Document ID: 32018D0622
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>23.4.2018&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 102/80</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2018/622
of 20 April 2018
not approving chlorophene as an existing active substance for use in biocidal products of product-type 3
(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 Article 89(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Delegated Regulation (EU) No 1062/2014<a>&#160;(<span>2</span>)</a> establishes a list of existing active substances to&#160;be&#160;evaluated for their possible approval for use in biocidal products.&#160;That list includes chlorophene (EC&#160;No:&#160;204-385-8, CAS No: 120-32-1).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Chlorophene has been evaluated for use in products of product-type&#160;3, veterinary hygiene, as described in Annex&#160;V to Regulation (EU) No&#160;528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Norway was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 22&#160;December 2016.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In accordance with Article 7(2) of Delegated Regulation (EU) No&#160;1062/2014, the opinion of the European Chemicals Agency was formulated on 3&#160;October 2017 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 3 containing chlorophene may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012. For that product-type, the scenarios evaluated in the human health 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 chlorophene for use in biocidal products of product-type 3.</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
Chlorophene (EC No: 204-385-8, CAS No: 120-32-1) is not approved as an active substance for use in biocidal products of product-type 3.
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, 20 April 2018.
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 ).
</note>