Commission Implementing Regulation (EU) 2024/2205 of 4 September 2024 granting a Union authorisation for the biocidal product family SICO Biocidal Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/2205of 4 September 2024granting a Union authorisation for the biocidal product family SICO Biocidal Product Family 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 30 April 2019, SICO submitted to the European Chemicals Agency ("the Agency") an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4), ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj. for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named "SICO Biocidal Product Family", of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-TA051413-55 in the Register for Biocidal Products ("the Register"). The application also indicated the application number of the related reference biocidal product family "SALVECO SALVESAFE PRODUCTS" later authorised by Commission Implementing Regulation (EU) 2023/1758Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family "SALVECO SALVESAFE PRODUCTS" in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 224, 12.9.2023, p. 34), ELI: http://data.europa.eu/eli/reg_impl/2023/1758/oj., recorded in the Register under case number BC-HC051278-51.(2)The same biocidal product family "SICO Biocidal Product Family" contains L-(+)-lactic acid as the active substances, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.(3)On 19 September 2022, the Agency submitted to the Commission its opinionECHA opinion of 19.9.2022 on the Union authorisation of the same biocidal product family "SICO Biocidal Product Family", https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics ("SPC") of "SICO Biocidal Product Family" in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.(4)In its opinion, the Agency concludes that the proposed differences between "SICO Biocidal Product Family" and the biocidal product family "SALVECO SALVESAFE PRODUCTS" are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4), ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj., and that based on the assessment of the related reference biocidal product family "SALVECO SALVESAFE PRODUCTS" and subject to compliance with the draft SPC, "SICO Biocidal Product Family" meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.(5)On 20 November 2023, the Agency transmitted to the Commission the revised SPCs of "SICO Biocidal Product Family" in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.(6)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family "SICO Biocidal Product Family".(7)The expiry date of this authorisation is aligned to the expiry date of the authorisation of the related reference biocidal product family "SALVECO SALVESAFE PRODUCTS".(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: