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Commission Directive 2011/25/EUShow full title

Commission Directive 2011/25/EU of 3 March 2011 amending Council Directive 91/414/EEC to include bupirimate as active substance and amending Commission Decision 2008/934/EC (Text with EEA relevance)

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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
‘337

Bupirimate

CAS No: 41483-43-6

CIPAC No: 261

5-butyl-2-ethylamino-6-methylpyrimidine-4-yl dimethylsulfamate

≥ 945 g/kg

Impurities:

Ethirimol: max. 2 g/kg

Toluene: max. 3 g/kg

1 June 201131 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on bupirimate, 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 protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,

  • the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigations, where appropriate,

  • the in-field risk to non-target arthropods.

The Member States concerned shall request the submission of confirmatory information as regards:

(1)

the specification of the technical material, as commercially manufactured, by appropriate analytical data; including information on the relevance of the impurities;

(2)

the equivalence between the specifications of the technical material; as commercially manufactured, and those of the test material used in the toxicity dossiers;

(3)

the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B (de-ethyl-bupirimate).

The Member States concerned shall ensure that the applicant submits such confirmatory data and information to the Commission set out in points (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013.’

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