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.)

What 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.) requires

Commission Implementing Decision (EU) 2018/1985, adopted on 13 December 2018 and published in the Official Journal of the European Union on 14 December 2018, formally declines to approve the microorganism Willaertia magna c2c maky as an active substance for use 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. The decision follows an application received on 17 March 2014 by the evaluating competent authority of France, an assessment report submitted on 15 March 2017, and a Biocidal Products Committee opinion formulated by the European Chemicals Agency on 26 April 2018 (ECHA/BPC/206/2018). 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. 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. The Decision entered into force on the twentieth day following its publication in the Official Journal.

Pillar: Legal & IP Sovereignty · Authority: European Commission · Version: 1.0.0 · Last updated: 2018-12-14

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018D1985

SHA-256 integrity: 61d1e11d760eb55ed7e4aa412efedfe17199cb82afdb3ab24868d65f86e02410

Primary Citations — 9 traced to source

• 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.'

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