Commission Implementing Regulation (EU) 2024/1541 of 3 June 2024 granting a Union authorisation for the biocidal product family Sanoserv H202 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/1541of 3 June 2024granting a Union authorisation for the biocidal product family Sanoserv H202 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 31 January 2017, Sanoserv International franchising Ltd submitted an application to the European Chemicals Agency ("the Agency") 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 "Sanoserv H202" of product-type 2, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-CQ029788-15 in the Register for Biocidal Products. The application also indicated the case number of the related reference biocidal product family "Oxy’Pharm H202" later authorised by Commission Implementing Regulation (EU) 2023/1764Commission Implementing Regulation (EU) 2023/1764 of 12 September 2023 granting a Union authorisation for the biocidal product family "Oxy’Pharm H202" in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 225, 13.9.2023, p. 21, ELI: http://data.europa.eu/eli/reg_impl/2023/1764/oj)., recorded in that register under case number BC-HC029658-43.(2)The biocidal product family "Sanoserv H202" contains hydrogen peroxide 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 2.(3)On 29 November 2022, the Agency submitted to the Commission its opinionEuropean Chemicals Agency opinion of 29 November 2022 on the Union authorisation of the same biocidal product family "Sanoserv H202" (https://echa.europa.eu/opinions-on-union-authorisation). and the draft summary of the biocidal product characteristics ("SPC") of "Sanoserv H202" in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.(4)In its opinion, the Agency concludes that the proposed differences between the biocidal product family "Sanoserv H202" and the related reference biocidal product family "Oxy’Pharm H202" are limited to information which can be the subject of an administrative change in accordance with 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 "Oxy’Pharm H202" and subject to compliance with the draft SPC, the biocidal product family "Sanoserv H202" meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.(5)On 2 February 2024, the Agency transmitted to the Commission the revised SPC of "Sanoserv H202" 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 "Sanoserv H202".(7)The expiry date of the authorisation should be aligned to the expiry date of the authorisation of the related reference biocidal product family "Oxy’Pharm H202".(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: