Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed) (c. 768)

[F1ANNEX VI U.K. LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

Textual Amendments

F1 Inserted by Commission Directive of 26 March 1986 (86/199/EEC).

PREAMBLE U.K.

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 concentration other than those laid down in this Annex 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 Annex.

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 Annex 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

Reference number	Substance	Maximum authorized concentration	Limitations and requirements	Conditions of use and warnings which must be printed on the label
^a Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.]
a	b	c	d	e
1	Benzoic acid, its salts and esters (*)	0,5 % (acid)
2	Propionic acid and its salts (*)	2 % (acid)
3	Salicylic acid and its salts (*)	0,5 % (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 age ^a
4	Sorbic acid (hexa-2,4-dienoic acid) and its salts (*)	0,6 % (acid)
5	Formaldehyde paraformaldehyde	0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde	Prohibited in aerosol dispensers (sprays)
[F2]
7	Biphenyl-2-ol (o-phenylphenol) and its salts (*)	0,2 % expressed as the phenol
8	Pyrithione zinc (INN) (*)	0,5 %	Authorized in products rinsed off Forbidden in products for oral hygiene
9	Inorganic sulphites and hydrogen- sulphites (*)	0,2 % expressed as free SO ₂
10	Sodium iodate	0,1 %	Rinse-off products only
11	Chlorobutanol (INN)	0,5 %	Prohibited in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid and its salts and esters (*)	0,4 % (acid) for 1 ester, 0,8 % (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)
[F314	Formic acid and its sodium salt (+)	0,5 % (expressed as acid)		]
[F115	3,3‘-Dibromo-4,4‘-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate)	0,1 %
16	Thiomersal (INN)	0,007 % (of Hg) If mixed with other mercurial compounds authorized by this Directive, the maximum concentration of Hg remains fixed at 0,007 %	For eye make-up and eye make-up remover only	Contains thiomersal
17	Phenylmercuric salts (including borate)	Ditto	Ditto	Contains phenylmercuric compounds
18	Undec-10-enoic acid and salts (*)	0,2 % (acid)	See Annex VI, Part 2, No 8
19	Hexetidine (INN) (*)	0,1 %	[F4]
20	5-Bromo-5-nitro-1,3-dioxane	0,1 %	Rinse-off products only Avoid formation of nitrosamines [F5]
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'-Tetrachloroazobenzene <1 ppm 3,3',4,4'-Tetrachloroazoxybenzene <1 ppm
24	4-Chloro-m-cresol (*)	0,2 %	Prohibited in the products intended to come into contact with mucous membranes
25	Tricolosan (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 (INNM)	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 (*)	1,0 %
35	1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt (*)	1,0 % 0,5 %	Products rinsed off For other products
[F636	1,2-Dibromo-2,4-dicyanobutane (methyldibromo glutaronitrile)	0,1 %	Rinse-off products only	]
37	6,6-Dibromo-4,4-dichloro2,2‘-methylene-diphenol (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	[F70,0015 %] (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one		]
[F840	2-Benzyl-4-chlorophenol (clorophene)	0.2 %		]
[F941	2-Chloroacetamide	0,3 %		Contains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+)	0,3 % expressed as clorhexidine
43	1-Phenoxypropan-2-ol	1,0 %	Only for rinse-off products	]
[F1044	Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*)	0,1 %
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 %		]
[F1147	1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) (+)	0,1 %		]
[F348	Glutaraldehyde (Pentane-1,5-dial)	0,1 %	Prohibited in aerosols (sprays)	Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0,05 %)
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	]
[F1250	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 AgCl	20 % AgCl (W/W) on TiO ₂ . 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	]
[F1353	Benzethonium chloride	0,1 %	Rinse-off products only	]
[F1454	Belzalkonium chloride, bromide and saccharinate (+)	0,1% calculated as benzalkonium chloride		Avoid contact with eyes]
[F1555	Benzylhemiformal	0,15 %	Only for products to be removed by rinsing
56	3-Iodo-2-propynylbutylcarbamate	0,05 %	1. Not to be used for oral hygiene and lipcare products
56	3-Iodo-2-propynylbutylcarbamate	0,05 %	2. If the concentration in products intended to remain on the skin exceeds 0,02 % add the phrase: Contains iodine	Contains iodine]