ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 26 on thifensulfuron-methyl is deleted; (2) in Part B, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity ( *1 ) Date of approval Expiration of approval Specific provisions ‘104 Thifensulfuron-methyl CAS No 79277-27-3 CIPAC No 452 methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate ≥ 960 g/kg 1 November 2016 31 October 2031 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 thifensulfuron-methyl, 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 groundwater; — the protection of non-target plants and aquatic organisms. Conditions of use shall include risk mitigation measures and the obligation to monitor the groundwater, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the absence of genotoxicity of metabolites IN-A4098 and its derivative IN-B5528, IN-A5546 and IN-W8268; (2) mechanistic data to rule out an endocrine mediated mode of action for mammary gland tumours; (3) the risk to aquatic organisms from thifensulfuron-methyl and metabolite IN-D8858 and the risk to soil organisms from metabolites IN-JZ789 and 2 acid 3 triuret; (4) the relevance of the metabolites IN-A4098, IN-L9223 and IN-JZ789 if thifensulfuron-methyl is classified as reprotoxic category 2 under Regulation (EC) No 1272/2008 and the risk that those metabolites contaminate groundwater. The applicant shall submit the information requested under point (1) by 31 March 2017, under points (2) and (3) by 30 June 2017 and under point (4) within six months after the notification of the classification decision concerning thifensulfuron-methyl.’ ( *1 ) Further details on identity and specification of active substance are provided in the review report.