# The Cosmetic Products (Safety) Regulations 2003, Part II: SUBSTANCES LISTED IN ANNEX III, PART 2 OF THE DIRECTIVE AS SUBSTANCES PROVISIONALLY ALLOWED (1) (2) (3) (4) (5) (6) (7) Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information Permitted for supply until Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule. 1 C.I. Basic Blue 7 Non-oxidising colouring agents for hair dyeing 0.2 per cent — Can cause allergic reaction 30.9.2004 2 2-Amino-3-nitrophenol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 3 per cent 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 3 4-Amino-3-nitrophenol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 3 per cent 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 4 Naphthalene-2,7-diol and its salts Oxidising colouring agents for hair dyeing 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent — 30.9.2004 5 3-Aminophenol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004 6 3, 4-Dimethylpyridine-2, 6-diol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 7 4-(3-Hydroxypropyl)- amino-3-nitrophenol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 5.2 per cent 2.6 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 8 6-Nitropyridine-2,5- diamine and its salts Non-oxidising colouring agent for hair dyeing 3 per cent — Can cause allergic reaction 30.9.2004 9 HC Blue No. 11 and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 3 per cent 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 10 2-(2-Nitro-p-toluidino)- ethanol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 2 per cent 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 11 2-(2-Hydroxyethyl- amino)-4,6-dinitro- phenol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 3 per cent 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 12 4-Methylaminophenol and its salts Oxidising colouring agent for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction 30.9.2004 13 2-(2,4-Diamino-5-methylphenoxy)ethanol and its salts Oxidising colouring agent for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction 30.9.2004 14 HC Violet No. 2 and its salts Non-oxidising colouring agent for hair dyeing 2 per cent — — 30.9.2004 15 2(2,6-Dinitro-p-anisidino)ethanol and its salts Non-oxidising colouring agent for hair dyeing 3 per cent — Can cause allergic reaction 30.9.2004 16 HC Blue No. 12 and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 1.5 per cent 1.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per cent Can cause allergic reaction Can cause allergic reaction 30.9.2004 17 4-Ethoxy-6-methyl-m-phenylenediamine and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004 18 4,4'-(Trimethylene- dioxy)di-m-phenylene-diamine and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004 19 3-Amino-2,4-dichloro- phenol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004 20 3-Methyl-1-phenyl-5-pyrazolone and its salts Oxidising colouring agents for hair dyeing 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004 21 5-(2-Hydroxyethyl-amine)-o-cresol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004 22 3,4-Dihydro-2H-1,4-benzoxazin-6-ol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004 23 Naphthalene-1,7-diol and its salts Oxidising colouring agents for hair dyeing 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent Can cause allergic reaction 30.9.2004 24 HC Yellow No. 10 and its salts Non-oxidising colouring agents for hair dyeing 0.2 per cent — — 30.9.2004 25 2,6-Dimethoxy-3,5-pyridinediamine and its salts Oxidising colouring agents for hair dyeing 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent Can cause allergic reaction 30.9.2004 26 HC Orange No. 2 and its salts Non-oxidising colouring agents for hair dyeing 1 per cent — — 30.9.2004 27 HC Violet No. 1 and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 0.5 per cent 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004 28 2-(3-Methylamino-4-nitrophenoxy) ethanol and its salts Non-oxidising colouring agents for hair dyeing 1 per cent — — 30.9.2004 29 2-(2-Methoxy-4-nitroanilino)ethanol and its salts Non-oxidising colouring agents for hair dyeing 1 per cent — — 30.9.2004 30 2-(4-Amino-2-chloro-5-nitroanilino)ethanol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 2 per cent 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 31 HC Red No. 13 Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 2.5 per cent 2.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent — 30.9.2004 32 Naphthalene-1,5-diol and its salts Oxidising colouring agents for hair dyeing 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent — 30.9.2004 33 2,2'-[2-Hydroxy-trimethylenebis(4-aminophenyl)imino] diethanol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction 30.9.2004 34 2-Aminophenol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 35 5-Amino-o-cresol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 36 2-(2,4-Diamino- phenoxy)ethanol and its salts Oxidising colouring agents for hair dyeing 4 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 2 per cent — 30.9.2004 37 2-Methylresorcinol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 38 4-Amino-m-cresol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 39 2-Amino-4-hydroxyethyl- aminoanisole and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 40 3,4-Diaminobenzoic acid and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 41 6-Amino-o-cresol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 42 2-Aminomethyl-p-aminophenol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 43 4-Amino-2-(2-hydroxyethylaminomethyl) phenol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 44 N-(2-Hydroxyethyl)-3,4-methylenedioxyaniline and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 45 C.I. Acid Black 52 and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 46 2-Nitro-p-phenylene- diamine and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 0.3 per cent 0.3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent — 30.9.2004 47 HC Blue No. 2 and its salts Non-oxidising colouring agents for hair dyeing 2.8 per cent — — 30.9.2004 48 4-(2-Hydroxyethylamino)-3-nitrophenol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 6 per cent 6 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent — 30.9.2004 49 2-(4-Nitrophenylamino)- ethylurea and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 0.5 per cent 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004 50 HC Red No. 10 + HC Red No. 11 and their salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 2 per cent 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 51 HC Yellow No. 6 and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 2 per cent 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 52 HC Yellow No. 12 and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 1 per cent 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent — 30.9.2004 53 HC Blue No. 10 and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 54 HC Blue No. 9 and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 2 per cent 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 55 2-Chloro-6-ethylamino-4-nitrophenol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 3 per cent 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004 56 2-Amino-6-chloro-4-nitrophenol and its salts Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 2 per cent 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004 57 C.I. Basic Blue 26 Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 0.5 per cent 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004 58 C.I. Acid Red 33 Non-oxidising colouring agents for hair dyeing 2 per cent — — 30.9.2004 59 C.I. Food Red 1 Non-oxidising colouring agents for hair dyeing 2 per cent — — 30.9.2004 60 C.I. Basic Violet 14 Oxidising colouring agents for hair dyeing Non-oxidising colouring agents for hair dyeing 0.3 per cent 0.3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent — 30.9.2004 61 1-tert-Butyl-3,5-dimethyl-2,4,6-trinitro- benzene (musk xylene) All cosmetic products, with the exception of oral care products 1 per cent in fine fragrance 0.4 per cent in eau de toilette 0.03 per cent in other products — — 30.9.2004 62 4'-tert-Butyl-2',6'-dimethyl-3',5'-dinitro- acetophenone (musk ketone) All cosmetic products, with the exception of oral care products 1.4 per cent in fine fragrance 0.56 per cent in eau de toilette 0.042 per cent in other products — — 30.9.2004 --- Source: https://www.legislation.gov.uk/uksi/2003/835/schedule/4/part/II (the official version) Page: https://openlegislation.uk/cosmetic-products-safety-regulations-2003/schedule-4/part-II Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.