Activities of Miroslav OUZKÝ related to 2009/0076(COD)
Plenary speeches (1)
Placing on the market and use of biocidal products (debate)
Amendments (16)
Amendment 118 #
Council position
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘'biocidal product’' means any substance, mixture or article, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention, except in the case of articles, where primary intention is required, of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action;
Amendment 172 #
Council position
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. TheAn applicantion for an authorisation shall submitcontain the following documents together with the application:
Amendment 173 #
Council position
Article 19 – paragraph 1 – point a – point i
Article 19 – paragraph 1 – point a – point i
(i) a dossier or a letter of access to a dossier for the biocidal product satisfying the requirements set out in Annex III;
Amendment 174 #
Council position
Article 19 – paragraph 1 – point a – point ii a (new)
Article 19 – paragraph 1 – point a – point ii a (new)
(ii a) a proposal for the terms and conditions of the authorisation referred to in Article 21 (1);
Amendment 176 #
Council position
Article 19 – paragraph 1 – point a – point iii a (new)
Article 19 – paragraph 1 – point a – point iii a (new)
(iii a) a dossier or a letter of access to a dossier satisfying the requirements set out in Annex II if the active substance is listed in category 6 of Annex I;
Amendment 177 #
Council position
Article 19 – paragraph 1 – point b – point i a (new)
Article 19 – paragraph 1 – point b – point i a (new)
(i a) a proposal for the terms and conditions of the authorisation referred to in Article 21 (1);
Amendment 189 #
Council position
Article 22 – paragraph 7
Article 22 – paragraph 7
7. Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, thate cancellation or amendment of the authorisation shall take effect five years after that decision. However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier datein accordance with the provisions of Chapter VIII.
Amendment 199 #
Council position
Article 30 – paragraph 3 – point a
Article 30 – paragraph 3 – point a
(a) a list to all relevant data that iwithout prejudice to Article 20 (1), all relevant data required under Article 19 that has generated since the initial authorisation or, as appropriate, previous renewal, or a letter of access to such data; and
Amendment 206 #
Council position
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The procedure shall be closed after all the Member States concerned have agreed on the summary of biocidal product characteristics together with the terms and conditions of the authorisation, and recorded their agreement in the Register for Biocidal Products.
Amendment 256 #
Council position
Article 57 – paragraph 1
Article 57 – paragraph 1
1. This Article shall apply exclusively to treated articles within the meaning of Article 3(1)(l) that are not biocidal products within the meaning of Article 3(1)(a). It shall not apply to treated articles where the sole treatment undertaken was the fumigation or disinfection of premises or containers used for storage or transport and where no residues are expected to remain from such treatment.
Amendment 265 #
Council position
Article 58 – paragraph 1 – introductory part
Article 58 – paragraph 1 – introductory part
1. Without prejudice to Articles 61 and 62, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:
Amendment 266 #
Council position
Article 58 – paragraph 1 – point a
Article 58 – paragraph 1 – point a
(a) the subsequent applicant has and submits a letter of access; or
Amendment 306 #
Council position
Article 79 – paragraph 3 – introductory part
Article 79 – paragraph 3 – introductory part
3. Both tThe implementing Regulation referred to in paragraph 1 and Member States' own rules concerning fees shall respect the following principles:
Amendment 307 #
Council position
Article 79 – paragraph 3 – point a
Article 79 – paragraph 3 – point a
(a) fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs, The level should also reflect the fact that (the funding of) the evaluation and authorisation procedure shall not be entirely financed by these fees;
Amendment 308 #
Council position
Article 79 – paragraph 3 – point c
Article 79 – paragraph 3 – point c
(c) the specific needs of SMEs shall be taken into account, as appropriatesmall and medium sized enterprises shall be taken into account, with respect to a fee payment system, as appropriate; this shall have no bearing on the responsibility of the relevant competent authority to carry out a careful assessment in accordance with the provisions of this Regulation;
Amendment 309 #
Council position
Article 79 – paragraph 3 – point f
Article 79 – paragraph 3 – point f
(f) as regards Member States' rules only, the deadlines for the payment of fees to competent authorities shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.