Document ID: 32016D0110
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>28.1.2016&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 21/86</p></td></tr></tbody></table>
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 ( 1 ) , and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Delegated Regulation (EU) No 1062/2014&#160;<a>(<span>2</span>)</a> establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes triclosan.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Triclosan has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council&#160;<a>(<span>3</span>)</a> 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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Denmark was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 8 April 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>It is therefore not appropriate to approve triclosan for use in biocidal products for product-type 1.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Triclosan (EC No 222-182-2, CAS No 3380-34-5) is not approved as an active substance for use in biocidal products for product-type 1.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 27 January 2016.
For the Commission
The President
Jean-Claude JUNCKER
<note>
( 1 ) OJ L 167, 27.6.2012, p. 1 .
( 2 ) 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 ).
( 3 ) 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 ).
</note>