{"change_dates":[],"dossier":{"amendments":[{"authors":"Liam Aylward","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-215","justification":"Having analysed the initial impact assessment of the Commission, no data could be found on\nthe impact of changing from a risk-based authorisation system to a hazard-based one. This is\nabsent vital information which should be provided to the institutions in order to make an\ninformed decision.","location":[["","Recital 6"]],"meps":[28114],"meta":{"created":"2020-01-20T00:11:56"},"new":["(6) Plant production has a very important","place in the Community. One of the most","important ways of protecting plants and","plant products against harmful organisms,","including weeds, and of improving","agricultural production is the use of plant","protection products. It should be ensured","that a complete impact assessment,","including the impact of any cut-off system","on agricultural activity, has been","undertaken."],"old":["(6) Plant production has a very important","place in the Community. One of the most","important ways of protecting plants and","plant products against harmful organisms,","including weeds, and of improving","agricultural production is the use of plant","protection products."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"215","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Robert Sturdy, Caroline Jackson, Richard Seeber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-216","justification":" This recognizes the importance of plant protection products. The extent to which this\n legislation will affect member states production practices and capabilities should be fully\n understood and evaluated in the interest of consumers, public health, farmers and industry.","location":[["","Recital 6 a (new)"]],"meps":[2037,1370,28252],"meta":{"created":"2020-01-20T00:11:56"},"new":["(6a) Therefore, as the Regulation could","have an impact on the landscape and the","supply and price of plants and food, the","Commission should carry out a thorough","and broad-reaching EU-wide impact","assessment of all aspects of this","Regulation on all industry sectors affected","including agriculture, horticulture,","gardening, landscaping and public and","private amenities prior to its","implementation."],"old":[""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"216","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-217","justification":" Reinstating first reading Amendment 10 with the first 4 words being the Commission\u2019s\n original text.","location":[["","Recital 14"]],"meps":[4524],"meta":{"created":"2020-01-20T00:11:56"},"new":["(14) In the interest of safety, the approval","period for active substances should be","limited in time. The approval period should","be proportional to the possible risks","inherent in the use of such substances.","Experience gained from the actual use of","plant protection products containing the","substances concerned and any","developments in science and technology","should be taken into account when any","decision regarding the renewal of an","approval is taken. After the first renewal, a","regular review of substances should take","place."],"old":["(14) In the interest of safety, the approval","period for active substances should be","limited in time. The approval period should","be proportional to the possible risks","inherent in the use of such substances.","Experience gained from the actual use of","plant protection products containing the","substances concerned and any","developments in science and technology","should be taken into account when any","decision regarding the renewal of an","approval is taken."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"217","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-218","justification":"It is supposed to be society that designates what is an \u201cacceptable risk\u201d and so if society feels\nthat a risk is not acceptable, then what is considered acceptable is redefined and the risk\nassessed accordingly. Therefore risks can only be deemed acceptable by all relevant\nStakeholders. This must include representatives of rural residents and communities, farmers\ngroups, (both organic and conventional) and environmental and consumer groups as well as\nthe public in general.\n\nReinstating first reading Amendment 13.","location":[["","Recital 17"]],"meps":[4524],"meta":{"created":"2020-01-20T00:11:56"},"new":["(17) Certain substances which are not","predominantly used as plant protection","products may be of value for plant","protection, but the economic interest of","applying for approval may be limited.","Therefore, specific provisions should","ensure that such substances, as far as their","risks are deemed acceptable by all relevant","stakeholders, may also be approved for","plant protection use."],"old":["(17) Certain substances which are not","predominantly used as plant protection","products may be of value for plant","protection, but the economic interest of","applying for approval may be limited.","Therefore, specific provisions should","ensure that such substances, as far as their","risks are acceptable, may also be approved","for plant protection use."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"218","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-219","justification":" There seems little point in having a Regulation with high standards if it gives the option to\n depart from those standards. There shouldn\u2019t be any reason for a delay in making a\n regulatory decision, as that is what the regulators are there for. Therefore this recital should\n be deleted.\n\n Amendment of a new recital introduced by Council.","location":[["","Recital 25"]],"meps":[4524],"meta":{"created":"2020-01-20T00:11:57"},"new":["deleted"],"old":["(25) In case the decision on approval","cannot be finalised within the period of","time provided for due to reasons not","falling under the responsibility of the","applicant, Member States should be able","to grant the provisional authorisations for","","a limited period of time in order to","facilitate the transition to the approval","procedure provided for under this","Regulation. In the light of the experience","gained with the approval of the active","substances under this Regulation, the","provisions on provisional authorisations","should cease to apply or be extended after","the period of five years, if necessary."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"219","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-220","justification":"The division into authorization zones is not appropriate as conditions in the proposed zones\nare often not comparable. While harmonization of the procedures is desirable, it must not\ncome at the expense political sovereignty of Member States. Member States should be entitled\nto decide within a clear time period whether they confirm, amend or reject an authorization\npursuant to their national situation. The discretion given to Member States in the Common\nPosition is so restrictive that it is virtually non-existent, and hence needs to be broadened.\n\nReinstating first reading Amendment 19. Replaces amendment 16 by the rapporteur.","location":[["","Recital 27"]],"meps":[1059],"meta":{"created":"2020-01-20T00:11:57"},"new":["(27) The principle of mutual recognition is","one of the means of ensuring the free","movement of goods within the","Community. To avoid unnecessary","duplication of work, to reduce the","administrative burden for industry and for","Member States and to facilitate more","harmonised availability of plant protection","products, authorisations granted by one","Member State should be notified to other","Member States in which the applicant","wishes to put the product on the market.","Those Member States should be entitled to","recognise an authorisation issued by","another Member State, amend it or refrain","from authorising the plant protection","product in their territory, if justified","because of specific agricultural or","environmental circumstances, that may,","but do not need to, be limited to that","Member State, or if the high level of","protection of human or animal health or","the environment set out in this Regulation","cannot be achieved, or to maintain a","higher protection level in their territory in","line with their National Pesticide Action","Plan."],"old":["(27) The principle of mutual recognition is","one of the means of ensuring the free","movement of goods within the","Community. To avoid any duplication of","work, to reduce the administrative burden","for industry and for Member States and to","provide for more harmonised availability","of plant protection products, authorisations","granted by one Member State should be","accepted by other Member States where","agricultural, plant health and","environmental (including climatic)","conditions are comparable. Therefore, the","Community should be divided into zones","with such comparable conditions in order","to facilitate such mutual recognition.","However, environmental or agricultural","","circumstances specific to the territory of a","Member State might require that, on","application, Member States recognise an","authorisation issued by another Member","State, amend it or refrain from authorising","the plant protection product in their","territory, if justified because of specific","agricultural circumstances or if the high","level of protection of both human and","animal health and the environment set out","in this Regulation can not be achieved."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"220","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kathy Sinnott","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-221","justification":" In order to protect human health it is important that imported food is not exposed to plant\n protection substances that are not approved by the EU. Importing foods not subject to the\n same standards would be a double standard for the health of external producers and\n disadvantage EU farmers.","location":[["","Recital 28 a (new)"]],"meps":[28119],"meta":{"created":"2020-01-20T00:11:57"},"new":["(28a) Imported food should be subject to","the same standards with regard to plant","protection and should not be treated with","substances that have not been approved in","accordance with the provisions of this","Regulation."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"221","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-222","justification":" Advertisements regarding pesticides and pesticide products must not mislead users or the\n public.\n\n Reinstating first reading Amendment 26.","location":[["","Recital 41"]],"meps":[4524],"meta":{"created":"2020-01-20T00:11:57"},"new":["(41) To ensure that advertisements do not","mislead users of plant protection products","or the public, it is appropriate to lay down","rules on the advertising of those products."],"old":["(41) To ensure that advertisements do not","mislead users of plant protection products,","it is appropriate to lay down rules on the","advertising of those products."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"222","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hanne Dahl","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-223","justification":"Paragraph 3 is to make the provisions of this Regulation minimum rule, thereby enabling\nindividual Member States to make further progress with the development of pesticides.\n\nParagraphs 4 and 5 are important to ensure that the achievements secured in the\ngroundwater directive are carried over into this Regulation in order to safeguard drinking\nwater.","location":[["","Article 1"]],"meps":[40817],"meta":{"created":"2020-01-20T00:11:57"},"new":["Subject matter and purpose","1. This Regulation lays down rules for the","authorisation of plant protection products","in commercial form and for their placing","on the market, use and control within the","Community.","2. This Regulation lays down both rules for","the approval of active substances, safeners","and synergists, which plant protection","products contain or consist of, and rules for","adjuvants and co-formulants.","3. Member States may not be prevented","from applying the precautionary principle","in restricting or prohibiting pesticides.","4. Member States may establish any","pesticide-free zones they deem necessary","in order to safeguard drinking water","resources. Such pesticide-free zones may","cover the entire Member State.","5. Member States may impose a ban on","the use and marketing of EU-authorised","pesticides where they are found in","measurable quantities outside the root","zone."],"old":["Subject matter","This Regulation lays down rules for the","authorisation of plant protection products","in commercial form and for their placing","on the market, use and control within the","Community.","This Regulation lays down both rules for","","the approval of active substances, safeners","and synergists, which plant protection","products contain or consist of, and rules for","adjuvants and co-formulants."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"223","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mojca Dr\u010dar Murko","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-224","justification":" Reintroduction of amendment adopted in 1st reading.","location":[["","Article 3 \u2013point 18"]],"meps":[28305],"meta":{"created":"2020-01-20T00:11:57"},"new":["18) \u2018good experimental practice\u2019","Practice in accordance with Directive","2004/10/EC;"],"old":["18) \u2018good experimental practice\u2019","Practice in accordance with the provisions","of European and Mediterranean Plant","Protection Organisation (EPPO)","Guidelines 181 and 152;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"224","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-225","justification":" Whilst use of pesticides in greenhouses may well reduce the release of pesticides into the\n environment it cannot be stated categorically that it will prevent it altogether, as greenhouses\n often have windows which may be opened and doors may also be left open for any length of\n time which could result in release of pesticides into the environment.\n\n Amendment of new text introduced by Council.","location":[["","Article 3 \u2013 point 23"]],"meps":[4524],"meta":{"created":"2020-01-20T00:11:57"},"new":["23) \"greenhouse\"","A walk-in, static, closed place of crop","production with a usually translucent outer","shell, which allows controlled exchange of","material and energy with the surroundings","and reduces release of plant protection","products into the environment.","For the purpose of this Regulation, closed","places of plant production where the outer","shell is not translucent (e.g. for production","of mushrooms or witloof) are also","considered as greenhouses;"],"old":["23) \"greenhouse\"","A walk-in, static, closed place of crop","production with a usually translucent outer","shell, which allows controlled exchange of","material and energy with the surroundings","and prevents release of plant protection","products into the environment.","For the purpose of this Regulation, closed","places of plant production where the outer","shell is not translucent (e.g. for production","of mushrooms or witloof) are also","considered as greenhouses;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"225","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-226","justification":"\nThere is a need for clarification. \u201cArea\u201d is for example used in Article 6h.","location":[["","Article 3 \u2013point 23 a (new)"]],"meps":[4319],"meta":{"created":"2020-01-20T00:11:58"},"new":["23a) \u2018area of application\u2019","Specific plants, plant species or plant","products together with those harmful","organisms against which plants and plant","products shall be protected or any other","purpose for which the plant protection","product shall be used;"],"old":[""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"226","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-227","justification":" This sentence has been newly added by Council. The proposed changes acknowledge that\n endocrine disruption has not been defined in this regulation and therefore can not be used to\n ban an active substance until clear implementation rules have been adopted and enforced.","location":[["","Article 4 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[28227],"meta":{"created":"2020-01-20T00:11:58"},"new":["The assessment of the active substance","shall first establish whether the approval","criteria set out in points 3.6.2 to 3.6.4 and","3.7 of Annex II are satisfied. If these","criteria are satisfied the assessment shall","continue to establish whether the other","approval criteria set out in points 2 and 3 of","Annex II are satisfied, including points","3.6.5 and 3.8.2 once specific scientific","criteria have been adopted for these","annex points in accordance with Article","78(2)."],"old":["The assessment of the active substance","shall first establish whether the approval","criteria set out in points 3.6.2 to 3.6.4 and","3.7 of Annex II are satisfied. If these","criteria are satisfied the assessment shall","continue to establish whether the other","approval criteria set out in points 2 and 3 of","Annex II are satisfied."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"227","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Johannes Blokland","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-228","justification":" This sentence has been newly added by Council. The proposed changes acknowledge that\n endocrine disruption has not been defined in this regulation and therefore can not be used to\n ban an active substance until clear implementation rules have been adopted and enforced.","location":[["","Article 4 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[1969],"meta":{"created":"2020-01-20T00:11:58"},"new":["The assessment of the active substance","shall first establish whether the approval","criteria set out in points 3.6.2 to 3.6.4 and","3.7 of Annex II are satisfied. If these","criteria are satisfied the assessment shall","continue to establish whether the other","approval criteria set out in points 2 and 3 of","Annex II are satisfied, including points","3.6.5 and 3.8.2 once specific scientific","criteria have been adopted for these","annex points in accordance with Article","78(2)."],"old":["The assessment of the active substance","shall first establish whether the approval","criteria set out in points 3.6.2 to 3.6.4 and","3.7 of Annex II are satisfied. If these","criteria are satisfied the assessment shall","continue to establish whether the other","approval criteria set out in points 2 and 3 of","Annex II are satisfied."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"228","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward, Christa Kla\u00df, Anne Laperrouze","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-229","justification":"This sentence has been newly added by Council. The proposed changes acknowledge that\nendocrine disruption has not been defined in this regulation and therefore can not be used to\nban an active substance until clear implementation rules have been adopted and enforced","location":[["","Article 4 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[28114,1929,28209],"meta":{"created":"2020-01-20T00:11:58"},"new":["The assessment of the active substance","shall first establish whether the approval","criteria set out in points 3.6.2 to 3.6.4 and","3.7 of Annex II are satisfied. If these","criteria are satisfied the assessment shall","continue to establish whether the other","approval criteria set out in points 2 and 3 of","annex II are satisfied, including points","3.6.5 and 3.8.2 once specific scientific","criteria have been adopted for these","annex points in accordance with Article","78(2)."],"old":["The assessment of the active substance","shall first establish whether the approval","criteria set out in points 3.6.2 to 3.6.4 and","3.7 of Annex II are satisfied. If these","criteria are satisfied the assessment shall","continue to establish whether the other","approval criteria set out in points 2 and 3 of","Annex II are satisfied."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"229","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-230","justification":" All the various population subgroups at risk of exposure to pesticides must be protected. This\n includes professional and non-professional users, residents, bystanders, workers, specific\n vulnerable groups and consumers, directly or indirectly exposed through air, food, feed,\n water and the environment. Considering agricultural pesticides are often used in mixtures,\n then the potential adverse health effects of mixtures, including any synergistic effects, must be\n assessed prior to their approval.\n\n Reinstating first reading Amendment 296.","location":[["","Article 4 \u2013 paragraph 2 \u2013 point a"]],"meps":[4524],"meta":{"created":"2020-01-20T00:11:58"},"new":["(a) they shall not have any harmful effects","on human health, in particular that of","users who are in direct contact with the","products, residents, bystanders and","vulnerable groups, or animal health, taking","into account known cumulative and","synergistic effects, or on surface water or","groundwater;"],"old":["(a) they shall not have any harmful effects","on human health, including vulnerable","groups, or animal health, taking into","account known cumulative and synergistic","effects where the methods to assess such","effects are agreed, or on groundwater;",""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"230","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-231","justification":" This amendment introduces two dimensions into this article. Firstly, that for all authorised\n pesticides there shall be methods available to identify residues. This is currently not the case,\n as standard laboratory equipment is capable of identifying only a limited number of\n substances\u2019 residues. Secondly, the methods used to assess health effects should be\n\nsufficiently sensitive, with respect to levels of concern in various environmental and\nbiological media, in order not to overlook effects that are not detected by methods in general\nuse.\n\nReinstating first reading Amendment 62. Replaces amendment 56 by the rapporteur.","location":[["","Article 4 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[1059],"meta":{"created":"2020-01-20T00:11:58"},"new":["For residues of all approved substances,","there shall be standardised methods in","general use for measuring them which are","sufficiently sensitive with respect to any","technically detectable levels that could be","present in any environmental and","biological media or be of drinking water","relevance. The residues shall be","detectable with the common multi-residue","methods as applied by Community","reference laboratories. Analytical","standards shall be commonly available."],"old":["For residues which are of toxicological,","ecotoxicological, environmental or","drinking water relevance, there shall be","methods in general use for measuring","them. Analytical standards shall be","commonly available."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"231","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-232","justification":"All the various subgroups at risk of exposure to pesticides must be protected, particularly\nresidents, who can be regularly exposed to pesticides from various sources. These include\nlong term exposure to airborne pesticides, exposure to vapours, which can occur days, weeks,\neven months after application, reactivation, precipitation, pesticides transported from\noutdoor applications and redistributed indoors, as well as long-range transportation, as\npesticides can travel in the air for miles.\n\nReinstating first reading Amendment 297.","location":[["","Article 4 \u2013 paragraph 3 \u2013 point (b)"]],"meps":[4524],"meta":{"created":"2020-01-20T00:11:58"},"new":["(b) it shall have no immediate or delayed","harmful effect on human health, in","particular that of residents and bystanders","and vulnerable groups, or animal health,","directly or through drinking water (taking","into account substances resulting from","water treatment), food, feed or air,","including in locations distant from its use","following long-range transportation, or","consequences in the workplace or through","other indirect effects, taking into account","cumulative and synergistic effects, or on","surface water and groundwater;"],"old":["(b) it shall have no immediate or delayed","harmful effect on human 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 methods to assess such effects","are agreed; or on groundwater;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"232","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anne Ferreira, St\u00e9phane Le Foll","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-233","justification":" It must be possible to authorise certain active substances in order to control a serious danger\n to plant health which cannot be contained by other available means. This authorisation must\n\nbe subject to strict conditions and should be granted for a shorter period, allowing this\ntemporary authorisation to be renewed twice.\n\nThis possible derogation cannot extend to carcinogenic or genotoxic substances or\nsubstances toxic for reproduction of Categories 1 and 2 or substances classified as endocrine\ndisruptors.","location":[["","Article 4 \u2013 paragraph 7"]],"meps":[5735,28162],"meta":{"created":"2020-01-20T00:11:59"},"new":["7. By way of derogation from paragraph 1,","where on the basis of documented","evidence, particularly an analysis of the","scientific documentation, an active","substance is necessary to control a serious","danger to plant health which cannot be","contained by other available means, such","active substance may be approved for a","period limited to two years even if it does","not satisfy the criteria set out in points","3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II,","provided that the use of the active","substance is subject to risk mitigation","measures to ensure that exposure of","humans and the environment is minimised.","This approval may be renewed once, in","accordance with the provisions of the","previous subparagraph.","In the case of these substances, the","maximum limits applicable to residues","have been laid down in accordance with","Regulation (EC) No 396/2005.","This derogation shall not apply to active","substances which are or have to be","classified in accordance with Directive","67/548/EEC, as carcinogenic or genotoxic,","substances toxic for reproduction of","Categories 1 and 2 or substances","classified as endocrine disruptors."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005.","This derogation shall not apply to active","substances which are or have to be","classified in accordance with Directive","67/548/EEC, as carcinogenic category 1 or","toxic for reproduction category 1."],"orig_lang":"fr","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"233","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Diana Wallis","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-234","justification":" The derogation should also apply to active substances which do not meet the environmental\n criteria. This would include in particular pendimethalin which is used in the treatment of\n land for pea growing.","location":[["","Article 4 \u2013 paragraph 7"]],"meps":[4544],"meta":{"created":"2020-01-20T00:11:59"},"new":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 , 3.7.1 or 3.8.2 of Annex II,","provided that the use of the active","substance is subject to risk mitigation","measures to ensure that exposure of","humans and the environment is minimised.","For such substances maximum residue","levels shall be set in accordance with","Regulation (EC) No 396/2005.","This derogation shall not apply to active","substances which are or have to be","classified in accordance with Directive","67/548/EEC, as carcinogenic category 1 or","toxic for reproduction category 1.","Member States should submit applications","with supporting evidence to the","Commission for approval."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005.","This derogation shall not apply to active","substances which are or have to be","classified in accordance with Directive","67/548/EEC, as carcinogenic category 1 or","toxic for reproduction category 1."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"234","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marianne Thyssen","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-235","justification":" The derogation should be extended to cover more cut-off criteria than those specified in the\n common position. All means necessary should be available to member states to control and\n contain threats to plant health that may arise.","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1"]],"meps":[1832],"meta":{"created":"2020-01-20T00:11:59"},"new":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5, 3.7.2, 3.7.3, 3.8.1 or 3.8.2 of","Annex II, provided that the use of the","active substance is subject to risk","mitigation measures to ensure that","exposure of humans and the environment is","minimised. For such substances maximum","residue levels shall be set in accordance","with Regulation (EC) No 396/2005."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"235","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-236","justification":"This clause has newly been added by Council. Development of resistance is one of the key\nissues that should be taken into account when looking at \u2018serious danger to plant health\u2019.\n\nNot all available means are suitable for reaching the anticipated goal of controlling a serious\ndanger to plant health. Therefore the wording should be clarified to better reflect the purpose\nof the clause","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1"]],"meps":[28227],"meta":{"created":"2020-01-20T00:11:59"},"new":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health, including","the development of resistance, which","cannot be contained by other appropriate","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"236","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward, Christa Kla\u00df","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-237","justification":" This clause has newly been added by Council. Not all available means are suitable for\n reaching the anticipated goal of controlling a serious danger to plant health. Therefore the\n wording should be clarified to better reflect the purpose of the clause.","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1"]],"meps":[28114,1929],"meta":{"created":"2020-01-20T00:11:59"},"new":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other appropriate","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"237","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Johannes Blokland","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-238","justification":"This clause has newly been added by Council. Development of resistance is one of the key\nissues that should be taken into account when looking at \u2018serious danger to plant health\u2019.\nFurthermore not all available means are suitable for reaching the anticipated goal of\ncontrolling a serious danger to plant health. Therefore the wording should be clarified to\nbetter reflect the purpose of the clause.","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1"]],"meps":[1969],"meta":{"created":"2020-01-20T00:11:59"},"new":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health, including","the development of resistance, which","cannot be contained by other appropriate","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"238","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward, Christa Kla\u00df","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-239","justification":" This clause has newly been added by Council. Development of resistance is one of the key\n issues that should be taken into account when looking at \u2018serious danger to plant health\u2019.","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1"]],"meps":[28114,1929],"meta":{"created":"2020-01-20T00:11:59"},"new":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health, including","the development of resistance, which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"239","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Robert Sturdy, Richard Seeber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-240","justification":" The derogation must be extended to cover more cut-off criteria than those specified in the\n common position. All means necessary must be available to member states to control and\n\ncontain threats to plant health that may arise","location":[["","Article 4 - paragraph 7 - subparagraph 1"]],"meps":[2037,28252],"meta":{"created":"2020-01-20T00:11:59"},"new":["7.By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5, 3.7.2, 3.7.3, 3.8.1 or 3.8.2 of","Annex II, provided that the use of the","active substance is subject to risk","mitigation measures to ensure that","exposure of humans and the environment is","minimised. For such substances maximum","residue levels shall be set in accordance","with Regulation (EC) No 396/2005."],"old":["7. By way of derogation from paragraph 1,","where on the basis of documented evidence","an active substance is necessary to control","a serious danger to plant health which","cannot be contained by other available","means, such active substance may be","approved for a time limited period not","exceeding five years even if it does not","satisfy the criteria set out in points 3.6.3,","3.6.4, 3.6.5 or 3.8.2 of Annex II, provided","that the use of the active substance is","subject to risk mitigation measures to","ensure that exposure of humans and the","environment is minimised. For such","substances maximum residue levels shall","be set in accordance with Regulation (EC)","No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"240","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-241","justification":"This clause has newly been added by Council. If a Member State faces a situation of serious\ndanger to plant health on it territory it should have the appropriate means to prevent serious\ndamage to crops under threat. Therefore the derogation should be extended to further criteria\nthen those mentioned by the common position.","location":[["","Article 4 \u2013 paragraph 7"]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:00"},"new":["7. By way of derogation from","paragraph 1, where on the basis of","documented evidence an active substance","is necessary to control a serious danger to","plant health which cannot be contained by","other available means, such active","substance may be approved for a time","limited period not exceeding five years","even if it does not satisfy the criteria set out","in points 3.6.2, 3.6.3, 3.6.4, 3.6.5, 3.7.2,","3.7.3 or 3.8.2 of Annex II, provided that","the use of the active substance is subject to","risk mitigation measures to ensure that","exposure of humans and the environment is","minimised. For such substances maximum","residue levels shall be set in accordance","with Regulation (EC) No 396/2005.","This derogation shall not apply to active","substances which are or have to be","classified in accordance with Directive","67/548/EEC, as mutagenic category 1,","carcinogenic category 1 or toxic for","reproduction category 1."],"old":["7. By way of derogation from","paragraph 1, where on the basis of","documented evidence an active substance","is necessary to control a serious danger to","plant health which cannot be contained by","other available means, such active","substance may be approved for a time","limited period not exceeding five years","even if it does not satisfy the criteria set out","in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of","Annex II, provided that the use of the","active substance is subject to risk","mitigation measures to ensure that","exposure of humans and the environment is","minimised. For such substances maximum","residue levels shall be set in accordance","with Regulation (EC) No 396/2005.","This derogation shall not apply to active","substances which are or have to be","classified in accordance with Directive","67/548/EEC, as carcinogenic category 1 or","toxic for reproduction category 1."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"241","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christa Kla\u00df","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-242","justification":" This clause has newly been added by Council. The Commission should be required to\n transmit the measures as proposed by the applying Member State to the Standing Committee\n for a decision.","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1 a (new)"]],"meps":[1929],"meta":{"created":"2020-01-20T00:12:00"},"new":["If a Member State applies for a","derogation under this paragraph the","Commission shall, within two months, put","forward the measures as proposed in this","application to the Standing Committee for","opinion and take a decision in accordance","with the regulatory procedure referred to","in Art. 79 (3). The derogation may in","some cases be limited to only that Member","State making the application."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"242","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward, Neil Parish","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-243","justification":"This clause has newly been added by Council. The Commission should be required to\ntransmit the measures as proposed by the applying Member State to the Standing Committee\nfor a decision.","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1 a (new)"]],"meps":[28114,4528],"meta":{"created":"2020-01-20T00:12:00"},"new":["If a Member State applies for a","derogation under this paragraph the","Commission shall, within two months, put","forward the measures as proposed in this","application to the Standing Committee for","opinion and take a decision in accordance","with the regulatory procedure referred to","in Art. 79 (3). The derogation may in","some cases be limited to only that Member","State making the application."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"243","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-244","justification":"This clause has newly been added by Council. The Commission should be required to\ntransmit the measures as proposed by the applying Member State to the Standing Committee\nfor a decision.","location":[["","Article 4 \u2013 paragraph 7 \u2013 subparagraph 1 a (new)"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:00"},"new":["If a Member State applies for a","derogation under this paragraph the","Commission shall, within two months, put","forward the measures as proposed in this","application to the Standing Committee for","opinion and take a decision in accordance","with the regulatory procedure referred to","in Art. 79 (3). The derogation may in","some cases be limited to only that Member","State making the application."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"244","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-245","justification":" Dossiers with incomplete or wrong information should be rejected.\n\n Reinstating first reading Amendment 74.","location":[["","Article 8 \u2013 paragraph 1 \u2013 point c"]],"meps":[4524],"meta":{"created":"2020-01-20T00:12:00"},"new":["(c) for each point of the data requirements","for the plant protection product, the","summaries and results of tests and studies,","the name of their owner and of the person","or institute that carried out the tests and","studies, relevant to the assessment of the","criteria provided for in Article 4(2) and (3)","for one or more plant protection products","which are representative of the uses","referred to in point (a), taking into account","the fact that any data gaps in the dossier, as","provided for in paragraph 2 of this Article,","resulting from the proposed limited range","of representative uses of the active","substance, shall lead to non-approval of","the active substance;"],"old":["(c) for each point of the data requirements","","for the plant protection product, the","summaries and results of tests and studies,","the name of their owner and of the person","or institute that carried out the tests and","studies, relevant to the assessment of the","criteria provided for in Article 4(2) and (3)","for one or more plant protection products","which are representative of the uses","referred to in point (a), taking into account","the fact that data gaps in the dossier, as","provided for in paragraph 2 of this Article,","resulting from the proposed limited range","of representative uses of the active","substance, may lead to restrictions in the","approval;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"245","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Erna Hennicot-Schoepges","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-246","justification":"Necessary clarification on the setting of the MRL if the conclusions of the Authority are not\nadopted within the prescribed time limit.","location":[["","Article 11 \u2013 paragraph 2 - subparagraph 1"]],"meps":[29019],"meta":{"created":"2020-01-20T00:12:00"},"new":["2. The draft assessment report shall also","include, where relevant, a proposal to set","maximum residue levels."],"old":["2. The draft assessment report shall also","include where relevant, a proposal to set","maximum residue levels. In such a case","the rapporteur Member State shall","forward the application, the evaluation","report and the supporting dossier referred","to in Article 9 of Regulation (EC) No","396/2005 to the Commission no later than","six months after the date of the","notification provided for in the first","subparagraph of Article 9(3) of this","Regulation."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"246","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-247","justification":"The Authority needs to be given enough time to prepare its conclusion. Current requirements\ngrant six months to EFSA. Experience so far has shown that a period of six months is critical\nto conduct an effective and scientifically robust peer review. A 120-day period would for\nexample not allow organising an expert meeting. As such, when a consultation of experts is\nrequired, the period should be extended by 60 days.\n\nCompromise suggestion based on first reading Amendment 83.","location":[["","Article 12 \u2013 paragraph 2 - subparagraph 2"]],"meps":[1059],"meta":{"created":"2020-01-20T00:12:00"},"new":["Within 120 days of the end of the period","provided for the submission of written","comments, the Authority shall adopt a","conclusion in the light of current scientific","and technical knowledge using guidance","documents available at the time of","application on whether the active substance","can be expected to meet the approval","criteria provided for in Article 4 and shall","communicate it to the applicant, the","Member States and the Commission and","shall make it available to the public. Where","a consultation as provided for in the first","subparagraph is organised, the 120-day","period shall be extended by 60 days."],"old":["Within 120 days of the end of the period","provided for the submission of written","comments, the Authority shall adopt a","conclusion in the light of current scientific","and technical knowledge using guidance","documents available at the time of","application on whether the active substance","can be expected to meet the approval","criteria provided for in Article 4 and shall","communicate it to the applicant, the","Member States and the Commission and","shall make it available to the public."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"247","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Erna Hennicot-Schoepges","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-248","justification":" Necessary clarification, the setting of the MRL can not take place before the conclusions of\n the Authority","location":[["","Article 12 \u2013 paragraph 6 a (new)"]],"meps":[29019],"meta":{"created":"2020-01-20T00:12:00"},"new":["6a. Where the conclusion of the Authority","is adopted within the time limit set out in","paragraph 2 of this Article, extended by","any additional time period set in","paragraph 3, the provisions of Article 11","of Regulation (EC) No 396/2005 shall not","apply and the provisions of Article 14 of","that Regulation shall apply without delay."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"248","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Erna Hennicot-Schoepges","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-249","justification":"Necessary clarification on the setting of the MRL if the conclusions of the Authority are not\nadopted within the prescribed time limit.","location":[["","Article 12 \u2013 paragraph 6 b (new)"]],"meps":[29019],"meta":{"created":"2020-01-20T00:12:01"},"new":["6b. Where the conclusion of the Authority","is not adopted within the time limit set out","in paragraph 2 of this Article, extended by","any additional time period set in","paragraph 3, the provisions of Articles 11","and 14 of Regulation (EC) No 396/2005","shall apply without delay."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"249","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-250","justification":"The approval time of candidates for substitution should not be the same as the general\napproval period. To ensure regular comparative assessment of products containing such\nsubstances, the approval period should be limited to 5 years (renewable).\n\nThis amendment should also clarify that Parliament never adopted a position that would have\nmeant an automatic phase out of candidates for substitution. Such phase out is only required\nwhen a series of conditions is fulfilled (see Art. 50).\n\nPartially reinstating first reading Amendment 106. Replaces amendment 92 by the\nrapporteur.","location":[["","Article 24 \u2013 paragraph 1"]],"meps":[1059],"meta":{"created":"2020-01-20T00:12:01"},"new":["1. An active substance complying with the","criteria provided for in Article 4 shall be","approved as a candidate for substitution if","it meets one or more of the additional","criteria laid down in point 4 of Annex II.","By way of derogation from Article 14(2),","the approval may be renewed once or more","for a period not exceeding five years."],"old":["1. An active substance complying with the","criteria provided for in Article 4 shall be","approved as a candidate for substitution if","it meets one or more of the additional","criteria laid down in point 4 of Annex II.","By way of derogation from Article 14(2),","the approval may be renewed once or more","for a period not exceeding ten years."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"250","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-251","justification":" The common position requires the drawing-up of a list of substances which ought to be\n replaced. This Regulation should therefore specify a precise date by which a substance must,\n if appropriate, be included in this list. It is logical that, for a given substance, the decision as\n to whether or not to include it in this list should be taken on the basis of Community re-\n examination.","location":[["","Article 24 \u2013 paragraph 2"]],"meps":[2025],"meta":{"created":"2020-01-20T00:12:01"},"new":["2. Without prejudice to paragraph 1,","Articles 4 to 21 shall apply. Candidates for","substitution shall be listed separately in the","Regulation referred to in Article 13(4)","following their approval or its renewal","pursuant to this Regulation."],"old":["2. Without prejudice to paragraph 1,","Articles 4 to 21 shall apply. Candidates for","substitution shall be listed separately in the","Regulation referred to in Article 13(4)."],"orig_lang":"fr","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"251","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-252","location":[["","Article 27 \u2013 paragraph 2 a (new)"]],"meps":[28299],"meta":{"created":"2020-01-20T00:12:01"},"new":["2a.Where a co-formulant is used in a","plant protection product authorised under","this Regulation, its specific use in plant","protection products shall be considered as","being registered in accordance with","Article 15(1) of Regulation (EC) No","1907/2006 of the European Parliament","and the Council of 18 December 2006","concerning the Registration, Evaluation,","Authorisation and Restriction of","Chemicals (REACH)1.","1","OJ L 396, 30.12.2006, p. 1. Corrected in OJ L","136, 29.5.2007, p. 3."],"old":["",""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"252","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-253","justification":"The law has to cover a provision what has to happen if the Commission does not make a\ndecision on the active substance in the three years provisional authorisation period of the\nplant protection product.","location":[["","Article 30 \u2013 paragraph 1 - subparagraph 1 a ( new)"]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:01"},"new":["If no decision concerning the active","substance has been made before the","provisional period of authorisation for the","plant protection product has expired, the","Member State may extend this","authorisation upon application up to the","date when a decision is made on the","authorisation of the active substance."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"253","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-254","justification":" Council has modified the text as adopted by Parliament in 1st reading and has introduced a\n new article regarding the provisional authorisation of products.\n\n The law has to cover a provision what has to happen if the Commission does not make a\n decision on the active substance in the three years provisional authorisation period of the\n plant protection product.","location":[["","Article 30 \u2013 paragraph 1 - subparagraph 1 a (new)"]],"meps":[4319],"meta":{"created":"2020-01-20T00:12:01"},"new":["If no decision concerning the active","substance has been made before the","provisional period of authorisation for the","plant protection product has expired, the","Member State may extend this","authorisation upon application up to the","date when a decision is made on the","authorisation of the active substance."],"old":[""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"254","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-255","justification":" The law has to cover a provision what has to happen if the Commission does not make a\n decision on the active substance in the three years provisional authorisation period of the\n plant protection product.","location":[["","Article 30 \u2013 paragraph 1 - subparagraph 1 a (new)"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:01"},"new":["If no decision concerning the active","substance has been made before the","provisional period of authorisation for the","plant protection product has expired, the","Member State may extend this","authorisation upon application up to the","date when a decision is made on the","authorisation of the active substance."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"255","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-256","justification":"Council has modified the text as adopted by Parliament in 1st reading and has introduced a\nnew article regarding the provisional authorisation of products. This new article needs to be\nmodified to reflect the proposed changes of the European Parliament in 1st reading.","location":[["","Article 30 \u2013 paragraph 2"]],"meps":[4319],"meta":{"created":"2020-01-20T00:12:02"},"new":["2. In such cases the Member State may","start its evaluation regarding a","provisional authorisation as soon as there","is evidence that the deadlines for the","substance authorisation will not be met","and shall immediately inform the other","Member States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"old":["2. In such cases the Member State shall","immediately inform the other Member","States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"256","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-257","justification":" Reintroduction of amendment adopted in 1st reading.","location":[["","Article 30 \u2013 paragraph 2"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:02"},"new":["2. In such cases the Member State may","start its evaluation regarding a","provisional authorisation as soon as there","is evidence that the deadlines for the","substance authorisation will not be met","and shall immediately inform the other","Member States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"old":["2. In such cases the Member State shall","immediately inform the other Member","States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"257","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-258","justification":" Reintroduction of amendment adopted in 1st reading.","location":[["","Article 30 \u2013 paragraph 2"]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:02"},"new":["2. In such cases the Member State may","start its evaluation regarding a","provisional authorisation as soon as there","is evidence that the deadlines for the","substance authorisation will not be met","and shall immediately inform the other","Member States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"old":["2. In such cases the Member State shall","immediately inform the other Member","States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"258","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Johannes Blokland","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-259","justification":"\nReintroduction of amendment adopted in 1st reading.","location":[["","Article 30 \u2013 paragraph 2"]],"meps":[1969],"meta":{"created":"2020-01-20T00:12:02"},"new":["2. In such cases the Member State may","start its evaluation regarding a","provisional authorisation as soon as there","is evidence that the deadlines for the","substance authorisation will not be met","and shall immediately inform the other","Member States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"old":["2. In such cases the Member State shall","","immediately inform the other Member","States and the Commission of its","assessment of the dossier and of the terms","of the authorisation, giving at least the","information provided for in Article 57 (1)."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"259","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Johannes Blokland","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-260","justification":"The law has to cover a provision what has to happen if the Commission does not make a\ndecision on the active substance in the three years provisional authorisation period of the\nplant protection product.","location":[["","Article 30 \u2013 paragraph 2 a (new)"]],"meps":[1969],"meta":{"created":"2020-01-20T00:12:02"},"new":["2a. If no decision concerning the active","substance has been made before the","provisional period of authorisation for the","plant protection product has expired, the","Member State may extend this","authorisation upon application up to the","date when a decision is made on the","authorisation of the active substance."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"260","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-261","justification":"The new regulation will lead to a significant decrease in the availability of plant protection\nsolutions. Point 7 of Article 4 was added by the European Council to allow for the possibility\nto approve active substances not meeting criteria set out in points 3.6.3, 3.6.4, 3.6.5 and 3.8.2\nof Annex II but that are indispensable to keep some agricultural production in Europe (no\nother solution available). However the European approval of an active substance may take\nseveral years. The amendment above allows Member States to provisionally authorize plant\nprotection products containing active substances while these are being evaluated/approved\nunder Article 4 point 7 in situations where no other control solutions exist.","location":[["","Article 30 \u2013 paragraph 3 a (new)"]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:02"},"new":["3a. By way of derogation from Article","29(1)(a), Member States may, on the basis","of documented evidence, authorise for a","provisional period not exceeding three","years the placing on the market of a plant","protection product containing an active","substance that does not satisfy the criteria","set out in points 3.6.3, 3.6.4, 3.6.5 and","3.8.2 of Annex II and which is not","approved, provided the plant protection","product is necessary to control a serious","danger to plant health, including the","development of resistance, which cannot","be controlled by other available means","and an application for the approval of the","active substance according to Article 4(7)","has been submitted. The use of the plant","protection product has to be subject to risk","mitigation measures to ensure that","exposure of humans and the environment","is minimised.","Following the approval of the active","substance, the validity of the plant","protection product authorisation shall be","adjusted so that it does not exceed the","expiry date of the active substance","approval.","If a decision on the possible approval of","the active substance has not been made by","the time the provisional authorisation","expires, Member States may extend the","authorisation until a decision on the","active substance has been taken.","For such substances, exemptions from","maximum residue levels shall be arranged","in accordance with the procedure set out","in Article 18(4) of Regulation (EC) No","396/2005."],"old":["","","","",""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"261","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Robert Sturdy, Richard Seeber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-262","justification":" The new regulation will lead to a significant decrease in the availability of plant protection\n solutions. Point 7 of Article 4 was added by the European Council to allow for the possibility\n to approve active substances not meeting criteria set out in points 3.6.3, 3.6.4, 3.6.5 and 3.8.2\n of Annex II but that are indispensable to keep some agricultural production in Europe (no\n other solution available). However the European approval of an active substance may take\n several years. The amendment above allows Member States to provisionally authorize plant\n protection products containing active substances while these are being evaluated/approved\n under Article 4 point 7 in situations where no other control solutions exist.","location":[["","Article 30 - paragraph 3 a (new)"]],"meps":[2037,28252],"meta":{"created":"2020-01-20T00:12:02"},"new":["3a. By way of derogation from Article","29(1)(a), Member States may, on the basis","of documented evidence, authorise for a","provisional period not exceeding three","years the placing on the market of a plant","protection product containing an active","substance that does not satisfy the criteria","set out in points 3.6.3, 3.6.4, 3.6.5 and","3.8.2 of Annex II and which is not","approved, provided the plant protection","product is necessary to control a serious","danger to plant health, including the","development of resistance, which cannot","be controlled by other available means","and an application for the approval of the","active substance according to Article 4(7)","has been submitted. The use of the plant","protection product has to be subject to risk","mitigation measures to ensure that","exposure of humans and the environment","is minimised.","Following the approval of the active","substance, the validity of the plant","protection product authorisation shall be","adjusted so that it does not exceed the","expiry date of the active substance","approval.","If a decision on the possible approval of","the active substance has not been made by","the time the provisional authorisation","expires, Member States may extend the","authorisation until a decision on the","active substance has been taken.","For such substances, exemptions from","maximum residue levels shall be arranged","in accordance with the procedure set out","in Article 18(4) of Regulation (EC) No","396/2005."],"old":[""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"262","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-263","justification":"It should be compulsory to indicate the information above in every authorisation.\n\nReinstating first reading Amendment 124.","location":[["","Article 31 \u2013 paragraph 2 \u2013 subparagraph 1 a (new)"]],"meps":[1059],"meta":{"created":"2020-01-20T00:12:02"},"new":["These requirements shall also include:","(a) the maximum dose per hectare in each","application;","(b) the period between the last application","and harvest;","(c) the number of applications per year."],"old":["",""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"263","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-264","justification":"Reinstating part of first reading Amendment 305.","location":[["","Article 31 \u2013 paragraph 2 \u2013 subparagraphs 2 a and 2 b (new)"]],"meps":[4524],"meta":{"created":"2020-01-20T00:12:02"},"new":["The authorisation shall also include:","(a) indications for proper use according to","the principles of integrated pest","management as defined in Article 3, to","apply from 2012 onwards;","(b) the obligation before the product is","used to inform any neighbours who could","be exposed to the spray drift and who","have requested to be informed."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"264","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-265","justification":" This amendment is linked to the amendment to Article 31, paragraph 2, subparagraph 1a by\n the rapporteur. This amendment should fall in case that amendment is not adopted.\n\n In line with the reinstatement of first reading Amendment 124.","location":[["","Article 31 \u2013 paragraph 3 \u2013 point (e)"]],"meps":[1059],"meta":{"created":"2020-01-20T00:12:02"},"new":["deleted"],"old":["(e) the maximum dose per hectare in","each application;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"265","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-266","justification":" This amendment is linked to the amendment to Article 31, paragraph 2, subparagraph 1a by\n the rapporteur. This amendment should fall in case that amendment is not adopted.\n\n In line with the reinstatement of first reading Amendment 124.","location":[["","Article 31 \u2013 paragraph 3 \u2013 point (f)"]],"meps":[1059],"meta":{"created":"2020-01-20T00:12:03"},"new":["deleted"],"old":["(f) the maximum number of","applications per year and interval between","applications;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"266","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-267","justification":"This amendment is linked to the amendment to Article 31, paragraph 2, subparagraph 1a by\nthe rapporteur. This amendment should fall in case that amendment is not adopted.\n\nIn line with the reinstatement of first reading Amendment 124.","location":[["","Article 31 \u2013 paragraph 3 \u2013 point (h)"]],"meps":[1059],"meta":{"created":"2020-01-20T00:12:03"},"new":["deleted"],"old":["(h) the pre-harvest interval, where","applicable;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"267","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-268","location":[["","Article 36 \u2013 paragraph 2"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:03"},"new":["2. The Member States concerned shall","grant authorisations within 180 days of","receiving an application accordingly on","the basis of the conclusions of the","assessment of the Member State examining","the application as provided for in Articles","31 and 32."],"old":["2. The Member States concerned shall","grant or refuse authorisations accordingly","on the basis of the conclusions of the","assessment of the Member State examining","the application as provided for in Articles","31 and 32."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"268","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mar\u00eda Sornosa Mart\u00ednez, Mar\u00eda Isabel Salinas Garc\u00eda","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-269","location":[["","Article 36 \u2013 paragraph 3"]],"meps":[1970,28361],"meta":{"created":"2020-01-20T00:12:03"},"new":["3. By way of derogation from paragraph 2","and subject to Community law, appropriate","conditions may be imposed with respect to","the requirements referred to in points (a)","and (b) of Article 31(3) and other risk","mitigation measures deriving from specific","conditions of use."],"old":["3. By way of derogation from paragraph 2","and subject to Community law, appropriate","conditions may be imposed with respect to","the requirements referred to in points (a)","and (b) of Article 31(3) and other risk","mitigation measures deriving from specific","conditions of use.","Where the concerns of a Member State","related to human or animal health or the","environment cannot be controlled by the","establishment of national risk mitigation","measures referred to in the first","subparagraph, a Member State may as a","last resort refuse authorisation of the","plant protection product in its territory if,","due to its very specific environmental or","agricultural circumstances, it has","substantiated reasons to consider that the","product in question poses a serious risk to","human or animal health or the","environment.","It shall immediately inform the applicant","and the Commission of its decision and","provide a technical or scientific","justification therefor.","Member States shall provide for a","possibility to challenge the decision","refusing the authorisation of such product","before the national courts or other","instances of appeal."],"orig_lang":"es","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"269","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-270","location":[["","Article 36 \u2013 paragraph 3"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:03"},"new":["3. By way of derogation from","paragraph 2 and subject to Community","law, appropriate conditions may be","imposed with respect to the requirements","referred to in points (a) and (b) of Article","31(3) and other risk mitigation measures","deriving from specific conditions of use","taking into account non-comparable","agricultural, plant health or","environmental conditions.","In very exceptional cases, where the","concerns of a Member State related to","human health cannot be controlled by the","establishment of national risk mitigation","measures referred to in the first","subparagraph, a Member State may as a","last resort refuse authorisation of the plant","protection product in its territory if, due to","its very specific environmental or","agricultural circumstances, it has","substantiated reasons to consider that the","product in question poses a serious risk to","human health.","It shall immediately inform the applicant","and the Commission of its decision and","provide a technical or scientific","justification therefore.","The Commission shall within 90 days","present a report with a conclusion","concerning the decision of the Member","State to refuse authorisation of the plant","protection product in its territory.","Member States shall provide for a","possibility to challenge a decision refusing","the authorisation of such product before the","national courts or other instances of appeal."],"old":["3. By way of derogation from","paragraph 2 and subject to Community","law, appropriate conditions may be","imposed with respect to the requirements","referred to in points (a) and (b) of Article","31(3) and other risk mitigation measures","deriving from specific conditions of use.","Where the concerns of a Member State","related to human or animal health or the","environment cannot be controlled by the","establishment of national risk mitigation","measures referred to in the first","subparagraph, a Member State may as a","last resort refuse authorisation of the plant","protection product in its territory if, due to","its very specific environmental or","agricultural circumstances, it has","substantiated reasons to consider that the","product in question poses a serious risk to","human or animal health or the","environment.","It shall immediately inform the applicant","and the Commission of its decision and","provide a technical or scientific","justification therefore.","Member States shall provide for a","possibility to challenge decision refusing","the authorisation of such product before the","national courts or other instances of appeal."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"270","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Johannes Blokland","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-271","justification":" Newly added sentence by the Council. A mutual recognition authorisation for third parties is\n not acceptable for the \u201coriginal\u201d authorisation holder without his liability exemption as it is\n in the law in cases of minor use extensions for third parties.","location":[["","Article 40 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[1969],"meta":{"created":"2020-01-20T00:12:03"},"new":["deleted"],"old":["In case the authorisation holder refuses","its consent, the competent authority of the","Member State concerned may accept the","application, on grounds of public interest."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"271","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dorette Corbey","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-272","justification":"Member States must have the opportunity to decide for themselves about the authorisation of\nplant protection products.","location":[["","Article 40 \u2013 paragraph 2 a (new)"]],"meps":[4558],"meta":{"created":"2020-01-20T00:12:03"},"new":["2a. Member States may refuse to","recognise a plant protection product if a","prima facie case can be made that the use","of the plant protection product in their","territory will have a different impact on","the environment than in the reference","Member State or if refusal to authorise it","accords with the established","environmental policy of the Member State","concerned;"],"orig_lang":"nl","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"272","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-273","location":[["","Article 41 \u2013 paragraph 1"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:03"},"new":["1. The Member State to which an","application under Article 40 is submitted","shall authorise the plant protection product","concerned under the same conditions as the","Member State examining the application.","Where the agricultural, plant health or","environmental conditions are non-","comparable, Article 36(2) and (3) shall","apply."],"old":["1. The Member State to which an","application under Article 40 is submitted","shall authorise the plant protection product","concerned under the same conditions as the","Member State examining the application","except where Article 36(3) applies."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"273","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-274","justification":" Clarification to achieve consistency with translation requirements in Article 33(5). A general\n translation requirement without request undermines the efficiency of the process.","location":[["","Article 42 \u2013 paragraph 1 - point a"]],"meps":[4319],"meta":{"created":"2020-01-20T00:12:03"},"new":["(a) a copy of the authorisation granted","by the reference Member State as well as,","where requested, a translation of the","authorisation into an official or national","language of the Member State receiving","the application;"],"old":["(a) a copy of the authorisation granted","by the reference Member State as well as a","translation of the authorisation into an","official language of the Member State","receiving the application;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"274","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-275","justification":" Council has introduced new provisions regarding periods of grace. The proposed change\n would achieve a consistent approach to periods of grace for active substances (Art 20 (2))\n and plant protection products.","location":[["","Article 46"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:03"},"new":["Where a Member State withdraws or","amends an authorisation or does not renew","it, it may grant a grace period for the","disposal, storage, placing on the market","and use of existing stocks in line with","Article 20(2).","Where the reasons for withdrawal,","amendment or not renewing the","authorisation permit it, the grace period","shall not exceed one year for the placing","on the market and in addition a maximum","of one year for the disposal, storage, and","use of existing stocks of the plant","protection products concerned.","If the authorisation is withdrawn or not","renewed because of immediate concerns","for human or animal health or the","environment, the plant protection","products concerned shall be withdrawn","from the market immediately."],"old":["Where a Member State withdraws or","amends an authorisation or does not renew","it, it may grant a grace period for the","disposal, storage, placing on the market","and use of existing stocks.","","Where the reasons for withdrawal,","amendment or not renewing the","authorisation permit it the grace period","shall be limited and not exceed six months","for the placing on the market and an","additional maximum of one year for the","disposal, storage, and use of existing stocks","of the plant protection products concerned."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"275","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-276","justification":"The term \u201cexceptional cases\u201d is undefined and is jeopardizing the predictability and\nworkability of the authorisation process.","location":[["","Article 50 \u2013 paragraph 2"]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:04"},"new":["deleted"],"old":["2. By way of derogation from Article 36","(2) Member States may in exceptional","cases also apply the provisions of","paragraph 1 when evaluating an","application for authorisation of a plant","protection product not containing a","candidate for substitution or a low risk","substance, if a non-chemical control or","prevention method exists for the same use","and it is in general use in that Member","State."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"276","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber, Christa Kla\u00df","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-277","justification":" The term \u201cexceptional cases\u201d is undefined and is jeopardizing the predictability and\n workability of the authorisation process.","location":[["","Article 50 \u2013 paragraph 2"]],"meps":[28227,1929],"meta":{"created":"2020-01-20T00:12:04"},"new":["deleted"],"old":["2. By way of derogation from Article 36","(2) Member States may in exceptional","cases also apply the provisions of","paragraph 1 when evaluating an","application for authorisation of a plant","protection product not containing a","candidate for substitution or a low risk","substance, if a non-chemical control or","prevention method exists for the same use","and it is in general use in that Member","","","State."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"277","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christofer Fjellner","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-278","justification":" Clarification: for minor uses the full authorisation procedure is not applicable. Therefore it is\n not an application for an authorisation but an application for an approval to extend an\n existing authorisation.","location":[["","Article 51 \u2013 paragraph 1"]],"meps":[28126],"meta":{"created":"2020-01-20T00:12:04"},"new":["1. The authorisation holder, official or","scientific bodies involved in agricultural","activities, professional agricultural","organisations or professional users may ask","for the approval of a plant protection","product already authorised in the Member","State concerned to be extended to minor","uses not yet covered by that authorisation."],"old":["1. The authorisation holder, official or","scientific bodies involved in agricultural","activities, professional agricultural","organisations or professional users may ask","for the authorisation of a plant protection","product already authorised in the Member","State concerned to be extended to minor","uses not yet covered by that authorisation."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"278","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bogus\u0142aw Sonik","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-279","location":[["","Article 51 \u2013 paragraph 4 \u2013 subparagraph 3"]],"meps":[28299],"meta":{"created":"2020-01-20T00:12:04"},"new":["The official publication or where","applicable the label shall include a","reference to the liability of the person using","the plant protection product with respect to","failures on the efficacy or to phytotoxicity","of the product for which the minor use was","granted. Without prejudice to Article 73,","the authorisation holder shall not be","liable for any losses arising from use in","accordance with extensions of","authorisation. The minor use extension","shall be separately identified in the label."],"old":["The official publication or where","","","applicable the label shall include a","reference to the liability of the person using","the plant protection product with respect to","failures on the efficacy or to phytotoxicity","of the product for which the minor use was","granted. The minor use extension shall be","separately identified in the label."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"279","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward, Anne Laperrouze","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-280","justification":"Council has newly introduced these provisions on packaging of parallel traded products.\nClarification to emphasise that re-packaging should not be allowed in order to prevent any\nopportunity for the import of counterfeited and unevaluated products.","location":[["","Article 52 \u2013 paragraph 3 \u2013 point (c)"]],"meps":[28114,28209],"meta":{"created":"2020-01-20T00:12:04"},"new":["(c) they are either the same or equivalent in","the co-formulants present"],"old":["(c) they are either the same or","equivalent in 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."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"280","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward, Anne Laperrouze","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-281","justification":" Council has newly introduced these provisions on packaging of parallel traded products.\n Clarification to emphasise that re-packaging should not be allowed in order to prevent any\n opportunity for the import of counterfeited and unevaluated products.","location":[["","Article 52 \u2013 paragraph 3 \u2013 point (c) a (new)"]],"meps":[28114,28209],"meta":{"created":"2020-01-20T00:12:04"},"new":["(ca) they have not been repackaged and","their packaging is the same as or","equivalent to that of the reference","products in terms of size, material and","form."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"281","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Erna Hennicot-Schoepges","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-282","justification":"Im EuGH Urteil vom 25.02.2008, Az. C-201/06, r\u00fcgt der EuGH das Fehlen eines\nvereinfachten Zulassungsverfahrens f\u00fcr Generika, in welchem die wesentliche\n\u00dcbereinstimmung eines Generikums mit einem Referenzerzeugnis \u00fcberpr\u00fcft wird. Aufgrund\nder ausdr\u00fccklichen Forderung des Gerichtshofes nach Einf\u00fchrung eines solchen Verfahrens\nist dessen Einf\u00fchrung in die vorliegende Verordnung dringend geboten, zumal der jetzt\nvorliegende Kompromissvorschlag eine solche Regelung vollst\u00e4ndig vermissen l\u00e4sst. Damit\nw\u00fcrde f\u00fcr die Paralleleinfuhr von Generika eine gesetzliche L\u00fccke entstehen, die die Garantie\ndes freien Warenverkehrs aus Art. 28 EG auch f\u00fcr solche Produkte verletzt.","location":[["","Article 52 \u2013 paragraph 3 \u2013 subparagraph 1 a (new)"]],"meps":[29019],"meta":{"created":"2020-01-20T00:12:04"},"new":["Plant protection products which do not","comply with the condition referred to in","subparagraph (a) but which do comply","with the all the other conditions referred","to in this paragraph shall be deemed to be","identical to the reference product if a","comparative assessment by a laboratory","officially recognised in accordance with","the Principles of Good Laboratory","Practice, which assessment is submitted to","the competent authority of the importing","Member State by the applicant, or a","comparative assessment by the competent","authority, confirms that the plant","protection product in respect of which an","import permit is requested is, in","substance, identical to the reference","product and that the following","requirements are met:","(a) the requirements of subparagraph 1,","points (b) and (c),","(b) the plant protection product in respect","of which an import permit is requested","does not contain a co-formulant or a co-","formulant substance which has not been","assessed,","(c) no co-formulant substances with","essential functions are lacking,","(d) the product does not feature different","nominal concentrations of co-formulants","with essential functions or co-formulant","substances which are more toxic or","ecotoxic than the reference product or are","less favourable from the point of view of","effectiveness or stability than those of the","reference product,","(e) no co-formulants are absent which","serve to protect users or third parties."],"old":[""],"orig_lang":"de","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"282","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward, Anne Laperrouze","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-283","justification":" Council has newly introduced these provisions on packaging of parallel traded products.\n Clarification to emphasise that re-packaging should not be allowed in order to prevent any\n opportunity for the import of counterfeited and unevaluated products.","location":[["","Article 52 \u2013 paragraph 4 \u2013 point (h)"]],"meps":[28114,28209],"meta":{"created":"2020-01-20T00:12:04"},"new":["(h) a sample of the product and packaging","which is intended to be introduced if it is","considered as necessary by the competent","authority of the Member State of","introduction;"],"old":["(h) a sample of the product which is","intended to be introduced if it is considered","as necessary by the competent authority of","the Member State of introduction;"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"283","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-284","justification":" Council introduced new provisions concerning identicality of parallel traded pesticides.\n Under transparency considerations, the information about parallel trade permits should be\n made available.","location":[["","Article 52 \u2013 paragraph 10 a (new)"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:04"},"new":["10a. Without prejudice to Article 63,","Member State authorities shall make","publicly available information about","parallel trade permits.."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"284","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kathy Sinnott","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-285","justification":"Agricultural stakeholders should be recognised as people who can contribute to this field and\nto best practice and not just as those who implement plant protection as directed by others.","location":[["","Article 54\u2013 paragraph 3 a (new)"]],"meps":[28119],"meta":{"created":"2020-01-20T00:12:04"},"new":["3a. Research and development should","take into account the needs and","experiences of agricultural stakeholders","such as farmers as they have a significant","contribution to make regarding","maximising crop outputs and day-to-day","implementation of plant protection","practices."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"285","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mojca Dr\u010dar Murko","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-286","justification":" The obligation to notify potentially unacceptable effects on - all - plant products is not in line\n with the principle of proportionality. This has to be limited to crops.","location":[["","Article 56 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[28305],"meta":{"created":"2020-01-20T00:12:04"},"new":["In particular, potentially harmful effects of","that plant protection product, or of residues","of an active substance, its metabolites, a","safener, synergist or co-formulant","contained in it, on human or animal health","or on groundwater, or their potentially","unacceptable effects on crops or crop","products or the environment shall be","notified."],"old":["In particular, potentially harmful effects of","that plant protection product, or of residues","of an active substance, its metabolites, a","safener, synergist or co-formulant","contained in it, on human or animal health","or on groundwater, or their potentially","unacceptable effects on plants or plant","products or the environment shall be","notified."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"286","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-287","justification":" The content of this article has been changed by Council. Indicating that an adjuvant shall not\n be placed on the market or used if it contains a co-formulant which has not been approved in\n accordance with the co-formulant article should suffice. Adjuvants shall be registered and\n documented under REACH and detailed rules are therefore not needed under Article 58.","location":[["","Article 58"]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:05"},"new":["An adjuvant shall not be placed on the","market or used if it contains a co-","formulant which has been prohibited in","accordance with Article 27."],"old":["1. An adjuvant shall not be placed on the","market or used unless it has been","authorised in the Member State","concerned in accordance with the","conditions established in the Regulation","referred to in paragraph 2.","2. Detailed rules for the authorisation of","adjuvants, including data requirements,","notification, evaluation, assessment and","decision making procedure shall be","adopted in accordance with the procedure","referred to in Article 79(4).","3. Article 81(3) shall apply."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"287","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward, Christa Kla\u00df, Anne Laperrouze","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-288","justification":"Retables amendment adopted in 1st reading and clarifies it.","location":[["","Article 59 \u2013 paragraph 1 \u2013 subparagraph 7"]],"meps":[28114,1929,28209],"meta":{"created":"2020-01-20T00:12:05"},"new":["A study submitted for the renewal or","review of an authorisation shall not be","protected except where required for the","purposes of legislative changes or updates","to scientific and technical knowledge, in","which case the time period of protection","shall be equivalent to that set out in the","fourth subparagraph."],"old":["A study shall also be protected if it was","necessary for the renewal or review of an","authorisation. 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The period for data","protection shall be 2 years and 6 months.","The first to fourth subparagraphs shall","apply with due changes."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"290","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Robert Sturdy, Richard Seeber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-291","justification":"From a legal point of view \u201cnormally\u201d is undefined and opens the door for arbitrariness.","location":[["","Article 63 \u2013 paragraph 2 - introduction"]],"meps":[2037,28252],"meta":{"created":"2020-01-20T00:12:05"},"new":["2. Disclosure of the following","information shall be deemed to undermine","the protection of the commercial interests","or of privacy and the integrity of the","individuals concerned:"],"old":["2. 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Disclosure of the following information","shall be deemed to undermine the","protection of the commercial interests or of","privacy and the integrity of the individuals","concerned:"],"old":["2. Disclosure of the following information","shall normally be deemed to undermine the","protection of the commercial interests or of","privacy and the integrity of the individuals","concerned:"],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"292","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-293","justification":" Children and other vulnerable groups may also be situated in homes and gardens near fields\n that are sprayed as well as in other public areas and so spraying near such areas should also\n not be advertised.\n\n Amendment of new text introduced by Council.","location":[["","Article 66 \u2013 paragraph 4"]],"meps":[4524],"meta":{"created":"2020-01-20T00:12:05"},"new":["4. 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Advertisements shall not contain any","visual representation of potentially","dangerous practices, such as mixing or","application without sufficient protective","clothing, not any use near food or use by or","in the vicinity of children."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"293","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-294","justification":" The provisions have to be reduced because they are a not proportional administrative burden.","location":[["","Article 67 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[4319],"meta":{"created":"2020-01-20T00:12:05"},"new":["1. Producers and importers of plant","protection products shall keep records of","the plant protection products they place on","the market for at least 3 years."],"old":["1. Producers, suppliers, distributors,","importers, exporters and professional","users of plant protection products shall","keep records of the plant protection","products they produce, import, export,","store, use or place on the market for at","least three years."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"294","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-295","justification":"\nThe subparagraphs under paragraph 2 and paragraph 4 have to be deleted because they\nviolate the legitimate expectations of the authorisation holders and the equal treatment of\nsimilar cases.","location":[["","Article 80 \u2013 paragraph 2 to 4"]],"meps":[4319],"meta":{"created":"2020-01-20T00:12:05"},"new":["2. 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This definition\nshould be based on a proper assessment of the risk involved in using a product under realistic\nfield conditions.","location":[["","Annex II - point 3.6.4."]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:06"},"new":["3.6.4. 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An active substance, safener or","synergist shall only be approved if, on the","basis of assessment of reproductive toxicity","testing carried out in accordance with the","data requirements for the active substances,","safeners or synergists and other available","data and information, including a review of","the scientific literature, reviewed by the","Authority, it is not or has not to be","classified, in accordance with the","provisions of Directive 67/548/EEC, as","toxic for reproduction category 1 or 2,","unless the exposure of humans to that","active substance, safener or synergist in a","plant protection product, under realistic","proposed conditions of use, is negligible,","i.e. the product is used in closed systems","or in other conditions excluding contact","with humans and where residues of the","","active substance, safener or synergist","concerned on food and feed do not exceed","the default value set in accordance with","point (b) of Article 18(1) of","Regulation (EC) No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"304","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marianne Thyssen","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-305","justification":" Council has introduced a new definition of the term \u201cnegligible exposure\u201d. This definition\n should be based on a proper assessment of the risk involved in using a product under realistic\n field conditions.","location":[["","Annex II - point 3.6.4."]],"meps":[1832],"meta":{"created":"2020-01-20T00:12:06"},"new":["3.6.4. An active substance, safener or","synergist shall only be approved if, on the","basis of assessment of reproductive toxicity","testing carried out in accordance with the","data requirements for the active substances,","safeners or synergists and other available","data and information, including a review of","the scientific literature, reviewed by the","Authority, it is not or has not to be","classified, in accordance with the","provisions of Directive 67/548/EEC, as","toxic for reproduction category 1 or 2,","unless the exposure of humans to that","active substance, safener or synergist in a","plant protection product, under realistic","proposed conditions of use, is negligible,","i.e. the margin of safety for humans under","realistic proposed conditions of all uses is","higher than 200"],"old":["3.6.4. An active substance, safener or","synergist shall only be approved if, on the","basis of assessment of reproductive toxicity","testing carried out in accordance with the","data requirements for the active substances,","safeners or synergists and other available","data and information, including a review of","the scientific literature, reviewed by the","Authority, it is not or has not to be","classified, in accordance with the","provisions of Directive 67/548/EEC, as","toxic for reproduction category 1 or 2,","unless the exposure of humans to that","active substance, safener or synergist in a","plant protection product, under realistic","proposed conditions of use, is negligible,","i.e. the product is used in closed systems","or in other conditions excluding contact","with humans and where residues of the","active substance, safener or synergist","concerned on food and feed do not exceed","the default value set in accordance with","","point (b) of Article 18(1) of","Regulation (EC) No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"305","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-306","justification":"Council has introduced a new definition of the term \u201cnegligible exposure\u201d. This definition\nshould be based on a proper assessment of the risk involved in using a product under realistic\nfield conditions.","location":[["","Annex II - point 3.6.4."]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:06"},"new":["3.6.4. An active substance, safener or","synergist shall only be approved if, on the","basis of assessment of reproductive toxicity","testing carried out in accordance with the","data requirements for the active substances,","safeners or synergists and other available","data and information, including a review of","the scientific literature, reviewed by the","Authority, it is not or has not to be","classified, in accordance with the","provisions of Directive 67/548/EEC, as","toxic for reproduction category 1 or 2,","unless the exposure of humans to that","active substance, safener or synergist in a","plant protection product, under realistic","proposed conditions of use, is negligible,","i.e. the margin of safety for humans under","realistic proposed conditions of all uses is","higher than 200."],"old":["3.6.4. An active substance, safener or","synergist shall only be approved if, on the","basis of assessment of reproductive toxicity","testing carried out in accordance with the","data requirements for the active substances,","safeners or synergists and other available","data and information, including a review of","the scientific literature, reviewed by the","Authority, it is not or has not to be","classified, in accordance with the","provisions of Directive 67/548/EEC, as","toxic for reproduction category 1 or 2,","unless the exposure of humans to that","active substance, safener or synergist in a","plant protection product, under realistic","proposed conditions of use, is negligible,","i.e. the product is used in closed systems","or in other conditions excluding contact","with humans and where residues of the","active substance, safener or synergist","concerned on food and feed do not exceed","the default value set in accordance with","point (b) of Article 18(1) of","Regulation (EC) No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"306","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward, Christa Kla\u00df","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-307","justification":" A newly introduced derogation for these substances has been set out in Article 4(7) which\n specifically refers to Annex II points 3.6.5 and 3.8.2 and this requires further clarity on the\n criteria to be applied.","location":[["","Annex II - point 3.6.5."]],"meps":[28114,1929],"meta":{"created":"2020-01-20T00:12:06"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved, if, 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 Authority, it is","not, on the basis of specific scientific","criteria once they are adopted in","accordance with Article 78(2), considered","to have endocrine disrupting properties that","may cause adverse effect in humans unless","the exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with Article 18(1)","(b) of Regulation (EC) No 396/2005."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved, if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with Article 18(1)","(b) of Regulation (EC) No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"307","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-308","justification":"A newly introduced derogation for these substances has been set out in Article 4(7) which\nspecifically refers to Annex II points 3.6.5 and 3.8.2 and this requires further clarity on the\ncriteria to be applied.","location":[["","Annex II - point 3.6.5."]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:07"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved, if, 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 Authority, it is","not, on the basis of specific scientific","criteria once they are adopted in","accordance with Article 78(2), considered","to have endocrine disrupting properties that","may cause adverse effect in humans unless","the exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with Article 18(1)","(b) of Regulation (EC) No 396/2005."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved, if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with Article 18(1)","(b) of Regulation (EC) No 396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"308","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Avril Doyle","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-309","justification":"This wording is consistent with Article 57(f) of Regulation 1907/2006 \"REACH\". It would set\n\n\n a more realistic standard for implementing measures on endocrine disruptors.","location":[["","Annex II - point 3.6.5."]],"meps":[4382],"meta":{"created":"2020-01-20T00:12:07"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties for which there is","scientific evidence of probable serious","effects for human health, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"309","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Robert Sturdy, Richard Seeber, Alyn Smith","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-310","justification":" This amendment reflects what appears to be the Commission\u2019s interpretation of this\n provision, and is similar to the interpretation adopted in the report published by KEMI (the\n Swedish Chemicals Agency) on 22 September 2008 . It would clarify that adverse effects of\n endocrine disruption in humans are those involving reproductive toxicity. Substances\n classified as toxic to reproduction category 1 and 2 are already subject to the provisions of\n paragraph 3.6.4; this paragraph therefore extends to substances classified as category 3, i.e.\n\nthose remaining substances for which there is some evidence of potential to have adverse\neffects on hormone systems.","location":[["","Annex II - point 3.6.5."]],"meps":[2037,28252,28508],"meta":{"created":"2020-01-20T00:12:07"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans such that it is not","or has not to be classified, in accordance","with the provisions of Directive","67/548/EEC, as toxic for reproduction","category 3, unless the exposure of humans","to that active substance, safener or","synergist in a plant protection product,","under realistic proposed conditions of use,","is negligible, i.e. the product is used in","closed systems or in other conditions","excluding contact with humans and where","residues of the active substance, safener or","synergist concerned on food and feed do","not exceed the default value set in","accordance with point (b) of Article 18(1)","of Regulation (EC) No 396/2005."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"310","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Glenis Willmott, Dorette Corbey","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-311","justification":"This amendment reflects what appears to be the Commission\u2019s interpretation of this\nprovision, and is similar to the interpretation adopted in the report published by KEMI (the\nSwedish Chemicals Agency) on 22 September 2008\nhttp://www.kemi.se/templates/News____5415.aspx . It would clarify that adverse effects of\n\n endocrine disruption in humans are those involving reproductive toxicity. Substances\n classified as toxic to reproduction category 1 and 2 are already subject to the provisions of\n paragraph 3.6.4; this paragraph therefore extends to substances classified as category 3, i.e.\n those remaining substances for which there is some evidence of potential to have adverse\n effects on hormone systems","location":[["","Annex II - point 3.6.5."]],"meps":[35743,4558],"meta":{"created":"2020-01-20T00:12:07"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans such that it is not","or has not to be classified, in accordance","with the provisions of Directive","67/548/EEC, as toxic for reproduction","category 3, unless the exposure of humans","to that active substance, safener or","synergist in a plant protection product,","under realistic proposed conditions of use,","is negligible, i.e. the product is used in","closed systems or in other conditions","excluding contact with humans and where","residues of the active substance, safener or","synergist concerned on food and feed do","not exceed the default value set in","accordance with point (b) of Article 18(1)","of Regulation (EC) No 396/2005."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"311","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-312","justification":" This process is too prescriptive and restrictive given the variety of substances that may fall\n into category 1 and category 2 . It would be advisable that experts should decide scope of\n negligibility .","location":[["","Annex II - point 3.6.5."]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:07"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"312","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-313","justification":"Council has introduced a new definition of the term \u201cnegligible exposure\u201d. This definition\nshould be based on a proper assessment of the risk involved in using a product under realistic\nfield conditions.","location":[["","Annex II - point 3.6.5."]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:07"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","margin of safety for humans under","realistic proposed conditions of all uses is","higher than 200."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"313","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marianne Thyssen","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-314","justification":" Council has introduced a new definition of the term \u201cnegligible exposure\u201d. This definition\n should be based on a proper assessment of the risk involved in using a product under realistic\n field conditions.","location":[["","Annex II - point 3.6.5."]],"meps":[1832],"meta":{"created":"2020-01-20T00:12:07"},"new":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","margin of safety for humans under","realistic proposed conditions of all uses is","higher than 200."],"old":["3.6.5. An active substance, safener or","synergist shall only be approved if, 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 Authority, it is","not considered to have endocrine","disrupting properties that may cause","adverse effect in humans, unless the","exposure of humans to that active","substance, safener or synergist in a plant","protection product, under realistic proposed","conditions of use, is negligible, i.e. the","product is used in closed systems or in","other conditions excluding contact with","humans and where residues of the active","substance, safener or synergist concerned","on food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"314","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Johannes Blokland","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-315","justification":"Partly reinstating Am 300 of first reading, in order to seek for a compromise with the\nCouncil. Neurotoxic and immunotoxic substances interfering at the developmental stage of\nlife pose a serious threat to society. Exposure to such chemicals should be prevented, but\nlimited to cases of serious concern. Amendment 300 of the EP is therefore adapted in such a\nway that not every risk will lead to non-approval but only in cases of significant risk.","location":[["","Annex II - point 3.6.5. a (new)"]],"meps":[1969],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.6.5a. An active substance shall only be","approved if, on the basis of the assessment","or other available data and information","including a review of the scientific","literature, it is not considered to cause a","significant risk (affecting 1 in a million","citizens) of developmental neurotoxic or","immunotoxic properties in humans,","taking into account exposure during","embryonic/foetal life and/or during","childhood as well as likely combination","effects."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"315","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dorette Corbey","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-316","justification":" Substances which cause neurodevelopmental or immunotoxic developmental disorders must\n not be permitted except in closed systems or in situations where people do not come into\n contact with the substances or if they are used in modern horticultural greenhouses where\n emissions into surface waters, soil and outside air have been minimised.","location":[["","Annex II - point 3.6.5. a (new)"]],"meps":[4558],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.6.5a. An active substance, safener or","synergist shall only be approved, if, on the","basis of evaluation of other available data","and information, including an overview of","the scientific literature, it is not","considered to give rise to a risk of","neurotoxic or immunotoxic developmental","disorders in humans, taking into account","exposure during embryonic/foetal life","and/or childhood or combined effects,","unless the exposure of humans to that","active substance, safener or synergist in a","plant protection product, under realistic","proposed conditions of use, is negligible,","i.e. the product is used in closed systems,","in horticultural greenhouses or in","conditions excluding contact with humans","and where residues of the active","substance, safener or synergist concerned","in food and feed do not exceed the default","value set in accordance with point (b) of","Article 18(1) of Regulation (EC) No","396/2005 and if the emissions into surface","waters, soil and outside air are kept to a","minimum. On the basis of risk analyses, a","Member State may however permit the","use of these substances."],"old":[""],"orig_lang":"nl","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"316","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anne Laperrouze, Dan J\u00f8rgensen","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-317","justification":"To be consistent with Article 4.3 b), tests are needed to prove that use of an active substance\ncontained in a plant protection product will not lead to the formation of harmful by-products\nfor human health during drinking water treatment.\n\nThe case of the substance called \u201cTolylfluanid\u201d in 2007 (Commission Decision\nn\u00b02007/322/EC) has clearly showed the need to include such tests in the procedure of\nevaluation and justifies the introduction of this new amendment.","location":[["","Annex II - point 3.6.5. a (new)"]],"meps":[28209,28156],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.6.5.a. An active substance shall only be","approved if:","- tests of behaviour of the active","substance, its metabolites and degradation","and reaction products in response to","different drinking water treatment","processes have not highlighted the","formation of potentially harmful by-","products for human health","- tests of treatability based on","common drinking water treatment","processes have demonstrated that","drinking water produced from raw waters","(ground and surface waters) containing","the active substance, its metabolites and","degradation and reaction products will","comply with the value of 0,1\u00b5g/l set in","Council Directive 98/83/EC of 3","November 1998 on the quality of water","intended for human consumption1 and","not involve risks for human health.","The tests will be carried out according to","common protocols established at EU level","and recognised by both water suppliers","and pesticide manufacturers.","1","OJ L 330, 5.12.1998, p. 32."],"old":[""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"317","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Hiltrud Breyer","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-318","justification":"This amendment brings the Regulation in line with the provisions of Annex D of the\nStockholm Convention, which also allows for other evidence than just certain tests.\n\nPartially reinstating first reading Amendment 230. Replaces amendment 195 by the\nrapporteur.","location":[["","Annex II - point 3.7.1. \u2013 3.7.1.1. \u2013 3.7.1.2."]],"meps":[1059],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.7.1. An active substance, safener or","synergist shall only be approved where it,","and its transformation products or","residues, are not considered to be","persistent organic pollutants (POPs).","A substance that fulfils all three of the","criteria of the sections below is a POP.","3.7.1.1. Persistence","An active substance, safener or synergist","fulfils the persistence criterion where there","is:","- evidence that the time it takes for a","degradation of 50 % (DT50) in water is","greater than two months, or that its DT50","in soil is greater than six months, or that its","DT50 in sediment is greater than","six months; or","- evidence that the active substance is","otherwise sufficiently persistent to be","considered in the context of the POPs","Convention;","3.7.1.2. Bioaccumulation","An active substance, safener or synergist","fulfils the bioaccumulation criterion where","there is:","- evidence that its bio-concentration factor","or bio accumulation factor in aquatic","species is greater than 2 000 or, in the","absence of such data, that the partition","coefficient n-octanol/water (log Ko/w) or","the partition coefficient n-octanol/air (log","Ko/a) is greater than 5; or","- evidence that the active substance,","safener or synergist present other reasons","for concern, such as high bioaccumulation","in other non-target species, high toxicity or","ecotoxicity; or","- evidence based on monitoring data in","biota indicating that the bio-accumulation","potential of the active substance is","sufficient for it to be considered under the","POPs Convention."],"old":["3.7.1. An active substance, safener or","synergist shall only be approved where it is","not considered to be a persistent organic","","pollutant (POP).","A substance that fulfils all three of the","criteria of the sections below is a POP.","3.7.1.1. Persistence","An active substance, safener or synergist","fulfils the persistence criterion where there","is evidence that the time it takes for a","degradation of 50 % (DT50) in water is","greater than two months, or that its DT50","in soil is greater than six months, or that its","DT50 in sediment is greater than","six months.","3.7.1.2. Bioaccumulation","An active substance, safener or synergist","fulfils the bioaccumulation criterion where","there is:","- evidence that its bio-concentration factor","or bioaccumulation factor in aquatic","species is greater than 5 000 or, in the","absence of such data, that the partition","coefficient n-octanol/water (log Ko/w) is","greater than 5; or","- evidence that the active substance,","safener or synergist present other reasons","for concern, such as high bioaccumulation","in other non-target species, high toxicity or","ecotoxicity.","",""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"318","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-319","justification":"As Council has not accepted the additional criterion on bee toxicity proposed by Parliament\nin first reading. This proposal would offer a compromise to take account of the concerns of\nboth institutions. Specific uses of a plant protection product shall not be authorized when it is\ndemonstrated that they have or are expected to have adverse and irreversible effects on bee\n\n colonies.","location":[["","Annex II - point 3.8.1. a (new)"]],"meps":[4319],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.8.1.a. An active substance, safener or","synergist shall only be approved if, used","under realistic conditions, it does not","result in adverse effects on bee colonies.","Evaluation must take into account the","severity of effects observed under field","conditions and the level at which adverse","effects are observed on colonies.","Uses of an active substance, safener or","synergist shall not be authorised if there is","evidence, under normal condition of use,","that exposure will result in adverse effects","on bee colonies."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"319","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-320","justification":" A newly introduced derogation for these substances has been set out in Article 4(7) which\n specifically refers to Annex II points 3.6.5 and 3.8.2 and this requires further clarity on the\n criteria to be applied.","location":[["","Annex II - point 3.8.2."]],"meps":[28227],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.8.2. An active substance, safener or","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not, on the basis of specific scientific","criteria once they are adopted in","accordance with Article 78(2), considered","to have endocrine disrupting properties that","may cause adverse effects on non-target","organisms unless the exposure of non-","target organisms to that active substance in","a plant protection product under realistic","proposed conditions of use is negligible."],"old":["3.8.2. An active substance, safener or","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not considered to have endocrine","disrupting properties that may cause","adverse effects on non-target organisms","unless the exposure of non-target","organisms to that active substance in a","plant protection product under realistic","proposed conditions of use is negligible."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"320","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Liam Aylward, Christa Kla\u00df","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-321","justification":"A newly introduced derogation for these substances has been set out in Article 4(7) which\nspecifically refers to Annex II points 3.6.5 and 3.8.2 and this requires further clarity on the\ncriteria to be applied.","location":[["","Annex II - point 3.8.2."]],"meps":[28114,1929],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.8.2. An active substance, safener or","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not, on the basis of specific scientific","criteria once they are adopted in","accordance with Article 78(2), considered","to have endocrine disrupting properties that","may cause adverse effects on non-target","organisms unless the exposure of non-","target organisms to that active substance in","a plant protection product under realistic","proposed conditions of use is negligible."],"old":["3.8.2. An active substance, safener or","","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not considered to have endocrine","disrupting properties that may cause","adverse effects on non-target organisms","unless the exposure of non-target","organisms to that active substance in a","plant protection product under realistic","proposed conditions of use is negligible."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"321","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Liam Aylward","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-322","justification":" Council has introduced a new definition of the term \u201cnegligible exposure\u201d. This definition\n should be based on a proper assessment of the risk involved in using a product under realistic\n field conditions.","location":[["","Annex II - point 3.8.2."]],"meps":[28114],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.8.2. An active substance, safener or","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not considered to have endocrine","disrupting properties that may cause","adverse effects on non-target organisms","unless the exposure of non-target","organisms to that active substance in a","plant protection product is negligible, i.e.","under realistic proposed conditions of use","the product does not lead to unacceptable","negative effects in the environment."],"old":["3.8.2. An active substance, safener or","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not considered to have endocrine","disrupting properties that may cause","adverse effects on non-target organisms","unless the exposure of non-target","organisms to that active substance in a","plant protection product under realistic","proposed conditions of use is negligible."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"322","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marianne Thyssen","changes":{},"committee":["ENVI"],"compromise":[" Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-323","justification":" Council has introduced a new definition of the term \u201cnegligible exposure\u201d. This definition\n should be based on a proper assessment of the risk involved in using a product under realistic\n field conditions.","location":[["","Annex II - point 3.8.2."]],"meps":[1832],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.8.2. An active substance, safener or","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not considered to have endocrine","disrupting properties that may cause","adverse effects on non-target organisms","unless the exposure of non-target","organisms to that active substance in a","plant protection product is negligible, i.e.","under realistic proposed conditions of use","the product does not lead to unacceptable","negative effects in the environment."],"old":["3.8.2. An active substance, safener or","synergist shall only be approved if, on the","basis of the assessment of Community or","internationally agreed test guidelines, it is","not considered to have endocrine","disrupting properties that may cause","adverse effects on non-target organisms","unless the exposure of non-target","organisms to that active substance in a","plant protection product under realistic","proposed conditions of use is negligible."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"323","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Erna Hennicot-Schoepges","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-324","justification":"Bee toxicity and realistic exposure routes should be taken into consideration.","location":[["","Annex II - point 3.8.2. a (new)"]],"meps":[29019],"meta":{"created":"2020-01-20T00:12:08"},"new":["3.8.2a. An active substance, safener or","synergist shall not be approved if the","hazard quotients (HQ) for oral or contact","exposure of honeybees resulting from","direct or indirect exposure via spray drift","or dust are greater than 50, unless it is","established that under realistic proposed","conditions of use:","- the exposure of honeybees to that active","substance in a plant protection product is","negligible,","- or if it is clearly established through an","appropriate risk assessment that under","field conditions there are no unacceptable","effects on honeybee larvae, honeybee","behaviour, or colony survival and","development."],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"324","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Caroline Lucas","changes":{},"committee":["ENVI"],"compromise":["Council common position"],"date":"2008-10-16T00:00:00","id":"PE412.111-325","justification":" Non-chemical methods and practices of crop management and pest prevention shall be taken\n into account in the comparative assessment. The priority should always be given to non-\n chemical methods.\n\n Reinstating first reading Amendment 251.","location":[["","Annex IV - point 1 \u2013 point (a)"]],"meps":[4524],"meta":{"created":"2020-01-20T00:12:08"},"new":["(a) substitution shall be applied only where","other methods, including non-chemical","methods of crop protection and pest","prevention, or the diversity of the active","substances is sufficient to minimise the","occurrence of resistance in the target","organism; and"],"old":["(a) substitution shall be applied only where","other methods or the chemical diversity of","the active substances is sufficient to","minimise the occurrence of resistance in","the target organism; and",""],"orig_lang":"en","peid":"PE412.111v01-00","reference":"2006/0136(COD)","seq":"325","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-412.111+01+DOC+PDF+V0//EN&language=EN"}],"changes":{"2014-11-10T01:35:15":[{"data":[{"body":"EC","commission":[{"Commissioner":"VASSILIOU Androulla","DG":{"title":"Health and Consumers","url":"http://ec.europa.eu/dgs/health_consumer/index_en.htm"}}],"date":"2006-07-12T00:00:00","docs":[{"celexid":"CELEX:52006PC0388:EN","text":["
PURPOSE : to\n lay down new harmonised EU rules for plant protection products, which aim to\n reinforce the protection of public health and the environment, support\n sustainable development in agriculture, reduce animal testing, boost\n competitiveness for producers and increase availability of plant protection\n products for farmers.
PROPOSED ACT :\n Regulation of the European Parliament and of the Council.
CONTENT : the\n use of plant protection products (PPP) may involve risks and hazards for\n humans, animals and the environment, especially if placed on the market\n without having been officially tested and authorized and if incorrectly used.\n Therefore harmonized rules should be adopted on the placing on the market of\n PPP.
This proposal\n follows extensive consultations with Member States and stakeholders over the\n past 5 years, as well as a comprehensive impact assessment. The proposed\n Regulation is fully in line with the overall Commission strategy on\n pesticides, and will complement the Commission’s proposal for a Directive on the\n sustainable use of pesticides (refer to COD/2006/0132).
The proposed\n Regulation replaces Directive 91/414/EEC concerning the placing of plant\n protection products on the market and repeals Council Directive 79/117/EEC\n prohibiting the placing on the market and use of plant protection products\n containing certain active substances. In a nutshell, it consists of the\n following elements:
- establishment\n at EU level of a positive list of active substances, safeners, synergists and\n a negative list of co-formulants;
- the\n time-span for the approval of active substances is shortened, with strict\n deadlines laid out for Member States, the European Food Safety Authority and\n the Commission;
-\n authorisations of active substances will no longer have to be renewed every 10\n years (just once, after the first 10 year period), in order to avoid a\n backlog of unnecessary applications which have already been found to be\n acceptable for use. However, a review of an authorisation can still be\n carried out at any time if new concerns arise about its safety;
- the EU will\n be divided into 3 zones with similar climatic and ecological features, and\n plant protection products authorised by any one Member State will\n automatically be cleared for use in the other Member States in that particular\n zone;
- national\n authorities will still be allowed, however, to impose specific national risk\n mitigation measures if deemed necessary;
- data\n protection rules are also simplified, to allow more transparency, greater\n competition and a level playing field for small and medium sized producers,\n while ensuring that this does not hamper innovation;
- provisions\n on packaging, labelling and advertising;
- obligation\n to keep records and to carry out controls;
- establishment\n of criteria for approval of active substances, safeners or synergists.
The proposal\n also includes new provisions which aim to protect human health, animal\n welfare and the environment:
- the safety\n evaluations of active substances will be founded on strict criteria, also\n based on health considerations and the effects on the environment (e.g.\n persistence in the environment);
- the European\n Food Safety Authority (EFSA) has a central role in the evaluation procedure;
- control\n measures are reinforced in the Commission’s proposal, and farmers and other\n professional users will have to keep records of their use of plant protection\n products. These will have to be made available on request to the drinking\n water industry and neighbours;
- avoid\n repetition of testing on vertebrates
- protect non-professional\n users.
For further information concerning\n the financial implications of this measure, please refer to the financial\n statement.
\nThe Council\n took note of information provided by the Commission on a proposal for a\n Regulation concerning the placing of plant protection products on the market.
Giving their\n first reactions, certain Member States identified a number of issues that\n will require further examination, including the need for specific rules on\n parallel imports, the proposed principle of compulsory mutual recognition\n within a three-zone system, and ways of taking into account the varying needs\n of individual Member States and ensuring that plant protection products are\n available for minor crops.
\nThe Committee\n on the Environment, Public Health and Food Safety adopted a report drawn up\n by Hiltrud BREYER (Greens/ALE, DE), and amended, in the first reading\n of the co-decision procedure, the proposal for a regulation concerning the\n placing of plant protection products on the market.
The main\n amendments are as follows : :
Objective\n and legal bases: Members specified that Articles\n 152 (4)(b) and 175(1) should be used as dual legal bases since the purpose of\n the Regulation is to ensure a high level of protection of both human and\n animal health and the environment. The purpose of the Regulation is\n furthermore to harmonise the rules on the placing on the market of plant\n protection products in order to harmonise the availability of plant\n protection products between farmers in different Member States. Member States\n may not be prevented from applying the precautionary principle in restricting\n or prohibiting pesticides. They may establish any pesticide-free zones they\n deem necessary in order to safeguard drinking water resources. Such\n pesticide-free zones may cover the entire Member State. Member States may\n impose a ban on the use and marketing of EU-authorised pesticides where they\n are found in measurable quantities outside the root zone.
Definitions: the Committee inserted and amended several definitions. It\n specified, particularly, that ‘plant protection products’ should be replaced\n with ‘pesticides’ and in the relevant places ‘pesticide products'.
Zonal\n licensing: in view of the objectives of the\n regulation, the Committee did not consider the Commission’s proposed\n introduction of zones and corresponding zonal licensing of pesticidal\n products to be useful, since it felt that dividing the EU into arbitrary\n zones did not meet environmental or nature-conservancy criteria. Risk\n assessment and risk management should be set up in accordance with smaller,\n differentiated nature conservancy areas and soil-climate conditions. In\n addition, each Member State should retain the option of going beyond the\n Community standard in its fundamental standard of protection or of making\n decisions in product licensing in order to implement established objectives\n of national pesticide action plans, health programmes or environmental\n protection measures. Each Member State should also be allowed to decide to\n link licensing decisions to a test of usefulness based on specific national\n conditions. The Committee stipulated, instead of arbitrary zones, that the\n principle of mutual recognition of national licensings should be retained,\n but that the Member States should, in the spirit of the subsidiarity\n principle, be allowed to make national or regional specifications. Member States\n should be entitled to confirm, reject or restrict the authorisation granted\n by another Member State on the basis of their specific agricultural needs or\n to maintain a higher protection level in line with their National Pesticide\n Action Plan.
Active\n substances: Members clarified that active\n substances that have no adverse effect on humans, animals or the environment\n can be considered as low-risk. The Commission may review the approval of an\n active substance at any time and will give due consideration to requests for\n review from a Member State, the European Parliament and other stakeholders,\n based on current scientific and technical knowledge and monitoring data. The\n Committee made clear that a derogation will not apply to any active substance\n classified in accordance with Directive 67/548/EEC as: carcinogenic,\n mutagenic, toxic to reproduction, sensitising, or to substances that are\n qualified as: persistent with a half-life of more than 60 days; endocrine\n disrupters appearing on the EU list of suspected endocrine disrupters; toxic;\n bioaccumulative and non-readily degradable. On e year after entry into force\n of the legislation, the Commission must review and if necessary specify the\n criteria for treating an active substance as a low risk substance and, if\n appropriate, submit proposals.
Approval\n criteria for an active substance or a metabolite in the use-phase: the Committee stated that cut-off criteria will be used for the\n exclusion of active substances, in order to protect human health and the\n environment against intrinsic hazards of certain substances. They must not\n have any harmful effects on human health, in particular that of users who are\n in direct contact with the products, residents, bystanders and vulnerable\n groups, such as pregnant and nursing women, embryos and foetuses, infants and\n children. All testing and decision-making strategies must follow this\n principle, and current scientific knowledge must be borne in mind in the\n process. Furthermore, to prevent animal testing, tests on vertebrate animals\n should for the purposes of the Regulation be carried out only as a last\n resort. The use of non-animal tests and intelligent testing strategies shall\n be promoted, and duplicate vertebrate animal testing shall be prohibited.\n Dossiers for each test or study involving vertebrate animals must show a\n justification of the steps taken to avoid animal testing and duplicative\n testing on vertebrate animals.
Substitution\n principle and comparative assessment: the\n Committee considered it important to follow the principles of the REACH and\n biocide directives, and to introduce the substitution principle and\n comparative assessment in order to reduce the risks and dangers of\n pesticides. Products that contain a candidate for substitution will not be\n approved by Member States if there are safer alternatives or methods\n available for a given crop. While Member States must not authorise any plant\n protection product where a comparative assessment shows the existence of\n safer alternatives, priority in comparative assessment and substitution shall\n be given to candidates for substitution. In addition, the aims of the\n Thematic Strategy on the compulsory introduction of standards of integrated\n pest management and integrated plant protection into agriculture should be\n incorporated into the definitions and measures of ‘good technical practice’\n and ‘proper handling of pesticides’ in the regulation. These conditions\n should become a compulsory component of the licensing process by 2012 instead\n of 2014.
Approval\n procedure: the Committee stated that the\n Authority must be responsible for coordinating the approval procedure, and in\n doing so, the Authority will rely on the competent authorities of Member\n States. An application for the approval of an active substance or for an\n amendment to the conditions of an approval shall be submitted by the producer\n of the active substance to the Authority (rather than the ‘rapporteur Member State ’). The Authority shall inform the competent authorities of the Member States\n of the applications it has received. A Member State may choose an active\n substance for which an application for approval has been received by the\n Authority, with the aim of becoming the rapporteur Member State. Disagreement should be solved in comitology, on the basis of objective criteria, such as\n geographic, agricultural and climatic conditions, especially with regard to\n the target organisms, the performance and impartiality of the competent\n authority and the reference laboratory, and the absence of interests linked\n to the producing companies.
Renewal of\n approval: whilst the Commission had specified\n that the renewal shall be for an unlimited period of time, the Committee\n stated that the approval may be renewed once or repeatedly for a period not\n exceeding 10 years. The approval period should be proportional to the\n possible risks inherent in the use of such substances and should be limited\n to a maximum of 15 years for low risk substances, 5 years for candidates for\n substitution and 10 years for other substances.
Transparency\n and competition: Members consider the greatest\n possible transparency in licensing and use, all the way through to the\n consumer, to be essential. For this reason information on permitted\n substances should be published on the Internet, and consumer-relevant\n information (e.g. eco-toxicological data) from the licensing procedure, as\n well as the results of residue monitoring, should be published. In addition\n to the proposed rule on keeping records on pesticide use, the Committee\n suggests a “pesticide pass”, with which greater transparency and traceability\n in the food chain could be achieved. Lastly, Members specified the need for a\n clear definition and a minimum set of community harmonized rules regulating\n the placing of products on the market through parallel trade.
\nThe European\n Parliament adopted a resolution drafted by Hiltrud BREYER (Greens/ALE,\n DE), and made some amendments to the proposal for a regulation concerning the\n placing of plant protection products on the market. With specific regard to\n the approval regime, the Commission's zone-based approach was rejected by\n Parliament, which preferred Member States to maintain national control over\n product approval.
The main\n points are as follows:
Objective\n and legal bases: Members specified that Articles\n 152 (4)(b) and 175(1) should be used as dual legal bases since the purpose of\n the Regulation is to ensure a high level of protection of both human and\n animal health and the environment. The purpose of the Regulation is\n furthermore to harmonise the rules on the placing on the market of plant\n protection products in order to harmonise the availability of plant\n protection products between farmers in different Member States. Member States\n may not be prevented from applying the precautionary principle in restricting\n or prohibiting pesticides. They may establish any pesticide-free zones they\n deem necessary in order to safeguard drinking water resources. Such\n pesticide-free zones may cover the entire Member State. Member States may\n impose a ban on the use and marketing of EU-authorised pesticides where they\n are found in measurable quantities outside the root zone.
Active\n substances: Members introduced a definition of\n 'active substances' as substances, including their metabolites present in the\n use phase, micro-organisms and viruses, having general or specific action\n against target organisms or on plants, parts of plants or plant products.\n They clarified that they must not have any harmful effects on human health,\n in particular that of users who are in direct contact with the products, residents,\n bystanders and vulnerable groups. Parliament accepted an amendment in plenary\n that such substances shall not have any unacceptable effect on the\n environment taking into account cumulative and synergistic effects and all\n relevant exposure routes to organisms in the environment. Methods to assess\n such effects will be presented by the European Food Safety Authority. A\n derogation will not apply to any active substance classified in accordance\n with Directive 67/548/EEC as: carcinogenic, mutagenic, toxic to reproduction,\n sensitising chemicals, or to substances that are qualified as: persistent\n with a half-life of more than 60 days; endocrine disrupters appearing on the\n EU list of suspected endocrine disrupters; toxic; bioaccumulative and\n non-readily degradable. On e year after entry into force of the legislation,\n the Commission must review and if necessary specify the criteria for treating\n an active substance as a low risk substance and, if appropriate, submit\n proposals. The Commission may review the approval of an active substance at\n any time and shall give due consideration to requests for review from a\n Member State, the European Parliament and other stakeholders, based on\n current scientific and technical knowledge and monitoring data.
Parliament\n added as part of the definition of “substance of concern” that any substance\n that has or potentially has either carcinogenic, mutagenic, endocrine\n disrupting, neurotoxic, immunotoxic, reprotoxic or genotoxic capabilities\n should be regarded as a substance of concern.
Zonal\n licensing: Parliament rejected the Commission’s\n proposal regarding the introduction of zones and corresponding zonal\n licensing of pesticidal products. It specified instead that authorisations\n granted by one Member State should be notified to other Member States. Member\n States should be entitled to confirm, reject or restrict the authorisation\n granted by another Member State on the basis of their specific agricultural\n needs or to maintain a higher protection level in line with their National\n Pesticide Action Plan. A new recital states that good administrative\n co-operation between Member States should be increased during all steps of\n the authorisation procedure and should be facilitated by a European Helpdesk.
Approval\n procedure: Parliament stated that the Authority\n must be responsible for coordinating the approval procedure, and in doing so,\n the Authority will rely on the competent authorities of Member States. An\n application for the approval of an active substance or for an amendment to\n the conditions of an approval shall be submitted by the producer of the\n active substance to the Authority (rather than the ‘rapporteur Member State ’). The Authority shall inform the competent authorities of the Member\n States of the applications it has received. A Member State may choose an\n active substance for which an application for approval has been received by\n the Authority, with the aim of becoming the rapporteur Member State. Disagreement should be solved in comitology, on the basis of objective criteria, such as\n geographic, agricultural and climatic conditions, especially with regard to\n the target organisms, the performance and impartiality of the competent\n authority and the reference laboratory, and the absence of interests linked\n to the producing companies.
The\n authorisation setting out the requirements relating to the placing on the\n market and use of the plant protection product will include indications for\n proper use according to the principles of Integrated Pest Management as\n defined in the legislation, to apply from 2012 onwards.
Renewal of\n approval: whilst the Commission had specified\n that the renewal shall be for an unlimited period of time, Parliament\n endorsed the views of its competent committee and stated that the approval\n may be renewed once or repeatedly for a period not exceeding 10 years. The\n approval period should be proportional to the possible risks inherent in the\n use of such substances and should be limited to a maximum of 15 years for low\n risk substances, 5 years for candidates for substitution and 10 years for\n other substances. After the first renewal, a regular review of substances\n should take place.
Substitution\n principle and comparative assessment: Member\n States must not authorise for use in a given crop a plant protection product\n either containing a candidate for substitution or posing a higher risk where\n a comparative assessment weighing up the risks and benefits, as set out in\n Annex IV, shows that safer alternatives are available, as defined in the\n legislation. While Member States must not authorise any plant protection\n product where a comparative assessment shows the existence of safer\n alternatives, priority in comparative assessment and substitution shall be\n given to candidates for substitution.
Minor uses: Member States must establish a list of minor uses. This list\n shall be made available to the public through official websites of the Member State and of the Commission. Not later than one year after entry into force of the\n legislation, the Commission must present a proposal to the European\n Parliament and the Council for establishing a European promotion fund for\n minor uses. The Fund shall also be entitled to finance additional residue\n tests for minor uses. Comparative assessments shall take authorised minor\n uses into account.
Transparency\n and competition: Producers, suppliers,\n distributors and professional users of plant protection products must keep\n records of the plant protection products they produce, store or use for at\n least 10 years after the end of production or use. They shall make the\n information contained in these records available to the competent authority.\n They shall also keep this information available for neighbours and residents,\n retailers or the drinking water industry who request direct access to it. The\n information on all applications of plant protection products on a given\n agricultural product shall be provided to retailers and wholesalers in the\n form of a pesticide passport. In addition, the Commission must maintain an\n updated list of approved active substances in Annex IIa and publish this list\n on the Internet. Lastly, Members specified the need for a clear definition\n and a minimum set of community harmonized rules regulating the placing of\n products on the market through parallel trade, and inserted a new Article on\n the granting of parallel trade permits.
Animal\n testing: in order to avoid animal testing,\n testing on vertebrate animals for the purposes of the Regulation must be\n undertaken only as a last resort. The use of non-animal tests and intelligent\n testing strategies must be promoted, and duplicate vertebrate animal testing\n shall be prohibited. Dossiers for each test or study involving vertebrate\n animals must show a justification of the steps taken to avoid animal testing\n and duplicative testing on vertebrate animals.
\nA number of\n Parliamentary amendments that, from a technical and editorial point of view,\n improved the initial proposal were adopted by the Commission, whilst others\n were partially accepted only.
Legal\n basis:
Although\n Parliament proposed Article 152(4)b and 174(1) of the EC Treaty as the legal\n basis for the Regulation, the Commission has decided to stick to its original\n proposal, namely that Articles 37(2) and 152(4)b should form the legal basis\n of this proposal.
Scope:
The Commission\n retains its view that there is no need to introduce a “future limitation” to\n the scope of the Regulation that excludes micro-organisms, viruses,\n pheromones and biological products once a separate Regulation to these\n products has been adopted. This is because there is no need for such a specific\n Regulation as such data requirements and criteria for authorisation are in\n place already. This amendment has, as a result, not been endorsed.
Definitions:
Parliamentary\n amendments that clarify the proposed definitions and which are linked to other\n amendments have been adopted by the Commission. Those that clarify\n definitions relating to: low risk; parallel trade; vulnerable groups; non chemical\n methods of plant protection; and minor uses were also acceptable to the\n Commission.
Approval\n criteria and range of uses:
The\n Commission’s initial proposal stated that for category 1 and 2 substances, a\n substance can not be approved – unless exposure is negligible. Parliamentary\n amendments concerning this proposal have mostly been accepted by the\n Commission. In cases where Parliament has sought to extend the proposed\n criteria in Annex II, the Commission has decided to keep the original\n proposal in line with related European legislation and has decided to clarify\n the text. It has decided to clarify that neurotoxin and immunotoxic\n substances should be approved as candidates for substitution.
An amendment\n on “negligible exposure” was deemed acceptable given that it keeps the\n risk-based approach, as foreseen in the original proposal, as well as\n clarifying the provision. On the matter of “evaluation of representative\n uses”, the Commission has opted to retain the format of the initial proposal\n and suggest that a limited number of uses must be evaluated at EU level and\n other uses left to the Member States, who are required to apply uniform\n criteria when granting authorisation.
Approval\n procedure, renewal and review:
The Commission\n has decided to reject a Parliamentary amendment concerning the role of the\n EFSA as coordinator of the approval procedure. The EFSA, in the Commission’s\n opinion, should coordinate scientific evaluation only. It should not be\n responsible for the approval procedure. Also rejected were variations from\n the proposed extension (or reduction) of the deadlines foreseen for various\n consultations and decisional phases. Amendments on renewal and review were\n accepted by the Commission, where they clarified the original proposal.
Low risk\n and basic substances:
An amendment\n on defining low risk substances has been incorporated into the revised\n proposal, although an amendment concerning different criteria biological\n control agents has not. Amendments relating to basic substances have been\n rejected on the ground that they should be approved for an unlimited period\n and on the basis of evaluations performed in other areas. Similarly, the\n Commission has decided not to accept a Parliamentary proposal to introduce a\n new article on reduced risk plant protection products and setting out\n different periods of data protection for the two categories of low risk\n products.
Safeners,\n synergists and co-formulants:
An amendment\n deleting temporary derogation for safeners and synergists has been rejected\n by the Commission. Further, any changes to the approval of co-forumlants have\n been rejects as it would create an overlapping obligation with respect to\n existing legislation on chemicals (REACH).
Zonal\n authorisation system and provisional authorisation:
Parliament was\n seeking to reject the zonal authorisation system for plant protection\n products that are linked to compulsory mutual recognition of authorisation\n within a zone. This, however, would have removed one of the proposal’s key elements.\n As the proposal stands, Member States can only impose stricter national\n measures for worker protection, given that EU legislation seeks minimum\n harmonisation only. A further amendment, on a system of provisional\n authorisation, has similarly been rejected by the Commission on the grounds\n that it is incompatible with the zonal authorisation system and EU\n legislation on maximum residue levels for pesticides.
Systematic\n information:
The Commission\n has decided not to include a new provision whereby farmer’s records would\n have been made available to the public and residents - the so called\n “pesticide passport”. Instead the Commission has decided to retain the\n original text of the proposal which provides that information should be made\n available to neighbours “upon request.” It would, argues the Commission, be\n impossible to maintain a pesticide passport for every lot of fruit and\n vegetables given that batches of crops are mixed in trade. Moreover, one side\n effect may be that controls are done only on declared pesticides.
Comparative\n assessment and substitution principle:
The Commission\n has decided not to endorse amendments that sought to extend comparative\n assessment to all plant protection products and to reduce the approval period\n for substances which are candidates for substitution. This option has not\n been adopted because it is not based on risk.
Minor uses:
Most proposed\n amendments relating to facilitating the extension of authorisations for minor\n uses have been taken on board by the Commission subject to some legal\n rewording, albeit that the proposed “European Promotion Fund” for minor uses\n has been rejected given that it does not fall within the proposal’s main\n objectives.
Parallel\n trade:
The Commission\n has decided to adopt new provisions concerning the trade of plant protection\n products that have already been authorised in other Member States. Some of\n the wording has been revised in order to make it compatible with the Treaty\n and Cases Law of the Court of Justice.
Data\n protection and data sharing:
Certain\n Parliamentary amendments on data protection and sharing have been rejected by\n the Commission on the grounds that they would weaken competition and reduce\n the availability of plant protection products to farmers. This issue has been\n carefully analysed in the impact assessment. The Commission is of the view\n that all studies on vertebrate animals should be protected in the same way as\n other studies. However, there is an obligation to share results and not to\n repeat studies.
Confidentiality\n and public access to information:
A\n Parliamentary suggestion to offer confidentiality to the Institutes or\n persons involved in vertebrate studies has not been taken up by the\n Commission. This is because under Article 60 of the proposal any person can\n request that disclosure of information, which may undermine their privacy and\n integrity.
Integrated Pest management and Good Environmental Practice:
Two\n amendments, the first on making integrated pest management (IPM) obligatory\n as from 2012 and the second, deleting an obligation for compulsory compliance\n with the principle of good environmental practice, have been rejected by the\n Commission.
Comitology\n and the link between the proposed Regulation and Regulation (EC) No 396/2005:
The Commission\n agrees to align procedures for the exercise of implementing powers conferred\n on Commission to the normal regulatory procedure. However, in cases where the\n Commission sees the need for curtailment of time limits for certain cases\n (such as respecting time limits for renewing procedures), the Commission has\n decided that the normal regulatory procedure should apply, rather than the\n regulatory procedure with scrutiny.
For cases that\n involve setting data requirement for safeners and synergists, the Commission\n can accept use of the regulatory procedure with scrutiny but not the co-decision\n procedure. Nor, argues the Commission, is it appropriate to use the\n co-decision procedure for technical provisions which need to be continuously\n updated.
On a final\n point, the Commission points out that the situation regarding the procedure\n affecting maximum residue levels (MRLs), will need to be clarified after the\n Plenary session of the European Parliament end November 2007.
\nThe Council\n adopted, by qualified majority, the common position in view of the adoption\n of a Regulation concerning the placing of plant protection products on the\n market. The Hungarian, Irish, Romanian and the UK delegations abstained.
The Council\n incorporated 19 amendments in full adopted by the European Parliament in its\n 1st reading. 59 other amendments were accepted in part or in\n principle. Certain amendments, such as those concerning provisional\n authorisations, renewal period for the approval of active substances, data\n protection for the studies necessary for renewal or review of the\n authorisation, confidentiality of names and addresses of persons involved in\n testing on vertebrate animals and cost recovery by Member States were totally\n or partially incorporated in the common position although they were not\n accepted initially by the Commission
The main\n issues of the common position:
Legal basis: the Council considered that, as the main purpose of the\n Regulation was to ensure the effective functioning of the internal market in\n plant protection products, Article 95 was the correct legal basis. The\n Council, however, decided to adopt a dual legal basis including Article 37(2)\n as a gesture towards the Commission.
Definitions: the Council took up those amendments which provide appropriate\n clarifications of the text of the definitions or which were essential because\n new provisions were introduced in the text. However, in some cases, the\n Council preferred to place the new definitions within the Articles containing\n the provisions on those areas (e.g. definitions of parallel trade, identical,\n rapporteur Member State or low-risk). The Council has deleted the definition\n of Integrated Pest Management from the Commission's proposal and has instead\n inserted a link to the Directive on sustainable use of pesticides. The\n Council could not incorporate an amendment as it considered that priority to\n non-chemical methods was not an essential element of good plant protection\n practice.
The Council\n has also inserted a number of additional definitions such as\n \"authorisation holder\", \"professional user\", \"minor\n use\", \"greenhouse\", \"post-harvest treatment\", \"biodiversity\",\n \"competent authority\", \"advertisement\", \"relevant\n metabolite\" and \"impurity\". It deleted the definitions of\n \"animals\" and \"integrated pest management\".
Approval of\n active substances: the Council introduced a\n sequential approach in the evaluation of the criteria set out in Annex II (procedure\n and criteria for the approval of active substances, safeners and synergists) whereby\n certain points of that Annex should be verified first before examining the\n rest of the criteria.
The Council\n has introduced in Annex II a clear definition of negligible exposure to\n carcinogenic, endocrine disrupting or toxic for reproduction substances and has\n established that mutagenic category 1 or 2 active substances should be banned\n even if human contact with those substances was negligible. It nevertheless\n thought it necessary to introduce, for exceptional cases, a derogation clause\n limited in time for those substances which are essential for the protection\n of a crop even if they do not meet the criteria.
The Council\n could not agree with the European Parliament's view that active substances with\n neurotoxic or immunotoxic properties should be excluded but it agreed to\n consider them as candidates for substitution. Like the Parliament, the\n Council opposed the unlimited renewal of approval of active substances as\n proposed by the Commission but established a maximum period of 15 years\n instead of 10 as requested by the Parliament.
Procedures: the Council has endeavoured to further streamline the procedures\n for approval of active substances and authorisation of plant protection\n products. It has paid particular attention to tightening the deadlines and\n defining more precisely the roles of the various players involved (Member\n States, the Commission, the European Food Safety Authority (EFSA)). The\n Council has thus accepted in full or in part a number of European Parliament\n amendments that tend in this direction and rejected others which might either\n cause unnecessary delays, or not allow enough time for the adequate\n completion of some stages of the procedures.
Low-risk\n active substances: the Council, like the\n Parliament, thought it useful to further explain the concept of \"low risk\"\n but instead of adding a definition or extra clarifications as proposed by the\n European Parliament, it has inserted more detailed criteria in Annex II.
Regarding data\n protection for low-risk plant protection products, the Council has extended\n the period of protection to a maximum of 13 years instead of 15 as proposed by\n the European Parliament. In case the authorisation of a low-risk plant\n protection product is extended to minor uses the data protection period could\n then be extended to up to 15 years.
Candidates\n for substitution: the Council has also clarified\n the criteria for active substances to be identified as candidates for\n substitution. The Council felt it was necessary to extend the period of approval\n from 7 to 10 years and therefore did not accept the Parliament’s amendment.
The Council\n was unable to agree with a number of amendments extending, in particular,\n comparative assessment to all plant protection products. The text has\n nevertheless been redrafted in order to give Member States the option, in\n exceptional cases, of not authorising or of restricting the use of a plant protection\n product which does not contain a candidate for substitution or a low-risk substance\n if a non-chemical method exists.
Mutual\n recognition of authorisations: the Council was\n not able to accept those amendments relating to the zonal authorisation and\n mutual recognition. On the contrary, the Council has confirmed the division into\n authorisation zones as proposed by the Commission and the system of\n compulsory mutual recognition of authorisations as it believes it is a good\n way to ensure the reduction of administrative burdens and the quick and wider\n availability for European farmers of plant protection products. The Council\n has extended this system to plant protection products for minor uses and has\n provided additional flexibility (e.g. the recognition of authorisations\n between Member States belonging to different zones or the possibility for a\n professional organisation to apply for an authorisation). The Council\n introduced provisions establishing that Member States impose additional risk\n mitigation measures relevant to their territory and, exceptionally, can\n refuse authorisations granted in another Member State in order to protect\n human or animal health or the environment. The Council has also inserted a\n review clause whereby a report is to be drawn up by the Commission within\n five years of the Regulation's entry into force.
National\n Provisional Authorisations: Member States decided\n to bring back the provisional authorisations as a transitional measure as\n they feared delays in the authorisation of plant protection products. They thought\n the new system needed to be tested first to check if deadlines could be met. National\n provisional authorisations will only be granted for a limited period of time (3\n years) and under certain circumstances. The Council and the Parliament's\n views substantially converge on this issue.
Animal\n testing: the Council has taken note of the\n European Parliament particular interest in avoiding or minimising animal\n testing.
Comitology: the Council has modified the Commission's proposal to bring it\n into line with the new Comitology Decision 2006/512/EC amending Decision\n 1999/468/EC and introducing the new regulatory procedure with scrutiny. In\n some cases the Council could not accept the regulatory procedure with\n scrutiny if the measures to be taken were of a purely implementational nature.\n In cases concerning the simple transfer of the requirements already contained\n in the Annexes to Directive 91/414/EC to the new Regulation or the adoption\n of non-binding guidelines, the Council was of the opinion that the advisory\n committee procedure was more appropriate. The Council thought instead that\n the most appropriate comitology procedure would be that of \"regulatory\n with scrutiny\" as the Regulations to be adopted following the provisions\n laid down in those articles would supplement the basic act by adding new\n non-essential elements.
The common\n position also includes other changes, not envisaged by the European Parliament,\n which address a number of concerns expressed by the Member States in the course\n of the negotiations:
Treated\n seeds: delegations considered that it was necessary\n to insert provisions on this area so as to protect the free movement of seeds\n treated with plant protection products in the EU unless they might pose a\n serious threat for human or animal health or the environment.
Parallel\n trade: the provisions concerning parallel trade\n were added by the Council following an almost unanimous request by Member\n States. The Council has thus incorporated the amendment and has adapted the\n provisions on parallel trade to the most recent jurisprudence. It has also\n introduced the requirement of official controls in this area.
Adjuvants: the Council has inserted provisions establishing that detailed\n rules for the authorisation of adjuvants should be set out following a\n comitology procedure.
\nThe Committee on the Environment, Public Health and Food\n Safety adopted a report drafted by Hiltrud BREYER (Greens/ALE, DE),\n and recommended amendments to the Council common position for adopting a\n regulation of the European Parliament and of the Council on the placing of\n plant protection products on the market and repealing Council Directives\n 79/117/EEC and 91/414/EEC. Most of the amendments were reinstatements of\n amendments from 1st reading. The main ones were as follows :
Legal bases:\n Members specified that Articles 152 (4)(b) and 175(1) should be used as dual\n legal bases since the purpose of the Regulation is to ensure a high level of\n protection of both human and animal health and the environment. The common\n position provides for Article 95 (internal market) and Article 37(2)\n (agriculture) to be used as legal bases.
Objective:\n the committee expanded considerably the purposes of the Regulation, stating\n that, in addition to autorisation and approval of active substances, purposes\n include: ensuring a high level of protection of both human and animal health\n and the environment; and harmonising the rules on the placing on the market\n of plant protection products in order to harmonise the availability of plant\n protection products between farmers in different Member States.
Precautionary principle: the Regulation is based on the precautionary principle\n in order to ensure that substances or products placed on the market do not\n adversely affect human or animal health or the environment. Member States may\n not be prevented from applying the precautionary principle in restricting or\n prohibiting pesticides. Member States may establish any pesticide-free zones\n they deem necessary in order to safeguard drinking water resources. Such\n pesticide-free zones may cover the entire Member State.
Active substances: Members re-introduced the definition of active\n substances that Parliament had proposed at 1st reading. With regard to the\n derogation from the criteria for the approval of a substance in case of a\n serious danger to plant health, the committee specified that there must be a\n public interest in controlling that danger. Such an active substance may be\n approved for a time-limited period necessary to control that serious danger\n but not exceeding 4 years (rather than 5 years) and a substitution plan on\n how to control the serious danger in two years' time by other means,\n including non-chemical methods, must be presented by the applicant. Regarding\n substances with endocrine-disrupting properties, the committee provides some\n examples of substances which may be considered as such. Further specific\n scientific criteria for the determination of endocrine disrupting properties\n shall be adopted in accordance with the regulatory procedure with scrutiny.
A new clause states that an active substance, safener or\n synergist shall only be approved if it is not considered to cause a\n significant risk (affecting at least one in a million citizens) of developmental\n neurotoxic or immunotoxic properties in humans, taking into account\n exposure during embryonic/foetal life and/or during childhood as well as\n likely combination effects, unless the exposure of humans to that active\n substance, safener or synergist in a plant protection product, under\n realistic proposed conditions of use, is negligible, i.e. the product is\n used in closed systems or in other conditions excluding contact with humans\n and where residues of the active substance, safener or synergist concerned on\n food and feed do not exceed the default value set in accordance with\n Regulation (EC) No 396/2005.
The committee also introduces in the criteria the\n consideration of risk to honeybees, honeybee larvae, honeybee\n behaviour, or colony survival and development.
Zoning:\n the committee deleted the proposed zoning system, since it felt that the\n latter undermines national authorisation and it is not in line with the EC\n principle of proportionality and subsidiarity because it is going beyond what\n is necessary to speeding up the decision making process. These objectives\n can be reached by amending the mutual recognition system without the concept of\n zoning. The committee proposes to keep the principle of compulsory mutual\n recognition of authorisations for plant protection products in the context of\n a one-zone system and introduces more flexibility for Member States to refuse\n mutual recognition. An amended recital states that authorisations granted by\n one Member State should be notified to other Member States in which the\n applicant wishes to put the product on the market. Those Member States should\n be entitled to recognise an authorisation issued by another Member State,\n amend it or refrain from authorising the plant protection product in their\n territory, if justified because of specific agricultural or environmental\n circumstances that may be, but do not need to be, limited to that Member\n State, or if the high level of protection of human or animal health or the\n environment set out in the Regulation cannot be achieved, or to maintain a\n higher protection level in their territory in line with their national action\n plan to reduce the risks associated with pesticides, adopted in accordance\n with Directive 2008/.../EC establishing a framework for Community action to\n achieve a sustainable use of pesticides.
Approval procedure: the committee insisted that the Authority (EFSA) shall\n be responsible for coordinating the approval procedure. In doing so, the\n Authority shall rely on the competent authorities of Member States. Upon\n being informed which Member State will examine the application, the applicant\n shall immediately forward to the Authority the complete and the summary\n dossiers. Within 180 days, the Member States concerned shall grant or refuse\n authorisations.
Substitution of dangerous substances with safer\n alternatives: the approval\n time of candidates for substitution should not be the same as the general approval\n period. To ensure regular comparative assessment of products containing such\n substances, the approval period should be limited to 5 years (renewable)\n rather than 10. Furthermore, any authorisation of plant protection products\n containing a candidate for substitution without comparative assessment should\n be limited to a maximum of 3 years. The adoption of the list of substances\n that are candidates for substitution should be done after 3 years at the\n latest, rather than 6.
Animal testing: Members specified that, in order to avoid animal\n testing, testing on vertebrate animals for the purposes of the Regulation\n shall be undertaken only as a last resort. The use of non-animal tests and\n intelligent testing strategies shall be promoted, and duplicate vertebrate\n animal testing shall be prohibited.
Standardised format for information: Members want records of plant protection\n products produced, imported, exported, stored, used or placed on the market\n to be kept for at least 10 years after the end of production or use, rather\n than for 3 years. This information must be available for neighbours and\n residents, retailers or the drinking water industry who request direct access\n to it. The information on all applications of plant protection products on a\n given agricultural product shall be provided to retailers and wholesalers\n using a standardised format, which will be established in accordance with the\n advisory procedure.
Promotion fund for minor uses: not later than one year after entry into force of the\n legislation, the Commission shall present a proposal to the European\n Parliament and the Council for the establishment of a European promotion fund\n for minor uses. The Fund shall also be entitled to finance additional residue\n tests for minor uses.
Comitology:\n the Commission must be empowered to approve active substances, to renew or\n review their approval, to adopt harmonised methods to determine the nature\n and quantity of active substances, safeners and synergists, and where\n appropriate of relevant impurities and co-formulants, to adopt detailed rules\n for allowing derogations from authorisation of plant protection products for\n research and development and the list of approved substances. Rules on these\n matters must be adopted in accordance with the regulatory procedure with\n scrutiny.
\nThe European\n Parliament adopted a legislative resolution amending the Council's common\n position for adopting a regulation of the European Parliament and of the\n Council on the placing of plant protection products on the market and\n repealing Council Directives 79/117/EEC and 91/414/EEC.
The\n recommendation for second reading (under the codecision procedure) had been\n tabled for consideration in plenary by Hiltrud BREYER (Greens/ALE,\n DE), on behalf of the Committee on the Environment, Public Health and Food\n Safety.
The amendments\n were the result of a compromise between Parliament and Council. The main\n amendments were as follows:
Legal bases: the compromise text stated that the legal bases were\n Articles 37(2) (agriculture), 95 (internal market) and 152(4)(b)\n (health).
Precautionary\n principle: the provisions are underpinned by the\n precautionary principle in order to ensure that active substances or products\n placed on the market do not adversely affect human health or the environment.\n Member States shall not be prevented from applying the precautionary\n principle where there is scientific uncertainty as to the risks with regard\n to human, animal health or the environment posed by the plant protection\n products to be authorised in their territory.
Active\n substances: Members dropped the definition of\n active substances that Parliament had proposed at 1st reading. The compromise\n text states that where an active substance is necessary to control a serious\n danger to plant health which cannot be contained by other available means\n including non-chemical methods, such active substance may be approved for a\n time limited period necessary to control that serious danger but not\n exceeding five years even if it does not satisfy the approval criteria.\n Members States may authorise plant protection products containing active\n substances approved in accordance with this derogation only when it is\n necessary to control that serious danger to plant health in their territory.\n At the same time, they shall elaborate a phasing out plan on how to control\n the serious danger by other means, including non-chemical methods, and shall\n forthwith transmit it to the Commission.
CMR and\n endocrine disruptors: with regard to the\n derogation from the approval criteria for active substances, the text\n provides that the derogation shall not apply to active substances which are\n or have to be classified in accordance with Directive 67/548/EEC, as\n carcinogenic category 1, carcinogenic category 2 without a threshold, or\n toxic for reproduction category An active substance must not have an inherent\n capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects.\n Those products that are affected will only be banned once their current\n approvals come up for renewal.
Zoning\n system: Parliament accepted that the three-zones\n division should be maintained.
Residents: residents should be taken into account for the authorisation of\n plant protection products
Honeybees: An active substance, safener or synergist shall be approved only\n if it is established that it will result in a negligible exposure of\n honeybees, or that there are no unacceptable acute or chronic effects on\n colony survival and development, taking into account effects on honeybee\n larvae and honeybee behaviour.
Application: assessment of an application may be performed by a number of\n Member States together under a co-rapporteur system. Scientific peer-reviewed\n open literature, as determined by the Authority, on the active substance and\n its relevant metabolites dealing with side-effects on health, the environment\n and non-target species and published within the last ten years before the date\n of dossier submission shall be added by the applicant to the dossier.
Animal\n testing: the summary dossier must include for\n each test or study involving vertebrate animals, a justification of the steps\n taken to avoid animal testing and duplicative testing on vertebrate animals.\n Furthermore, the Commission's work programme must include measures to\n minimise animal testing, in particular the use of non-animal test methods and\n intelligent testing strategies.
Testing on\n vertebrate animals: this may be undertaken only\n where no other methods are available. Repetition of tests and studies\n involving vertebrates shall be avoided. Seven years after entry into force of\n the regulation, the Commission shall report on the effects of the provisions\n concerning data protection of tests and studies involving vertebrate animals.
Comitology: the regulatory procedure with scrutiny will apply to harmonised\n methods to determine the nature and quantity of active substances, safeners\n and synergists as well as relevant impurities and coformulants. It will also\n apply to detailed rules for the maximum quantities of plant protection\n products which may be released during experiments.
Minor uses: 2 years after entry into force of the legislation, the Commission\n shall present a report to the European Parliament and the Council on the\n establishment of a European fund for minor uses, accompanied, if appropriate,\n by a legislative proposal.
Advertising: Member States may prohibit or restrict the advertising of plant\n protection products in certain media subject to Community law.
Record-keeping: records must be kept for at least five years. Professional users\n of plant protection products shall keep records of the plant protection\n products they use, containing the name of the plant protection product, the\n time and the dose of application, the area and the crop where the plant\n protection product was used, for at least three years. 3 years after entry\n into force of the legislation, the Commission shall present a report on costs\n and benefits of the traceability of the information from users to retailers\n concerning the plant protection products' applications on agricultural\n products accompanied, if necessary, with appropriate legislative\n proposals. Producers of plant protection products shall undertake\n post-authorisation monitoring on request of the competent authorities and\n notify the competent authorities of the relevant results.
\nPURPOSE: to ensure a high level of protection of both human and\n animal health and the environment and to improve the functioning of the\n internal market through the harmonisation of the rules on the placing on the\n market of plant protection products, while improving agricultural production.
LEGISLATIVE\n ACT: Regulation (EC) No 1107/2009 of the European Parliament and of the Council\n concerning the placing of plant protection products on the market and\n repealing Council Directives 79/117/EEC and 91/414/EEC.
CONTENT:\n following an agreement reached at second reading of the codecision procedure,\n the Council adopted a regulation concerning the placing of plant protection\n products on the market.
The proposed\n Regulation would replace the existing legislation on the placing on the\n market of plant protection products (Council Directive 91/414/EEC),\n thoroughly revising the procedures for the safety evaluation of active\n substances and plant protection products. However, it keeps the two steps\n procedure of the Directive:
For\n simplification, it would also repeal Council Directive 79/117/EEC prohibiting\n the placing on the market and use of plant protection products containing\n certain active substances. The main aim of the proposal is to maintain a high\n level of protection for humans, animals and the environment; to reduce the\n administrative burdens of the present approval and authorisation procedures\n and to achieve a higher level of harmonization.
This proposal\n should be seen as part of a package together with the Thematic\n Strategy on the Sustainable Use of Pesticides and the proposal for a\n Framework Directive, which fills a legal gap in the use phase of pesticides,\n as well as a proposal\n for a Regulation on the collection of statistics regarding the placing on\n the market and the use of plant protection products.
The main\n elements of this new Regulation are as follows:
Subject\n matter and purpose: this Regulation lays down\n rules for the authorisation of plant protection products in commercial form\n and for their placing on the market, use and control within the Community. It\n lays down both rules for the approval of active substances, safeners and\n synergists, which plant protection products contain or consist of, and rules\n for adjuvants and co-formulants.
The purpose of\n this Regulation is to ensure a high level of protection of both human and\n animal health and the environment and to improve the functioning of the\n internal market through the harmonisation of the rules on the placing on the\n market of plant protection products, while improving agricultural production.\n The provisions of this Regulation are underpinned by the precautionary\n principle in order to ensure that active substances or products placed on the\n market do not adversely affect human or animal health or the environment. In\n particular, Member States shall not be prevented from applying the precautionary\n principle where there is scientific uncertainty as to the risks with\n regard to human or animal health or the environment posed by the plant\n protection products to be authorised in their territory.
Criteria: strict cut-off criteria for the approval at EU level of active\n substances are laid down in the new Regulation which will ban from the market\n the most toxic substances currently available. However, in exceptional cases,\n temporary derogations from these criteria could be granted in case of a\n serious threat to plant health. Under the new Regulation, a substance shall\n only be approved if, inter alia:
Derogations: where on the basis of documented evidence included in the\n application an active substance is necessary to control a serious danger to\n plant health which cannot be contained by other available means including\n non-chemical methods, such active substance may be approved for a limited\n period necessary to control that serious danger but not exceeding five years,\n provided that the use of the active substance is subject to risk mitigation\n measures to ensure that exposure of humans and the environment is minimised.\n This derogation shall not apply to active substances which are or have to be\n classified as carcinogenic category 1A, carcinogenic category 1B without a\n threshold, or toxic for reproduction category 1A.
Member States\n may authorise plant protection products containing active substances approved\n in accordance with this derogation only when it is necessary to control that\n serious danger to plant health in their territory. At the same time, they\n shall draw up a phasing out plan concerning the control of the serious danger\n by other means, including non-chemical methods, and shall without delay\n transmit that plan to the Commission.
Procedures: the procedures for the approval of active substances and\n authorisation of plant protection products have been harmonised and\n simplified, deadlines have been tightened, and the roles of the Member\n States, the Commission, and European Food Safety Authority (EFSA) have been\n clarified. First approval shall be for a period not exceeding 10 years. An\n application for the approval of an active substance or for an amendment to\n the conditions of an approval shall be submitted by the producer of the\n active substance to a Member State, (the rapporteur Member State), together\n with a summary and a complete dossier or a scientifically reasoned\n justification for not providing certain parts of those dossiers, demonstrating\n that the active substance fulfils the approval criteria provided for in this\n Regulation. A joint application may be submitted by an association of\n producers designated by the producers for the purpose of compliance with this\n Regulation. Scientific peer-reviewed open literature, as determined by the\n Authority, on the active substance and its relevant metabolites dealing with\n side-effects on health, the environment and non-target species and published\n within the last 10 years before the date of submission of the dossier shall\n be added by the applicant to the dossier. Member States should, within a\n delay of 120 days, decided on the mutual recognition. The renewal of the\n approval should be for a period not exceeding 15 years.
Regular\n examinations of products: under this Regulation\n Member States should regularly examine plant protection products containing\n substances which pose a high risk for human health or the environment with\n the aim of replacing them by plant protection products containing active substances\n which require less risk mitigation or by non-chemical control or prevention\n methods. In addition, incentives should be given for the placing on the\n market of low-risk plant protection products.
Definition\n of zones for the authorisation of plant protection products: the Regulation also sets out a system of three geographical\n zones (north, centre and south) for the mutual recognition of plant\n protection products which will increase the availability of plant protection\n products throughout the EU and reduce the workload for Member States.\n Nevertheless Member States will have the possibility to limit or reject the\n authorisations granted in another Member State in certain environmental or\n agricultural circumstances.
Animal\n testing: the Regulation stipulates that animal\n testing for the purposes of this Regulation should be minimised and tests on\n vertebrates should be undertaken as a last resort. Duplicative testing and\n duplication of tests and studies on vertebrates should be prohibited.
It should also\n be noted that an active substance, safener or synergist shall be approved\n only if it is established following an appropriate risk assessment on the\n basis of Community or internationally agreed test guidelines, that the use\n under the proposed conditions of use of plant protection products containing\n this active substance, safener or synergist: (i) will result in a negligible\n exposure of honeybees, or (ii) has no unacceptable acute or chronic\n effects on colony survival and development, taking into account effects on\n honeybee larvae and honeybee behaviour.
Candidates\n for substitution: an active substance complying\n with the criteria shall be approved, for a period not exceeding seven years,\n as a candidate for substitution if it meets one or more of the additional\n criteria laid down in the regulation. By way of derogation, the approval may\n be renewed once or more for periods not exceeding seven years.
Other\n provisions: the new regulation also includes, in\n particular, rules on data protection, classification, packaging and\n labelling, advertising, record-keeping, parallel trade and on seeds treated\n with plant protection products.
Review\n clause: by 14 December 2014, the Commission shall\n present a report to the European Parliament and the Council on the\n functioning of mutual recognition of authorisations and in particular on the the\n division of the Community into three zones and on the application of the\n criteria for the approval of active substances, safeners and synergists as\n set out in Annex II and the impact thereof on the diversification and\n competitiveness of agriculture as well as on human health and on the\n environment. The report may be accompanied, if necessary, by the appropriate\n legislative proposals to amend those provisions.
By 14 June\n 2011, the Commission shall adopt the following: (a) a Regulation containing\n the list of the active substances already approved at the moment of adoption\n of that Regulation; (b) a Regulation on data requirements for active\n substances; (c) a Regulation on data requirements for plant protection\n products; (d) a Regulation on uniform principles for risk assessment for\n plant protection products; (e) a Regulation containing the requirements of\n the labelling of plant protection products.
ENTRY INTO\n FORCE: 14.12.2009.
APPLICATION:\n from 14.06.2011.
\nPURPOSE : to\n lay down new harmonised EU rules for plant protection products, which aim to\n reinforce the protection of public health and the environment, support\n sustainable development in agriculture, reduce animal testing, boost\n competitiveness for producers and increase availability of plant protection\n products for farmers.
PROPOSED ACT :\n Regulation of the European Parliament and of the Council.
CONTENT : the\n use of plant protection products (PPP) may involve risks and hazards for\n humans, animals and the environment, especially if placed on the market\n without having been officially tested and authorized and if incorrectly used.\n Therefore harmonized rules should be adopted on the placing on the market of\n PPP.
This proposal\n follows extensive consultations with Member States and stakeholders over the\n past 5 years, as well as a comprehensive impact assessment. The proposed\n Regulation is fully in line with the overall Commission strategy on\n pesticides, and will complement the Commission’s proposal for a Directive on the\n sustainable use of pesticides (refer to COD/2006/0132).
The proposed\n Regulation replaces Directive 91/414/EEC concerning the placing of plant\n protection products on the market and repeals Council Directive 79/117/EEC\n prohibiting the placing on the market and use of plant protection products\n containing certain active substances. In a nutshell, it consists of the\n following elements:
- establishment\n at EU level of a positive list of active substances, safeners, synergists and\n a negative list of co-formulants;
- the\n time-span for the approval of active substances is shortened, with strict\n deadlines laid out for Member States, the European Food Safety Authority and\n the Commission;
-\n authorisations of active substances will no longer have to be renewed every 10\n years (just once, after the first 10 year period), in order to avoid a\n backlog of unnecessary applications which have already been found to be\n acceptable for use. However, a review of an authorisation can still be\n carried out at any time if new concerns arise about its safety;
- the EU will\n be divided into 3 zones with similar climatic and ecological features, and\n plant protection products authorised by any one Member State will\n automatically be cleared for use in the other Member States in that particular\n zone;
- national\n authorities will still be allowed, however, to impose specific national risk\n mitigation measures if deemed necessary;
- data\n protection rules are also simplified, to allow more transparency, greater\n competition and a level playing field for small and medium sized producers,\n while ensuring that this does not hamper innovation;
- provisions\n on packaging, labelling and advertising;
- obligation\n to keep records and to carry out controls;
- establishment\n of criteria for approval of active substances, safeners or synergists.
The proposal\n also includes new provisions which aim to protect human health, animal\n welfare and the environment:
- the safety\n evaluations of active substances will be founded on strict criteria, also\n based on health considerations and the effects on the environment (e.g.\n persistence in the environment);
- the European\n Food Safety Authority (EFSA) has a central role in the evaluation procedure;
- control\n measures are reinforced in the Commission’s proposal, and farmers and other\n professional users will have to keep records of their use of plant protection\n products. These will have to be made available on request to the drinking\n water industry and neighbours;
- avoid\n repetition of testing on vertebrates
- protect non-professional\n users.
For further information concerning\n the financial implications of this measure, please refer to the financial\n statement.
\nThe Council\n took note of information provided by the Commission on a proposal for a\n Regulation concerning the placing of plant protection products on the market.
Giving their\n first reactions, certain Member States identified a number of issues that\n will require further examination, including the need for specific rules on\n parallel imports, the proposed principle of compulsory mutual recognition\n within a three-zone system, and ways of taking into account the varying needs\n of individual Member States and ensuring that plant protection products are\n available for minor crops.
\nThe Committee\n on the Environment, Public Health and Food Safety adopted a report drawn up\n by Hiltrud BREYER (Greens/ALE, DE), and amended, in the first reading\n of the co-decision procedure, the proposal for a regulation concerning the\n placing of plant protection products on the market.
The main\n amendments are as follows : :
Objective\n and legal bases: Members specified that Articles\n 152 (4)(b) and 175(1) should be used as dual legal bases since the purpose of\n the Regulation is to ensure a high level of protection of both human and\n animal health and the environment. The purpose of the Regulation is\n furthermore to harmonise the rules on the placing on the market of plant\n protection products in order to harmonise the availability of plant\n protection products between farmers in different Member States. Member States\n may not be prevented from applying the precautionary principle in restricting\n or prohibiting pesticides. They may establish any pesticide-free zones they\n deem necessary in order to safeguard drinking water resources. Such\n pesticide-free zones may cover the entire Member State. Member States may\n impose a ban on the use and marketing of EU-authorised pesticides where they\n are found in measurable quantities outside the root zone.
Definitions: the Committee inserted and amended several definitions. It\n specified, particularly, that ‘plant protection products’ should be replaced\n with ‘pesticides’ and in the relevant places ‘pesticide products'.
Zonal\n licensing: in view of the objectives of the\n regulation, the Committee did not consider the Commission’s proposed\n introduction of zones and corresponding zonal licensing of pesticidal\n products to be useful, since it felt that dividing the EU into arbitrary\n zones did not meet environmental or nature-conservancy criteria. Risk\n assessment and risk management should be set up in accordance with smaller,\n differentiated nature conservancy areas and soil-climate conditions. In\n addition, each Member State should retain the option of going beyond the\n Community standard in its fundamental standard of protection or of making\n decisions in product licensing in order to implement established objectives\n of national pesticide action plans, health programmes or environmental\n protection measures. Each Member State should also be allowed to decide to\n link licensing decisions to a test of usefulness based on specific national\n conditions. The Committee stipulated, instead of arbitrary zones, that the\n principle of mutual recognition of national licensings should be retained,\n but that the Member States should, in the spirit of the subsidiarity\n principle, be allowed to make national or regional specifications. Member States\n should be entitled to confirm, reject or restrict the authorisation granted\n by another Member State on the basis of their specific agricultural needs or\n to maintain a higher protection level in line with their National Pesticide\n Action Plan.
Active\n substances: Members clarified that active\n substances that have no adverse effect on humans, animals or the environment\n can be considered as low-risk. The Commission may review the approval of an\n active substance at any time and will give due consideration to requests for\n review from a Member State, the European Parliament and other stakeholders,\n based on current scientific and technical knowledge and monitoring data. The\n Committee made clear that a derogation will not apply to any active substance\n classified in accordance with Directive 67/548/EEC as: carcinogenic,\n mutagenic, toxic to reproduction, sensitising, or to substances that are\n qualified as: persistent with a half-life of more than 60 days; endocrine\n disrupters appearing on the EU list of suspected endocrine disrupters; toxic;\n bioaccumulative and non-readily degradable. On e year after entry into force\n of the legislation, the Commission must review and if necessary specify the\n criteria for treating an active substance as a low risk substance and, if\n appropriate, submit proposals.
Approval\n criteria for an active substance or a metabolite in the use-phase: the Committee stated that cut-off criteria will be used for the\n exclusion of active substances, in order to protect human health and the\n environment against intrinsic hazards of certain substances. They must not\n have any harmful effects on human health, in particular that of users who are\n in direct contact with the products, residents, bystanders and vulnerable\n groups, such as pregnant and nursing women, embryos and foetuses, infants and\n children. All testing and decision-making strategies must follow this\n principle, and current scientific knowledge must be borne in mind in the\n process. Furthermore, to prevent animal testing, tests on vertebrate animals\n should for the purposes of the Regulation be carried out only as a last\n resort. The use of non-animal tests and intelligent testing strategies shall\n be promoted, and duplicate vertebrate animal testing shall be prohibited.\n Dossiers for each test or study involving vertebrate animals must show a\n justification of the steps taken to avoid animal testing and duplicative\n testing on vertebrate animals.
Substitution\n principle and comparative assessment: the\n Committee considered it important to follow the principles of the REACH and\n biocide directives, and to introduce the substitution principle and\n comparative assessment in order to reduce the risks and dangers of\n pesticides. Products that contain a candidate for substitution will not be\n approved by Member States if there are safer alternatives or methods\n available for a given crop. While Member States must not authorise any plant\n protection product where a comparative assessment shows the existence of\n safer alternatives, priority in comparative assessment and substitution shall\n be given to candidates for substitution. In addition, the aims of the\n Thematic Strategy on the compulsory introduction of standards of integrated\n pest management and integrated plant protection into agriculture should be\n incorporated into the definitions and measures of ‘good technical practice’\n and ‘proper handling of pesticides’ in the regulation. These conditions\n should become a compulsory component of the licensing process by 2012 instead\n of 2014.
Approval\n procedure: the Committee stated that the\n Authority must be responsible for coordinating the approval procedure, and in\n doing so, the Authority will rely on the competent authorities of Member\n States. An application for the approval of an active substance or for an\n amendment to the conditions of an approval shall be submitted by the producer\n of the active substance to the Authority (rather than the ‘rapporteur Member State ’). The Authority shall inform the competent authorities of the Member States\n of the applications it has received. A Member State may choose an active\n substance for which an application for approval has been received by the\n Authority, with the aim of becoming the rapporteur Member State. Disagreement should be solved in comitology, on the basis of objective criteria, such as\n geographic, agricultural and climatic conditions, especially with regard to\n the target organisms, the performance and impartiality of the competent\n authority and the reference laboratory, and the absence of interests linked\n to the producing companies.
Renewal of\n approval: whilst the Commission had specified\n that the renewal shall be for an unlimited period of time, the Committee\n stated that the approval may be renewed once or repeatedly for a period not\n exceeding 10 years. The approval period should be proportional to the\n possible risks inherent in the use of such substances and should be limited\n to a maximum of 15 years for low risk substances, 5 years for candidates for\n substitution and 10 years for other substances.
Transparency\n and competition: Members consider the greatest\n possible transparency in licensing and use, all the way through to the\n consumer, to be essential. For this reason information on permitted\n substances should be published on the Internet, and consumer-relevant\n information (e.g. eco-toxicological data) from the licensing procedure, as\n well as the results of residue monitoring, should be published. In addition\n to the proposed rule on keeping records on pesticide use, the Committee\n suggests a “pesticide pass”, with which greater transparency and traceability\n in the food chain could be achieved. Lastly, Members specified the need for a\n clear definition and a minimum set of community harmonized rules regulating\n the placing of products on the market through parallel trade.
\nThe European\n Parliament adopted a resolution drafted by Hiltrud BREYER (Greens/ALE,\n DE), and made some amendments to the proposal for a regulation concerning the\n placing of plant protection products on the market. With specific regard to\n the approval regime, the Commission's zone-based approach was rejected by\n Parliament, which preferred Member States to maintain national control over\n product approval.
The main\n points are as follows:
Objective\n and legal bases: Members specified that Articles\n 152 (4)(b) and 175(1) should be used as dual legal bases since the purpose of\n the Regulation is to ensure a high level of protection of both human and\n animal health and the environment. The purpose of the Regulation is\n furthermore to harmonise the rules on the placing on the market of plant\n protection products in order to harmonise the availability of plant\n protection products between farmers in different Member States. Member States\n may not be prevented from applying the precautionary principle in restricting\n or prohibiting pesticides. They may establish any pesticide-free zones they\n deem necessary in order to safeguard drinking water resources. Such\n pesticide-free zones may cover the entire Member State. Member States may\n impose a ban on the use and marketing of EU-authorised pesticides where they\n are found in measurable quantities outside the root zone.
Active\n substances: Members introduced a definition of\n 'active substances' as substances, including their metabolites present in the\n use phase, micro-organisms and viruses, having general or specific action\n against target organisms or on plants, parts of plants or plant products.\n They clarified that they must not have any harmful effects on human health,\n in particular that of users who are in direct contact with the products, residents,\n bystanders and vulnerable groups. Parliament accepted an amendment in plenary\n that such substances shall not have any unacceptable effect on the\n environment taking into account cumulative and synergistic effects and all\n relevant exposure routes to organisms in the environment. Methods to assess\n such effects will be presented by the European Food Safety Authority. A\n derogation will not apply to any active substance classified in accordance\n with Directive 67/548/EEC as: carcinogenic, mutagenic, toxic to reproduction,\n sensitising chemicals, or to substances that are qualified as: persistent\n with a half-life of more than 60 days; endocrine disrupters appearing on the\n EU list of suspected endocrine disrupters; toxic; bioaccumulative and\n non-readily degradable. On e year after entry into force of the legislation,\n the Commission must review and if necessary specify the criteria for treating\n an active substance as a low risk substance and, if appropriate, submit\n proposals. The Commission may review the approval of an active substance at\n any time and shall give due consideration to requests for review from a\n Member State, the European Parliament and other stakeholders, based on\n current scientific and technical knowledge and monitoring data.
Parliament\n added as part of the definition of “substance of concern” that any substance\n that has or potentially has either carcinogenic, mutagenic, endocrine\n disrupting, neurotoxic, immunotoxic, reprotoxic or genotoxic capabilities\n should be regarded as a substance of concern.
Zonal\n licensing: Parliament rejected the Commission’s\n proposal regarding the introduction of zones and corresponding zonal\n licensing of pesticidal products. It specified instead that authorisations\n granted by one Member State should be notified to other Member States. Member\n States should be entitled to confirm, reject or restrict the authorisation\n granted by another Member State on the basis of their specific agricultural\n needs or to maintain a higher protection level in line with their National\n Pesticide Action Plan. A new recital states that good administrative\n co-operation between Member States should be increased during all steps of\n the authorisation procedure and should be facilitated by a European Helpdesk.
Approval\n procedure: Parliament stated that the Authority\n must be responsible for coordinating the approval procedure, and in doing so,\n the Authority will rely on the competent authorities of Member States. An\n application for the approval of an active substance or for an amendment to\n the conditions of an approval shall be submitted by the producer of the\n active substance to the Authority (rather than the ‘rapporteur Member State ’). The Authority shall inform the competent authorities of the Member\n States of the applications it has received. A Member State may choose an\n active substance for which an application for approval has been received by\n the Authority, with the aim of becoming the rapporteur Member State. Disagreement should be solved in comitology, on the basis of objective criteria, such as\n geographic, agricultural and climatic conditions, especially with regard to\n the target organisms, the performance and impartiality of the competent\n authority and the reference laboratory, and the absence of interests linked\n to the producing companies.
The\n authorisation setting out the requirements relating to the placing on the\n market and use of the plant protection product will include indications for\n proper use according to the principles of Integrated Pest Management as\n defined in the legislation, to apply from 2012 onwards.
Renewal of\n approval: whilst the Commission had specified\n that the renewal shall be for an unlimited period of time, Parliament\n endorsed the views of its competent committee and stated that the approval\n may be renewed once or repeatedly for a period not exceeding 10 years. The\n approval period should be proportional to the possible risks inherent in the\n use of such substances and should be limited to a maximum of 15 years for low\n risk substances, 5 years for candidates for substitution and 10 years for\n other substances. After the first renewal, a regular review of substances\n should take place.
Substitution\n principle and comparative assessment: Member\n States must not authorise for use in a given crop a plant protection product\n either containing a candidate for substitution or posing a higher risk where\n a comparative assessment weighing up the risks and benefits, as set out in\n Annex IV, shows that safer alternatives are available, as defined in the\n legislation. While Member States must not authorise any plant protection\n product where a comparative assessment shows the existence of safer\n alternatives, priority in comparative assessment and substitution shall be\n given to candidates for substitution.
Minor uses: Member States must establish a list of minor uses. This list\n shall be made available to the public through official websites of the Member State and of the Commission. Not later than one year after entry into force of the\n legislation, the Commission must present a proposal to the European\n Parliament and the Council for establishing a European promotion fund for\n minor uses. The Fund shall also be entitled to finance additional residue\n tests for minor uses. Comparative assessments shall take authorised minor\n uses into account.
Transparency\n and competition: Producers, suppliers,\n distributors and professional users of plant protection products must keep\n records of the plant protection products they produce, store or use for at\n least 10 years after the end of production or use. They shall make the\n information contained in these records available to the competent authority.\n They shall also keep this information available for neighbours and residents,\n retailers or the drinking water industry who request direct access to it. The\n information on all applications of plant protection products on a given\n agricultural product shall be provided to retailers and wholesalers in the\n form of a pesticide passport. In addition, the Commission must maintain an\n updated list of approved active substances in Annex IIa and publish this list\n on the Internet. Lastly, Members specified the need for a clear definition\n and a minimum set of community harmonized rules regulating the placing of\n products on the market through parallel trade, and inserted a new Article on\n the granting of parallel trade permits.
Animal\n testing: in order to avoid animal testing,\n testing on vertebrate animals for the purposes of the Regulation must be\n undertaken only as a last resort. The use of non-animal tests and intelligent\n testing strategies must be promoted, and duplicate vertebrate animal testing\n shall be prohibited. Dossiers for each test or study involving vertebrate\n animals must show a justification of the steps taken to avoid animal testing\n and duplicative testing on vertebrate animals.
\nA number of\n Parliamentary amendments that, from a technical and editorial point of view,\n improved the initial proposal were adopted by the Commission, whilst others\n were partially accepted only.
Legal\n basis:
Although\n Parliament proposed Article 152(4)b and 174(1) of the EC Treaty as the legal\n basis for the Regulation, the Commission has decided to stick to its original\n proposal, namely that Articles 37(2) and 152(4)b should form the legal basis\n of this proposal.
Scope:
The Commission\n retains its view that there is no need to introduce a “future limitation” to\n the scope of the Regulation that excludes micro-organisms, viruses,\n pheromones and biological products once a separate Regulation to these\n products has been adopted. This is because there is no need for such a specific\n Regulation as such data requirements and criteria for authorisation are in\n place already. This amendment has, as a result, not been endorsed.
Definitions:
Parliamentary\n amendments that clarify the proposed definitions and which are linked to other\n amendments have been adopted by the Commission. Those that clarify\n definitions relating to: low risk; parallel trade; vulnerable groups; non chemical\n methods of plant protection; and minor uses were also acceptable to the\n Commission.
Approval\n criteria and range of uses:
The\n Commission’s initial proposal stated that for category 1 and 2 substances, a\n substance can not be approved – unless exposure is negligible. Parliamentary\n amendments concerning this proposal have mostly been accepted by the\n Commission. In cases where Parliament has sought to extend the proposed\n criteria in Annex II, the Commission has decided to keep the original\n proposal in line with related European legislation and has decided to clarify\n the text. It has decided to clarify that neurotoxin and immunotoxic\n substances should be approved as candidates for substitution.
An amendment\n on “negligible exposure” was deemed acceptable given that it keeps the\n risk-based approach, as foreseen in the original proposal, as well as\n clarifying the provision. On the matter of “evaluation of representative\n uses”, the Commission has opted to retain the format of the initial proposal\n and suggest that a limited number of uses must be evaluated at EU level and\n other uses left to the Member States, who are required to apply uniform\n criteria when granting authorisation.
Approval\n procedure, renewal and review:
The Commission\n has decided to reject a Parliamentary amendment concerning the role of the\n EFSA as coordinator of the approval procedure. The EFSA, in the Commission’s\n opinion, should coordinate scientific evaluation only. It should not be\n responsible for the approval procedure. Also rejected were variations from\n the proposed extension (or reduction) of the deadlines foreseen for various\n consultations and decisional phases. Amendments on renewal and review were\n accepted by the Commission, where they clarified the original proposal.
Low risk\n and basic substances:
An amendment\n on defining low risk substances has been incorporated into the revised\n proposal, although an amendment concerning different criteria biological\n control agents has not. Amendments relating to basic substances have been\n rejected on the ground that they should be approved for an unlimited period\n and on the basis of evaluations performed in other areas. Similarly, the\n Commission has decided not to accept a Parliamentary proposal to introduce a\n new article on reduced risk plant protection products and setting out\n different periods of data protection for the two categories of low risk\n products.
Safeners,\n synergists and co-formulants:
An amendment\n deleting temporary derogation for safeners and synergists has been rejected\n by the Commission. Further, any changes to the approval of co-forumlants have\n been rejects as it would create an overlapping obligation with respect to\n existing legislation on chemicals (REACH).
Zonal\n authorisation system and provisional authorisation:
Parliament was\n seeking to reject the zonal authorisation system for plant protection\n products that are linked to compulsory mutual recognition of authorisation\n within a zone. This, however, would have removed one of the proposal’s key elements.\n As the proposal stands, Member States can only impose stricter national\n measures for worker protection, given that EU legislation seeks minimum\n harmonisation only. A further amendment, on a system of provisional\n authorisation, has similarly been rejected by the Commission on the grounds\n that it is incompatible with the zonal authorisation system and EU\n legislation on maximum residue levels for pesticides.
Systematic\n information:
The Commission\n has decided not to include a new provision whereby farmer’s records would\n have been made available to the public and residents - the so called\n “pesticide passport”. Instead the Commission has decided to retain the\n original text of the proposal which provides that information should be made\n available to neighbours “upon request.” It would, argues the Commission, be\n impossible to maintain a pesticide passport for every lot of fruit and\n vegetables given that batches of crops are mixed in trade. Moreover, one side\n effect may be that controls are done only on declared pesticides.
Comparative\n assessment and substitution principle:
The Commission\n has decided not to endorse amendments that sought to extend comparative\n assessment to all plant protection products and to reduce the approval period\n for substances which are candidates for substitution. This option has not\n been adopted because it is not based on risk.
Minor uses:
Most proposed\n amendments relating to facilitating the extension of authorisations for minor\n uses have been taken on board by the Commission subject to some legal\n rewording, albeit that the proposed “European Promotion Fund” for minor uses\n has been rejected given that it does not fall within the proposal’s main\n objectives.
Parallel\n trade:
The Commission\n has decided to adopt new provisions concerning the trade of plant protection\n products that have already been authorised in other Member States. Some of\n the wording has been revised in order to make it compatible with the Treaty\n and Cases Law of the Court of Justice.
Data\n protection and data sharing:
Certain\n Parliamentary amendments on data protection and sharing have been rejected by\n the Commission on the grounds that they would weaken competition and reduce\n the availability of plant protection products to farmers. This issue has been\n carefully analysed in the impact assessment. The Commission is of the view\n that all studies on vertebrate animals should be protected in the same way as\n other studies. However, there is an obligation to share results and not to\n repeat studies.
Confidentiality\n and public access to information:
A\n Parliamentary suggestion to offer confidentiality to the Institutes or\n persons involved in vertebrate studies has not been taken up by the\n Commission. This is because under Article 60 of the proposal any person can\n request that disclosure of information, which may undermine their privacy and\n integrity.
Integrated Pest management and Good Environmental Practice:
Two\n amendments, the first on making integrated pest management (IPM) obligatory\n as from 2012 and the second, deleting an obligation for compulsory compliance\n with the principle of good environmental practice, have been rejected by the\n Commission.
Comitology\n and the link between the proposed Regulation and Regulation (EC) No 396/2005:
The Commission\n agrees to align procedures for the exercise of implementing powers conferred\n on Commission to the normal regulatory procedure. However, in cases where the\n Commission sees the need for curtailment of time limits for certain cases\n (such as respecting time limits for renewing procedures), the Commission has\n decided that the normal regulatory procedure should apply, rather than the\n regulatory procedure with scrutiny.
For cases that\n involve setting data requirement for safeners and synergists, the Commission\n can accept use of the regulatory procedure with scrutiny but not the co-decision\n procedure. Nor, argues the Commission, is it appropriate to use the\n co-decision procedure for technical provisions which need to be continuously\n updated.
On a final\n point, the Commission points out that the situation regarding the procedure\n affecting maximum residue levels (MRLs), will need to be clarified after the\n Plenary session of the European Parliament end November 2007.
\nThe Council\n adopted, by qualified majority, the common position in view of the adoption\n of a Regulation concerning the placing of plant protection products on the\n market. The Hungarian, Irish, Romanian and the UK delegations abstained.
The Council\n incorporated 19 amendments in full adopted by the European Parliament in its\n 1st reading. 59 other amendments were accepted in part or in\n principle. Certain amendments, such as those concerning provisional\n authorisations, renewal period for the approval of active substances, data\n protection for the studies necessary for renewal or review of the\n authorisation, confidentiality of names and addresses of persons involved in\n testing on vertebrate animals and cost recovery by Member States were totally\n or partially incorporated in the common position although they were not\n accepted initially by the Commission
The main\n issues of the common position:
Legal basis: the Council considered that, as the main purpose of the\n Regulation was to ensure the effective functioning of the internal market in\n plant protection products, Article 95 was the correct legal basis. The\n Council, however, decided to adopt a dual legal basis including Article 37(2)\n as a gesture towards the Commission.
Definitions: the Council took up those amendments which provide appropriate\n clarifications of the text of the definitions or which were essential because\n new provisions were introduced in the text. However, in some cases, the\n Council preferred to place the new definitions within the Articles containing\n the provisions on those areas (e.g. definitions of parallel trade, identical,\n rapporteur Member State or low-risk). The Council has deleted the definition\n of Integrated Pest Management from the Commission's proposal and has instead\n inserted a link to the Directive on sustainable use of pesticides. The\n Council could not incorporate an amendment as it considered that priority to\n non-chemical methods was not an essential element of good plant protection\n practice.
The Council\n has also inserted a number of additional definitions such as\n \"authorisation holder\", \"professional user\", \"minor\n use\", \"greenhouse\", \"post-harvest treatment\", \"biodiversity\",\n \"competent authority\", \"advertisement\", \"relevant\n metabolite\" and \"impurity\". It deleted the definitions of\n \"animals\" and \"integrated pest management\".
Approval of\n active substances: the Council introduced a\n sequential approach in the evaluation of the criteria set out in Annex II (procedure\n and criteria for the approval of active substances, safeners and synergists) whereby\n certain points of that Annex should be verified first before examining the\n rest of the criteria.
The Council\n has introduced in Annex II a clear definition of negligible exposure to\n carcinogenic, endocrine disrupting or toxic for reproduction substances and has\n established that mutagenic category 1 or 2 active substances should be banned\n even if human contact with those substances was negligible. It nevertheless\n thought it necessary to introduce, for exceptional cases, a derogation clause\n limited in time for those substances which are essential for the protection\n of a crop even if they do not meet the criteria.
The Council\n could not agree with the European Parliament's view that active substances with\n neurotoxic or immunotoxic properties should be excluded but it agreed to\n consider them as candidates for substitution. Like the Parliament, the\n Council opposed the unlimited renewal of approval of active substances as\n proposed by the Commission but established a maximum period of 15 years\n instead of 10 as requested by the Parliament.
Procedures: the Council has endeavoured to further streamline the procedures\n for approval of active substances and authorisation of plant protection\n products. It has paid particular attention to tightening the deadlines and\n defining more precisely the roles of the various players involved (Member\n States, the Commission, the European Food Safety Authority (EFSA)). The\n Council has thus accepted in full or in part a number of European Parliament\n amendments that tend in this direction and rejected others which might either\n cause unnecessary delays, or not allow enough time for the adequate\n completion of some stages of the procedures.
Low-risk\n active substances: the Council, like the\n Parliament, thought it useful to further explain the concept of \"low risk\"\n but instead of adding a definition or extra clarifications as proposed by the\n European Parliament, it has inserted more detailed criteria in Annex II.
Regarding data\n protection for low-risk plant protection products, the Council has extended\n the period of protection to a maximum of 13 years instead of 15 as proposed by\n the European Parliament. In case the authorisation of a low-risk plant\n protection product is extended to minor uses the data protection period could\n then be extended to up to 15 years.
Candidates\n for substitution: the Council has also clarified\n the criteria for active substances to be identified as candidates for\n substitution. The Council felt it was necessary to extend the period of approval\n from 7 to 10 years and therefore did not accept the Parliament’s amendment.
The Council\n was unable to agree with a number of amendments extending, in particular,\n comparative assessment to all plant protection products. The text has\n nevertheless been redrafted in order to give Member States the option, in\n exceptional cases, of not authorising or of restricting the use of a plant protection\n product which does not contain a candidate for substitution or a low-risk substance\n if a non-chemical method exists.
Mutual\n recognition of authorisations: the Council was\n not able to accept those amendments relating to the zonal authorisation and\n mutual recognition. On the contrary, the Council has confirmed the division into\n authorisation zones as proposed by the Commission and the system of\n compulsory mutual recognition of authorisations as it believes it is a good\n way to ensure the reduction of administrative burdens and the quick and wider\n availability for European farmers of plant protection products. The Council\n has extended this system to plant protection products for minor uses and has\n provided additional flexibility (e.g. the recognition of authorisations\n between Member States belonging to different zones or the possibility for a\n professional organisation to apply for an authorisation). The Council\n introduced provisions establishing that Member States impose additional risk\n mitigation measures relevant to their territory and, exceptionally, can\n refuse authorisations granted in another Member State in order to protect\n human or animal health or the environment. The Council has also inserted a\n review clause whereby a report is to be drawn up by the Commission within\n five years of the Regulation's entry into force.
National\n Provisional Authorisations: Member States decided\n to bring back the provisional authorisations as a transitional measure as\n they feared delays in the authorisation of plant protection products. They thought\n the new system needed to be tested first to check if deadlines could be met. National\n provisional authorisations will only be granted for a limited period of time (3\n years) and under certain circumstances. The Council and the Parliament's\n views substantially converge on this issue.
Animal\n testing: the Council has taken note of the\n European Parliament particular interest in avoiding or minimising animal\n testing.
Comitology: the Council has modified the Commission's proposal to bring it\n into line with the new Comitology Decision 2006/512/EC amending Decision\n 1999/468/EC and introducing the new regulatory procedure with scrutiny. In\n some cases the Council could not accept the regulatory procedure with\n scrutiny if the measures to be taken were of a purely implementational nature.\n In cases concerning the simple transfer of the requirements already contained\n in the Annexes to Directive 91/414/EC to the new Regulation or the adoption\n of non-binding guidelines, the Council was of the opinion that the advisory\n committee procedure was more appropriate. The Council thought instead that\n the most appropriate comitology procedure would be that of \"regulatory\n with scrutiny\" as the Regulations to be adopted following the provisions\n laid down in those articles would supplement the basic act by adding new\n non-essential elements.
The common\n position also includes other changes, not envisaged by the European Parliament,\n which address a number of concerns expressed by the Member States in the course\n of the negotiations:
Treated\n seeds: delegations considered that it was necessary\n to insert provisions on this area so as to protect the free movement of seeds\n treated with plant protection products in the EU unless they might pose a\n serious threat for human or animal health or the environment.
Parallel\n trade: the provisions concerning parallel trade\n were added by the Council following an almost unanimous request by Member\n States. The Council has thus incorporated the amendment and has adapted the\n provisions on parallel trade to the most recent jurisprudence. It has also\n introduced the requirement of official controls in this area.
Adjuvants: the Council has inserted provisions establishing that detailed\n rules for the authorisation of adjuvants should be set out following a\n comitology procedure.
\nThe Committee on the Environment, Public Health and Food\n Safety adopted a report drafted by Hiltrud BREYER (Greens/ALE, DE),\n and recommended amendments to the Council common position for adopting a\n regulation of the European Parliament and of the Council on the placing of\n plant protection products on the market and repealing Council Directives\n 79/117/EEC and 91/414/EEC. Most of the amendments were reinstatements of\n amendments from 1st reading. The main ones were as follows :
Legal bases:\n Members specified that Articles 152 (4)(b) and 175(1) should be used as dual\n legal bases since the purpose of the Regulation is to ensure a high level of\n protection of both human and animal health and the environment. The common\n position provides for Article 95 (internal market) and Article 37(2)\n (agriculture) to be used as legal bases.
Objective:\n the committee expanded considerably the purposes of the Regulation, stating\n that, in addition to autorisation and approval of active substances, purposes\n include: ensuring a high level of protection of both human and animal health\n and the environment; and harmonising the rules on the placing on the market\n of plant protection products in order to harmonise the availability of plant\n protection products between farmers in different Member States.
Precautionary principle: the Regulation is based on the precautionary principle\n in order to ensure that substances or products placed on the market do not\n adversely affect human or animal health or the environment. Member States may\n not be prevented from applying the precautionary principle in restricting or\n prohibiting pesticides. Member States may establish any pesticide-free zones\n they deem necessary in order to safeguard drinking water resources. Such\n pesticide-free zones may cover the entire Member State.
Active substances: Members re-introduced the definition of active\n substances that Parliament had proposed at 1st reading. With regard to the\n derogation from the criteria for the approval of a substance in case of a\n serious danger to plant health, the committee specified that there must be a\n public interest in controlling that danger. Such an active substance may be\n approved for a time-limited period necessary to control that serious danger\n but not exceeding 4 years (rather than 5 years) and a substitution plan on\n how to control the serious danger in two years' time by other means,\n including non-chemical methods, must be presented by the applicant. Regarding\n substances with endocrine-disrupting properties, the committee provides some\n examples of substances which may be considered as such. Further specific\n scientific criteria for the determination of endocrine disrupting properties\n shall be adopted in accordance with the regulatory procedure with scrutiny.
A new clause states that an active substance, safener or\n synergist shall only be approved if it is not considered to cause a\n significant risk (affecting at least one in a million citizens) of developmental\n neurotoxic or immunotoxic properties in humans, taking into account\n exposure during embryonic/foetal life and/or during childhood as well as\n likely combination effects, unless the exposure of humans to that active\n substance, safener or synergist in a plant protection product, under\n realistic proposed conditions of use, is negligible, i.e. the product is\n used in closed systems or in other conditions excluding contact with humans\n and where residues of the active substance, safener or synergist concerned on\n food and feed do not exceed the default value set in accordance with\n Regulation (EC) No 396/2005.
The committee also introduces in the criteria the\n consideration of risk to honeybees, honeybee larvae, honeybee\n behaviour, or colony survival and development.
Zoning:\n the committee deleted the proposed zoning system, since it felt that the\n latter undermines national authorisation and it is not in line with the EC\n principle of proportionality and subsidiarity because it is going beyond what\n is necessary to speeding up the decision making process. These objectives\n can be reached by amending the mutual recognition system without the concept of\n zoning. The committee proposes to keep the principle of compulsory mutual\n recognition of authorisations for plant protection products in the context of\n a one-zone system and introduces more flexibility for Member States to refuse\n mutual recognition. An amended recital states that authorisations granted by\n one Member State should be notified to other Member States in which the\n applicant wishes to put the product on the market. Those Member States should\n be entitled to recognise an authorisation issued by another Member State,\n amend it or refrain from authorising the plant protection product in their\n territory, if justified because of specific agricultural or environmental\n circumstances that may be, but do not need to be, limited to that Member\n State, or if the high level of protection of human or animal health or the\n environment set out in the Regulation cannot be achieved, or to maintain a\n higher protection level in their territory in line with their national action\n plan to reduce the risks associated with pesticides, adopted in accordance\n with Directive 2008/.../EC establishing a framework for Community action to\n achieve a sustainable use of pesticides.
Approval procedure: the committee insisted that the Authority (EFSA) shall\n be responsible for coordinating the approval procedure. In doing so, the\n Authority shall rely on the competent authorities of Member States. Upon\n being informed which Member State will examine the application, the applicant\n shall immediately forward to the Authority the complete and the summary\n dossiers. Within 180 days, the Member States concerned shall grant or refuse\n authorisations.
Substitution of dangerous substances with safer\n alternatives: the approval\n time of candidates for substitution should not be the same as the general approval\n period. To ensure regular comparative assessment of products containing such\n substances, the approval period should be limited to 5 years (renewable)\n rather than 10. Furthermore, any authorisation of plant protection products\n containing a candidate for substitution without comparative assessment should\n be limited to a maximum of 3 years. The adoption of the list of substances\n that are candidates for substitution should be done after 3 years at the\n latest, rather than 6.
Animal testing: Members specified that, in order to avoid animal\n testing, testing on vertebrate animals for the purposes of the Regulation\n shall be undertaken only as a last resort. The use of non-animal tests and\n intelligent testing strategies shall be promoted, and duplicate vertebrate\n animal testing shall be prohibited.
Standardised format for information: Members want records of plant protection\n products produced, imported, exported, stored, used or placed on the market\n to be kept for at least 10 years after the end of production or use, rather\n than for 3 years. This information must be available for neighbours and\n residents, retailers or the drinking water industry who request direct access\n to it. The information on all applications of plant protection products on a\n given agricultural product shall be provided to retailers and wholesalers\n using a standardised format, which will be established in accordance with the\n advisory procedure.
Promotion fund for minor uses: not later than one year after entry into force of the\n legislation, the Commission shall present a proposal to the European\n Parliament and the Council for the establishment of a European promotion fund\n for minor uses. The Fund shall also be entitled to finance additional residue\n tests for minor uses.
Comitology:\n the Commission must be empowered to approve active substances, to renew or\n review their approval, to adopt harmonised methods to determine the nature\n and quantity of active substances, safeners and synergists, and where\n appropriate of relevant impurities and co-formulants, to adopt detailed rules\n for allowing derogations from authorisation of plant protection products for\n research and development and the list of approved substances. Rules on these\n matters must be adopted in accordance with the regulatory procedure with\n scrutiny.
\nThe European\n Parliament adopted a legislative resolution amending the Council's common\n position for adopting a regulation of the European Parliament and of the\n Council on the placing of plant protection products on the market and\n repealing Council Directives 79/117/EEC and 91/414/EEC.
The\n recommendation for second reading (under the codecision procedure) had been\n tabled for consideration in plenary by Hiltrud BREYER (Greens/ALE,\n DE), on behalf of the Committee on the Environment, Public Health and Food\n Safety.
The amendments\n were the result of a compromise between Parliament and Council. The main\n amendments were as follows:
Legal bases: the compromise text stated that the legal bases were\n Articles 37(2) (agriculture), 95 (internal market) and 152(4)(b)\n (health).
Precautionary\n principle: the provisions are underpinned by the\n precautionary principle in order to ensure that active substances or products\n placed on the market do not adversely affect human health or the environment.\n Member States shall not be prevented from applying the precautionary\n principle where there is scientific uncertainty as to the risks with regard\n to human, animal health or the environment posed by the plant protection\n products to be authorised in their territory.
Active\n substances: Members dropped the definition of\n active substances that Parliament had proposed at 1st reading. The compromise\n text states that where an active substance is necessary to control a serious\n danger to plant health which cannot be contained by other available means\n including non-chemical methods, such active substance may be approved for a\n time limited period necessary to control that serious danger but not\n exceeding five years even if it does not satisfy the approval criteria.\n Members States may authorise plant protection products containing active\n substances approved in accordance with this derogation only when it is\n necessary to control that serious danger to plant health in their territory.\n At the same time, they shall elaborate a phasing out plan on how to control\n the serious danger by other means, including non-chemical methods, and shall\n forthwith transmit it to the Commission.
CMR and\n endocrine disruptors: with regard to the\n derogation from the approval criteria for active substances, the text\n provides that the derogation shall not apply to active substances which are\n or have to be classified in accordance with Directive 67/548/EEC, as\n carcinogenic category 1, carcinogenic category 2 without a threshold, or\n toxic for reproduction category An active substance must not have an inherent\n capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects.\n Those products that are affected will only be banned once their current\n approvals come up for renewal.
Zoning\n system: Parliament accepted that the three-zones\n division should be maintained.
Residents: residents should be taken into account for the authorisation of\n plant protection products
Honeybees: An active substance, safener or synergist shall be approved only\n if it is established that it will result in a negligible exposure of\n honeybees, or that there are no unacceptable acute or chronic effects on\n colony survival and development, taking into account effects on honeybee\n larvae and honeybee behaviour.
Application: assessment of an application may be performed by a number of\n Member States together under a co-rapporteur system. Scientific peer-reviewed\n open literature, as determined by the Authority, on the active substance and\n its relevant metabolites dealing with side-effects on health, the environment\n and non-target species and published within the last ten years before the date\n of dossier submission shall be added by the applicant to the dossier.
Animal\n testing: the summary dossier must include for\n each test or study involving vertebrate animals, a justification of the steps\n taken to avoid animal testing and duplicative testing on vertebrate animals.\n Furthermore, the Commission's work programme must include measures to\n minimise animal testing, in particular the use of non-animal test methods and\n intelligent testing strategies.
Testing on\n vertebrate animals: this may be undertaken only\n where no other methods are available. Repetition of tests and studies\n involving vertebrates shall be avoided. Seven years after entry into force of\n the regulation, the Commission shall report on the effects of the provisions\n concerning data protection of tests and studies involving vertebrate animals.
Comitology: the regulatory procedure with scrutiny will apply to harmonised\n methods to determine the nature and quantity of active substances, safeners\n and synergists as well as relevant impurities and coformulants. It will also\n apply to detailed rules for the maximum quantities of plant protection\n products which may be released during experiments.
Minor uses: 2 years after entry into force of the legislation, the Commission\n shall present a report to the European Parliament and the Council on the\n establishment of a European fund for minor uses, accompanied, if appropriate,\n by a legislative proposal.
Advertising: Member States may prohibit or restrict the advertising of plant\n protection products in certain media subject to Community law.
Record-keeping: records must be kept for at least five years. Professional users\n of plant protection products shall keep records of the plant protection\n products they use, containing the name of the plant protection product, the\n time and the dose of application, the area and the crop where the plant\n protection product was used, for at least three years. 3 years after entry\n into force of the legislation, the Commission shall present a report on costs\n and benefits of the traceability of the information from users to retailers\n concerning the plant protection products' applications on agricultural\n products accompanied, if necessary, with appropriate legislative\n proposals. Producers of plant protection products shall undertake\n post-authorisation monitoring on request of the competent authorities and\n notify the competent authorities of the relevant results.
\nPURPOSE: to ensure a high level of protection of both human and\n animal health and the environment and to improve the functioning of the\n internal market through the harmonisation of the rules on the placing on the\n market of plant protection products, while improving agricultural production.
LEGISLATIVE\n ACT: Regulation (EC) No 1107/2009 of the European Parliament and of the Council\n concerning the placing of plant protection products on the market and\n repealing Council Directives 79/117/EEC and 91/414/EEC.
CONTENT:\n following an agreement reached at second reading of the codecision procedure,\n the Council adopted a regulation concerning the placing of plant protection\n products on the market.
The proposed\n Regulation would replace the existing legislation on the placing on the\n market of plant protection products (Council Directive 91/414/EEC),\n thoroughly revising the procedures for the safety evaluation of active\n substances and plant protection products. However, it keeps the two steps\n procedure of the Directive:
For\n simplification, it would also repeal Council Directive 79/117/EEC prohibiting\n the placing on the market and use of plant protection products containing\n certain active substances. The main aim of the proposal is to maintain a high\n level of protection for humans, animals and the environment; to reduce the\n administrative burdens of the present approval and authorisation procedures\n and to achieve a higher level of harmonization.
This proposal\n should be seen as part of a package together with the Thematic\n Strategy on the Sustainable Use of Pesticides and the proposal for a\n Framework Directive, which fills a legal gap in the use phase of pesticides,\n as well as a proposal\n for a Regulation on the collection of statistics regarding the placing on\n the market and the use of plant protection products.
The main\n elements of this new Regulation are as follows:
Subject\n matter and purpose: this Regulation lays down\n rules for the authorisation of plant protection products in commercial form\n and for their placing on the market, use and control within the Community. It\n lays down both rules for the approval of active substances, safeners and\n synergists, which plant protection products contain or consist of, and rules\n for adjuvants and co-formulants.
The purpose of\n this Regulation is to ensure a high level of protection of both human and\n animal health and the environment and to improve the functioning of the\n internal market through the harmonisation of the rules on the placing on the\n market of plant protection products, while improving agricultural production.\n The provisions of this Regulation are underpinned by the precautionary\n principle in order to ensure that active substances or products placed on the\n market do not adversely affect human or animal health or the environment. In\n particular, Member States shall not be prevented from applying the precautionary\n principle where there is scientific uncertainty as to the risks with\n regard to human or animal health or the environment posed by the plant\n protection products to be authorised in their territory.
Criteria: strict cut-off criteria for the approval at EU level of active\n substances are laid down in the new Regulation which will ban from the market\n the most toxic substances currently available. However, in exceptional cases,\n temporary derogations from these criteria could be granted in case of a\n serious threat to plant health. Under the new Regulation, a substance shall\n only be approved if, inter alia:
Derogations: where on the basis of documented evidence included in the\n application an active substance is necessary to control a serious danger to\n plant health which cannot be contained by other available means including\n non-chemical methods, such active substance may be approved for a limited\n period necessary to control that serious danger but not exceeding five years,\n provided that the use of the active substance is subject to risk mitigation\n measures to ensure that exposure of humans and the environment is minimised.\n This derogation shall not apply to active substances which are or have to be\n classified as carcinogenic category 1A, carcinogenic category 1B without a\n threshold, or toxic for reproduction category 1A.
Member States\n may authorise plant protection products containing active substances approved\n in accordance with this derogation only when it is necessary to control that\n serious danger to plant health in their territory. At the same time, they\n shall draw up a phasing out plan concerning the control of the serious danger\n by other means, including non-chemical methods, and shall without delay\n transmit that plan to the Commission.
Procedures: the procedures for the approval of active substances and\n authorisation of plant protection products have been harmonised and\n simplified, deadlines have been tightened, and the roles of the Member\n States, the Commission, and European Food Safety Authority (EFSA) have been\n clarified. First approval shall be for a period not exceeding 10 years. An\n application for the approval of an active substance or for an amendment to\n the conditions of an approval shall be submitted by the producer of the\n active substance to a Member State, (the rapporteur Member State), together\n with a summary and a complete dossier or a scientifically reasoned\n justification for not providing certain parts of those dossiers, demonstrating\n that the active substance fulfils the approval criteria provided for in this\n Regulation. A joint application may be submitted by an association of\n producers designated by the producers for the purpose of compliance with this\n Regulation. Scientific peer-reviewed open literature, as determined by the\n Authority, on the active substance and its relevant metabolites dealing with\n side-effects on health, the environment and non-target species and published\n within the last 10 years before the date of submission of the dossier shall\n be added by the applicant to the dossier. Member States should, within a\n delay of 120 days, decided on the mutual recognition. The renewal of the\n approval should be for a period not exceeding 15 years.
Regular\n examinations of products: under this Regulation\n Member States should regularly examine plant protection products containing\n substances which pose a high risk for human health or the environment with\n the aim of replacing them by plant protection products containing active substances\n which require less risk mitigation or by non-chemical control or prevention\n methods. In addition, incentives should be given for the placing on the\n market of low-risk plant protection products.
Definition\n of zones for the authorisation of plant protection products: the Regulation also sets out a system of three geographical\n zones (north, centre and south) for the mutual recognition of plant\n protection products which will increase the availability of plant protection\n products throughout the EU and reduce the workload for Member States.\n Nevertheless Member States will have the possibility to limit or reject the\n authorisations granted in another Member State in certain environmental or\n agricultural circumstances.
Animal\n testing: the Regulation stipulates that animal\n testing for the purposes of this Regulation should be minimised and tests on\n vertebrates should be undertaken as a last resort. Duplicative testing and\n duplication of tests and studies on vertebrates should be prohibited.
It should also\n be noted that an active substance, safener or synergist shall be approved\n only if it is established following an appropriate risk assessment on the\n basis of Community or internationally agreed test guidelines, that the use\n under the proposed conditions of use of plant protection products containing\n this active substance, safener or synergist: (i) will result in a negligible\n exposure of honeybees, or (ii) has no unacceptable acute or chronic\n effects on colony survival and development, taking into account effects on\n honeybee larvae and honeybee behaviour.
Candidates\n for substitution: an active substance complying\n with the criteria shall be approved, for a period not exceeding seven years,\n as a candidate for substitution if it meets one or more of the additional\n criteria laid down in the regulation. By way of derogation, the approval may\n be renewed once or more for periods not exceeding seven years.
Other\n provisions: the new regulation also includes, in\n particular, rules on data protection, classification, packaging and\n labelling, advertising, record-keeping, parallel trade and on seeds treated\n with plant protection products.
Review\n clause: by 14 December 2014, the Commission shall\n present a report to the European Parliament and the Council on the\n functioning of mutual recognition of authorisations and in particular on the the\n division of the Community into three zones and on the application of the\n criteria for the approval of active substances, safeners and synergists as\n set out in Annex II and the impact thereof on the diversification and\n competitiveness of agriculture as well as on human health and on the\n environment. The report may be accompanied, if necessary, by the appropriate\n legislative proposals to amend those provisions.
By 14 June\n 2011, the Commission shall adopt the following: (a) a Regulation containing\n the list of the active substances already approved at the moment of adoption\n of that Regulation; (b) a Regulation on data requirements for active\n substances; (c) a Regulation on data requirements for plant protection\n products; (d) a Regulation on uniform principles for risk assessment for\n plant protection products; (e) a Regulation containing the requirements of\n the labelling of plant protection products.
ENTRY INTO\n FORCE: 14.12.2009.
APPLICATION:\n from 14.06.2011.
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