# The Cosmetic Products (Safety) Regulations 2004, Part 2: SUBSTANCES LISTED IN ANNEX III, PART 2 OF THE DIRECTIVE AS SUBSTANCES PROVISIONALLY ALLOWED

Extent: E+W+S+N.I.

(1)
(2)
(3)
(4)
(5)
(6)
(7)
Reference Number
Name of substance
Purpose of substance or type of product
Maximum concentration of substance in product
Other requirements
Required information
Permitted for supply until
Combination Rules
A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1.
B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substances shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above.
C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.
Note 1: 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 sun must not exceed the limits given in column 4.
1
C.I. Basic Blue 7
(CAS No 2390-60-5)
Non-oxidising colouring agents for hair dyeing
0.2 per cent
—
Can cause allergic reaction
30.9.2004
2
2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
Non-oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
3
4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
Non-oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
4
Naphthalene-2,7-diol (CAS No 582-17-2) and its salts
Oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent
—
30.9.2004
5
3-Aminophenol (CAS No 591-27-5) 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
30.9.2004
6
3,4-Dimethylpyridine-2,6-diol (CAS No 84540-47-6) 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
30.9.2004
7
4-(3-Hydroxypropyl)amino-3-nitrophenol (CAS No 92952-81-3) and its salts
Oxidising colouring agents for hair dyeing
5.2 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per cent
Can cause allergic reaction
30.9.2004
Non-oxidising colouring agents for hair dyeing
2.6 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per cent
Can cause allergic reaction
30.9.2004
8
6-Nitropyridine-2,5-diamine (CAS No 69825-83-8) and its salts
Non-oxidising colouring agent for hair dyeing
3 per cent
—
Can cause allergic reaction
30.9.2004
9
HC Blue No. 11 (CAS No 23920-15-2) and its salts
Oxidising colouring agent for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
Non-oxidising colouring agents for hair dyeing
2 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
10
2-(2-Nitro-p-toluidino)-ethanol (CAS No 100418-33-5) 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
30.9.2004
Non-oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent
Can cause allergic reaction
30.9.2004
11
2-(2-Hydroxyethylamino)-4,6-dinitrophenol (CAS No 99610-72-7) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
Non-oxidising colouring agents for hair dyeing
2 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
12
4-Methylaminophenol (CAS No 150-75-4) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
13
2-(2,4-Diamino-5-methylphenoxy)ethanol (CAS No 141614-05-3) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
14
HC Violet No. 2 (CAS No 104226-19-9) and its salts
Non-oxidising colouring agent for hair dyeing
2 per cent
—
—
30.9.2004
15
2-(2,6-Dinitro-p-anisidino)ethanol (CAS No 122252-11-3) and its salts
Non-oxidising colouring agent for hair dyeing
3 per cent
—
Can cause allergic reaction
30.9.2004
16
HC Blue No. 12 (CAS No 104516-93-0) and its salts
Oxidising colouring agents for hair dyeing
1.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per cent
Can cause allergic reaction
30.9.2004
Non-oxidising colouring agent for hair dyeing
1.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per cent
Can cause allergic reaction
30.9.2004
17
4-Ethoxy-6-methyl-m-phenylenediamine (CAS No 113715-25-6) 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
30.9.2004
18
4,4’-(Trimethylenedioxy)di-m-phenylenediamine (CAS No 81892-72-0) 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
30.9.2004
19
3-Amino-2,4-dichlorophenol (CAS No 61693-43-4) 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
30.9.2004
20
3-Methyl-l-phenyl-5-pyrazolone (CAS No 89-25-8) and its salts
Oxidising colouring agents for hair dyeing
0.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
Can cause allergic reaction
30.9.2004
21
5-(2-Hydroxyethyl)amino- o-cresol (CAS No 55302-96-0) 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
30.9.2004
22
3,4 Dihydro-2H-1,4-benzoxazin-6-ol (CAS No 26021-57-8) 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
30.9.2004
23
Naphthalene-1,7-diol (CAS No 575-38-2) and its salts
Oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent
Can cause allergic reaction
30.9.2004
24
HC Yellow No.10 (CAS No 109023-83-8) and its salts
Non-oxidising colouring agents for hair dyeing
0.2 per cent
—
—
30.9.2004
25
2,6-Dimethoxy-3,5- pyridinediamine (CAS No 85679-78-3) and its salts
Oxidising colouring agents for hair dyeing
0.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
Can cause allergic reaction
30.9.2004
26
HC Orange No.2 (CAS No 85765-48-6) and its salts
Non-oxidising colouring agent for hair dyeing
1 per cent
—
—
30.9.2004
27
HC Violet No.1 (CAS No 82576-75-8) and its salts
Oxidising colouring agents for hair dyeing
0.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
0.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
—
30.9.2004
28
2-(3-Methylamino-4-nitrophenoxy)ethanol (CAS No 59820-63-2) and its salts
Non-oxidising colouring agents for hair dyeing
1 per cent
—
—
30.9.2004
29
2-(2-Methoxy-4-nitroanilino)ethanol (CAS No 66095-81-6) and its salts
Non-oxidising colouring agents for hair dyeing
1 per cent
—
—
30.9.2004
30
2-(4-Amino-2-chloro-5-nitroanilino)ethanol (CAS No 50610-28-1) 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
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent
—
30.9.2004
31
HC Red No. 13 (CAS No 94158-13-1)
Oxidising colouring agents for hair dyeing
2.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
2.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent
—
30.9.2004
32
Naphthalene-1,5-diol (CAS No 83-56-7) and its salts
Oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent
—
30.9.2004
33
2,2’-[2-Hydroxy-trimethylenebis(4-aminophenyl)imino]diethanol (CAS No 128729-30-6) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
Can cause allergic reaction
30.9.2004
34
2-Aminophenol (CAS No 95-55-6) 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
—
30.9.2004
35
5-Amino-o-cresol (CAS No 2835-95-2) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
36
2-(2,4-Diamino-phenoxy)ethanol (CAS No 66422-95-5) and its salts
Oxidising colouring agents for hair dyeing
4 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 2 per cent
—
30.9.2004
37
2-Methylresorcinol (CAS No 608-25-3) 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
—
30.9.2004
38
4-Amino-m-cresol (CAS No 2835-99-6) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
39
2-Amino-4-hydroxyethyl-aminoanisole (CAS No 83763-47-7) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
40
3,4-Diaminobenzoic acid (CAS No 619-05-6) 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
—
30.9.2004
41
6-Amino-o-cresol (CAS No 17672-22-9) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
42
2-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
43
2-Amino-2-(2-hydroxyethylaminomethyl) (CAS No 110952-46-0 and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
44
N-(2-Hydroxyethyl)-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
45
C.I. Acid Black 52 (CAS No 3618-58-4) 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
—
30.9.2004
46
2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts
Oxidising colouring agents for hair dyeing
0.3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
0.3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent
—
30.9.2004
47
HC Blue No.2 (CAS No 33229-34-4) and its salts
Non-oxidising colouring agents for hair dyeing
2.8 per cent
—
—
30.9.2004
48
4-(2-Hydroxyethylamino)-3-nitrophenol (CAS No 65235-31-6) and its salts
Oxidising colouring agents for hair dyeing
6 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
6 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent
—
30.9.2004
49
2-(4-Nitrophenylamino)-ethylurea (CAS No 27080-42-8) and its salts
Oxidising colouring agents for hair dyeing
0.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
0.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
—
30.9.2004
50
HC Red No. 10 (CAS No 95576-89-9) + HC Red No. 11 (CAS No 95576-92-4) and their 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
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent
—
30.9.2004
51
HC Yellow No. 6 (CAS No 104333-00-8) 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
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent
—
30.9.2004
52
HC Yellow No.12 (CAS No 59320-13-7) and its salts
Oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
0.5 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent
—
30.9.2004
53
HC Blue No. 10 (CAS No 102767-27-1) 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
—
30.9.2004
54
HC Blue No. 9 (CAS No 114087-47-1) 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
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
1 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent
—
30.9.2004
55
2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its salts
Oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent
—
30.9.2004
56
2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) 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
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
2 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent
—
30.9.2004
57
C.I. Basic Blue 26 (CAS No 2580-56-5) (C.I. No. 44045)
Oxidising colouring agents for hair dyeing
0.5%
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
0.5%
In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent
—
30.9.2004
58
C.I. Acid Red 33 (CAS No 3567-66-6)
(C.I. No. 17200)
Non-oxidising colouring agents for hair dyeing
2 per cent
—
—
30.9.2004
59
C. I. Food Red 1 (CAS No 4548-53-2)
(C.I. No. 14700)
Non-oxidising colouring agents for hair dyeing
2 per cent
—
—
30.9.2004
60
C.I. Basic Violet 14 (CAS No 632-99-5)
(C.I. No. 42510)
Oxidising colouring agents for hair dyeing
0.3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent
—
30.9.2004
Non-oxidising colouring agents for hair dyeing
0.3 per cent
In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent
—
30.9.2004
61
1-tert-Butyl-3,5-dimethyl-2,4,6-trinitrobenzene (CAS No 81-15-2)
(musk xylene)
All cosmetic products, with the exception of oral care products
1 per cent in fine fragrance
0.4 per cent in eau de toilette
0.03 per cent in other products
—
—
30.9.2004
62
4’-tert-Butyl-2’,6’-dimethyl-3’, 5’-dinitroacetophenone (CAS No 81-14-1) (musk ketone)
All cosmetic products, with the exception of oral care products
1.4 per cent in fine fragrance
0.56 per cent in eau de toilette
0.042 per cent in other products
—
—
30.9.2004

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Source: https://www.legislation.gov.uk/uksi/2004/2152/schedule/4/part/2 (the official version)
Page: https://openlegislation.uk/cosmetic-products-safety-regulations-2004/schedule-4/part-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.