{
  "url": "https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.1/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.1/division-1.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.1/division/1",
  "kind": "division",
  "number": "1",
  "heading": "Intended and unintended changes",
  "text": "As part of the identification and evaluation of the potential adverse effects referred to in Section A, the e.r.a shall identify the intended and unintended changes resulting from the genetic modification and shall evaluate their potential to cause adverse effects on human health and on the environment.\nIntended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.\nUnintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.\nIntended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.",
  "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.1/division/1",
    "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."
}