Commission Implementing Regulation (EU) No 356/2013 of 18 April 2013 approving the active substance halosulfuron-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

Approval of active substance

Article 1

The active substance halosulfuron-methyl, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Re-evaluation of plant protection products

Article 2

1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing halosulfuron-methyl as an active substance by 31 March 2014. By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009. 2.   By way of derogation from paragraph 1, for each authorised plant protection product containing halosulfuron-methyl as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 September 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009. Following that determination Member States shall: (a) in the case of a product containing halosulfuron-methyl as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or (b) in the case of a product containing halosulfuron-methyl as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

Amendments to Implementing Regulation (EU) No 540/2011

Article 3

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 4

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 October 2013.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Halosulfuron-methyl CAS No 100785-20-1 CIPAC No 785.201 methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate ≥ 980 g/kg 1 October 2013 30 September 2023 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 halosulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk of leakage to groundwater of the metabolite ‘halosulfuron rearrangement’ (HSR)  ( 2 ) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron, — the risk to non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) information as regards the equivalence between the technical specifications of the material, as commercially manufactured, and those of the material used in the toxicological and ecotoxicological studies; (b) information on the toxicological relevance of the impurities present in the technical specification of the material as commercially manufactured; (c) data to clarify the potential genotoxic properties of chlorosulfonamide acid  ( 3 ) . The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015. ( 1 )   Further details on identity and specification of active substance are provided in the review report. ( 2 )   3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1 H -pyrazole-4-carboxylic acid. ( 3 )   3-chloro-1-methyl-5-sulfamoyl-1 H -pyrazole-4-carboxylic acid.

ANNEX IISupplementary provisions

ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: ‘35 Halosulfuron-methyl CAS No 100785-20-1 CIPAC No 785.201 methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate ≥ 980 g/kg 1 October 2013 30 September 2023 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 halosulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk of leakage to groundwater of the metabolite ‘halosulfuron rearrangement’ (HSR)  ( 1 ) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron, — the risk to non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and the test material used in the toxicological and ecotoxicological studies; (b) information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured; (c) data to clarify the potential genotoxic properties of chlorosulfonamide acid  ( 2 ) . The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015. ( 1 )   3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1 H -pyrazole-4-carboxylic acid. ( 2 )   3-chloro-1-methyl-5-sulfamoyl-1 H -pyrazole-4-carboxylic acid.’