Article 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Commission Implementing Directive 2011/40/EU of 11 April 2011 amending Council Directive 91/414/EEC to include sintofen as active substance and amending Commission Decision 2008/934/EC Text with EEA relevance
Commission Implementing Directive 2011/40/EU of 11 April 2011 amending Council Directive 91/414/EEC to include sintofen as active substance and amending Commission Decision 2008/934/EC Text with EEA relevance
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 2
The line concerning sintofen in the Annex to Decision 2008/934/EC is deleted.
Article 3
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
1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing sintofen 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 sintofen 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 sintofen 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 sintofen. 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 sintofen 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 sintofen 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
This Directive shall enter into force on 1 June 2011.
Article 6
This Directive is addressed to the Member States.
Supplementary provisions
ANNEXSupplementary provisions
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 ‘347 Sintofen CAS No 130561-48-7 CIPAC No 717 1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid ≥ 980 g/kg Impurities: 2-methoxyethanol, not more than 0,25 g/kg N,N-dimethylformamide, not more than 1,5 g/kg 1 June 2011 31 May 2021 PART A Only uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sintofen, and in particular Appendices I and II thereto, 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 the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain. The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, supported by appropriate analytical data; (2) the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide; (3) the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material; (4) the metabolic profile of sintofen in rotational crops. The Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 1 December 2011 and the information set out in point (4) by 31 May 2013.’ ( 1 ) Further details on identity and specification of active substance are provided in the review report.
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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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