The Cosmetic Products (Safety) Regulations 2003

PART I SUBSTANCES LISTED IN ANNEX III, PART 1 OF THE DIRECTIVE AS SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1)	(2)	(3)	(4)	(5)	(6)
Reference Number	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information
Note 1: These substances 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 sum must not exceed the limits given in column (4).
1a	Boric acid, borates, and tetraborates	Talcum powder	5 per cent	Not to be used in products intended for children under three years old Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid	Not to be used for bathing children under three years old Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)
		Oral hygiene products	0.1 per cent	Not to be used in products intended for children under three years old	Do not swallow Not to be used for children under three years old
		Other products (excluding bath products and hair waving products)	3 per cent	Not to be used in products intended for children under three years old Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid	Not to be used for children under three years old Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)
			The above-mentioned percentages are calculated as boric acid
1b	Tetraborates	Bath products	18 per cent	Not to be used in products for children under three years old	Not to be used for bathing children under three years old
		Hair waving products	8 per cent The above-mentioned percentages are calculated as boric acid
2a	Thioglycolic acid and its salts	(a) Hair waving or straightening products for general use	8 per cent ready for use	pH 7 to 9.5	Contains thioglycolate. Follow the instructions. Keep out of reach of children
		(b) Hair waving or straightening products for professional use	11 per cent ready for use	pH 7 to 9.5	Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
		(c) Depilatories	5 per cent ready for use	pH 7 to 12.7	Contains thioglycolate. Follow the instructions. Keep out of reach of children
		(d) Other hair-care products which are removed after application	2 per cent ready for use	pH 7 to 9.5	Contains thioglycolate. Follow the instructions. Keep out of reach of children
			The above-mentioned percentages are calculated as thioglycolic acid	(a), (b), (c) and (d): The directions for use must incorporate the following: — Avoid contact with eyes — In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice — Wear suitable gloves ((a), (b) and (d) only)
2b	Thioglycolic acid esters	(a) Hair waving or straightening products for general use	8 per cent ready for use	pH 6 to 9.5	Contains thioglycolate. Follow the instructions. Keep out of reach of children
		(b) Hair waving or straightening products for professional use	11 per cent ready for use	pH 6 to 9.5	Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
			The above-mentioned percentages are calculated as thioglycolic acid	(a) and (b): The directions for use must incorporate the following: — May cause sensitization in the event of skin contact — Avoid contact with eyes — In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice — Wear suitable gloves
3	Oxalic acid, its esters and alkaline salts	Hair care products	5 per cent	—	For professional use only
4	Ammonia	All purposes and products	6 per cent calculated as NH3	—	Contains ammonia (not required when concentration is not more than 2 per cent)
5	Tosylchlora-mide sodium (INN) [Chloramine-T]	All purposes and products	0.2 per cent	—	—
6	Chlorates of alkali metals	Toothpaste	5 per cent	—	—
		Other uses	3 per cent	—	—
7	Dichloro-methane	All purposes and products	35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent)	Purity of the dichloromethane must be not less than 99.8 per cent	—
8	m- and p-Phenylenedia-mines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines (see Note 1), with the exception of those derivatives listed elsewhere in this Schedule	Oxidizing colouring agents for hair-dyeing for general use	6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below	—	Contains phenylenediamines Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
		Oxidizing colouring agents for hair-dyeing for professional use	6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below	—	Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
9	Methylphenylenediamines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (Toluenediamines (other than toluene-1, 3-diamine and its salts), their N-substituted derivatives and their salts)	Oxidizing colouring agents for hair-dyeing for general use	10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below	—	Contains phenylene-diamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
		Oxidizing colouring agents for hair-dyeing for professional use	10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below	—	Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
10	Diaminophenols	Oxidizing colouring agents for hair-dyeing for general use	10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below	—	Contains diaminophenols. Can cause allergic reaction. Do not use to dye eyelashes or eyebrows
		Oxidizing colouring agents for hair-dyeing for professional use	10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below	—	Contains diaminophenols. For professional use only. Can cause allergic reaction. Wear suitable gloves
11	Dichlorophen (INN) [Dichlorophene]	All purposes and products	0.5 per cent	—	Contains dichlorophen
12	Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide	(a) Hair-care preparations (b) Skin-care preparations (c) Nail hardening preparations (d) Oral hygiene products	12 per cent of H2O2 present or released 4 per cent of H2O2 present or released 2 per cent of H2O2 present or released 0.1 per cent of H2O2 present or released	— — —	(a): Wear suitable gloves (a)(b)(c): Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them     —
13	Formaldehyde (see also Part I of Schedule 6)	Nail hardeners	5 per cent	—	Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)
14	Hydroquinone	Oxidizing colouring agent for hair dyeing for general use	0.3 per cent subject to the provisions of “Combination Rule B” set out below	—	Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them
		Oxidizing colouring agent for hair dyeing for professional use	0.3 per cent subject to the provisions of “Combination Rule B” set out below	—	Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them
15a	Potassium hydroxide and sodium hydroxide	Nail cuticle solvent	5 per cent calculated as sodium hydroxide (see Note 2)	—	Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		Hair straightener for general use	2 per cent calculated as sodium hydroxide (see Note 2)	—	Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		Hair straightener for professional use	4.5 per cent calculated as sodium hydroxide (see Note 2)	—	For professional use only. Avoid contact with eyes. Can cause blindness
		pH adjuster for depilatories	—	pH value not to exceed 12.7	Keep out of reach of children Avoid contact with eyes
		Other uses as pH adjuster	—	pH value not to exceed 11	—
15b	Lithium hydroxide	Hair straightener for general use	2 per cent calculated as sodium hydroxide (see Note 2)	—	Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		Hair straightener for professional use	4.5 per cent calculated as sodium hydroxide (see Note 2)	—	For professional use only. Avoid contact with eyes. Can cause blindness
		pH adjuster for depilatories	—	pH value not to exceed 12.7	Contains alkali. Keep out of reach of children. Avoid contact with eyes
		Other uses as pH adjuster (for rinse-off products only)	—	pH value not to exceed 11	—
15c	Calcium hydroxide	Hair straighteners containing two components: calcium hydroxide and aguanidine salt	7 per cent by weight of calcium hydroxide	—	Contains alkali. Avoid contact with eyes. Keep out of reach of children. Can cause blindness
		pH adjuster for depilatories	—	pH value not to exceed 12.7	Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		Other uses e.g. pH adjuster processing aid	—	pH value not to exceed 11	—
16	α-Naphthol [1-Naphthol] 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
17	Sodium nitrite	Rust inhibitor	0.2 per cent	Do not use with secondary and/or tertiary amines or other substances forming nitrosamines	—
18	Nitromethane	Rust inhibitor	0.3 per cent	—	—
19	Phenol and its alkali salts	Soaps and shampoos	1 per cent calculated as phenol	—	Contains phenol
20	ENTRY DELETED
21	Quinine and its salts	Shampoos	0.2 per cent calculated as quinine base	—	—
		Hair lotions	0.5 per cent calculated as quinine base	—	—
22	Resorcinol	Oxidizing colouring agent for hair dyeing for general use	5 per cent subject to the provisions of “Combination Rule B” set out below	—	Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them
		Oxidizing colouring agent for hair dyeing for professional use	5 per cent subject to the provisions of “Combination Rule B” set out below	—	Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them
		Hair lotions and shampoos	0.5 per cent subject to the provisions of “Combination Rule B” set out below	—	Contains resorcinol
23a	Alkali sulphides	Depilatories	2 per cent calculated as sulphur	pH value not to exceed 12.7	Keep out of reach of children. Avoid contact with eyes
23b	Alkaline earth sulphides	Depilatories	6 per cent calculated as sulphur	pH value not to exceed 12.7	Keep out of reach of children. Avoid contact with eyes
24	Water-soluble zinc salts with the exception of zinc 4-hydroxybenzene-sulphonate	All purposes and products	1 per cent calculated as zinc	—	—
25	Zinc 4-hydroxybenzene-sulphonate [Zinc phenolsulfonate]	Deodorants, antiperspirants and astringent lotions	6 per cent calculated as percentage of anhydrous substance	—	Avoid contact with eyes
26	Ammonium monofluoro-phosphate	Oral hygiene products	0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent	—	Contains ammonium monofluorophosphate
27	Sodium monofluoro-phosphate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains sodium monofluoro-phosphate
28	Potassium monofluoro-phosphate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains potassium monofluoro-phosphate
29	Calcium monofluoro-phosphate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains calcium monofluoro-phosphate
30	Calcium fluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains calcium fluoride
31	Sodium fluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains sodium fluoride
32	Potassium fluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains potassium fluoride
33	Ammonium fluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains ammonium fluoride
34	Aluminium fluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains aluminium fluoride
35	Stannous fluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains stannous fluoride
36	Hexadecylammonium fluoride [Cetylamine hydrofluoride]	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains hexadecylammonium fluoride
37	3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxyethyl)-ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride]	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)- propylbis(2-hydroxyethyl)- ammoniumdifluoride
38	N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropyl-enediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride]	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains N,N',N'-tris (polyoxyethylene)-N-hexa-decylpropylenediamine dihydrofluoride
39	Octadecenylammonium fluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains octadecenylammonium fluoride
40	Sodium fluorosilicate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains sodium fluorosilicate
41	Potassium fluorosilicate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains potassium fluorosilicate
42	Ammonium fluorosilicate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains ammonium fluorosilicate
43	Magnesium fluorosilicate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains magnesium fluorosilicate
44	1,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea]	Hair care preparations	2 per cent	Not to be used in aerosol dispensers	Contains 1,3-bis(hydroxymethyl) imidazolidene-2-thione
		Nail care preparations	2 per cent	pH value as applied must be less than 4	Contains 1,3-bis(hydroxymethyl) imidazolidene-2-thione
45	Benzyl alcohol (See also Part I of Schedule 6)	Solvent, perfumes and flavourings	—	—	—
46	6-Methylcoumarin	Oral hygiene products	0.003 per cent	—	—
47	Nicomethanol hydrofluoride	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains nicomethanol hydrofluoride
48	Silver nitrate	Products to dye eyelashes or eyebrows	4 per cent	—	Contains silver nitrate. Rinse eyes immediately if product comes into contact with them
49	Selenium disulphide [Selenium sulfide]	Anti-dandruff shampoos	1 per cent	—	Contains selenium disulphide. Avoid contact with eyes or damaged skin
50	Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and aluminium zirconium chloride hydroxide glycine complexes	Anti-perspirants	20 per cent as anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium	The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10 The ratio of the number of (Al + Zr) atoms to chlorine atoms must be between 0.9 and 2.1 Not to be used in aerosol dispensers (sprays)	Do not apply to irritated or damaged skin
51	Quinolin-8-ol and bis-(8-hydroxyquinolinium sulphate) (See also Part I of Schedule 3) [Oxyquinoline and Oxyquinoline sulfate]	Stabilizer for hydrogen peroxide in rinse-off hair care preparations	0.3 per cent calculated as base	—	—
		Stabilizer for hydrogen peroxide in non rinse-off hair care preparations	0.03 per cent calculated as base	—	—
52	Methanol	Denaturant for ethanol and isopropyl alcohol	5 per cent calculated as a percentage of ethanol and isopropyl alcohol	—	—
53	Etidronic acid and its salts (1-hydroxyethylidene-diphosphonic acid and its salts)	Hair care	1.5 per cent expressed as etidronic acid	—	—
		Soap	0.2 per cent expressed as etidronic acid	—	—
54	1-Phenoxy-propan-2-ol (See also Part I of Schedule 6) [Phenoxy-isopropanol]	Products rinsed off after use	2 per cent	Prohibited in oral hygiene products	—
55	Lead acetate	Only for hair dyeing	0.6 per cent calculated as lead	—	Contains lead acetate. Keep away from children. Avoid all contact with the eyes. Wash hands after use. Do not use to dye eyelashes, eyebrows or moustaches If irritation develops discontinue use
56	Magnesium fluoride	Dental hygiene products	0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent	—	Contains magnesium fluoride
57	Strontium chloride hexahydrate	(a) Toothpaste	3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent	—	Contains strontium chloride Frequent use by children is not advisable
		(b) Shampoo and face care products	2.1 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 2.1 per cent	—	—
58	Strontium acetate hemihydrate	Toothpaste	3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent	—	Contains strontium acetate. Use by children is not advisable
59	Talc: hydrated magnesium silicate	(a) Powdery products intended to be used for children under three years of age	—	—	(a): Keep powder away from children’s nose and mouth
		(b) other products	—	—
60	Fatty acid dialkanolamides	All purposes and products	Maximum dialkanolamine content: 0.5 per cent	Do not use with nitrosating systems. Maximum dialkanolamine content: 5 per cent (applies to raw materials. Maximum N-nitroso-dialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers	—
61	Monoalkanolamines	All purposes and products	Maximum dialkanolamine content: 0.5 per cent	Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers	—
62	Trialkanolamines	(a) non-rinse-off (b) other products	(a) 2.5 per cent —	(a) (b): Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitroso-dialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrate-free containers	—
63	Strontium hydroxide	pH-regulator in depilatory products	3.5 per cent calculated as strontium	pH value not to exceed 12.7	Keep out of reach of children. Avoid contact with the eyes
64	Strontium peroxide	Rinse-off hair care preparations for professional use	4.5 per cent calculated as strontium in the ready-for-use preparation	All products must meet the hydrogen peroxide release requirements	Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves
65	Benzalkonium chloride (INN), bromide and saccharinate (eg. Cetalkonium chloride Stearalkonium chloride, Cetearalkonium bromide)	Hair care products rinsed off after use	3 per cent calculated as benzalkonium chloride	In the finished product the concentration of benzalkonium chloride, bromide and saccharinate with an alkyl chain-length of C14 or less must not exceed 0.1 per cent calculated as benzalkonium chloride	Avoid contact with the eyes
		Other products	0.1 per cent calculated as benzalkonium chloride	—	Avoid contact with the eyes
66	Polyacrylamides	Body-care leave-on products	—	Maximum residual acrylamide content 0.1 μg/kg	—
		Other cosmetic products	—	Maximum residual acrylamide content 0.5 μg/kg	—