30.4.2014 EN Official Journal of the European Union L 128/64
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,
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.
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.