27 Amendments of Edit HERCZOG related to 2009/0076(COD)
Amendment 48 #
Proposal for a regulation
Recital 45
Recital 45
(45) In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trade of substantially identical biocidal products that are authorised in different Member States.
Amendment 84 #
Proposal for a regulation
Article 9 – paragraph 1 – point d
Article 9 – paragraph 1 – point d
Amendment 87 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
2. Application for authorisation shall be made by, or on behalf of, the person who shall belding the authorisation, who may or may not be the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Amendment 90 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 3 a (new)
Article 15 – paragraph 2 – subparagraph 3 a (new)
An applicant seeking authorisation for a group of products as part of a frame formulation may submit a single application for authorisation.
Amendment 121 #
Proposal for a regulation
Articolo 23 – paragraph 1
Articolo 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 125 #
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 126 #
Proposal for a regulation
Article 25 – paragraph 5 – subparagraph 1 a (new)
Article 25 – paragraph 5 – subparagraph 1 a (new)
In the event of mutual recognition, a single authorisation number shall be used in all Member States involved.
Amendment 127 #
Proposal for a regulation
Article 25 – paragraph 5 a (new)
Article 25 – paragraph 5 a (new)
5a. In the case of mutual recognition procedures, the Commission shall adopt implementing measures laying down the criteria and procedures for assigning a single authorisation number in all Member States concerned.
Amendment 128 #
Proposal for a regulation
Article 27 – paragraph 1 – subparagraph 2
Article 27 – paragraph 1 – subparagraph 2
Amendment 130 #
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 134 #
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 136 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2 a (new)
Article 29 – paragraph 2 – subparagraph 2 a (new)
Amendment 139 #
Proposal for a regulation
Article 33
Article 33
Amendment 140 #
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. The Community authorisation may be granted to the followingall categories of biocidal products:
Amendment 141 #
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
Amendment 145 #
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 146 #
Proposal for a regulation
Article 35 – paragraph 5
Article 35 – paragraph 5
Amendment 148 #
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 157 #
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 3
Article 44 – paragraph 1 – subparagraph 3
The application shall be accompanied by all the information necessary to demonstrate that the biocidal product is substantially identical to the reference product as defined in paragraph 3.
Amendment 158 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. A biocidal product shall be considered as substantially identical to the reference product if one ofall the following conditions isare met: a) the source of the active substances it contains is the same in terms of manufacturer and location of thit has been manufactured by the same company or one of its associate companies or under licence, following the same production plant; rocess; b) it is either the same or similar with regard to the non-specifications, the active substances present and the type of formulation; c) it is either the same or equivalent, as regards the co-formulants it contains and the format, materials and form of its packaging, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Amendment 163 #
Proposal for a regulation
Article 47 – paragraph 2 – point a
Article 47 – paragraph 2 – point a
(a) the name, using wherever possible common nomenclature (e.g. INCI), of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials, where relevant, and of all active substances which are intended to be released under normal or foreseeable conditions of use from the treated article or material, unless labelling requirements or alternative means to meet information requirements already exist under sector-specific legislation;
Amendment 165 #
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 167 #
Proposal for a regulation
Article 47 – paragraph 2 – point c
Article 47 – paragraph 2 – point c
Amendment 172 #
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
(d) only for treated articles and where relevant, any hazard statement or precautionary statement set out in the authorisation for the biocidal product.
Amendment 187 #
Proposal for a regulation
Article 55 – paragraph 2 – subparagraph 1
Article 55 – paragraph 2 – subparagraph 1
2. Disclosure of the following information shall be deemed to undermine the protection of the commercial interests of the concerned person and may not be disclosed publicly: a) details of the full composition of a biocidal product; b) the precise use, function or application of a substance or mixture; c) the precise tonnage of the substance or mixture manufactured or placed on the market; d) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product; (da) manufacturers of the active substances (names and addresses including location of manufacturing sites); (db) the location of a biocidal product's manufacturing site; (dc) the date of issue of an authorisation and the expiry date; (dd) doses and instructions for use.
Amendment 191 #
Proposal for a regulation
Article 58 – paragraph 2 – point e
Article 58 – paragraph 2 – point e
e) directions for use and the dose rate, expressed in metric unita manner that is meaningful and comprehensible to users, for each use provided for under the terms of the authorisation;
Amendment 201 #
Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 3
Article 77 – paragraph 1 – subparagraph 3
During the work programme, the Commission shall decide pursuant to the procedure laid down in Article 72(4) that an active substance shall be included in Annex I of this Regulation and under which conditions, or, in cases where the requirements of Article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I of this Regulation. The decision shall specify the date on which the inclusion in Annex I becomes effective, which shall be two years after the decision.