Commission Implementing Regulation (EU) 2024/2409 of 13 September 2024 granting a Union authorisation for the single biocidal product Hydroflex IPA 70 Biocide in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/2409of 13 September 2024granting a Union authorisation for the single biocidal product Hydroflex IPA 70 Biocide 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 September 2023, Hydroflex Group GmbH 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 "Hydroflex IPA 70 Biocide", of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012, referring to the single biocidal product "Isopropanol 70 Biocide" (authorisation number EU-0027707-0022), which is a part of the related reference biocidal product family "Brenntag GmbH Propan-2-ol Product Family". The application was recorded under case number BC-BX088801-11 in the Register for Biocidal Products. The application also indicated the authorisation number of the related reference biocidal product family "Brenntag GmbH Propan-2-ol Product Family" authorised by Commission Implementing Regulation (EU) 2022/2252Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family "Brenntag GmbH Propan-2-ol Product Family" (OJ L 297, 17.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2022/2252/oj), with authorisation number EU-0027707-0000.(2)The single biocidal product "Hydroflex IPA 70 Biocide" contains propan-2-ol 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 4.(3)On 12 January 2024, the Agency submitted to the Commission its opinionEuropean Chemicals Agency opinion of 12 January 2024 on the Union authorisation of the same single biocidal product "Hydroflex IPA 70 Biocide", https://echa.europa.eu/opinions-on-union-authorisation and the draft summary of the biocidal product characteristics ("SPC") of "Hydroflex IPA 70 Biocide" 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 "Hydroflex IPA 70 Biocide" and the related single biocidal product "Isopropanol 70 Biocide", which is a part of the related reference biocidal product family "Brenntag GmbH Propan-2-ol Product Family", 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 "Brenntag GmbH Propan-2-ol Product Family" and subject to compliance with the draft SPC, the same single biocidal product "Hydroflex IPA 70 Biocide" meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.(5)On 4 April 2024, the Agency transmitted to the Commission the revised SPC of "Hydroflex IPA 70 Biocide" 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 "Hydroflex IPA 70 Biocide".(7)The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family "Brenntag GmbH Propan-2-ol Product Family".(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: