This Regulation approves transfluthrin for use in biocidal products for product-type 18, but only under the Annex conditions and not for nanomaterials.
24.4.2014 | EN | Official Journal of the European Union | L 121/14 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) No 407/2014 of 23 April 2014 approving transfluthrin 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 transfluthrin. ---|--- (2) | Transfluthrin 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) | The Netherlands was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 13 July 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 18 and containing transfluthrin 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 transfluthrin for use in biocidal products for product-type 18 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 1 Transfluthrin 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. 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, 23 April 2014. For the Commission The President José Manuel BARROSO * * * (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). * * * ANNEX Common name | IUPAC name Identification numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions (2) ---|---|---|---|---|---|--- Transfluthrin | IUPAC Name: 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate or 2,3,5,6-tetrafluorobenzyl (1R)-trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate EC No: 405-060-5 CAS No: 118712-89-3 | 965 g/kg of 1R trans configuration | 1 November 2015 | 31 October 2025 | 18 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. Authorisations are subject to the following condition: In view of the risks for water, sediment and soil compartments, transfluthrin shall not be used in vaporisers for indoor use or insecticidal coils unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level. * * * (1) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. (2) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm * * *