The Cosmetic Products (Safety) Regulations 2008

Regulation 8

SCHEDULE 6 U.K. 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 U.K. LIST OF PRESERVATIVES ALLOWED

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.
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.
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	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)
		Oral care products: 1.7% (expressed as acid)
		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 age1
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)
		0.1% (products for oral hygiene) expressed as free formaldehyde
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
			Prohibited in products for oral hygiene
9	Inorganic sulfites and hydrogen-sulfites (*)	0.2% expressed as free SO2
10	Sodium iodate	0.1%	Rinse-off products only
Entry deleted from 18/10/2008
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,
		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
		If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0.007%
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)	F1 . . .
19	Hexetidine (INN)	0.1%
20	5-Bromo-5-nitro-1,3-dioxane	0.1%	Rinse off products only
			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'-
			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,
			(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
56          Entry deleted from 18/10/2008	3-Iodo-2-propynylbutylcarbamate	0.05%	1. Not to be used for oral hygiene and lipcare products	Contains iodine
			2. If the concentration on products intended to remain on the skin exceeds 0.02% add the phrase: Contains iodine
56          Entry 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”3
	(IPBC)		(a) Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo
	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 cream2	(b) “Not to be used for children under three years of age”4
	CAS No: 55406-53-6		- not to be used in preparations for children under three years of age
57	Methylisothiazolinone (INCI)	0.01%

Textual Amendments

F1 Words in Sch. 6 Pt. 1 entry 18 omitted (16.11.2008) by The Cosmetic Products (Safety) (Amendment) Regulations 2008 (S.I. 2008/2173), regs. 1(1), 2(f)

PART 2 U.K. 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

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