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of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed)

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[F1PART 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 (*)

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

2. If the concentration in products intended to remain on the skin exceeds 0,02 % add the phrase: Contains iodine

Contains iodine]

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