{
  "url": "https://openlegislation.uk/eu-regulation-2009-1223/annex-I/part-A/division-8",
  "json_url": "https://openlegislation.uk/eu-regulation-2009-1223/annex-I/part-A/division-8.json",
  "legislation": "eur/2009/1223",
  "legislation_title": "Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2009-1223",
  "path": "annex/I/part/A/division/8",
  "kind": "division",
  "number": "8",
  "heading": "Toxicological profile of the substances",
  "text": "Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.\nAll significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.\nParticular consideration shall be given to any possible impacts on the toxicological profile due to\nparticle sizes, including nanomaterials,\nimpurities of the substances and raw material used, and\ninteraction of substances.\nAny read-across shall be duly substantiated and justified.\nThe source of information shall be clearly identified.",
  "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/2009/1223/annex/I/part/A/division/8",
    "retrieved_at": "2026-11-01T14:51:03.124433+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."
}