{
  "url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.3/division-II.6.3.6/division-II.6.3.6.6",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.3/division-II.6.3.6/division-II.6.3.6.6.json",
  "legislation": "eur/2018/782",
  "legislation_title": "Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2018-782",
  "path": "annex/I/division/II/division/II.6/division/II.6.3/division/II.6.3.6/division/II.6.3.6.6",
  "kind": "division",
  "number": "II.6.3.6.6",
  "heading": null,
  "text": "The results from the genotoxicity tests shall contribute to the evaluation of the need for carcinogenicity data. Other factors that shall be considered in determining the need for carcinogenicity data shall be the existence of relevant structural alerts and the occurrence of pre-neoplastic findings in repeat dose toxicity tests.",
  "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/2018/782/annex/I/division/II/division/II.6/division/II.6.3/division/II.6.3.6/division/II.6.3.6.6",
    "retrieved_at": "2026-11-01T14:44:06.594245+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."
}