EN Official Journal of the European Union L 120/13

COMMISSION IMPLEMENTING REGULATION (EU) 2017/796

of 10 May 2017

approving dichlofluanid 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 dichlofluanid.

(2) Dichlofluanid 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) The United Kingdom was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 22 October 2015.

(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 11 October 2016 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 containing dichlofluanid 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 dichlofluanid for use in biocidal products of product-type 21, subject to compliance with certain specifications and conditions.

(8) Since dichlofluanid meets the criteria for classification as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating dichlofluanid should be appropriately labelled when placed on the market.

(9) 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.

(10) 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

Dichlofluanid 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, 10 May 2017. 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).

(3) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).