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:
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| 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:
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| 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 |
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| 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 | — | ||
Notes on Schedule 4
Footnotes
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O.J. No. L132, 1.6.1996, p.1.