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 ‘41 Spiromesifen CAS No 283594-90-1 CIPAC No 747 3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate ≥ 965 g/kg (racemic) The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material. 1 October 2013 30 September 2023 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 spiromesifen, 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: — the long-term risk to aquatic invertebrates, — the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible, — the protection of workers and operators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.’ ( *1 ) Further details on identity and specification of active substance are provided in the review report.