Document ID: 32018D1985
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>14.12.2018&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 317/27</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2018/1985
of 13 December 2018
not approving Willaertia magna c2c maky as an active substance for use in biocidal products of product-type 11
(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 9(1)(b) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The evaluating competent authority of France received on 17&#160;March 2014 an application for the approval of the microorganism<span>Willaertia magna c2c maky</span> for use as an active substance in biocidal products of product-type 11, preservatives for liquid cooling and processing systems, as described in Annex V to Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The evaluating competent authority of France submitted the assessment report together with its conclusions on 15&#160;March 2017 in accordance with Article 8(1) of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The opinion of the European Chemicals Agency was formulated on 26&#160;April 2018 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority&#160;<a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>According to that opinion, biocidal products of product-type 11 containing<span>Willaertia magna c2c maky</span> may not be expected to meet the criteria laid down in Article 19(1)(b) of Regulation (EU) No 528/2012. In particular, the scenarios evaluated in the human health risk assessment identified unacceptable risks and no safe use could be identified. Moreover, the innate efficacy of<span>Willaertia magna c2c maky</span> to control<span>Legionella pneumophila</span> was not sufficiently demonstrated.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Taking into account the opinion of the European Chemicals Agency, the Commission considers it not appropriate to approve<span>Willaertia magna c2c maky</span> for use in biocidal products of product-type 11.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</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
Willaertia magna c2c maky is not approved as an active substance for use in biocidal products of product-type 11.
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, 13 December 2018.
For the Commission
The President
Jean-Claude JUNCKER
<note>
( 1 ) OJ L 167, 27.6.2012, p. 1 .
( 2 ) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Willaertia magna c2c maky, product-type 11, ECHA/BPC/206/2018, adopted on 26 April 2018.
</note>