SCHEDULE 5 continued PART 2
| Colour index number or denomination | Colour | Field of application | Other limitations and requirements | Authorisation valid until | |||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||||
Note: There are no entries in this part at the date that these Regulations are made.
Regulation 8
Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.
The substances marked with the symbol (*) may also be added to cosmetic products in concentrations other those laid down in this Schedule for other specific purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.
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 Schedule.
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.
All finished products containing formaldehyde or substances in this Schedule and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0.05%.
| Reference number | Substances | Maximum authorised concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label |
|---|---|---|---|---|
| a | b | c | d | e |
(1)
Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin. |
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(2)
Concerns any products aimed to be applied on a large part of the body. |
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(3)
Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age. |
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(4)
Solely for products which might be used for children under three years of age. |
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| 1 | Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-21-1) | Rinse-off products, except oral care products 2.5% (expressed as acid) | ||
| Oral care products: 1.7% (expressed as acid) | ||||
| Leave-on products: 0.5% (expressed as acid) | ||||
| 1a | Benzoic acid, its salts and esters other than those listed under reference number 1 | 0.5% (expressed as acid) | ||
| 2 | Propionic acid and its salts | 2% (expressed as acid) | ||
| 3 | Salicylic acid and its salts | 0.5% (expressed as 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(1) |
| 4 | Sorbic acid (hex-2,4-dienoic acid) and its salts | 0.6% (expressed as acid) | ||
| 5 | Formaldehyde paraformaldehyde (*) | 0.2% (except for oral hygiene products) expressed as free formaldehyde | Prohibited in aerosol dispensers (sprays) | |
| 0.1% (products for oral hygiene) expressed as free formaldehyde | ||||
| 6 | [omitted] | |||
| 7 | Biphenyl-2-ol (o-phenylphenol) and its salts | 0.2% expressed a phenol | ||
| 8 | Zinc pyrithione (CAS No 13463-41-7)(*) | Hair products: 1,00% Other products: 0,5% |
Rinse-off products only | |
| Prohibited in products for oral hygiene | ||||
| 9 | Inorganic sulfites and hydrogen-sulfites (*) | 0.2% expressed as free SO(2) | ||
| 10 | Sodium iodate | 0.1% | Rinse-off products only | |
| Entry deleted from 18/10/2008 | ||||
| 11 | Chlorobutanol (INN) | 0.5% | Prohibited in aerosol dispensers (sprays) | Contains chlorobutanol |
| 12 | 4-Hydroxybenzoic acid and its salts and esters | 0.4% (expressed as acid) for a single ester, | ||
| 0.8% (expressed as 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) | |
| 14 | Formic acid and its sodium salt | 0.5% (expressed as acid) | ||
| 15 | 3,3’-Dibromo-4,4’-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate) | 0.1% | ||
| 16 | Thiomersal (INN) For eye | 0.007% (of Hg) | For eye make up and eye make-up remover only | Contains thiomersal |
| If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0.007% | ||||
| 17 | Phenylmercuric salts (including borate) | 0.007% (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0.007% | For eye make up and eye make-up remover only | Contains phenylmercuric compounds |
| 18 | Undec-1-0-enoic acid and salts | 0.2% (expressed as acid) | See Schedule 6, Part 2, No 8 | |
| 19 | Hexetidine (INN) (*) | 0.1% | ||
| 20 | 5-Bromo-5-nitro-1,3-dioxane | 0.1% | Rinse off products only | |
| Avoid formation of nitrosamines | ||||
| 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’-Tetrachloroazo-benzene ≤1 mg/kg 3,3’,4,4’- | |
| Tetrachloroazoxybenzene ≤1 mg/kg | ||||
| 24 | 4-Chrloro-m-cresol | 0.2% | Prohibited in 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 (INN) | 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% | ||
| 35 | 1-Hydroxy-4-methyl-6(2,4,4-trimethyl-pentyl) 2-pyridon and its monoethanolamine salt | 1,0% 0.5% |
Rinse off products Other products |
|
| 36 | Entry deleted | |||
| 37 | 6,6-Dibromo-4,4-dichloro2,2’-methylenediphenol (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 | 0.0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3 (2H)-one and 2-methylisothiazol-3 (2H)-one | ||
| 40 | 2-Benzyl-4-chlorophenol (clorophene) | 0.2% | ||
| 41 | 2-Chloroacetamide | 0.3% | Cointains chloroacetamide | |
| 42 | Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride | 0,3% expressed as chlorhexidine | ||
| 43 | 1-Phenoxypropan-2-ol(*) | 1.0% | Only rinse-off products | |
| 44 | Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*) | 1.0% | ||
| 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% | ||
| 47 | 1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) | 0,1% | ||
| 48 | Glutaraldehyde (Pentane-1,5-dial) | 0.1% | Prohibited in aerosols (sprays) | Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.5%) |
| 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 | |
| 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 AgC1 | The ratio of titanium dioxide to silver chloride shall be 4:1 by mass. 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 | |
| 53 | Benzethonium Chloride (INCI) | 0.1% | (a) Rinse off products, | |
| (b) Leave-on products other than for oral care use | ||||
| 54 | Benzalkonium chloride, bromide and saccharinate (*) | 0,1% calculated as benzalkonium chloride | Avoid contact with eyes | |
| 55 | Benzylhemiformal | 0.15% | Only for products to be removed by rinsing | |
| 56 Entry deleted from 18/10/2008 | 3-Iodo-2-propynylbutylcarbamate | 0.05% | 1. Not to be used for oral hygiene and lipcare products | Contains iodine |
| 2. If the concentration on products intended to remain on the skin exceeds 0.02% add the phrase: Contains iodine | ||||
| 56 Entry inserted from 18/10/2008 | Iodopropynyl butyl-carbamate | (a) rinse-off products: 0.02% | Not to be used in oral hygiene and lip care products | (a) “Not to be used for children under three years of age”(3) |
| (IPBC) | (a) Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo | |||
| 3-iodo-2-propynl-butylcarbamate | (b) leave-on products: 0.01% except in deodorants/anti-perspirants: 0.0075% | (b) - not to be used in body lotion and body cream(2) | (b)“Not to be used for children under three years of age”(4) | |
| CAS No: 55406-53-6 | - not to be used in preparations for children under three years of age | |||
| 57 | Methylisothiazolinone (INCI) | 0.01% | ||