The Cosmetic Products (Safety) Regulations 1989

Regulations 4(5) and 6(1)

SCHEDULE 4 LIST OF PRESERVATIVES 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 or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. 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, “A” indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that–

(a) the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and

(b) the purpose for which any such excess is present in the product is apparent from the labelling of the product.

In this Schedule–

“salts” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;

“esters” means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.

In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning “contains formaldehyde” when the concentration of formaldehyde in the final product exceeds 0.05 per cent.

PART I preservatives listed in annex vi, part i of the directive(1) as preservatives which cosmetic products may 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
a Note: (1) This entry is deleted with effect from the dates specified in regulation 1(2). Until then the corresponding entry in Part I of Schedule 5 to S.I. 1984/1260 (substituted by Schedule 4 to S.I. 1987/1920) continues in force.
1	Benzoic acid, its salts and esters	All products	0.5 per cent (acid)A	—	—
2	Propionic acid and its salts	All products	2 per cent (acid)A	—	—
3	Salicylic acid and its salts	All products	0.5 per cent (acid)A	Not to be used in preparations for children under three years of age except for shampoos	Not to be used for children under three years of age (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin)
4	Sorbic acid (hexa-2,4-dienoic acid) and its salts	All products	0.6 per cent (acid)A	—	—
5	Formaldehyde and paraformaldehyde	For oral hygiene	0.1 per cent (concentrations expressed as free formaldehyde)	Not to be used in aerosol dispensers (sprays)	—
		Except for oral hygiene (see also Part I of Schedule 2)	0.2 per cent (concentrations expressed as free formaldehyde)
6	Hexachlorophene (INN) (1)a
7	Biphenyl-2-ol (o-phenylphenol) and its salts	All products	0.2 per cent expressed as the phenolA	—	—
8	Pyrithione zinc (INN)	Products rinsed off after use	0.5 per centA	Not to be used in oral hygiene products	—
9	Inorganic sulphites and hydrogen sulphites	All products	0.2 per cent expressed as free SO2A	—	—
10	Sodium iodate	Products rinsed off after use	0.1 per cent	—	—
11	Chlorobutanol (INN)	All products	0.5 per cent	Not to be used in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid and its salts and esters	All products	0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of estersA	—	—
13	3-Acetyl-6-methylpyran-2,4-(3H)-dione (Dehydracetic acid) and its salts	All products	0.6 per cent (acid)	Not to be used in aerosol dispensers (sprays)	—
14	Formic acid	All products	0.5 per cent (acid)A	—	—
15	3,3'-Dibromo-4,4'-hexamethylene-dioxydibenzamidine-(Dibromohexamidine) and its salts (including isethionate)	All products	0.1 per cent	—	—
16	Thiomersal (INN)	Eye make-up and eye make-up remover	0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent	—	Contains thiomersal
17	Phenylmercuric salts (including borate)	Eye make-up and eye make-up remover	0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent	—	Contains phenylmercuric compounds
18	Undec-10-enoic acid and its salts	All products	0.2 per cent (acid)A	—	—
19	Hexetidine (INN)	Products rised off after use	0.1 per centA	—	—
20	5-Bromo-5-nitro-1,3-dioxane	Products rinsed off after use	0.1 per cent	Avoid formation of nitrosamines	—
21	Bronopol (INN)	All products	0.1 per centA	Avoid formation of nitrosamines	—
22	2,4-Dichlorobenzyl alcohol	All products	0.15 per centA	—	—
23	Triclocarban (INN)	All products	0.2 per centA	Purity criteria: 3,3'4,4'-Tetrachloroazobenzene 1 ppm 3,3',4,4'-Tetrachloroazoxybenzene 1 ppm	—
24	4-Chloro-m-cresol	Not to be used in products intended to come into contact with mucous membranes	0.2 per centA	—	—
25	Triclosan (INN)	All products	0.3 per centA	—	—
26	4-Chloro-3,5-xylenol	All products	0.5 per centA	—	—
27	3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (“Imidazolidinyl urea”)	All products	0.3 per centA	—	—
28	Poly(1-hexamethylene-biguanide hydrochloride)	All products	0.3 per centA	—	—
29	2-Phenoxyethanol	All products	1.0 per centA	—	—
30	Hexamethylenetetramine (methenamine (INN))	All products	0.15 per centA	—	—
31	Methenamine 3-chloroallylochloride (INNM)	All products	0.2 per cent	—	—
32	1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-di-methylbutan-2-one	All products	0.5 per centA	—	—
33	1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione	All products	0.6 per centA	—	—
34	Benzyl alcohol (See also Part I of Schedule 2)	All products	1.0 per centA	—	—
35	1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt	Products rinsed off after use	1.0 per centA	—	—
		For other products	0.5 per centA	—	—
36	1,2-Dibromo-2,4-dicyanobutane	All products	0.1 per cent	Not to be used in cosmetic sunscreen products	—
37	6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol (Bromochlorophen)	All products	0.1 per centA	—	—
38	4-Isopropyl—m-cresol	All products	0.1 per cent	—	—
39	Mixture of 5-Chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate	All products	0.0015 per cent 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 (Chlorophene)	All products	0.2 per cent	—	—
41	2-Chloroacetamide	All products	0.3 per cent	—	Contains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride	All products	0.3 per centA	—	—
43	1-Phenoxypropan-2-ol (see also Part I, of Schedule 2)	Products rinsed off after use	1.0 per cent	—	—

PART II preservatives listed in annex vi part 2 of the directive(2) as preservatives which cosmetic products may not contain except subject to the restrictions laid down and where supplied before a certain date

(1)	(2)	(3)	(4)	(5)	(6)	(7)
Reference Number in Annex VI Part 2 of the Directive	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information	Preservative supplied until
a Notes: (1) Prior to the coming into force of article 1(7) to Directive 88/233/EEC Chlorophensin (INN) item 2 above is permitted to be used up to a maximum concentration figure of 0.5 per cent.
b (1) Certain entries are deleted with effect from the dates specified in regulation 1(3) or (4). Until then the corresponding entries relating to the substances in question where appropriate in Part II of Schedule 5 to S.I. 1984/1260 (substituted by Schedule 4 to S.I. 1987/1920) continue in force.
1	ENTRY DELETED (2)b
2	Chlorphenesin (INN) (see note (1))a	All products	0.3 per cent	—	—	31.12.1989
3	ENTRY DELETED (2)b
4	Alkyl (C12–C22) trimethylammonium bromide and chloride (including Cetrimonium bromide (INN))	All products	0.1 per centA	—	—	31.12.1989
5	ENTRY DELETED (2)b
6	4,4-Dimethyl-1,3-oxazolidine	Products rinsed off after use	0.1 per cent	The pH of the finished product shall not be lower than 6	—	31.12.1989
7 to 14	ENTRIES DELETED (2)b
15	Benzethonium chloride (INN)	Not to be used in products intended to come into contact with mucous membranes	0.1 per centA	—	—	31.12.1989
16	Benzalkonium chloride (INN) bromide and saccharinate	All products	0.25 per centA	—	—	31.12.1989
17	1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea	All products	0.5 per cent	—	—	31.12.1989
18 to 19	ENTRY DELETED (2)b
20	Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate)	All products	0.1 per centA	—	—	31.12.1989
21	Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol)	All products	0.2 per cent	—	—	31.12.1989
22 to 25	ENTRIES DELETED (2)b
26	Glutaraldehyde	Prohibited in aerosols (sprays)	0.1 per cent	Contains glutaraldehyde where the glutaraldehyde concentration in the finished product exceeds 0.05 per cent	—	31.12.1991

(1)

See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.

(2)

See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.