{
  "url": "https://openlegislation.uk/eu-directive-2001-18/annex-5/division-II/division-C",
  "json_url": "https://openlegislation.uk/eu-directive-2001-18/annex-5/division-II/division-C.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/5/division/II/division/C",
  "kind": "division",
  "number": "C",
  "heading": "Characteristics of the modified organism",
  "text": "1.. Information relating to the genetic modification:\n(a) methods used for the modification;\n(b) methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;\n(c) description of the insert and/or vector construction;\n(d) purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function;\n(e) methods and criteria used for selection;\n(f) sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence.\n2.. Information on the final GMO:\n(a) description of genetic trait(s) or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;\n(b) structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism;\n(c) stability of the organism in terms of genetic traits;\n(d) rate and level of expression of the new genetic material. Method and sensitivity of measurement;\n(e) activity of the expressed protein(s);\n(f) description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector;\n(g) sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;\n(h) history of previous releases or uses of the GMO;\n(i) considerations for human health and animal health, as well as plant health:\n(i) toxic or allergenic effects of the GMOs and/or their metabolic products;\n(ii) comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;\n(iii) capacity for colonisation;\n(iv) if the organism is pathogenic to humans who are immunocompetent:\ndiseases caused and mechanism of pathogenicity including invasiveness and virulence,\ncommunicability,\ninfective dose,\nhost range, possibility of alteration,\npossibility of survival outside of human host,\npresence of vectors or means of dissemination,\nbiological stability,\nantibiotic resistance patterns,\nallergenicity,\navailability of appropriate therapies;\n(v) other product hazards.",
  "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/eudr/2001/18/annex/5/division/II/division/C",
    "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."
}