{
  "url": "https://openlegislation.uk/eu-regulation-2016-1198/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-1198/introduction.json",
  "legislation": "eur/2016/1198",
  "legislation_title": "Commission Regulation (EU) 2016/1198 of 22 July 2016 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-2016-1198",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2016/1198\nof 22 July 2016\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(1) thereof,\nWhereas:\n(1)\nMethylisothiazolinone is authorised as a preservative in cosmetic products at concentrations up to 0,01 % weight/weight (100 ppm) through entry 57 of Annex V to Regulation (EC) No 1223/2009.\n(2)\nThe Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the safety of methylisothiazolinone (sensitisation only) on 12 December 2013.\n(3)\nThe SCCS concluded that current clinical data indicate that the concentration of 100 ppm of methylisothiazolinone in cosmetic products is not safe for the consumer. For leave-on cosmetic products (including ‘wet wipes’), no safe concentrations of methylisothiazolinone for induction of contact allergy or elicitation have been adequately demonstrated.\n(4)\nIn light of the SCCS opinion mentioned above, it is important to address the increased incidence of allergies induced by methylisothiazolinone and this substance should therefore be banned in leave-on products.\n(5)\nRegulation (EC) No 1223/2009 should therefore be amended accordingly.\n(6)\nThe application of the above-mentioned ban should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of this Regulation.\n(7)\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/1521/13 Revision of 27 March 2014."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/1198/introduction",
    "retrieved_at": "2026-11-01T14:45:40.524175+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."
}