ANNEX
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 |
---|---|---|---|---|---|---|
‘338 | Fenbutatin oxide CAS No: 13356-08-6 CIPAC No: 359 | bis[tris(2-methyl-2-phenylpropyl)-tin]oxide | ≥ 970 g/kg Impurities: bis[hydroxybis(2-methyl-2-phenylpropyl)tin]oxide (SD 31723): not more than 3 g/kg | 1 June 2011 | 31 May 2021 | PART AOnly uses as acaricide in greenhouses may be authorised. PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenbutatin oxide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to:
Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of information confirming the results of the risk assessment, on the basis of most recent scientific knowledge, as regards the impurity SD 31723. That information shall concern the following points: (a) genotoxicological potential; (b) ecotoxicological relevance; (c) spectra, storage stability and methods of analysis in the formulation. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.’ |