{
  "url": "https://openlegislation.uk/eu-regulation-2006-1907/annex-XI/division-1/division-1.1/division-1.1.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-1907/annex-XI/division-1/division-1.1/division-1.1.3.json",
  "legislation": "eur/2006/1907",
  "legislation_title": "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2006-1907",
  "path": "annex/XI/division/1/division/1.1/division/1.1.3",
  "kind": "division",
  "number": "1.1.3",
  "heading": "Historical human data",
  "text": "Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.\nThe strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:\n(1) the proper selection and characterisation of the exposed and control groups;\n(2) adequate characterisation of exposure;\n(3) sufficient length of follow-up for disease occurrence;\n(4) valid method for observing an effect;\n(5) proper consideration of bias and confounding factors; and\n(6) a reasonable statistical reliability to justify the conclusion.\nIn all cases adequate and reliable documentation shall be provided.\nWhen nanoforms are covered by the registration the above approach shall address the nanoforms separately.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance)."
    },
    {
      "type": "X",
      "label": "X1",
      "text": "Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2006/1907/annex/XI/division/1/division/1.1/division/1.1.3",
    "retrieved_at": "2026-11-01T14:53:13.283023+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."
}