Date: 2018-12-14Category: Not ApplicableState: Union GovernmentCountry: Europe
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.)
Issued by European Commission
· Directorate-General for Health and Food Safety
**Summary:**
This Commission Implementing Decision (EU) 2018/1985, dated 13 December 2018, formally disapproves the use of *Willaertia magna c2c maky* as an active substance in biocidal products of product-type 11 (preservatives for liquid cooling and processing systems) within the European Union. The decision, based on Regulation (EU) No 528/2012, follows an evaluation by the French competent authority and an opinion from the European Chemicals Agency (ECHA) Biocidal Products Committee (BPC). The BPC opinion (ECHA/BPC/206/2018, adopted on 26 April 2018) concluded that biocidal products containing *Willaertia magna c2c maky* do not meet the criteria outlined in Article 19(1)(b) of Regulation (EU) No 528/2012. Specifically, the human health risk assessment identified unacceptable risks with no safe use identified, and the efficacy of *Willaertia magna c2c maky* in controlling *Legionella pneumophila* was not sufficiently demonstrated. The decision was adopted in accordance with the opinion of the Standing Committee on Biocidal Products and entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Willaertia magna c2c maky: A microorganism considered for use as an active substance in biocidal products of product-type 11.
Regulation (EU) No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
France: The member state of the European Union whose evaluating competent authority received the application for approval of Willaertia magna c2c maky.
European Chemicals Agency: An agency of the European Union that provides scientific advice on chemicals.
Biocidal Products Committee: A committee within the European Chemicals Agency that formulates opinions on biocidal products.
Jean-Claude Juncker: The President of the European Commission at the time the decision was adopted.
14.12.2018 EN Official Journal of the European Union L 317/27
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:
(1) The evaluating competent authority of France received on 17 March 2014 an application for the approval of the
microorganism Willaertia magna c2c maky 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.
(2) The evaluating competent authority of France submitted the assessment report together with its conclusions on
15 March 2017 in accordance with Article 8(1) of Regulation (EU) No 528/2012.
(3) The opinion of the European Chemicals Agency was formulated on 26 April 2018 by the Biocidal Products
Committee, having regard to the conclusions of the evaluating competent authority (2).
(4) According to that opinion, biocidal products of product-type 11 containing Willaertia magna c2c maky 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 Willaertia magna c2c maky to control Legionella pneumophila was not
sufficiently demonstrated.
(5) Taking into account the opinion of the European Chemicals Agency, the Commission considers it not
appropriate to approve Willaertia magna c2c maky for use in biocidal products of product-type 11.
(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
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.
(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.L 317/28 EN Official Journal of the European Union 14.12.2018
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