My bookmarksSign up free
Source

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

Open ↗

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

Article 2

Open ↗

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

Article 3

Open ↗

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

Open ↗

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

Open ↗

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 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environmentDirective 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securitiesCouncil Directive 2001/40/EC of 28 May 2001 on the mutual recognition of decisions on the expulsion of third country nationalsDirective 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information societyDirective 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human useDirective 2001/24/EC of the European Parliament and of the Council of 4 April 2001 on the reorganisation and winding up of credit institutionsDirective 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission DeclarationCouncil Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businessesDirective 2000/84/EC of the European Parliament and of the Council of 19 January 2001 on summer-time arrangementsCommission Directive 2001/2/EC of 4 January 2001 adapting to technical progress Council Directive 1999/36/EC on transportable pressure equipment (Text with EEA relevance)Commission Directive 2000/82/EC of 20 December 2000 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on fruit and vegetables, cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation

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

Contents

What to look at next