ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, the entry relating to fluroxypyr is deleted; (2) in Part B, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions ‘9 Fluroxypyr CAS No 69377-81-7 CIPAC No 431 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid ≥ 950 g/kg (fluroxypyr-meptyl) 1 January 2012 31 December 2021 PART A Only uses as herbicide 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 fluroxypyr, 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: (1) pay particular attention to the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil and/or with vulnerable climatic conditions; (2) pay particular attention to the risk to aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the relevance of the impurities present in the technical specifications; (b) the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material; (c) the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr methoxypyridine; (d) the residue analytical methods for plants; (e) the fate of fluroxypyr esters in animal matrices; (f) the long-term risk for earthworms and soil organisms. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) and (b) by 1 July 2012 and the information set out in points (c), (d), (e) and (f) by 31 December 2013.’ ( 1 ) Further details on identity and specification of active substance are provided in the review report.