Commission Implementing Regulation (EU) 2022/2108 of 3 November 2022 granting a Union authorisation for the single biocidal product ‘Ecolab UA Lactic acid single product dossier’ (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/2108of 3 November 2022granting a Union authorisation for the single biocidal product Ecolab UA Lactic acid single product dossier(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 paragraph, thereof,Whereas:(1)On 16 April 2019, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named "Ecolab UA Lactic acid single product dossier" of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Latvia had agreed to evaluate the application. The application was recorded under case number BC-XS050968-91 in the Register for Biocidal Products.(2)"Ecolab UA Lactic acid single product dossier" contains L-(+)-lactic acid, as 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 March 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 European Chemicals Agency ("the Agency").(4)On 4 November 2021, the Agency submitted to the Commission an opinionECHA opinion of 12 October 2021 on the Union authorisation of the biocidal product "Ecolab UA Lactic acid single product dossier" (ECHA/BPC/294/2021), https://echa.europa.eu/it/opinions-on-union-authorisation., the draft summary of the biocidal product characteristics ("SPC") of "Ecolab UA Lactic acid single product dossier" and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.(5)The opinion concludes that "Ecolab UA Lactic acid single product dossier" is a single biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.(6)On 22 November 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 "Ecolab UA Lactic acid single product dossier".(8)In its opinion, the Agency recommends that the Commission request the authorisation holder to conduct a shelf-life study of "Ecolab UA Lactic acid single product dossier" in commercial packaging in which the product is to be made available on the market, as a condition of the authorisation. The study should show relevant data demonstrating satisfactory chemical and physical properties prior to and after storage. The Commission agrees with that recommendation and considers that the submission of the results of that study should be a condition relating to the making available on the market and use of the single biocidal product pursuant to Article 22(1) of Regulation (EU) No 528/2012. Given the fact that that study is already being conducted, the authorisation holder should submit the results of that study to the Agency by 3 months after the date of entry into force of this Regulation. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of Regulation (EU) No 528/2012 on the basis of 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: