Commission Implementing Directive 2011/60/EUShow full title

Commission Implementing Directive 2011/60/EU of 23 May 2011 amending Council Directive 91/414/EEC to include tebufenozide as active substance and amending Commission Decision 2008/934/EC (Text with EEA relevance)

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.

NoCommon name, identification numbersIUPAC namePurityaEntry into forceExpiration of inclusionSpecific 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 201131 May 2021

PART A

Only uses as insecticide may be authorised.

PART B

For 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.’