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of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed)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

PREAMBLE U.K.

1.

Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.

2.

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.

3.

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.

4.

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.

5.

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

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.] ]
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
[F3 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 [F4 (*)]	2 % (acid)
3	Salicylic acid and its salts (*)	0,5 % (acid)	Not to be used in [F5 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 [F4 (*)]	0,6 % (acid)
5	Formaldehyde paraformaldehyde [F6 (*)]	0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde	Prohibited in aerosol dispensers (sprays)
[F7 ]
7	Biphenyl-2-ol (o-phenylphenol) and its salts [F4 (*)]	0,2 % expressed as the phenol
[F3 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
[ F8 ]
11	Chlorobutanol (INN)	0,5 %	Prohibited in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid and its salts and esters [F4 (*)]	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)
[F9 14	Formic acid and its sodium salt [F4 (+)]	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 [F4 (*)]	0,2 % (acid)	See Annex VI, Part 2, No 8
19	Hexetidine (INN) [F4 (*)]	0,1 %	[F10 ]
20	5-Bromo-5-nitro-1,3-dioxane	0,1 %	Rinse-off products only Avoid formation of nitrosamines [F11 ]
21	Bronopol (INN) [F4 (*)]	0,1 %	Avoid formation of nitrosamines
22	2,4-Dichlorobenzyl alcohol [F4 (*)]	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 [F4 (*)]	0,2 %	Prohibited in the products intended to come into contact with mucous membranes
25	Tricolosan (INN) [F4 (*)]	0,3 %
26	4-Chloro-3,5-xylenol [F4 (*)]	0,5 %
27	3,3'-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (‘Imidazolidinyl urea’) [F4 (*)]	0,6 %
28	Poly (1-hexamethylenebiguanide hydrochloride [F4 (*)]	0,3 %
29	2-Phenoxyethanol [F4 (*)]	1,0 %
30	Hexamethylenetetramine [F4 (*)] (methenamine) (INN)	0,15 %
31	Methenamine 3-chloroallylochloride (INNM)	0,2 %
32	1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one [F4 (*)]	0,5 %
33	1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [F4 (*)]	0,6 %
34	Benzyl alchohol (*)	1,0 %
35	1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt [F4 (*)]	1,0 % 0,5 %	Products rinsed off For other products
[ F4 ]
37	6,6-Dibromo-4,4-dichloro2,2‘-methylene-diphenol (Bromochlorophen) [F4 (*)]	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	[F12 0,0015 %] (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one		]
[F13 40	2-Benzyl-4-chlorophenol (clorophene)	0.2 %		]
[F14 41	2-Chloroacetamide	0,3 %		Contains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride [F4 (+)]	0,3 % expressed as clorhexidine
43	1-Phenoxypropan-2-ol [F6 (*)]	1,0 %	Only for rinse-off products	]
[F15 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 %		]
[F16 47	1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) [F4 (+)]	0,1 %		]
[F9 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	]
[F17 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	]
[F18 53	Benzethonium Chloride (INCI)	0,1 %	(a) Rinse-off products, (b) Leave-on products other than for oral care use	]
[F19 54	Belzalkonium chloride, bromide and saccharinate (+)	0,1 % calculated as benzalkonium chloride		Avoid contact with eyes]
[F20 55	Benzylhemiformal	0,15 %	Only for products to be removed by rinsing
[F21 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 [F5 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 [F5 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
[F22 57	Methylisothiazolinone (INCI)	0,01 %		]

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 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).

F4 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).

F5 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).

F6 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).

F7 Deleted by Commission Directive of 2 February 1987 (87/137/EEC).

F8 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).

F9 Inserted by Commission Directive of 29 June 1994 (94/32/EC).

F10 Deleted by Commission Directive of 2 March 1988 (88/233/EEC).

F11 Deleted by Commission Directive of 21 February 1989 (89/174/EEC).

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

F13 Inserted by Commission Directive of 2 February 1987 (87/137/EEC).

F14 Inserted by Commission Directive of 2 March 1988 (88/233/EEC).

F15 Inserted by Commission Directive of 12 March 1991 (91/184/EEC).

F16 Inserted by Commission Directive of 21 October 1992 (92/86/EEC).

F17 Inserted by Commission Directive of 25 June 1996 (96/41/EC).

F18 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).

F19 Inserted by Commission Directive of 3 September 1998 (98/62/EC).

F20 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).

F21 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).

F22 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).

[F1 PART 2 U.K. LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

Reference number	Substance	Maximum authorized concentration	Limitations and requirements	Conditions of use and warnings which must be printed on the label	Allowed until
a	b	c	d	e	f
[F11 ]
[F23 ]
[F11 ]
[F24 ]
[F11 ]
[F24 ]
[F10 ]
[F7 ]
[F10 ]
[F7 ]
[F10 ]
[F25 ]
[F26 ]
[F24 ]
[F10 ]
[F11 ]
[F27 ]
[ F28 ]
[F10 ]
[F11 ]
[F29 ]					]
[ F28 ]
[ F23 ]

Textual Amendments

F23 Deleted by Commission Directive of 25 June 1996 (96/41/EC).

F24 Deleted by Commission Directive of 12 March 1991 (91/184/EEC).

F25 Deleted by Commission Directive of 10 July 1995 (95/34/EC).

F26 Deleted by Commission Directive of 3 September 1998 (98/62/EC).

F27 Deleted by Commission Directive of 21 October 1992 (92/86/EEC).

F28 Deleted 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).

F29 Deleted by Commission Directive of 29 June 1994 (94/32/EC).