Commission Implementing Decision (EU) 2016/110
of 27 January 2016
not approving triclosan as an existing active substance for use in biocidal products for product-type 1
(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, and in particular the third subparagraph of Article 89(1) thereof,
OJ L 167, 27.6.2012, p. 1.
Whereas:
(1) Commission Delegated Regulation (EU) No 1062/2014 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes triclosan.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
(2) Triclosan has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council for use in product-type 1, human hygiene biocidal products, as defined in Annex V to that Directive, which corresponds to product-type 1, as defined in Annex V to Regulation (EU) No 528/2012.
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
(3) Denmark was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 8 April 2013.
(4) In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 17 June 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
(5) According to that opinion, biocidal products used for product-type 1 and containing triclosan may not be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. The scenarios evaluated in the environmental risk assessment identified unacceptable risks.
(6) It is therefore not appropriate to approve triclosan for use in biocidal products for product-type 1.
(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DECISION: