{
  "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.9/division-5.9.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.9/division-5.9.3.json",
  "legislation": "eur/2013/283",
  "legislation_title": "Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-283",
  "path": "annex/section/5/division/5.9/division/5.9.3",
  "kind": "division",
  "number": "5.9.3",
  "heading": "Direct observations",
  "text": "Available reports from the open literature, relating to clinical cases and poisoning incidents, where they are from refereed journals or official reports, shall be submitted together with reports of any follow-up studies undertaken. Such reports shall, where available, contain complete descriptions of the nature, level and duration of exposure, as well as the clinical symptoms observed, first aid and therapeutic measures applied and measurements and observations made.\nWhere supported with the necessary level of detail, such documentation shall be used to confirm the validity of extrapolations from animal data to man and to identify unexpected adverse effects which are specific to humans.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.9/division/5.9.3",
    "retrieved_at": "2026-11-01T14:48:46.014078+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."
}