12 Amendments of Dagmar ROTH-BEHRENDT related to 2009/0076(COD)
Amendment 155 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
4a. 1. Active substances as such or in biocidal products may only be placed on the market in the Union for use in biocidal products if they have been included in Annex I in accordance with the provisions of this Regulation. 2. Unless otherwise provided in this Regulation, all manufacturers of an active substance, as such or in a biocidal product, shall submit to the Agency an application for inclusion in Annex I.
Amendment 288 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. 1. The receiving competent authority or, in the case of evaluation of an application for a Community authorisation, the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewalfor a renewal, subject to this Regulation, of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1). Comparative assessment shall be applied to all biocidal products for the same purpose when there is sufficient experience, and a minimum of five years, in use.
Amendment 290 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application forrenewal of a Community authorisation, also to the Commission.
Amendment 293 #
Proposal for a regulation
Article 21 – paragraph 3 – introductory part
Article 21 – paragraph 3 – introductory part
3. The receiving competent authority or, in the case of a decision on an application for renewal of a Community authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met:
Amendment 296 #
Proposal for a regulation
Article 21 – paragraph 3 – point a
Article 21 – paragraph 3 – point a
a) for the uses specified in the application, another authorised biocidal products or a non-chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment and which prove equally effective and involve no significant increase in the risks for any other parameter;
Amendment 300 #
Proposal for a regulation
Article 21 – paragraph 3 – point b
Article 21 – paragraph 3 – point b
b) the biocidal product or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages;
Amendment 302 #
Proposal for a regulation
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3a. The Commission shall, on the basis of paragraph 3, adopt implementing measures laying down the procedure necessary for the definition of an application for comparative assessment of biocidal products. These measures shall define the criteria and algorithms to be used in a comparative assessment to ensure that there is a uniform application throughout the Community. Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure without scrutiny referred to in Article 72(3).
Amendment 303 #
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
Amendment 311 #
Proposal for a regulation
Article 21 – paragraph 7 a (new)
Article 21 – paragraph 7 a (new)
7a. By way of derogation from paragraph 1, a comparative assessment shall not be required for biocidal products whose use has been shown to be safe.
Amendment 449 #
Proposal for a regulation
Article 70 – paragraph 2 – point a
Article 70 – paragraph 2 – point a
a) a reduced fee shall be set for small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises; 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 452 #
Proposal for a regulation
Article 70 – paragraph 2 – point d
Article 70 – paragraph 2 – point d
d) an annual fee shall be paid by persons placing biocidal products on the market; aneleted
Amendment 455 #
Proposal for a regulation
Article 70 – paragraph 2 – point e
Article 70 – paragraph 2 – point e
e) tfees shall be charged only when genuinely necessary. The structure and amount of the fees shall take account of the work required by this Regulation to be carried out by the Agency and the competent authorities and shall be fixed at such level as to ensure that the revenue derived from the fees when combined with other sources of the Agency's revenue pursuant to this Regulation is sufficient to cover the cost of the services delivered.