28 Amendments of Françoise GROSSETÊTE related to 2009/0076(COD)
Amendment 112 #
Council position
Article 2 – paragraph 2 – point j a (new)
Article 2 – paragraph 2 – point j a (new)
j (a) 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 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 138 #
Council position
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Amendment 141 #
Proposal for a regulation
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Amendment 182 #
Council position
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The receiving competent authority or, in the case of an evaluation of an application for a Union authorisation, the evaluating competent authority, shall perform a comparative assessment as part of the evaluation of an application for authorisation or for renewalrenewal pursuant to this Regulation of authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 10(1). Comparative assessment shall be carried out on all biocidal products used for the same purpose provided that sufficient (at least five years’) experience of their use exists.
Amendment 183 #
Council position
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1 a. By derogation from paragraph 1, comparative assessment shall not be carried out on biocidal products which have been shown to be safe in use.
Amendment 184 #
Council position
Article 22 – paragraph 2
Article 22 – 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 Union authorisation, also to the Commission.
Amendment 185 #
Council position
Article 22 – paragraph 3 – introductory part
Article 22 – paragraph 3 – introductory part
3. The receiving competent authority or, in the case of a decision on an application forthe renewal of a Union authorisation, the Commission shall prohibit or restrict the making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment in accordance with Annex VI (‘comparative assessment’) demonstrates that both of the following criteria are met:
Amendment 186 #
Council position
Article 22 – paragraph 3 – point a
Article 22 – paragraph 3 – point a
(a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention methods already exists which presents a significantly lower overall risk for human and animal health and the environment, isare sufficiently effective and presents no other significant economic or practical disadvantages;
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 231 #
Council position
Article 40
Article 40
A Union authorisation issued by the Commission in accordance with this Section shall be valid throughout the Union unless otherwise specified. It shall confer the same rights and obligations in each Member State as a national authorisation. For those categories of biocidal products referred to in Article 41(1), the applicant may apply for Union authorisation as an alternative to applying for a national authorisation and mutual recognition.
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 234 #
Council position
Article 41
Article 41
Amendment 254 #
Council position
Article 55 – paragraph 1 – subparagraph 1
Article 55 – paragraph 1 – subparagraph 1
1. By way of derogation from Article 17, an experiment or a test for the purposes of research or development involving an unauthorised biocidal product new biocidal product which cannot be deemed to be a minor change to a product that has already been authorised, or a non- approved active substance intended exclusively for use in a biocidal product ("experiment" or "test") may take place only under the conditions laid down in this Article.
Amendment 255 #
Council position
Article 55 – paragraph 2 – subparagraph 1
Article 55 – paragraph 2 – subparagraph 1
2. Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the relevant competent authority of the Member State where the experiment or test will occur. The notification shall include the information listed in the second subparagraph of paragraph 1. dentity of the biocidal product or active substance, labelling data and quantities supplied. The person concerned shall also compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. They shall make this information available to the competent authorities on request.
Amendment 297 #
Council position
Article 68 – paragraph 2 – subparagraph 1 – introductory part
Article 68 – paragraph 2 – subparagraph 1 – introductory part
In addition to compliance with paragraph 1, authorisation holders shall ensure that labels are not misleading in respect of the risks from the product to human health or the environment or its efficacy and, in any case, do not mention the indications "low- risk biocidal product", "non-toxic", "harmless", "natural", "environmentally friendly", "animal friendly" or similar indications. In addition, the label must show clearly and indelibly the following information:
Amendment 301 #
Council position
Article 71 – paragraph 3
Article 71 – paragraph 3
3. Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment or its efficacy. In any case, the advertising of a biocidal product shall not mention "low-risk biocidal product", "non toxic", "harmless", "natural", "environmentally friendly", "animal friendly" or any similar indication.
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