ANNEX VLIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
|---|---|---|---|---|---|---|---|---|
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) | |||
Salicylic acid 62 and its salts | Salicylic acid | 69-72-7 | 200-712-3 | 0,5 % (acid) | Not to be used in products for children under 3 years of age. | Not to be used for children under 3 years of age 73 | ||
Not to be used in oral products. | ||||||||
Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. | ||||||||
Calcium salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA- salicylate | 824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5 | 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 age63 | |||
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) | |||
6 | Moved or deleted | |||||||
F127 | Biphenyl-2-ol 80 | o-Phenylphenol | 90-43-7 | 201-993-5 |
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| Avoid contact with eyes | |
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F20. . . | F20. . . | F20. . . | F20. . . | F20. . . | F20. . . | F20. . . | F20. . . | |
9 | Inorganic sulphites and hydrogen- sulphites66 | 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 | |
F1312 | 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 | |||
F1412a | 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) urea67 | 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 % | ||
F1525 | 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 % | |||
F528 | Polyhexamethylene biguanide hydrochloride | Polyaminopropyl biguanide | 32289-58-0, 27083-27-8, 28757-47-3, 133029-32-0 | 608-723-9 608-042-7 | 0,1 % | Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation | ||
29 | 2-Phenoxyethanol | Phenoxyethanol | 122-99-6 | 204-589-7 | 1,0 % | |||
30 | Methenamine | Methenamine | 100-97-0 | 202-905-8 | 0,15 % | |||
F1632 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one 81 | Climbazole | 38083-17-9 | 253-775-4 | ||||
33 | 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione | DMDM Hydantoin | 6440-58-0 | 229-222-8 | 0,6 % | |||
F134 | Benzyl alcohol 68 | 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 % | |||
F1739 | Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one | Methylchloroisothiazolinone (and) Methylisothiazolinone 78 | 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) | ||
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-ol69 | Phenoxyisopropanol | 770-35-4 | 212-222-7 | Only for rinse-off products | 1,0 % | ||
Alkyl (C 12-22 ) trimethyl ammonium bromide and chloride | Behentrimonium chloride 76 , | 17301-53-0, | 241-327-0, | 0,1 % | ||||
cetrimonium bromide, | 57-09-0, | 200-311-3, | ||||||
cetrimonium chloride 77 , | 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 chloride 77 | 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 glutaral70 | |
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 % | F21Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w | ||
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 saccharinate71 | 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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F1057 | 2-Methyl-2H-isothiazol-3-one | Methylisothiazolinone 79 | 2682-20-4 | 220-239-6 | Rinse-off products | 0,0015 % | ||
Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride 75 | 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 | |||
F1960 | 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one | Hydroxyethoxyphenyl Butanone | 569646-79-3 | 933-435-8 | 0,7 % | |||
For uses other than 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. | ||||||||
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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. | ||||||||
From 17 June 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be placed on the Union market. From 17 September 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be made available on the Union market. | ||||||||
For use other than as a preservative, see Annex III, entry 310. | ||||||||
From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be placed on the Union market. From 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be made available on the Union market. | ||||||||