Commission Implementing Regulation (EU) No 1031/2013 of 24 October 2013 approving the active substance penflufen, 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 penflufen, 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 penflufen as an active substance by 31 July 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 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 penflufen 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 January 2014 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 penflufen as the only active substance, where necessary, amend or withdraw the authorisation by 31 July 2015 at the latest; or (b) in the case of a product containing penflufen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 July 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 February 2014.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Penflufen CAS No 494793-67-8 CIPAC No 826 2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide ≥ 950 g/kg 1:1 (R:S) ratio of enantiomers 1 February 2014 31 January 2024 PART A Only uses to treat seed potato tubers before or during planting, may be authorised, limited to one application every third year on the same field. 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 penflufen, 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: (a) the protection of operators; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the long term risk to birds; (2) the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council  ( 2 ) as ‘carcinogen category 2’. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 September 2015 and the information set out in point (2) within six months from the notification of the classification decision concerning that substance. The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. ( 1 )   Further details on identity and specification of active substance are provided in the review report. ( 2 )    OJ L 353, 31.12.2008, p. 1 .

ANNEX IISupplementary provisions

ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity  ( *1 ) Date of approval Expiration of approval Specific provisions ‘55 Penflufen CAS No 494793-67-8 CIPAC No 826 2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide ≥ 950 g/kg 1:1 (R:S) ratio of enantiomers 1 February 2014 31 January 2024 PART A Only uses to treat seed potato tubers before or during planting, may be authorised, limited to one application every third year on the same field. 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 penflufen, 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: (a) the protection of operators; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the long term risk to birds; (2) the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 as ‘carcinogen category 2’. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 September 2015 and the information set out in point (2) within six months from the notification of the classification decision concerning that substance. The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.’ ( *1 )   Further details on identity and specification of active substance are provided in the review report.