{
  "url": "https://openlegislation.uk/eu-directive-2008-107/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2008-107/annex.json",
  "legislation": "eudr/2008/107",
  "legislation_title": "Commission Directive 2008/107/EC of 25 November 2008 amending Council Directive 91/414/EEC to include abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2008-107",
  "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‘216\nAbamectin\nCAS No 71751-41-2\navermectin B1a\nCAS No 65195-55-3\nAvermectin B1b\nCAS No 65195-56-4\nabamectin\nCIPAC No 495\nAvermectinB1a\n(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside\nAvermectinB1b\n(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside\n≥ 850 g/kg\n1 May 2009\n30 April 2019\nPART A\nOnly uses as insecticide, acaricide.\nPART B\nIn assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information are provided before such an authorisation is granted.\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on (abamectin), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 residues in food of plant origin and evaluate the dietary exposure of consumers,\nthe protection of bees, non-target arthropods, birds, mammals and aquatic organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, waiting periods, should be applied where appropriate.\nThe Member States concerned shall request the submission of:\nfurther studies on the specification,\ninformation to further address the risk assessment for birds and mammals,\ninformation to address the risk to aquatic organisms with respect to the major soil metabolites,\ninformation to address the risk to groundwater with respect to the metabolite U8.\nThey shall ensure that the notifiers provide such studies to the Commission within two years from the entry into force of this Directive.\n217\nEpoxiconazole\nCAS No 135319-73-2 (formerly 106325-08-0)\nCIPAC No 609\n(2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole\n≥ 920 g/kg\n1 May 2009\n30 April 2019\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 epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 where appropriate,\nthe dietary exposure of consumers to the epoxiconazole (triazole) metabolites,\nthe potential for long-range transport via air,\nthe risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.\nThe Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest.\nThe concerned Member States shall ensure that the notifier submits within two years from the entry into force of this Directive, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals.\n218\nFenpropimorph\nCAS No 67564-91-4\nCIPAC No 427\n(RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine\n≥ 930 g/kg\n1 May 2009\n30 April 2019\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 fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe 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, such as restrictions of the daily work rate,\nthe protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles.\nThe Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.\n219\nFenpyroximate\nCAS No 134098-61-6\nCIPAC No 695\ntert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate\n> 960 g/kg\n1 May 2009\n30 April 2019\nPART A\nOnly uses as acaricide may be authorised.\nThe following uses must not be authorised:\napplications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications.\nPART B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.\nThe Member States concerned shall request the submission of information to further address:\nthe risk to aquatic organisms from metabolites containing the benzyl moiety,\nthe risk of biomagnification in aquatic food chains.\nThey shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the entry into force of this Directive.\n220\nTralkoxydim\nCAS No 87820-88-0\nCIPAC No 544\n(RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one\n≥ 960 g/kg\n1 May 2009\n30 April 2019\nPART A\nOnly uses as herbicide may be authorised.\nPART B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.\nIn this overall assessment Member States must pay particular attention to:\nthe protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions,\nthe protection of herbivorous mammals.\nConditions of use shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of:\ninformation to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim.\nThey shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the entry into force of this Directive.’",
  "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/2008/107/annex",
    "retrieved_at": "2026-11-01T15:22:17.489032+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."
}