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 silver zinc zeolite (CAS No: 130328-20-0) for product-types 2, 7 and 9.

(2) Silver zinc zeolite has been evaluated for use in biocidal products of product-types 2 (private area and public health area disinfectants and other biocidal products), 7 (film preservatives) and 9 (fibre, leather, rubber and polymerised materials preservatives), as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond respectively to product-types 2 (disinfectants and algaecides not intended for direct application to humans or animals), 7 (film preservatives) and 9 (fibre, leather, rubber and polymerised materials preservatives), as described in Annex V to Regulation (EU) No 528/2012.

(3) Sweden was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 7 May 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 opinions of the Agency on 29 February 2024 (4) , (5) , (6), having regard to the conclusions of the evaluating competent authority.

(6) Taking into account the opinions of the Agency, it can be concluded that biocidal products of product-types 2, 7 and 9 containing silver zinc zeolite may be expected to satisfy the requirements laid down in Article 5(1), points (b), (c) and (d), read in conjunction with Article 10(1) of Directive 98/8/EC, provided that certain requirements concerning their use are complied with. It is therefore appropriate to approve silver zinc zeolite as an active substance for use in biocidal products of product-types 2, 7 and 9 subject to compliance with certain conditions, including certain conditions for placing on the market of treated articles treated with or incorporating silver zinc zeolite.

(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,