{
  "url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.6/division-3.6.2/division-3.6.2.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.6/division-3.6.2/division-3.6.2.1.json",
  "legislation": "eur/2008/1272",
  "legislation_title": "Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-1272",
  "path": "annex/I/division/3/division/3.6/division/3.6.2/division/3.6.2.1",
  "kind": "division",
  "number": "3.6.2.1",
  "heading": "For the purpose of classification for carcinogenicity, substances are allocated to one of two categories based on strength of evidence and additional considerations (weight of evidence). In certain instances, route-specific classification may be warranted, if it can be conclusively proved that no other route of exposure exhibits the hazard.",
  "text": "Table 3.6.1\nHazard categories for carcinogens\nNote: See 3.6.2.2.4.\nCategories\nCriteria\nCATEGORY 1:\nKnown or presumed human carcinogens\nA substance is classified in Category 1 for carcinogenicity on the basis of epidemiological and/or animal data. A substance may be further distinguished as:\nCategory 1A:\nCategory 1A, known to have carcinogenic potential for humans, classification is largely based on human evidence, or\nCategory 1B:\nCategory 1B, presumed to have carcinogenic potential for humans, classification is largely based on animal evidence.\nThe classification in Category 1A and 1B is based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived from:\nhuman studies that establish a causal relationship between human exposure to a substance and the development of cancer (known human carcinogen); or\nanimal experiments for which there is sufficient evidence to demonstrate animal carcinogenicity (presumed human carcinogen).\nIn addition, on a case-by-case basis, scientific judgement may warrant a decision of presumed human carcinogenicity derived from studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals.\nCATEGORY 2:\nSuspected human carcinogens\nThe placing of a substance in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B, based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived either from limited evidence of carcinogenicity in human studies or from limited evidence of carcinogenicity in animal studies.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Note: See 3.6.2.2.4."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2008/1272/annex/I/division/3/division/3.6/division/3.6.2/division/3.6.2.1",
    "retrieved_at": "2026-11-01T14:51:47.470832+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."
}