EN Official Journal of the European Union L 180/21

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1088

of 5 July 2016

approving copper flakes (coated with aliphatic acid) as an existing active substance for use in biocidal products of product-type 21

(Text with EEA relevance)

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 the third subparagraph of Article 89(1) thereof,

Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes copper, to be named copper flakes (coated with aliphatic acid) as a result of its evaluation.

(2) Copper flakes (coated with aliphatic acid) has been evaluated for use in products of product-type 21, antifouling products, as described in Annex V to Regulation (EU) No 528/2012.

(3) France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 31 October 2014.

(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 9 December 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(5) According to that opinion, biocidal products of product-type 21 and containing copper flakes (coated with aliphatic acid) 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.

(6) The acceptability of the risks related to the use of antifouling products, as well as the suitability of the proposed risk mitigation measures, should however be further confirmed. In order to facilitate, at the time of the renewal of the approvals of existing antifouling active substances, the review and comparison of the risks and benefits of those substances as well as of the risk mitigation measures applied, the expiry date of approval of all those substances should be the same.

(7) It is therefore appropriate to approve copper flakes (coated with aliphatic acid) for use in biocidal products of product-type 21, subject to compliance with certain specifications and conditions.

(8) 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.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Copper flakes (coated with aliphatic acid) is approved as an active substance for use in biocidal products of product-type 21, subject to the specifications and conditions set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 5 July 2016. For the Commission The President Jean-Claude JUNCKER

(1) OJ L 167, 27.6.2012, p. 1.

(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).