{
  "url": "https://openlegislation.uk/eu-directive-2008-44/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2008-44/annex.json",
  "legislation": "eudr/2008/44",
  "legislation_title": "Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2008-44",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "In Annex I to Directive 91/414/EEC, the following rows are added at the end of the table:\nFurther details on identity and specification of active substances are provided in the review report.\nNo\nCommon name, identification numbers\nIUPAC name\nPurity\nEntry into force\nExpiration of inclusion\nSpecific provisions\n‘169\nBenthiavalicarb\nCAS No 413615-35-7\nCIPAC No 744\n[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid\n≥ 910 g/kg\nThe following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:\n6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg\nbis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg\n1 August 2008\n31 July 2018\nPart A\nOnly uses as fungicide may be authorised.\nPart B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on benthiavalicarb, 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.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety,\nthe protection of non-target arthropods.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\nIn assessing applications to authorise plant protection products containing benthiavalicarb for uses other than 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.\nThe Member States shall inform the Commission in accordance with Article 13(5) on the specification of the technical material as commercially manufactured.\n170\nBoscalid\nCAS No 188425-85-6\nCIPAC No 673\n2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide\n≥ 960 g/kg\n1 August 2008\n31 July 2018\nPart A\nOnly uses as fungicide may be authorised.\nPart B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on boscalid, 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.\nIn this overall assessment Member States must pay particular attention\nto the operator safety,\nto the long term risk to birds and soil organisms,\nto the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation.\nConditions of use shall include adequate risk mitigation measures, where appropriate.\n171\nCarvone\nCAS No 99-49-0 (d/l mixture)\nCIPAC No 602\n5-isopropenyl-2-methylcyclohex-2-en-1-one\n≥ 930 g/kg with a d/l ratio of at least 100:1\n1 August 2008\n31 July 2018\nPart A\nOnly uses as plant growth regulator may be authorised.\nPart B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on carvone, 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.\nIn this overall assessment Member States must pay particular attention to the operator safety.\nConditions of use shall include risk mitigation measures, where appropriate.\n172\nFluoxastrobin\nCAS No 361377-29-9\nCIPAC No 746\n(E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime\n≥ 940 g/kg\n1 August 2008\n31 July 2018\nPart A\nOnly uses as fungicide may be authorised.\nPart B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluoxastrobin, 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.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield,\nthe protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,\nthe levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate,\nthe risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe concerned Member States shall request the submission of:\ndata to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures,\ndata on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff.\nThey shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the entry into force of the Directive of inclusion.\n173\nPaecilomyces lilacinus (Thom)\nSamson 1974 strain 251 (AGAL: No 89/030550)\nCIPAC No 753\nNot applicable\n1 August 2008\n31 July 2018\nPart A\nOnly uses as nematicide may be authorised.\nPart B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on Paecilomyces lilacinus, 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.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers),\nthe protection of leaf dwelling non-target arthropods.\nConditions of use shall include risk mitigation measures, where appropriate.\n174\nProthioconazole\nCAS No 178928-70-6\nCIPAC No 745\n(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione\n≥ 970 g/kg\nThe following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:\nToluene: < 5 g/kg\nProthioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)\n1 August 2008\n31 July 2018\nPart A\nOnly uses as fungicide may be authorised.\nPart B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on prothioconazole, 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.\nIn this overall assessment Member States must pay particular attention to:\nthe operator safety in spray applications. Conditions of use shall include adequate protective measures,\nthe protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,\nthe protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe concerned Member States shall request the submission of:\ninformation to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin,\na comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds,\ninformation to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment.\nThey shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the entry into force of the Directive of inclusion.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Further details on identity and specification of active substances are provided in the review report."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2008/44/annex",
    "retrieved_at": "2026-11-01T15:22:21.747978+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."
}