# The Cosmetic Products (Safety) Regulations 2003, Part I: SUBSTANCES LISTED IN ANNEX III, PART 1 OF THE DIRECTIVE AS SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN (1) (2) (3) (4) (5) (6) Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information Note 1: These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4). 1a Boric acid, borates, and tetraborates Talcum powder 5 per cent Not to be used in products intended for children under three years old Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid Not to be used for bathing children under three years old Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid) Oral hygiene products 0.1 per cent Not to be used in products intended for children under three years old Do not swallow Not to be used for children under three years old Other products (excluding bath products and hair waving products) 3 per cent Not to be used in products intended for children under three years old Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid Not to be used for children under three years old Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid) The above-mentioned percentages are calculated as boric acid 1b Tetraborates Bath products 18 per cent Not to be used in products for children under three years old Not to be used for bathing children under three years old Hair waving products 8 per cent The above-mentioned percentages are calculated as boric acid 2a Thioglycolic acid and its salts (a) Hair waving or straightening products for general use 8 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children (b) Hair waving or straightening products for professional use 11 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only (c) Depilatories 5 per cent ready for use pH 7 to 12.7 Contains thioglycolate. Follow the instructions. Keep out of reach of children (d) Other hair-care products which are removed after application 2 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children The above-mentioned percentages are calculated as thioglycolic acid (a), (b), (c) and (d): The directions for use must incorporate the following: — Avoid contact with eyes — In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice — Wear suitable gloves ((a), (b) and (d) only) 2b Thioglycolic acid esters (a) Hair waving or straightening products for general use 8 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children (b) Hair waving or straightening products for professional use 11 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only The above-mentioned percentages are calculated as thioglycolic acid (a) and (b): The directions for use must incorporate the following: — May cause sensitization in the event of skin contact — Avoid contact with eyes — In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice — Wear suitable gloves 3 Oxalic acid, its esters and alkaline salts Hair care products 5 per cent — For professional use only 4 Ammonia All purposes and products 6 per cent calculated as NH3 — Contains ammonia (not required when concentration is not more than 2 per cent) 5 Tosylchlora-mide sodium (INN) [Chloramine-T] All purposes and products 0.2 per cent — — 6 Chlorates of alkali metals Toothpaste 5 per cent — — Other uses 3 per cent — — 7 Dichloro-methane All purposes and products 35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent) Purity of the dichloromethane must be not less than 99.8 per cent — 8 m- and p-Phenylenedia-mines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines (see Note 1), with the exception of those derivatives listed elsewhere in this Schedule Oxidizing colouring agents for hair-dyeing for general use 6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylenediamines Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows Oxidizing colouring agents for hair-dyeing for professional use 6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves 9 Methylphenylenediamines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (Toluenediamines (other than toluene-1, 3-diamine and its salts), their N-substituted derivatives and their salts) Oxidizing colouring agents for hair-dyeing for general use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylene-diamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows Oxidizing colouring agents for hair-dyeing for professional use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves 10 Diaminophenols Oxidizing colouring agents for hair-dyeing for general use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains diaminophenols. Can cause allergic reaction. Do not use to dye eyelashes or eyebrows Oxidizing colouring agents for hair-dyeing for professional use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains diaminophenols. For professional use only. Can cause allergic reaction. Wear suitable gloves 11 Dichlorophen (INN) [Dichlorophene] All purposes and products 0.5 per cent — Contains dichlorophen 12 Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide (a) Hair-care preparations (b) Skin-care preparations (c) Nail hardening preparations (d) Oral hygiene products 12 per cent of H2O2 present or released 4 per cent of H2O2 present or released 2 per cent of H2O2 present or released 0.1 per cent of H2O2 present or released — — — (a): Wear suitable gloves (a)(b)(c): Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them — 13 Formaldehyde (see also Part I of Schedule 6) Nail hardeners 5 per cent — Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent) 14 Hydroquinone Oxidizing colouring agent for hair dyeing for general use 0.3 per cent subject to the provisions of “Combination Rule B” set out below — Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them Oxidizing colouring agent for hair dyeing for professional use 0.3 per cent subject to the provisions of “Combination Rule B” set out below — Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them 15a Potassium hydroxide and sodium hydroxide Nail cuticle solvent 5 per cent calculated as sodium hydroxide (see Note 2) — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children Hair straightener for general use 2 per cent calculated as sodium hydroxide (see Note 2) — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children Hair straightener for professional use 4.5 per cent calculated as sodium hydroxide (see Note 2) — For professional use only. Avoid contact with eyes. Can cause blindness pH adjuster for depilatories — pH value not to exceed 12.7 Keep out of reach of children Avoid contact with eyes Other uses as pH adjuster — pH value not to exceed 11 — 15b Lithium hydroxide Hair straightener for general use 2 per cent calculated as sodium hydroxide (see Note 2) — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children Hair straightener for professional use 4.5 per cent calculated as sodium hydroxide (see Note 2) — For professional use only. Avoid contact with eyes. Can cause blindness pH adjuster for depilatories — pH value not to exceed 12.7 Contains alkali. Keep out of reach of children. Avoid contact with eyes Other uses as pH adjuster (for rinse-off products only) — pH value not to exceed 11 — 15c Calcium hydroxide Hair straighteners containing two components: calcium hydroxide and aguanidine salt 7 per cent by weight of calcium hydroxide — Contains alkali. Avoid contact with eyes. Keep out of reach of children. Can cause blindness pH adjuster for depilatories — pH value not to exceed 12.7 Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children Other uses e.g. pH adjuster processing aid — pH value not to exceed 11 — 16 α-Naphthol [1-Naphthol] 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 17 Sodium nitrite Rust inhibitor 0.2 per cent Do not use with secondary and/or tertiary amines or other substances forming nitrosamines — 18 Nitromethane Rust inhibitor 0.3 per cent — — 19 Phenol and its alkali salts Soaps and shampoos 1 per cent calculated as phenol — Contains phenol 20 ENTRY DELETED 21 Quinine and its salts Shampoos 0.2 per cent calculated as quinine base — — Hair lotions 0.5 per cent calculated as quinine base — — 22 Resorcinol Oxidizing colouring agent for hair dyeing for general use 5 per cent subject to the provisions of “Combination Rule B” set out below — Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them Oxidizing colouring agent for hair dyeing for professional use 5 per cent subject to the provisions of “Combination Rule B” set out below — Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them Hair lotions and shampoos 0.5 per cent subject to the provisions of “Combination Rule B” set out below — Contains resorcinol 23a Alkali sulphides Depilatories 2 per cent calculated as sulphur pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with eyes 23b Alkaline earth sulphides Depilatories 6 per cent calculated as sulphur pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with eyes 24 Water-soluble zinc salts with the exception of zinc 4-hydroxybenzene-sulphonate All purposes and products 1 per cent calculated as zinc — — 25 Zinc 4-hydroxybenzene-sulphonate [Zinc phenolsulfonate] Deodorants, antiperspirants and astringent lotions 6 per cent calculated as percentage of anhydrous substance — Avoid contact with eyes 26 Ammonium monofluoro-phosphate Oral hygiene products 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent — Contains ammonium monofluorophosphate 27 Sodium monofluoro-phosphate Oral hygiene products As for ammonium monofluorophosphate — Contains sodium monofluoro-phosphate 28 Potassium monofluoro-phosphate Oral hygiene products As for ammonium monofluorophosphate — Contains potassium monofluoro-phosphate 29 Calcium monofluoro-phosphate Oral hygiene products As for ammonium monofluorophosphate — Contains calcium monofluoro-phosphate 30 Calcium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains calcium fluoride 31 Sodium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains sodium fluoride 32 Potassium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains potassium fluoride 33 Ammonium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains ammonium fluoride 34 Aluminium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains aluminium fluoride 35 Stannous fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains stannous fluoride 36 Hexadecylammonium fluoride [Cetylamine hydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains hexadecylammonium fluoride 37 3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxyethyl)-ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)- propylbis(2-hydroxyethyl)- ammoniumdifluoride 38 N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropyl-enediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains N,N',N'-tris (polyoxyethylene)-N-hexa-decylpropylenediamine dihydrofluoride 39 Octadecenylammonium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains octadecenylammonium fluoride 40 Sodium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains sodium fluorosilicate 41 Potassium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains potassium fluorosilicate 42 Ammonium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains ammonium fluorosilicate 43 Magnesium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains magnesium fluorosilicate 44 1,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea] Hair care preparations 2 per cent Not to be used in aerosol dispensers Contains 1,3-bis(hydroxymethyl) imidazolidene-2-thione Nail care preparations 2 per cent pH value as applied must be less than 4 Contains 1,3-bis(hydroxymethyl) imidazolidene-2-thione 45 Benzyl alcohol (See also Part I of Schedule 6) Solvent, perfumes and flavourings — — — 46 6-Methylcoumarin Oral hygiene products 0.003 per cent — — 47 Nicomethanol hydrofluoride Oral hygiene products As for ammonium monofluorophosphate — Contains nicomethanol hydrofluoride 48 Silver nitrate Products to dye eyelashes or eyebrows 4 per cent — Contains silver nitrate. Rinse eyes immediately if product comes into contact with them 49 Selenium disulphide [Selenium sulfide] Anti-dandruff shampoos 1 per cent — Contains selenium disulphide. Avoid contact with eyes or damaged skin 50 Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and aluminium zirconium chloride hydroxide glycine complexes Anti-perspirants 20 per cent as anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10 The ratio of the number of (Al + Zr) atoms to chlorine atoms must be between 0.9 and 2.1 Not to be used in aerosol dispensers (sprays) Do not apply to irritated or damaged skin 51 Quinolin-8-ol and bis-(8-hydroxyquinolinium sulphate) (See also Part I of Schedule 3) [Oxyquinoline and Oxyquinoline sulfate] Stabilizer for hydrogen peroxide in rinse-off hair care preparations 0.3 per cent calculated as base — — Stabilizer for hydrogen peroxide in non rinse-off hair care preparations 0.03 per cent calculated as base — — 52 Methanol Denaturant for ethanol and isopropyl alcohol 5 per cent calculated as a percentage of ethanol and isopropyl alcohol — — 53 Etidronic acid and its salts (1-hydroxyethylidene-diphosphonic acid and its salts) Hair care 1.5 per cent expressed as etidronic acid — — Soap 0.2 per cent expressed as etidronic acid — — 54 1-Phenoxy-propan-2-ol (See also Part I of Schedule 6) [Phenoxy-isopropanol] Products rinsed off after use 2 per cent Prohibited in oral hygiene products — 55 Lead acetate Only for hair dyeing 0.6 per cent calculated as lead — Contains lead acetate. Keep away from children. Avoid all contact with the eyes. Wash hands after use. Do not use to dye eyelashes, eyebrows or moustaches If irritation develops discontinue use 56 Magnesium fluoride Dental hygiene products 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent — Contains magnesium fluoride 57 Strontium chloride hexahydrate (a) Toothpaste 3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent — Contains strontium chloride Frequent use by children is not advisable (b) Shampoo and face care products 2.1 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 2.1 per cent — — 58 Strontium acetate hemihydrate Toothpaste 3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent — Contains strontium acetate. Use by children is not advisable 59 Talc: hydrated magnesium silicate (a) Powdery products intended to be used for children under three years of age — — a): Keep powder away from children’s nose and mouth (b) other products — — 60 Fatty acid dialkanolamides All purposes and products Maximum dialkanolamine content: 0.5 per cent Do not use with nitrosating systems. Maximum dialkanolamine content: 5 per cent (applies to raw materials. Maximum N-nitroso-dialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers — 61 Monoalkanolamines All purposes and products Maximum dialkanolamine content: 0.5 per cent Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers — 62 Trialkanolamines (a) non-rinse-off (b) other products (a) 2.5 per cent — (a) (b): Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitroso-dialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrate-free containers — 63 Strontium hydroxide pH-regulator in depilatory products 3.5 per cent calculated as strontium pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with the eyes 64 Strontium peroxide Rinse-off hair care preparations for professional use 4.5 per cent calculated as strontium in the ready-for-use preparation All products must meet the hydrogen peroxide release requirements Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves 65 Benzalkonium chloride (INN), bromide and saccharinate (eg. Cetalkonium chloride Stearalkonium chloride, Cetearalkonium bromide) Hair care products rinsed off after use 3 per cent calculated as benzalkonium chloride In the finished product the concentration of benzalkonium chloride, bromide and saccharinate with an alkyl chain-length of C14 or less must not exceed 0.1 per cent calculated as benzalkonium chloride Avoid contact with the eyes Other products 0.1 per cent calculated as benzalkonium chloride — Avoid contact with the eyes 66 Polyacrylamides Body-care leave-on products — Maximum residual acrylamide content 0.1 μg/kg — Other cosmetic products — Maximum residual acrylamide content 0.5 μg/kg — --- Source: https://www.legislation.gov.uk/uksi/2003/835/schedule/4/part/I (the official version) Page: https://openlegislation.uk/cosmetic-products-safety-regulations-2003/schedule-4/part-I Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.