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of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed)

[F1 PART 1 U.K. LIST OF PRESERVATIVES ALLOWED

a Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.]
Reference number	Substance	Maximum authorized concentration	Limitations and requirements	Conditions of use and warnings which must be printed on the label
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)
[F3 14	Formic acid and its sodium salt (+)	0,5 % (expressed as acid)		]
[F1 15	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
[F6 36	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	[F7 0,0015 %] (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one		]
[F8 40	2-Benzyl-4-chlorophenol (clorophene)	0.2 %		]
[F9 41	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	]
[F10 44	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 %		]
[F11 47	1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) (+)	0,1 %		]
[F3 48	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	]
[F12 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 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	]
[F13 53	Benzethonium chloride	0,1 %	Rinse-off products only	]
[F14 54	Belzalkonium chloride, bromide and saccharinate (+)	0,1% calculated as benzalkonium chloride		Avoid contact with eyes]
[F15 55	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
			2. If the concentration in products intended to remain on the skin exceeds 0,02 % add the phrase: Contains iodine	Contains iodine]

Textual Amendments

F2 Deleted by Commission Directive of 2 February 1987 (87/137/EEC).

F3 Inserted by Commission Directive of 29 June 1994 (94/32/EC).

F4 Deleted by Commission Directive of 2 March 1988 (88/233/EEC).

F5 Deleted by Commission Directive of 21 February 1989 (89/174/EEC).

F6 Substituted by Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F7 Inserted by Commission Directive of 21 February 1989 (89/174/EEC).

F8 Inserted by Commission Directive of 2 February 1987 (87/137/EEC).

F9 Inserted by Commission Directive of 2 March 1988 (88/233/EEC).

F10 Inserted by Commission Directive of 12 March 1991 (91/184/EEC).

F11 Inserted by Commission Directive of 21 October 1992 (92/86/EEC).

F12 Inserted by Commission Directive of 25 June 1996 (96/41/EC).

F13 Inserted by Commission Directive of 14 July 1997 (97/45/EC).

F14 Inserted by Commission Directive of 3 September 1998 (98/62/EC).

F15 Inserted by Commission Directive 2000/6/EC of 29 February 2000 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

Textual Amendments

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