Commission Directive 2011/30/EU (repealed)Show full title

Commission Directive 2011/30/EU of 7 March 2011 amending Council Directive 91/414/EEC to include fenbutatin oxide as active substance and amending Commission Decision 2008/934/EC (Text with EEA relevance) (repealed)

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.

NoCommon Name, Identification NumbersIUPAC NamePurityaEntry into forceExpiration of inclusionSpecific 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 201131 May 2021

PART A

Only uses as acaricide in greenhouses may be authorised.

PART B

For 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:

  • the technical specification of the impurity content,

  • the residue levels in small tomato varieties (cherry tomatoes),

  • the operator safety. Conditions of use shall prescribe the application of adequate personal protective equipment, where appropriate,

  • the risk to aquatic organisms.

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.’