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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 productsnote, and in particular Article 14(4), point (a), thereof,Whereas:
(1)Metofluthrin was included in Annex I to Directive 98/8/EC of the European Parliament and of the Councilnote as an active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2)On 25 October 2019, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of metofluthrin for use in biocidal products of product-type 18 (‘the application’). The application was evaluated by the competent authority of Ireland (‘the evaluating competent authority’).
(3)During the examination of metofluthrin, the name of that active substance has been changed by the evaluating competent authority and the European Chemicals Agency (‘the Agency’) to epsilon-metofluthrin.
(4)On 7 March 2024, the evaluating competent authority submitted a recommendation on the renewal of the approval of epsilon-metofluthrin to the Agency.
(5)In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for renewal of approval of active substances. The Biocidal Products Committee adopted the opinion of the Agency on 25 November 2024note, having regard to the conclusions of the evaluating competent authority.
(6)In its opinion, the Agency concluded that biocidal products of product-type 18 containing epsilon-metofluthrin may be expected to still satisfy the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that certain conditions concerning their use are complied with. Therefore, the conditions for renewal set out in Article 12(1), read in conjunction with Article 4(1), of Regulation (EU) No 528/2012 are considered satisfied.
(7)It is therefore appropriate to renew the approval of epsilon-metofluthrin for use in biocidal products of product-type 18, subject to compliance with certain conditions, including a condition for placing on the market of treated articles treated with or incorporating epsilon-metofluthrin. A period of transition should be set for new requirements concerning the placing on the market of treated articles treated with or incorporating epsilon-metofluthrin in order to allow sufficient time for economic operators to adapt.
(8)In its opinion, the Agency also concludes that epsilon-metofluthrin meets the criteria for being a persistent and toxic substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Councilnote. Epsilon-metofluthrin therefore meets the condition laid down in Article 10(1), point (d), of Regulation (EU) No 528/2012 and should, therefore, for the purposes of Article 23(1) of that Regulation, be considered a candidate for substitution. Therefore, the period of renewal should not exceed 7 years, pursuant to Article 10(4) of Regulation (EU) No 528/2012.
(9)In accordance with Article 23(1) of Regulation (EU) No 528/2012 the competent authorities of the Member States are to perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing an active substance that is a candidate for substitution.
(10)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#
The approval of epsilon-metofluthrin as an active substance for use in biocidal products of product-type 18 is renewed, subject to the 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.
| Common Name | IUPAC NameIdentification Numbers | Minimum degree of purity of the active substancenote | Expiry date of approval | Product type | Specific conditions |
|---|---|---|---|---|---|
| epsilon-metofluthrin | IUPAC name:2,3,5,6-tetrafluoro-4-(methoxymethyl)benyzl-(1R,3R)-2,2-dimethyl-3-[(Z)-prop-1-enyl]cyclopropane carboxylateEC No: noneCAS No: 240494-71-7 | sum of all isomers: 946 g/kg RTZ (1 R, 3R = Trans, Z -2,3,5,6-tetrafluoro-4-(methoxymethyl)benyzl-(1R,3R)-2,2-dimethyl-3-[(Z)-prop-1-enyl]cyclopropane carboxylate) isomer: 870 g/kg | 31 May 2032 | 18 | 1.Epsilon-metofluthrin is a candidate for substitution in accordance with Article 10(1), point (d), of Regulation (EU) No 528/2012.2.The authorisation of biocidal products containing epsilon-metofluthrin as an active substance is subject to the following conditions:(a) the product assessment pays 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 assessment of the active substance;(b) for products that may lead to residues in food or feed, it is assessed whether new maximum residue limits or maximum residue levels need to be set or the existing maximum residue limits or maximum residue levels need to be amended respectively in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council, and any appropriate risk mitigation measures are taken to ensure that such maximum residue limits or maximum residue levels are not exceeded;(c) Member States’ competent authorities or, in the case of a Union authorisation, the Commission, specify in the summary of the biocidal product characteristics the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012.3.The placing on the market of treated articles is subject to the following condition: as from 1 December 2025, the person responsible for the placing on the market of a treated article treated with or incorporating epsilon-metofluthrin shall ensure that the label of that treated article provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012. |
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