Commission Implementing Regulation (EU) 2017/2003 of 8 November 2017 approving fludioxonil as an active substance for use in biocidal products of product-types 7, 9 and 10 (Text with EEA relevance)
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THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 9(1)(a) thereof,
Whereas:
(1) Denmark received on 8 October 2014 an application for the approval of the active substance fludioxonil for use in biocidal products of product-type 7, film preservatives, product-type 9, fibre, leather, rubber and polymerised materials preservatives, and product-type 10, construction material preservatives, as described in Annex V to Regulation (EU) No 528/2012.
(2) Denmark submitted the assessment reports together with its recommendations on 5 April 2016 in accordance with Article 8(1) of Regulation (EU) No 528/2012.
(3) The opinions of the European Chemicals Agency were formulated on 2 March 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
(4) According to those opinions, biocidal products of product-types 7, 9 and 10 and containing fludioxonil may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
(5) It is therefore appropriate to approve fludioxonil for use in biocidal products of product-types 7, 9 and 10, subject to compliance with certain specifications and conditions.
(6) Since fludioxonil meets the criteria laid down in Regulation (EC) No 1907/2006 of the European Parliament and of the Council(2) for being very persistent, treated articles treated with or incorporating fludioxonil should be appropriately labelled when placed on the market.
(7) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
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/EC (OJ L 396, 30.12.2006, p. 1).
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