ANNEX III – PART 1
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTION AND CONDITIONS LAID DOWN
EU Ref # | Substance | Restrictions | Conditions of Use and Warning Which Must be Printed on the Labels | ||
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Field of Application And/or Use | Maximum Allowable Concentration In the Finished Cosmetic Product | Other Limitations & Requirements | |||
a | b | c | d | e | f |
1a | Boric Acid, borates and tetraborates | (a) Talc | (a) 5% (by Mass/mass as boric acid) | (a) 1. Not to be used in products for children under 3 years of age2. Not to be use on peeling or irritated skin | (a) 1. Not to be used for children under 3 years old of age 2. Not to be use on peeling or irritated skin |
(b) Products for oral hygiene | (b) 0.1% (by mass/mass as boric acid) | (b) 1. Not to be used in products for children under 3 years of age | (b) 1. Not to be swallowed2. Not to be used for children under 3 years of age | ||
(c) Other products (excluding bath products and hair waving | (c) 3% (by mass/mass as boric acid) | (c) 1. Not to be used in products for children2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5% (by mass/mass as boric acid) | (c) 1. Not to be used for children under 3 years2. Not to be used on peeling or irritated skin | ||
1b | Tetraborates | (a) Bath products | (a) 18% (by mass/mass as boric acid) | (a) 1. Not to be used in products for children under 3 years of age | (a) Not to be used of bathing children under 3 years of age |
(b) Hair waving products | (b) 8% (by mass/mass as boric acid) | (b) Rinse well | |||
2a | Thioglycollic acid and its salts | (a) Hair waving or straightening products: (1) General use | 8% ready for use pH 7-9.5 | a) b) c) The directions for use drawn up in the national or official languages(s) must obligatorily incorporate the following sentences:
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a)
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(2) Professional use | 11% ready for use pH 7-9.5 |
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(b) Depilatories | (b) 5% ready for use pH 7-12.7 | b) and c)
(c) Other hair care products which are removed after application(c) 2% ready for use pH 7-9,5 Percentage calculated as Thioglycollic acid |
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2b | Thioglycollic acid esters | Hair waving or straightening products:(a) General use(b) Professional use | (a) 8% ready for use pH 6-9,5 | The directions for use drawn up in the national or official language(s) must obligatorily incorporate the followimg sentences:
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3 | Oxalic Acid, its esters and Alkaline salts | Hair care products | 5% |
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4 | Ammonia | 6% calculated as NH3 |
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5 | Tosylchloramide sodium (*) | 0.2% | |||
6 | Chlorates of Alkali metals | (a) Toothpaste (b) Other uses | (a) 5%(b) 3% | ||
7 | Dichloromethane | 35% (when mixed with 1,1,1 -trichloroethane, total concentration must Not exceed 35%) | 0.2% as maximum impurity content | ||
8 | m-and p- Phenylenediamines, their N- substituted derivatives and their salts; N- substituted derivatives of o-phenylenediamines (1) | Oxidizing colouring agents for hair dyeing (a) General use(b) Professional use | 6% calculated as free base | (a)
(b)
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9 | Methylphenylenediamines, their N- substituted derivatives and their salts (1) with The of substance N°364 and 413 in Annex II | Oxidizing colouring agents for hair dyeing(a) General use(b) Professional use | 6% calculated as free base | (a)
(b)
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10 | Diaminophenols (1) | Oxidizing colouring agents for hair dyeing(a) General use(b) Professional use | 10% calculated as free base | (a)
(b)
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11 | Dichlorophen (*) | 0.50% | Contains dichlorophen | ||
12 | Hydrogen peroxide, and other compounds or mixture that release hydrogen peroxide including carbamide eroxide and zinc peroxide | (a) Hair-care preparations(b) Skin-Care preparations(c) Nail hardening preparations(d) Oral hygiene products | 12% H2O2 (40 volumes) present or released4% of H2O2 present or released2% of H2O2 present or released0.1% of H2O2 present or released | (a) (b) (c)
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13 | Formaldehyde | Nail hardeners | 5% calculated as formaldehyde |
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14 | Hydroquinone (1) | Oxidizing colouring agent for hair dyeing(a) General use(b) Professional use | 0.30% | (a) 1.
2.
(b)
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15a | Potassium or sodium hydroxide | (a) Nail cuticle solvent(b) Hair straightener(1) Generaluse(2) Professional use(c) pH adjuste – depilatories(d) Other uses as pH adjuster | (a) 5% by weight (3)(b)(1) 2% by weight (3)(2) 4.5% by weight(c) up to pH 12.7(d) up to pH 11 | (a)
(b)(1)
(2)
(c)
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15b | Lithium hydroxide | (a) Hair straightener(1) General use(2) Professional use(b) Other uses | (a) (1) 2% by weight (1)(2) 4.5% by weight (1) | (a) (1)
(2)
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15c | Calcium hydroxide | (a) Hair straighteners containing two componets: calcium hydroxide and a guanidine salts(b) Other uses | (a) 7% by weight calcium hydroxide | (a)
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16 | Alpha-naphthol | Colouring agent for hair dyeing | 0.50% | Contains alpha-naphthol | |
17 | Sodium nitrite | 0.20% | Do not use with secondary and/ or Tertiary amines or other substances Forming nitrosamines | ||
18 | Nitromethane | Rust inhibitor | 0.30% | ||
19 | Phenol and its alkali salts | Soaps and /shampoos | 1% calculated as phenol |
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20 | Quinine and its salts | (a) Shampoos(b) Hair lotions | (a) 0.5% calculated as quinine base(b) 0.2% calculated as quinine base | ||
21 | Resorcinol (1) | (a) Oxidizing colouring agent for hair dyeing(1) General use(2) Professional use(b) Hair lotions and shampoos | (a) 5%(b) Hair lotions and shampoos | (a) (1)
(2)
(b)
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22 | (a) Alkali sulphides(b) Alkaline earth sulphides | (a) Depilatories(b) Depilatories | (a) 2% calculated as sulphur pH to 12.7(b) 6% calculated as sulphur pH up to 12.7 | (a)
(b)
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23 | Water Soluble zinc salts with exception of zinc-4- hydrobenzenesulphonate and zinc pyrithione | 1% calculated as zinc | |||
24 | Zinc 4-hydroxyybenzene sulphonate | Deodorants, antiperspirant and astringent lotions | 6% calculated as 5 of anhydrous substance | Avoid contact with eyes | |
25 | Amomonium monofluorophosphate | Oral hygiene products | 0.15% calculated as F when mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%. | Contains ammonium monofluorophosphste | |
26 | Sodium monoflourophosphate | Ditto | 0.15% Ditto | Contains sodium monoflourophosphate | |
27 | Potassium monofluorophosphate | Ditto | 0.50% Ditto | Contains potassium monoflourophosphate | |
28 | Calcium monofluorophosphate | Ditto | 0.50% Ditto | Contains monoflourophosphate | |
29 | Calcium fluoride | Ditto | 0.15% Ditto | Contains calcium flouride | |
30 | Soduim fluoride | Ditto | 0.15% Ditto | Contains Soduim flouride | |
31 | Potassium fluoride | Ditto | 0.15% Ditto | Contains potassiun flouride | |
32 | Ammonium fluoride | Ditto | 0.50% Ditto | Contains ammonium flouride | |
33 | Aluminum fluoride | Ditto | 0.15% Ditto | Contains ammonium flouride | |
34 | Aluminum fluoride | Ditto | 0.15% Ditto | Contains Stannous flouride | |
35 | Hexadecyl ammonium fluoride | Ditto | 0.15% Ditto | Contains hexadecyl ammonium fluoride | |
36 | 3-(N-Hexadecyl-N-2 hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium dihy-Droflouride | Ditto | 0.15% Ditto | Contains3-(N-Hexadecyl-N-2 hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium dihydrofluoride | |
37 | NN’N-Tris (polyoxyethylene)-N- hexadedecylpropy-lenediamine dihydrofluoride | Ditto | 0.15% Ditto | Contains NN’N-Tris (polyoxyethylene) -N- hexadedecylpropylenediamine dihydrofluoride | |
38 | Octadecynyl-ammonium fluoride | Ditto | 0.15% Ditto | Conatains octadecyl-ammonium fluoride | |
39 | Sodium fluorosilicate | Ditto | 0.15% Ditto | Contains Sodium fluorosilicate | |
40 | Potassium fluorosilicate | Ditto | 0.15% Ditto | Contains ammonium fluorosilicate | |
40 | Magnesium fluorosilicate | Ditto | 0.15% Ditto | Contains magnesium fluorosilicate | |
41 | Ammonium fluorosilicate | Ditto | 0.15% Ditto | Contains ammonium fluorosilicate | |
42 | Magnesium fluorosilicate | Ditto | 0.15% Ditto | ƒ Contains magnesium fluorosilicate | |
43 | 1,3-Bis(hydroxymethyl) imidazolidine-2-thione | (a) Hair care preparations | (a) Up to 2% | (a) Prohibited in aerosol dispensers(spray) | Contains 1,3-bis (hydroxymethyl) imidazolidin-2-thione |
(b) Nail care preparations | (b) Up to 2% | (b) The pH of the product as applied must be less than 4 | |||
44 | Benzyl alcohol | Solvents, perfumes and flavouring | |||
45 | 6-Methylcoumarin | Oral hygiene products | 0.00% | ||
46 | Nicomethanol hydrofluoride | Oral hygiene products | 0.15% calculated as F. When mixed other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% | Contains nicomethanol hydroflouride | |
47 | Silver Nitrate | Solely for products intended | 4% | ƒ Contains silver nitrate ƒ Rinse the eyes immediately if ƒ Products comes into contact with them | |
48 | Selenium disulphide | Anti-dandruff shampoo | 1% | ƒ Contains selenium disulphide ƒ Avoid contact with eyes or damaged skin | |
49 | Aluminium zirconium chloride hydroxide complexes alxZR (OH)yCLz and the Aluminium zirconium chloride hydroxide glycine complexes | Antiperspirant | 20% as anhydrous aluminum zirconium chloride hydroxide | (1) The ratio of the number of aluminum atoms to that of zirconium atoms must be between 2 and 10(2) The ratio of the number of (AI + Zr) atoms to that chlorine atoms must be Between 0.9 and 2.1(3) Prohibited in aerosol dispensers (sprays) | Do not apply to irritated or damaged |
50 | Quinolin-8-ol and bis (8-hydroxyquinolinium) sulphate | ƒ stabilizer for hydrogen peroxide in rinse-off hair care preparations | ƒ calculated as base | ||
ƒ stabilizer for hydrogen peroxide in non-rinse | ƒ 0.03% calculated as base | ||||
51 | Methanol | Denaturant for ethanol and isopropyl alcohol | 5% calculated as a % of ethanol and isopropyl alcohol | ||
52 | Etidronic acids and its salts (1-hydroxy-ethylidene- diphosphonic acid and its salts) | (a) Hair – care | (a) 1.5% expressed as etidronic acid | ||
(b) Soap | (b) 0.2% expressed as etidronic acid | ||||
53 | Rinse of products onlyProhibited in oral hygiene products | 2% | As a preservative, see Annex VI, Part 1, No43 | ||
54 | Lead Acetate | Only for hair dyeing | 0.6% calculated in lead | ƒ Keep away from children. ƒ Avoid contact with the eyes ƒ Wash hands after use ƒ Contains lead acetate ƒ Do not use to dye eyelashes, eyes or moustaches ƒ If irritation develops, discontinue | |
55 | Magnesium fluoride | Dental hygiene products | 0.15% calculated as F. When mixed With other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% | Contains magnesium fluoride | |
56 | Strontium chloride hexahydrate | (a) Toothpaste | (a) 3.5% calculated as strontium. When mixed with other permitted Strontium products the total Strontium content must not Exceed 3.5% | ƒ Contains strontium chloride ƒ Frequent use by children is not advisable | |
(b) Shampoo and face care products | (b) 2.1% calculated as strontium compounds, the total strontium content must not exceed 2.10% | ||||
57 | Strontium acetate hemihydrate | Toothpaste | 3.5% calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5% | ƒ Contains strontium acetate ƒ Frequent use by children is not advisable | |
58 | Talc: hydrated magnesium silicate | (a) Powdery products intended to be used by children(b) Other products | (a) Keep powder away from children’s nose & mouth | ||
59 | Fatty acid dialkanolamides | Maximum dialkanolamine content: 0.5% | ƒ Do not use withnitrosating systems ƒ Maximum dialkanolamine content : 50 ug/kg ƒ Keep in nitrate-free containers | ||
60 | Monoalkanolamines | Maximum dialkanolamine content: 0.5% | ƒ Do not use with nitrosating system ƒ Minimum purity : 99% ƒ Maximum secondary alkanolamine content: ƒ 0.5% (concerns raw materials) ƒ Maximum N- Nitroso- dialkanolamine content: 50 ug/kg ƒ Keep in nitrate-free containers | ||
61 | Trialkanolamines | (a) Non rinse-off products | (a) 2.5% | (a) (b): ƒ Do not use with nitrosating system ƒ Minimum purity: 99% ƒ Maximum secondary alkanolamine content: ƒ 0.5% ( concerns raw materials) ƒ Maximum N-nitroso-dialkanolamine content: 50ug/kg ƒ Keep in nitrite-free containers | |
(b) Other products | |||||
62 | Strontium hydroxide | pH-regulator in depilatory products | 3.5% calculated as strontium, max pH of 12.7 | ƒ Keep out of reach of children ƒ Avoid contact with the eyes | |
63 | Strontium peroxide | Rinse-off hair care preparations Professional use | 4.5% calculated as strontium in the ready-for-use preparation | All products must meet the hydrogen Peroxide release requirements | ƒ Avoid contact with eyes ƒ Rinse eyes immediately if products comes into contact with them ƒ For professional use only ƒ Wear suitable gloves |
64 | Benzalkonium choloride, bromide and saccharinate | (a) Rinse-off hair (head) care products | (a) 3% (as benzalkonium chloride) | (a) In the final products the concentrations of benzalkonium chloride, bromide and Sacchinate with an alkyl chain of C14, or Less must not exceed 0.1% (as benzalkoinium chloride) | (a) Avoid contact with the eyes |
(b) other products | (b) 0.1% (as benzalkonium chloride | (b) Avoid contact with the eyes |