25.10.2013 EN Official Journal of the European Union L 283/35
COMMISSION IMPLEMENTING REGULATION (EU) No 1036/2013
of 24 October 2013
approving etofenprox as an existing active substance for use in biocidal products for product-type 18
(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 etofenprox.
(2) Etofenprox has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive, which corresponds to product-type 18 as defined in Annex V to Regulation (EU) No 528/2012.
(3) Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 9 August 2011 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, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.
(5) It appears from that report that biocidal products used for product-type 18 and containing etofenprox may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
(6) It also appears from the reports that the characteristics of etofenprox render it liable to bioaccumulate (B) and toxic (T), in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4). The period of approval should be 10 years in consistency with the current practice under Directive 98/8/EC, since the conditions of Article 90(2) of Regulation (EU) No 528/2012 are not met. However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, etofenprox shall be considered as a candidate for substitution pursuant to Article 10(1)(d) of that Regulation.
(7) It is therefore appropriate to approve etofenprox for use in biocidal products for product-type 18.
(8) 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.
(9) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Etofenprox shall be approved as an active substance for use in biocidal products for product-type 18, 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.