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of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed)

Changes over time for: ANNEX VI

Version Superseded: 11/07/2013

Alternative versions:

Status:

EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.

[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.
^b [F2Concerns any products aimed to be applied on a large part of the body.
^c Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.
^d Solely for products which might be used for children under three years of age.]
^e [F3For other uses than preservatives, see Annex III, Part I, entry No 207.] ]
a	b	c	d	e
[F41	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 % (acid) Oral care products: 1,7 % (acid) Leave-on products: 0,5 % (acid)
1a	Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid	0,5 % (acid)		]
2	Propionic acid and its salts [F5(*)]	2 % (acid)
3	Salicylic acid and its salts (*)	0,5 % (acid)	Not to be used in [F6mixtures] 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 [F5(*)]	0,6 % (acid)
5	Formaldehyde paraformaldehyde [F7(*)]	0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde	Prohibited in aerosol dispensers (sprays)
[F8]
7	Biphenyl-2-ol (o-phenylphenol) and its salts [F5(*)]	0,2 % expressed as the phenol
[F48	Zinc pyrithione (*) (CAS No 13463-41-7)	Hair products: 1,0 % Other products: 0,5 %	Rinse-off products only. No use in products for oral hygiene	]
9	Inorganic sulphites and hydrogen- sulphites (*)	0,2 % expressed as free SO ₂
[ F9 ]
11	Chlorobutanol (INN)	0,5 %	Prohibited in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid and its salts and esters [F5(*)]	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)
[F1014	Formic acid and its sodium salt [F5(+)]	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 [F5(*)]	0,2 % (acid)	See Annex VI, Part 2, No 8
19	Hexetidine (INN) [F5(*)]	0,1 %	[F11]
20	5-Bromo-5-nitro-1,3-dioxane	0,1 %	Rinse-off products only Avoid formation of nitrosamines [F12]
21	Bronopol (INN) [F5(*)]	0,1 %	Avoid formation of nitrosamines
22	2,4-Dichlorobenzyl alcohol [F5(*)]	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 [F5(*)]	0,2 %	Prohibited in the products intended to come into contact with mucous membranes
25	Tricolosan (INN) [F5(*)]	0,3 %
26	4-Chloro-3,5-xylenol [F5(*)]	0,5 %
27	3,3'-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (‘Imidazolidinyl urea’) [F5(*)]	0,6 %
28	Poly (1-hexamethylenebiguanide hydrochloride [F5(*)]	0,3 %
29	2-Phenoxyethanol [F5(*)]	1,0 %
30	Hexamethylenetetramine [F5(*)] (methenamine) (INN)	0,15 %
31	Methenamine 3-chloroallylochloride (INNM)	0,2 %
32	1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one [F5(*)]	0,5 %
33	1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [F5(*)]	0,6 %
34	Benzyl alchohol (*)	1,0 %
35	1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt [F5(*)]	1,0 % 0,5 %	Products rinsed off For other products
[ F5 ]
37	6,6-Dibromo-4,4-dichloro2,2‘-methylene-diphenol (Bromochlorophen) [F5(*)]	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	[F130,0015 %] (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one		]
[F1440	2-Benzyl-4-chlorophenol (clorophene)	0.2 %		]
[F1541	2-Chloroacetamide	0,3 %		Contains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride [F5(+)]	0,3 % expressed as clorhexidine
43	1-Phenoxypropan-2-ol [F7(*)]	1,0 %	Only for rinse-off products	]
[F1644	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 %		]
[F1747	1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) [F5(+)]	0,1 %		]
[F1048	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	]
[F1850	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	]
[F1953	Benzethonium Chloride (INCI)	0,1 %	(a) Rinse-off products, (b) Leave-on products other than for oral care use	]
[F2054	Belzalkonium chloride, bromide and saccharinate (+)	0,1 % calculated as benzalkonium chloride		Avoid contact with eyes]
[F2155	Benzylhemiformal	0,15 %	Only for products to be removed by rinsing
[F2256	iodopropynyl butylcarbamate (IPBC) 3-iodo-2-propynylbutylcarbamate CAS No: 55406-53-6	(a) rinse-off products: 0,02 % (b) leave-on products: 0,01 %, except in deodorants/antiperspirants: 0,0075 %	Not to be used in oral hygiene and lip care products (a) Not to be used in [F6mixtures] for children under three years of age, except in bath products/shower gels and shampoo (b) Not to be used in body lotion and body cream ^b Not to be used in [F6mixtures] for children under three years of age	(a) ‘ Not to be used for children under three years of age ’^c (b) ‘ Not to be used for children under three years of age] ]’^d
[F2357	Methylisothiazolinone (INCI)	0,01 %		]
[F358	Ethyl Lauroyl Arginate HCl (INCI) (*) ^e Ethyl-Ν ^α -dodecanoyl-L-arginate hydrochloride CAS No 60372-77-2 EC No 434-630-6	0,4 %	Not to be used in lip products, oral products and spray products.	]