{
  "url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.5/division-3.5.2/division-3.5.2.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.5/division-3.5.2/division-3.5.2.2.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/3.5/division/3.5.2/division/3.5.2.2",
  "kind": "division",
  "number": "3.5.2.2",
  "heading": "For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories as shown in Table 3.5.1.",
  "text": "Table 3.5.1\nHazard categories for germ cell mutagens\nCategories\nCriteria\nCATEGORY 1:\nSubstances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.\nSubstances known to induce heritable mutations in the germ cells of humans.\nCategory 1A:\nThe classification in Category 1A is based on positive evidence from human epidemiological studies.\nSubstances to be regarded as if they induce heritable mutations in the germ cells of humans.\nCategory 1B:\nThe classification in Category 1B is based on:\npositive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or\npositive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. It is possible to derive this supporting evidence from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or\npositive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.\nCATEGORY 2:\nSubstances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans\nThe classification in Category 2 is based on:\npositive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:\nsomatic cell mutagenicity tests in vivo, in mammals; or\nother in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.\nNote: Substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens.",
  "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/2008/1272/annex/I/division/3/division/3.5/division/3.5.2/division/3.5.2.2",
    "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."
}