Part I substances listed in annex iii, part i 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 |
| Combination Rules
| |||||
| 1 | Boric acid | Talcum powder | 5 per cent | Not to be used in products intended for children less than three years old | Not to be used for children under three years of age |
| Oral hygiene products | 0.5 per cent | — | — | ||
| Other products | 3 per cent | — | — | ||
| 2 | (a) Thioglycollic acid, its salts and esters | Hair waving or straightening products for general use | 8 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 9.5 | Contains thioglycollate. Follow the instructions. Keep out of reach of children. For professional use only (where applicable) |
| Hair waving or straightening products for professional use | 11 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 9.5 | |||
| Depilatories | 5 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 12.7 | |||
| Other hair care products which are removed after application | 2 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 9.5 The directions for use drawn up in national or official languages must incorporate the following instructions—Avoid contact with eyes. In the event of contact with the eyes rinse immediately with plenty of water and seek medical advice. Wear suitable gloves (this latter instruction does not apply to Depilatories) | |||
| (b) Thioglycollic acid esters | Hair waving or straightening products for general use | 8 per cent (calculated as thioglycollic acid) ready for use | pH value 6 to 9.5 | ||
| Hair waving or straightening products for professional use | 11 per cent (calculated as thioglycollic acid) ready for use | pH value 6 to 9.5 The directions for use drawn up in national or official languages must incorporate the following instructions—May cause sensitisation in the event of contact with the skin. Avoid contact with eyes. In the event of contact with the 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 | Tosylchloramide Sodium | All purposes and products | 0.2 per cent | — | — |
| 6 | Chlorates of alkali metals | Toothpaste | 5 per cent | — | — |
| Other uses | 3 per cent | — | — | ||
| 7 | Dichloromethane | 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-andp-Phenylenediamines, theirN-substituted derivativesand their salts;N-substituted derivatives ofo-phenylenediamines | 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. Sensitivity test advisable before use. 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. Sensitivity test advisable before use | ||
| 9 | Methylphenylenediamines (other than 4-methyl—m-phenylenediamine and its salts), theirN-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 phenylenediamines. Can cause an allergic reaction. Sensitivity test advisable before use. 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. Sensitivity test advisable before use | ||
| 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 an allergic reaction. Sensitivity test advisable before use. 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. Sensitivity test advisable before use | ||
| 11 | Dichlorophen | All purposes and products | 0.5 per cent | — | Contains dichlorophen |
| 12 | Hydrogen peroxide | Hair care products preparations | 12 per cent of H2O2 (40 volumes) | — | Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them |
| Skin hygiene preparations | 4 per cent of H2O2 | — | Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them | ||
| Nail hardening preparations | 2 per cent of H2O2 | — | 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 4) | 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 | 2 per cent subject to the provision 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 | 2 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 | ||
| Agents for localised skin lightener | 2 per cent | — | Contains hydroquinone. Avoid contact with eyes. Apply to small areas. If irritation develops discontinue use. Do not use on children under the age of 12 | ||
| 15 | Potassium and sodium hydroxide | Nail cuticle solvent | 5 per cent calculated as sodium hydroxide | — | 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 | — | 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 | — | 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 | Keep out of reach of children. Avoid contact with eyes | ||
| 16 | α-Naphthol | Colouring agent for hair dyeing | 0.5 per cent | — | Contains α-naphthol |
| 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 | Pyrogallol | Oxidizing colouring agent for hair dyeing for general use | 5 per cent subject to the provisions of “Combination Rule B” set out below | — | Contains pyrogallol. 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 pyrogallol. For professional use only. Rinse eyes immediately if product comes into contact with them | ||
| 21 | Quinine and its salts | Shampoos | 0.5 per cent calculated as quinine base | — | — |
| Hair lotions | 0.2 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 | ||
| 23 | (a) 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 |
| (b) 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-hydroxybenzenesulphonate | All purposes and products | 1 per cent calculated as zinc | — | — |
| 25 | Zinc 4-hydroxybenzenesulphonate | Deodorants, antiperspirants and astringent lotions | 6 per cent calculated as percentage of anhydrous substance | — | Avoid contact with eyes |
| 26 | Ammonium monofluorophosphate | Oral hygiene products | 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds total fluorine concentration must not exceed 0.15 per cent | — | Contains ammonium monofluorophosphate |
| 27 | Sodium monofluorophosphate | Oral hygiene products | As for ammonium monofluorophosphate | — | Contains sodium monofluorophosphate |
| 28 | Potassium monofluorophosphate | Oral hygiene products | As for ammonium monofluorophosphate | — | Contains potassium monofluorophosphate |
| 29 | Calcium monofluorophosphate | Oral hygiene products | As for ammonium monofluorophosphate | — | Contains calcium monofluorophosphate |
| 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 | Hexadecyl ammonium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | — | Contains hexadecyl ammonium fluoride |
| 37 | 3-(n-Hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride | Oral hygiene products | As for ammonium monofluorophosphate | — | Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride |
| 38 | NN'N'-Tris(polyoxyethylene)—N-hexadecylpropylenediamine dihydrofluoride | Oral hygiene products | As for ammonium monofluorophosphate | — | ContainsNN'N'-tris(polyoxyethylene)—N-hexadecylpropylenediamine dihydrofluoride |
| 39 | Octadecenyl ammonium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | — | Contains octadecenyl ammonium 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 | Hair care preparations | 2 per cent | Not to be used in aerosol dispensers | Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-2-thione |
| Nail care preparations | 2 per cent | pH as applied value must be less than 4 | Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-2-thione | ||
| 45 | Benzyl alcohol (See also Part I of Schedule 4) | 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 | 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 the 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 betweeen 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-hydroxy-quinolinium sulphate) (See also Part II of this Schedule) | 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-hydroxy-ethylidene-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-Phenoxypropan-2-ol (See also Part I of Schedule 4) | Products rinsed off after use. Prohibited in oral hygiene products | 2 per cent | — | — |