ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 37 on metalaxyl-M is deleted; (2) in Part B, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions ‘140 Metalaxyl-M methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate ≥ 920 g/kg 1 June 2020 31 May 2035 When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised. CAS No 70630-17-0 (R) CIPAC No 580 The following impurities are of toxicological concern and must not exceed the following levels in the technical material: 2,6-dimethylphenylamine: max. content 0,5 g/kg 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide: max. content 1 g/kg 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester: max. content 0,18 g/kg 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 metalaxyl-M, 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 specification of the technical material as commercially manufactured; — the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of non-target arthropods, birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 by 26 May 2022. ( 1 ) Further details on the identity and the specification of the active substance are provided in the review report.’