Commission Implementing Regulation (EU) 2020/1187
of 7 August 2020
granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’
(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 products(1), and in particular the first subparagraph of Article 44(5) thereof,
Whereas:
(1) On 13 August 2015, CID LINES NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine based products – CID LINES NV’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-BY019142-30 in the Register for Biocidal Products.
(2) ‘Iodine based products – CID LINES NV’ 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) 2017/2100(2), the Commission is carrying out a review of 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 consider whether the Union authorisations for products containing the active substance have to be cancelled or amended in accordance with Article 48 of Regulation (EU) No 528/2012.
(3) On 28 May 2019, 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 17 January 2020, the Agency submitted to the Commission an opinion(3), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Iodine based products – CID LINES NV’ 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 ‘Iodine based products – CID LINES NV’ is a biocidal product family within the meaning of 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, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.
(6) On 4 February 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.
(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Iodine based products – CID LINES NV’.
(8) According to the opinion of the Agency, as regards the non-active substances sodium iodide and sodium iodate contained in ‘Iodine based products – CID LINES NV’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Delegated Regulation (EU) 2017/2100 within the period for the evaluation of the application. Further examination of sodium iodide and sodium iodate should therefore take place. If it is concluded that sodium iodide or sodium iodate or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Iodine based products – CID LINES NV’ in accordance with Article 48 of Regulation (EU) No 528/2012.
(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:
Commission 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).
ECHA opinion of 11 December 2019 on the Union authorisation of ‘Iodine based products – CID LINES NV’ (ECHA/BPC/237/2019).