Legalize / United Kingdom / Statutory-Instrument

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

Source legislation.gov.uk

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			*Restrictions*	*Restrictions*	*Restrictions*
Reference number	Substance	Substance	Field of application and/or use	Maximum authorised concentration in the finished cosmetic product	Other limitations and requirements	Conditions of use and warnings which must be printed on the label	Allowed until
			Field of application and/or use	Maximum authorised concentration in the finished cosmetic product	Other limitations and requirements
a	b	b	c	d	e	f	g
1	omitted	omitted
2	omitted	omitted
3	. . .	. . .	. . .	. . .	. . .	. . .	. . .
3	. . .	. . .			. . .	. . .	. . .
4	. . .	. . .	. . .	. . .	. . .	. . .	. . .
5	. . .	. . .	. . .	. . .	. . .	. . .	. . .
6	. . .	. . .	. . .	. . .	. . .	. . .	. . .
7	. . .	. . .
7	. . .	. . .
8	omitted	omitted
9	. . .	. . .
9	. . .	. . .
10	Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts	Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	(a) [image omitted] 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 a rash on your face or sensitive, irritated and damaged scalp,—you have ever experienced any reaction after colouring your hair,—you have experienced a reaction to a temporary “black henna” tattoo in the past.(b) ...	31.12.2011
10	Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts	Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts	(b) Non-oxidising colouring agents for hair dyeing	(b) 1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	(a) [image omitted] 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 a rash on your face or sensitive, irritated and damaged scalp,—you have ever experienced any reaction after colouring your hair,—you have experienced a reaction to a temporary “black henna” tattoo in the past.(b) ...	31.12.2011
11	. . .	. . .	. . .	. . .	. . .	...	. . .
11	. . .	. . .			. . .	...	. . .
12	. . .	. . .	. . .	. . .	. . .	. . .	. . .
13	omitted	omitted
14	. . .	. . .
15	omitted	omitted
16	. . .	. . .	. . .	. . .	. . .	...	. . .
16	. . .	. . .			. . .	...	. . .
17	omitted	omitted
18	. . .	. . .
19	. . .	. . .	. . .	. . .	. . .	. . .	. . .
20	. . .	. . .	. . .	. . .	. . .	. . .	. . .
21	. . .	. . .	. . .	. . .	. . .	. . .	. . .
22	. . .	. . .	. . .	. . .	. . .	. . .	. . .
23	omitted	omitted
24	. . .	. . .
25	. . .	. . .	. . .	. . .	. . .	. . .	. . .
26	. . .	. . .	. . .	. . .			. . .
27	. . .	. . .	. . .	. . .	. . .	. . .	. . .
27	. . .	. . .			. . .	. . .	. . .
28	. . .	. . .
29	. . .	. . .	. . .	. . .			. . .
30	omitted	omitted
31	. . .	. . .	. . .	. . .	. . .	. . .	. . .
31	. . .	. . .			. . .		. . .
32	. . .	. . .	. . .	. . .	. . .	. . .	. . .
33	. . .	. . .	. . .	. . .	. . .	. . .	. . .
34	. . .	. . .	. . .	. . .	. . .	. . .	. . .
35	. . .	. . .	. . .	. . .	. . .	. . .	. . .
36	. . .	. . .	. . .	. . .	. . .	. . .	. . .
37	. . .	. . .	. . .	. . .	. . .	. . .	. . .
38	. . .	. . .	. . .	. . .	. . .	. . .	. . .
39	. . .	. . .	. . .	. . .	. . .	. . .	. . .
40	omitted	omitted
41	omitted	omitted
42	omitted	omitted
43	omitted	omitted
44	. . .	. . .	. . .	. . .	. . .	. . .	. . .
45	omitted	omitted
46	omitted	omitted
47	. . .	. . .
48	. . .	. . .	. . .	. . .	. . .	. . .	. . .
48	. . .	. . .			. . .	. . .	. . .
49	. . .	. . .	. . .	. . .	. . .	. . .	. . .
49	. . .	. . .			. . .		. . .
50	HC Red No 10 + HC Red No 11 (CAS No 95576-89-9+ 95576-92-4) and its salts	HC Red No 10 + HC Red No 11 (CAS No 95576-89-9+ 95576-92-4) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	(a) [image omitted] 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 a rash on your face or sensitive, irritated and damaged scalp, —you have ever experienced any reaction after colouring your hair, —you have experienced a reaction to a temporary “black henna” tattoo in the past.	31.12.2011
50	HC Red No 10 + HC Red No 11 (CAS No 95576-89-9+ 95576-92-4) and its salts	HC Red No 10 + HC Red No 11 (CAS No 95576-89-9+ 95576-92-4) and its salts	(b) Non-oxidising colouring agents for hair dyeing	(b) 1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		31.12.2011
51	omitted	omitted
52	omitted	omitted
53	omitted	omitted
54	omitted	omitted
55	. . .	. . .	. . .	. . .	. . .	. . .	. . .
55	. . .	. . .			. . .		. . .
56	. . .	. . .	. . .	. . .	. . .	. . .	. . .
56	. . .	. . .			. . .	. . .	. . .
57	. . .	. . .
58	. . .	. . .
59	...	...
60	...	...

SCHEDULE 5

PART 1 — LIST OF COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS

Field of Application

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.

Colour index number or denomination	Colour	Field of application	Field of application	Field of application	Field of application	Other limitations and requirements[^f01016]
Colour index number or denomination	Colour	1	2	3	4	Other limitations and requirements[^f01016]
(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.
10006	Green				X
10020	Green			X
10316[^f01017]	Yellow		X
11680	Yellow			X
11710	Yellow			X
11725	Orange				X
11920	Orange	X
12010	Red			X
12085[^f01017]	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[^f01017]	Orange		X
15525	Red	X
15580	Red	X
15620	Red				X
15630[^f01017]	Red	X				3% maximum concentration in the finished product
15800	Red			X
15850[^f01017]	Red	X
15865[^f01017]	Red	X
15880	Red	X
15980	Orange	X				E 111
15985[^f01017]	Yellow	X				E 110
16035	Red	X
16185	Red	X				E 123
16230	Orange			X
16255[^f01017]	Red	X				E 124
16290	Red	X				E 126
17200[^f01017]	Red	X
18050	Red			X
18130	Red				X
18690	Yellow				X
18736	Red				X
18820	Yellow				X
18965	Yellow	X
19140[^f01017]	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[^f01017]	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[^f01017]	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[^f01017]	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[^f01017]	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[^f01017]	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

PART 2 — LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR USE IN COSMETIC PRODUCTS

Field of application

Colour index number or denomination	Colour	Field of application	Field of application	Field of application	Field of application	Other limitations and requirements	Authorisation valid until
Colour index number or denomination	Colour	1	2	3	4	Other limitations and requirements	Authorisation valid until

SCHEDULE 6 — LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

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%.

PART 1 — LIST OF PRESERVATIVES ALLOWED

Reference number	Substances	Maximum authorised concentration	Limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
(1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.	(1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.	(1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.	(1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.	(1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.
(2) Concerns any products aimed to be applied on a large part of the body.	(2) Concerns any products aimed to be applied on a large part of the body.	(2) Concerns any products aimed to be applied on a large part of the body.	(2) Concerns any products aimed to be applied on a large part of the body.	(2) Concerns any products aimed to be applied on a large part of the body.
(3) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.	(3) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.	(3) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.	(3) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.	(3) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.
(4) Solely for products which might be used for children under three years of age.	(4) Solely for products which might be used for children under three years of age.	(4) Solely for products which might be used for children under three years of age.	(4) Solely for products which might be used for children under three years of age.	(4) Solely for products which might be used for children under three years of age.
1	Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1)	Rinse-off products, except oral care products 2.5% (expressed as acid)
1	Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1)	Oral care products: 1.7% (expressed as acid)
1	Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1)	Leave-on products: 0.5% (expressed as acid)
1a	Salts and esters of benzoic acid other than those listed under reference number 1	0.5% (expressed as acid)
2	Propionic acid and its salts	2% (expressed as acid)
3	Salicylic acid and its salts	0.5% (expressed as acid)	Not to be used in preparations for children under three years of age, except for shampoos	Not to be used for children under three years of age[^f01018]
4	Sorbic acid (hex-2,4-dienoic acid) and its salts	0.6% (expressed as acid)
5	Formaldehyde paraformaldehyde (*)	0.2% (except for oral hygiene products) expressed as free formaldehyde	Prohibited in aerosol dispensers (sprays)
5	Formaldehyde paraformaldehyde (*)	0.1% (products for oral hygiene) expressed as free formaldehyde	Prohibited in aerosol dispensers (sprays)
6	[omitted]
7	Biphenyl-2-ol (o-phenylphenol) and its salts	0.2% expressed a phenol
8	Zinc pyrithione (CAS No 13463-41-7)(*)	Hair products: 1,00% Other products: 0,5%	Rinse-off products only
8	Zinc pyrithione (CAS No 13463-41-7)(*)	Hair products: 1,00% Other products: 0,5%	Prohibited in products for oral hygiene
9	Inorganic sulfites and hydrogen-sulfites (*)	0.2% expressed as free SO[^f01019]
10	Sodium iodate	0.1%	Rinse-off products only
Entry deleted from 18/10/2008	Sodium iodate	0.1%	Rinse-off products only
11	Chlorobutanol (INN)	0.5%	Prohibited in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid and its salts and esters	0.4% (expressed as acid) for a single ester,
12	4-Hydroxybenzoic acid and its salts and esters	0.8% (expressed as acid) for mixtures of esters
13	3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts	0.6% (acid)	Prohibited in aerosol dispensers (sprays)
14	Formic acid and its sodium salt	0.5% (expressed as acid)
15	3,3’-Dibromo-4,4’-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate)	0.1%
16	Thiomersal (INN) For eye	0.007% (of Hg)	For eye make up and eye make-up remover only	Contains thiomersal
16	Thiomersal (INN) For eye	If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0.007%	For eye make up and eye make-up remover only	Contains thiomersal
17	Phenylmercuric salts (including borate)	0.007% (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0.007%	For eye make up and eye make-up remover only	Contains phenylmercuric compounds
18	Undec-1-0-enoic acid and salts	0.2% (expressed as acid)	See Schedule 6, Part 2, No 8
19	Hexetidine (INN)	0.1%
20	5-Bromo-5-nitro-1,3-dioxane	0.1%	Rinse off products only
20	5-Bromo-5-nitro-1,3-dioxane	0.1%	Avoid formation of nitrosamines
21	Bronopol (INN)	0.1%	Avoid formation of nitrosamines
22	2.4-Dichlorobenzyl alcohol	0.15%
23	Triclocarban (INN) (*)	0.2%	Purity criteria:3,3’,4,4’-Tetrachloroazo-benzene ≤1 mg/kg 3,3’,4,4’-
23	Triclocarban (INN) (*)	0.2%	Tetrachloroazoxybenzene ≤1 mg/kg
24	4-Chrloro-m-cresol	0.2%	Prohibited in products intended to come into contact with mucous membranes
25	Triclosan (INN)	0.3%
26	4-Chloro-3,5-xylenol	0.5%
27	3,3’-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1’-methylenediurea (‘Imidazolidinyl urea)	0.6%
28	Poly (1-hexamethylenebiguanide hydrochloride	0.3%
29	2-Phenoxyethanol	1.0%
30	Hexamethylenetetramine (methenamine) (INN)	0.15%
31	Methenamine 3-chloroallylochloride (INN)	0.2%
32	1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one	0.5%
33	1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione	0.6%
34	Benzyl alchohol (*)	1%
35	1-Hydroxy-4-methyl-6(2,4,4-trimethyl-pentyl) 2-pyridon and its monoethanolamine salt	1,0% 0.5%	Rinse off products Other products
36	Entry deleted
37	6,6-Dibromo-4,4-dichloro2,2’-methylenediphenol (Bromochlorophen)	0.1%
38	4-Isopropyl-m-cresol	0.1%
39	Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate	0.0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3 (2H)-one and 2-methylisothiazol-3 (2H)-one
40	2-Benzyl-4-chlorophenol (clorophene)	0.2%
41	2-Chloroacetamide	0.3%		Cointains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride	0,3% expressed as chlorhexidine
43	1-Phenoxypropan-2-ol(*)	1.0%	Only rinse-off products
44	Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*)	1.0%
45	4,4-dimethyl-1,3-oxizalidine	0.1%	The pH of the finished product must not be lower than 6
46	N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N’-(hydroxymethyl) urea	0.5%
47	1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate)	0,1%
48	Glutaraldehyde (Pentane-1,5-dial)	0.1%	Prohibited in aerosols (sprays)	Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.5%)
49	5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane	0.3%	Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes
50	3-(p-chlorophenoxy)-propane-1,2 diol (chlorphenesin)	0.3%
51	Sodium hydroxymethylamino acetate (Sodium Hydroxymethylglycinate)	0.5%
52	Silver chloride deposited on titanium dioxide	0.004% calculated as AgC1	The ratio of titanium dioxide to silver chloride shall be 4:1 by mass. Prohibited in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips
53	Benzethonium Chloride (INCI)	0.1%	(a) Rinse off products,
53	Benzethonium Chloride (INCI)	0.1%	(b) Leave-on products other than for oral care use
54	Benzalkonium chloride, bromide and saccharinate (*)	0,1% calculated as benzalkonium chloride		Avoid contact with eyes
55	Benzylhemiformal	0.15%	Only for products to be removed by rinsing
56Entry deleted from 18/10/2008	3-Iodo-2-propynylbutylcarbamate	0.05%	1. Not to be used for oral hygiene and lipcare products	Contains iodine
	3-Iodo-2-propynylbutylcarbamate	0.05%	2. If the concentration on products intended to remain on the skin exceeds 0.02% add the phrase: Contains iodine	Contains iodine
56Entry inserted from 18/10/2008	Iodopropynyl butyl-carbamate	(a) rinse-off products: 0.02%	Not to be used in oral hygiene and lip care products	(a) “Not to be used for children under three years of age”[^f01020]
	(IPBC)	(a) rinse-off products: 0.02%	(a) Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo	(a) “Not to be used for children under three years of age”[^f01020]
	3-iodo-2-propynl-butylcarbamate	(b) leave-on products: 0.01% except in deodorants/anti-perspirants: 0.0075%	(b) - not to be used in body lotion and body cream[^f01019]	(b)“Not to be used for children under three years of age”[^f01021]
	CAS No: 55406-53-6	(b) leave-on products: 0.01% except in deodorants/anti-perspirants: 0.0075%	- not to be used in preparations for children under three years of age	(b)“Not to be used for children under three years of age”[^f01021]
57	Methylisothiazolinone (INCI)	0.01%

PART 2 — LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

Reference number	Substance	Maximum authorised concentration	Limitation and requirement	Conditions of use and warnings which must be printed on the label	Allowed until
a	b	c	d	e	f

SCHEDULE 7

PART 1

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.

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) Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	(1) Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	(1) Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	(1) Not required if concentration is 0.5% or less and when it is used only for product protection purposes.	(1) Not required if concentration is 0.5% or less and when it is used only for product protection purposes.
1	4-Aminobenzoic acid	5.0%
2	N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate	6.0%
3	Homosalate (INN)	10%
4	Oxybenzone (INN)	10%		Contains oxybenzone[^f01022]
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% in sunscreen products

PART 2 — LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY PROVISIONALLY CONTAIN

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

SCHEDULE 8 — SUPPLEMENTARY PROVISIONS ABOUT LABELLING OF COSMETIC PRODUCTS

PART 1

	[image omitted]

PART 2

	[image omitted]

SCHEDULE 9

PART 1 — PARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY

1

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2

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PART 2 — PROCEDURE FOR GRANT OF REGISTRATION NUMBER

3

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4

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SCHEDULE 10 — SAMPLING AND TESTING

1

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2

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3

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4

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5

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6

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Signed

Gareth Thomas — Parliamentary Under-Secretary of State for Trade and Consumer Affairs — 2008-05-13

Explanatory note

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Footnotes

[^f00001]: 1972 c.68. Section 2(2) amended by section 27 and paragraph 1A of Schedule 2 inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c.51).

[^f00002]: S.I. 1972/1811, 1975/1707, 1993/2661.

[^f00003]: 1987 c.43. Section 11(1) has been amended by S.I. 2005/1803.

[^f00004]: OJ No L262, 27.9.76, p169.

[^f00005]: OJ No L 396, 30.12.2006, p1.

[^f00006]: Ingredient names are listed in the twelfth edition of the International Cosmetic Ingredient Dictionary and Handbook (ISBN 978-1-882621-43-91) published in 2005 by The Cosmetic Toiletry and Fragrance Association. The EINECS identification reference is the reference given in the European Inventory of Existing Commercial Chemical Substances. The ELINCS identification reference is given in the European List of Notified Chemical Substances. The CAS identification reference is assigned by the Chemical Abstracts Service. An ingredient’s International Non-proprietary name (INN) is specified in the International Non-proprietary Names (INN) for Chemical Substances CD ROM (ISBN 13 9789240560239), ISBN 10 9240560234) published in 2007 (http://www.who.int/publications/en/). An ingredient’s colour index number is specified in the fourth edition of The Colour Index International 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/). International Nomenclature of Cosmetic Ingredients names, European Pharmacopoeia names, International Non-proprietary Names and EINECS, IUPAC and CAS identification references are listed in Commission Decision 96/335/EC (OJ No L132, 1.6.96, p1), as amended by Commission Decision 2006/257/EC (OJ No L97, 5.4.2006, p. 1).

[^f00007]: OJ No L140, 23.6.95, p 26.

[^f00008]: OJ No L50, 20.2.2004, p44, implemented by the Good Laboratory Practice (Codification Amendment Etc.) Regulations 2004 (S.I. 2004/994).

[^f00009]: S.I. 2007/289.

[^f00010]: 1983 c.54. Section 3 has been amended by S.I. 2006/1914.

[^f00011]: S.I. 2007/2781.

[^f00012]: S.I. 2007/3544 to which there are amendments not relevant to these Regulations.

[^f00013]: Lakes or salts of these colouring agents using substances not prohibited under Schedule 3 are equally allowed.

[^f00014]: 96/335/EC (O.J. No. L132, 1.6.96, p.1), as amended by Commission Decision 2006/1257/EC (OJ No L97 5.4.2006, p1).

[^f00015]: 80/1335/EEC (O.J. No. L383, 31.12.1980 p.27-46).

[^f00016]: 87/143/EEC (O.J. No. L57, 27.2.1987, p.56).

[^f00017]: 82/434/EEC (O.J. No. L185, 30.6.1982, p.1-28).

[^f00018]: 90/207/EEC (O.J. No. L108, 28.4.1990 p.92-101).

[^f00019]: 83/514/EEC (O.J. No. L291, 24.10.1983, p.9-46).

[^f00020]: 85/490/EEC (O.J. No. L295, 7.11.1985, p.30-45).

[^f00021]: 93/73/EEC (O.J. No. L231, 14.9.1993).

[^f00022]: 95/32/EC (O.J. No. L178, 28.7.1995).

[^f00023]: 96/45/EC (O.J. No. L213, 22.8.1996 p.8).

[^f00024]: 87/143/EEC (O.J. No. L057, 27.02.1987 p.56).

Labelling requirements

Responsible persons and competent authorities

Information to be made accessible to competent authority

Qualified persons

Medical treatment

Authorisation by the Secretary of State

Requests for confidentiality

Contravention of these Regulations

Enforcement

Proceedings

Amendment to Legislative and Regulatory Reform (Regulatory Functions) Order 2007

Naming of substances is based on botanical Latin names, International Nomenclature of Cosmetic Ingredients (INCI), International Non-proprietary Names (INN) and International Organization of Standardization (ISO)

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