{
  "url": "https://openlegislation.uk/eu-directive-2012-21/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2012-21/annex.json",
  "legislation": "eudr/2012/21",
  "legislation_title": "Commission Implementing Directive 2012/21/EU of 2 August 2012 amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2012-21",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Directive 76/768/EEC is amended as follows:\n(1) in Annex II, the following entry is added:\nRef. No\nChemical name\nCAS No / EC No\n‘1373\nN-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts\nCAS No 160219-76-1’\n(2) Annex III is amended as follows:\n(a) Part 1 is amended as follows:\n(i) the following entries are added:\nRef. No\nSubstance\nRestrictions\nConditions of use and warnings which must be printed on the label\nField of application and/or use\nMax. authorised concentration in the finished cosmetic product\nOther limitations and requirements\na\nb\nc\nd\ne\nf\n‘253\n2,2′-[(4-Aminophenyl))imino]bis(ethanol) sulphate\nN,N-bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate\nCAS No 54381-16-7\nEC No 259-134-5\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % (calculated as sulphate)\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\nAs mentioned in reference number 205, column f (a)\n254\n1,3-Benzenediol, 4-chloro-\n4-Chlororesorcinol\nCAS No 95-88-5\nEC No 202-462-0\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %\nAs mentioned in reference number 205, column f (a)\n255\n2,4,5,6-Tetraaminopyrimidine sulphate\nTetraaminopyrimidine Sulfate\nCAS No 5392-28-9\nEC No 226-393-0\n(a)\nHair dye substance in oxidative hair dye products\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,4 % (calculated as sulphate)\n(a)\nAs mentioned in reference number 205, column f (a)\n(b)\nHair dye substance in non-oxidative hair dye products\n(b)\n3,4 % (calculated as sulphate)\n256\n3-(2-Hydroxyethyl)-p-phenylenediammonium sulphate\nHydroxyethyl-p-Phenylenediamine Sulfate\nCAS No 93841-25-9\nEC No 298-995-1\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)\nAs mentioned in reference number 205, column f (a)\n257\n1H-Indole-5,6-diol\nDihydroxyindole\nCAS No 3131-52-0\nEC No 412-130-9\n(a)\nHair dye substance in oxidative hair dye products\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %\n(a)\nAs mentioned in reference number 205, column f (a)\n(b)\nHair dye substance in non-oxidative hair dye products\n(b)\n0,5 %\n(b)\nAs mentioned in reference number 208, column f\n258\n5-Amino-4-chloro-2-methylphenol hydrochloride\n5-Amino-4-Chloro-o-Cresol HCl\nCAS No 110102-85-7\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride)\nAs mentioned in reference number 205, column f (a)\n259\n1H-Indol-6-ol\n6-Hydroxyindole\nCAS No 2380-86-1\nEC No 417-020-4\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %\nAs mentioned in reference number 205, column f (a)\n260\n1H-Indole-2,3-Dione\nIsatin\nCAS No 91-56-5\nEC No 202-077-8\nHair dye substance in non-oxidative hair dye products\n1,6 %\nAs mentioned in reference number 208, column f\n261\n2-Aminopyridin-3-ol\n2-Amino-3-Hydroxypyridine\nCAS No 16867-03-1\nEC No 240-886-8\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %\nAs mentioned in reference number 205, column f (a)\n262\n2-Methyl-1-naphthyl acetate\n1-Acetoxy-2-Methylnaphthalene\nCAS No 5697-02-9\nEC No 454-690-7\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %.)\nAs mentioned in reference number 205, column f (a)\n263\n1-Hydroxy-2-methylnaphthalene\n2-Methyl-1-Naphthol\nCAS No 7469-77-4\nEC No 231-265-2\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %.)\nAs mentioned in reference number 205, column f (a)\n264\nDisodium 5,7-dinitro-8-oxido-2-naphthalenesulfonate\nAcid Yellow 1\nCAS No 846-70-8\nEC No 212-690-2\nCI 10316\n(a)\nHair dye substance in oxidative hair dye products\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %\n(a)\nAs mentioned in reference number 205, column f (a)\n(b)\nHair dye substance in non-oxidative hair dye products\n(b)\n0,2 %\n(b)\nAs mentioned in reference number 208, column f\n265\n4-Nitro-1,2-phenylenediamine\n4-Nitro-o-Phenylenediamine\nCAS No 99-56-9\nEC No 202-766-3\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %\nAs mentioned in reference number 205, column f (a)\n266\n2-(4-Amino-3-nitroanilino)ethanol\nHC Red No 7\nCAS No 24905-87-1\nEC No 246-521-9\nHair dye substance in non-oxidative hair dye products\n1,0 %\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\nAs mentioned in reference number 208, column f\n267\n2-[bis(2-Hydroxyethyl)amino]-5-nitrophenol\nHC Yellow No 4\nCAS No 59820-43-8\nEC No 428-840-7\nHair dye substance in non-oxidative hair dye products\n1,5 %\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\n268\n2-[(2-Nitrophenyl)amino]ethanol\nHC Yellow No 2\nCAS No 4926-55-0\nEC No 225-555-8\n(a)\nHair dye substance in oxidative hair dye products\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 %\nFor (a) and (b):\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\n(a)\nAs mentioned in reference number 205, column f (a)\n(b)\nHair dye substance in non-oxidative hair dye products\n(b)\n1,0 %\n269\n4-[(2-Nitrophenyl)amino]phenol\nHC Orange No 1\nCAS No 54381-08-7\nEC No 259-132-4\nHair dye substance in non-oxidative hair dye products\n1,0 %\n270\n2-Nitro-N1-phenyl-benzene-1,4-diamine\nHC Red No 1\nCAS No 2784-89-6\nEC No 220-494-3\nHair dye substance in non-oxidative hair dye products\n1,0 %\nAs mentioned in reference number 208, column f\n271\n1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride\nHC Yellow No 9\nCAS No 86419-69-4\nEC No 415-480-1\nHair dye substance in non-oxidative hair dye products\n0,5 % (calculated as hydrochloride)\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\n272\n1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene\nHC Yellow No 7\nCAS No 104226-21-3\nEC No 146-420-6\nHair dye substance in non-oxidative hair dye products\n0,25 %\n273\nN-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline\nHC Yellow No 13\nCAS No 10442-83-8\nEC No 443-760-2\n(a)\nHair dye substance in oxidative hair dye products\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %\nFor (a) and (b):\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\n(a)\nAs mentioned in reference number 205, column f (a)\n(b)\nHair dye substance in non-oxidative hair dye products\n(b)\n2,5 %\n274\nBenzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chloride\nBasic Yellow 57\nCAS No 68391-31-1\nEC No 269-943-5\nHair dye substance in non-oxidative hair dye products\n2,0 %\n275\nEthanol, 2,2′-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-\nDisperse Black 9\nCAS No 20721-50-0\nEC No 243-987-5\nHair dye substance in non-oxidative hair dye products\n0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)\n276\n9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-\nHC Blue No 14\nCAS No 99788-75-7\nEC No 421-470-7\nHair dye substance in non-oxidative hair dye products\n0,3 %\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\n277\n2-(4-Methyl-2-nitroanilino)ethanol\nHydroxyethyl-2-Nitro-p-Toluidine\nCAS No 100418-33-5\nEC No 408-090-7\n(a)\nHair dye substance in oxidative hair dye products\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %\nFor (a) and (b):\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\n(a)\nAs mentioned in reference number 205, column f (a)\n(b)\nHair dye substance in non-oxidative hair dye products\n(b)\n1,0 %\n278\n1-Amino-2-nitro-4-(2′,3′-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2′,3′-dihydroxypropyl)amino-2-nitro-5-chlorobenzene\nHC Red No 10 + HC Red No 11\nCAS No 95576-89-9 + 95576-92-4\n(a)\nHair dye substance in oxidative hair dye products\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %\nFor (a) and (b):\nDo not use with nitrosating agents\nMaximum nitrosamine content: 50 μg/kg\nKeep in nitrite-free containers\n(a)\nAs mentioned in reference number 205, column f (a)’\n(b)\nHair dye substance in non-oxidative hair dye products\n(b)\n2,0 %\n(ii) the entries with reference numbers 16 and 22 are replaced by the following:\nRef. No\nSubstance\nRestrictions\nConditions of use and warnings which must be printed on the label\nField of application and/or use\nMax. authorized concentration in the finished cosmetic product\nOther limitations and requirements\na\nb\nc\nd\ne\nf\n‘16\n1-Naphthalenol\n1-Naphthol\nCAS No 90-15-3\nEC No 201-969-4\nHair dye substance in oxidative hair dye products\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %\nAs mentioned in reference number 205, column f (a)\n22\n1,3-benzenediol\nResorcinol\nCAS No 108-46-3\nEC No 203-585-2\n(a)\nHair dye substance in oxidative hair dye products\n1.. general use\n2.. professional use\n(a)\nAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %\n(a)\n1.. Contains resorcinol\nRinse hair well after application.\nDo not use to dye eyelashes or eyebrows.\nRinse eyes immediately if product comes into contact with them.\nAs mentioned in reference number 205, column f (a).\n2.. For professional use only\nContains resorcinol.\nRinse eyes immediately if product comes into contact with them.\nAs mentioned in reference number 205, column f (a)\n(b)\nHair lotions and shampoos\n(b)\n0,5 %\n(b)\nContains resorcinol.’\n(b) in Part 2 the entries with reference numbers 10 and 50 are deleted.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2012/21/annex",
    "retrieved_at": "2026-11-01T15:21:57.009631+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."
}