European Commission - Growth

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EC Regulation (v.2)

Annex III

LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Ref. Substance identification Restrictions
Chemical name / INN Name of Common Ingredients Glossary CAS Number EC Number Product Type, body parts Maximum concentration in ready for use preparation
1a Boric acid, borates and tetraborates with the exception of substance no 1184 in Annex II BORIC ACID 10043-35-3   233-139-2   (a) Talc
(b) Oral products
(c) Other products (excluding bath products and hair waving products)
 
(a) 5% (as boric acid)
(b) 0.1% (as boric acid)
(c) 3% (as boric acid) 
1b Tetraborates, see also 1a)     (a) Bath products
(b) Hair products
 
(a) 18% (as boric acid)
(b) 8% (as boric acid)
 
2a Thioglycolic acid and its salts THIOGLYCOLIC ACID 68-11-1  200-677-4  (a) Hair products
(b) Depilatories
(c) Hair rinse-off products
(d) Products intended for eyelash waving 
(a)
1) 8%
2) 11%
(b) 5%
(c) 2%
(d) 11%
The abovementioned percentages are calculated as thioglycollic acid 
2b Thioglycolic acid esters     Hair waving or straightening products
 
(a) 8%
(b) 11%
The abovementioned percentages are calculated as thioglycollic acid 
3 Oxalic acid, its esters and alkaline salts OXALIC ACID 144-62-7  205-634-3  Hair products  5% 
4 Ammonia AMMONIA 7664-41-7 / 1336-21-6  231-635-3 / 215-647-6    6% (as NH3) 
5 Tosylchloramide sodium (INN) CHLORAMINE-T 127-65-1  204-854-7    0.2% 
6 Chlorates of alkali metals POTASSIUM CHLORATE / SODIUM CHLORATE 3811-04-9 / 7775-09-9  223-289-7 / 231-887-4  (a) Toothpaste
(b) Other products 
(a) 5%
(b) 3%
 
7 Dichloromethane DICHLOROMETHANE 75-09-2  200-838-9    35%
(when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35%) 
8a p-Phenylenediamine and its salts 106-50-3 / 624-18-0 / 16245-77-5  203-404-7 / 210-834-9 / 240-357-1  Hair dye substance in oxidative hair dye products   
8b p- Phenylene-diamine and its salts P-PHENYLENEDIAMINE; P-PHENYLENEDIAMINE HCL; P-PHENYLENEDIAMINE SULPHATE 106-50-3 / 624-18-0 / 16245-77-5  203-404-7 / 210-834-9 / 240-357-1  Products intended for colouring eyelashes   
8 N-substituted derivatives of p- Phenylenediamine and their salts; N- substituted derivatives of o-Phenylenediamine (1 ), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II     Hair dye substance in oxidative hair dye products  (a) General use
(b) Professional use
For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3 % calculated as free base 
9a Toluene-2,5-diamine
Toluene-2,5-diamine sulphate
95-70-5 / 615-50-9  202-442-1 / 210-431-8  Hair dye substance in oxidative hair dye products
(a) General use
(b) Professional use
For (a) and (b):
After mixing under oxidative conditions the maximum concentration to hair must not exceed 4% calculated as free base. 
 
9 Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of the substance under reference number 9a in this annex and substances under reference numbers 364, 1310 and 1313 in Annex II     Hair dye substance in oxidative hair dye products  (a) General use
(b) Professional use
For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base 
10 Diaminophenols (1)     Oxidising colouring agents for hair dyeing  10% (as free base) 
11 Dichlorophen DICHLOROPHEN 97-23-4  202-567-1    0.5% 
12 Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide HYDROGEN PEROXIDE 7722-84-1  231-765-0  (a) Hair products
(b) Skin products
(c) Nail hardening products
(d) Oral products, including mouth rinse, tooth paste and tooth whitening or bleaching products
(e) Tooth whitening or bleaching products
(f) Products intended for eyelashes 
(a) 12% of H2O2 (40 volumes), present or released
(b) 4% of H2O2, present or released
(c) 2% of H2O2, present or released
(d) ≤ 0,1 % of H 2O 2, present or released
e) > 0,1 % ≤ 6 % of H2O2, present or released
(f) 2 % of H 2O 2, present or released 
13 Formaldehyde FORMALDEHYDE 50-00-0  200-001-8  Nail hardening products  5 % (as formaldehyde) 
14 Hydroquinone HYDROQUINONE 123-31-9  204-617-8  Artificial nail systems
 
0.02% (after mixing for use)
 
15a Potassium or sodium hydroxide POTASSIUM HYDROXIDE / SODIUM HYDROXIDE 1310-58-3 / 1310-73-2  215-181-3 / 215-185-5  (a) Nail cuticle solvent
(b) Hair straightener
(c) pH adjuster for depilatories
(d) Other uses as pH adjuster
15d- Callosity softener/remover 
(a) 5% (5)
(b)
1. 2% (5)
2. 4.5% (5)
15d- 1,5% (5) 
15b Lithium hydroxide LITHIUM HYDROXIDE 1310-65-2  215-183-4  (a) Hair straightener
(b) pH ajuster for depilatories
(c) Other uses as pH ajuster (for rinse-off products only)

 
(a)
1. 2% (6)
2. 4.5% (6)
 
15c Calcium hydroxide CALCIUM HYDROXIDE 1305-62-0  215-137-3  (a) Hair straighteners containing two components: calcium hydroxide and a guanidine salt
(b) pH ajuster for depilatories
(c) Other uses (e.g. pH adjuster, processing aid)
 
(a) 7% (as calcium hydroxide)
 
16 1- Naphthalenol 1-NAPHTHOL 90-15-3  201-969-4  Hair dye substance in oxidative hair dye products   
16 1-Naphthol and its salts 1-NAPHTHOL 90-15-3  201-969-4  Hair dye substance in oxidative hair dye products   
17 Sodium nitrite SODIUM NITRITE 7632-00-0  231-555-9  Rust inhibitor  0.2% 
18 Nitromethane NITROMETHANE 75-52-5  200-876-6  Rust inhibitor  0.3% 
21 Cinchonan-9-ol, 6'-methoxy-, (8.alpha.,9R)- its salts QUININE 130-95-0  205-003-2  (a) Hair rinse-off products
(b) Hair leave-on products
 
(a) 0.5% (as quinine base)
(b) 0.2% (as quinine base)
 
22 1,3-benzenediol RESORCINOL 108-46-3  203-585-2  (a) Hair dye substance in oxidative hair dye products
(b) Products intended for colouring eyelashes
(c) Hair lotions and shampoos 
(c) 0,5% 
23 (a) Alkali sulphides
(b) Alkaline earth sulphides
    (a) Depilatories
(b) Depilatories 
(a) 2% (as sulphur)
(b) 6% (as sulphur)  
24 Water-soluble zinc salts with the exception of zinc 4-hydroxybenzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V, entry 8) ZINC ACETATE / ZINC CHLORIDE / ZINC GLUCONATE / ZINC GLUTAMATE   1% (as zinc) 
25 Zinc 4-hydroxybenzene sulphonate ZINC PHENOLSULFONATE 127-82-2  204-867-8  Deodorants, antiperspirants and astringent lotions  6% (as % of anhydrous substance) 
26 Ammonium monofluorophosphate AMMONIUM MONOFLUOROPHOSPHATE 20859-38-5 -- 66115-19-3  - -- -  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
27 Sodium monofluorophosphate 10163-15-2 -- 7631-97-2  233-433-0 -- 231-552-2  Oral products  0.15% calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% 
28 Potassium monofluorophosphate 14104-28-0  237-957-0  Oral products  0.15% calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% 
29 Calcium monofluorophosphate 7789-74-4  232-187-1  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
30 Calcium fluoride 7789-75-5  232-188-7  Oral products  0.15% calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% 
31 Sodium fluoride 7681-49-4  231-667-8  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
32 Potassium fluoride POTASSIUM FLUORIDE 7789-23-3  232-151-5  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
33 Ammonium fluoride AMMONIUM FLUORIDE 12125-01-8  235-185-9  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
34 Aluminium fluoride ALUMINIUM FLUORIDE 7784-18-1  232-051-1  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
35 Stannous Fluoride 7783-47-3  231-999-3  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
36 Cetylamine Hydrofluoride CETYLAMINE HYDROFLUORIDE 3151-59-5  221-588-7  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
37 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
38 N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride     Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
39 Octadecenyl- Ammonium Fluoride OCTADECENYLAMMONIUM FLUORIDE 2782-81-2  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
40 Sodium Fluorosilicate SODIUM FLUOROSILICATE 16893-85-9  240-934-8  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
41 Potassium Fluorosilicate POTASSIUM FLUOROSILICATE 16871-90-2  240-896-2  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
42 Ammonium fluorosilicate 16919-19-0  240-968-3  Oral products  0.15% calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% 
43 Magnesium Fluorosilicate MAGNESIUM FLUOROSILICATE 16949-65-8  241-022-2  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
44 1,3-Bis(hydroxymethyl)imidazolidine-2-thione DIMETHYLOL ETHYLENE THIOUREA 15534-95-9  239-579-1  (a) Hair products
(b) Nail products 
(a) 2%
(b) 2%
 
45 Benzyl Alcohol BENZYL ALCOHOL 100-51-6  202-859-9  (a) Solvent
(b) Fragrance/ aromatic compositions/ their raw materials 
 
46 6-Methylcoumarin 6-METHYLCOUMARIN 92-48-8  202-158-8  Oral products  0.003% 
47 Nicomethanol Hydrofluoride NICOMETHANOL HYDROFLUORIDE 62756-44-9  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
48 Silver nitrate SILVER NITRATE 7761-88-8  231-853-9  Only for colouring eyelashes and eyebrows  4% 
49 Selenium sulfide SELENIUM DISULPHIDE 7488-56-4  231-303-8  Antidandruff shampoos  1% 
50 Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and the aluminium zirconium chloride hydroxide glycine complexes     Anti-perspirants  20% (as anhydrous aluminium zirconium chloride hydroxide)
5.4% (as zirconium) 
51 Quinolin-8-ol and bis(8-hydroxyquinolium) sulphate OXYQUINOLINE / OXYQUINOLINE SULFATE 148-24-3 / 134-31-6  205-711-1 / 205-137-1  (a) Stabilizer for hydrogen peroxide in rinse-off hair products
(b) Stabilizer for hydrogen peroxide in leave-on hair products
 
(a) 0.3% (as base)
(b) 0.03% (as base)
 
52 Methanol METHYL ALCOHOL 67-56-1  200-659-6  Denaturant for ethanol and isopropyl alcohol  5% (as a % of ethanol and isopropyl alcohol) 
53 (1-Hydroxyethylidene)diphosphonic acid and its salts ETIDRONIC ACID 2809-21-4  220-552-8  (a) Hair product
(b) Soap
 
(a) 1.5% (as etidronic acid)
(b) 0.2% (as etidronic acid)
 
54 1-Phenoxypropan-2-ol (8) 770-35-4  212-222-7  Rinse-off products
Not to be used in oral products 
2% 
56 Magnesium fluoride MAGNESIUM FLUORIDE 7783-40-6  231-995-1  Oral products  0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % 
57 Strontium chloride hexahydrate STRONTIUM CHLORIDE 10476-85-4  233-971-6  (a) Oral products
(b) Shampoo and face products
 
(a) 3.5% (as strontium)
When mixed with other permitted strontium products the total strontium content must not exceed 3.5%
(b) 2.1% (as strontium)
When mixed with other permitted strontium products the total strontium content must not exceed 2.1%
 
58 Strontium acetate hemihydrate STRONTIUM ACETATE 543-94-2  208-854-8  Oral products  3.5% (as strontium)
When mixed with other permitted strontium products the total strontium content must not exceed 3.5% 
59 Talc: Hydrated magnesium silicate TALC 14807-96-6  238-877-9  (a) Powdery products intended to be used for children under 3 years of age
(b) Other products
 
 
60 Fatty acid dialkylamides and dialkanolamides       Maximum secondary amine content: 0.5% 
61 Monoalkylamines, monoalkanolamines and their salts       Maximum secondary amine content: 0.5% 
62 Trialkylamines, trialkanolamines and their salts (a) Leave-on products
(b) Rinse-off products
 
(a) 2.5%
 
63 Strontium hydroxide STRONTIUM HYDROXIDE 18480-07-4  242-367-1  pH-adjuster for depilatories  3.5% (as strontium)  
64 Strontium peroxide STRONTIUM PEROXIDE 1314-18-7  215-224-6  Rinse-off hair products  4.5% (as strontium) 
65 Benzalkonium chloride, bromide and saccharinate (9) BENZALKONIUM CHLORIDE / BENZALKONIUM BROMIDE / BENZALKONIUM SACCHARINATE 91080-29-4 / 63449-41-2 / 68391-01-5 / 68424-85-1 / 85409-22-9 / 68989-01-5  293-522-5 / 264-151-6 / 269-919-4 / 270-325-2 / 287-089-1 / 273-545-7  Rinse-off hair (head) products

 
3% (as benzalkonium chloride)
 
66 Polyacrylamides     (a) Body leave-on products
(b) Other products
 
 
67 2-Benzylideneheptanal AMYL CINNAMAL 122-40-7  204-541-5     
69 Cinnamyl alcohol CINNAMYL ALCOHOL 104-54-1  203-212-3     
70 3,7-Dimethyl-2,6-octadienal
CITRAL 5392-40-5  226-394-6     
71 Phenol, 2-methoxy-4-(2-propenyl)-

EUGENOL 97-53-0  202-589-1     
72 Hydroxycitronellal HYDROXYCITRONELLAL 107-75-5  203-518-7  (a) Oral products
(b) Other products 
(b) 1,0 % 
73 Isoeugenol ISOEUGENOL 97-54-1 -- 5932-68-3   202-590-7 -- 227-678-2   (a) Oral products
(b) Other products 
b) 0,02 % 
74 2-Pentyl-3-phenylprop-2-en-1-ol

AMYLCINNAMYL ALCOHOL 101-85-9  202-982-8     
75 Benzyl salicylate BENZYL SALICYLATE 118-58-1  204-262-9     
76 2-Propenal, 3-phenyl-
CINNAMAL 104-55-2  203-213-9     
77 2H-1-Benzopyran-2-one
COUMARIN 91-64-5  202-086-7     
78 2,6-Octadien-1-ol, 3,7-dimethyl-, (2E)-

GERANIOL 106-24-1  203-377-1     
80 4-Methoxybenzyl alcohol ANISE ALCOHOL 105-13-5  203-273-6     
81 2-Propenoic acid, 3-phenyl-, phenylmethyl ester BENZYL CINNAMATE 103-41-3  203-109-3     
82 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl-
FARNESOL 4602-84-0  225-004-1     
83 2-(4-tert-Butylbenzyl)propionaldehyde BUTYLPHENYL METHYLPROPIONAL 80-54-6  201-289-8     
84 1,6-Octadien-3-ol, 3,7-dimethyl-
LINALOOL 78-70-6   201-134-4      
85 Benzyl benzoate BENZYL BENZOATE 120-51-4  204-402-9     
86 Citronellol /+- 3,7-dimethyloct-6-en-1-ol
CITRONELLOL 106-22-9 / 26489-01-0  203-375-0 / 247-737-6     
87 2-Benzylideneoctanal HEXYL CINNAMAL 101-86-0  202-983-3     
88 Limonene LIMONENE 5989-27-5  227-813-5     
89 Methyl 2-Octynoate 111-12-6  203-836-6  (a) Oral products
(b) Other products 
(b) 0.01% when used alone
When present in combination with methyl octine carbonate, the combined level in the finished product shall not exceed 0,01 % (of which methyl octine carbonate shall not be more than 0,002 %) 
90 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one ALPHA-ISOMETHYL IONONE 127-51-5  204-846-3     
91 Oak moss extract EVERNIA PRUNASTRI EXTRACT 90028-68-5   289-861-3     
92 Treemoss extract EVERNIA FURFURACEA EXTRACT 90028-67-4  289-860-8      
93 2,4-Pyrimidinediamine, 3-oxide DIAMINOPYRIMIDINE OXIDE 74638-76-9  Hair products  1.5% 
94 Dibenzoyl peroxide BENZOYL PEROXIDE 94-36-0  202-327-6  Artificial nail systems  0.7% (after mixing for use) 
95 Hydroquinone methylether / Mequinol P-HYDROXYANISOLE 150-76-5  205-769-8  Artificial nail systems  0.02% (after mixing for use) 
96 5-tert-Butyl-2,4,6-trinitro-m-xylene
MUSK XYLENE 81-15-2  201-329-4  All cosmetic products, with the exception of oral products
 
(a) 1.0% in fine fragrance
(b) 0.4% in eau de toilette
(c) 0.03% in other products
 
97 4'-tert-Butyl-2',6'-dimethyl-3',5'-dinitroacetophenone
MUSK KETONE 81-14-1  201-328-9  All cosmetic products, with the exception of oral care products
 
(a) 1.4% in fine fragrance
(b) 0.56% in eau de toilette
(c) 0.042% in other products