Commission Implementing Regulation (EU) 2024/2404 of 12 September 2024 granting a Union authorisation for the single biocidal product Nordkalk SL 90 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/2404of 12 September 2024granting a Union authorisation for the single biocidal product Nordkalk SL 90 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 27 August 2018, Nordkalk Oy Ab 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 a Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named "Nordkalk SL 90" 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-AA039301-77 in the Register for Biocidal Products. The application also indicated the case number of the related reference single biocidal product "EuLA hydra-lime 23" later authorised by Commission Implementing Regulation (EU) 2023/2701Commission Implementing Regulation (EU) 2023/2701 of 4 December 2023 granting a Union authorisation for the single biocidal product EuLA hydra-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2701, 5.12.2023 ELI: http://data.europa.eu/eli/reg_impl/2023/2701/oj)., recorded in that register under case number BC-JR038510-32.(2)The single biocidal product "Nordkalk SL 90" contains calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime 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 13 October 2022, the Agency submitted to the Commission its opinionEuropean Chemicals Agency opinion of 13 October 2022 on the Union authorisation of the same single biocidal product "Nordkalk SL 90", https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics ("SPC") of "Nordkalk SL 90" 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 "Nordkalk SL 90" and the related reference single biocidal product "EuLA hydra-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 hydra-lime 23" and subject to compliance with the draft SPC, the same single biocidal product "Nordkalk SL 90" meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.(5)On 21 February 2024, the Agency transmitted to the Commission the revised draft SPC of "Nordkalk SL 90" 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 "Nordkalk SL 90".(7)The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference single biocidal product "EuLA hydra-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: