Commission Implementing Regulation (EU) 2016/1424 of 25 August 2016 renewing the approval of the active substance thifensulfuron-methyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

Renewal of the approval of active substance

Article 1

The approval of the active substance thifensulfuron-methyl, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force and date of application

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 November 2016.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions 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 of the European Parliament and of the Council  ( 2 ) 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. ( 2 )   Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 ).

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.