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Commission Implementing Directive 2011/46/EU of 14 April 2011 amending Council Directive 91/414/EEC to include hexythiazox as active substance and amending Commission Decision 2008/934/EC Text with EEA relevance

Commission Implementing Directive 2011/46/EU of 14 April 2011 amending Council Directive 91/414/EEC to include hexythiazox as active substance and amending Commission Decision 2008/934/EC Text with EEA relevance

Directive 2011/46/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 hexythiazox 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 hexythiazox 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 hexythiazox 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 hexythiazox 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 hexythiazox. 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 hexythiazox 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 hexythiazox 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 ‘343 Hexythiazox CAS No 78587-05-0 CIPAC No 439 (4 RS ,5 RS )-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide ≥ 976 g/kg (1:1 mixture of (4 R , 5 R ) and (4 S , 5 S )) 1 June 2011 31 May 2021 PART A Only uses as acaricide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hexythiazox, 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: — the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate, — the operators and workers safety. Conditions of use shall include protective measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the toxicological relevance of the metabolite PT-1-3  ( *1 ) ; (b) the potential occurrence of the metabolite PT-1-3 in processed commodities; (c) the potential adverse effects of hexythiazox on bee brood; (d) the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) 2 years after the adoption of specific guidance.’ ( 1 )   Further details on identity and specification of active substance are provided in the review report. ( *1 )   (4 S ,5 S )-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4 R ,5 R )-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.

Other acts of the same type
Council Directive 90/653/EEC of 4 December 1990 laying down amendments for the purpose of implementing in Germany certain Community Directives relating to statistics on the carriage of goods and statistics on gas and electricity pricesCommission Directive 90/623/EEC of 7 November 1990 amending Annex II to Council Directive 66/402/EEC on the marketing of cereal seedCommission Directive 90/629/EEC of 30 October 1990 adapting to technical progress Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor vehicle safety beltsCommission Directive 90/630/EEC of 30 October 1990 adapting to technical progress Council Directive 77/649/EEC on the approximation of the laws of the Member States relating to the field of vision of motor vehicle driversCouncil Directive 90/428/EEC of 26 June 1990 on trade in equidae intended for competitions and laying down the conditions for participation thereinCouncil Directive 90/269/EEC of 29 May 1990 on the minimum health and safety requirements for the manual handling of loads where there is a risk particularly of back injury to workers (fourth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)Council Directive 90/270/EEC of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)Commission Directive 90/207/EEC of 4 April 1990 amending the Second Directive 82/434/EEC on the approximation of the laws of the Member State relating to methods of analysis necessary for checking the composition of cosmetic productsCouncil Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contractsCouncil Directive 89/654/EEC of 30 November 1989 concerning the minimum safety and health requirements for the workplace (first individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC)Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC)Council Directive 89/617/EEC of 27 November 1989 amending Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement

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

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