[ParlTrack]

Proposal for a regulation
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.

2013/09/30
Committee: ENVI

Julie GIRLING, Miroslav OUZKÝ

Proposal for a regulation
Recital 17

(17) The third subparagraph of Article 95(1) of Regulation (EU) No 528/2012 intends to extend the right to refer to data provided in the second subparagraph of Article 63(3) to all studies required for the human health and environmental risk assessment, in order to allow prospective relevant persons to be included in the list referred to in Article 95(2). Without such a right to refer, many prospective relevant persons will not have time to comply with Article 95(1) by such time as required in order to be included in the list by the date referred to in Article 95(3). However, the third subparagraph of Article 95(1) fails to include studies on environmental fate and behaviour. Moreover, since prospective relevant persons will pay for the right to refer in accordance with Article 63(3), they should be entitled to fully benefit from that right by passing it onto applicants for product authorisation. This Article should therefore be amended accordingly.deleted

2013/09/30
Committee: ENVI

Julie GIRLING, Miroslav OUZKÝ

Proposal for a regulation
Article 1 – point 1 – point b

Regulation 528/2012/EU
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);"

2013/09/30
Committee: ENVI

Julie GIRLING, Miroslav OUZKÝ

Proposal for a regulation
Article 1 – point 13

Regulation 528/2012/EU
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.

2013/09/30
Committee: ENVI

Christa KLASS, Matthias GROOTE, Michèle RIVASI, Julie GIRLING, Corinne LEPAGE, Miroslav OUZKÝ

Proposal for a regulation
Article 1 point 13

Regulation 528/2012/EU
Article 95 – paragraph 7 a (new)

7a. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the Agency a letter of access to all the data which was considered by the evaluating competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (the 'relevant data'). Following the renewal of the approval of an active substance, the Agency shall remove from the list referred to in paragraph 1 any substance supplier or product supplier included therein who has not within 6 months from the renewal submitted all the relevant data or a letter of access to all the relevant data, either in accordance with the second subparagraph of paragraph 1 or in an application in accordance with Article 13.

2013/09/30
Committee: ENVI

5 Amendments of Miroslav OUZKÝ related to 2013/0150(COD)

ParlTrack - 2011-2024