles or materials if","the biocidal product is intended to come","into direct contact with humans and the","environment;"],"old":["b) where relevant, the biocidal property","attributed to treated articles or materials;"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"138","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-139","justification":"Furthermore there is a risk that additional labelling which does not provide safe use guidance\nmight lead to unnecessary concerns and alarm amongst consumers; therefore additional\nlabelling should only be required when relevant.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point b"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:20"},"new":["b) where relevant, the biocidal property","attributed to treated articles;"],"old":["b) where relevant, the biocidal property","attributed to treated articles or materials;"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"139","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-140","justification":"The inclusion on the product label of the authorisation number of the biocidal product used to\ntreat the article will disclose the recipient/supplier relationship and will, in addition, clearly\n\n limit the flexibility of a formulator to switch from one supplier to another, as each change\n would require an artwork change. Also, the inclusion of the authorisation number does not\n have any consumer safety benefits. For the purposes of enforcement by competent authorities,\n the authorisation number can be obtained through other means.","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point c"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:20"},"new":["deleted"],"old":["c) the authorisation number of all","biocidal products that were used for the","treatment or were incorporated in the","articles or materials;"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"140","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-141","justification":" These labelling requirements should only concern articles that have been treated with a\n biocidal product which might come into contact with humans and the environment, as only\n these might really prove hazardous.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meta":{"created":"2019-07-03T05:38:20"},"new":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product if the biocidal product","is intended to come into direct contact","with humans and the environment."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"141","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-142","justification":" Furthermore there is a risk that additional labelling which does not provide safe use guidance\n\nmight lead to unnecessary concerns and alarm amongst consumers; therefore additional\nlabelling should only be required when relevant.","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 2 \u2013 point d"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:20"},"new":["d) only for treated articles and where","relevant, any hazard statement or","precautionary statement set out in the","authorisation for the biocidal product."],"old":["d) any hazard statement or precautionary","statement set out in the authorisation for","the biocidal product."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"142","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-143","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:20"},"new":["3. Every year, starting in 2013, competent","authorities shall submit to the Commission","a report on the implementation of this","Regulation in their respective territories.","The report shall include:"],"old":["3. Every three years, starting in 2013,","competent authorities shall submit to the","Commission a report on the","implementation of this Regulation in their","respective territories. The report shall","include:"],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"143","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-144","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 3 \u2013 point b"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:20"},"new":["b) information on any poisonings involving","biocidal products and the possible health","implications for vulnerable groups, such","as children, pregnant women or the sick;"],"old":["b) information on any poisonings involving","biocidal products."],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"144","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-145","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 3 \u2013 point b a (new)"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:20"},"new":["ba) information on the impact on the","environment;"],"old":["",""],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"145","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-146","location":[[" Proposal for a regulation","Article 54 \u2013 paragraph 3 \u2013 point b b (new)"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:20"},"new":["bb) information on possible measures to","minimise risk and develop alternatives."],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"146","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Evelyne Gebhardt","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-147","location":[[" Proposal for a regulation","Article 54 \u2013 paragraph 4"]],"meps":[1913],"meta":{"created":"2019-07-03T05:38:20"},"new":["4. The Commission shall draw up a report","on the implementation of this Regulation","and, in particular, on the functioning of the","Community authorisation procedure and","mutual recognition, by 1 January 2019","and every three years thereafter. The","Commission shall submit the report to the","European Parliament and the Council."],"old":["4. The Commission shall draw up a report","on the implementation of this Regulation","and, in particular, on the functioning of the","Community authorisation procedure and","mutual recognition, by 1 January 2023.","The Commission shall submit the report to","the European Parliament and the Council."],"orig_lang":"de","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"147","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-148","justification":"The legislative text should clearly state the timelines applicable. Two years have previously\nbeen agreed upon by the Competent Authorities.","location":[[" Proposal for a regulation","Article 77 \u2013 paragraph 1 \u2013 subparagraph 3"]],"meta":{"created":"2019-07-03T05:38:20"},"new":["During the work programme, the","Commission shall decide pursuant to the","procedure laid down in Article 72(4) that","an active substance shall be included in","Annex I of this Regulation and under","which conditions, or, in cases where the","requirements of Article 4 are not satisfied","or where the requisite information and data","have not been submitted within the","prescribed period, that such active","substance shall not be included in Annex I","of this Regulation. 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The decision shall","specify the date on which the inclusion in","Annex I becomes effective."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"148","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Amalia Sartori","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-149","location":[["Proposal for a regulation","Article 77 \u2013 paragraph 4 \u2013 subparagraph 1 a (new)"]],"meps":[4423],"meta":{"created":"2019-07-03T05:38:20"},"new":["Disposal, storage and use of existing","stocks of biocidal products for which the","competent authority of the Member State","has rejected an application for","authorisation submitted under paragraph","3 or has decided not to grant","authorisation are allowed until 18 months","after such a rejection or a decision."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"149","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Amalia Sartori","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-150","location":[[" Proposal for a regulation","Article 81 \u2013 paragraph 1 a (new)"]],"meps":[4423],"meta":{"created":"2019-07-03T05:38:20"},"new":["Disposal, storage and use of existing","stocks of biocidal products which are not","authorised for the relevant use by the","competent authority or the Commission","are allowed until 12 months after the date","of the decision referred to in the first","subparagraph of Article 80(2) or 12","months after the date referred to in the","second subparagraph of Article 80(2),","whichever is the later."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"150","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-151","justification":" The addition of this paragraph taken from Article 80 ensures consistent measures for the new\n products which will fall under the scope of the Biocidal Products Regulation.","location":[[" Proposal for a regulation","Article 81 \u2013 paragraph 1 a (new)"]],"meta":{"created":"2019-07-03T05:38:20"},"new":["Disposal, storage and use of existing","stocks of biocidal products which are not","authorised for the relevant use by the","competent authority or the Commission","are allowed until 12 months after the date","of the decision referred to in the first","subparagraph of Article 80(2) or 12","months after the date referred to in the","second subparagraph of Article 80(2),","whichever is the later."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"151","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox, Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-152","justification":" Food contact materials should not be within the scope of the Proposal as this would lead to\n double regulation and assessment. Food contact materials are already regulated by the Food\n Contact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made\n to the rules governing food contact materials, they should be addressed through a revision of\n the food contact legislation, not by extending the scope of the BPR.","location":[["Proposal for a regulation","Article 82"]],"meps":[96957,28227],"meta":{"created":"2019-07-03T05:38:20"},"new":["Article 82 deleted","contact materials"],"old":["Transitional measures concerning food","1. Applications for the authorisation of","biocidal products which are food contact","materials and which were available on the","market on [OJ: insert the date referred to","in the first subparagraph of Article 85]","shall be submitted at the latest 1 January","2017.","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was submitted in accordance with","paragraph 1 may continue to be placed on","the market until the date of the decision","granting the authorisation or refusing to","grant the authorisation. In case of a","refusal to grant an authorisation to place","such biocidal product on the market, such","biocidal product shall no longer be placed","on the market within six months after","such decision.","Food contact materials which were","available on the market on [OJ: insert the","date referred to in the first subparagraph","of Article 85] for which an application","was not submitted in accordance with","paragraph 1 may continue to be placed on","the market until six months after the date","referred to in paragraph 1.","2. 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These substances are known to decompose beyond\n accepted guidelines (FAO, WHO limits). Therefore, in such cases, it is more appropriate that\n the stability and the shelf-life is determined by other means, such as extrapolating the\n analytical data of the active substance from product aging experiments until reaching the\n\nefficacy threshold.","location":[[" Proposal for a regulation","Annex III \u2013 Title 1 - point 3.7 \u2013 subpoint 1 a (new)"]],"meta":{"created":"2019-07-03T05:38:21"},"new":["Storage stability and shelf life will be","generally determined based on the","stability of the active substance. In the","case of readily decomposable active","substances, the storage stability and the","shelf life may be determined by other valid","scientific means, such as extrapolating","the analytical data of the active substance","from product aging experiments until","reaching the efficacy threshold."],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"153","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Emma McClarkin, Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2010-03-23T00:00:00","id":"PE439.908-154","justification":"It is necessary to keep former Directive 98/80/EC\u2019s biocidal product type 20 (\u2018Preservatives\nfor food or feedstocks\u2019), but its definition needs to be amended, given that these biocidal\nproducts are not preservatives but disinfectants (as a consequence, the older definition led to\nconfusion). For instance, products used to disinfect feed from human pathogens such as\nSalmonella do not meet the requirements of the feed additives regulations. Indeed, the\nproducts do not \u2018favourably affect the feed\u2019 nor enhance its performance.","location":[["Proposal for a regulation","Annex V"]],"meps":[96919],"meta":{"created":"2019-07-03T05:38:21"},"new":["Product-type 20: Food and feed","disinfectants","Products used for disinfecting food or","feedstocks by the control of harmful","organisms."],"old":["Product-type 20: -"],"orig_lang":"en","peid":"PE439.908v01-00","reference":"2009/0076(COD)","seq":"154","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-439.908+01+DOC+PDF+V0//EN&language=EN"}],"changes":{"2014-11-10T00:20:53":[{"data":[{"body":"EC","commission":[{"Commissioner":"POTO\u010cNIK Janez","DG":{"title":"Environment","url":"http://ec.europa.eu/dgs/environment/"}}],"date":"2009-06-12T00:00:00","docs":[{"celexid":"CELEX:52009PC0267:EN","text":["
PURPOSE: to improve the safety of biocidal products used and\n placed on the market in the European Union and to simplify authorisation\n procedures.
PROPOSED ACT: Regulation\n of the European Parliament and of the Council.
BACKGROUND: Directive 98/8/EC establishes a harmonised regulatory\n framework for the authorisation and the placing on the market of biocidal\n products, the mutual recognition of these authorisations within the Community\n and the establishment at Community level of a positive list of active\n substances that may be used in biocidal products.
The review of the implementation\n of the Directive has indicated that for the evaluation of active substances,\n the simplified procedures provided for in the Directive, notably for low-risk\n products (Annex IA to the Directive), have no real effect. It has also\n indicated that the data requirements and data waiving provisions may be\n unclear or inconsistently applied. In addition, although product\n authorisation has not yet started, simplification of the procedures\n concerning the authorisation of biocidal products in Member States may be\n beneficial in reducing costs and administrative burden for companies and\n public authorities alike.
IMPACT ASSESSMENT: the impact\n assessment covers five main issues requiring action:
CONTENT: on 8 October 2008,\n the Commission submitted a report on the implementation of Directive 98/8/EC\n and the functioning of the simplified procedures (see COD/1993/0465\n under follow-up documents). Based on the conclusions of the report, the\n present proposal for a revision of Directive 98/8/EC aims to tackle the\n identified weaknesses of the regulatory framework during the first eight\n years of its implementation, to improve and update certain elements of the\n system and to avoid problems anticipated in the future. The main elements of\n the revision are as follows:
Legal form: the Directive is turned into a\n Regulation. As a result, there will be no need for national transposition measures,\n which is also expected to ensure more harmonised implementation of the\n regulatory framework in the Member States.
Scope: the scope is extended to\n biocides in materials that might come into contact with food. With regard to\n materials containing biocidal products, under the current situation, if an\n article is treated in the EU, then only a biocidal product that is authorised\n for that purpose may be used. However, if the article is treated with a\n biocidal product outside the EU and then imported, there is no control over\n the substance it may incorporate. This could represent risks for human health\n or for the environment. In addition, this situation is discriminatory to the\n EU industry, and could lead to the production of treated articles or\n materials being moved out of the EU in order to circumvent restrictions on\n certain substances. As part of the revision of the Biocides Directive, it is\n proposed that all articles or materials must be treated only with\n biocidal products authorised for that purpose in at least one Member State .
Labelling requirements: these have two objectives: (i)\n to inform consumers that the article was treated with a biocidal product; and\n (ii) to alert competent authorities in the Member States and trigger any\n existing inspection provisions aimed at ensuring compliance. The labelling\n provisions apply equally to EU and non EU manufacturers.
Authorisation: the proposal provides for\n harmonised procedures for the authorisation of biocidal products. The\n provisions regarding mutual recognition of authorisations are reworked and\n clarified, in particular the resolution of disputes between Member States, or\n between Member States and applicants. Apart from authorisations granted by\n Member States, a centralised authorisation system is proposed. This\n will be available for products identified as low-risk - without having to go\n through a separate evaluation of the active substance first- and for products\n containing new active substances.
The technical and scientific\n tasks relevant to this centralised system will be carried out by the European\n Chemicals Agency (ECHA). In addition, ECHA will undertake the\n coordination of organisational and technical tasks for the evaluation of all\n applications for inclusion of active substances in Annex I (the Community positive\n list for active substances) which were until now attributed to the Commission\n Joint Research Centre.
The simplified procedures\n involving the current Annex IA and IB are repealed, as very little use has\n been made of them so far. The simplified procedure involving frame\n formulations is modified so as to allow, within a group of products belonging\n to the same frame formulation, the replacement of any non-active ingredient\n by other non-active ingredients (currently, this is restricted to pigments,\n dyes, and perfumes).
The rules on comparative\n assessment are also modified: the proposed system comprises a first stage\n where active substances that still give rise to concern and are listed in\n Annex I, but are also flagged for substitution. Biocidal products containing\n these active substances may be compared with others that are available on the\n market for the same or similar use pattern, and if they present significantly\n higher risk than the latter, their authorisations are refused or cancelled at\n national level.
Research on animals: the new proposal will also\n reduce the number of tests on animals. In line with recent policy\n developments, animal testing may only be carried out once. Following the\n example of REACH (Community legislation on chemicals), the proposed\n Regulation shall force undertakings, that make a request for an\n authorisation, to share the results of their studies on animals, in exchange\n for equitable compensation. Moreover, tests proving the safety and\n effectiveness of a biocidal product shall only be required when there is a\n real need.
Data protection: the data protection system is\n significantly simplified, without cutting back on any acquired rights under\n the current system. It also grants protection to data submitted after the\n inclusion of the active substance in Annex I (mainly during product\n authorisation): these studies are not protected by the current legislation.\n The proposed data protection system also covers the case of newly generated\n studies.
Data requirements: these are modified: (i) the\n principle of proposing adaptations to the data requirements is formalised and\n Member States have to inform and assist the applicants with their adaptation\n requests; (ii) the grounds for waiving of data provided for in REACH will\n apply also for the proposed Regulation; (iii) the core data requirements are\n modified and certain long-term animal studies are only required when\n necessary. Lastly, the confidentiality provisions are slightly\n modified and aligned with those of REACH. This is to facilitate their application\n by ECHA.
Specific parallel trade rules: for the purpose of\n facilitating the movement of biocidal products in the EU territory, the\n proposal provides for specific parallel trade rules: authorised biocidal\n products that have the same use, contain the same active substance and have\n essentially identical composition to products authorised in another Member\n State may be placed on the market of that other Member State via a simplified\n administrative procedure.
BUDGETARY\n IMPLICATION: the proposal will have budgetary implications as there is a need\n to support the European Chemicals Agency (the Agency) in taking up the\n additional tasks related to the assessment and inclusion of active substances\n used in biocidal products in Annex I of the Regulation and the centralised\n authorisation of certain biocidal products. The Agency will receive specific\n fees from applicants for certain of these activities as well as an annual fee\n on products centrally authorised by the Community. The revenue from the fees\n will have to be supplemented by a subsidy from the Community.
\nThe presidency\n presented to the Council a progress report on the proposed regulation\n on biocides.
In addition to\n the improvements made to the drafting of the Regulation, discussions also indicate\n broad agreement on the following principles:
While there is\n support for the system of Union authorisations, there are differences\n in views on the scope of the system and the relevant decision-making\n procedures. With respect to scope, there seems to be a preference to include\n specific product types (e.g., in-can preservatives, metal-working fluids).
Several\n areas of disagreement remain at this stage, in\n particular regarding the role of the European Chemicals Agency (ECHA),\n specific procedures to encourage the placing on the market of low-risk\n products and on what measures, if any, should be taken to deal with \"free-riders\"\n (companies that place substances and products on the market without having contributed\n to the costs of their evaluation).
\nThe Committee\n on Environment, Public Health and Food Safety adopted the report drawn up by\n Christa KLASS on the proposal for a regulation of the European Parliament and\n of the Council concerning the placing on the market and use of biocidal\n products. It recommended that the European Parliament’s position at first reading\n under the ordinary legislative procedure (formerly known as the\n codecision procedure) should be to amend the Commission\n proposal as follows:
Precautionary\n principle and special vulnerability of children:\n the purpose of the Regulation is to ensure a high level of protection of both\n human and animal health and the environment and to improve the functioning of\n the internal market through the harmonisation of the rules on the placing on\n the market and use of biocidal products. The provisions of this Regulation\n are underpinned by the precautionary principle, the aim of which is to\n safeguard the health of humans, animals and the environment. Special\n attention shall be paid to protecting children, pregnant women and the sick.
Nanomaterials: there is scientific uncertainty about\n the safety of nanomaterials for human health and the environment and the\n Scientific Committee on Emerging and Newly Identified Health Risks\n (SCENIHR) has identified some specific health hazards as well as\n toxic effects on environmental organisms for some nanomaterials.\n SCENIHR has furthermore found a general lack of high-quality\n exposure data for both humans and the environment, concluding that the\n knowledge on the methodology for both exposure estimates and hazard\n identification needs to be further developed, validated and standardised.\n More and more biocidal products contain nanosilver. The use of\n nanomaterials in biocidal products may increase with the further development\n of technology. In order to ensure a high level of consumer protection, free\n movement of goods and legal certainty for manufacturers, it is necessary to\n develop a uniform definition for nanomaterials at international level. The\n Union should endeavour to reach an agreement on a definition in\n appropriate international fora. Should such an agreement be reached, the\n definition of nanomaterials in this Regulation should be adapted accordingly.\n At present, there is inadequate information on the risks associated with\n nanomaterials. In order to better assess their safety, the Scientific\n Committee for Consumer Safety (SCCS) should provide guidance in cooperation\n with relevant bodies on test methodologies which take into account specific\n characteristics of nanomaterials.
Exclusion\n from the scope: the Regulation will not apply to\n biocidal products within the scope of Regulation (EC) No 1935/2004 (Food\n Contact Regulation), Council Directive 98/83/EC on the quality of water\n intended for human consumption and Directive 2000/60/EC establishing a\n framework for Community action in the field of water policy.
Inclusion\n of an active substance in Annex I: Members specify that substances that fall under the exclusion\n criteria should only be included in Annex I for a maximum period of 5 years.\n This is in line with the PPP regulation.
Furthermore, active\n substances as such or in biocidal products may be placed on the market in\n the Union for use in biocidal products only if they have\n been included in Annex I in accordance with the provisions of this\n Regulation. Unless otherwise provided in this Regulation, all manufacturers\n of an active substance, as such or in a biocidal product, shall submit to the\n Agency an application for inclusion in Annex I. The committee states\n that only if manufacturers are obliged to comply with the same data\n requirements in Annex II will fair treatment be possible.
With regard to\n exclusion criteria: not later than 13 December 2013, the\n Commission shall adopt, by means of delegated acts, measures on specific\n scientific criteria for determining endocrine-disrupting properties. Pending\n the adoption of those criteria, substances that are or have to be classified,\n in accordance with the provisions of Regulation (EC) No 1272/2008, as\n carcinogenic category 2 and toxic for reproduction category 2, shall be\n considered as having endocrine-disrupting properties. In addition,\n substances such as those that have to be classified, in accordance with the\n provisions of Regulation (EC) No 1272/2008, as toxic for reproduction\n category 2 and which have toxic effects on the endocrine organs, may be considered as\n having such endocrine-disrupting properties.
With regard to\n data requirements for an application, the report specifies that a\n letter of access to a dossier may be part of the application. Members state\n that the applicants might not own the data required to support an\n application. They also make several amendments to provisions on the\n submission and validation of applications, with particular reference to the\n time limits, and state that the Agency should observe the same timeframes for\n the validation of applications as those introduced under Article 20 of REACH.\n
With respect\n to active substances which are candidates for substitution, Members\n consider that the criteria for identifying candidates of substitution should\n be aligned with the criteria for substances to be authorised under Regulation\n (EC) No 1907/2006 (REACH) (Article 57). Since the Agency will carry out the\n task of examining if an active substance fulfils any of the criteria, the\n committee states that consistency between the two regulations is advisable.\n It also considers that non-active isomers do not pose a danger to health or\n the environment. There is therefore no need to include them among substances\n that are candidates for substitution.
Renewal and\n review of an active substance inclusion:\n unless more strictly specified in the decision to renew the\n inclusion of an active substance in Annex I, the renewal\n may be renewed for a period not exceeding 10\n years (rather than an indefinite period, as stated in the proposal.) The\n committee considers that indefinite authorisations of new active substances\n will limit the incentive to conduct new research and provide new scientific\n data. In line with the current directive on biocides as well as the\n pesticides/plant protection legislation, there is a need for review of the\n active substances on a regular basis.
The committee\n also made amendments to the clauses on the submission and validation of\n applications, and aligned comitolgy provisions with the TFEU.
General\n principles of authorisation: application for\n authorisation shall be submitted to the Agency. When an applicant\n submits an application for national authorisation, that applicant shall, with\n the agreement of the Member State concerned on whose territory the national\n authorisation would be applicable, identify the evaluating\n competent authority in the application itself. The committee considers that\n the ECHA should conduct the initial validation of all applications.
Conditions for\n authorisation include a consideration of cumulative or synergistic effects.\n Where nanomaterials are used, the risk to the environment and to health has\n been assessed separately.
The report\n states that infestation with harmful organisms shall be avoided by\n suitable measures of deterrence to banish or repel these organisms. In\n addition, other precautionary steps have to be taken, such\n as proper warehousing of goods, compliance with hygiene standards and\n immediate disposal of waste. Only if these measures show no effect\n shall further steps be taken. Biocidal products that pose low risks for\n humans, animals and the environment shall always be used in\n preference to others. Biocidal products that are intended to harm, kill\n or destroy animals that are capable of experiencing pain and distress\n shall only be applied as a last resort.
Mandatory\n measures shall be established with a framework directive\n for Union action in order to achieve the sustainable professional\n use of biocidal products including the introduction of National Action\n Plans, integrated pest management, risk reduction measures and the promotion\n of alternatives.
With respect\n to the criteria for low-risk biocidal products, the committee states\n that the Commission's proposal does not contain any kind of evaluation at\n EU-level of low risk active substances. It is completely unclear what active\n substances a low-risk product can contain. In order to categorise anything as\n a low-risk product, it is crucial to know what it contains. Therefore, the\n active substances of a low risk product should as a very minimum be evaluated\n at an EU-level and be included on Annex I in order for the product to be\n recognised as a low-risk product.
Members go on\n to specify that low-risk products that are based on active substances\n included in Annex I or that are being evaluated with a view to inclusion in\n Annex I should require access to the data for the active substance. Property\n and data protection for active substances that have been included in Annex I\n should not be undermined.
The Commission\n should, provide technical and scientific guidance and tools, above all\n for SMEs.
Comparative\n assessment must be carried out in relation\n to all biocidal products having the same purpose, when sufficient\n experience has been gained in their use and they have been in use for at\n least five years. The aim is to provide a clearer definition of how the\n comparative assessment should be carried out. One element to be taken into\n consideration is the need for sufficient experience in the use of the\n product. This should be the rule and not the exception.
Members state\n that the Commission shall adopt measures laying down the procedure necessary\n for the definition of an application for comparative assessment of biocidal\n products. These measures shall define the criteria and algorithms to be used\n in a comparative assessment to ensure that there is a uniform application\n throughout the Union.
National\n authorisations: the person responsible for the\n placing of a biocidal product on the market, or his representative, shall\n submit an application for a national or Union authorisation to the\n Agency and inform the Agency of the name of the competent authority of the\n Member State of his choice which shall be responsible for the evaluation of\n the application (the 'evaluating competent authority'). The Agency\n shall, within three weeks after the receipt of the application, notify the\n evaluating competent authority that the application is available in the\n Agency database. Members state that the ECHA should carry out the initial\n validation of all applications throughout the Union, so that the\n evaluating competent authorities can concentrate on actual assessment of the\n applications. Currently, where the evaluating competent authorities\n consider both the administrative and the scientific aspects of applications,\n there have been inconsistencies in their approach. The Agency should observe\n the same timeframes for the validation of applications as those introduced\n under REACH.
Mutual\n recognition procedures: applications for a\n national authorisation which involve a mutual recognition procedure may be\n submitted to the competent authority in English. A single authorisation\n number shall be used in all the Member States involved.
The report\n sets out procedures and the time period for the resolution of disputes\n between Member States.
Community\n authorisations: the Union authorisation\n may be granted to any category of biocidal products. The\n report states that a centralised authorisation system has clear benefits for\n the functioning of the internal market by ensuring consistent assessments and\n a harmonised implementation of the requirements in\n all Member States, driving best practices and same standards of\n consumer protection across Europe. The Community authorisation procedure\n should therefore extend to all product categories instead of only a small\n minority of products (low risk biocidal products and products with new active\n substances).
A new clause\n is inserted on biocidal products with similar conditions of use.
The report\n makes several amendments to provisions on the cancellation, review and\n amendments of authorisations. It notes that in addition to revision of\n the inclusion of an active substance in Annex I, an indication (from\n practical measurements) that the aims of the Water Framework Directive are\n jeopardised must also be grounds for cancelling or amending the authorisation\n of a biocidal product.
Derogations\n and research: under the Commission proposal, a\n test on an unauthorised biocidal product for research and development\n purposes which involved the release of the product into the environment would\n require prior national authorisation. The time required in order to obtain it\n could hamper innovation. It is proposed instead that a 30-day period be set\n to allow the authority to assess whether the proposed test gives rise to any\n concern and to deliver its opinion. The report also makes some amendments to\n the provisions on data protection and data sharing.
Report: the Commission shall draw up a report on\n the implementation of this Regulation and, in particular, on the functioning\n of the Union authorisation procedure and mutual recognition, by 1 January\n 2016 (instead of 1 January 2023).
Information: the label must show whether the product contains nanomaterials\n and any specific related risks and, following\n each reference to nanomaterials, the word \"nano\" in brackets.\n Safety data sheets must contain specified information. The report states that\n Member States shall take the necessary measures to provide the public with\n information about the benefits and risks associated with biocidal\n products and ways of minimising the use of those products. The Commission\n shall make available on the internet a list of all active substances\n available within the internal market.
National\n helpdesks in Member States: Member States shall\n establish national helpdesks to provide advice to applicants, in particular\n to SMEs, and any other interested parties on their respective\n responsibilities and obligations under this Regulation. These shall\n be in addition to any assistance provided by the Agency.
Comitology: Members made certain amendments in order\n to align the comitology regime to the new system of delegated acts in\n accordance with Article 290 TFEU, and provided for transitional measures\n until the new rules on implementing acts are adopted.
\nThe European\n Parliament adopted by 550 votes in favour to 22 against with 80 abstentions,\n a resolution under the ordinary legislative procedure (formerly the co\n decision procedure).on the proposal for a regulation of the European\n Parliament and of the Council concerning the placing on the market and use of\n biocidal products. The main points are as follows:
Precautionary\n principle and special vulnerability of children:\n the purpose of this Regulation is to ensure a high level of protection of\n both human and animal health and the environment and to improve the\n functioning of the internal market through the harmonisation of the rules on\n the placing on the market and use of biocidal products. The provisions of\n this Regulation are underpinned by the precautionary principle, in order to\n ensure that active substances or products placed on the market do not have\n harmful effects on humans, non-target species and the environment. Special\n attention shall be paid to protecting children, pregnant women and the sick.
Nanomaterials: there is scientific uncertainty about the safety of\n nanomaterials for human health and the environment and the Scientific\n Committee on Emerging and Newly Identified Health Risks (SCENIHR) has\n identified some specific health hazards as well as toxic effects on\n environmental organisms for some nanomaterials. SCENIHR has furthermore found\n a general lack of high-quality exposure data for both humans and the\n environment, concluding that the knowledge on the methodology for both\n exposure estimates and hazard identification needs to be further developed,\n validated and standardised. More and more biocidal products contain\n nanosilver. The use of nanomaterials in biocidal products may increase with\n the further development of technology. In order to ensure a high level of\n consumer protection, free movement of goods and legal certainty for manufacturers,\n it is necessary to develop a uniform definition for nanomaterials at\n international level. The Union should endeavour to reach an agreement on a\n definition in appropriate international fora. Should such an agreement be\n reached, the definition of nanomaterials in this Regulation should be adapted\n accordingly. At present, there is inadequate information on the risks\n associated with nanomaterials. In order better to assess their safety, the\n Scientific Committee for Consumer Safety (SCCS) should provide guidance in\n cooperation with relevant bodies on test methodologies which take into\n account specific characteristics of nanomaterials. The Commission should\n regularly review the provisions on nanomaterials in the light of scientific\n progress.
AFS\n Convention: in view of the environmental impact\n that anti-fouling products can have in the water, the Commission must take\n steps at international level to ensure that the AFS Convention (International\n Convention on the Control of Harmful Anti-Fouling Systems on Ships) is\n ratified worldwide and adapted to the Regulation.
Exclusion\n from the scope: active substances which shall\n not be included in Annex I include active substances which have been\n classified in accordance with Regulation (EC) No 1272/2008 as, or which meet\n the criteria to be classified as, carcinogen/ mutagen/oxic for reproduction\n category 1A or 1B. They also include: active substances which, on the basis\n of the assessment of Union or internationally agreed test guidelines or other\n peer-reviewed scientific data and information, are considered as having\n endocrine-disrupting properties that may cause adverse effect in humans, or\n which are identified under Regulation (EC) No 1907/2006 as having endocrine\n disrupting properties; persistent, bio-accumulative and toxic; and persistent\n organic pollutants (POP).
However, these\n may be included in Annex I under certain specified circumstances – for\n example, if it is shown by evidence that the active substance is necessary to\n prevent or control a serious danger to public or animal health or to the\n environment, to food and feed safety, or to the public interest and that\n there are no effective alternative substances or technologies available.
Member\n State authorising a biocidal product containing an active substance included\n in Annex I pursuant to this provision shall draw up a substitution plan\n concerning the control of the serious danger by other means including\n non-chemical methods, which are as effective as the biocidal product\n concerned and shall without delay transmit that plan to the Commission. The\n use of the biocidal product with the active substance concerned shall be\n restricted to those Member States where the serious danger has to be\n prevented or, if it occurs, controlled.
Lastly, not\n later than 13 December 2013, the Commission shall adopt, by means of\n delegated acts measures on specific scientific criteria for determining\n endocrine-disrupting properties. Pending the adoption of those criteria,\n substances that are or have to be classified, in accordance with the provisions\n of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for\n reproduction category 2, shall be considered as having endocrine-disrupting\n properties. Substances such as those that are classified, in accordance with\n the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction\n category 2 and which have toxic effects on the endocrine organs, may be\n considered as having such endocrine-disrupting properties.
With regard to\n data requirements for an application, the resolution specifies\n that a letter of access to a dossier may be part of the application.\n They also make several amendments to provisions on the submission and\n validation of applications, with particular reference to the time limits, and\n state that the Agency should observe the same timeframes for the validation\n of applications as those introduced under Article 20 of REACH.
With respect\n to active substances which are candidates for substitution, Members\n considers that non-active isomers do not pose a danger to health or the\n environment. There is therefore no need to include them among substances that\n are candidates for substitution.
Renewal and\n review of an active substance inclusion:\n unless more strictly specified in the decision to renew the\n inclusion of an active substance in Annex I, the renewal\n may be renewed for a period not exceeding 10\n years (rather than an indefinite period, as stated in the proposal.)
Parliament\n also made amendments to the clauses on the submission and validation of\n applications, and aligned comitolgy provisions with the TFEU.
General\n principles of authorisation: application for\n authorisation shall be submitted to the Agency. When an applicant\n submits an application for national authorisation, that applicant shall, with\n the agreement of the Member State concerned on whose territory the national\n authorisation would be applicable, identify the evaluating\n competent authority in the application itself. Parliament considers that\n the ECHA should conduct the initial validation of all applications.
Conditions\n for authorisation include a consideration of\n cumulative or synergistic effects. Where nanomaterials are used, the risk to\n the environment and to health has been assessed separately. The resolution\n states that infestation with harmful organisms shall be avoided by suitable\n measures of deterrence to banish or repel these organisms. In addition, other\n precautionary steps have to be taken, such as proper warehousing of goods,\n compliance with hygiene standards and immediate disposal of waste. Only if\n these measures show no effect shall further steps be taken. Biocidal products\n that pose low risks for humans, animals and the environment shall always be\n used in preference to others. Biocidal products that are intended to harm,\n kill or destroy animals that are capable of experiencing pain and distress\n shall only be applied as a last resort.
Within two\n years of the date of adoption of the Regulation, mandatory measures shall be\n established and implemented with a framework directive for Union action in\n order to achieve the sustainable professional use of biocidal products\n including the introduction of National Action Plans, integrated pest\n management, risk reduction measures and the promotion of alternatives.
With respect\n to the criteria for low-risk biocidal products, Parliament\n expanded the criteria for those substances which should not be considered as\n low risk, including substances that are corrosive, explosive, contain a\n nanomaterial, and very toxic or toxic. It deleted the derogation in cases of\n negligible exposure.
Comparative\n assessment must be carried out in relation to all biocidal\n products having the same purpose, when sufficient experience has been gained\n in their use and they have been in use for at least five years. Members state\n that the Commission shall adopt measures laying down the procedure necessary\n for the definition of an application for comparative assessment of biocidal\n products. These measures shall define the criteria and algorithms to be used\n in a comparative assessment to ensure that there is a uniform application\n throughout the Union.
National\n authorisations: the person responsible for the\n placing of a biocidal product on the market, or his representative, shall\n submit an application for a national or Union authorisation to the Agency and\n inform the Agency of the name of the competent authority of the Member State\n of his choice which shall be responsible for the evaluation of the\n application (the 'evaluating competent authority'). The Agency shall, within\n three weeks after the receipt of the application, notify the evaluating\n competent authority that the application is available in the Agency database.\n
Mutual\n recognition procedures: applications for a national authorisation which\n involve a mutual recognition procedure may be submitted to the competent\n authority in English. A single authorisation number shall be used in all the\n Member States involved.
Community\n authorisations: from 2013 the Community\n authorisation may be granted to the following categories of biocidal products:\n (a) biocidal products containing one or more new active substances; (b)\n low-risk biocidal products. From 2017 the Community authorisation may be\n granted to all categories of biocidal products with the exception of biocidal\n products that contain active substances that fall under the provisions on the\n exclusion criteria. A Member State shall notify the Commission\n where it restricts or prohibit the Union authorisation for certain\n biocidal products in the territory of that Member State. Such restriction or\n prohibition must be justified on specified grounds.
Parliament\n makes several amendments to provisions on the cancellation, review and\n amendments of authorisations.
Labelling: the label must show whether the product contains nanomaterials\n and any specific related risks and, following\n each reference to nanomaterials, the word \"nano\" in\n brackets. Safety data sheets must contain specified information. The\n resolution states that Member States shall take the necessary measures to provide\n the public with information about the benefits and risks associated\n with biocidal products and ways of minimising the use of those products. The\n Commission shall make available on the internet a list of all active\n substances available within the internal market.
Treated\n articles or material: these must contain\n the words \"treated with biocidal products\", followed by\n the name, using wherever possible common nomenclature (e.g.\n INCI), of all active substances that were used to treat the article or\n materials or that were incorporated in the articles or materials, where\n relevant, and for all active substances which are intended to be released\n under normal or foreseeable conditions of use from the treated article or\n material, unless at least equivalent labelling requirements or alternative\n means to meet information requirements already exist under sector-specific\n legislation ; the names of all nanomaterials followed by the word\n \"nano\" in brackets. They must also contain any hazard statement or\n precautionary statement set out in the authorisation for the biocidal product\n but only if the biocidal product is intended to be released under normal or\n reasonably foreseeable conditions of use.
National\n helpdesks in Member States: Member States shall\n establish national helpdesks to provide advice to applicants, in particular\n to SMEs, and any other interested parties on their respective\n responsibilities and obligations under this Regulation. These shall\n be in addition to any assistance provided by the Agency under the terms\n of the Regulation.
Comitology: Members made certain amendments in order to align the\n comitology regime to the new system of delegated acts in accordance with\n Article 290 TFEU, and provided for transitional measures until the new rules\n on implementing acts are adopted.
Reports: the Commission must submit the following reports:
Animal\n testing: given that animal\n testing should be avoided, testing on vertebrate animals shall be undertaken\n only as a last resortwhere no alternative solution can be employed without\n producing an impact on humans or animals. Testing on vertebrate animals shall\n not be repeated for the purposes of the Regulation. Where those tests or\n studies have already been submitted in connection with a previous\n application, the competent authority or the Agency shall, without delay,\n assess technical equivalence in relation to the comparison source. If the\n technical equivalence assessment is positive, the competent authority or\n the Agency shall without delay communicate the name and contact details of\n the owner of the information to the prospective applicant.
Annexes: Parliament made certain amendments to the Annexes.
\nThe Council adopted its position on first\n reading with a view to the adoption of a regulation of the European\n Parliament and of the Council concerning the making available on the market\n and use of biocidal products.
The European Parliament adopted several\n hundred amendments to the Commission proposal. Many are acceptable to the\n Council and it has therefore included them in its position at first reading\n (wholly, in part, or in principle).
The following points should be mentioned:\n
The Council's\n position at first reading also includes a number of changes other than those\n envisaged in the European Parliament's position. The changes of substance\n compared to the Commission's initial proposal concern principally the following\n points:
1) Consequences of\n the Lisbon Treaty: like the\n European Parliament, the Council had to adapt the text of the original\n proposal to the new regime laid down by the Lisbon Treaty regarding powers\n conferred by the legislator on the Commission. However, the Council\n considered certain matters which the Parliament was prepared to delegate to\n the Commission, to be of such importance that they should be decided at the\n legislative level, i.e. by Parliament and Council jointly. The Council also\n considered certain decisions for which the Parliament had considered\n delegated acts appropriate to be in the nature of implementing measures\n rather than acts which supplement or amend the basic act.
2) Procedure for\n the approval of active substances: approval of active substances will, as at present,\n require the Commission to adopt a legal act. However, rather than amending\n the basic act repeatedly, the Council considered free-standing implementing\n measures preferable to a list of approved active substances in an annex to\n the basic act. This change to the procedure for the approval of active\n substances parallels that recently agreed for plant protection products.\n While they were listed in Annex I to Directive 91/414/EEC, Regulation (EC) No\n 1107/2009 provides for their approval via implementing acts, for their\n compilation into a free-standing list and for electronic public access to\n that list.
3) ECHA's role: ECHA will have an essential coordination role to play in the\n approval of active substances and the Union authorisation of biocidal\n products. However, the Council considers that:
4) Products subject to a simplified\n authorisation procedure: the Council suggests the\n establishment of a specific list of active substances presenting low concern\n and a simplified authorisation procedure for biocidal products containing\n those active substances. To encourage widespread marketing and use of such\n products, they could as a general rule circulate throughout the Union after authorisation by a single Member State and a simple notification procedure in\n other Member States. If another Member State raises objections, the dispute\n settlement mechanisms of the mutual recognition procedure would be\n applicable.
5) Fees:\n the Council considers that a different approach needs to be taken for fees\n payable to ECHA from those payable to Member States' competent authorities.\n While it is appropriate for the Commission to adopt an implementing act\n laying down the fees payable to ECHA (rather than delegated acts, as the\n Commission proposed), Member States should be free to set national fees.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the recommendation for second reading in the\nreport by Christa KLASS (EPP, DE) regarding the Council position at\nfirst reading with a view to the adoption of a regulation of the\nEuropean Parliament and of the Council concerning the making\navailable on the market and use of biocidal products.
\nThe committee reinserted several amendments adopted by\nthe European Parliament in forst reading. It recommended that\nParliaments position on second reading should modify the\nCouncils position as follows:
\nPurpose of the Regulation: Members want to specify that the purpose of\nprotecting both human and animal health and the environment is at\nan equal level as the purpose of the functioning of the internal\nmarket, and not just an ancillary purpose. In view of the\nprecautionary principle, it is necessary to ensure that\nactive substances or products placed on the market do not\nhave harmful effects on humans, on-target species and the\nenvironment. Special attention shall be paid to protecting\nchildren, pregnant women and the sick.
\nScope: Council\nDirective 98/83/EC on the quality of water intended for human\nconsumption should remain the main legislation applicable biocidal\nproducts used for drinking water treatment.
\nFurthermore, materials and articles intended to come\ninto contact with food, including any biocidal products linked to\nsuch materials, are already covered by Regulation (EC)\nNo 1935/2004, and should be excluded from the scope of this\nregulation.
\nThe report specifies that Member States may allow for\nexemptions from this Regulation in specific cases for\ncertain biocidal products, on their own or in a treated article,\nwhere necessary in the interests of defence or of animal\ndisease control.
\nDangerous substances: a\nsubstance which fulfils the criteria for being a POP under\nRegulation (EC) No 850/2004, or which fulfils the criteria for\nbeing persistent, bio-accumulative and toxic (PBT) or very\npersistent and very bio-accumulative (vPvB) in accordance with\nAnnex XIII of Regulation (EC) No 1907/2006 should be considered a\ndangerous substance.
\nNanomaterials: Members\nconsider that the definition of nanomaterials is an essential\nelement of the regulation and thus needs to be adopted by the\nlegislator. No later than six months after the adoption of the\nRecommendation concerning the definition of nanomaterials, the\nCommission shall make a legislative proposal to amend this\nRegulation to include that definition in this\nRegulation.
\nNanomaterials can have very different characteristics\nto the same substances in normal form. The risks posed by\nnanomaterials in biocidal products to the environment and to\nhealth must therefore be investigated separately.
\nFurthermore, in light of the current lack of\nappropriate risk assessment of nanomaterials, they should not\nqualify for the simplified authorisation procedure. Where a treated\narticle contains a biocidal product, the person\nresponsible for the placing on the market of that treated article\nshall ensure that the label provides certain specified information\nincluding the name of all nanomaterials, followed by the word\n\"nano\" in brackets.
\nInclusion of active substances: an active substance\nmay not be placed on the market for use in a biocidal product\nunless it is included in Annex I, in accordance with the\nRegulation. An active substance referred to in Article 5 may only\nbe included in Annex -I for an initial period of 5 years.\nSubstances that come under the exclusion criteria may only be\nincluded in Annex 1 for an initial period of 5 years.
\nExclusion criteria:\nMembers specify that active substances shall not be approved for\ninclusion in Annex I if, on the basis of the assessment of Union or\ninternationally agreed test guidelines or other peer-reviewed\nscientific data and information, including a review of the\nscientific literature, reviewed by the Agency, they are considered\nas having endocrine-disrupting properties that may cause\nadverse effects in humans.
\nNo later than 13 December 2013, the Commission\nshall adopt delegated acts specifying scientific criteria for the\ndetermination of endocrine disrupting properties.
\nMembers suggest that active substances may not be\nincluded in Annex I unless at least one of the following conditions\nis fulfilled:
\n\n· \nthe exposure of humans or the\nenvironment to the active substance in question in a\nbiocidal product, under normal conditions of use, is\nnegligible, meaning that the product is used in closed systems\nor under other conditions excluding contact with\nhumans;
\n\n· \nit is shown by evidence that the active\nsubstance is necessary to prevent or control a serious\ndanger to public or animal health or to the environment,\nto food and feed safety, or to the public interest and\nthat there are no effective alternative substances or technologies\navailable.
\nThe use of any biocidal product containing active\nsubstances included in Annex I shall be subject to appropriate\nrisk mitigation measures to ensure that exposure of humans\nand the environment is minimised.
\nMember State authorising a biocidal product containing\nan active substance included in Annex I shall draw up a\nsubstitution plan concerning the control of the serious\ndanger by other means including non-chemical methods, which are as\neffective as the biocidal product concerned and shall without delay\ntransmit that plan to the Commission. The use of the biocidal\nproduct with the active substance concerned shall be restricted to\nthose Member States where the serious danger has to be prevented\nor, if it occurs, controlled.
\nApproval of an active substance: in order to preserve Parliaments rights of\ncontrol, active substances should continue to be included in an\nAnnex to the Regulation and decided by means of delegated\nacts. The act should include the conditions and relevant dates\nof inclusion and expiry of inclusion. There should also be a\ndecision in its own right if a substance is not included in Annex\nI, in order to have a record of all decisions.
\nActive substances for substitution: active substances must be candidates or substitution\nif (i) it meets the criteria to be classified, in accordance with\nRegulation (EC) No 1272/2008, as a respiratory sensitiser; (ii)\nthere are reasons for concern linked to the nature of the critical\neffects, in particular developmental neurotoxic or immunotoxic\neffects.
\nRenewal and review of approval: unless more strictly specified in the\ndecision to renew the approval of an active substance, the renewal\nshall be for ten years (and not 15 as the Council had\nprescribed) for all product-types to which the approval\napplies.
\nThe Commission may review the approval of an active\nsubstance for one or more product-types at any time where there\nare significant indications, not only serious\nindications, that any of the conditions laid down) are no\nlonger met. The Commission may also inclusion where there are\nsignificant indications that the objectives of Directive 2000/60/EC\non water may not be achieved.
\nGeneral conditions of authorisation: Members consider that the notification of products\nshould be made at least 30 days in advance to allow a real market\nmonitoring. They made certain amendments to make it easier for\nbiocidal products with the same formulation and intended use to be\nmarketed under different brand names and by different\nmanufacturers. As such authorisations relate to biocidal products\nwhose formulations are identical, there is no need to assess their\nimpact on human health and the environment again.
\nMeasures geared to the sustainable use of biocidal\nproducts: the committee states that\nMember States shall establish and implement mandatory measures on\nthe basis of a Union framework directive in order to achieve the\nsustainable professional use of biocidal products, including\nthe introduction of National Action Plans, integrated pest\nmanagement, risk reduction measures and the promotion of\nalternatives.
\nThe Commission shall submit a legislative proposal for\nthe framework directive within two years of adoption of the\nregulation.
\nMutual recognition: for\nthe purposes of simplification, Members state that in the case of a\nbiocidal product family, one single authorisation number\nshall be provided for all biocidal products which belong to that\nproduct family.
\nUnion authorisations:\nthe amended text stipulates that applicants may apply for Union\nauthorisation for biocidal products which have similar conditions\nof use across the Union with the exception of biocidal\nproducts that contain active substances that fall under Article 5\n(exclusion criteria):
\n\n· \nfrom 2013 the Union authorisation may be\ngranted to biocidal products containing one or more new active\nsubstances;
\n\n· \nfrom 2017 the Union authorisation may be granted\nto all categories of biocidal products.
\nTreated articles or materials: the labelling shall be clearly visible, easily\nlegible and appropriately durable. Where necessary because of the\nsize or the function of the treated article, the labelling shall be\nprinted on the packaging, on the instructions for use or on the\nwarranty in the national language or languages of\nthe Member State on whose market the treated article\nis to be placed. In the case of treated goods which are not\nproduced as part of a series, but rather designed and manufactured\nto meet a specific order, the manufacturer may agree other methods\nof providing the customer with the relevant information.
\nAnimal testing: any\nperson intending to perform tests or studies involving vertebrate\nanimals or non-vertebrate animals, (\"the prospective applicant\"),\nshall submit a written request to the Agency to determine\nwhether such tests or studies have already been submitted to the\nAgency, or to a competent authority in connection with a previous\napplication under this Regulation or\nDirective 98/8/EC for an identical or technically\nequivalent product.
\nThe request shall be accompanied by fees\nin accordance with the text.
\nFurthermore, Members want to align the text relating\nto data sharing with the provisions in REACH.
\nReports: every three\nyears, Member States shall submit to the Commission a report on the\nimplementation of this Regulation in their respective territories.\nThe implementation reports shall be published on the relevant\nwebsite of the Commission. The report shall include\ninformation on any poisonings and, where available, occupational\ndiseases involving biocidal products, especially regarding\nvulnerable groups, and the actions undertaken to lower the risk of\nfuture cases, and information on the impact on the\nenvironment.
\n\n· \nNot later than five years after the entry into\nforce of this Regulation, the Commission shall draw up a report on\nthe impact of the spread of biocidal products in the\nenvironment.
\n\n· \nAt the latest two years after the entry into\nforce of the Regulation, the Commission shall submit a report on\nthe assessment of the risks to human health and the environment\npresented by the use of nanomaterials in biocidal products and on\nspecific measures to be taken with regard to them.
\nPublic access: the\nCommission shall make available on the internet a list of all\nactive substances available within the internal market. The persons\nresponsible for the placing on the market of biocidal products\nshall make available on the internet a list of such products. This\nwebsite shall serve to increase transparency for consumers and to\nfacilitate an easy and fast collection of data on the properties\nand conditions of use of these products.
\nComitology: the amended\ntext contains several amendments with a view to aligning the\ncomitology procedure to the new system on delegated acts in\naccordance with Article 290 TFEU. The Regulation must contain\ndetailed provisions on the delegation of power.
\nThe European Parliament adopted a legislative\nresolution on the Council position with a view to the adoption of a\nregulation of the European Parliament and of the Council concerning\nthe making available on the market and use of biocidal\nproducts.
\nParliament adopted its position in second reading\nfollowing the ordinary legislative procedure. The amendments\nadopted in plenary are the result of a compromise negotiated\nbetween Parliament and Council. They amend the Councils\nposition as follows:
\nPurpose and scope: as\nrequired by Parliament, the amended text clarifies that special\nattention shall be paid to the protection of vulnerable\ngroups.
\nThe Regulation shall not apply to biocidal products or\ntreated articles that are within the scope of the\ninstruments specified in the text, amongst which is Directive\n2009/48/EC on the safety of toys.
\nIt will not apply to: (i) food or feed used\nas repellents or attractants; (ii) biocidal products when used\nas processing aids.
\nNothing in the Regulation shall prevent Member States\nfrom restricting or banning the use of biocidal products in the\npublic supply of drinking water.
\nBiocidal product: the definition in the amended text covers any\nsubstance or mixture generated from substances or mixtures which\nare not themselves biocidal products in the meaning of the\nRegulation to be used with the intention of destroying, deterring,\nrendering harmless, preventing the action of, or otherwise exerting\na controlling effect on, any harmful organism by any means other\nthan mere physical or mechanical action.
\nSubstance of concern: this means a substance which fulfils the criteria\nfor being a POP under Regulation (EC) No 850/2004, or which fulfils\nthe criteria for being persistent, bio-accumulative and toxic (PBT)\nor very persistent and very bio-accumulative (vPvB) in accordance\nwith Annex XIII of Regulation (EC) No 1907/2006.
\nNanomaterial: this is defined as a natural or manufactured\nactive substance or non-active substance containing particles, in\nan unbound state or as an aggregate or as an agglomerate and where,\nfor 50 % or more of the particles in the number size distribution,\none or more external dimensions is in the size range 1 nm-100 nm.\nFullerenes, graphene flakes and single wall carbon nanotubes with\none or more external dimensions below 1 nm shall be considered as\nnanomaterials.
\nFor the purposes of the definition of nanomaterial,\nparticle, agglomerate and\naggregate are defined.
\nThe Commission shall be empowered to adopt delegated\nacts in order to adapt the definition of nanomaterial in view of\ntechnical and scientific progress and taking into account the\nCommission Recommendation 2011/696/EU.
\nWith regard to authorisation, the text conforms to\nParliaments request and states that risks posed by\nnanomaterials in biocidal products to health and the environment\nmust be examined separately.
\nA biocidal product shall be eligible for the\nsimplified procedure only if the biocidal product does not\ncontain a nanomaterial.
\nWith regard to treated articles, the person\nresponsible for the placing on the market of that treated article\nshall ensure that the label states the name of all\nnanomaterials contained in biocidal products, followed by the word\nnano in brackets.
\nApproval of active substances: an active substance may only be approved for an\ninitial period not exceeding 5 years. The approval\nshall specify the date of approval and the expiry date of the\napproval of the active substance.
\nExclusion criteria:\nactive substances which are considered as having\nendocrine-disrupting properties that may cause adverse effects in\nhumans shall not be approved. No later than 13 December 2013,\nthe Commission shall adopt delegated acts specifying\nscientific criteria for the determination of endocrine disrupting\nproperties.
\nActive substances may be approved if it is shown that\nat least one of the following conditions is met:
\n\n· \nthe risk to humans or the environment from\nexposure to the active substance in a biocidal product, under\nrealistic worst case conditions of use, is negligible, in\nparticular where the product is used in closed systems\nor under other conditions which aim at excluding\ncontact with humans and release to the environment;
\n\n· \nit is shown by evidence that the active\nsubstance is essential to prevent or to control a serious danger to\npublic or animal health or to the environment; or not\napproving the active substance would cause disproportionate\nnegative impacts for society when compared with the risk to human\nhealth or the environment arising from the use of the\nsubstance.
\nWhen deciding whether an active substance may be\napproved in accordance with the first subparagraph, the\navailability of suitable and sufficient alternative substances\nor technologies shall be a key consideration.
\nThe use of any biocidal product containing active\nsubstances approved in accordance with the regulation shall be\nsubject to appropriate risk mitigation measures to ensure that\nexposure of humans and the environment is minimised.
\nSubmission and validation of\napplications: the evaluating\ncompetent authority shall, as soon as possible after the Agency has\naccepted an application, inform the applicant of the fees payable\nunder the regulation and shall reject the application if the\napplicant fails to pay the fees within 30 days.
\nWhere the evaluating competent authority considers\nthat there are concerns for human health or the environment as\na result of the cumulative effects from the use of biocidal\nproducts containing the same or\ndifferent active substances, it shall document its\nconcerns and include this as part of its conclusions.
\nActive substances which are candidates for\nsubstitution: an active substance\nshall be considered a candidate for substitution if it meets\nthe criteria to be classified, in accordance with Regulation (EC)\nNo 1272/2008, as a respiratory sensitiser.
\nRenewal and review of approval: the renewal shall be for 15 years for all\nproduct-types to which the approval applies, unless a shorter\nperiod is specified in the Regulation renewing the approval of an\nactive substance.
\nThe Commission may review the approval of an active\nsubstance for one or more product-types at any time where there\nare significant indications that the conditions laid down\nin the regulation are no longer met.
\nGeneral conditions of authorisation: as Members had asked, the notification of products\nshould be made at least 30 days in advance to allow a real\nmarket monitoring. The Commission shall, by means of an\nimplementing act, specify procedures for the authorisation of the\nsame biocidal products by the same or different enterprises under\nthe same terms and conditions.
\nFor applications for Union authorisations, the\nsummary of the characteristics of the biocidal product shall\nbe provided in one of the official languages of the Union accepted\nby the evaluating competent authority at the time of application\nand in all official languages of the Union before the authorisation\nof the product.
\nMeasures geared to the sustainable use of biocidal\nproducts: three years after the entry\ninto force of the Regulation, the Commission shall, on the basis of\nexperience gained with the application of the Regulation, present a\nreport on how the Regulation contributes to a sustainable use of\nbiocidal products, including on the need to introduce additional\nmeasures, in particular for professional users, to reduce the risks\nposed to human and animal health and the environment by biocidal\nproducts. That report shall, inter alia, examine:
\n\n· \nthe promotion of best practices as a means of\nreducing the use of biocidal products to the minimum;
\n\n· \nthe most effective approaches for monitoring the\nuse of biocidal products;
\n\n· \nthe development and application of integrated\npest management principles with respect to the use of biocidal\nproducts;
\n\n· \nthe risks posed by the use of biocidal products\nin specific areas such as schools, workplaces, kindergartens,\npublic spaces, geriatric care centres or in the vicinity of surface\nor groundwater and whether additional measures are needed to\naddress them;
\n\n· \nthe role that the improved performance of the\nequipment used for the application of biocidal products could make\nto sustainable use.
\nOn basis of that report, the Commission shall, if\nappropriate, present a legislative proposal.
\nUnion authorisations:\nthe amended text stipulates that applicants may apply for Union\nauthorisation for biocidal products which have similar conditions\nof use across the Union with the exception of biocidal\nproducts that contain active substances that fall under Article 5\n(exclusion criteria) and certain product types:
\n\n· \nfrom 1 September 2013, the Union authorisation\nmay be granted to biocidal products containing one or more new\nactive substances and biocidal products of\nproduct-types 1 (human hygiene), 3 (veterinary hygiene), 5\n(drinking water), 18 (insecticides, acaricides and products to\ncontrol other arthropods) and 19 (repellents and\nattractants);
\n\n· \nfrom 1 January 2017, the Union authorisation may\nbe granted to biocidal products of product-types 2 (Disinfectants\nand algaecides not intended for direct application to humans\nor animals) , 6 (preservatives for products during storage)\nand 13 (working or cutting fluid preservatives);
\n\n· \nfrom 1 January 2020, the Union\nauthorisation may be granted to all categories\nof biocidal products.
\nDerogation from the requirements: by way of derogation, a competent authority may\npermit, for a period not exceeding 180 days, the making\navailable on the market or use of a biocidal product which does not\nfulfil the conditions for authorisation laid down in the\nRegulation, for a limited and controlled use under the\nsupervision of the competent authority , if such a measure is\nnecessary because of a danger to public health, animal\nhealth or the environment which cannot be contained by other\nmeans.
\nResearch and development: any person intending to carry out an experiment or\ntest that may involve, or result in, release of the biocidal\nproduct into the environment shall first notify the relevant\ncompetent authority of the Member State where the experiment or\ntest will occur. The notification shall include the identity\nof the biocidal product or active substance, labelling data and\nquantities supplied and all available data on possible effects on\nhuman or animal health or impact on the environment. The person\nconcerned shall make any other information available to the\ncompetent authorities on request.
\nLabelling: the person\nresponsible for the placing on the market of a treated article\nshall label it with any relevant instructions for use, including\nany precautions to be taken, if this is necessary to protect humans\nand the environment. The supplier of a treated article shall, upon\nrequest by a consumer, provide, within 45 days, free of charge,\ninformation on the biocidal treatment of the treated\narticle.
\nThe labelling shall be clearly visible, easily legible\nand appropriately durable. Where necessary because of the size or\nthe function of the treated article, the labelling shall be printed\non the packaging, on the instructions for use or on the\nwarranty in the official language or languages of the Member\nState of introduction, unless that Member State provides\notherwise.
\nAnimal testing: in order\nto avoid animal testing, testing on vertebrate animals for the\npurposes of this Regulation shall be undertaken only as a last\nresort. Any person intending to perform tests or studies\nshall, in the case of data involving tests on vertebrate animals,\nsubmit a written request to the Agency to\ndetermine whether such tests or studies have already been\nsubmitted to the Agency or to a competent authority in\nconnection with a previous application under the Regulation or\nDirective 98/8/EC.
\nWhere such tests or studies have already been\nsubmitted to the Agency or to a competent authority in\nconnection with a previous application, the Agency shall, without\ndelay, communicate the name and contact details of the\ndata submitter(s) and data owner(s) to the\nprospective applicant.
\nData owners must share information in exchange\nfor equitable compensation.
\nThe Regulation shall apply from\n1 September 2013.
\nPURPOSE: to improve free movement of biocidal products\nin the Union whilst ensuring a high level of human, animal and\nenvironmental protection.
\nLEGISLATIVE ACT: Regulation (EU) No 528/2012 of\nthe European Parliament and of the Council concerning the making\navailable on the market and use of biocidal products.
\nCONTENT: following in second reading, the Council and\nthe European Parliament adopted a regulation concerning the placing\non the market and use of biocidal products. The provisions of the\nRegulation are based on the precautionary principle, the aim\nof which is to safeguard the health of humans, the health of\nanimals and the environment.
\nAs required by the European Parliament, particular\nattention shall be paid to the protection of vulnerable\ngroups.
\nThe Regulation applies to insecticides, disinfectants\nand repellents, but not medicines or agricultural pesticides. It\naims to simplify the authorisation procedures in the\ninternal market through the harmonisation of legislation on\nbiocidal products, while ensuring a high level of protection for\nboth human and animal health and the environment.
\nThe Regulation lays down certain\nprinciples.
\n(1) The establishment at Union level of a list of\nactive substances which may be used in biocidal\nproducts.
\n(2) Conditions for the approval and renewal of\napproval of active substances :
\n\n· \nan active substance shall be approved for an\ninitial period not exceeding 10 years if at least one biocidal\nproduct containing that active substance may be expected to meet\nthe criteria laid down in the text ;
\n\n· \nactive substances that are classified as\ncarcinogenic, mutagenic, toxic for reproduction or considered as\nhaving endocrine-disrupting properties, shall not be approved\nexcept in specified circumstances ;
\n\n· \nthe approval of an active substance shall not\ncover nanomaterials except where explicitly\nmentioned ;
\n\n· \nan active substance that falls under the\nexclusion criteria may only be approved for an initial period not\nexceeding five years ;
\n\n· \nthe renewal of an approval of an active\nsubstance shall be for 15 years for all product-types to which the\napproval applies, unless a shorter period is specified in the\nimplementing regulation renewing such an approval ;
\n\n· \nthe Commission may review the approval of an\nactive substance for one or more product-types at any time where\nthere are significant indications that the conditions laid down in\nthe Regulation are no longer met.
\n(3) The granting of an authorisation for biocidal\nproducts: biocidal products should neither be made available on\nthe market nor used unless authorised in accordance with the\nRegulation. As requested by the European Parliament, the\nauthorisation holder shall notify each competent authority at least\n30 days before placing it on the market.
\n(4) The mutual recognition of authorisations within\nthe Union so as to reduce the administrative burden on\nproducers.
\n(5) The making available on the market and the use\nof biocidal products within one or more Member States or the\nUnion: the Regulation introduces the possibility of granting an\nUnion authorisation for biocidal products, in addition to the\ncurrent system of national product authorisation. A first series of\nproduct-types may be authorised at Union level as from 2013. From\n2020 onwards, most biocidal products will qualify for this\nprocedure.
\n(6) The placing on the market of treated articles\nwhich are not biocidal products: articles incorporating pest\ncontrol chemicals may not be treated with unauthorised chemicals\nanymore and must be labelled under the conditions specified in the\nRegulation. These obligations apply to all articles treated with\nbiocidal products on the EU market, including imported\nones.
\nAuthorisation holders shall keep records of the\nbiocidal products they place on the market for at least 10 years\nafter placing on the market, or 10 years after the date on which\nthe authorisation was cancelled or expired, whichever is the\nearlier.
\nThe Agency shall establish and maintain an information\nsystem which shall be referred to as the Register for Biocidal\nProducts.
\nENTRY INTO FORCE: 17/07/2012.
\nAPPLICATION: from 01/09/2013.
\nDELEGATED ACTS: the Commission is empowered to adopt\ndelegated acts to supplement or amend the Regulation. The power to\nadopt delegated acts is conferred on the Commission for a period of\nfive years from 17 July 2012. This shall be tacitly extended for\nperiods of an identical duration, unless the European Parliament or\nthe Council opposes such extension. A delegated act shall\nenter into force only if no objection has been expressed either by\nthe European Parliament or the Council within a period of two\nmonths of notification (this period may be extended by two months).\nIf objections are made by the European Parliament or the Council,\nthe delegated act shall not enter into force.
\nPURPOSE: to improve the safety of biocidal products used and\n placed on the market in the European Union and to simplify authorisation\n procedures.
PROPOSED ACT: Regulation\n of the European Parliament and of the Council.
BACKGROUND: Directive 98/8/EC establishes a harmonised regulatory\n framework for the authorisation and the placing on the market of biocidal\n products, the mutual recognition of these authorisations within the Community\n and the establishment at Community level of a positive list of active\n substances that may be used in biocidal products.
The review of the implementation\n of the Directive has indicated that for the evaluation of active substances,\n the simplified procedures provided for in the Directive, notably for low-risk\n products (Annex IA to the Directive), have no real effect. It has also\n indicated that the data requirements and data waiving provisions may be\n unclear or inconsistently applied. In addition, although product\n authorisation has not yet started, simplification of the procedures\n concerning the authorisation of biocidal products in Member States may be\n beneficial in reducing costs and administrative burden for companies and\n public authorities alike.
IMPACT ASSESSMENT: the impact\n assessment covers five main issues requiring action:
CONTENT: on 8 October 2008,\n the Commission submitted a report on the implementation of Directive 98/8/EC\n and the functioning of the simplified procedures (see COD/1993/0465\n under follow-up documents). Based on the conclusions of the report, the\n present proposal for a revision of Directive 98/8/EC aims to tackle the\n identified weaknesses of the regulatory framework during the first eight\n years of its implementation, to improve and update certain elements of the\n system and to avoid problems anticipated in the future. The main elements of\n the revision are as follows:
Legal form: the Directive is turned into a\n Regulation. As a result, there will be no need for national transposition measures,\n which is also expected to ensure more harmonised implementation of the\n regulatory framework in the Member States.
Scope: the scope is extended to\n biocides in materials that might come into contact with food. With regard to\n materials containing biocidal products, under the current situation, if an\n article is treated in the EU, then only a biocidal product that is authorised\n for that purpose may be used. However, if the article is treated with a\n biocidal product outside the EU and then imported, there is no control over\n the substance it may incorporate. This could represent risks for human health\n or for the environment. In addition, this situation is discriminatory to the\n EU industry, and could lead to the production of treated articles or\n materials being moved out of the EU in order to circumvent restrictions on\n certain substances. As part of the revision of the Biocides Directive, it is\n proposed that all articles or materials must be treated only with\n biocidal products authorised for that purpose in at least one Member State .
Labelling requirements: these have two objectives: (i)\n to inform consumers that the article was treated with a biocidal product; and\n (ii) to alert competent authorities in the Member States and trigger any\n existing inspection provisions aimed at ensuring compliance. The labelling\n provisions apply equally to EU and non EU manufacturers.
Authorisation: the proposal provides for\n harmonised procedures for the authorisation of biocidal products. The\n provisions regarding mutual recognition of authorisations are reworked and\n clarified, in particular the resolution of disputes between Member States, or\n between Member States and applicants. Apart from authorisations granted by\n Member States, a centralised authorisation system is proposed. This\n will be available for products identified as low-risk - without having to go\n through a separate evaluation of the active substance first- and for products\n containing new active substances.
The technical and scientific\n tasks relevant to this centralised system will be carried out by the European\n Chemicals Agency (ECHA). In addition, ECHA will undertake the\n coordination of organisational and technical tasks for the evaluation of all\n applications for inclusion of active substances in Annex I (the Community positive\n list for active substances) which were until now attributed to the Commission\n Joint Research Centre.
The simplified procedures\n involving the current Annex IA and IB are repealed, as very little use has\n been made of them so far. The simplified procedure involving frame\n formulations is modified so as to allow, within a group of products belonging\n to the same frame formulation, the replacement of any non-active ingredient\n by other non-active ingredients (currently, this is restricted to pigments,\n dyes, and perfumes).
The rules on comparative\n assessment are also modified: the proposed system comprises a first stage\n where active substances that still give rise to concern and are listed in\n Annex I, but are also flagged for substitution. Biocidal products containing\n these active substances may be compared with others that are available on the\n market for the same or similar use pattern, and if they present significantly\n higher risk than the latter, their authorisations are refused or cancelled at\n national level.
Research on animals: the new proposal will also\n reduce the number of tests on animals. In line with recent policy\n developments, animal testing may only be carried out once. Following the\n example of REACH (Community legislation on chemicals), the proposed\n Regulation shall force undertakings, that make a request for an\n authorisation, to share the results of their studies on animals, in exchange\n for equitable compensation. Moreover, tests proving the safety and\n effectiveness of a biocidal product shall only be required when there is a\n real need.
Data protection: the data protection system is\n significantly simplified, without cutting back on any acquired rights under\n the current system. It also grants protection to data submitted after the\n inclusion of the active substance in Annex I (mainly during product\n authorisation): these studies are not protected by the current legislation.\n The proposed data protection system also covers the case of newly generated\n studies.
Data requirements: these are modified: (i) the\n principle of proposing adaptations to the data requirements is formalised and\n Member States have to inform and assist the applicants with their adaptation\n requests; (ii) the grounds for waiving of data provided for in REACH will\n apply also for the proposed Regulation; (iii) the core data requirements are\n modified and certain long-term animal studies are only required when\n necessary. Lastly, the confidentiality provisions are slightly\n modified and aligned with those of REACH. This is to facilitate their application\n by ECHA.
Specific parallel trade rules: for the purpose of\n facilitating the movement of biocidal products in the EU territory, the\n proposal provides for specific parallel trade rules: authorised biocidal\n products that have the same use, contain the same active substance and have\n essentially identical composition to products authorised in another Member\n State may be placed on the market of that other Member State via a simplified\n administrative procedure.
BUDGETARY\n IMPLICATION: the proposal will have budgetary implications as there is a need\n to support the European Chemicals Agency (the Agency) in taking up the\n additional tasks related to the assessment and inclusion of active substances\n used in biocidal products in Annex I of the Regulation and the centralised\n authorisation of certain biocidal products. The Agency will receive specific\n fees from applicants for certain of these activities as well as an annual fee\n on products centrally authorised by the Community. The revenue from the fees\n will have to be supplemented by a subsidy from the Community.
\nThe presidency\n presented to the Council a progress report on the proposed regulation\n on biocides.
In addition to\n the improvements made to the drafting of the Regulation, discussions also indicate\n broad agreement on the following principles:
While there is\n support for the system of Union authorisations, there are differences\n in views on the scope of the system and the relevant decision-making\n procedures. With respect to scope, there seems to be a preference to include\n specific product types (e.g., in-can preservatives, metal-working fluids).
Several\n areas of disagreement remain at this stage, in\n particular regarding the role of the European Chemicals Agency (ECHA),\n specific procedures to encourage the placing on the market of low-risk\n products and on what measures, if any, should be taken to deal with \"free-riders\"\n (companies that place substances and products on the market without having contributed\n to the costs of their evaluation).
\nThe Committee\n on Environment, Public Health and Food Safety adopted the report drawn up by\n Christa KLASS on the proposal for a regulation of the European Parliament and\n of the Council concerning the placing on the market and use of biocidal\n products. It recommended that the European Parliament’s position at first reading\n under the ordinary legislative procedure (formerly known as the\n codecision procedure) should be to amend the Commission\n proposal as follows:
Precautionary\n principle and special vulnerability of children:\n the purpose of the Regulation is to ensure a high level of protection of both\n human and animal health and the environment and to improve the functioning of\n the internal market through the harmonisation of the rules on the placing on\n the market and use of biocidal products. The provisions of this Regulation\n are underpinned by the precautionary principle, the aim of which is to\n safeguard the health of humans, animals and the environment. Special\n attention shall be paid to protecting children, pregnant women and the sick.
Nanomaterials: there is scientific uncertainty about\n the safety of nanomaterials for human health and the environment and the\n Scientific Committee on Emerging and Newly Identified Health Risks\n (SCENIHR) has identified some specific health hazards as well as\n toxic effects on environmental organisms for some nanomaterials.\n SCENIHR has furthermore found a general lack of high-quality\n exposure data for both humans and the environment, concluding that the\n knowledge on the methodology for both exposure estimates and hazard\n identification needs to be further developed, validated and standardised.\n More and more biocidal products contain nanosilver. The use of\n nanomaterials in biocidal products may increase with the further development\n of technology. In order to ensure a high level of consumer protection, free\n movement of goods and legal certainty for manufacturers, it is necessary to\n develop a uniform definition for nanomaterials at international level. The\n Union should endeavour to reach an agreement on a definition in\n appropriate international fora. Should such an agreement be reached, the\n definition of nanomaterials in this Regulation should be adapted accordingly.\n At present, there is inadequate information on the risks associated with\n nanomaterials. In order to better assess their safety, the Scientific\n Committee for Consumer Safety (SCCS) should provide guidance in cooperation\n with relevant bodies on test methodologies which take into account specific\n characteristics of nanomaterials.
Exclusion\n from the scope: the Regulation will not apply to\n biocidal products within the scope of Regulation (EC) No 1935/2004 (Food\n Contact Regulation), Council Directive 98/83/EC on the quality of water\n intended for human consumption and Directive 2000/60/EC establishing a\n framework for Community action in the field of water policy.
Inclusion\n of an active substance in Annex I: Members specify that substances that fall under the exclusion\n criteria should only be included in Annex I for a maximum period of 5 years.\n This is in line with the PPP regulation.
Furthermore, active\n substances as such or in biocidal products may be placed on the market in\n the Union for use in biocidal products only if they have\n been included in Annex I in accordance with the provisions of this\n Regulation. Unless otherwise provided in this Regulation, all manufacturers\n of an active substance, as such or in a biocidal product, shall submit to the\n Agency an application for inclusion in Annex I. The committee states\n that only if manufacturers are obliged to comply with the same data\n requirements in Annex II will fair treatment be possible.
With regard to\n exclusion criteria: not later than 13 December 2013, the\n Commission shall adopt, by means of delegated acts, measures on specific\n scientific criteria for determining endocrine-disrupting properties. Pending\n the adoption of those criteria, substances that are or have to be classified,\n in accordance with the provisions of Regulation (EC) No 1272/2008, as\n carcinogenic category 2 and toxic for reproduction category 2, shall be\n considered as having endocrine-disrupting properties. In addition,\n substances such as those that have to be classified, in accordance with the\n provisions of Regulation (EC) No 1272/2008, as toxic for reproduction\n category 2 and which have toxic effects on the endocrine organs, may be considered as\n having such endocrine-disrupting properties.
With regard to\n data requirements for an application, the report specifies that a\n letter of access to a dossier may be part of the application. Members state\n that the applicants might not own the data required to support an\n application. They also make several amendments to provisions on the\n submission and validation of applications, with particular reference to the\n time limits, and state that the Agency should observe the same timeframes for\n the validation of applications as those introduced under Article 20 of REACH.\n
With respect\n to active substances which are candidates for substitution, Members\n consider that the criteria for identifying candidates of substitution should\n be aligned with the criteria for substances to be authorised under Regulation\n (EC) No 1907/2006 (REACH) (Article 57). Since the Agency will carry out the\n task of examining if an active substance fulfils any of the criteria, the\n committee states that consistency between the two regulations is advisable.\n It also considers that non-active isomers do not pose a danger to health or\n the environment. There is therefore no need to include them among substances\n that are candidates for substitution.
Renewal and\n review of an active substance inclusion:\n unless more strictly specified in the decision to renew the\n inclusion of an active substance in Annex I, the renewal\n may be renewed for a period not exceeding 10\n years (rather than an indefinite period, as stated in the proposal.) The\n committee considers that indefinite authorisations of new active substances\n will limit the incentive to conduct new research and provide new scientific\n data. In line with the current directive on biocides as well as the\n pesticides/plant protection legislation, there is a need for review of the\n active substances on a regular basis.
The committee\n also made amendments to the clauses on the submission and validation of\n applications, and aligned comitolgy provisions with the TFEU.
General\n principles of authorisation: application for\n authorisation shall be submitted to the Agency. When an applicant\n submits an application for national authorisation, that applicant shall, with\n the agreement of the Member State concerned on whose territory the national\n authorisation would be applicable, identify the evaluating\n competent authority in the application itself. The committee considers that\n the ECHA should conduct the initial validation of all applications.
Conditions for\n authorisation include a consideration of cumulative or synergistic effects.\n Where nanomaterials are used, the risk to the environment and to health has\n been assessed separately.
The report\n states that infestation with harmful organisms shall be avoided by\n suitable measures of deterrence to banish or repel these organisms. In\n addition, other precautionary steps have to be taken, such\n as proper warehousing of goods, compliance with hygiene standards and\n immediate disposal of waste. Only if these measures show no effect\n shall further steps be taken. Biocidal products that pose low risks for\n humans, animals and the environment shall always be used in\n preference to others. Biocidal products that are intended to harm, kill\n or destroy animals that are capable of experiencing pain and distress\n shall only be applied as a last resort.
Mandatory\n measures shall be established with a framework directive\n for Union action in order to achieve the sustainable professional\n use of biocidal products including the introduction of National Action\n Plans, integrated pest management, risk reduction measures and the promotion\n of alternatives.
With respect\n to the criteria for low-risk biocidal products, the committee states\n that the Commission's proposal does not contain any kind of evaluation at\n EU-level of low risk active substances. It is completely unclear what active\n substances a low-risk product can contain. In order to categorise anything as\n a low-risk product, it is crucial to know what it contains. Therefore, the\n active substances of a low risk product should as a very minimum be evaluated\n at an EU-level and be included on Annex I in order for the product to be\n recognised as a low-risk product.
Members go on\n to specify that low-risk products that are based on active substances\n included in Annex I or that are being evaluated with a view to inclusion in\n Annex I should require access to the data for the active substance. Property\n and data protection for active substances that have been included in Annex I\n should not be undermined.
The Commission\n should, provide technical and scientific guidance and tools, above all\n for SMEs.
Comparative\n assessment must be carried out in relation\n to all biocidal products having the same purpose, when sufficient\n experience has been gained in their use and they have been in use for at\n least five years. The aim is to provide a clearer definition of how the\n comparative assessment should be carried out. One element to be taken into\n consideration is the need for sufficient experience in the use of the\n product. This should be the rule and not the exception.
Members state\n that the Commission shall adopt measures laying down the procedure necessary\n for the definition of an application for comparative assessment of biocidal\n products. These measures shall define the criteria and algorithms to be used\n in a comparative assessment to ensure that there is a uniform application\n throughout the Union.
National\n authorisations: the person responsible for the\n placing of a biocidal product on the market, or his representative, shall\n submit an application for a national or Union authorisation to the\n Agency and inform the Agency of the name of the competent authority of the\n Member State of his choice which shall be responsible for the evaluation of\n the application (the 'evaluating competent authority'). The Agency\n shall, within three weeks after the receipt of the application, notify the\n evaluating competent authority that the application is available in the\n Agency database. Members state that the ECHA should carry out the initial\n validation of all applications throughout the Union, so that the\n evaluating competent authorities can concentrate on actual assessment of the\n applications. Currently, where the evaluating competent authorities\n consider both the administrative and the scientific aspects of applications,\n there have been inconsistencies in their approach. The Agency should observe\n the same timeframes for the validation of applications as those introduced\n under REACH.
Mutual\n recognition procedures: applications for a\n national authorisation which involve a mutual recognition procedure may be\n submitted to the competent authority in English. A single authorisation\n number shall be used in all the Member States involved.
The report\n sets out procedures and the time period for the resolution of disputes\n between Member States.
Community\n authorisations: the Union authorisation\n may be granted to any category of biocidal products. The\n report states that a centralised authorisation system has clear benefits for\n the functioning of the internal market by ensuring consistent assessments and\n a harmonised implementation of the requirements in\n all Member States, driving best practices and same standards of\n consumer protection across Europe. The Community authorisation procedure\n should therefore extend to all product categories instead of only a small\n minority of products (low risk biocidal products and products with new active\n substances).
A new clause\n is inserted on biocidal products with similar conditions of use.
The report\n makes several amendments to provisions on the cancellation, review and\n amendments of authorisations. It notes that in addition to revision of\n the inclusion of an active substance in Annex I, an indication (from\n practical measurements) that the aims of the Water Framework Directive are\n jeopardised must also be grounds for cancelling or amending the authorisation\n of a biocidal product.
Derogations\n and research: under the Commission proposal, a\n test on an unauthorised biocidal product for research and development\n purposes which involved the release of the product into the environment would\n require prior national authorisation. The time required in order to obtain it\n could hamper innovation. It is proposed instead that a 30-day period be set\n to allow the authority to assess whether the proposed test gives rise to any\n concern and to deliver its opinion. The report also makes some amendments to\n the provisions on data protection and data sharing.
Report: the Commission shall draw up a report on\n the implementation of this Regulation and, in particular, on the functioning\n of the Union authorisation procedure and mutual recognition, by 1 January\n 2016 (instead of 1 January 2023).
Information: the label must show whether the product contains nanomaterials\n and any specific related risks and, following\n each reference to nanomaterials, the word \"nano\" in brackets.\n Safety data sheets must contain specified information. The report states that\n Member States shall take the necessary measures to provide the public with\n information about the benefits and risks associated with biocidal\n products and ways of minimising the use of those products. The Commission\n shall make available on the internet a list of all active substances\n available within the internal market.
National\n helpdesks in Member States: Member States shall\n establish national helpdesks to provide advice to applicants, in particular\n to SMEs, and any other interested parties on their respective\n responsibilities and obligations under this Regulation. These shall\n be in addition to any assistance provided by the Agency.
Comitology: Members made certain amendments in order\n to align the comitology regime to the new system of delegated acts in\n accordance with Article 290 TFEU, and provided for transitional measures\n until the new rules on implementing acts are adopted.
\nThe European\n Parliament adopted by 550 votes in favour to 22 against with 80 abstentions,\n a resolution under the ordinary legislative procedure (formerly the co\n decision procedure).on the proposal for a regulation of the European\n Parliament and of the Council concerning the placing on the market and use of\n biocidal products. The main points are as follows:
Precautionary\n principle and special vulnerability of children:\n the purpose of this Regulation is to ensure a high level of protection of\n both human and animal health and the environment and to improve the\n functioning of the internal market through the harmonisation of the rules on\n the placing on the market and use of biocidal products. The provisions of\n this Regulation are underpinned by the precautionary principle, in order to\n ensure that active substances or products placed on the market do not have\n harmful effects on humans, non-target species and the environment. Special\n attention shall be paid to protecting children, pregnant women and the sick.
Nanomaterials: there is scientific uncertainty about the safety of\n nanomaterials for human health and the environment and the Scientific\n Committee on Emerging and Newly Identified Health Risks (SCENIHR) has\n identified some specific health hazards as well as toxic effects on\n environmental organisms for some nanomaterials. SCENIHR has furthermore found\n a general lack of high-quality exposure data for both humans and the\n environment, concluding that the knowledge on the methodology for both\n exposure estimates and hazard identification needs to be further developed,\n validated and standardised. More and more biocidal products contain\n nanosilver. The use of nanomaterials in biocidal products may increase with\n the further development of technology. In order to ensure a high level of\n consumer protection, free movement of goods and legal certainty for manufacturers,\n it is necessary to develop a uniform definition for nanomaterials at\n international level. The Union should endeavour to reach an agreement on a\n definition in appropriate international fora. Should such an agreement be\n reached, the definition of nanomaterials in this Regulation should be adapted\n accordingly. At present, there is inadequate information on the risks\n associated with nanomaterials. In order better to assess their safety, the\n Scientific Committee for Consumer Safety (SCCS) should provide guidance in\n cooperation with relevant bodies on test methodologies which take into\n account specific characteristics of nanomaterials. The Commission should\n regularly review the provisions on nanomaterials in the light of scientific\n progress.
AFS\n Convention: in view of the environmental impact\n that anti-fouling products can have in the water, the Commission must take\n steps at international level to ensure that the AFS Convention (International\n Convention on the Control of Harmful Anti-Fouling Systems on Ships) is\n ratified worldwide and adapted to the Regulation.
Exclusion\n from the scope: active substances which shall\n not be included in Annex I include active substances which have been\n classified in accordance with Regulation (EC) No 1272/2008 as, or which meet\n the criteria to be classified as, carcinogen/ mutagen/oxic for reproduction\n category 1A or 1B. They also include: active substances which, on the basis\n of the assessment of Union or internationally agreed test guidelines or other\n peer-reviewed scientific data and information, are considered as having\n endocrine-disrupting properties that may cause adverse effect in humans, or\n which are identified under Regulation (EC) No 1907/2006 as having endocrine\n disrupting properties; persistent, bio-accumulative and toxic; and persistent\n organic pollutants (POP).
However, these\n may be included in Annex I under certain specified circumstances – for\n example, if it is shown by evidence that the active substance is necessary to\n prevent or control a serious danger to public or animal health or to the\n environment, to food and feed safety, or to the public interest and that\n there are no effective alternative substances or technologies available.
Member\n State authorising a biocidal product containing an active substance included\n in Annex I pursuant to this provision shall draw up a substitution plan\n concerning the control of the serious danger by other means including\n non-chemical methods, which are as effective as the biocidal product\n concerned and shall without delay transmit that plan to the Commission. The\n use of the biocidal product with the active substance concerned shall be\n restricted to those Member States where the serious danger has to be\n prevented or, if it occurs, controlled.
Lastly, not\n later than 13 December 2013, the Commission shall adopt, by means of\n delegated acts measures on specific scientific criteria for determining\n endocrine-disrupting properties. Pending the adoption of those criteria,\n substances that are or have to be classified, in accordance with the provisions\n of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for\n reproduction category 2, shall be considered as having endocrine-disrupting\n properties. Substances such as those that are classified, in accordance with\n the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction\n category 2 and which have toxic effects on the endocrine organs, may be\n considered as having such endocrine-disrupting properties.
With regard to\n data requirements for an application, the resolution specifies\n that a letter of access to a dossier may be part of the application.\n They also make several amendments to provisions on the submission and\n validation of applications, with particular reference to the time limits, and\n state that the Agency should observe the same timeframes for the validation\n of applications as those introduced under Article 20 of REACH.
With respect\n to active substances which are candidates for substitution, Members\n considers that non-active isomers do not pose a danger to health or the\n environment. There is therefore no need to include them among substances that\n are candidates for substitution.
Renewal and\n review of an active substance inclusion:\n unless more strictly specified in the decision to renew the\n inclusion of an active substance in Annex I, the renewal\n may be renewed for a period not exceeding 10\n years (rather than an indefinite period, as stated in the proposal.)
Parliament\n also made amendments to the clauses on the submission and validation of\n applications, and aligned comitolgy provisions with the TFEU.
General\n principles of authorisation: application for\n authorisation shall be submitted to the Agency. When an applicant\n submits an application for national authorisation, that applicant shall, with\n the agreement of the Member State concerned on whose territory the national\n authorisation would be applicable, identify the evaluating\n competent authority in the application itself. Parliament considers that\n the ECHA should conduct the initial validation of all applications.
Conditions\n for authorisation include a consideration of\n cumulative or synergistic effects. Where nanomaterials are used, the risk to\n the environment and to health has been assessed separately. The resolution\n states that infestation with harmful organisms shall be avoided by suitable\n measures of deterrence to banish or repel these organisms. In addition, other\n precautionary steps have to be taken, such as proper warehousing of goods,\n compliance with hygiene standards and immediate disposal of waste. Only if\n these measures show no effect shall further steps be taken. Biocidal products\n that pose low risks for humans, animals and the environment shall always be\n used in preference to others. Biocidal products that are intended to harm,\n kill or destroy animals that are capable of experiencing pain and distress\n shall only be applied as a last resort.
Within two\n years of the date of adoption of the Regulation, mandatory measures shall be\n established and implemented with a framework directive for Union action in\n order to achieve the sustainable professional use of biocidal products\n including the introduction of National Action Plans, integrated pest\n management, risk reduction measures and the promotion of alternatives.
With respect\n to the criteria for low-risk biocidal products, Parliament\n expanded the criteria for those substances which should not be considered as\n low risk, including substances that are corrosive, explosive, contain a\n nanomaterial, and very toxic or toxic. It deleted the derogation in cases of\n negligible exposure.
Comparative\n assessment must be carried out in relation to all biocidal\n products having the same purpose, when sufficient experience has been gained\n in their use and they have been in use for at least five years. Members state\n that the Commission shall adopt measures laying down the procedure necessary\n for the definition of an application for comparative assessment of biocidal\n products. These measures shall define the criteria and algorithms to be used\n in a comparative assessment to ensure that there is a uniform application\n throughout the Union.
National\n authorisations: the person responsible for the\n placing of a biocidal product on the market, or his representative, shall\n submit an application for a national or Union authorisation to the Agency and\n inform the Agency of the name of the competent authority of the Member State\n of his choice which shall be responsible for the evaluation of the\n application (the 'evaluating competent authority'). The Agency shall, within\n three weeks after the receipt of the application, notify the evaluating\n competent authority that the application is available in the Agency database.\n
Mutual\n recognition procedures: applications for a national authorisation which\n involve a mutual recognition procedure may be submitted to the competent\n authority in English. A single authorisation number shall be used in all the\n Member States involved.
Community\n authorisations: from 2013 the Community\n authorisation may be granted to the following categories of biocidal products:\n (a) biocidal products containing one or more new active substances; (b)\n low-risk biocidal products. From 2017 the Community authorisation may be\n granted to all categories of biocidal products with the exception of biocidal\n products that contain active substances that fall under the provisions on the\n exclusion criteria. A Member State shall notify the Commission\n where it restricts or prohibit the Union authorisation for certain\n biocidal products in the territory of that Member State. Such restriction or\n prohibition must be justified on specified grounds.
Parliament\n makes several amendments to provisions on the cancellation, review and\n amendments of authorisations.
Labelling: the label must show whether the product contains nanomaterials\n and any specific related risks and, following\n each reference to nanomaterials, the word \"nano\" in\n brackets. Safety data sheets must contain specified information. The\n resolution states that Member States shall take the necessary measures to provide\n the public with information about the benefits and risks associated\n with biocidal products and ways of minimising the use of those products. The\n Commission shall make available on the internet a list of all active\n substances available within the internal market.
Treated\n articles or material: these must contain\n the words \"treated with biocidal products\", followed by\n the name, using wherever possible common nomenclature (e.g.\n INCI), of all active substances that were used to treat the article or\n materials or that were incorporated in the articles or materials, where\n relevant, and for all active substances which are intended to be released\n under normal or foreseeable conditions of use from the treated article or\n material, unless at least equivalent labelling requirements or alternative\n means to meet information requirements already exist under sector-specific\n legislation ; the names of all nanomaterials followed by the word\n \"nano\" in brackets. They must also contain any hazard statement or\n precautionary statement set out in the authorisation for the biocidal product\n but only if the biocidal product is intended to be released under normal or\n reasonably foreseeable conditions of use.
National\n helpdesks in Member States: Member States shall\n establish national helpdesks to provide advice to applicants, in particular\n to SMEs, and any other interested parties on their respective\n responsibilities and obligations under this Regulation. These shall\n be in addition to any assistance provided by the Agency under the terms\n of the Regulation.
Comitology: Members made certain amendments in order to align the\n comitology regime to the new system of delegated acts in accordance with\n Article 290 TFEU, and provided for transitional measures until the new rules\n on implementing acts are adopted.
Reports: the Commission must submit the following reports:
Animal\n testing: given that animal\n testing should be avoided, testing on vertebrate animals shall be undertaken\n only as a last resortwhere no alternative solution can be employed without\n producing an impact on humans or animals. Testing on vertebrate animals shall\n not be repeated for the purposes of the Regulation. Where those tests or\n studies have already been submitted in connection with a previous\n application, the competent authority or the Agency shall, without delay,\n assess technical equivalence in relation to the comparison source. If the\n technical equivalence assessment is positive, the competent authority or\n the Agency shall without delay communicate the name and contact details of\n the owner of the information to the prospective applicant.
Annexes: Parliament made certain amendments to the Annexes.
\nThe Council adopted its position on first\n reading with a view to the adoption of a regulation of the European\n Parliament and of the Council concerning the making available on the market\n and use of biocidal products.
The European Parliament adopted several\n hundred amendments to the Commission proposal. Many are acceptable to the\n Council and it has therefore included them in its position at first reading\n (wholly, in part, or in principle).
The following points should be mentioned:\n
The Council's\n position at first reading also includes a number of changes other than those\n envisaged in the European Parliament's position. The changes of substance\n compared to the Commission's initial proposal concern principally the following\n points:
1) Consequences of\n the Lisbon Treaty: like the\n European Parliament, the Council had to adapt the text of the original\n proposal to the new regime laid down by the Lisbon Treaty regarding powers\n conferred by the legislator on the Commission. However, the Council\n considered certain matters which the Parliament was prepared to delegate to\n the Commission, to be of such importance that they should be decided at the\n legislative level, i.e. by Parliament and Council jointly. The Council also\n considered certain decisions for which the Parliament had considered\n delegated acts appropriate to be in the nature of implementing measures\n rather than acts which supplement or amend the basic act.
2) Procedure for\n the approval of active substances: approval of active substances will, as at present,\n require the Commission to adopt a legal act. However, rather than amending\n the basic act repeatedly, the Council considered free-standing implementing\n measures preferable to a list of approved active substances in an annex to\n the basic act. This change to the procedure for the approval of active\n substances parallels that recently agreed for plant protection products.\n While they were listed in Annex I to Directive 91/414/EEC, Regulation (EC) No\n 1107/2009 provides for their approval via implementing acts, for their\n compilation into a free-standing list and for electronic public access to\n that list.
3) ECHA's role: ECHA will have an essential coordination role to play in the\n approval of active substances and the Union authorisation of biocidal\n products. However, the Council considers that:
4) Products subject to a simplified\n authorisation procedure: the Council suggests the\n establishment of a specific list of active substances presenting low concern\n and a simplified authorisation procedure for biocidal products containing\n those active substances. To encourage widespread marketing and use of such\n products, they could as a general rule circulate throughout the Union after authorisation by a single Member State and a simple notification procedure in\n other Member States. If another Member State raises objections, the dispute\n settlement mechanisms of the mutual recognition procedure would be\n applicable.
5) Fees:\n the Council considers that a different approach needs to be taken for fees\n payable to ECHA from those payable to Member States' competent authorities.\n While it is appropriate for the Commission to adopt an implementing act\n laying down the fees payable to ECHA (rather than delegated acts, as the\n Commission proposed), Member States should be free to set national fees.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the recommendation for second reading in the\nreport by Christa KLASS (EPP, DE) regarding the Council position at\nfirst reading with a view to the adoption of a regulation of the\nEuropean Parliament and of the Council concerning the making\navailable on the market and use of biocidal products.
\nThe committee reinserted several amendments adopted by\nthe European Parliament in forst reading. It recommended that\nParliaments position on second reading should modify the\nCouncils position as follows:
\nPurpose of the Regulation: Members want to specify that the purpose of\nprotecting both human and animal health and the environment is at\nan equal level as the purpose of the functioning of the internal\nmarket, and not just an ancillary purpose. In view of the\nprecautionary principle, it is necessary to ensure that\nactive substances or products placed on the market do not\nhave harmful effects on humans, on-target species and the\nenvironment. Special attention shall be paid to protecting\nchildren, pregnant women and the sick.
\nScope: Council\nDirective 98/83/EC on the quality of water intended for human\nconsumption should remain the main legislation applicable biocidal\nproducts used for drinking water treatment.
\nFurthermore, materials and articles intended to come\ninto contact with food, including any biocidal products linked to\nsuch materials, are already covered by Regulation (EC)\nNo 1935/2004, and should be excluded from the scope of this\nregulation.
\nThe report specifies that Member States may allow for\nexemptions from this Regulation in specific cases for\ncertain biocidal products, on their own or in a treated article,\nwhere necessary in the interests of defence or of animal\ndisease control.
\nDangerous substances: a\nsubstance which fulfils the criteria for being a POP under\nRegulation (EC) No 850/2004, or which fulfils the criteria for\nbeing persistent, bio-accumulative and toxic (PBT) or very\npersistent and very bio-accumulative (vPvB) in accordance with\nAnnex XIII of Regulation (EC) No 1907/2006 should be considered a\ndangerous substance.
\nNanomaterials: Members\nconsider that the definition of nanomaterials is an essential\nelement of the regulation and thus needs to be adopted by the\nlegislator. No later than six months after the adoption of the\nRecommendation concerning the definition of nanomaterials, the\nCommission shall make a legislative proposal to amend this\nRegulation to include that definition in this\nRegulation.
\nNanomaterials can have very different characteristics\nto the same substances in normal form. The risks posed by\nnanomaterials in biocidal products to the environment and to\nhealth must therefore be investigated separately.
\nFurthermore, in light of the current lack of\nappropriate risk assessment of nanomaterials, they should not\nqualify for the simplified authorisation procedure. Where a treated\narticle contains a biocidal product, the person\nresponsible for the placing on the market of that treated article\nshall ensure that the label provides certain specified information\nincluding the name of all nanomaterials, followed by the word\n\"nano\" in brackets.
\nInclusion of active substances: an active substance\nmay not be placed on the market for use in a biocidal product\nunless it is included in Annex I, in accordance with the\nRegulation. An active substance referred to in Article 5 may only\nbe included in Annex -I for an initial period of 5 years.\nSubstances that come under the exclusion criteria may only be\nincluded in Annex 1 for an initial period of 5 years.
\nExclusion criteria:\nMembers specify that active substances shall not be approved for\ninclusion in Annex I if, on the basis of the assessment of Union or\ninternationally agreed test guidelines or other peer-reviewed\nscientific data and information, including a review of the\nscientific literature, reviewed by the Agency, they are considered\nas having endocrine-disrupting properties that may cause\nadverse effects in humans.
\nNo later than 13 December 2013, the Commission\nshall adopt delegated acts specifying scientific criteria for the\ndetermination of endocrine disrupting properties.
\nMembers suggest that active substances may not be\nincluded in Annex I unless at least one of the following conditions\nis fulfilled:
\n\n· \nthe exposure of humans or the\nenvironment to the active substance in question in a\nbiocidal product, under normal conditions of use, is\nnegligible, meaning that the product is used in closed systems\nor under other conditions excluding contact with\nhumans;
\n\n· \nit is shown by evidence that the active\nsubstance is necessary to prevent or control a serious\ndanger to public or animal health or to the environment,\nto food and feed safety, or to the public interest and\nthat there are no effective alternative substances or technologies\navailable.
\nThe use of any biocidal product containing active\nsubstances included in Annex I shall be subject to appropriate\nrisk mitigation measures to ensure that exposure of humans\nand the environment is minimised.
\nMember State authorising a biocidal product containing\nan active substance included in Annex I shall draw up a\nsubstitution plan concerning the control of the serious\ndanger by other means including non-chemical methods, which are as\neffective as the biocidal product concerned and shall without delay\ntransmit that plan to the Commission. The use of the biocidal\nproduct with the active substance concerned shall be restricted to\nthose Member States where the serious danger has to be prevented\nor, if it occurs, controlled.
\nApproval of an active substance: in order to preserve Parliaments rights of\ncontrol, active substances should continue to be included in an\nAnnex to the Regulation and decided by means of delegated\nacts. The act should include the conditions and relevant dates\nof inclusion and expiry of inclusion. There should also be a\ndecision in its own right if a substance is not included in Annex\nI, in order to have a record of all decisions.
\nActive substances for substitution: active substances must be candidates or substitution\nif (i) it meets the criteria to be classified, in accordance with\nRegulation (EC) No 1272/2008, as a respiratory sensitiser; (ii)\nthere are reasons for concern linked to the nature of the critical\neffects, in particular developmental neurotoxic or immunotoxic\neffects.
\nRenewal and review of approval: unless more strictly specified in the\ndecision to renew the approval of an active substance, the renewal\nshall be for ten years (and not 15 as the Council had\nprescribed) for all product-types to which the approval\napplies.
\nThe Commission may review the approval of an active\nsubstance for one or more product-types at any time where there\nare significant indications, not only serious\nindications, that any of the conditions laid down) are no\nlonger met. The Commission may also inclusion where there are\nsignificant indications that the objectives of Directive 2000/60/EC\non water may not be achieved.
\nGeneral conditions of authorisation: Members consider that the notification of products\nshould be made at least 30 days in advance to allow a real market\nmonitoring. They made certain amendments to make it easier for\nbiocidal products with the same formulation and intended use to be\nmarketed under different brand names and by different\nmanufacturers. As such authorisations relate to biocidal products\nwhose formulations are identical, there is no need to assess their\nimpact on human health and the environment again.
\nMeasures geared to the sustainable use of biocidal\nproducts: the committee states that\nMember States shall establish and implement mandatory measures on\nthe basis of a Union framework directive in order to achieve the\nsustainable professional use of biocidal products, including\nthe introduction of National Action Plans, integrated pest\nmanagement, risk reduction measures and the promotion of\nalternatives.
\nThe Commission shall submit a legislative proposal for\nthe framework directive within two years of adoption of the\nregulation.
\nMutual recognition: for\nthe purposes of simplification, Members state that in the case of a\nbiocidal product family, one single authorisation number\nshall be provided for all biocidal products which belong to that\nproduct family.
\nUnion authorisations:\nthe amended text stipulates that applicants may apply for Union\nauthorisation for biocidal products which have similar conditions\nof use across the Union with the exception of biocidal\nproducts that contain active substances that fall under Article 5\n(exclusion criteria):
\n\n· \nfrom 2013 the Union authorisation may be\ngranted to biocidal products containing one or more new active\nsubstances;
\n\n· \nfrom 2017 the Union authorisation may be granted\nto all categories of biocidal products.
\nTreated articles or materials: the labelling shall be clearly visible, easily\nlegible and appropriately durable. Where necessary because of the\nsize or the function of the treated article, the labelling shall be\nprinted on the packaging, on the instructions for use or on the\nwarranty in the national language or languages of\nthe Member State on whose market the treated article\nis to be placed. In the case of treated goods which are not\nproduced as part of a series, but rather designed and manufactured\nto meet a specific order, the manufacturer may agree other methods\nof providing the customer with the relevant information.
\nAnimal testing: any\nperson intending to perform tests or studies involving vertebrate\nanimals or non-vertebrate animals, (\"the prospective applicant\"),\nshall submit a written request to the Agency to determine\nwhether such tests or studies have already been submitted to the\nAgency, or to a competent authority in connection with a previous\napplication under this Regulation or\nDirective 98/8/EC for an identical or technically\nequivalent product.
\nThe request shall be accompanied by fees\nin accordance with the text.
\nFurthermore, Members want to align the text relating\nto data sharing with the provisions in REACH.
\nReports: every three\nyears, Member States shall submit to the Commission a report on the\nimplementation of this Regulation in their respective territories.\nThe implementation reports shall be published on the relevant\nwebsite of the Commission. The report shall include\ninformation on any poisonings and, where available, occupational\ndiseases involving biocidal products, especially regarding\nvulnerable groups, and the actions undertaken to lower the risk of\nfuture cases, and information on the impact on the\nenvironment.
\n\n· \nNot later than five years after the entry into\nforce of this Regulation, the Commission shall draw up a report on\nthe impact of the spread of biocidal products in the\nenvironment.
\n\n· \nAt the latest two years after the entry into\nforce of the Regulation, the Commission shall submit a report on\nthe assessment of the risks to human health and the environment\npresented by the use of nanomaterials in biocidal products and on\nspecific measures to be taken with regard to them.
\nPublic access: the\nCommission shall make available on the internet a list of all\nactive substances available within the internal market. The persons\nresponsible for the placing on the market of biocidal products\nshall make available on the internet a list of such products. This\nwebsite shall serve to increase transparency for consumers and to\nfacilitate an easy and fast collection of data on the properties\nand conditions of use of these products.
\nComitology: the amended\ntext contains several amendments with a view to aligning the\ncomitology procedure to the new system on delegated acts in\naccordance with Article 290 TFEU. The Regulation must contain\ndetailed provisions on the delegation of power.
\nThe European Parliament adopted a legislative\nresolution on the Council position with a view to the adoption of a\nregulation of the European Parliament and of the Council concerning\nthe making available on the market and use of biocidal\nproducts.
\nParliament adopted its position in second reading\nfollowing the ordinary legislative procedure. The amendments\nadopted in plenary are the result of a compromise negotiated\nbetween Parliament and Council. They amend the Councils\nposition as follows:
\nPurpose and scope: as\nrequired by Parliament, the amended text clarifies that special\nattention shall be paid to the protection of vulnerable\ngroups.
\nThe Regulation shall not apply to biocidal products or\ntreated articles that are within the scope of the\ninstruments specified in the text, amongst which is Directive\n2009/48/EC on the safety of toys.
\nIt will not apply to: (i) food or feed used\nas repellents or attractants; (ii) biocidal products when used\nas processing aids.
\nNothing in the Regulation shall prevent Member States\nfrom restricting or banning the use of biocidal products in the\npublic supply of drinking water.
\nBiocidal product: the definition in the amended text covers any\nsubstance or mixture generated from substances or mixtures which\nare not themselves biocidal products in the meaning of the\nRegulation to be used with the intention of destroying, deterring,\nrendering harmless, preventing the action of, or otherwise exerting\na controlling effect on, any harmful organism by any means other\nthan mere physical or mechanical action.
\nSubstance of concern: this means a substance which fulfils the criteria\nfor being a POP under Regulation (EC) No 850/2004, or which fulfils\nthe criteria for being persistent, bio-accumulative and toxic (PBT)\nor very persistent and very bio-accumulative (vPvB) in accordance\nwith Annex XIII of Regulation (EC) No 1907/2006.
\nNanomaterial: this is defined as a natural or manufactured\nactive substance or non-active substance containing particles, in\nan unbound state or as an aggregate or as an agglomerate and where,\nfor 50 % or more of the particles in the number size distribution,\none or more external dimensions is in the size range 1 nm-100 nm.\nFullerenes, graphene flakes and single wall carbon nanotubes with\none or more external dimensions below 1 nm shall be considered as\nnanomaterials.
\nFor the purposes of the definition of nanomaterial,\nparticle, agglomerate and\naggregate are defined.
\nThe Commission shall be empowered to adopt delegated\nacts in order to adapt the definition of nanomaterial in view of\ntechnical and scientific progress and taking into account the\nCommission Recommendation 2011/696/EU.
\nWith regard to authorisation, the text conforms to\nParliaments request and states that risks posed by\nnanomaterials in biocidal products to health and the environment\nmust be examined separately.
\nA biocidal product shall be eligible for the\nsimplified procedure only if the biocidal product does not\ncontain a nanomaterial.
\nWith regard to treated articles, the person\nresponsible for the placing on the market of that treated article\nshall ensure that the label states the name of all\nnanomaterials contained in biocidal products, followed by the word\nnano in brackets.
\nApproval of active substances: an active substance may only be approved for an\ninitial period not exceeding 5 years. The approval\nshall specify the date of approval and the expiry date of the\napproval of the active substance.
\nExclusion criteria:\nactive substances which are considered as having\nendocrine-disrupting properties that may cause adverse effects in\nhumans shall not be approved. No later than 13 December 2013,\nthe Commission shall adopt delegated acts specifying\nscientific criteria for the determination of endocrine disrupting\nproperties.
\nActive substances may be approved if it is shown that\nat least one of the following conditions is met:
\n\n· \nthe risk to humans or the environment from\nexposure to the active substance in a biocidal product, under\nrealistic worst case conditions of use, is negligible, in\nparticular where the product is used in closed systems\nor under other conditions which aim at excluding\ncontact with humans and release to the environment;
\n\n· \nit is shown by evidence that the active\nsubstance is essential to prevent or to control a serious danger to\npublic or animal health or to the environment; or not\napproving the active substance would cause disproportionate\nnegative impacts for society when compared with the risk to human\nhealth or the environment arising from the use of the\nsubstance.
\nWhen deciding whether an active substance may be\napproved in accordance with the first subparagraph, the\navailability of suitable and sufficient alternative substances\nor technologies shall be a key consideration.
\nThe use of any biocidal product containing active\nsubstances approved in accordance with the regulation shall be\nsubject to appropriate risk mitigation measures to ensure that\nexposure of humans and the environment is minimised.
\nSubmission and validation of\napplications: the evaluating\ncompetent authority shall, as soon as possible after the Agency has\naccepted an application, inform the applicant of the fees payable\nunder the regulation and shall reject the application if the\napplicant fails to pay the fees within 30 days.
\nWhere the evaluating competent authority considers\nthat there are concerns for human health or the environment as\na result of the cumulative effects from the use of biocidal\nproducts containing the same or\ndifferent active substances, it shall document its\nconcerns and include this as part of its conclusions.
\nActive substances which are candidates for\nsubstitution: an active substance\nshall be considered a candidate for substitution if it meets\nthe criteria to be classified, in accordance with Regulation (EC)\nNo 1272/2008, as a respiratory sensitiser.
\nRenewal and review of approval: the renewal shall be for 15 years for all\nproduct-types to which the approval applies, unless a shorter\nperiod is specified in the Regulation renewing the approval of an\nactive substance.
\nThe Commission may review the approval of an active\nsubstance for one or more product-types at any time where there\nare significant indications that the conditions laid down\nin the regulation are no longer met.
\nGeneral conditions of authorisation: as Members had asked, the notification of products\nshould be made at least 30 days in advance to allow a real\nmarket monitoring. The Commission shall, by means of an\nimplementing act, specify procedures for the authorisation of the\nsame biocidal products by the same or different enterprises under\nthe same terms and conditions.
\nFor applications for Union authorisations, the\nsummary of the characteristics of the biocidal product shall\nbe provided in one of the official languages of the Union accepted\nby the evaluating competent authority at the time of application\nand in all official languages of the Union before the authorisation\nof the product.
\nMeasures geared to the sustainable use of biocidal\nproducts: three years after the entry\ninto force of the Regulation, the Commission shall, on the basis of\nexperience gained with the application of the Regulation, present a\nreport on how the Regulation contributes to a sustainable use of\nbiocidal products, including on the need to introduce additional\nmeasures, in particular for professional users, to reduce the risks\nposed to human and animal health and the environment by biocidal\nproducts. That report shall, inter alia, examine:
\n\n· \nthe promotion of best practices as a means of\nreducing the use of biocidal products to the minimum;
\n\n· \nthe most effective approaches for monitoring the\nuse of biocidal products;
\n\n· \nthe development and application of integrated\npest management principles with respect to the use of biocidal\nproducts;
\n\n· \nthe risks posed by the use of biocidal products\nin specific areas such as schools, workplaces, kindergartens,\npublic spaces, geriatric care centres or in the vicinity of surface\nor groundwater and whether additional measures are needed to\naddress them;
\n\n· \nthe role that the improved performance of the\nequipment used for the application of biocidal products could make\nto sustainable use.
\nOn basis of that report, the Commission shall, if\nappropriate, present a legislative proposal.
\nUnion authorisations:\nthe amended text stipulates that applicants may apply for Union\nauthorisation for biocidal products which have similar conditions\nof use across the Union with the exception of biocidal\nproducts that contain active substances that fall under Article 5\n(exclusion criteria) and certain product types:
\n\n· \nfrom 1 September 2013, the Union authorisation\nmay be granted to biocidal products containing one or more new\nactive substances and biocidal products of\nproduct-types 1 (human hygiene), 3 (veterinary hygiene), 5\n(drinking water), 18 (insecticides, acaricides and products to\ncontrol other arthropods) and 19 (repellents and\nattractants);
\n\n· \nfrom 1 January 2017, the Union authorisation may\nbe granted to biocidal products of product-types 2 (Disinfectants\nand algaecides not intended for direct application to humans\nor animals) , 6 (preservatives for products during storage)\nand 13 (working or cutting fluid preservatives);
\n\n· \nfrom 1 January 2020, the Union\nauthorisation may be granted to all categories\nof biocidal products.
\nDerogation from the requirements: by way of derogation, a competent authority may\npermit, for a period not exceeding 180 days, the making\navailable on the market or use of a biocidal product which does not\nfulfil the conditions for authorisation laid down in the\nRegulation, for a limited and controlled use under the\nsupervision of the competent authority , if such a measure is\nnecessary because of a danger to public health, animal\nhealth or the environment which cannot be contained by other\nmeans.
\nResearch and development: any person intending to carry out an experiment or\ntest that may involve, or result in, release of the biocidal\nproduct into the environment shall first notify the relevant\ncompetent authority of the Member State where the experiment or\ntest will occur. The notification shall include the identity\nof the biocidal product or active substance, labelling data and\nquantities supplied and all available data on possible effects on\nhuman or animal health or impact on the environment. The person\nconcerned shall make any other information available to the\ncompetent authorities on request.
\nLabelling: the person\nresponsible for the placing on the market of a treated article\nshall label it with any relevant instructions for use, including\nany precautions to be taken, if this is necessary to protect humans\nand the environment. The supplier of a treated article shall, upon\nrequest by a consumer, provide, within 45 days, free of charge,\ninformation on the biocidal treatment of the treated\narticle.
\nThe labelling shall be clearly visible, easily legible\nand appropriately durable. Where necessary because of the size or\nthe function of the treated article, the labelling shall be printed\non the packaging, on the instructions for use or on the\nwarranty in the official language or languages of the Member\nState of introduction, unless that Member State provides\notherwise.
\nAnimal testing: in order\nto avoid animal testing, testing on vertebrate animals for the\npurposes of this Regulation shall be undertaken only as a last\nresort. Any person intending to perform tests or studies\nshall, in the case of data involving tests on vertebrate animals,\nsubmit a written request to the Agency to\ndetermine whether such tests or studies have already been\nsubmitted to the Agency or to a competent authority in\nconnection with a previous application under the Regulation or\nDirective 98/8/EC.
\nWhere such tests or studies have already been\nsubmitted to the Agency or to a competent authority in\nconnection with a previous application, the Agency shall, without\ndelay, communicate the name and contact details of the\ndata submitter(s) and data owner(s) to the\nprospective applicant.
\nData owners must share information in exchange\nfor equitable compensation.
\nThe Regulation shall apply from\n1 September 2013.
\nPURPOSE: to improve free movement of biocidal products\nin the Union whilst ensuring a high level of human, animal and\nenvironmental protection.
\nLEGISLATIVE ACT: Regulation (EU) No 528/2012 of\nthe European Parliament and of the Council concerning the making\navailable on the market and use of biocidal products.
\nCONTENT: following in second reading, the Council and\nthe European Parliament adopted a regulation concerning the placing\non the market and use of biocidal products. The provisions of the\nRegulation are based on the precautionary principle, the aim\nof which is to safeguard the health of humans, the health of\nanimals and the environment.
\nAs required by the European Parliament, particular\nattention shall be paid to the protection of vulnerable\ngroups.
\nThe Regulation applies to insecticides, disinfectants\nand repellents, but not medicines or agricultural pesticides. It\naims to simplify the authorisation procedures in the\ninternal market through the harmonisation of legislation on\nbiocidal products, while ensuring a high level of protection for\nboth human and animal health and the environment.
\nThe Regulation lays down certain\nprinciples.
\n(1) The establishment at Union level of a list of\nactive substances which may be used in biocidal\nproducts.
\n(2) Conditions for the approval and renewal of\napproval of active substances :
\n\n· \nan active substance shall be approved for an\ninitial period not exceeding 10 years if at least one biocidal\nproduct containing that active substance may be expected to meet\nthe criteria laid down in the text ;
\n\n· \nactive substances that are classified as\ncarcinogenic, mutagenic, toxic for reproduction or considered as\nhaving endocrine-disrupting properties, shall not be approved\nexcept in specified circumstances ;
\n\n· \nthe approval of an active substance shall not\ncover nanomaterials except where explicitly\nmentioned ;
\n\n· \nan active substance that falls under the\nexclusion criteria may only be approved for an initial period not\nexceeding five years ;
\n\n· \nthe renewal of an approval of an active\nsubstance shall be for 15 years for all product-types to which the\napproval applies, unless a shorter period is specified in the\nimplementing regulation renewing such an approval ;
\n\n· \nthe Commission may review the approval of an\nactive substance for one or more product-types at any time where\nthere are significant indications that the conditions laid down in\nthe Regulation are no longer met.
\n(3) The granting of an authorisation for biocidal\nproducts: biocidal products should neither be made available on\nthe market nor used unless authorised in accordance with the\nRegulation. As requested by the European Parliament, the\nauthorisation holder shall notify each competent authority at least\n30 days before placing it on the market.
\n(4) The mutual recognition of authorisations within\nthe Union so as to reduce the administrative burden on\nproducers.
\n(5) The making available on the market and the use\nof biocidal products within one or more Member States or the\nUnion: the Regulation introduces the possibility of granting an\nUnion authorisation for biocidal products, in addition to the\ncurrent system of national product authorisation. A first series of\nproduct-types may be authorised at Union level as from 2013. From\n2020 onwards, most biocidal products will qualify for this\nprocedure.
\n(6) The placing on the market of treated articles\nwhich are not biocidal products: articles incorporating pest\ncontrol chemicals may not be treated with unauthorised chemicals\nanymore and must be labelled under the conditions specified in the\nRegulation. These obligations apply to all articles treated with\nbiocidal products on the EU market, including imported\nones.
\nAuthorisation holders shall keep records of the\nbiocidal products they place on the market for at least 10 years\nafter placing on the market, or 10 years after the date on which\nthe authorisation was cancelled or expired, whichever is the\nearlier.
\nThe Agency shall establish and maintain an information\nsystem which shall be referred to as the Register for Biocidal\nProducts.
\nENTRY INTO FORCE: 17/07/2012.
\nAPPLICATION: from 01/09/2013.
\nDELEGATED ACTS: the Commission is empowered to adopt\ndelegated acts to supplement or amend the Regulation. The power to\nadopt delegated acts is conferred on the Commission for a period of\nfive years from 17 July 2012. This shall be tacitly extended for\nperiods of an identical duration, unless the European Parliament or\nthe Council opposes such extension. A delegated act shall\nenter into force only if no objection has been expressed either by\nthe European Parliament or the Council within a period of two\nmonths of notification (this period may be extended by two months).\nIf objections are made by the European Parliament or the Council,\nthe delegated act shall not enter into force.
\n