Commission Implementing Regulation (EU) 2021/978 of 10 June 2021 granting a Union authorisation for the biocidal product family “Lyso IPA Surface Disinfection” (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/978of 10 June 2021granting a Union authorisation for the biocidal product family Lyso IPA Surface Disinfection(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 22 June 2016, Schuelke & Mayr 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 authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named "Lyso IPA Surface Disinfection", of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-GX025200-35 in the Register for Biocidal Products ("the Register"). The application also indicated the application number of the related reference product family "perform-IPA", recorded in the Register under case number BC-AB023095-72.(2)The same biocidal product family "Lyso IPA Surface Disinfection" contains propan-2-ol, 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 12 May 2020, the Agency submitted to the Commission an opinionECHA opinion of 11 May 2020 on the Union authorisation of the same biocidal product family "Lyso IPA Surface Disinfection", https://echa.europa.eu/en/opinions-on-union-authorisation and the draft summary of the biocidal product characteristics ("SPC") of "Lyso IPA Surface Disinfection" in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.(4)The opinion concludes that "Lyso IPA Surface Disinfection" is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same biocidal product family and the related reference biocidal 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)., that "Lyso IPA Surface Disinfection" is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012, and that based on the assessment of the related reference "perform-IPA" product family and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.(5)On 6 November 2020, 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 biocidal product family "Lyso IPA Surface Disinfection".(7)The same biocidal product family "Lyso IPA Surface Disinfection" contains the non-active substance diethyl phthalate, for which it was not possible to conclude whether it meets the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1). within the period for the evaluation of the application for the related reference biocidal product family. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for "Lyso IPA Surface Disinfection" in accordance with Article 48 of Regulation (EU) No 528/2012.(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: