ANNEX IISupplementary provisions
ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Number Common name, identification numbers IUPAC name Purity ( *1 ) Date of approval Expiration of approval Specific provisions ‘31 Cyflumetofen CAS No 400882-07-7 CIPAC No 721 2-methoxyethyl ( RS )-2-(4- tert -butylphenyl)-2-cyano-3-oxo-3-( α,α,α -trifluoro-o-tolyl)propionate ≥ 975 g/kg (racemic) 1 June 2013 31 May 2023 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyflumetofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers; — the protection of groundwater, when the substance is applied in regions with vulnerable soils and/or climatic conditions; — the protection of drinking water; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, like the use of personal protection equipment, where appropriate. The applicant shall submit confirmatory information as regards: (a) the possible mutagenic potential of the metabolite B3 (2-(trifluoromethyl) benzamide), by excluding an in vivo relevance of observed in vitro effects by an appropriate test protocol ( in vivo Comet assay); (b) additional information to establish an ARfD for metabolite B3; (c) further ecotoxicological studies and assessments for aquatic vertebrates that cover their full life-cycle. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 May 2015.’ ( *1 ) Further details on identity and specification of active substance are provided in the review report.