LegalizeCommission Implementing Regulation (EU) 2016/1937 of 4 November 2016 approving cyfluthrin as an existing active substance for use in biocidal products of product-type 18 (Text with EEA relevance )
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| 5.11.2016 | EN | Official Journal of the European Union | L 299/51 |
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 Delegated Regulation (EU) No 1062/2014 2 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes cyfluthrin.
- (2) Cyfluthrin has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council 3 for use in products of 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) Germany was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 23 December 2010.
- (4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 16 February 2016 for use in products of product-type 18 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
- (5) According to that opinion, biocidal products of product-type 18 containing cyfluthrin may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.
- (6) It is therefore appropriate to approve cyfluthrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.
- (7) 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.
- (8) 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
Cyfluthrin is approved as an active substance for use in biocidal products of 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, 4 November 2016.
For the Commission
The President
Jean-Claude JUNCKER
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
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 substance4 | Date of approval | Expiry date of approval | Product type | Specific conditions |
|---|---|---|---|---|---|---|
| Cyfluthrin | IUPAC Name: (RS)-α-Cyano-4-fluoro-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate EC No: 269-855-7 CAS No: 68359-37-5 | 955 g/kg (95,5 % w/w) | 1 March 2018 | 28 February 2028 | 18 | The authorisations of biocidal products are subject to the following conditions: 1. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance. 2. In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to: (a) surface water and sediment for products used in domestic premises and animal housing with release to a sewage treatment plant; (b) surface water and sediment for products used in animal housing with direct release to surface water; (c) surface water and sediment after manure application on agricultural soil for products used in animal housings. 3. For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council5 or Regulation (EC) No 396/2005 of the European Parliament and of the Council6 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. |
The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 89(1) 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.
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
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