Commission Implementing Regulation (EU) 2024/2188 of 3 September 2024 granting a Union authorisation for the biocidal product family Kersia’s Lactic acid based products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/2188of 3 September 2024granting a Union authorisation for the biocidal product family Kersia’s Lactic acid based products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(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 productsOJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj., and in particular Article 44(5), first subparagraph, thereof,Whereas:(1)On 26 April 2019, HYPRED SAS submitted to the European Chemicals Agency ("the Agency") an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named "Kersia’s Lactic acid based products" of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-CH051281-59 in the Register for Biocidal Products.(2)"Kersia’s Lactic acid based products" contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 3.(3)On 30 November 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.(4)On 30 June 2023, the Agency submitted to the Commission its opinionOpinion of the Biocidal Products Committee of 6 June 2023 on the Union authorisation of "Kersia’s Lactic acid based products" (ECHA/BPC/381/2023), https://echa.europa.eu/opinions-on-union-authorisation., the draft summary of the biocidal product characteristics ("SPC") of "Kersia’s Lactic acid based products" and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.(5)The opinion concludes that "Kersia’s Lactic acid based products" is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. The opinion does not recommend the authorisation of the use of the products as teat disinfectants applied prior to milking, due to an exceedance of the acceptable daily intake of a co-formulant contained in all products of the biocidal product family "Kersia’s Lactic acid based products".(6)On 13 July 2023, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.(7)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family "Kersia’s Lactic acid based products" in accordance with the recommendations in that opinion.(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: