{
  "url": "https://openlegislation.uk/eu-directive-2011-48/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2011-48/annex.json",
  "legislation": "eudr/2011/48",
  "legislation_title": "Commission Implementing Directive 2011/48/EU of 15 April 2011 amending Council Directive 91/414/EEC to include bromadiolone as active substance and amending Commission Decision 2008/941/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2011-48",
  "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‘352\nbromadiolone\nCAS No: 28772-56-7\nCIPAC No: 371\n3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin\n≥ 970 g/kg\n1 June 2011\n31 May 2021\nPART A\nOnly uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels may be authorised.\nThe nominal concentration of the active substance in the plant protection products shall not exceed 50 mg/kg.\nAuthorisations shall be granted for uses by professional users only.\nPART B\nFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on bromadiolone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.\nIn this overall assessment Member States shall:\npay particular attention to the risk to professional operators and ensure that conditions of use include the application of adequate personal protective equipment where appropriate,\npay particular attention to the risk to birds and non-target mammals from primary and secondary poisoning.\nConditions of authorisation shall include risk mitigation measures, where appropriate.\nThe Member States concerned shall request the submission of confirmatory information as regards:\n(a) the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data;\n(b) the relevance of the impurities;\n(c) the determination of bromadiolone in water with a limit of quantification of 0,01 μg/l;\n(d) the effectiveness of proposed mitigation measures to reduce risk to birds and non-target mammals;\n(e) the groundwater exposure assessment in respect of metabolites.\nThe Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 30 November 2011 and the information set out in points (d) and (e) by 31 May 2013.’",
  "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/2011/48/annex",
    "retrieved_at": "2026-11-01T15:22:00.998587+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."
}