Commission Implementing Regulation (EU) 2023/1091 of 5 June 2023 granting a Union authorisation for the single biocidal product ‘APESIN alcogel’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/1091of 5 June 2023granting a Union authorisation for the single biocidal product APESIN alcogel 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., and in particular Article 44(5), first subparagraph, thereof,Whereas:(1)On 23 April 2019, Tana-Chemie GmbH 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). for Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named "APESIN alcogel", of product-type 1, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-TV051115-15 in the Register for Biocidal Products ("the Register"). The application also indicated the application number of the related reference biocidal product family "Knieler & Team Propanol Family", recorded in the Register under case number BC-AQ050985-22.(2)The same single biocidal product "APESIN alcogel" contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.(3)On 8 December 2021, the Agency submitted to the Commission an opinionECHA opinion on "APESIN alcogel" of 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics ("SPC") of "APESIN alcogel" in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.(4)The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product 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)., and that based on the assessment of the related reference biocidal product family "Knieler & Team Propanol Family" and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.(5)On 20 October 2022, the Agency transmitted to the Commission the draft SPC 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 "APESIN alcogel".(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,HAS ADOPTED THIS REGULATION: