Commission Implementing Regulation (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family ‘SOPUROXID’ (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/964of 10 June 2022granting a Union authorisation for the biocidal product family SOPUROXID(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 the first subparagraph of Article 44(5) thereof,Whereas:(1)On 1 September 2017, SOPURA N.V. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named "SOPUROXID" of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-KV033704-17 in the Register for Biocidal Products.(2)"SOPUROXID" contains peracetic acid, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.(3)On 27 August 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency ("the Agency").(4)On 31 March 2021, the Agency submitted to the Commission an opinionECHA opinion of 4 March 2021 on the Union authorisation of "SOPUROXID" (ECHA/BPC/279/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation, including the draft summary of the biocidal product characteristics ("SPC") of "SOPUROXID" and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.(5)The opinion concludes that "SOPUROXID" is a "biocidal product family" within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.(6)On 28 April 2021, 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.(7)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for "SOPUROXID".(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: