{
  "url": "https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.3/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.3/division-2.json",
  "legislation": "eudr/2001/18",
  "legislation_title": "Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC",
  "legislation_url": "https://openlegislation.uk/eu-directive-2001-18",
  "path": "annex/II/division/C/division/C.3/division/2",
  "kind": "division",
  "number": "2",
  "heading": "Hazard characterisation",
  "text": "The magnitude of each potential adverse effect shall be evaluated. This evaluation shall assume that such an adverse effect will occur. The e.r.a shall consider that the magnitude is likely to be influenced by the receiving environment(s) into which the GMO is intended to be released and by the scale and conditions of the release.\nWhere possible, the evaluation shall be expressed in quantitative terms.\nWhere the evaluation is expressed in qualitative terms, a categorical description ( ‘ high ’ , ‘ moderate ’ , ‘ low ’ or ‘ negligible ’ ) shall be used and an explanation of the scale of effect represented by each category shall be provided.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/18/annex/II/division/C/division/C.3/division/2",
    "retrieved_at": "2026-11-01T15:23:00.934371+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."
}