Activities of Catherine SOULLIE related to 2009/0076(COD)
Plenary speeches (1)
Placing on the market and use of biocidal products (debate)
Amendments (16)
Amendment 127 #
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 129 #
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 food1; 1 OJ L 338, 13.11.2004, p. 4.
Amendment 141 #
Proposal for a regulation
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Amendment 195 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
Amendment 197 #
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
b) it meets two of the criteria to beis considered as a persistent, bio- accumulative and toxic substance in accordance with the criterias set out in Annex XIII of Regulation (EC) No 1907/2006; (The justification given below also applies to amendments relating to Article 9(1)(c), (d) and (f), and (2).
Amendment 200 #
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 thait is considered as a persistent, bio- accumulative and toxic substance 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 205 #
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 208 #
Proposal for a regulation
Article 9 – paragraph 1 – point f
Article 9 – paragraph 1 – point f
f) it is considered to havea substance, such as those with 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 dataor persistent, bioaccumulative and toxic properties or very persistent, very bioaccumulative properties which do not comply with the criteria referred to in points (b) and (c) – for which scientific evidence exists of possible serious effects on public health or the environment giving rise to a level of concern equivalent to that applicable to other substances referred to in points (b) and (c).
Amendment 211 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. When preparing an opinion on the inclusion or renewal of the inclusion of an active substance in Annex I, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and whether exposure is not adequately controlled, bearing in mind the intrinsic hazards of the substance, and shall address the matter in its opinion.
Amendment 229 #
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 bewill be the holder of the authorisation. The person may be, but is not necessarily, the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Amendment 232 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 3 a (new)
Article 15 – paragraph 2 – subparagraph 3 a (new)
A single application for authorisation may be made by the applicant for a group of products to be authorised in the context of a frame formulation.
Amendment 282 #
Proposal for a regulation
Article 20 – paragraph 3 – point b
Article 20 – paragraph 3 – point b
b) the permitted alteration of the composition of this reference biocidal product expressed inas a reduction in the percentage of the active substance(s) and/or as an alteration in the percentage of the non-active substances contained in the biocidal products which are considered to belong to that frame formulation;
Amendment 382 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 2
Article 46 – paragraph 1 – subparagraph 2
In the case of scientific research and development comprising research and development performed on products and processes, 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 385 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 3
Article 46 – paragraph 1 – subparagraph 3
Amendment 386 #
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 authorisation 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 issued national authorisationdelivered a favourable opinion for this purpose which may impose further conditions. In the absence of an opinion from the competent authority delivered within 30 days after notification of the information required in paragraph 1, the biocidal product or active substance should be placed on the market for the purposes of the notified experiment or test.
Amendment 475 #
Proposal for a regulation
Article 82
Article 82