Activities of Ashley FOX related to 2009/0076(COD)
Plenary speeches (1)
Placing on the market and use of biocidal products (debate)
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products
Amendments (14)
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 126 #
Proposal for a regulation
Article 33 – paragraph 1 – point b a (new)
Article 33 – paragraph 1 – point b a (new)
ba) biocidal products designed to be used by consumers in domestic settings, or by professional users, according to conditions and instructions of use which are similar within the European Union, and which meet the criteria listed in Article 33 a.
Amendment 127 #
Proposal for a regulation
Article 33 a (new)
Article 33 a (new)
In accordance with point (ba) of Article 33(1), a product shall be considered a biocidal product with similar use conditions if all of the following criteria are met: (i) it has similar conditions of use across the European Union, according to use instructions; (ii) it is already placed or is intended to be placed on the market in at least [...] Member States within two years of the authorisation being granted; (iii) it does not require personal protective equipment in conditions of use according to Annex VI, and when used under normal and reasonably foreseeable conditions of use, meets the requirements in Article 16(1). In order to define or adapt the number of Member States referred to in point (ii), the Commission shall adopt delegated acts in accordance with Article [....].
Amendment 132 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 2
Article 46 – paragraph 1 – subparagraph 2
In the case of scientific research and development, including product and process-oriented 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.
Amendment 133 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 2
Article 46 – paragraph 1 – subparagraph 2
Amendment 134 #
Proposal for a regulation
Article 46 – paragraph 2
Article 46 – paragraph 2
2. An unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve, or result in, release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisatpositive opinion for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions. The competent authority shall without delay inform the Commission and other competent authorities about the issuedmay impose further conditions. In the absence of an opinion from the competent authority within 30 days of the notification of the information required in paragraph 1, the biocidal product or active substance may be placed on the market for the purpose of the naotional authorisationfied experiment or test.
Amendment 135 #
Proposal for a regulation
Article 46 – paragraph 3 – subparagraph 1
Article 46 – paragraph 3 – subparagraph 1
3. Where any experiment or test takes place in a Member State other than the Member State where placing on the market of the biocidal product occurs, the applicant shall obtain experiment or test authorisation fromnotify the competent authority of the Member State in the territory of which the experiments or tests are to be conducted. The applicant shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data and quantities supplied, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. The applicant shall, if requested, make this information available to the competent authority.
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 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