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Version Superseded: 25/09/2004
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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:
| |
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] |
Textual Amendments
F3 Inserted by Commission Directive of 29 June 1994 (94/32/EC).
F4 Deleted by Commission Directive of 2 March 1988 (88/233/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).
Textual Amendments
F1 Inserted by Commission Directive of 26 March 1986 (86/199/EEC).
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