{
  "url": "https://openlegislation.uk/eu-regulation-2013-1197/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-1197/introduction.json",
  "legislation": "eur/2013/1197",
  "legislation_title": "Commission Regulation (EU) No 1197/2013 of 25 November 2013 amending Annex III 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-2013-1197",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) No 1197/2013\nof 25 November 2013\namending Annex III 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,\nAfter consulting the Scientific Committee on Consumer Safety,\nWhereas:\n(1)\nFollowing the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, subsequently replaced by the Scientific Committee on Consumer Products (‘SCCP’), pursuant to Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment, concluded that the potential risks of the use of hair dyes were of concern. The SCCP, in its opinions, recommended that the Commission take further steps to control the use of hair dye substances.\n(2)\nThe SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity or mutagenicity.\n(3)\nFollowing the opinions of the SCCP, the Commission agreed with Member States and stakeholders on an overall strategy to regulate substances used in hair dye products according to which the industry was required to submit files, containing updated scientific data on the safety of hair dye substances, for a risk assessment by the SCCP.\n(4)\nThe SCCP, subsequently replaced by the Scientific Committee on Consumer Safety (‘SCCS’) pursuant to Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC, assessed the safety of individual substances for which updated files had been submitted by the industry.\n(5)\nAs regards the evaluation of possible consumer health risks by reaction products formed by oxidative hair dye substances during the hair dyeing process, based on the data yet available, the SCCS, in its opinion of 21 September 2010, did not raise any major concern regarding genotoxicity and carcinogenicity of hair dyes and their reaction products currently used in the Union.\n(6)\nIn order to ensure the safety of hair dye products for human health it is appropriate to limit the maximum concentrations of 21 assessed hair dye substances and to list them in Annex III to Regulation (EC) No 1223/2009, by taking into account the final opinions given by the SCCS on their safety.\n(7)\nFollowing the assessment by the SCCS concerning the substance Toluene-2,5-Diamine, listed in entry 9a of Annex III to Regulation (EC) No 1223/2009, it is appropriate to change the maximum authorised concentrations thereof in the finished cosmetic product.\n(8)\nThe definition of a hair product in Regulation (EC) No 1223/2009 excluded its application on eyelashes. This exclusion was motivated by the fact that the level of risk is different when cosmetic products are applied on the hair on the head and on eyelashes respectively. A specific safety assessment was therefore needed for the application of hair dye substances on eyelashes.\n(9)\nThe SCCS, in its opinion on oxidative hair dye substances and hydrogen peroxide used in products to colour eyelashes of 12 October 2012, concluded that oxidative hair dye substances p-Phenylenediamine, Resorcinol, 6-Methoxy-2-Methylamino-3-Aminopyridine HCl, m-Aminophenol, 2-Methyl-5-Hydroxyethyl Aminophenol, 4-Amino-2-Hydroxytoluene, 2,4-Diaminophenoxyethanol HCl, 4-Amino-m-Cresol, 2-Amino-4-Hydroxyethylaminoanisole and 2,6-Diaminopyridine, listed in Annex III to Regulation (EC) No 1223/2009 and found safe for use in hair dye products, can be safely used by professionals in products intended for colouring eyelashes. In addition, the SCCS concluded that up to 2 % of hydrogen peroxide, which is listed under entry 12 in Annex III to Regulation (EC) No 1223/2009, can be considered safe for consumers when applied on eyelashes.\n(10)\nOn the basis of the scientific assessment of those substances their use should be allowed in products intended for colouring eyelashes in the same concentrations as in hair dye products. However, in order to avoid any risk connected with the self-application of products intended for colouring eyelashes by consumers, they should be allowed for professional use only. In order to allow professionals to inform consumers about possible adverse effects of eyelash colouring and to lower the risk of skin sensitisation to those products, appropriate warnings should be printed on their labels.\n(11)\nRegulation (EC) No 1223/2009 should therefore be amended accordingly.\n(12)\nIn order to avoid a disruption on the market due to the transition from Council Directive 76/768/ECC of 27 July 1976 on cosmetic products to Regulation (EC) No 1223/2009, this Regulation should apply from the same date as Regulation (EC) No 1223/2009.\n(13)\nA sufficient transition period should be granted to economic operators in order to comply with the new warnings for products intended for colouring eyelashes.\n(14)\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": "OJ L 66, 4.3.2004, p. 45."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ L 241, 10.9.2008, p. 21."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ L 262, 27.9.1976, p. 169."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/1197/introduction",
    "retrieved_at": "2026-11-01T14:48:13.543115+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."
}