Commission Implementing Regulation (EU) 2019/423 of 13 March 2019 granting a Union authorisation for the biocidal product family ‘Teat disinfectants biocidal product family of Novadan’
Commission Implementing Regulation (EU) 2019/423of 13 March 2019granting a Union authorisation for the biocidal product family Teat disinfectants biocidal product family of NovadanTHE 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) thereof,Whereas:(1)On 27 August 2015, SCC GmbH, on behalf of Novadan ApS, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named "Teat disinfectants biocidal product family of Novadan" ("the biocidal product family") of product-type 3, as described in Annex V to that Regulation. The competent authority of Denmark agreed to evaluate the application as referred to in Article 43(1) of Regulation (EU) No 528/2012. The application was recorded under the case number BC-YV019394-00 in the Register for Biocidal Products.(2)The biocidal product family contains iodine, including polyvinylpyrrolidone iodine, 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. Taking into account the intrinsic properties of the active substance, and 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)., the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.(3)On 11 April 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency ("the Agency").(4)On 31 October 2018, the Agency submitted to the Commission an opinionECHA opinion of 6 July 2018 on the Union authorisation of "Teat disinfectants biocidal product family of Novadan" (ECHA/BPC/215/2018)., including the draft summary of the biocidal product characteristics ("SPC") of the biocidal product family and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that the biocidal product family falls within the definition of "biocidal product family" laid down in Article 3(1)(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, the biocidal product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.(5)On 17 January 2019, 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 biocidal product family.(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: