{
  "url": "https://openlegislation.uk/eu-directive-2008-108/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2008-108/annex.json",
  "legislation": "eudr/2008/108",
  "legislation_title": "Commission Directive 2008/108/EC of 26 November 2008 amending Council Directive 91/414/EEC to include flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as active substances (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2008-108",
  "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‘193\nFlutolanil\nCAS No 66332-96-5\nCIPAC No 524\nα,α,α-trifluoro-3′-isopropoxy-o-toluanilide\n≥ 975 g/kg\n1 March 2009\n28 February 2019\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, 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 flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.\nConditions of authorisation should include risk mitigation measures, where appropriate.\n194\nBenfluralin\nCAS No 1861-40-1\nCIPAC No 285\nN-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine\n≥ 960 g/kg\nImpurities:\nethyl-butyl-nitrosamine: max. 0,1 mg/kg\n1 March 2009\n28 February 2019\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, 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 benfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\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 food of plant and animal origin and evaluate the dietary exposure of consumers,\nthe protection of birds, mammals, surface waters and aquatic organisms. 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 metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.\n195\nFluazinam\nCAS No 79622-59-6\nCIPAC No 521\n3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine\n≥ 960 g/kg\nImpurities:\n5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine\nnot more than 2 g/kg\n1 March 2009\n28 February 2019\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, 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 fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of the operators' and workers' 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 food of plant and animal origin and evaluate the dietary exposure of consumers,\nthe protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.\nThe Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.\n196\nFuberidazole\nCAS No 3878-19-1\nCIPAC No 525\n2-(2′-furyl)benzimidazole\n≥ 970 g/kg\n1 March 2009\n28 February 2019\nPART A\nOnly uses as fungicide may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, 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 fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 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,\nlong-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\n197\nMepiquat\nCAS No 15302-91-7\nCIPAC No 440\n1,1-dimethylpiperidinium chloride (mepiquat chloride)\n≥ 990 g/kg\n1 March 2009\n28 February 2019\nPART A\nOnly uses as plant growth regulator may be authorised.\nPART B\nIn assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, 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 mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.\nThe Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.’",
  "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/2008/108/annex",
    "retrieved_at": "2026-11-01T15:22:17.431534+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."
}