Commission Implementing Regulation (EU) No 740/2011 of 27 July 2011 approving the active substance bispyribac, 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 bispyribac, 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 bispyribac as active substance by 31 January 2012. 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 Part B of 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 bispyribac 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 31 July 2011 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 Part B of 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 bispyribac as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2013 at the latest; or (b) in the case of a product containing bispyribac as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2013 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 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.

Repeal

Article 4

Directive 2011/22/EU is repealed.

Entry into force and date of application

Article 5

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union . It shall apply from 1 August 2011.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Bispyribac CAS No 125401-75-4 CIPAC No 748 2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid ≥ 930 g/kg (referred to as bispyribac-sodium) 1 August 2011 31 July 2021 PART A Only uses as herbicide in rice may be authorised. PART B 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 bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment, Member States shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures where appropriate. The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03  ( 2 ) , M04  ( 3 ) and M10  ( 4 ) . They shall ensure that the applicant provides such information to the Commission by 31 July 2013. ( 1 )   Further details on identity and specification of active substances are provided in the review report. ( 2 )   2-hydroxy-4,6-dimethoxypyrimidine. ( 3 )   2,4-dihydroxy-6-methoxypyrimidine. ( 4 )   sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.

ANNEX IISupplementary provisions

ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: ‘1 Bispyribac CAS No 125401-75-4 CIPAC No 748 2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid ≥ 930 g/kg (referred to as bispyribac-sodium) 1 August 2011 31 July 2021 PART A Only uses as herbicide in rice may be authorised. PART B 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 bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment, Member States shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures where appropriate. The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03  ( *1 ) , M04  ( *2 ) and M10  ( *3 ) . They shall ensure that the applicant provides such information to the Commission by 31 July 2013. ( *1 )   2-hydroxy-4,6-dimethoxypyrimidine. ( *2 )   2,4-dihydroxy-6-methoxypyrimidine. ( *3 )   sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.’