ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 83 on alpha-cypermethrin is deleted; (2) in Part E, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity ( * ) Date of approval Expiration of approval Specific provisions ‘12 alpha-cypermethrin CAS No 67375-30-8 CIPAC No 454 Racemate comprising: (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate or (R)-α-cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate ≥ 980 g/kg The manufacturing impurity hexane is considered to be of toxicological concern and must not exceed 1 g/kg in the technical material 1 November 2019 31 October 2026 For the implementation of the uniform principles, as referred to in Article 9(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on alpha-cypermethrin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that the conditions of use prescribe the application of adequate personal protective equipment; — the consumer risk assessment; — the protection of aquatic organisms, bees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety; 2. the potential relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR); 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water; 4. Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605. The applicant shall submit the information referred to in point 1 by 30 October 2020; the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of isomer mixtures; and the information referred to in point 3 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. As regards Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of androgenic endocrine activity shall be submitted by 30 October 2021.’ ( *1 ) Further details on the identity and the specification of the active substance are provided in the renewal report.