{
  "url": "https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.3/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.3/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.3/division/1",
  "kind": "division",
  "number": "1",
  "heading": "Problem formulation including hazard identification",
  "text": "The problem formulation shall:\n(a) identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the GMO with those of the chosen non-genetically modified comparator under corresponding conditions of release or use;\n(b) identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under point (a) above;\nPotential adverse effects shall not be discounted on the basis that they are unlikely to occur.\nPotential adverse effects will vary from case to case, and may include:\neffects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity,\naltered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors,\ncompromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine,\neffects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material,\ndisease affecting humans, including allergenic or toxic reactions,\ndisease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate.\nWhere potential long-term adverse effects of a GMO are identified, they shall be assessed in the form of desk based studies using, where possible, one or more of the following:\n(i) evidence from previous experiences;\n(ii) available data sets or literature;\n(iii) mathematical modelling;\n(c) identify relevant assessment endpoints.\nThose potential adverse effects that could impact the identified assessment endpoints shall be considered in the next steps of the risk assessment;\n(d) identify and describe the exposure pathways or other mechanisms through which adverse effects may occur.\nAdverse effects may occur directly or indirectly through exposure pathways or other mechanisms which may include:\nthe spread of the GMO(s) in the environment,\nthe transfer of the inserted genetic material to the same organism or other organisms, whether genetically modified or not,\nphenotypic and genetic instability,\ninteractions with other organisms,\nchanges in management, including, where applicable, in agricultural practices;\n(e) formulate testable hypotheses, and define relevant measurement endpoints, to allow, where possible, a quantitative evaluation of the potential adverse effect(s);\n(f) consider possible uncertainties, including knowledge gaps and methodological limitations.",
  "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/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."
}