The Cosmetic Products (Safety) Regulations 2004

Regulation 5(2) and 7(9)

SCHEDULE 5 U.K. LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR AND EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule the colouring agents referred to in regulation 5(2)(d) are—

(i) those identified in column 1 either by name or by colour index number (the colour index numbers being those specified in the fourth edition of The Colour Index published by the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists (available by on-line subscription at http://www.colour-index.org/). ;

(ii) lakes or salts of these colouring agents which do not use substances prohibited under Schedule 3.

In the case of colouring agents identified by the addition of (*) to the name or colour index number, the insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8 of the Directive.

Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 23rd October 1962 on the approximation of the rules of Member States concerning foodstuffs and colouring matter (1), as amended (2) adapted (3) and replaced in part (4) must fulfil the purity requirements laid down in those Directives.

PART I U.K. COLOURING AGENTS LISTED IN ANNEX IV, PART 1 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Commencement Information

I1 Sch. 5 Pt. I in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I2 Sch. 5 Pt. I in force at 11.3.2005 in so far as commenced by inducing reg. 7(9), see reg. 1(2)

Field of application U.K.

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-column 3 = Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin

(1)	(2)	(3)				(4)
Name or colour index number	Colour	Type of production Field of application				Other requirement
		1	2	3	4
10006	Green				X
10020	Green			X
10316*	Yellow	X
11680	Yellow			X
11710	Yellow			X
11725	Orange				X
11920	Orange	X
12010	Red			X
12085*	Red	X				3 per cent maximum concentration in the finished product
12120	Red				X
12150	Red	X
12370	Red				X
12420	Red				X
12480	Brown				X
12490	Red	X
12700	Yellow				X
13015	Yellow	X				E 105
14270	Orange	X				E 103
14700	Red	X
14720	Red	X				E 122
14815	Red	X				E 125
15510*	Orange		X
15525	Red	X
15580	Red	X
15620	Red				X
15630*	Red	X				3 per cent maximum concentration in the finished product
15800	Red			X
15850*	Red	X
15865*	Red	X
15800	Red	X
15980	Orange	X				E 111
15985*	Yellow	X				E 110
16035	Red	X
16185	Red	X				E 123
16230	Orange			X
16255*	Red	X				E 124
16290	Red	X				E 126
17200*	Red	X
18050	Red			X
18130	Red				X
18690	Yellow				X
18736	Red				X
18820	Yellow				X
18965	Yellow	X
19140*	Yellow	X				E 102
20040	Yellow				X	Maximum 3,3’-dimethyl-benzidine concentration in the colouring agent: 5 mg/kg
20170	Orange			X
20470	Black				X
21100	Yellow				X	Maximum 3,3’-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21108	Yellow				X	Maximum 3,3’-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21230	Yellow			X
24790	Red				X
26100	Red			X		Purity criteria: aniline ≤ 0.2 per cent, 2-naphthol ≤ 0.2 per cent, azobenzen-4-amine ≤ 0.1 per cent, 1-phenylazo-2- naphthol ≤ 3 per cent, 1-[2-(phenylazo)phenylazo]-2-naphthol ≤ 2 per cent
27290*	Red				X
27755	Black	X				E 152
28440	Black	X				E 151
40215	Orange				X
40800	Orange	X
40820	Orange	X				E 160e
40825	Orange	X				E 160f
40850	Orange	X				E 161g
42045	Blue			X
42051*	Blue	X
42053	Green	X
42080	Blue				X
42090	Blue	X
42100	Green				X
42170	Green				X
42510	Violet			X
42520	Violet				X	Maximum concentration in the finished product: 5 mg/kg
42735	Blue			X
44045	Blue			X
44090	Green	X				E 142
45100	Red				X
45190	Violet				X
45220	Red				X
45350	Yellow	X				6 per cent. maximum concentration in the finished product
45370	Orange	X				Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45380*	Red	X				As immediately above
45396	Orange	X				When used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent
45405	Red		X			Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45410*	Red	X				As immediately above
45425	Red	X				Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3 per cent 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45430*	Red	X				As immediately above, E 127
47000	Yellow			X
47005	Yellow	X				E 104
50325	Violet				X
50420	Black			X
51319	Violet				X
58000	Red	X
59040	Green			X
60724	Violet				X
60725	Violet	X
60730	Violet			X
61565	Green	X
61570	Green	X
61585	Blue				X
62045	Blue				X
69800	Blue	X				E 130
69825	Blue	X
71105	Orange			X
73000	Blue	X
73015	Blue	X				E 132
73360	Red	X
73385	Violet	X
73900	Violet				X
73915	Red				X
74100	Blue				X
74160	Blue	X
74180	Blue				X
74260	Green		X
75100	Yellow	X
75120	Orange	X				E 160b
75125	Yellow	X				E 160d
75130	Orange	X				E 160a
75135	Yellow	X				E 161d
75170	White	X
75300	Yellow	X				E 100
75470	Red	X				E 120
75810	Green	X				E 140 and E 141
77000	White	X
77002	White	X
77004	White	X
77007	Blue	X
77015	Red	X
77120	White	X
77163	White	X
77220	White	X				E 170
77231	White	X
77266	Black	X
77267	Black	X
77268:1	Black	X				E 153
77288	Green	X				Free from chromate ions
77289	Green	X				Free from chromate ions
77346	Green	X
77400	Brown	X
77480	Brown	X				E 175
77489	Orange	X				E 172
77491	Red	X				E 172
77492	Yellow	X				E 172
77499	Black	X				E 172
77510	Blue	X				Free from cyanide ions
77713	White	X
77742	Violet	X
77745	Red	X
77820	White	X				E 174
77891	White	X				E 171
77947	White	X
Acid Red 195	Red			X
Aluminium, zinc, magnesium and calcium stearates	White	X
Anthocyanins	Red	X				E 163
Beetroot red	Red	X				E 162
Bromocresol green	Green				X
Bromothymol blue	Blue				X
Caramel	Brown	X				E 150
Capsanthin, capsorubin	Orange	X				E 160c
Lactoflavin	Yellow	X				E 101

PART II U.K. COLOURING AGENTS LISTED IN ANNEX IV, PART 2 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE COSMETIC PRODUCT SUPPLIED BEFORE A CERTAIN DATE

Commencement Information

I3 Sch. 5 Pt. II in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I4 Sch. 5 Pt. II in force at 11.3.2005 in so far as commence by inducing reg. 7(9), see reg. 1(2)

Field of application U.K.

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-section 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

(1)	(2)	(3)				(4)	(5)
Name or colour index number	Colour	Type of production Field of application				Other requirement	Cosmetic product supplied until
Note: There are no entries in this Part at the date that these Regulations are made.
		1	2	3	4

(1)

O.J. No. 115, 11.11.62, p.2645.

(2)

Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/358/EEC, 76/399/EEC, 78/144/EEC, 81/20/EEC and

85/7/EEC (O.J. Nos. L178, 26.10.65, p.2793; L263, 30.10.67, p. 4; L309, 24.12.68, p.24; L157, 18.7.70, p.36; L108,26.4.76, p.19; L44, 15.2.78, p.20; L43, 14.2.81, p.11; L2, 3.1.85, p.22).

(3)

Annexes 1 and VII to the Act of Accession of 22nd January 1972, as adjusted by the Council Decision of 1st January 1973 (O.J. No. L2, 1.1.73, p.1).

(4)

Council Directive 94/36/EC (O.J) No. L237, 10.9.94, p.13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.95, p.1).