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Commission Implementing Directive 2011/52/EUShow full title

Commission Implementing Directive 2011/52/EU of 20 April 2011 amending Council Directive 91/414/EEC to include carboxin as active substance and amending Commission Decision 2008/934/EC (Text with EEA relevance)

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Changes over time for: Commission Implementing Directive 2011/52/EU (Annexes only)

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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.

b

2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.

c

(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.

d

2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.

e

2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.

NoCommon name, identification numbersIUPAC namePurityaEntry into forceExpiration of inclusionSpecific provisions
‘357

Carboxin

CAS No: 5234-68-4

CIPAC No: 273

5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide≥ 970 g/kg1 June 201131 May 2021

PART A

Only uses as fungicide for seed treatment may be authorised.

Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carboxin, 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 pay particular attention to:

(a)

the risk to operators;

(b)

the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

(c)

the risk to birds and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

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

(a)

the specification of the technical material, as commercially manufactured, including appropriate analytical data;

(b)

the relevance of the impurities;

(c)

comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;

(d)

analytical methods for the monitoring of the metabolite M6b in soil, groundwater and surface water and for the monitoring of metabolite M9c in groundwater;

(e)

additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54d and P/V-55e;

(f)

rotational crop metabolism;

(g)

the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals;

(h)

the relevance for ground water of the soil metabolites P/V-54, P/V-55 and M9 if carboxin is classified under Regulation (EC) No 1272/2008 as “suspected of causing cancer”.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 1 December 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) within six months after the notification of the Decision classifying carboxin.’

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