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The Cosmetic Products (Safety) Regulations 2008

Type Statutory-Instrument

Publication 2008-05-13

Last updated 2020-12-31

State In force

Department King's Printer of Acts of Parliament

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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 substance shall not in any event exceed the limit specified for those 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.

In column headed field of application an “X” in a sub-column means that the colouring agents must not be used other than as follows—

Sub-column 1 - Colouring agent 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⁾Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom.	⁽¹⁾Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom.	⁽¹⁾Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom.	⁽¹⁾Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom.	⁽¹⁾Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom.	⁽¹⁾Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom.	⁽¹⁾Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom.
⁽²⁾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.	⁽²⁾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.	⁽²⁾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.	⁽²⁾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.	⁽²⁾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.	⁽²⁾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.	⁽²⁾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.
Colour index number or denomination	Colour	Field of application	Field of application	Field of application	Field of application	Other limitations and requirements¹
Colour index number or denomination	Colour	1	2	3	4	Other limitations and requirements¹
10006	Green				X
10020	Green			X
10316 ⁽²⁾	Yellow		X
11680	Yellow			X
11710	Yellow			X
11725	Orange				X
11920	Orange	X
12010	Red			X
12085 ⁽²⁾	Red	X				3% maximum concentration in the finished product
12120	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 ⁽²⁾	Orange		X
15525	Red	X
15580	Red	X
15620	Red				X
15630 ⁽²⁾	Red	X				3% maximum concentration in the finished product
15800	Red			X
15850 ⁽²⁾	Red	X
15865 ⁽²⁾	Red	X
15880	Red	X
15980	Orange	X				E 111
15985 ⁽²⁾	Yellow	X				E 110
16035	Red	X
16185	Red	X				E 123
16230	Orange			X
16255 ⁽²⁾	Red	X				E 124
16290	Red	X				E 126
17200 ⁽²⁾	Red	X
18050	Red			X
18130	Red				X
18690	Yellow				X
18736	Red				X
18820	Yellow				X
18965	Yellow	X
19140 ⁽²⁾	Yellow	X				E 102
20040	Yellow				X	maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 mg/kg
20470	Black				X
21100	Yellow				X	maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 mg/kg
21108	Yellow				X	As immediately above
21230	Yellow			X
24790	Red				X
26100	Red			X		Purity criteria: aniline ⿤ 0,2 % 2-naphtol ⿤ 0,2 % 4-aminoazobenzene ⿤ 0,1% 1-(phenylazo)-2-naphtol ⿤ 3 % 1-[2-(phenylazo)phenylazo]- 2-napthalenol ⿤ 2 %
27755	Black	X				E 152
28440	Black	X				E 151
40215	Orange				X
40800	Orange	X
40820	Orange	X				E 160 e
40825	Orange	X				E 160 f
40850	Orange	X				E 161 g
42045	Blue			X
42051 ⁽²⁾	Blue	X				E 131
42053	Green	X
42080	Blue				X
42090	Blue	X
42100	Green				X
42170	Green				X
42510	Violet			X
42520	Violet				X	5 mg/kg maximum concentration in the finished product
42735	Blue			X
44045	Blue			X
44090	Green	X				E 142
45100	Red				X
45190	Violet				X
45220	Red				X
45350	Yellow	X				6 % maximum concentration in the finished product
45370 ⁽²⁾	Orange	X				not more than 1 % 2-(6- hydroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 %2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45380 ⁽²⁾	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 %
45405	Red		X			not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45410 ⁽²⁾	Red	X				As immediately above
45425	Red	X				not more than 1 % 2-(6-hydroxy-3-oxo-3Hxanthen-9-yl) benzoic acid and 3 % 2-(iodo-6-hydroxy-3-oxo-3Hxanthen-9-yl) benzoic acid[entry deleted from 18/10/2008]
45430 ⁽²⁾	Red	X				E 127 - not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3% 2-(iodo-6-hydroxy-3-oxo-3H-xanthen -9-yl)benzoic acid
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 160 b
75125	Yellow	X				E 160 d
75130	Orange	X				E 160 a
75135	Yellow	X				E 161 d
75170	White	X
75300	Yellow	X				E 100
75470	Red	X				E 120
75810	Green	X				E 140 and E 141
77000	White	X				E 173
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 ion
77289	Green	X				free from chromate ion
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
Lactoflavin	yellow	X				E 101
Caramel	Brown	X				E 150
Capsanthin, capsorubin	Orange	X				E 160 c
Beetroot red	Red	X				E 162
Anthocyanins	Red	X				E 163
Aluminium, zinc, magnesium and calcium stearates	White	X
Bromothymol blue	Blue				X
Bromocresol green	Green				X
Acid red 195	Red			X

Note: There are no entries in this part at the date that these Regulations are made.

Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.

The substances marked with the symbol (*) may also be added to cosmetic products in concentrations other those laid down in this Schedule for other specific purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.

Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Schedule.

For the purposes of this list:

— “Salts” is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.

— “Esters” is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.

All finished products containing formaldehyde or substances in this Schedule and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0.05%.

Note: There are no entries in this Part at the date that these Regulations are made.

For the purposes of this Regulation, UV filters are substances which, contained in cosmetic sun-screen products, are specifically intended to filter certain UV rays in order to protect the skin from certain harmful effects of these rays.

The UV filters may be added to other cosmetic products within the limits and under the conditions laid down in this Schedule.

Other UV filters used in cosmetic products solely for the purpose of protecting the product against UV rays are not included in this list.

¹Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	¹Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	¹Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	¹Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	¹Not required if concentration is 0.5% or less and when it is used only for product protection purposes.
Reference No	Substances	Maximum authorised concentration	Other limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
1	. . .	. . .
2	N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate	6.0%
3	Homosalate (INN)	10%
4	Oxybenzone (INN)	10%		Contains oxybenzone¹
5	[omitted]
6	2-phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts	8% (expressed as acid)
7	3,3'-(1,4-Phenylenedimethylene) bis (7, 7-dimethyl-2-oxobicyclo-[2,2,1]hept-1-ylmethanesulfonic acid) and its salts	10% (expressed as acid)
8	1-(4-tert-butylphenyl)-3-(4-methoxyphenyl) propane-1,3-dione	5%
9	alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulfonic acid and its salts	6% (expressed as acid)
10	2-cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester (Octocrylene)	10% (expressed as acid)
11	Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]-benzyl}acrylamide	6%
12	Octyl methoxycinnamate	10%
13	Ethoxylated Ethyl-4-Aminobenzoate (PEG-25 PABA)	10%
14	Isopentyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate)	10%
15	2,4,6-Trianilino-(p-Carbo-2'-Ethylhexyl-1'Oxy)-1,3,5-Triazine (Octyl Triazone)	5%
16	Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-6-(2-Methyl-3-(1,3,3,3-Tetramethyl-I-(Trimethylsilyl)Oxy)-Disiloxanyl)Propyl) (Drometrizole Trisiloxane)	15%
17	Benzoic acid, 4,4-((6-(((1,1-dimethylethyl)amino)car-bonyl)phenyl)amino)1,3,5-triazine-2,4-diyl)diimino)bis-, bis-(2-ethylhexyl)ester)	10%
18	3-(4'-Methylbenxylidene)-d-1 camphor(4-Methylbenzylidene Camphor)	4%
19	3-Benzylidene camphor (3-Benzylidene Camphor)	2%
20	2-Ethylhexyl salicylate (Octyl-salicylate)	5%
21	4-Dimethyl-amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA)	8%
22	2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid (Benzophenone-5) and its sodium salt	5% (expressed as acid)
23	2,2'-Methylene-bis-6-(2H-benzotriazol-2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol	10%
24	Monosodium salt of 2-2'-bis-(1,4-phenylene) 1H-benzimidazole-4,6-disulphonic acid)	10% (expressed as acid)
25	(1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexyloxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl)	10%
26	Dimethicodiethylbenzal-malonate (CAS No 207574-74-1)	10%
27	Titanium dioxide	25%
28	Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-, hexylester (INCI name: Diethylamino Hydroxybenzoyl Hexyl Benzoate; CAS No 302776-68-7)	10% ...

Note: There are no entries in Part 2 at the date that these Regulations are made.

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Editorial notes

[^key-8d1c53bfc5a409bd6133578182e37c54]: Regulations revoked (11.7.2013 with savings for any cosmetic product placed on the market before that day) by The Cosmetic Products Enforcement Regulations 2013 (S.I. 2013/1478), Sch. 1 (with regs. 3, 6(5))

[^key-7c8ba69a68673aa80d36a9608b405662]: Regulations revoked (11.7.2013 with savings for any cosmetic product placed on the market before that day) by The Cosmetic Products Enforcement Regulations 2013 (S.I. 2013/1478), Sch. 1 (with regs. 3, 6(5)) Regulations as so saved modified (31.12.2020) by S.I. 2013/1478, reg. 3(2)(3) (as amended by S.I. 2019/696, reg. 1, Sch. 34 para. 31 (with Sch. 34 para. 32) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1))

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Commission Directive 2008/123/EC (O.J. No. L340, 19.12.2008, p. 71-72).

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Commission Directive 2009/6/EC (O.J. No. L36, 5.2.2009, p. 15-17).

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Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on persons under the age of 16.

Temporary “black henna” tattoos may increase your risk of allergy.

Do not colour your hair if:

—you have experienced a reaction to a temporary “black henna” tattoo in the past.

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