Commission Implementing Regulation (EU) 2018/1258 of 18 September 2018 granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2018/1258of 18 September 2018granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family(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) thereof,Whereas:(1)On 23 July 2015, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Ecolab Iodine PT3 Family ("the product family") of product-type 3, as described in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-VG018734-32 in the Register for Biocidal Products ("the Register").(2)The biocidal product family contains iodine, including polyvinylpyrrolidone iodine, 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. Taking into account the intrinsic properties of the active substance, once 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). will become applicable, 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 6 June 2017, 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 12 January 2018, the Agency submitted to the Commission an opinionECHA opinion of 12 December 2017 on the Union authorisation of Ecolab Iodine PT3 Family (ECHA/BPC/177/2017)., including the draft summary of the biocidal product characteristics ("SPC") and the final assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the 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 was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.(5)On 26 February 2018, 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 therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012.(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: