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Commission Directive 2011/2/EU of 7 January 2011 amending Council Directive 91/414/EEC to include myclobutanil as active substance and amending Decision 2008/934/EC Text with EEA relevance

Commission Directive 2011/2/EU of 7 January 2011 amending Council Directive 91/414/EEC to include myclobutanil as active substance and amending Decision 2008/934/EC Text with EEA relevance

Directive 2011/2/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 myclobutanil 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 myclobutanil 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 myclobutanil 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 myclobutanil 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 myclobutanil. 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 myclobutanil 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 myclobutanil 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/EC: No Common name, identification numbers IUPAC name Purity  ( 1 ) Entry into force Expiration of inclusion Specific provisions ‘324 Myclobutanil CAS No: 88671-89-0 CIPAC No: 442 (RS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile ≥ 925 g/kg The impurity 1-methylpyrrolidin-2-one shall not exceed 1g/kg in the technical material 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 myclobutanil, 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 the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.’ ( 1 )   Further details on identity and specification of active substance are provided in the review report.

Other acts of the same type
Directive 2011/77/EU of the European Parliament and of the Council of 27 September 2011 amending Directive 2006/116/EC on the term of protection of copyright and certain related rightsCouncil Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive wasteCommission Implementing Directive 2011/68/EU of 1 July 2011 amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species Text with EEA relevanceCouncil Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to manufactured tobacco (codification)Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 Text with EEA relevanceDirective 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products Text with EEA relevanceDirective 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) Text with EEA relevanceCommission Directive 2011/63/EU of 1 June 2011 amending, for the purpose of its adaptation to technical progress, Directive 98/70/EC of the European Parliament and of the Council relating to the quality of petrol and diesel fuelsCommission 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 relevanceDirective 2011/51/EU of the European Parliament and of the Council of 11 May 2011 amending Council Directive 2003/109/EC to extend its scope to beneficiaries of international protection Text with EEA relevanceCommission Implementing Directive 2011/56/EU of 27 April 2011 amending Council Directive 91/414/EEC to include cyproconazole as active substance and amending Commission Decision 2008/934/EC Text with EEA relevanceCommission Implementing Directive 2011/57/EU of 27 April 2011 amending Council Directive 91/414/EEC to include fluometuron as active substance and amending Commission Decision 2008/934/EC 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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