The Cosmetic Products (Safety) Regulations 2008

Regulations 6 and 21(1)

SCHEDULE 4 U.K.

PART 1 U.K. LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND CONDITIONS

1 The 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.
2 Only if the concentration exceeds 0.05%.
3 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 2.
4 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column d.
5 The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d.
6 As a preservative, see Schedule 6, Part 1, entry 3.
7 Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.
8 As a preservative, see Schedule 6, Part 1, entry 9.
9 As a preservative, see Schedule 6, Part 1, entry 23.
10 As a preservative, see Schedule 6, Part 1, entry 8.
Reference number	Substance	Restrictions			Conditions of use and warnings which must be printed on the label
		Field of application and/or use	Maximum authorised concentration in the finished cosmetic product	Other limitations and requirements
a	b	c	d	e	f
1a	Boric acid, borates and tetraborates with the exception of N,N-dimethyl anilium tatrakis (pentafluorophenyl) borate	(a) Talc	(a) 5% (by mass/mass as boric acid)	(a) 1. Not to be used in products for children under 3 years of age	(a) 1. Not to be used for children under 3 years of age
				2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5% (by mass/mass as boric acid)	2. Not to be used on peeling or irritated skin
		(b) Products for all hygiene	(b) 0,1 % (by mass/mass as boric acid)	(b) 1. Not to be used in products for children under 3 years of age	(b) 1. Not to be swallowed
					2. Not to be used for children under 3 years of age
		(c) Other products (excluding bath products and hair waving products)	(c) 3% (by mass//mass as boric acid)	(c) 1. Not to be used in products for children under 3 years of age	(c) 1. Not to be used for children under 3 years of age
				2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5% (by mass/mass as boric acid)	2. Not to be used on peeling or irritated skin
1b	Tetraborates	(a) Bath products	(a) 18% (by mass/mass as boric acid)	(a) Not to be used in products for children under 3 years of age	(a) Not to be used for bathing children under 3 years of age
		(b) Hair waving products	(b) 8% (by mass/mass as boric acid)		(b) Rinse well
2a	Thioglycollic acid and its salts	(a) Hair waving or straightening products:		(a) (b) (c): The directions must obligatorily incorporate the following sentences:	(a):
		— general use	— 8% ready for use pH 7 to 9.5		— Contains thioglycolate
		— professional use	— 11% ready for use pH 7 to 9.5		— Follow the instructions
		(b) Depilatories	— 5% ready for use pH 7 to 12.7	— Avoid contact with eyes	—Keep out of reach of children
		(c) Other hair-care products which are removed after application	— 2% ready for use pH to 9.5	— In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice	— For professional use only (b) and (c):
			The abovementioned percentages are calculated as thioglycollic acid		— Contains thioglycolate
					— Follow the instructions
				— Wear suitable gloves ((a) and (c) only)	— Keep out of each of children
2b	Thioglycollic acid esters	Hair waving or straightening products:		The directions for use must obligatorily incorporate the following sentences:	— Contains thioglycolate
					— Follow the instructions
					— Keep out of reach of children
					— For professional use only
		— general use	— 8% ready for use pH 6 to 9.5	— may cause sensitisation — In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice
		— professional use	— 11% ready for use pH 6 to 9.5	— Avoid contact with eyes	— For professional use only
			The abovementioned % are calculated as thioglycollic acid	— Wear suitable gloves
3	Oxalic acid, its esters and alkaline salts	Hair care products	5%		For professional use only
4	Ammonia		6% calculated as ammonia (NH3)		Above 2%: contains ammonia
5	Tosylchloramide sodium (INN)		0.2%
6	Chlorates of alkali metals	(a) Toothpaste	(a) 5%
		(b) Other uses	(b) 3%
7	Dichloromethane		35%	0.2% as maximum impurity content
8	p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine1, with the exception of those derivatives listed elsewhere in this Schedule and under reference numbers 364, 1309,1311 and 1312 in Schedule 3	Oxidizing colouring agents for hair dyeing	6% calculated as free base, subject to the provisions of “Combination Rule A” at the end of this schedule.
		(a) general use			(a) Can cause allergic reaction. Contains phenylenediamines. Do not use to dye eye lashes or eyebrows
		(b) professional use			(b) For professional use only. Contains phenylenediamines. Can cause an allergic reaction. Wear suitable gloves.
9	Methylphenylene-diamines, their N-substituted derivatives and their salts(1) with the exception of substances numbers 364, 1310 and 1313 in Schedule 3.	Oxidizing colouring agents for hair dyeing	10% calculated as free base, subject to the provisions of “Combination Rule A” at the end of this schedule.
		(a) general use			(a) Can cause an allergic reaction. Contains phenylenediamines. Do not use to dye eyelashes or eyebrows.
		(b) professional use			(b) For professional use only. Contains phenylenediamines. Can cause an allergic reaction. Wear suitable gloves.
10	Diaminophenols1	Oxidizing colouring agents for hair dyeing	10% calculated as free base, subject to the provisions of “Combination Rule A”
		(a) general use			(a) Can cause an allergic reaction. Contains diaminophenols. Do not use to dye eyelashes or eyebrows.
		(b) professional use			(b) For professional use only. Contains diaminophenols. Can cause allergic reaction. Wear suitable gloves.
11	Dichlorophen (INN)		0.5%		Contains dichlorophen
12	Hydrogen peroxide, and other compounds or mixture that release hydrogen peroxide, including carbamide peroxide and zinc peroxide	(a) hair-care preparations	12% of H2O2 (40 volumes), present or released		Wear suitable gloves
		(b) Skin-care preparations	4% of H2O2, present or released
		(c) Nail hardening preparations	2% of H2O2 present or released		(a) (b) (c): Contains hydrogen peroxide.
		(d) Oral hygiene products	0.1% of H2O2, present or released		Avoid contact with eyes.
					Rinse immediately if product comes into contact with them
13	Formaldehyde	Nail hardeners	5% calculated as formaldehyde		Protect cuticles with grease or oil. Contains formaldehyde2
14	Hydroquinone3	(a) Oxidising colouring agent for hair-dying:	0.3%, subject to the provisions of “Combination Rule B”		(a) 1. — Do not use to dye eyelashes or eyebrows
		1. General use			— Rinse the eyes immediately if the products comes into contact with them
					— contains hydroquinone
		2. Professional use			2. — For professional use only
					— Contains hydroquinone
					— Rinse the eyes immediately if the product comes into contact with them
		(b) Artificial nail systems	0.02% (after mixing for use), %, subject to the provisions of “Combination Rule B”	Professional use only	(b) — For professional use only
					— Avoid skin contact
					— Read directions for use carefully
15a	Potassium or sodium hydroxide	(a) Nail cuticle solvent	(a) 5% by weight4		(a) Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		(b) Hair straightener	(b)		(b)
		1. General use	1. 2% by weight4		1. Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		2. Professional use	2. 4.5% by weight4		2. For professional use only. Avoid contact with eyes. Can cause blindness.
		(c) pH adjuster	(c) Not to exceed pH 12.7		(c) Keep out of each of children. Avoid contact with eyes
		— depilatories
		(d) Other uses as pH adjuster	(d) Not to exceed pH 11
15b	Lithium hydroxide	(a) Hair straighteners	(a)		(a)
		1. General use	1. 2%5 by weight		1. Contains alkali
					Avoid contact with eyes
					Can cause blindness
					Keep out of each of children
		2. Professional use	2. 4.5%(6) by weight		2. For professional use only Avoid contact with eyes Can cause blindness
		(b) pH adjuster – for depilatories		(b) pH value not to exceed pH 12.7	(b) Contains alkali
					Keep out of reach of children
					Avoid contact with eyes
		(c) Other uses – as pH adjuster (for rinse-off products only)		(c) pH value not to exceed pH 11
15c	Calcium hydroxide	(a) Hair straighteners containing two components: calcium hydroxide and a guanidine salt	(a) 7% by weight of calcium hydroxide		(a) Contains alkali
					Avoid contact with eyes
					Keep out of reach of children
					Can cause blindness
		(b) pH adjuster – for depilatories		(b) pH value not to exceed pH 12.7	(b) Contains alkali
					Keep out of reach of children
					Avoid contact with eyes
		(c) Other uses (e.g. pH adjuster, processing aid)		(c) pH value not to exceed pH 11
16	1-Naphthol (CAS No 90-15-3) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction
17	Sodium nitrite	Rust inhibitor	0.2%	Do not use with secondary and/or tertiary amines or other substances forming nitrosamines
18	Nitromethane	Rust inhibitor	0.3%
19	[omitted]
20	[omitted]
21	Quinine and its salts	(a) Shampoos	(a) 0.5% calculated as quinine base
		(b) Hair lotions	(b) 0.2% calculated as quinine base
22	Resorcinol3	(a) Oxidizing colouring agent for hair dyeing	(a) 5%		(a)
		1. general use			1. 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
		2. professional use			2. For professional use only. Contains resorcinol.
					Rinse eyes immediately if product comes into contact with them
		(b) hair lotions and shampoos	(b) 0.5%		(b) Contains resorcinol
23	(a) Alkali sulfides	(a) Depilatories	(a) 2% calculated as sulphur	(a) pH value not to exceed 12.7	(a) Keep out of reach of children.
					Avoid contact with eyes
	(b) Alkaline earth sulfides2 (see Schedule 5, Part 1)	(b) Depilatories	(b) 6% calculated as sulphur	(b) pH value not to exceed 12.7	(b) Keep out of reach of children.
					Avoid contact with eyes
24	Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulfonate and zinc pyrithione		1% calculated as zinc
25	Zinc 4-hydroxybenzene sulfonate	Deodorants, antiperspirants and astringent lotions	6% calculated as a percentage of anhydrous substance		Avoid contact with eyes
26	Sodium monofluorophosphate	Oral hygiene products	0.15 % calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15 %		Contains ammonium monofluorophosphate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
27	Sodium monofluorophosphate	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains sodium monofluorophosphate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
28	Potassium monofluorophosphate	Oral Hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains potassium monofluorophosphate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19thMarch 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
29	Contains Calcium monofluorophosphate	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Calcium monofluorophosphate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
30	Calcium Fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Calcium monofluorophosphate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th January 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
31	Sodium fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains Sodium fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
32	Potassium fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains potassium fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
33	Ammonium fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains ammonium fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
34	Aluminium fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains aluminium fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
35	Stannous fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains stannous fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
36	Hexadecyl ammonium fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains hexadecyl ammonium fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
37	3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammoniumdifluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammoniumdifluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
38	NN'N'-Tris(polyoxyethylene)-N-hexadecylpropylene-diamine dihydrofluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains NN'N'-Tris(polyoxyethylene)-N-hexadecylpropylene-diamine dihydrofluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
39	Octadecenyl-ammonium fluoride	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains octadecenyl-ammonium fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th | March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
40	Sodium fluorosilicate	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains sodium fluorosilicate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
41	Potassium fluorosilicate	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains potassium fluorosilicate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
42	Ammonium fluorosilicate	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains ammonium fluorosilicate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
43	Magnesium fluorosilicate	Oral hygiene products	0.15% calculated as F. When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		Contains magnesium fluorosilicate
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
44	1,3-Bis (hydroxymethyl)imidazolidine-2-thione	(a) Hair-care preparations	(a) Up to 2%	(a) Prohibited in aerosol dispensers (sprays)	Contains 1,3-bis (hydroxymethyl)imidazolidine-2-thione
		(b) Nail-care preparations	(b) Up to 2%	(b) The pH of the product as applied must be less than 4
45	Benzyl alcohol	Solvents, perfumes and flavourings
46	6-methylcoumarin	Oral hygiene products	0.003%
47	Nicomethanol hydrofluoride	Oral hygiene products	0.15% calculated as F		Contains nicomethanol hydrofluoride
			When mixed with other fluorine compounds permitted under this Schedule, total F concentration must not exceed 0.15%		For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
48	Silver nitrate	Solely for products intended for colouring eyelashes and eyebrows	4%		— Contains silver nitrate
					— Rinse the eyes immediately if product comes into contact with them
49	Selenium disulfide	Antidandruff shampoos	1%		— Contains selenium disulphide
					— Avoid contact with eyes or damaged skin
50	Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and the aluminium zirconium chloride hydroxide glycine complexes	Antiperspirants	20% as anhydrous aluminium zirconium chloride hydroxide 5.4% as zirconium	1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between two and 10	Do not apply to irritated or damaged skin
				2. The ratio of the number of (Al + Zr) atoms to that of chlorine atoms must be between 0.9 and 2.1
				3. Prohibited in aerosol dispensers (sprays)
51	Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate	Stabilizer for hydrogen peroxide in rinse-off hair-care preparations	0.3 % calculated as base
		Stabilizer for hydrogen peroxide in non-rinse-off hair-care preparations	0.03 % calculated as base
52	Methanol	Denaturant for ethanol and isopropyl alcohol	5 % calculated as a percentage of ethanol and isopropyl alcohol
53	Etidronic acid and its salts (1-hydroxyethylidene-di-phosphonic acid and its salts)	(a) Hair-care	1.5% expressed as etidronic acid
		(b) Soap	0.2% expressed as etidronic acid
54	1-Phenoxy-propan-2-ol	Rinse-off products only	2%	Prohibited in oral hygiene products
				As a preservative, see Schedule 6, Part I, No 43
55	Omitted
56	Magnesium fluoride	Dental hygiene products	0.15% calculated as F. When mixed with other flourine compounds permitted under this Schedule, total F concentration must not exceed 0.15%.		Contains magnesium fluoride
					For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
					“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
57	Strontium chloride hexahydrate	(a) Toothpaste	3.5% calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 %		Contains strontium chloride. Frequent use by children is not advisable
		(b) Shampoo and face care products	2,1 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 2,1 %
58	Strontium acetate hemihydrate	Toothpaste	3.5% calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 %		Contains strontium acetate. Frequent 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			Keep powder away from children's nose and mouth
		(b) other products
60	Fatty acid dialkylamides and dialkanolamides		Maximum secondary amine content: 0.5%	— Do not use with nitrosating systems
				— Maximum secondary amine content: 5% (applies to raw materials)
				— Maximum nitrosamine content: 50 μg/kg
				— Keep in nitrite-free containers
61	Monoalkylamines, monoalkanolamines and their salts		Maximum secondary amine content: 0.5%	— Do not use with nitrosating systems
				— Minimum purity: 99 %
				— Maximum secondary amine content: 0,5 % (applies to raw materials)
				— Maximum nitrosamine content: 50 μg/kg
				— Keep in nitrite-free containers
62	Trialkylamines, trialkanolamines and their salts	(a) Non-rinse-off products	(a) 2.5%	(a) (b)
		(b) Other products		— Do not use with nitrosating systems
				— Minimum purity: 99%
				— Maximum secondary amine content: 0.5% (applies to raw materials)
				— Maximum nitrosamine content: 50 μg/kg
				— Keep in nitrite-free containers
63	Strontium hydroxide	pH-regulator in depilatory products	3.5% 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 professional use	4.5 % 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, bromide and saccharinate	(a) Rinse-off hair (head) care products	(a) 3% (as benzalkonium chloride	(a) In the final products the concentrations of benzalkonium chloride, bromide and saccharinate with an alkyl chain of C14, or less must not exceed 0,1 % (as benzalkonium chloride)	(a) Avoid contact with the eyes
		(b) Other products	(b) 0.1% (as benzalkonium chloride)		(b) Avoid contact with the eyes
66	Polyacrylamides	(a) Body-care leave-on products		(a) Maximum residual acrylamide content 0.1 mg/kg
		(b) Other cosmetic products		(b) Maximum residual acrylamide content 0.1kg/mg
67	Amyl cinnamal (CAS No 122-40-7)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
68	Benzyl alcohol (CAS No 100-51-6)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
69	Cinnamyl alcohol (CAS No 104-54-1)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
70	Citral (CAS No 5392-40-5)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
71	Eugenol (CAS No 97-53-0)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
72	Hydroxy-citronellal (CAS No 107-75-5)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
73	Isoeugenol (CAS No 97-54-1)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
74	Amyl cinnamyl alcohol (CAS No 101-85-9)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
75	Benzyl salicylate (CAS No 118-58-1)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
76	Cinnamal (CAS No 104-55-2)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
77	Coumarin (CAS No 91-64-5)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
78	Geraniol (CAS No 106-24-1)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
79	Hydroxy-methylpentylcyclohexenecarboxaldehyde (CAS No 31906-04-4)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
80	Anisyl alcohol (CAS No 105-13-5)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
81	Benzyl cinnamate (CAS No 103-41-3)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
82	Farnesol (CAS No 4602-84-0)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
83	2-(4-tert-Butylbenzyl) propionaldehyde (CAS No 80-54-6)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
84	Linalool (CAS No 78-70-6)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
85	Benzyl benzoate (CAS No 120-51-4)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
86	Citronellol (CAS No 106-22-9)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
87	Hexylcinnam-aldehyde (CAS No 101-86-0)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
88	d-Limonene (CAS No 5989-27-5)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
89	Methyl heptin carbonate (CAS No 111-12-6)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
90	3-Methyl-4-(2,6,6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one (CAS No 127-51-5)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
91	Oak moss extract (CAS No 90028-68-5)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
92	Tree moss extract (CAS No 90028-67-4)			The presence of the substance must be indicated in the list of ingredients referred to in regulation 12 when its concentration exceeds
				— 0.001% in leave-on products
				— 0.01% in rinse-off products
93	2,4-Diamino-pyrimidine-3-oxide (CAS No 74638-76-9)	Hair care formulations	1.5%
94	Benzoyl peroxide	Artificial nail systems	0.7% (after mixing)	Professional use only	— For professional use only
					— Avoid skin contact
					— Read directions for use carefully
95	Hydroquinone methylether	Artificial nail systems	0.02% (after mixing)	Professional use only	— For professional use only
					— Avoid skin contact
					— Read directions for use carefully
96	Musk xylene (CAS No 81-15-2)	All cosmetic products, with the exception of oral care products	(a) 1.0% in fine fragrance
			(b) 0.4% in eau de toilette
			(c) 0.03% in other products
97	Musk ketone (CAS No 81-14-1)	All cosmetic products, with the exception of oral care products	(a) 1.4% in fine fragrance
			(b) 0.56% in eau de toilette
			(c) 0.042% in other products
98	Salicylic acid6	(a) Rinse-off hair products	(a) 3.0%	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 age7
		(b) Other products	(b) 2.0%	For purposes other than inhibiting the development of micro-organisms in the product.
				This purpose has to be apparent from the presentation of the product.
99	Inorganic sulfites and bisulfites8	(a) Oxidative hair dye products	(a) 0.67% (expressed as free SO2)	For purpose other than inhibiting the development of micro-organisms in the product.
		(b) Hair straightening products	(b) 6.7% (expressed as free SO2)
		(c) Self tanning products for the face	(c) 0.45% (expressed as free SO2)	This purpose has to be apparent from the presentation of the product.
		(d) Other self tanning products	(d) 0.40% (expressed as free SO2)
100	Triclocarban9 (CAS No 101-20-2)	Rinse-off products	1.5%	Purity criteria: 3,3',4,4'- Tetrachloroazobenzene ≤=1ppm: 3,3',4,4'- Tetrachloroazoxybenzene ≤=1ppm
				For purposes other than inhibiting the development of micro-organisms in the product.
				This purpose has to be apparent from the presentation of the product.
101	Zinc pyrithione10 (CAS No 13463-41-7)	Leave-on hair products	0.1%	For purposes other than inhibiting the development of micro-organisms in the product.
				This purpose has to be apparent from the presentation of the product.

Combination Rules U.K.

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.

PART 2 U.K. SUBSTANCES LISTED IN PART 2 OF ANNEX III TO THE DIRECTIVE WHICH ARE PROVISONALLY ALLOWED

			Restrictions
Reference number	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
a	b		c	d	e	f	g
1	omitted
2		omitted
3	4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	(a) (b) Can cause allergic reaction	31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 3.0%
4	2,7-Naphthalenediol (CAS No 582-17-2) and its salts		Oxidising colouring agents for hair dyeing	1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%		31.12.2009
5	m-Aminophenol (CAS No 591-27-5) and its salts		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	31.12.2009
6	2,6-Dihydroxy-3-4-dimethylpyridine (CAS No 84540-47-6 and its salts)		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	31.12.2009
7	4-Hydroxypropy-lamino-3-nitrophenol (CAS No 92952-81-3) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 5.2%	In combination with hydrogen peroxide the maximum use concentration upon application is 2.6%	(a) (b) Can cause allergic reaction	31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 2.6%
8	omitted
9	HC Blue No 11 (CAS No 23920-15-2) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	(a) (b) Can cause allergic reaction	31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 2.0%
10	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) (b) Can cause allergic reaction	31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 1.0%
11	2-Hydroxyethyl-picramic acid (CAS No 99610-72-7) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	(a) (b) Can cause allergic reaction	31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 2.0%
12	p-Methylamino-phenol (CAS No 150-75-4) and its salts		Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	Can cause allergic reaction	31.12.2009
13	omitted
14	HC Violet No 2 CAS No 104226-19-9) and its salts		Non-oxidising colouring agents for hair dyeing	2.0%			31.12.2009
15	omitted
16	HC Blue No 12 (CAS No 104516-93-0) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 1.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.75%	(a) (b) Can cause allergic reaction	31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 1.5%
17	omitted
18	1,3-Bis-(2,4-diaminophenoxy) propane (CAS No 81892-72-0) and its salts		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	31.12.2009
19	3-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its salts		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	31.12.2009
20	Phenyl methyl pyrazolone (CAS No 89-25-8) and its salts		Oxidising colouring agents for hair dyeing	0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		31.12.2009
21	2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) and its salts		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	31.12.2009
22	Hydroxybenzo-morpholine (CAS No 26021-57-8) and its salts		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	31.12.2009
23	omitted
24	HC Yellow No 10 (CAS No 109023-83-8) and its salts		Non-oxidising colouring agents for hair dyeing	0.2%			31.12.2009
25	2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3) and its salts		Oxidising colouring agents for hair dyeing	0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%	Can cause allergic reaction	31.12.2009
26	HC Orange No 2 (CAS No 85765-48-6) and its salts		Non-oxidising colouring agents for hair dyeing	1.0%			31.12.2009
27	HC Violet No 1 (CAS No 82576-75-8) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 0.5%
28	3-Methylamino-4-nitrophenoxyethanol (CAS No 59820-63-2) and its salts		Non-oxidising colouring agents for hair dyeing	1.0%			31.12.2009
29	2-Hydroxy-ethylamino-5-nitro-anisole (CAS No 66095-81-6) and its salts		Non-oxidising colouring agents for hair dyeing	1.0%			31.12.2009
30	omitted
31	HC Red No 13 (CAS No 94158-13-1) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 2.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.25%		31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 2.5%
32	1,5-Naphthalenediol (CAS No 83-56-7) and its salts		Oxidising colouring agents for hair dyeing	1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%		31.12.2009
33	Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its salts		Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	Can cause allergic reaction	31.12.2009
34	o-Aminophenol (CAS No 95-55-6) and its salts		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		31.12.2009
35	4-Amino-2-hydroxytoluene (CAS No 2835-95-2) and its salts		Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		31.12.2009
36	2,4-Diaminophen-oxyethanol (CAS No 66422- 95-5) and its salts		Oxidising colouring agents for hair dyeing	4.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 2.0%		31.12.2009
37	2-Methylresorcinol (CAS No 608-25-3) and its salts		Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		31.12.2009
38	4-Amino-m-cresol (CAS No 2835-99-6) and its salts		Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		31.12.2009
39	2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) and its salts		Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		31.12.2009
40	omitted
41	omitted
42	omitted
43	omitted
44	Hydroxyethyl-3,4-methylene-dioxyaniline(CAS No 81329-90-0) and its salts		Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		31.12.2009
45	omitted
46	omitted
47	HC Blue No 2 (CAS No 33229-34-4) and its salts		Non-oxidising colouring agents for hair dyeing	2.8%			31.12.2009
48	3-Nitro-p-hydroxyethyla-minophenol (CAS No 65235-31-6) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 6.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 3.0%		31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 6.0%
49	4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 0.5%
50	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%		31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 1.0%
51	omitted
52	omitted
53	omitted
54	omitted
55	2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		31.12.2009
			(b) Non-oxidising oxidising colouring agents for hair dyeing	(b) 3.0%
56	2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) 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%		31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 2.0%
57	Basic Blue 26 (CAS No 2580-56-5) (CI 44045) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		31.12.2009
			(b) Non-oxidising colouring agents for hair dyeing	(b) 0.5%
58	Acid Red 33 (CAS No 3567-66-6) (CI 17200) and its salts		Non-oxidising colouring agents for hair dyeing	2.0%			31.12.2009
59	Ponceau SX (CAS No 4548-53-2) (CI 14700) and its salts		Non-oxidising colouring agents for hair dyeing	2.0%			31.12.2009
60	Basic Violet 14 (CAS No 632-99-5) (CI 42510) and its salts		(a) Oxidising colouring agents for hair dyeing	(a) 0.3%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.15%		31.12.2009