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.