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Commission Directive 2011/9/EU of 1 February 2011 amending Council Directive 91/414/EEC to include dodine as active substance and amending Decision 2008/934/EC Text with EEA relevance

Commission Directive 2011/9/EU of 1 February 2011 amending Council Directive 91/414/EEC to include dodine as active substance and amending Decision 2008/934/EC Text with EEA relevance

Directive 2011/9/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 dodine 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 dodine 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 dodine 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 dodine 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 dodine. 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 dodine 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 dodine 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.

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 ‘326 Dodine CAS No: 2439-10-3 CIPAC No: 101 1-dodecylguanidinium acetate ≥ 950 g/kg 1 June 2011 31 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 dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the potential long-term risk to birds and mammals; (b) the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures; (c) the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures; (d) the monitoring of residue levels in pome fruit. The Member States concerned shall request the submission of confirmatory information as regards: (a) long-term risk assessment for birds and mammals; (b) risk assessment in natural surface water systems where major metabolites have potentially formed. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.’ ( 1 )   Further details on identity and specification of active substance are provided in the review report.

Other acts of the same type
Directive 97/63/EC of the European Parliament and of the Council of 24 November 1997 amending Directives 76/116/EEC, 80/876/EEC, 89/284/EEC and 89/530/EEC on the approximation of the laws of the Member States relating to fertilizersCouncil Directive 97/62/EC of 27 October 1997 adapting to technical and scientific progress Directive 92/43/EEC on the conservation of natural habitats and of wild fauna and floraDirective 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemesDirective 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of servicesCouncil Directive 96/75/EC of 19 November 1996 on the systems of chartering and pricing in national and international inland waterway transport in the CommunityCouncil Directive 96/72/EC of 18 November 1996 amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seedCouncil Directive 96/67/EC of 15 October 1996 on access to the groundhandling market at Community airportsCouncil Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT)Council Directive 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the Community the maximum authorized dimensions in national and international traffic and the maximum authorized weights in international trafficCouncil Directive 96/52/EC of 23 July 1996 amending Directive 85/350/EEC with regard to the Community list of less-favoured farming areas within the meaning of Directive 75/268/EEC (Ireland)Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (Text with EEA relevance)Commission Directive 96/40/EC of 25 June 1996 establishing a common model for an identity card for inspectors carrying out port State control (Text with EEA relevance)

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

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