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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

Directive 2011/52/EU · Directive · 7 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2

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The line concerning carboxin in the Annex to Decision 2008/934/EC is deleted.

Article 3

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Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 December 2011. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 4

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1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing carboxin as an active substance by 30 November 2011. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to carboxin are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive. 2. By way of derogation from paragraph 1, for each authorised plant protection product containing carboxin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning carboxin. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing carboxin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or (b) in the case of a product containing carboxin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 5

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This Directive shall enter into force on 1 June 2011.

Article 6

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This Directive is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

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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: No Common name, identification numbers IUPAC name Purity ( 1 ) Entry into force Expiration of inclusion Specific provisions ‘357 Carboxin CAS No: 5234-68-4 CIPAC No: 273 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide ≥ 970 g/kg 1 June 2011 31 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 M6 ( *1 ) in soil, groundwater and surface water and for the monitoring of metabolite M9 ( *2 ) in groundwater; (e) additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 ( *3 ) and P/V-55 ( *4 ) ; (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.’ ( 1 ) Further details on identity and specification of active substance are provided in the review report. ( *1 ) 2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate. ( *2 ) (2 RS )-2-hydroxy-2-methyl- N -phenyl-1,4-oxathiane-3-carboxamide 4-oxide. ( *3 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. ( *4 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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