Commission Directive 2008/40/EC of 28 March 2008 amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances (Text with EEA relevance)
Modified by
  • Commission Decisionof 10 October 2008correcting Directive 2008/40/EC amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances(notified under document number C(2008) 5703)(Text with EEA relevance)(2008/791/EC), 32008D0791, October 11, 2008
  • Regulation (EC) No 1107/2009 of the European Parliament and of the Councilof 21 October 2009concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, 32009R1107, November 24, 2009
Commission Directive 2008/40/ECof 28 March 2008amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances(Text with EEA relevance)
Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2Member States shall adopt and publish by 30 June 2009 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 July 2009.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 31.Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing amidosulfuron and nicosulfuron as active substances by 30 June 2009.By that date they shall in particular verify that the conditions in Annex I to that Directive relating to amidosulfuron and nicosulfuron 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 amidosulfuron and nicosulfuron 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 December 2008 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 amidosulfuron and nicosulfuron respectively. 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 amidosulfuron and nicosulfuron as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2012 at the latest; or(b)in the case of a product containing amidosulfuron and nicosulfuron as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2012 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 4This Directive shall enter into force on 1 January 2009.
Article 5This Directive is addressed to the Member States.
nullANNEXThe following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
Further details on identity and specification of active substance are provided in the review report.
NoCommon name, identification numbersIUPAC namePurityEntry into forceExpiration of inclusionSpecific provisions
"175AmidosulfuronCAS No 120923-37-7CIPAC No 5153-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)ureaor1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea≥ 970 g/kg1 January 200931 December 2018PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions,the protection of aquatic plants.In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.
176NicosulfuronCAS No 111991-09-4CIPAC No 7092-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamideor1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea≥ 930 g/kg1 January 200931 December 2018PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:the potential exposure of the aquatic environment to metabolite DUDN when nicosulfuron is applied in regions with vulnerable soil conditions,the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones,the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone,the protection of groundwater and surface water under vulnerable soil and climatic conditions."
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Further details on identity and specification of active substance are provided in the review report.
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