ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, the entry 61 on Mesotrione is deleted; (2) in Part B, the following entry is added: ‘112 Mesotrione CAS No 104206-82-8 CIPAC No 625 Mesotrione 2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione ≥ 920 g/kg R287431 max 2 mg/kg R287432 max 2 g/kg 1,2-dichloroethane max 1 g/kg 1 June 2017 31 May 2032 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on mesotrione, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, — the protection of groundwater in vulnerable regions, — the protection of mammals, aquatic and non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the genotoxic profile of the metabolite AMBA; 2. the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors; 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water. The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under point 1 by 1 July 2017 and the relevant information requested under point 2 by 31 December 2017. The applicant shall submit to the Commission, the Member States and the Authority the confirmatory information requested under point 3 within a period of two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.’