Part I PRESERVATIVES LISTED IN ANNEX VI, PART I OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
| (1) | (2) | (3) | (4) | (5) | (6) | |
|---|---|---|---|---|---|---|
| Reference Number | Name of substance | Purpose of substance or type of product | Maximum concentration of substance in product | Other requirements | Required information | |
| 1 | Benzoic acid, its salts and esters | All products | 0.5 per cent (acid) | A | — | — |
| 2 | Propionic acid and its salts | All products | 2 per cent (acid) | A | — | — |
| 3 | Salicylic acid and its salts | All products | 0.5 per cent (acid) | A | 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 (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin) |
| 4 | Sorbic acid (hexa-2,4-dienoic acid) and its salts | All products | 0.6 per cent (acid) | A | — | — |
| 5 | Formaldehyde and paraformaldehyde | For oral hygiene | 0.1 per cent (expressed as free formaldehyde) | Not to be used in aerosol dispensers (sprays) | — | |
| Except for oral hygiene (see also Part I of Schedule 2) | 0.2 per cent (expressed as free formaldehyde) | |||||
| 6 | ENTRY DELETED | |||||
| 7 | Biphenyl-2-ol [o-phenylphenol] and its salts | All products | 0.2 per cent (expressed as the phenol) | A | — | — |
| 8 | Pyrithione zinc (INN) [Zinc pyrithione] | Products rinsed off after use | 0.5 per cent | A | Not to be used in oral hygiene products | — |
| 9 | Inorganic sulphites and hydrogen sulphites | All products | 0.2 per cent (expressed as free SO2) | A | — | — |
| 10 | Sodium iodate | Products rinsed off after use | 0.1 per cent | — | — | |
| 11 | Chlorobutanol (INN) | All products | 0.5 per cent | Not to be used in aerosol dispensers (sprays) | Contains chlorobutanol | |
| 12 | 4-Hydroxybenzoic acid and its salts and esters [the Parabens] | All products | 0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of esters | A | — | — |
| 13 | 3-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its salts | All products | 0.6 per cent (acid) | Not to be used in aerosol dispensers (sprays) | — | |
| 14 | Formic acid and its sodium salt | All products | 0.5 per cent (expressed as acid) | A | — | — |
| 15 | 3,3'-Dibromo-4,4'-hexamethylene-dioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate) | All products | 0.1 per cent | — | — | |
| 16 | Thiomersal (INN) [Thimerosal] | Eye make-up and eye make-up remover | 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent | — | Contains thiomersal | |
| 17 | Phenylmercuric salts (including borate) | Eye make-up and eye make-up remover | 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent | — | Contains phenylmercuric compounds | |
| 18 | Undec-10-enoic acid [Undecylenic acid] and its salts | All products | 0.2 per cent (acid) | A | — | — |
| 19 | Hexetidine (INN) | Products rinsed off after use | 0.1 per cent | A | — | — |
| 20 | 5-Bromo-5-nitro-1,3-dioxane | Products rinsed off after use | 0.1 per cent | Avoid formation of nitrosamines | — | |
| 21 | Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol] | All products | 0.1 per cent | A | Avoid formation of nitrosamines | — |
| 22 | 2,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol] | All products | 0.15 per cent | A | — | — |
| 23 | Triclocarban (INN) | All products | 0.2 per cent | A | Purity criteria: 3,3'4,4'-tetrachloro-azobenzene<1 mg/kg 3,3',4,4'-tetrachloro-azoxybenzene<1 mg/kg | — |
| 24 | 4-Chloro-m-cresol [p-Chloro-m-cresol] | Not to be used in products intended to come into contact with mucous membranes | 0.2 per cent | A | — | — |
| 25 | Triclosan (INN) | All products | 0.3 per cent | A | — | — |
| 26 | 4-Chloro-3,5-xylenol [Chloroxylenol] | All products | 0.5 per cent | A | — | — |
| 27 | 3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea [Imidazolidinyl urea] | All products | 0.6 per cent | A | — | — |
| 28 | Poly(1-hexamethylene-biguanide hydrochloride) [Polyaminopropyl biguanide] | All products | 0.3 per cent | A | — | — |
| 29 | 2-Phenoxyethanol [Phenoxyethanol] | All products | 1.0 per cent | A | — | — |
| 30 | Hexamethylenetetramine (Methenamine (INN)) [Methenamine] | All products | 0.15 per cent | A | — | — |
| 31 | Methenamine 3-chloroallylochloride (INNM) [Quaternium-15] | All products | 0.2 per cent | — | — | |
| 32 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole] | All products | 0.5 per cent | A | — | — |
| 33 | 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin] | All products | 0.6 per cent | A | — | — |
| 34 | Benzyl alcohol (See also Part I of Schedule 2) | All products | 1.0 per cent | A | — | — |
| 35 | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine] | Products rinsed off after use Other products | 1.0 per cent 0.5 per cent | A A | — — | — — |
| 36 | 1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile] | All products | 0.1 per cent | Not to be used in cosmetic sunscreen products at a concentration exceeding 0.025 per cent | — | |
| 37 | 6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol [Bromochlorophen] | All products | 0.1 per cent | A | — | — |
| 38 | 4-Isopropyl-m-cresol [o-Cymen-5-ol] | All products | 0.1 per cent | — | — | |
| 39 | Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate [Methylchloroisothiazolinone and Methylisothiazolinone] | All products | 0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one | — | — | |
| 40 | 2-Benzyl-4-chlorophenol [Chlorophene] | All products | 0.2 per cent | — | — | |
| 41 | 2-Chloroacetamide [Chloroacetamide] | All products | 0.3 per cent | — | Contains chloroacetamide | |
| 42 | Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride | All products | 0.3 per cent | A | — | — |
| 43 | 1-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part I of Schedule 2) | Products rinsed off after use | 1.0 per cent | — | — | |
| 44 | Alkyl (C12-C22)-trimethylammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM)) | All products | 0.1 per cent | A | — | — |
| 45 | 4,4-Dimethyl-1,3-oxazolidine [Dimethyl oxazolidine] | All products | 0.1 per cent | The pH of the finished product must not be lower than 6 | — | |
| 46 | 1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea] | All products | 0.5 per cent | — | — | |
| 47 | Hexamidine (INN) (4,4'-(Hexamethylene-dioxy)dibenzamidine) and its salts, including isethionate and p-hydroxybenzoate | All products | 0.1 per cent | A | — | — |
| 48 | Glutaraldehyde (pentane-1,5-dial) [Glutaral] | All products | 0.1 per cent | Prohibited in aerosols (sprays) | Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent) | |
| 49 | 5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane[7-Ethylbicyclooxazolidine] | All products | 0.3 per cent | Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes | — | |
| 50 | Chlorphenesin (INN) [Chlorphenesin] | All products | 0.3 per cent | — | — | |
| 51 | Sodium N-hydroxymethylglycinate [Sodium hydroxymethyl-glycinate] | All products | 0.5 per cent | — | — | |
| 52 | Silver chloride deposited on titanium dioxide | Not to be used 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 | 0.004 per cent calculated as silver chloride | The ratio of titanium dioxide to silver chloride shall be 4:1 by mass | — |
Annotations
Footnotes
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See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC, 96/41/EC.
Notes on Schedule 4
Footnotes
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O.J. No. L132, 1.6.1996, p.1.