ANNEX IISupplementary provisions
ANNEX II In the Annex to Implementing Regulation (EU) No 540/2011 the following Part E is added: ‘PART E Candidates for substitution Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions 1 Flumetralin CAS No 62924-70-3 CIPAC No 971 N -(2-chloro-6-fluorobenzyl)- N -ethyl-α,α,α-trifluoro-2,6-dinitro- p -toluidine 980 g/kg The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material. 11 December 2015 11 December 2022 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 flumetralin, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the risk to herbivorous mammals; (d) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production); 2. the compliance of the toxicity batches with the confirmed technical specification. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016. ( 1 ) Further details on identity and specification of active substance are provided in the review report.’