ANNEX VLIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
Preamble
1.
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.
2.
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 %.
Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
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Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||
a | b | c | d | e | f | g | h | i |
1 | Benzoic acid and its sodium salt | Benzoic acid Sodium Benzoate | 65-85-0 532-32-1 | 200-618-2 208-534-8 | Rinse-off products, except oral products | 2,5 % (acid) | ||
Oral 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 | Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate | 1863-63-4, 2090-05-3, 582-25-2, 553-70-8, 4337-66-0, 93-58-3, 93-89-0, 2315-68-6, 136-60-7, 120-50-3, 939-48-0, 93-99-2 | 217-468-9, 218-235-4, 209-481-3, 209-045-2, 224-387-2, 202-259-7, 202-284-3, 219-020-8, 205-252-7, 204-401-3, 213-361-6, 202-293-2 | 0,5 % (acid) | |||
2 | Propionic acid and its salts | Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate | 79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6 | 201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4 | 2 % (acid) | |||
3 | Salicylic acid46 and its salts | Salicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate | 69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5 | 200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3 | 0,5 % (acid) | Not to be used in products for children under 3 years of age, except for shampoos | Not to be used for children under 3 years of age47 | |
4 | Hexa-2,4-dienoic acid and its salts | Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate | 110-44-1, 7492-55-9, 7757-81-5, 24634-61-5 | 203-768-7, 231-321-6, 231-819-3, 246-376-1 | 0,6 % (acid) | |||
5 | Formal-dehyde, paraformaldehyde48 | Formaldehyde Paraformaldehyde | 50-00-0, 30525-89-4 | 200-001-8 | Oral products | 0,1 % (free formaldehyde) | Not to be used in aerosol dispensers (sprays) | |
Other products | 0,2 % (free formaldehyde) | |||||||
6 | Moved or deleted | |||||||
7 | Biphenyl-2-ol, and its salts | o-Phenylphenol, sodium o-phenylphenate, potassium o-phenylphenate, MEA o-phenylphenate | 90-43-7, 132-27-4, 13707-65-8, 84145-04-0 | 201-993-5, 205-055-6, 237-243-9, 282-227-7 | 0,2 % (as phenol) | |||
8 | Pyrithione zinc49 | Zinc pyrithione | 13463-41-7 | 236-671-3 | Hair products | 1,0 % | Only in rinse-off products Not to be used in oral products | |
Other products | 0,5 % | |||||||
9 | Inorganic sulphites and hydrogen- sulphites50 | Sodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite | 7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8 | 231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-3 | 0,2 % (as free SO2) | |||
10 | Moved or deleted | |||||||
11 | Chlorobutanol | Chlorobutanol | 57-15-8 | 200-317-6 | 0,5 % | Not to be used in aerosol dispensers (sprays) | Contains Chlorobutanol | |
F712 | 4-Hydroxybenzoic acid and its Methyl- and Ethyl-esters, and their salts | 4-Hydroxybenzoic acid methylparaben potassium ethylparaben potassium paraben sodium methylparaben sodium ethylparaben ethylparaben sodium paraben potassium methylparaben calcium paraben | 99-96-7 99-76-3 36457-19-9 16782-08-4 5026-62-0 35285-68-8 120-47-8 114-63-6 26112-07-2 69959-44-0 | 202-804-9 202-785-7 253-048-1 240-830-2 225-714-1 252-487-6 204-399-4 204-051-1 247-464-2 274-235-4 | 0,4 % (as acid) for single ester 0,8 % (as acid) for mixtures of esters | |||
F812a | Butyl 4-hydroxybenzoate and its salts Propyl 4-hydroxybenzoate and its salts | Butylparaben propylparaben sodium propylparaben sodium butylparaben potassium butylparaben potassium propylparaben | 94-26-8 94-13-3 35285-69-9 36457-20-2 38566-94-8 84930-16-5 | 202-318-7 202-307-7 252-488-1 253-049-7 254-009-1 284-597-5 | 0,14 % (as acid) for the sum of the individual concentrations 0,8 % (as acid) for mixtures of substances mentioned in entry 12 and 12a, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 % | Not to be used in leave-on products designed for application on the nappy area of children under three years of age. | For leave-on products designed for children under three years of age: ‘Do not use on the nappy area’ | |
13 | 3-Acetyl-6-methylpyran-2,4 (3H)-dione and its salts | Dehydroacetic acid, sodium dehydroacetate | 520-45-6, 4418-26-2, 16807-48-0 | 208-293-9, 224-580-1 | 0,6 % (as acid) | Not to be used in aerosol dispensers (sprays) | ||
14 | Formic acid and its sodium salt | Formic acid, sodium formate | 64-18-6, 141-53-7 | 200-579-1, 205-488-0 | 0,5 % (as acid) | |||
15 | 3,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate) | Dibromohexamidine Isethionate | 93856-83-8 | 299-116-4 | 0,1 % | |||
16 | Thiomersal | Thimerosal | 54-64-8 | 200-210-4 | Eye products | 0,007 % (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 % | Contains Thiomersal | |
17 | Phenylmercuric salts (including borate) | Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate | 62-38-4, 94-43-9 | 200-532-5, 202-331-8 | Eye products | 0,007 % (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 % | Contains Phenylmercuric compounds | |
18 | Undec-10-enoic acid and its salts | Undecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate | 112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2 | 203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-7 | 0,2 % (as acid) | |||
19 | 5- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl- | Hexetidine | 141-94-6 | 205-513-5 | 0,1 % | |||
20 | 5-Bromo-5-nitro-1,3-dioxane | 5-Bromo-5-nitro-1,3-dioxane | 30007-47-7 | 250-001-7 | Rinse-off products | 0,1 % | Avoid formation of nitrosamines | |
21 | Bronopol | 2-Bromo-2-nitropropane-1,3-diol | 52-51-7 | 200-143-0 | 0,1 % | Avoid formation of nitrosamines | ||
22 | 2,4-Dichlorobenzyl alcohol | Dichlorobenzyl Alcohol | 1777-82-8 | 217-210-5 | 0,15 % | |||
23 | 1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) urea51 | Triclocarban | 101-20-2 | 202-924-1 | 0,2 % | Purity criteria: 3,3',4,4'-Tetrachloroazobenzene <1 ppm 3,3',4,4'-Tetrachloroazoxybenzene <1 ppm | ||
24 | Chlorocresol | p-Chloro-m-Cresol | 59-50-7 | 200-431-6 | Not to be used in products applied on mucuous membranes | 0,2 % | ||
F925 | 5-Chloro-2- (2,4- dichlorophenoxy) phenol | Triclosan | 3380-34-5 | 222-182-2 |
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26 | Chloro-xylenol | Chloroxylenol | 88-04-0 | 201-793-8 | 0,5 % | |||
27 | N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea] | Imidazolidinyl urea | 39236-46-9 | 254-372-6 | 0,6 % | |||
28 | Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl] amino]-, dihydrochloride | Polyaminopropyl biguanide | 70170-61-5, 28757-47-3, 133029-32-0 | 0,3 % | ||||
29 | 2-Phenoxyethanol | Phenoxyethanol | 122-99-6 | 204-589-7 | 1,0 % | |||
30 | Methenamine | Methenamine | 100-97-0 | 202-905-8 | 0,15 % | |||
31 | Methenamine 3-chloroallylochloride | Quaternium-15 | 4080-31-3 | 223-805-0 | 0,2 % | |||
32 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one | Climbazole | 38083-17-9 | 253-775-4 | 0,5 % | |||
33 | 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione | DMDM Hydantoin | 6440-58-0 | 229-222-8 | 0,6 % | |||
F134 | Benzyl alcohol52 | Benzyl Alcohol | 100-51-6 | 202-859-9 | 1,0 % | |||
35 | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine | 50650-76-5, 68890-66-4 | 272-574-2 | Rinse-off products | 1,0 % | ||
Other products | 0,5 % | |||||||
36 | Moved or deleted | |||||||
37 | 2,2'-methylenebis(6-bromo-4-chlorophenol) | Bromochlorophene | 15435-29-7 | 239-446-8 | 0,1 % | |||
38 | 4-Isopropyl-m-cresol | o-Cymen-5-ol | 3228-02-2 | 221-761-7 | 0,1 % | |||
F1039 | Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one | Methylchloroisothiazolinone (and) Methylisothiazolinone62 | 26172-55-4, 2682-20-4, 55965-84-9 | 247-500-7, 220-239-6 | Rinse-off products | 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 | Chlorophene | 120-32-1 | 204-385-8 | 0,2 % | |||
41 | 2-Chloroacetamide | Chloroacetamide | 79-07-2 | 201-174-2 | 0,3 % | Contains chloroacetamide | ||
42 | N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride | Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride | 55-56-1, 56-95-1, 18472-51-0, 3697-42-5 | 200-238-7, 200-302-4, 242-354-0, 223-026-6 | 0,3 % (as chlorhexidine) | |||
43 | 1-Phenoxypropan-2-ol53 | Phenoxyisopropanol | 770-35-4 | 212-222-7 | Only for rinse-off products | 1,0 % | ||
Alkyl (C12-22) trimethyl ammonium bromide and chloride | Behentrimonium chloride60, | 17301-53-0, | 241-327-0, | 0,1 % | ||||
cetrimonium bromide, | 57-09-0, | 200-311-3, | ||||||
cetrimonium chloride61, | 112-02-7, | 203-928-6, | ||||||
laurtrimonium bromide, | 1119-94-4, | 214-290-3, | ||||||
laurtrimonium chloride, | 112-00-5, | 203-927-0, | ||||||
steartrimonium bromide, | 1120-02-1, | 214-294-5, | ||||||
steartrimonium chloride61 | 112-03-8 | 203-929-1 | ||||||
45 | 4,4-Dimethyl-1,3-oxazolidine | Dimethyl Oxazolidine | 51200-87-4 | 257-048-2 | 0,1 % | pH > 6 | ||
46 | N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea | Diazolidinyl Urea | 78491-02-8 | 278-928-2 | 0,5 % | |||
47 | Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate) | Hexamidine, Hexamidine diisethionate, Hexamidine paraben | 3811-75-4, 659-40-5, 93841-83-9 | 211-533-5, 299-055-3 | 0,1 % | |||
48 | Glutaraldehyde (Pentane-1,5-dial) | Glutaral | 111-30-8 | 203-856-5 | 0,1 % | Not to be used in aerosols (sprays) | Contains glutaral54 | |
49 | 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane | 7-Ethylbicyclooxazolidine | 7747-35-5 | 231-810-4 | 0,3 % | Not to be used in oral products and in products applied on mucous membranes | ||
50 | 3-(p-Chlorophenoxy)-propane-1,2 diol | Chlorphenesin | 104-29-0 | 203-192-6 | 0,3 % | |||
51 | Sodium hydroxymethylamino acetate | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | 0,5 % | |||
52 | Silver chloride deposited on titanium dioxide | Silver chloride | 7783-90-6 | 232-033-3 | 0,004 % (as AgCl) | 20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products | ||
53 | Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride | Benzethonium Chloride | 121-54-0 | 204-479-9 |
| 0,1 % | ||
54 | Benzalkonium chloride, bromide and saccharinate55 | Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate | 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 | 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 | 0,1 % (as benzalkonium chloride) | Avoid contact with eyes | ||
55 | Methanol, (phenylmethoxy-) | Benzylhemiformal | 14548-60-8 | 238-588-8 | Rinse-off products | 0,15 % | ||
56 | 3-Iodo-2-propynylbutylcarbamate | Iodopropynyl butylcarbamate | 55406-53-6 | 259-627-5 |
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F657 | 2-Methyl-2H-isothiazol-3-one | Methylisothiazolinone63 | 2682-20-4 | 220-239-6 | Rinse-off products | 0,0015 % | ||
Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride59 | Ethyl Lauroyl Arginate HCl | 60372-77-2 | 434-630-6 |
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1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate | Citric acid (and) Silver citrate | — | 460-890-5 | 0,2 %, corresponding to 0,0024 % of silver | Not to be used in oral products and eye products | |||
For use other than as a preservative, see Annex III, No. 98. | ||||||||
Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin. | ||||||||
For use other than as a preservative, see Annex III, No. 13. | ||||||||
For use other than as a preservative, see Annex III. No. 101. | ||||||||
For use other than as a preservative, see Annex III, No. 99. | ||||||||
For use other than as a preservative, see Annex III, No. 100. | ||||||||
For other uses than preservatives, see Annex III, entry No 45. | ||||||||
For use other than as a preservative, see Annex III, No. 54. | ||||||||
Only if the concentration exceeds 0,05 %. | ||||||||
For use other than as a preservative, see Annex III, No. 65. | ||||||||
Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age. | ||||||||
Solely for products which might be used for children under 3 years of age. | ||||||||
Concerns any products aimed to be applied on a large part of the body. | ||||||||
For other uses than preservatives, see Annex III, entry No 197. | ||||||||
For use other than as a preservative, see Annex III, No 287. | ||||||||
For use other than as a preservative, see Annex III, No 286. | ||||||||
Methylisothiazolinone is also regulated in entry 57. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product. | ||||||||
Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product. | ||||||||