{
  "url": "https://openlegislation.uk/eu-decision-2013-674/annex/division-3/division-3.4/division-3.4.2",
  "json_url": "https://openlegislation.uk/eu-decision-2013-674/annex/division-3/division-3.4/division-3.4.2.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/3.4/division/3.4.2",
  "kind": "division",
  "number": "3.4.2",
  "heading": "Evidence of the technical unavoidability of traces of prohibited substances",
  "text": "While the procedure outlined in paragraph 3.4.1 should be followed for all known impurities and traces to evaluate their toxicological impact, further investigation is required for prohibited substances present as traces in the finished product.\nWhen such presence is technically unavoidable, the cosmetics manufacturers are required to provide evidence of the technical unavoidability. That means they have to justify the presence of those traces by all necessary means. The presence of traces of prohibited substances should be kept as low as is reasonably achievable under good manufacturing practices. In addition, the safety assessor has to decide whether their levels are toxicologically acceptable and whether the product is still safe.\nEspecially in the case of non-threshold genotoxic and carcinogenic substances, the cosmetic industry should keep improving its best practices in order to eliminate these substances (ALARA principle) in the finished cosmetic product. The main concern is to ensure the protection of human health, as required by Article 3 of Regulation (EC) No 1223/2009.\nTraces generated by the degradation of substances within the final product (stability issues), by preservation or transport problems, or by the interaction of raw materials should be avoided through good manufacturing practices, or possibly through re-formulation of the product.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Article 17 of Regulation (EC) No 1223/2009 establishes that traces of prohibited substances are only permitted if they are technically unavoidable and if they have no impact on the safety of the cosmetic products."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "The ‘non-threshold genotoxic and carcinogenic substances’ are the genotoxic and carcinogenic substances without a threshold for the carcinogenic-genotoxic effects."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances Which are both Genotoxic and Carcinogenic, the EFSA Journal (2005) 282, pp. 1-31."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2013/674/annex/division/3/division/3.4/division/3.4.2",
    "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."
}