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 ‘67 Spinetoram CAS No 935545-74-7 CIPAC No 802 XDE-175-J (Major factor) (2 R ,3a R ,5a R ,5b S ,9 S ,13 S ,14 R ,16a S , 16b R )-2-(6-deoxy-3- O -ethyl-2,4-di- O -methyl-α-L-mannopyranosyloxy)-13-[(2 R ,5 S ,6 R )-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1 H - as -indaceno[3,2- d ]oxacyclododecine-7,15-dione XDE_175-L (Minor factor) (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione ≥ 830 g/kg 50-90 % XDE-175-J; and 50-10 % XDE-175-L Tolerance limits (g/kg): XDE-175-J = 581-810 XDE-175-L = 83-270 1 July 2014 30 June 2024 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 spinetoram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic and soil organisms; (b) the risk to non-target arthropods in-field; (c) the risk to bees during the application (overspray) and subsequently. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 December 2014.’ ( *1 ) Further details on identity and specification of active substance are provided in the review report.