98 Amendments of Aldo PATRICIELLO related to 2009/0076(COD)
Amendment 45 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) As the WHO Pesticide Evaluation Scheme (WHOPES) constitutes a system for effective testing and evaluation of the impact of insecticides on public health, compliance with the final recommendations approved under that scheme should be regarded as equivalent to the product authorisation required by this Regulation.
Amendment 46 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 47 #
Proposal for a regulation
Recital 24
Recital 24
(24) In order to facilitate access to the internal market and to avoid the additional costs and time involved in obtaining separate national authorisations in separate Member States, the Commission, taking into account the experience with the provisions on Community authorisations, may has decided to extend the scope of theintroduce a Community authorisation procedure to otherfor all biocidal products.
Amendment 49 #
Proposal for a regulation
Recital 48
Recital 48
(48) Applicants that have invested in supporting the inclusion of an active substance in Annex I or in the authorisation of a biocidal product in accordance with the provisions of this Regulation and/or those of Directive 98/8/EC should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants.
Amendment 50 #
Proposal for a regulation
Recital 49
Recital 49
(49) In view of ensuring that all proprietary information submitted in support of an inclusion of an active substance in Annex I or an authorisation of a biocidal product is protected from the moment of its submission and to prevent situations where some information is without protection, the provision on information protection periods should also apply to information submitted for the purposes of Directive 98/8/EC.
Amendment 52 #
Proposal for a regulation
Recital 61
Recital 61
(61) In particular, the Commission should be empowered to adopt measures to decide on the application to include the active substance in Annex I or to renew or review the inclusion, to specify the procedures related to the renewal and review of an inclusion of an active substance in Annex I, to extend the provisions on Community authorisations to other categories of biocidal productsI, to specify the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation, including a dispute settlement mechanism, to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted, to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competent authorities and the Agency, to adapt the Annexes to scientific and technical progress, to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme and to extend the duration of the work programme for a determined period. Since those measures are of general scope and are designed to amend non- essential elements of this Regulation, inter alia, by supplementing this Regulation with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 53 #
Proposal for a regulation
Recital 66
Recital 66
(66) Taking into consideration that some products were not previously covered by the Community legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances, treated articles and materials and food contact materials.
Amendment 54 #
Proposal for a regulation
Article 2 – paragraph 2 – point p a (new)
Article 2 – paragraph 2 – point p a (new)
(pa) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC.
Amendment 55 #
Proposal for a regulation
Article 2 – paragraph 8 a (new)
Article 2 – paragraph 8 a (new)
(8a) Biocidal products for Product Type 18 manufactured in accordance with the Final Recommendations approved under the WHO Pesticide Evaluation Scheme (WHOPES) shall be considered to be authorised within the meaning of Chapter VII of this Regulation. Articles 38 and 57 shall apply accordingly.
Amendment 58 #
Proposal for a regulation
Article 3 – paragraph 1 – point n
Article 3 – paragraph 1 – point n
(n) 'authorisation' means national authorisation or Community authorisation or primary authorisation or duplicate authorisation or additional authorisation;
Amendment 59 #
Proposal for a regulation
Article 3 – paragraph 1 – point n a (new)
Article 3 – paragraph 1 – point n a (new)
(na) 'duplicate authorisation' means an administrative act by which, for the benefit of the holder of a primary authorisation, a Member State or the Commission authorises the placing on the market and the use of the same biocidal product under a different name;
Amendment 60 #
Proposal for a regulation
Article 3 – paragraph 1 – point n b (new)
Article 3 – paragraph 1 – point n b (new)
(nb) 'additional authorisation' means an administrative act by which a Member State or the Commission authorises the placing on the market and the use, under a different name, of a biocidal product based on a primary authorisation and on approval by the holder of the primary authorisation;
Amendment 63 #
Proposal for a regulation
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Amendment 64 #
Proposal for a regulation
Article 3 – paragraph 1 – point u a (new)
Article 3 – paragraph 1 – point u a (new)
Amendment 65 #
Proposal for a regulation
Article 3 – paragraph 1 – point u b (new)
Article 3 – paragraph 1 – point u b (new)
(ub) 'limited variation' means a variation to an existing authorisation which is not deemed to be an administrative variation, in that it requires a fresh partial assessment of the risk to public health or the environment and/or of the efficacy of the product. The variation must not aggravate the level of risk to public health or the environment or the efficacy of the product.
Amendment 66 #
Proposal for a regulation
Article 3 – paragraph 1 – point u c (new)
Article 3 – paragraph 1 – point u c (new)
(uc) 'major (or substantial) variation' means a variation to an existing authorisation which is not deemed to be an administrative variation or a limited variation.
Amendment 67 #
Proposal for a regulation
Article 3 – paragraph 1 – point u d (new)
Article 3 – paragraph 1 – point u d (new)
(ud) 'manufacturer' means: - with reference to an active substance produced within Community territory or placed on the market, the person who manufactures that active substance or a person resident in the Community who is designated by the manufacturer as his sole representative for the purposes of the present Regulation, - with reference to an active substance produced outside Community territory, the person resident in the Community who is designated by the manufacturer of the active substance as his sole representative for the purposes of the present Regulation or, if no such person has been designated, the person who imports the active substance in question into the Community, - with reference to an active substance produced outside Community territory, the person resident in the Community who is designated by the manufacturer of the active substance as his sole representative for the purposes of the present Regulation or, if no such person has been designated, the person who imports the biocidal product in question into the Community,
Amendment 68 #
Proposal for a regulation
Article 3 a (new – first Article of Chapter II)
Article 3 a (new – first Article of Chapter II)
Article 3a 1. Any prospective applicant for inclusion of an active substance in Annex I shall inquire of the Agency whether - an application for inclusion of the same substance in Annex I has already been submitted or - the same substance is included in Annex I or - the same substance is registered pursuant to Regulation (EC) No 1907/2006. 2. Any prospective applicant shall forward the following information to the Agency with the application: (a) its identity as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006, with the exception of Nos 1.2 and 1.3; (b) the identity of the substance as specified in section 2 of Annex VI to Regulation (EC) No 1907/2006; (c) which requests for information will require new studies involving vertebrate animals which it will have to perform; (d) which requests for information will require other new studies which it will have to perform. 3. If the same substance is not included in Annex I or not registered pursuant to Regulation (EC) No 1907/2006, the Agency shall inform the prospective applicant accordingly. 4. If an application for inclusion of the same active substance in Annex I has already been submitted; if the same active substance is already included in Annex I or if it has been registered pursuant to Regulation (EC) No 1907/2006, the Agency shall inform the prospective applicant, without delay, of the name and address of the previous applicants and registrants and the study summaries or robust study summaries of the information, as the case may be, already supplied. 5. The Agency shall at the same time inform the previous applicant or registrant of the name and address of the prospective applicant for inclusion in Annex I. The available studies of vertebrate animals shall be shared with the prospective applicant in accordance with Chapter XI of this Regulation.
Amendment 69 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. An active substance shall be included in Annex I for an initial period not exceeding 10 years if at least one of the biocidal products containing that active substance fulfils the conditions laid down in point (b) of Article 16(1).
Amendment 70 #
Proposal for a regulation
Article 4 – paragraph 3 - introductory part
Article 4 – paragraph 3 - introductory part
3. An active substance and a statement of the reference source for the determination of technical equivalence shall, where appropriate, be included in Annex I together with any of the following conditions:
Amendment 71 #
Proposal for a regulation
Article 4 – paragraph 3 – point f a (new)
Article 4 – paragraph 3 – point f a (new)
(fa) indication of the chemical identity as regards stereoisomers.
Amendment 76 #
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) a dossier for the active substance satisfying the requirements set out in Annex II or a letter of access;
Amendment 77 #
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) a dossier or a letter of access for at least one representative biocidal product that contains the active substance satisfying the requirements set out in Annex III.
Amendment 78 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 a (new)
Article 7 – paragraph 1 – subparagraph 1 a (new)
The Agency shall assign a reference number to each application, which shall be used for all correspondence concerning the application until the substance is included in Annex I, and a submission date, which shall be the date of receipt by the Agency.
Amendment 79 #
Proposal for a regulation
Article 7 – paragraph 3 – introductory part
Article 7 – paragraph 3 – introductory part
Within two monthhree weeks after the receipt of an application, the Agency shall validate the application if it complies with the following requirements:
Amendment 80 #
Proposal for a regulation
Article 7 – paragraph 4 a (new)
Article 7 – paragraph 4 a (new)
4a. Within two months after the receipt of an application, the Agency shall register each part of the information in the dossier with a unique identifying code.
Amendment 83 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. An active substance fulfilling at least one of the following criteria shall be considered a candidate for substitution in accordance with the procedure referred to in paragraph 2: (a) its acceptable daily intake, acute reference dose or acceptablsubstances which are operator exposure level is significantly lower than those of the majority of the active substances included in Annex I for the same product type; (b) it meets two of the criteria to be considered as a persistent, bio- accumulative and toxic substance assistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of Regulation (EC) No 1907/2006; (cb) there are reasons for concern linked to the nature of the critical effects, in particular developmental neurotoxic or immunotoxic effects, which, in combination with the use patterns, amount to use that could still cause concern, even with very restrictive risk management measures; (d) it contains a significant proportion of non-active isomers; (e) it is classified orsubstances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of Regulation (EC) No 1907/2006; (c) substances which meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, muta carcinogens, category 1A or 1B mutagens or toxic for reproduction category 1A or 1B; (fd) it is considered to havesubstances – such as those with endocrine disrupting properties that may cause adverse effect on humans on the basis of the assessment of Community or internationally agreed test guidelines or other available dataor persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties which do not comply with the criteria referred to in point (b) or (c) – for which scientific evidence exists of probable serious effects on public health or the environment giving rise to a level of concern equivalent to that applicable to the substances referred to in point (b) or (c).
Amendment 85 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. When preparing an opinion on the inclusion or renewal of the inclusion of an active substance in Annex I, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and, if exposure is not adequately controlled, bearing in mind the intrinsic hazards of the substance, shall address the matter in its opinion.
Amendment 88 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 2
Article 15 – paragraph 2 – subparagraph 2
Amendment 89 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 3
Article 15 – paragraph 2 – subparagraph 3
Application for Community authorisation shall be submitted to the Agency. The applicant may, in agreement with a Member State, have his application validated by that Member State and must identify the evaluating competent authority in the application itself, as laid down in Article 22.
Amendment 93 #
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
a) the active substances included therein are listed in Annex I, a registration number is assigned to them in accordance with Article 8, paragraph 5a, and any conditions included in that Annex together with those active substances are complied with;
Amendment 94 #
Proposal for a regulation
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
c) the naturechemical identity, the quantity and the technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;
Amendment 95 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 2 a (new)
Article 16 – paragraph 2 – subparagraph 2 a (new)
The evaluation of the compliance of the biocidal products with the criteria set out in point (b) of paragraph 1 should be based as far as possible on existing information on the substances of concern contained in the biocidal product in order to keep tests on animals to a minimum. In particular, use should be made of the provisions of Directive 1999/45/EC or Regulation (EC) No 1272/2008 on identifying the danger posed by biocidal products and consequent risk assessment.
Amendment 96 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraphs 2a and 2 b (new)
Article 16 – paragraph 2 – subparagraphs 2a and 2 b (new)
The evaluation of the compliance of the biocidal products with the criteria set out in point (b) of paragraph 1 should be based as far as possible on existing information on the substances of concern contained in the biocidal product in order to keep tests on animals to a minimum. In particular, use should be made of the provisions of Directive 1999/45/EC or Regulation (EC) No 1272/2008 on identifying the danger posed by biocidal products and consequent risk evaluation. The evaluation of the compliance of the biocidal product with the criteria set out in point (b) and the requirements set out in point (c) of paragraph 1 shall not take into account a substance contained in the biocidal product if it is present in a preparation at a concentration lower than any of the following: (a) the applicable concentrations laid down in Article 3(3) of Directive 1999/45/EC; (b) the concentration limit values given in Annex I to Directive 67/548/EEC; (c) the concentration limit values given in Part B of Annex II to Directive 1999/45/EC; (d) the concentration limit values given in Part B of Annex III to Directive 1999/45/EC; (e) the concentration limit given in an agreed entry in the classification and labelling inventory established under Title V of Regulation (EC) No 1272/2008; (f) 0.1% weight by weight (w/w), if the substance meets the criteria in Annex XIII to Regulation (EC) No 1907/2006.
Amendment 97 #
Proposal for a regulation
Article 16 – paragraph 6
Article 16 – paragraph 6
6. In the case of a frame formulation, a reduction in the percentagethe following variations are permitted in respect of one or more reference biocidal products: (a) elimination of thean active substance in therespect of a reference biocidal product may be allowed, and/or an alterawith at least two active substances; (b) reduction in the percentage composiof the active substances; (c) elimination of one or more non-active substances, and/or the replacement of one or more non-active substances by others presenting the same or lower risk; (d) variation in the percentage composition of one or more non-active substances; (e) replacement of one or more non-active substances.
Amendment 98 #
Proposal for a regulation
Article 16 – paragraph 6 a (new)
Article 16 – paragraph 6 a (new)
6a. In accordance with the procedure laid down in Article 72(2), the Commission shall provide scientific and technical guidance for the authorisation of products, particularly as regards uniform requirements for data, evaluation procedures and decisions by the Member States.
Amendment 100 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The applicant for an primary authorisation shall submit the following documents together with the application:
Amendment 101 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The application for primary authorisation shall be accompanied by the fees payable under Article 70.
Amendment 102 #
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
3. The receiving competent authoritAgency may require that applications for a national authorisation be submitted in one or more of the official languages of the Member State where that competent authority is situated.
Amendment 103 #
Proposal for a regulation
Article 18 – paragraph 5 a (new)
Article 18 – paragraph 5 a (new)
5a. In accordance with the procedure laid down in Article 72(2), the Commission shall provide a standard technical and legal guide and, in particular, assistance with authorisation applications in accordance with Articles 18, 19 and 20, particularly for SME.
Amendment 104 #
Proposal for a regulation
Article 20 – paragraph 2 - point e
Article 20 – paragraph 2 - point e
e) qualitative and quantitative composition in terms of the active substances and non- active substances, taking into consideration the concentration limit values given in Article 16, in so far as knowledge of whichthese is essential for proper use of the biocidal product;
Amendment 105 #
Proposal for a regulation
Article 20 – paragraph 2 – point g
Article 20 – paragraph 2 – point g
g) manufacturers of the active substances (names and addresses including location of manufacturing sites) and registration number of the active substance, in accordance with Article 8(5a);
Amendment 106 #
Proposal for a regulation
Article 20 – paragraph 3 – point a
Article 20 – paragraph 3 – point a
a) the reference biocidal product within the group of products comprising the frame formulation that has the highest allowed concentration of the active substances;
Amendment 107 #
Proposal for a regulation
Article 20 – paragraph 3 – point b
Article 20 – paragraph 3 – point b
b) the permitted alteration of the composition of this reference biocidal product expressed in percentage of the non-active substances contained in the biocidal products which are considered to belong to that frame formulation;variations permitted in accordance with Article 16(6).
Amendment 108 #
Proposal for a regulation
Article 20 – paragraph 3 – point c
Article 20 – paragraph 3 – point c
Amendment 109 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. The receiving competent authority or, in the case of evaluation of an application for a Community authorisation, the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewalfor the renewal, in accordance with this regulation, of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1). A comparative assessment shall be required for all biocidal products having the same purpose when sufficient experience has been gained in their use and they have been in use for at least five years.
Amendment 111 #
Proposal for a regulation
Article 21 – paragraph 1 a (new)
Article 21 – paragraph 1 a (new)
1a. By way of derogation from paragraph 1, a comparative assessment shall not be required for biocidal products whose use has been shown to be safe.
Amendment 112 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application fora renewal of a Community authorisation, also to the Commission.
Amendment 115 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. The receiving competent authority or, in the case of a decision on an application for renewal of a Community authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met: (a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention methods already exists which presents significantly lower risk for human or animal health or the environment; (b) the biocidal product or non-chemical control or prevention method and which prove equally effective and involve no significant increase in the risks for any other parameter; (b) the biocidal products referred to in point (a) does not present significant economic or practical disadvantages; (c) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.
Amendment 117 #
Proposal for a regulation
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3a. The Commission shall adopt the measures and procedures required to define how a comparative assessment should be carried out for biocidal products in accordance with paragraph 3. These measures shall define the criteria and algorithms to be used for a comparative assessment so as to ensure uniform application throughout the Community.
Amendment 119 #
Proposal for a regulation
Article 21 a (new) – to be inserted at the end of Chapter IV
Article 21 a (new) – to be inserted at the end of Chapter IV
Amendment 120 #
Proposal for a regulation
Article 22
Article 22
Amendment 122 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. The receiving competent authority shall, within twelvesix months after the validation referred to in Article 22, decide on the application in accordance with Article 16.
Amendment 123 #
Proposal for a regulation
Article 23 – paragraph 2 a (new)
Article 23 – paragraph 2 a (new)
2a. If the ingredients contained in the biocidal product have already been registered for use in biocidal products in accordance with Regulation No 1907/2006, the evaluating competent authority shall not carry out a further assessment.
Amendment 124 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 1
Article 24 – paragraph 1 – subparagraph 1
1. The authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least eighteentwelve months before the expiry date of the authorisation.
Amendment 129 #
Proposal for a regulation
Article 27 – paragraph 1 – subparagraph 2
Article 27 – paragraph 1 – subparagraph 2
The Commission shall, after consultation with the applicant, adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 72(3).
Amendment 131 #
Proposal for a regulation
Article 27 – paragraph 1 – subparagraph 2 a (new)
Article 27 – paragraph 1 – subparagraph 2 a (new)
Within three months of receiving the notification, the Commission shall make a proposal for a decision. Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion.
Amendment 132 #
Proposal for a regulation
Article 28 – paragraph 9 – subparagraph 2
Article 28 – paragraph 9 – subparagraph 2
The Commission shall, after consultation with the applicant, adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 72(3).
Amendment 133 #
Proposal for a regulation
Article 28 – paragraph 9 – subparagraph 3 a (new)
Article 28 – paragraph 9 – subparagraph 3 a (new)
Within three months of receiving the notification, the Commission shall make a proposal for a decision. Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion.
Amendment 135 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2
Article 29 – paragraph 2 – subparagraph 2
The Commission shall, after consultation with the applicant, adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in Article 72(3). The competent authority of the concerned Member State shall without delay adopt all appropriate measures to comply with that decision.
Amendment 137 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2 a (new)
Article 29 – paragraph 2 – subparagraph 2 a (new)
Amendment 138 #
Proposal for a regulation
Article 33
Article 33
Amendment 142 #
Proposal for a regulation
Article 34
Article 34
Amendment 143 #
Proposal for a regulation
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
1a. Should the ingredients contained in the biocidal product have already been registered, in conformity with Regulation No 1907/2006, for use in biocidal products, the evaluating competent authority shall not duplicate that evaluation.
Amendment 144 #
Proposal for a regulation
Article 35 – paragraph 3 – subparagraph 1
Article 35 – paragraph 3 – subparagraph 1
3. Within ninthree months from the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.
Amendment 147 #
Proposal for a regulation
Article 35 – paragraph 5
Article 35 – paragraph 5
Amendment 149 #
Proposal for a regulation
Article 36 – paragraph 1 – subparagraph 1
Article 36 – paragraph 1 – subparagraph 1
1. The authorisation holder or his representative shall submit an application for renewal of a Community authorisation to the Agency at least 182 months before the expiry date of the authorisation.
Amendment 150 #
Proposal for a regulation
Chapter VIIa (new) – Article 37a (new)
Chapter VIIa (new) – Article 37a (new)
Amendment 151 #
Proposal for a regulation
Article 37b (new – second article in the new Chapter VIIa)
Article 37b (new – second article in the new Chapter VIIa)
Amendment 152 #
Proposal for a regulation
Article 38 – paragraph 1 – point c a (new)
Article 38 – paragraph 1 – point c a (new)
(ca) changes in the origin or composition of the active substance.
Amendment 153 #
Proposal for a regulation
Article 39 - paragraph 3 a (new)
Article 39 - paragraph 3 a (new)
3a. The cancellation or amendment of a primary authorisation shall apply to duplicate and additional authorisations based on that authorisation.
Amendment 154 #
Proposal for a regulation
Article 40 - paragraph 1
Article 40 - paragraph 1
The competent authority that has granted the nationalan authorisation or in case of Community authorisation, the Commission, shall cancel the authorisation at the request of its holder, who shall state the reasons for such request. If such a request concerns a duplicate or additional Community authorisation, it shall be submitted to the Agency.
Amendment 155 #
Proposal for a regulation
Article 41 - paragraph 2 a (new)
Article 41 - paragraph 2 a (new)
2a. The amendment of a primary authorisation at the request of the holder of the primary authorisation shall apply to duplicate and additional authorisations based on that authorisation.
Amendment 156 #
Proposal for a regulation
Article 42 – paragraph 1 a (new)
Article 42 – paragraph 1 a (new)
The criteria and procedures referred to in the first paragraph of this article shall be based, non-exclusively, on the following principles for which a simplified notification procedure has been requested: (a) administrative changes to the authorisation; (b) changes to the biocidal product within the range permitted under an existing authorised frame formulation; (c) placing on the market of a new biocidal product within the limits of an existing authorised frame formulation; (d) changes in a biocidal product which do not adversely alter the level of the risk or efficacy of the product.
Amendment 161 #
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – paragraph 1
1. By way of derogation from Article 15, an experiment or a test for the purposes of research or development, including product- and process-oriented research and development activities, involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product may only take place in the case of scientific research and development or in the case of product and process-oriented research and development, and under the conditions laid down in the second and third subparagraphs. In the case of scientific research and development, the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start. The person shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, and quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. The persons concerned shall, if requested, make this information available to the competent authority. In the case of product and process- oriented research and development, the person who intends to carry out the experiment or the test shall, prior to the placing of the biocidal product or the active substance on the market, notify the information required in the second subparagraph to the competent authority of the Member State where the placing on the market occurs.
Amendment 164 #
Proposal for a regulation
Article 47 – paragraph 2 – point a
Article 47 – paragraph 2 – point a
a) the name, using wherever possible a common nomenclature (e.g. INCI), of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials where relevant, and of all active substances intended to be released by the article or material treated in normal or foreseeable conditions of use, unless this is already required under labelling rules or alternative ways of satisfying information requirements already existing in specific sectoral legislation;
Amendment 166 #
Proposal for a regulation
Article 47 – paragraph 2 – point b
Article 47 – paragraph 2 – point b
b) where relevant, the biocidal property attributed to treated articles or materials;
Amendment 168 #
Amendment 173 #
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
d) solely in the case of treated articles and where appropriate, any hazard statement or precautionary statement set out in the authorisation for the biocidal product.
Amendment 176 #
Proposal for a regulation
Article 48 – paragraph 1 – point a
Article 48 – paragraph 1 – point a
a) the subsequent applicant has written agreement in the form of a letter of access from the first applicant that he can use that informationin accordance with the requirements of Article 50,
Amendment 177 #
Proposal for a regulation
Article 48 – paragraph 1 – point b a (new)
Article 48 – paragraph 1 – point b a (new)
(ba) the subsequent applicant is also an owner of the data.
Amendment 178 #
Proposal for a regulation
Article 48 – paragraph 4
Article 48 – paragraph 4
4. TEvery element of information in the list referred to in paragraph 2, identified by a unique code, shall be entered by the Agency in the Biocides Data Sharing Register, including all the identifying details and linked to the identity of the first applicant and data owner(s).
Amendment 180 #
Proposal for a regulation
Article 49 – paragraph 4
Article 49 – paragraph 4
Amendment 188 #
Proposal for a regulation
Articolo 55 – paragrafo 3
Articolo 55 – paragrafo 3
3. Any person submitting information related to an active substance or a biocidal product to the Agency or a competent authority for the purposes of this Regulation can request that the information in Article 56(2) shall not be made available including a justification as to why the disclosure of the information could be harmful for his or any other concerned party's commercial interests.
Amendment 189 #
Proposal for a regulation
Article 56 – paragraph 2 – point e
Article 56 – paragraph 2 – point e
Amendment 190 #
Proposal for a regulation
Article 58 – paragraph 2 – introductory part
Article 58 – paragraph 2 – introductory part
2. Labels shall not be misleading and, in any case, shall not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or similar indications. In addition, the label must show clearly and indelibly the following information:
Amendment 195 #
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
3. Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment. In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar indication.
Amendment 196 #
Proposal for a regulation
Article 70 – paragraph 2 – point a
Article 70 – paragraph 2 – point a
a) a reduced fee shall be set for small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises; this in no way alters the responsibility of the evaluating competent authority for carrying out an accurate evaluation within the meaning of the Regulation;
Amendment 197 #
Proposal for a regulation
Article 70 – paragraph 2 – point d
Article 70 – paragraph 2 – point d
d) an annualthe fee shall be applied only when it is actually necessary and the structure and amount of the fees shall be paid by persons placing biocidal producttake account of the work required by this Regulation to be carried out by the Agency and the competent authorities and shall be fixed at such level as to ensure that the revenue derived from the fees when combined with other sources onf the market; and Agency's revenue pursuant to this Regulation is sufficient to cover the cost of the services delivered.
Amendment 198 #
Proposal for a regulation
Article 70 – paragraph 2 – point e
Article 70 – paragraph 2 – point e
Amendment 199 #
Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 1
Article 77 – paragraph 1 – subparagraph 1
1. The Commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC and achieve it by 14 May31 December 20148. The Commission may adopt implementing rules to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).
Amendment 200 #
Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 3
Article 77 – paragraph 1 – subparagraph 3
Amendment 202 #
Proposal for a regulation
Article 77 – paragraph 3 – subparagraph 3
Article 77 – paragraph 3 – subparagraph 3
Biocidal products, for which an application for a product authorisation has not been submitted in accordance with the second subparagraph, shall no longer be placed on the market with effect from six months after the date on which the inclusion becomes effective. Disposal, storage and use of existing stocks of biocidal products for which an application for authorisation has not been submitted in accordance with the second subparagraph are allowed until eighteensix months after the date on which the inclusion becomes effective.
Amendment 203 #
Proposal for a regulation
Article 82
Article 82
Amendment 204 #
Proposal for a regulation
Article 83 – paragraph -1 (new)
Article 83 – paragraph -1 (new)
From 1 January 2014 all manufacturers of an existing active substance placed on the market for use in biocidal products shall submit to the Agency a request to include the substance in Annex I. Competent authorities shall carry out official controls in accordance with Article 54(1).
Amendment 205 #
Proposal for a regulation
Article 83 – paragraph 2 a (new)
Article 83 – paragraph 2 a (new)
Competent authorities shall take the necessary measures in accordance with Article 54(2).
Amendment 206 #
Proposal for a regulation
Annex III – Title 1 – point 2.2
Annex III – Title 1 – point 2.2
2.2. Detailed quantitative and qualitative information on the composition of the biocidal product, e.g. active substance(s), impurities, adjutants, inert components, taking into account the concentration limits laid down in Article 16
Amendment 207 #
Proposal for a regulation
Annex III - paragraph 1 a (new)
Annex III - paragraph 1 a (new)
1a. The information shall, as far as possible, be taken from existing data in order to minimise animal tests. The provisions of Directive 1999/45/EC and Regulation (EC) No 1272/2008 shall, in particular, be applied.