{
  "url": "https://openlegislation.uk/eu-decision-2013-674/annex/division-3/division-3.8",
  "json_url": "https://openlegislation.uk/eu-decision-2013-674/annex/division-3/division-3.8.json",
  "legislation": "eudn/2013/674",
  "legislation_title": "Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance) (2013/674/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2013-674",
  "path": "annex/division/3/division/3.8",
  "kind": "division",
  "number": "3.8",
  "heading": "Toxicological profile of the substances",
  "text": "The aim of this section of the cosmetic product safety report is to describe the toxicological hazard of each of the substances in the finished product, determine the potential exposure, and draw up a risk characterisation. These aspects are of crucial importance in order to perform the risk assessment, as they are the three essential steps of the risk assessment process .\nThe endpoints to be considered, as well as the necessary data, depend on a number of factors, including the routes of exposure, the conditions of use of the product, the physico/chemical characteristics and the possible absorption of the substance. The choice of relevant endpoints should be the responsibility of the safety assessor, who should justify their decisions.\nThe safety assessor should ensure that the experimental data comply with the requirements of Article 18 of Regulation (EC) No 1223/2009 concerning animal testing. Such requirements are clarified in the Commission Communication on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics .\nPoint 8 of Part A of Annex I to Regulation (EC) No 1223/2009 establishes the key requirements for the cosmetic product safety report as far as the toxicological profile of substances is concerned.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "M. Pauwels, V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), p. 261."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, COM(2013) 135 final."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2013/674/annex/division/3/division/3.8",
    "retrieved_at": "2026-11-01T15:14:57.936012+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."
}