COMMISSION IMPLEMENTING REGULATION (EU) No 1091/2014
of 16 October 2014
approving tralopyril as a new 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 Article 90(2) thereof,
Whereas:
(1)
The United Kingdom has received on 17 July 2007 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance tralopyril in its Annex I for use in product-type 21, antifouling products, as defined in Annex V to that Directive.
(2)
Tralopyril was not on the market on 14 May 2000 as an active substance of a biocidal product.
(3)
The United Kingdom submitted the assessment report, together with its recommendations, to the Commission on 1 September 2009 in accordance with Article 11(2) of Directive 98/8/EC.
(4)
The opinion of the European Chemicals Agency was formulated on 8 April 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.
(5)
It appears from that opinion that biocidal products used for product-type 21 and containing tralopyril 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 tralopyril for use in biocidal products for product-type 21 subject to compliance with certain specifications and conditions.
(7)
Since the evaluations did not address nanomaterials, the approvals 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 1
Tralopyril 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 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, 16 October 2014.