European Commission - Growth

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Annex V

LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS

Ref. Substance identification Conditions
Chemical name / INN Name of Common Ingredients Glossary CAS Number EC Number Product Type, body parts Maximum concentration in ready for use preparation
1 Benzoic acid and its sodium salt BENZOIC ACID; SODIUM BENZOATE 65-85-0 / 532-32-1  200-618-2 / 208-534-8  a) Rinse-off products, except oral care products b) Oral care products c) Leave-on products  a) 2.5% (acid)
b) 1.7% (acid)
c) 0.5% (acid)
 
1a Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid AMMONIUM BENZOATE / BUTYL BENZOATE / CALCIUM BENZOATE / ETHYL BENZOATE / ISOBUTYL BENZOATE / ISOPROPYL BENZOATE / MAGNESIUM BENZOATE / MEA-BENZOATE / METHYL BENZOATE / PHENYL BENZOATE / POTASSIUM BENZOATE / PROPYL 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 / 1205-50-3 / 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 acid and its salts SALICYLIC ACID, CALCIUM SALICYLATE, MAGNESIUM SALICYLATE, MEA- SALICYLATE, SODIUM SALICYLATE, POTASSIUM SALICYLATE, TEA- SALICYLATE 69-72-7[1]/ 824-35-1[2]/ 18917-89-0[3]/ 59866-70-5[4]/ 54-21-7[5]/ 578-36-9[6]/ 2174-16-5[7]  200-712-3[1]/ 212-525-4[2]/ 242-669-3[3]/ 261-963-2[4]/ 200-198-0[5]/ 209-421-6[6]/ 218-531-3[7]    Salicylic acid: 0,5 % (acid)

Salicylic acid salts: 0,5 % (acid)

 
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) 
7 Biphenyl-2-ol O-PHENYLPHENOL 90-43-7  201-993-5    The use of o-phenylphenol as a preservative should be allowed with a maximum concentration of 0,15 % (as phenol) in leave-on and 0,2 % (as phenol) in rinse-off cosmetic products.
Contact with eyes should be avoided.
The use of sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate as preservatives should not be allowed. 
9 Inorganic sulphites and hydrogensulphites (5) 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) 
11 Chlorobutanol CHLOROBUTANOL 57-15-8  200-317-6    0.5% 
12 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 /26112-0-2 /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 
12 a Butyl 4-hydroxy­benzoate and its salts Propyl 4-hydroxy­benzoate and its salts BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/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, here the sum of the individual concentrations of butyl and propylparaben and their salts does not exceed 0,14% 
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) 
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'-hexamethylenedioxydibenzamidine 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 authorized by this Regulation, the maximum concentration of Hg remains fixed at 0.007% 
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 authorized by this Directive, the maximum concentration of Hg remains fixed at 0.007% 
18 Undec-10-enoic acid and its salts UNDECYLENIC ACID / POTASSIUM UNDECYLENATE / SODIUM UNDECYLENATE / CALCIUM UNDECYLENATE / MEA-UNDECYLENATE / TEA-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% 
21 Bronopol 2-BROMO-2-NITROPROPANE-1,3-DIOL 52-51-7  200-143-0    0.1% 
22 2,4-Dichlorobenzyl alcohol DICHLOROBENZYL ALCOHOL 1777-82-8  217-210-5    0.15% 
23 1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea (6)
TRICLOCARBAN 101-20-2  202-924-1    0.2% 
24 Chlorocresol P-CHLORO-M-CRESOL 59-50-7  200-431-6  Not to be used in products applied on mucous membranes  0.2% 
25 5-Chloro-2-(2,4-dichlorophenoxy)phenol
TRICLOSAN 3380-34-5  222-182-2  (a) Toothpastes Hand soaps Body soaps/ Shower gels Deodorants (non-spray) Face powders and blemish concealers Nail products for cleaning the fingernails and toenails before the application of artificial nail systems. (b) Mouthwashes  (a) 0.3%

(b) 0.2% 
26 Chloroxylenol CHLOROXYLENOL 88-04-0 / 1321-23-9  201-793-8 / 215-316-6    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 Polyhexamethylene biguanide hydrochloride POLYAMINOPROPYL BIGUANIDE 32289-58-0 [1]/ 27083-27-8 [2]/ 28757-47-3 [3]/ 133029-32-0 [4]  608-723-9 [1]/ 608-042-7 [2]    0.1% 
29 2-Phenoxyethanol PHENOXYETHANOL 122-99-6  204-589-7    1.0% 
30 Methenamine METHENAMINE 100-97-0  202-905-8     0.15% 
32 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one CLIMBAZOLE 38083-17-9  253-775-4  (a) Hair lotions (b) Face creams (c) Foot care products (d) Rinse-off shampoo  (a) 0,2 %
(b) 0,2 %
(c) 0,2 %
(d) 0,5 % 
33 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione DMDM HYDANTOIN 6440-58-0  229-222-8    0.6% 
34 Benzyl alcohol (7) 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  a) Rinse-off products b) Other products  a) 1.0%
b) 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% 
39 Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-Methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate METHYLCHLOROISOTHIAZOLINONE AND METHYLISOTHIAZOLINONE 26172-55-4, 2682-20-4, 55965-84-9  247-500-7, 220-239-6  Rinse-off  0.0015% (of a mixture in the ratio 3:1 of 5-Chloro-2-methyl-isothiazol-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-ol (8) PHENOXYISOPROPANOL 770-35-4  212-222-7  Only for rinse-off products  1.0% 
44 Alkyl (C12-C22) trimethyl ammonium bromide and chloride BEHENTRIMONIUM CHLORIDE (1) / CETRIMONIUM BROMIDE / CETRIMONIUM CHLORIDE (2)/ LAURTRIMONIUM BROMIDE / LAURTRIMONIUM CHLORIDE / STEARTRIMONIUM BROMIDE / STEARTRIMONIUM CHLORIDE (2) 17301-53-0 / 57-09-0 / 112-02-7 / 1119-94-4 / 112-00-5 / 1120-02-1 / 112-03-8  241-327-0 / 200-311-3 / 203-928-6 / 214-290-3 / 203-927-0 / 214-294-5 / 203-929-1    0.1% 
45 4,4-Dimethyl-1,3-oxazolidine DIMETHYL OXAZOLIDINE 51200-87-4  257-048-2    0.1% 
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 isothionate and p-hydroxybenzoate) HEXAMIDINE / HEXAMIDINE DIISETHIONATE / HEXAMIDINE DIPARABEN / 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% 
49 5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0] octane 7-ETHYLBICYCLOOXAZOLIDINE 7747-35-5  231-810-4    0.3% 
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) 
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  a) Rinse-off products b) Leave-on products other than oral products   0.1% 
54 Benzalkonium chloride, bromide and saccharinate (10) 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) 
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  a) Rinse-off products b) Leave-on products c) Deodorants/antiperspirants  a) 0.02%
b) 0.01%
c) 0.0075%
 
57 2-Methyl-2H-isothiazol-3-one METHYLISOTHIAZOLINONE 2682-20-4  220-239-6    0,0015 % Rinse-off products 
58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride 60372-77-2  434-630-6  (a) Mouthwashes (b) Other products  (a) 0,15 %

(b) 0,4 % 
59 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 5949-29-1; 77-92-9; 36701-38-9  460-890-5    0,2% corresponding to 0,0024% of silver 
60 4-(3-ethoxy-4-hy­droxyphenyl)bu­tan-2-one HYDROXYETHOXY­PHENYL BUTANONE, HEPB 569646-79-3   933-435-8   Allowed for use as a preservative in rinse off, oral care and leave-on cosmetic products at a maximum concentration of 0,7 % in ready for use preparation.  0.7 %