{
  "url": "https://openlegislation.uk/eu-regulation-2019-1858/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-1858/introduction.json",
  "legislation": "eur/2019/1858",
  "legislation_title": "Commission Regulation (EU) 2019/1858 of 6 November 2019 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2019-1858",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2019/1858\nof 6 November 2019\namending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, and in particular Article 31(2) thereof,\nWhereas:\n(1)\nThe substance 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one (CAS Number 569646-79-3), which has been assigned the name Hydroxyethoxyphenyl Butanone (HEPB) under the International Nomenclature of Cosmetic Ingredients, has the function of preservative and skin conditioning. It is currently not listed in Regulation (EC) No 1223/2009.\n(2)\nThe Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 7 April 2017 that, under an aggregate exposure scenario, HEPB can be considered safe when used as a preservative in rinse off, oral care and leave-on cosmetic products at a maximum concentration of 0,7 %. The SCCS also concluded that more evidence would be needed to exclude eye irritation.\n(3)\nFollowing concerns raised by several Member States on HEPB as a potential eye irritant and additional scientific data submitted to it by the applicant, the SCCS concluded in its opinion of 5 March 2019 that, under an aggregate exposure scenario, the use of HEPB as a preservative in rinse-off, oral care and leave-on cosmetic products at a maximum concentration of 0,7 % is safe with regard to eye irritation.\n(4)\nIn light of the opinions mentioned above and in order to take into account technical and scientific progress, HEPB should be allowed for use as a preservative in rinse off, oral care and leave-on cosmetic products at a maximum concentration of 0,7 % in ready for use preparation.\n(5)\nRegulation (EC) No 1223/2009 should therefore be amended accordingly.\n(6)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 342, 22.12.2009, p. 59."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "SCCS (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone — ‘Hydroxyethoxyphenyl Butanone’ (HEPB) — Cosmetics Europe No P98, SCCS/1582/16, 7 April 2017."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "SCCS (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone — ‘Hydroxyethoxyphenyl Butanone’ (HEPB) — Cosmetics Europe No P98 — Submission II eye irritation, preliminary version of 21 December 2018, final version of 5 March 2019, SCCS/1604/18."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/1858/introduction",
    "retrieved_at": "2026-11-01T14:43:02.530979+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."
}