Activities of Julie GIRLING related to 2013/0150(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with regard to certain conditions for access to the market PDF (258 KB) DOC (338 KB)
Amendments (15)
Amendment 18 #
Proposal for a regulation
Recital 1
Recital 1
(1) Article 19(4)(c) of Regulation (EU) No 528/20122 prohibits authorisation for making available for use by the general public of biocidal products meeting the criteria for being persistent, bioaccumulative and toxic (‘PBT’), or very persistent and very bioaccumulative (‘vPvB’) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC3 . However, whereas biocidal products are often mixtures and sometimes articles, those criteria apply only to substances. Article 19(4)(c) of Regulation (EU) No 528/2012 should therefore refer to biocidal products consisting of, containing or generating substances meeting those criteria. __________________ 2 3, in a concentration equal to or above 0.1% weight by weight (w/w). __________________ 2 OJ L 167, 27.6.2012, p. 1. OJ L 167, 27.6.2012, p. 1. 3 OJ L 396, 30.12.2006, p.1. OJ L 396, 30.12.2006, p.1.
Amendment 19 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
Amendment 20 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
Amendment 22 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In order for the system established by this Regulation to operate effectively, there should be good cooperation, coordination and exchange of information between the Member States, the Agency and the Commission regarding enforcement.
Amendment 24 #
Proposal for a regulation
Recital 12
Recital 12
(12) Article 89(4) and Article 93(2) of Regulation (EU) No 528/2012 provide phase-out periods for biocidal products for which no authorisation is granted. The sameDifferent phase out periods should apply for phasing out the existing form of a product already on the market, where an authorisation is granted but the conditions of the authorisation require the product to be changedto the products depending on whether the labelling change affects the safe use and/or efficacy of the product.
Amendment 26 #
Proposal for a regulation
Recital 17
Recital 17
Amendment 27 #
Proposal for a regulation
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Regulation 528/2012/EU
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Article 3(1)(s) is replaced by the following: (s) "biocidal product family" means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their compositionand similar composition with specified variations which do not adversely affect the level of risk or significantly reduce the efficacy of the products, the active substances of which have the same specifications;
Amendment 28 #
Proposal for a regulation
Article 1 – point 1 – point b
Article 1 – point 1 – point b
Regulation 528/2012/EU
Article 19 – paragraph 4 – point c
Article 19 – paragraph 4 – point c
"(c) it consists of, contains or generates a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006 in a concentration equal to or above 0.1% weight by weight (w/w);"
Amendment 29 #
Proposal for a regulation
Article 1 – point 1 – point b a (new)
Article 1 – point 1 – point b a (new)
(ba) Article 19(6) is replaced by the following: "6. In the case of a biocidal product family, a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate). A biocidal product family shall be authorised only if all the biocidal products within it, taking into account the permitted variations referred to in the first subparagraph,risk assessment for the biocidal product family conducted according to the common principles set out in Annex VI shall be based on the composition(s) and use(s) with the highest risk level for human health and animals, and the environment respectively. For each product within the biocidal product family, the classification, hazard and precautionary statements shall be the same as, or of a lower concern than, those of the worst-case composition(s) evaluated in the risk assessment, and the level of exposure shall be the same as or lower than the worst case use(s) evaluated in that assessment. A biocidal product family shall be authorised only if the permitted variations in composition and the uses referred to in the first subparagraph can be easily identified in the application together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures, and if all the biocidal products within the family are expected to comply with the conditions set out in paragraph 1."
Amendment 38 #
Proposal for a regulation
Article 1 – point 8 b (new)
Article 1 – point 8 b (new)
Regulation 528/2012/EU
Article 74 – paragraph 2
Article 74 – paragraph 2
(8b) Articles 74(2) is amended as follows: Articles 77(4), 78 to 84, 86, 89 and 90 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis, taking into account the role of the Agency and the role of the Member States' authorities with respect to this Regulation.
Amendment 41 #
Proposal for a regulation
Article 1 – point 9 a (new)
Article 1 – point 9 a (new)
Regulation 528/2012/EU
Article 78 – paragraph 2
Article 78 – paragraph 2
(9a) In Article 78 paragraph 2 shall be deleted.
Amendment 45 #
Proposal for a regulation
Article 1 – point 11 – point c
Article 1 – point 11 – point c
Regulation 528/2012/EU
Article 89 – paragraph 4
Article 89 – paragraph 4
Where a Member State's competent authority decides to rejects the application for authorisation of a biocidal product submitted under paragraph 3, or decides not to grant authorisation, or decides to impose conditions of the authorisation making it necessary to change a product, the following shall apply: a) the biocidal product which has not been authorised or, where relevant, which does not comply withthat biocidal product shall no longer be made available on the market 180 days after the date of such rejection or decision. Disposal and use of existing stocks of such biocidal products may continue until 365 days after the date of such rejection or decision. Where a Member State's competent authority decides to authorise a biocidal product, and the product as already placed on the market does not comply with the requirements of this Regulation or the conditions of the authorisation, sthall no longert product: may continue to be made available on the market with effect from 180 days after the date of the decisfor a period of: - 365 days from the date of authorisation where the failure to comply with the requirements of this Regulation or the conditions of authorisation is of an administrative nature only and does not affect levels of risk mitigation or standards of efficacy imposed on the biocidal product by the requirements of this Regulation or by any conditions of authorisation; of the authority; (b) disposal and use of exr 180 days from the date of authorisation in all other cases; and may continue to be used or disposed of for a period of: - 550 days from the date of authorisation where the failure to comply with the requirements of this Regulation or the conditions of authorisating stocks of the biocidal product may continue untilon is of an administrative nature only and does not affect levels of risk mitigation or standards of efficacy imposed on the biocidal product by the requirements of this Regulation or by any conditions of authorisation; or 365 days afterfrom the date of the decision of the authorityauthorisation in all other cases.
Amendment 48 #
Proposal for a regulation
Article 1 – point 12
Article 1 – point 12
Regulation 528/2012/EU
Article 93 – paragraph 2
Article 93 – paragraph 2
By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market biocidal products referred to in paragraph 1 of this Article for which an application was submitted in accordance with paragraph 1 of this Article until the date of the decision granting the authorisation. In the case of a decision refusing to grant the authorisation, or imposing conditions on the authorisation making it necessary to change a product, the biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market 180 days after such a decisionand disposed of in accordance with Article 89(4).
Amendment 49 #
Proposal for a regulation
Article 1 – point 13
Article 1 – point 13
Regulation 528/2012/EU
Article 95 – paragraph 3
Article 95 – paragraph 3
3. For the purposes of making a submission in accordance with the second subparagraph of paragraph 1, Article 63(3) of this Regulation shall apply to all toxicological, and ecotoxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrates.
Amendment 50 #
Proposal for a regulation
Article 1 point 13
Article 1 point 13
Regulation 528/2012/EU
Article 95 – paragraph 7 a (new)
Article 95 – paragraph 7 a (new)