Activities of Holger KRAHMER related to 2009/0076(COD)
Plenary speeches (1)
Placing on the market and use of biocidal products (debate)
Amendments (16)
Amendment 154 #
Council position
Article 10 – paragraph 1 – point e
Article 10 – paragraph 1 – point e
Amendment 164 #
Council position
Article 17 – paragraph 2 – subparagraph 2
Article 17 – paragraph 2 – subparagraph 2
Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State (‘the receiving competent authority’)Agency.
Amendment 168 #
Council position
Article 18 – paragraph 2 – point b a (new)
Article 18 – paragraph 2 – point b a (new)
(b a) The evaluation of the compliance of the biocidal product with the criteria set out in points (b) and (c) of paragraph 1 shall not take into account a substance contained in the biocidal product if it is present in a preparation at a concentration lower than any of the concentrations mentioned in points (a) to (f) of Article 14(2) of Regulation (EC) No 1907/2006;
Amendment 170 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 177 #
Proposal for a regulation
Article 5 – paragraph 2 – point d
Article 5 – paragraph 2 – point d
d) active substances identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties. Until 30 June 2015, the Commission shall, by means of delegated acts in accordance Articles XY, adopt measures on specific scientific criteria for determining endocrine-disrupting properties.
Amendment 179 #
Council position
Article 21 – paragraph 2 – point e
Article 21 – paragraph 2 – point e
(e) qualitative and quantitative composition in terms of the active substances and non- active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %taking account of the concentration limits in Article 18(2b) and in so far as this information is required for proper use of the biocidal product;
Amendment 188 #
Council position
Article 22 – paragraph 6
Article 22 – paragraph 6
6. Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a periods not exceeding five years and renewed for a periods not exceeding five years.
Amendment 196 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
Amendment 198 #
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
b) it meets two of the criteria to be considered as asubstances which are persistent, bio- accumulative and toxic substance asin accordance with the criteria set out in Annex XIII of Regulation (EC) No 1907/2006;
Amendment 201 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
c) there are reasons for concern linked to the nature of the critical effects, in particular developmental neurotoxic or immunotoxic effects, which, in combination with the use patterns, amount to use thasubstances which are very persistent and very bioaccumulative in accordance with the criteria set could still cause concern, even with very restrictive risk management measurest in Annex XIII of Regulation (EC) No 1907/2006;
Amendment 204 #
Proposal for a regulation
Article 9 – paragraph 1 – point d
Article 9 – paragraph 1 – point d
d) it contains a significant proportion of non-active isomers;eleted
Amendment 207 #
Proposal for a regulation
Article 9 – paragraph 1 – point f
Article 9 – paragraph 1 – point f
f) it is considered tosubstances — such as those haveing endocrine disrupting properties that may cause adverse effect on humans on the basis of the assessment of Community or internationally agreed test guidelines or other available data.or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (b) or (c) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (b), (c) or (e) and which are identified on a case-by- case basis in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006;
Amendment 215 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. By way of derogation from Article 10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be renewed for a periods not exceeding ten years.
Amendment 309 #
Proposal for a regulation
Article 21 – paragraph 6
Article 21 – paragraph 6
6. Notwithstanding Article 15(4), an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a periods not exceeding five years.
Amendment 338 #
Council position
Annex III - Title 1 - point 2.3 - Column 1
Annex III - Title 1 - point 2.3 - Column 1
2.3. CompleteDetailed quantitative (g/kg, g/l or % w/w (v/v))and qualitative information on the composition of the biocidal product, i.e. declaration of all active substances and co-formulants (substance or mixture according to Article 3 of Regulation (EC) No 1907/2006), which are intentionally added to the biocidal product (formulation) as well as detailed quantitative and qualitative informatione.g. active substance(s), impurities, adjutants, inert components, taking account onf the composition of the active substance(s) contained. For co- formulants, a safety data sheet in compliance with Article 31 of Regulation (EC) No 1907/2006 has to be provided. In addition, all relevant information on individual ingredients, their function and, in case of a reaction mixture, the final composition of the biocidal product shall be given. ncentrations referred to in Article 18(2)(ba) Or. en (Reinstatement of amendment 296 from first reading.)
Amendment 350 #
Council position
Annex VI – Introduction – point 2
Annex VI – Introduction – point 2
2. The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances. For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information. In the case of biocidal products containing nanomaterials the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information. The guidance, for substances falling under Recommendation 20../…/EC of … with regard to specific requirements under this Regulation relating to their nature as nanomaterials shall not apply where these substances contain: - less than 10 wt-% of nano-objects or - less than 50 wt-% of aggregates /agglomerates consisting of nano-objects or - have not been intentionally manufactured at the nanoscale in order to take advantage of their specific nano qualities