22 Amendments of Anja WEISGERBER related to 2009/0076(COD)
Amendment 106 #
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, and treated articles and materials and food contact materials.
Amendment 109 #
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 111 #
Proposal for a regulation
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Amendment 136 #
Proposal for a regulation
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) 'placing on the market' means the first supply of a biocidal product for distribution or for use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;to third parties, whether in return for payment or free of charge, or the making available of a biocidal product to third parties. Importation shall be deemed to be placing on the market. No supply to third parties is involved, for example, when in the course of a commercial activity treated materials or products are individually manufactured and then incorporated by the manufacturer.
Amendment 137 #
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 for all active substances which are intended to be released under normal or foreseeable conditions of use from the treated article or material, unless labelling requirements or alternative means to meet information requirements already exist under sector- specific legislation.
Amendment 139 #
Proposal for a regulation
Article 3 – paragraph 1 – point k a (new)
Article 3 – paragraph 1 – point k a (new)
ka. 'External biocidal effect' means the effect of applications whereby the incorporated biocidal product is intended to be released under normal conditions of use which can reasonably be foreseen.
Amendment 139 #
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 140 #
Proposal for a regulation
Article 47 – paragraph 2 – point c
Article 47 – paragraph 2 – point c
Amendment 142 #
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 152 #
Proposal for a regulation
Article 82
Article 82
Amendment 227 #
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 be responsible for the initial placing on the market of a biocidal product in a particular Member State or in the Community.
Amendment 393 #
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. Treated materials or articles that incorporate one or more biocidal productactive substances shall not be placed on the market unless the biocidal productactive substance(s) used for treating the materials or articles are listed in Annex I (the positive list for active substances) and from a source supported by the named applicant listed alongside the Annex I inclusion for that active substance. authorised for this use in the Community or in at least one Member State.
Amendment 402 #
Proposal for a regulation
Article 47 – paragraph 2 – point b
Article 47 – paragraph 2 – point b
b) where relevant, the biocidal propertyies attributed to treated articles materials or products if the biocidal product is intended to be released under nor materialsl conditions of use which can reasonably be foreseen;
Amendment 407 #
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product if the biocidal product is intended to be released under normal conditions of use which can reasonably be foreseen.
Amendment 412 #
Proposal for a regulation
Article 47 – paragraph 2 – subparagraph 3
Article 47 – paragraph 2 – subparagraph 3
Where this is necessary because of the size or the function of the treated article or material, the labelling shall be printed on the packaging, on the instructions for use or on the warranty of the treated article or material. In the case of treated materials or articles which are not produced as part of a series, but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the relevant information with the customer.
Amendment 418 #
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. Where no such agreement is reached two months after the request was made according to Article 51(2), both the owner of the information and the prospective applicant shall without delay inform the Agency and the owner of the information thereof. Within two months of being informed about the failure to reach an agreement, the Agency shall give the prospective applicant the right to refer to the tests or studies involving tests on vertebrate animals. National courtsBoth the owner of the information and the prospective applicant will submit to legally binding abitration. The arbitration will be carried out under the rules of a recognised independent arbitration institute decided by the owner of the information after consulting with the prospective applicant. An arbitration shall be started and concluded promptly and in any event be concluded within 6 months of the parties informing the Agency of their failure to reach an agreement. An arbitration shall decide on the proportionate share of all the costs associated with the generation and use of the information that the prospective applicant shall pay to the data owner.
Amendment 433 #
Proposal for a regulation
Article 56 – paragraph 3 a (new)
Article 56 – paragraph 3 a (new)
3a. Public access shall be granted free of charge to an inventory containing details of biocidal products authorised pursuant to Article 16(3) and of the corresponding manufacturers.
Amendment 437 #
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. The description 'low-risk biocidal product' shall be reserved for products authorised pursuant to Article 16(3). In addition, the label must show clearly and indelibly the following information:
Amendment 442 #
Proposal for a regulation
Article 58 – paragraph 2 – point m a (new)
Article 58 – paragraph 2 – point m a (new)
(ma) where appropriate, the description 'low-risk biocidal product' for products authorised pursuant to Article 16(3).
Amendment 446 #
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. Advertising employing the description 'low-risk biocidal product' shall be permissible only for products authorised pursuant to Article 16(3).
Amendment 456 #
Proposal for a regulation
Article 70 – paragraph 2 – point e a (new)
Article 70 – paragraph 2 – point e a (new)
(ea) fees may not exceed EUR 45 000.
Amendment 473 #
Proposal for a regulation
Article 81
Article 81
By way of derogation from Article 47, treated articles and materials that incorporate biocidal products which are not authorised in the Community or in at least one Member State and which were available on the market on ... [OJ: insert the date referred to in the first subparagraph of Article 85] may, until the date of a decision granting authorisation to these biocidal products, continue to be placed on the market if the application for authorisation is submitted at the latest by 1 January 2017. In the case of a refusal to grant an authorisation to place a biocidal product on the market, treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six12 months after such decision. The deadline must be extended to take account of importers' business cycles. Traders order goods up to 18 months before they appear on the shelves. A 12-month deadline would guarantee importers the legal security they need.Or.deJustification