Commission Implementing Regulation (EU) 2024/1674 of 13 June 2024 granting a Union authorisation for the single biocidal product SANICALCO Q in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/1674of 13 June 2024granting a Union authorisation for the single biocidal product SANICALCO Q 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 20 April 2018, CARMEUSE EUROPE S.A. 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 single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named "SANICALCO Q", of product-types 2 and 3, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-PV038808-97 in the Register for Biocidal Products. The application also indicated the case number of the related reference single biocidal product "EuLA oxi-lime 23" later authorised by Commission Implementing Regulation (EU) 2023/2703Commission Implementing Regulation (EU) 2023/2703 of 4 December 2023 granting a Union authorisation for the single biocidal product "EuLA oxi-lime 23" in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2703, 5.12.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj)., recorded in that register under case number BC-VJ038509-19.(2)The single biocidal product "SANICALCO Q" contains calcium oxide/lime/burnt lime/quicklime 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-types 2 and 3.(3)On 8 September 2022, the Agency submitted to the Commission its opinionEuropean Chemicals Agency opinion of 8 September 2022 on the Union authorisation of the same single biocidal product "BIOCALCO Q", https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics ("SPC") of "SANICALCO Q" 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 single biocidal product "SANICALCO Q" and the related reference single biocidal product "EuLA oxi-lime 23" 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 single biocidal product "EuLA oxi-lime 23" and subject to compliance with the draft SPC, the same single biocidal product "SANICALCO Q" meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.(5)On 26 January 2024, the Agency transmitted to the Commission the revised SPC of "SANICALCO Q" 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 single biocidal product "SANICALCO Q".(7)The expiry date of the authorisation should be aligned to the expiry date of the authorisation of the related reference single biocidal product "EuLA oxi-lime 23".(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: