# Commission Implementing Regulation (EU) No 437/2014Show full title

Commission Implementing Regulation (EU) No 437/2014 of 29 April 2014 approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as            an existing active substance for use in biocidal products for product-type 21 (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 437/2014                     

# of 29 April 2014

# approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an existing active substance for use in biocidal products for 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 Regulation (EC) No 1451/2007(2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive                              98/8/EC of the European Parliament and of the Council(3). That list includes 4,5-Dichloro-2-octyl-2H-isothiazol-3-one.

(2)4,5-Dichloro-2-octyl-2H-isothiazol-3-one has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use                              in product-type 21, antifouling products, as defined in Annex V to that Directive, which corresponds to product-type 21 as                              defined in Annex V to Regulation (EU) No 528/2012.

(3)Norway was designated as Rapporteur and submitted the competent authority report, together with a recommendation, to the Commission                              on 21 December 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(4)The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation                              (EC) No 1451/2007, the findings of the review were incorporated in an assessment report reviewed within the Standing Committee                              on Biocidal Products on 13 March 2014.

(5)According to that assessment report, biocidal products used for product-type 21 and containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one                              may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that certain specifications                              and conditions relating to its use are satisfied.

(6)It is therefore appropriate to approve 4,5-Dichloro-2-octyl-2H-isothiazol-3-one for use in biocidal products for product-type                              21 subject to compliance with such specifications and conditions.

(7)Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4)                              of Regulation (EU) No 528/2012.

(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 laid down.

(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 1U.K.

4,5-Dichloro-2-octyl-2H-isothiazol-3-one shall be approved as an active substance for use in biocidal products for product-type                     21, subject to the specifications and conditions set out in the Annex.                  

# Article 2U.K.

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, 29 April 2014.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

1

OJ L 167, 27.6.2012, p. 1.                           

2

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in                              Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products                              on the market (OJ L 325, 11.12.2007, p. 3).                           

3

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products                              on the market (OJ L 123, 24.4.1998, p. 1).