Commission Implementing Regulation (EU) 2023/708 of 20 March 2023 granting a Union authorisation for the biocidal product family ‘HYPO-CHLOR Product Family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/708of 20 March 2023granting a Union authorisation for the biocidal product family HYPO-CHLOR Product Family 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 20 December 2018, Veltek Associates Inc. Europe submitted to the European Chemicals Agency ("the Agency") an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named "HYPO-CHLOR Product Family" of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-EF047438-44 in the Register for Biocidal Products.(2)"HYPO-CHLOR Product Family" contains active chlorine released from sodium hypochlorite 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 for product-type 2.(3)On 24 August 2021, 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 Agency.(4)On 23 March 2022, the Agency submitted to the Commission its opinionECHA opinion of 3 March 2022 on the Union authorisation of the biocidal product family "Hypo-Chlor product family" (ECHA/BPC/321/2022), https://echa.europa.eu/bpc-opinions-on-union-authorisation, including the draft summary of the biocidal product characteristics ("SPC") of "HYPO-CHLOR Product Family" 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 "HYPO-CHLOR Product Family" 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 12 April 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.(7)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for "HYPO-CHLOR Product Family".(8)In its opinion, the Agency recommends that the authorisation holder conducts a long-term ambient storage stability test for products in meta-SPC 2A and 2B in the commercial packaging in which the products are to be made available on the market, as a condition in the authorisation. The test should address the relevant physical, chemical and technical properties of the products, both prior to and after storage, to confirm a shelf life of 24 months. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family "HYPO-CHLOR Product Family" pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation has been granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on the existing data.(9)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,HAS ADOPTED THIS REGULATION: