{
  "url": "https://openlegislation.uk/eu-directive-2008-116/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2008-116/annex.json",
  "legislation": "eudr/2008/116",
  "legislation_title": "Commission Directive 2008/116/EC of 15 December 2008 amending Council Directive 91/414/EEC to include aclonifen, imidacloprid and metazachlor as active substances (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2008-116",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:\nFurther details on identity and specification of active substance are provided in the review report.\nNo\nCommon name, identification numbers\nIUPAC name\nPurity\nEntry into force\nExpiration of inclusion\nSpecific provisions\n‘221\nAclonifen\nCAS No 74070-46-5\nCIPAC No 498\n2-chloro-6-nitro-3-phenoxyaniline\n≥ 970 g/kg\nThe impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.\n1 August 2009\n31 July 2019\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, 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.\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,\nthe protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,\nthe residues in rotational crops and evaluate the dietary exposure of consumers,\nthe protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.\nThe Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.\nThey shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.\n222\nImidacloprid\nCAS No 138261-41-3\nCIPAC No 582\n(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine\n≥ 970 g/kg\n1 August 2009\n31 July 2019\nPART A\nOnly uses as insecticide may be authorised.\nFor the protection of non-target organisms, in particular honey bees and birds, for use as seed treatment:\nthe seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded,\nadequate application equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust clouds emission. Member States shall ensure that the label of treated seed includes the indication that the seeds were treated with imidacloprid and sets out the risk mitigation measures provided for in the authorisation.\nPART B\nIn assessing applications to authorise plant protection products containing imidacloprid for uses other than tomatoes in glasshouses, 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.\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures,\nthe protection of honey bees, in particular for spray applications and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.\nThe Member States concerned shall request the submission of:\ninformation to further address the risk assessment for operators and workers,\ninformation to further address the risk to birds and mammals.\nThey shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.\n223\nMetazachlor\nCAS No 67129-08-2\nCIPAC No 411\n2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide\n≥ 940 g/kg\nThe manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,01 % is established.\n1 August 2009\n31 July 2019\nPART A\nOnly uses as herbicide may be authorised; application max. of 1,0 kg/ha only every third year on the same field.\nPART B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,\nthe protection of aquatic organisms,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.\nIf metazachlor is classified under Directive 67/548/EEC as “limited evidence of a cancerogenic effect”, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.\nThey shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Further details on identity and specification of active substance are provided in the review report."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2008/116/annex",
    "retrieved_at": "2026-11-01T15:22:17.093144+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}