Commission Implementing Decision (EU) 2020/1765
of 25 November 2020
not approving chlorophene as an existing active substance for use in biocidal products of product-type 2
(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 products1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That lists includes chlorophene (EC No: 204-385-8; CAS No 120-32-1).
Chlorophene has been evaluated for use in biocidal products of product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, as described in Annex V to Regulation (EU) No 528/2012.
Norway was designated as a rapporteur State and its evaluating competent authority submitted the assessment report together with its conclusions to the European Chemicals Agency (‘Agency’) on 22 December 2016.
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinion of the Agency on 4 March 20203, having regard to the conclusions of the evaluating competent authority.
According to that opinion, biocidal products of product-type 2 containing chlorophene may not be expected to meet the criteria laid down in Article 19(1)(b) of Regulation (EU) No 528/2012 as the human health risk assessment identified unacceptable risks.
Taking into account the opinion of the Agency, it is not appropriate to approve chlorophene for use in biocidal products of product-type 2.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal products,
HAS ADOPTED THIS DECISION: