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of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed) (c. 768)

[F1 ANNEX 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).

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.
b [F2 Concerns 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 [F3 For other uses than preservatives, see Annex III, Part I, entry No 207.] ]
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
[F4 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 % (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 [F6 mixtures] 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 missing text]
7	Biphenyl-2-ol (o-phenylphenol) and its salts [F5 (*)]	0,2 % expressed as the phenol
[F4 8	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)
[F10 14	Formic acid and its sodium salt [F5 (+)]	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 [F5 (*)]	0,2 % (acid)	See Annex VI, Part 2, No 8
19	Hexetidine (INN) [F5 (*)]	0,1 %	[F11 missing text]
20	5-Bromo-5-nitro-1,3-dioxane	0,1 %	Rinse-off products only Avoid formation of nitrosamines [F12 missing text]
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	[F13 0,0015 %] (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one		]
[F14 40	2-Benzyl-4-chlorophenol (clorophene)	0.2 %		]
[F15 41	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	]
[F16 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 %		]
[F17 47	1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) [F5 (+)]	0,1 %		]
[F10 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	]
[F18 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	]
[F19 53	Benzethonium Chloride (INCI)	0,1 %	(a) Rinse-off products, (b) Leave-on products other than for oral care use	]
[F20 54	Belzalkonium chloride, bromide and saccharinate (+)	0,1 % calculated as benzalkonium chloride		Avoid contact with eyes]
[F21 55	Benzylhemiformal	0,15 %	Only for products to be removed by rinsing
[F22 56	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 [F6 mixtures] 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 [F6 mixtures] 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
[F23 57	Methylisothiazolinone (INCI)	0,01 %		]
[F3 58	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.	]

Textual Amendments

F2 Inserted by Commission Directive 2007/22/EC of 17 April 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress (Text with EEA relevance).

F3 Inserted by Commission Directive 2010/3/EU of 1 February 2010 amending, for the purpose of adaptation to technical progress, Annexes III and VI to Council Directive 76/768/EEC concerning cosmetic products.

F4 Substituted by Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance).

F5 Deleted by Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance).

F6 Substituted by Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC of the European Parliament and of the Council in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F7 Inserted by Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance).

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

F9 Deleted by Commission Directive 2007/22/EC of 17 April 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress (Text with EEA relevance).

F10 Inserted by Commission Directive of 29 June 1994 (94/32/EC).

F11 Deleted by Commission Directive of 2 March 1988 (88/233/EEC).

F12 Deleted by Commission Directive of 21 February 1989 (89/174/EEC).

F13 Inserted by Commission Directive of 21 February 1989 (89/174/EEC).

F14 Inserted by Commission Directive of 2 February 1987 (87/137/EEC).

F15 Inserted by Commission Directive of 2 March 1988 (88/233/EEC).

F16 Inserted by Commission Directive of 12 March 1991 (91/184/EEC).

F17 Inserted by Commission Directive of 21 October 1992 (92/86/EEC).

F18 Inserted by Commission Directive of 25 June 1996 (96/41/EC).

F19 Substituted by Commission Directive 2005/42/EC of 20 June 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI thereto to technical progress (Text with EEA relevance).

F20 Inserted by Commission Directive of 3 September 1998 (98/62/EC).

F21 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).

F22 Substituted by Commission Directive 2007/22/EC of 17 April 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress (Text with EEA relevance).

F23 Inserted by Commission Directive 2005/42/EC of 20 June 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI thereto to technical progress (Text with EEA relevance).