{
  "url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.7/division-3.7.2/division-3.7.2.2/division-3.7.2.2.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.7/division-3.7.2/division-3.7.2.2/division-3.7.2.2.3.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/3.7/division/3.7.2/division/3.7.2.2/division/3.7.2.2.3",
  "kind": "division",
  "number": "3.7.2.2.3",
  "heading": null,
  "text": "For human evidence to provide the primary basis for a Category 1A classification there must be reliable evidence of an adverse effect on reproduction in humans. Evidence used for classification shall ideally be from well conducted epidemiological studies which include the use of appropriate controls, balanced assessment, and due consideration of bias or confounding factors. Less rigorous data from studies in humans shall be supplemented with adequate data from studies in experimental animals and classification in Category 1B shall be considered.",
  "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/3.7/division/3.7.2/division/3.7.2.2/division/3.7.2.2.3",
    "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."
}