BETA

27 Amendments of Edit HERCZOG related to 2009/0076(COD)

Amendment 48 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 84 #
Proposal for a regulation
Article 9 – paragraph 1 – point d
(d) it contains a significant proportion of non-active isomers;deleted
2010/02/25
Committee: ITRE
Amendment 87 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 90 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 121 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 125 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 126 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 127 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 128 #
Proposal for a regulation
Article 27 – paragraph 1 – subparagraph 2
TAfter consulting the applicant, the Commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 72(3).
2010/02/25
Committee: ITRE
Amendment 130 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 134 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 136 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2 a (new)
The regulation should set out the time period for the resolution of disputes between Member States. Three months would seem to be appropriate timing time for the Commission to draw up a proposal for a decision on the refusal, or restriction, of authorisWithin three months of receiving the notification, the Commission shall make a proposal for a decision. Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion. Or. it Justification.
2010/02/25
Committee: ITRE
Amendment 139 #
Proposal for a regulation
Article 33
1. The Community authorisation may be granted to the following categories of biocidal products: (a) biocidal products containing one or more new active substances; (b) low-risk biocidal products. 2. Following the report of the Commission on the implementation of this Regulation referred to in Article 54(4) and in light of the experience gained with the Community authorisations, the Commission may add otherany categoriesy of biocidal products in paragraph 1 of this Article. Those measures, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).
2010/02/25
Committee: ITRE
Amendment 140 #
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
1. The Community authorisation may be granted to the followingall categories of biocidal products:
2010/02/25
Committee: ITRE
Amendment 141 #
Proposal for a regulation
Article 33 – paragraph 2
2. Following the report of the Commission on the implementation of this Regulation referred to in Article 54(4) and in light of the experience gained with the Community authorisations, the Commission may add other categories of biocidal products in paragraph 1 of this Article. Those measures, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).deleted
2010/02/25
Committee: ITRE
Amendment 145 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 146 #
Proposal for a regulation
Article 35 – paragraph 5
5. If the decision referred to in paragraph 4 refuses to grant a Community authorisation to a biocidal product because it does not fulfil the criteria for a low-risk biocidal product in accordance with Article 17, the applicant may apply, if relevant, for a Community authorisation in accordance with point (a) of Article 33(1) or a national authorisation in accordance with Chapter V.deleted
2010/02/25
Committee: ITRE
Amendment 148 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 157 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 158 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 163 #
Proposal for a regulation
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;
2010/02/25
Committee: ITRE
Amendment 165 #
Proposal for a regulation
Article 47 – paragraph 2 – point b
(b) where relevant, the biocidal property attributed to treated articles or materials;
2010/02/25
Committee: ITRE
Amendment 167 #
Proposal for a regulation
Article 47 – paragraph 2 – point c
(c) the authorisation number of all biocidal products that were used for the treatment or were incorporated in the articles or materials;deleted
2010/02/25
Committee: ITRE
Amendment 172 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 187 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE
Amendment 191 #
Proposal for a regulation
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;
2010/02/25
Committee: ITRE
Amendment 201 #
Proposal for a regulation
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.
2010/02/25
Committee: ITRE