BAKGRUNN (fra kommisjonsforordningen)

(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 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (‘prallethrin’) (CAS No: 23031-36-9) for product-type 18.

(2) Prallethrin has been evaluated for use in biocidal products of product-type 18 (insecticides, acaricides and products to control other arthropods), as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which corresponds to product-type 18 as described in Annex V to Regulation (EU) No 528/2012.

(3) Greece was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 9 April 2012. After the submission of the assessment report, discussions took place in technical meetings organised by the European Chemicals Agency (‘the Agency’).

(4) It follows from Article 90(2), first subparagraph, of Regulation (EU) No 528/2012 that substances for which the Member States’ evaluation has been completed by 1 September 2013 are to be evaluated in accordance with the substantive conditions for approval laid down in Directive 98/8/EC.

(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 approval of active substances. In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014 read in conjunction with Article 75(1) and (4) of Regulation (EU) No 528/2012, the Biocidal Products Committee adopted the opinion of the Agency on 26 February 2024 (4), 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 prallethrin may be expected to satisfy the requirements laid down in Article 5(1), points (b), (c) and (d), of Directive 98/8/EC, provided that certain requirements concerning their use are complied with.

(7) Taking into account the opinion of the Agency, it is appropriate to approve prallethrin as an active substance for use in biocidal products of product-type 18 subject to compliance with certain conditions, including certain conditions for placing on the market of treated articles treated with or incorporating prallethrin.

(8) In its opinion, the Agency also concludes that prallethrin meets the criteria for being a very persistent and toxic substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (5). Prallethrin 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.

(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) Since it can be derived from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States' evaluation has been completed by 1 September 2013 should be approved under the substantive conditions for approval laid down in Directive 98/8/EC, the period of approval should be 10 years, in accordance with the practice established under that Directive.

(11) 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.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,