Document ID: 32016D0109
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 21/84</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2016/109
of 27 January 2016
not to approve PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-types 1, 6 and 9
(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 PHMB (1600; 1.8).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>PHMB (1600; 1.8) has been evaluated for use in product-type 1, human hygiene, product-type 6, preservatives for products during storage, and product-type 9, fibre, leather, rubber and polymerised materials preservatives, 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>France was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, on 5 September 2013, 8 October 2013 and 14 February 2014, respectively.</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 opinions of the European Chemicals Agency were formulated on 16 and 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 those opinions, biocidal products used for product-types 1, 6 and 9 and containing PHMB (1600; 1.8) may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No&#160;528/2012. For these product-types, the scenarios evaluated in the human health risk assessments and the environmental risk assessments 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 PHMB (1600; 1.8) for use in biocidal products for product-types 1, 6 and 9.</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
PHMB (1600; 1.8) (EC No: n.a., CAS No 27083-27-8 and 32289-58-0) is not approved as an active substance for use in biocidal products for product-types 1, 6 and 9.
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 ).
</note>