The Cosmetic Products (Safety) Regulations 1996

Regulations 4(2), 5(1) and 6(2)

SCHEDULE 2 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(1).

PART I SUBSTANCES LISTED IN ANNEX III, PART I 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: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4).
1	Boric acid	Talcum powder	5 per cent	Not to be used in products intended for children less than three years old	Not to be used for children under three years of age
		Oral hygiene products	0.5 per cent	—	—
		Other products	3 per cent	—	—
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 abovementioned 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 abovementioned 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	Tosylchloramide 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	Dichloromethane	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-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines	Oxidizing colouring agents for hair-dyeing for general use	6 per cent calculated as a free base, subject to the provision 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 phenylenediamines. 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 afree 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 4)	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	2 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	2 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
		Agents for localised skin lightener	2 per cent	—	Contains hydroquinone. Avoid contact with eyes. Apply to small areas. If irritation develops discontinue use. Do not use on children under the age of 12
15a	Potassium hydroxide and sodium hydroxide (see Note 1)	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
		Other uses	—	—	—
15c	Calcium hydroxide	Hair straighteners containing two components: calcium hydroxide and guanidine salt	7 per cent	—	Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		Other uses	—	—	—
16	α-Naphthol[1-Naphthol]	Colouring agent for hair dyeing	0.5 per cent	—	Contains α-napthol
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	0.5 per cent calculated as quinine base	—	—
		Hair lotions	0.2 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-hydroxybenzenesulphonate	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 monofluorophosphate	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 monofluorophosphate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains sodium monofluorophosphate
28	Potassium monofluorophosphate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains potassium monofluorophosphate
29	Calcium monofluorophosphate	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains calcium monofluorophosphate
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)ammonium difluoride
38	N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride]	Oral hygiene products	As for ammonium monofluorophosphate	—	Contains N,N',N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine 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 4)	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 II of this Schedule) [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 Soap	1.5 per cent expressed as etidronic acid 0.2 per cent expressed as etidronic acid	— —	— —
54	1-Phenoxypropan-2-ol (See also Part I of Schedule 4) [Phenoxyisopropanol]	Products rinsed off after use. Prohibited in oral hygiene products	2 per cent	—	—
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	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. Use by children is not advisable
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-nitrosodialkanolamine content: 50 μ g/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 μ g/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-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-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

PART II SUBSTANCES LISTED IN ANNEX III, PART 2 (FORMERLY ANNEX IV, PART 1) OF THE DIRECTIVE(2) AS SUBSTANCES PROVISIONALLY ALLOWED

(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 use until
NOTE—There are presently no entries in this Part. 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 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.

(1)

O.J. No. L132, 1.6.1996, p.1.

(2)

See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC.