ANNEXU.K.
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
a Further details on identity and specification of active substance are provided in the review report. | ||||||
No | Common name, identification numbers | IUPAC name | Puritya | Entry into force | Expiration of inclusion | Specific provisions |
---|---|---|---|---|---|---|
‘355 | Tebufenozide CAS No: 112410-23-8 CIPAC No: 724 | N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide | ≥ 970 g/kg Relevant impurity t-butyl hydrazine < 0,001 g/kg | 1 June 2011 | 31 May 2021 | PART AOnly uses as insecticide may be authorised. PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on tebufenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall: (1) pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment; (2) pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (3) pay particular attention to the protection of aquatic organisms and ensure that conditions of use prescribe adequate mitigation measures; (4) pay particular attention to the risk to Lepidoptera non-target insects. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information, as regards: (1) the relevance of metabolites RH-6595, RH-2651, M2; (2) the degradation of tebufenozide in anaerobic soils and soils of alkaline pH. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013.’ |