This document lists 49 preservatives that are allowed for use in cosmetic products along with their maximum authorized concentrations and any limitations or requirements. It provides the chemical name, CAS number, maximum percentage allowed, and any conditions of use or warnings that must be printed on the label for each preservative. The list is intended to inform manufacturers of which preservatives may be added to cosmetic products and at what levels to inhibit microbial growth while ensuring consumer safety.
This document lists 49 preservatives that are allowed for use in cosmetic products along with their maximum authorized concentrations and any limitations or requirements. It provides the chemical name, CAS number, maximum percentage allowed, and any conditions of use or warnings that must be printed on the label for each preservative. The list is intended to inform manufacturers of which preservatives may be added to cosmetic products and at what levels to inhibit microbial growth while ensuring consumer safety.
This document lists 49 preservatives that are allowed for use in cosmetic products along with their maximum authorized concentrations and any limitations or requirements. It provides the chemical name, CAS number, maximum percentage allowed, and any conditions of use or warnings that must be printed on the label for each preservative. The list is intended to inform manufacturers of which preservatives may be added to cosmetic products and at what levels to inhibit microbial growth while ensuring consumer safety.
This document lists 49 preservatives that are allowed for use in cosmetic products along with their maximum authorized concentrations and any limitations or requirements. It provides the chemical name, CAS number, maximum percentage allowed, and any conditions of use or warnings that must be printed on the label for each preservative. The list is intended to inform manufacturers of which preservatives may be added to cosmetic products and at what levels to inhibit microbial growth while ensuring consumer safety.
ANNEX VI List of preservatives allowed for use in cosmetic products
ANNEX VI LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN
Preamble 1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products. 2. The substances marked with the symbol (+) may also be added to cosmetic products in concentration other than those laid down in this ANNEX for other purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos. 3. 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 the ANNEX. 4. 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.
5. 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%.
th
Revised based on agreement of 17 ACSB MeetingASEAN Cosmetic Documents1
Annex VI Part 1 List of preservatives allowed for use in cosmetic products
ANNEX VI PART 1 LIST OF PRESERVATIVES ALLOWED Reference Number
Substance
Maximum authorized concentration
Limitations and requirements
Benzoic acid (CAS No. 65-85-0), and its
sodium salt (CAS No 532-32-1)
Rinse off products, except
oral care products; 2.5 % (acid) Oral care 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
0.5 % (acid)
Propionic acid and its salts
2% (acid) (1)
Salicylic acid and its salts (+)
0.5% (acid)
Sorbic acid (hexa-2,4-dienoic acid) and its salts
0.6% (acid)
Formaldehyde and paraformaldehyde(+)(7)
0.2% (except for products
for oral hygiene) 0.1% (for oral hygiene) expressed as free formaldehyde
Entry moved or deleted
Revised January 2015
Not to be used in preparations for children under three years of age, except for shampoos
Conditions of use and
warnings which must be printed on the label e
- Not to be used for
children under three years of age (2)
Prohibited in aerosol dispensers(sprays)
ASEAN Cosmetic Documents155
Annex VI Part 1 List of preservatives allowed for use in cosmetic products
Reference Number
Substance
Maximum authorized concentration
Limitations and requirements
Biphenyl-2-ol (o-phenylphenol) and its salts
(3)
0.2% expressed as phenol
Zinc pyrithione (+)
Inorganic sulphites and hydrogensulphites(+) (4) 0.2% expressed as free SO2
10
Entry moved or deleted
11
Chlorobutanol (INN)
0.5%
12
4-Hydroxybenzoic acid and its Methyl- and
Ethyl- esters, and their salts (INCI) 4-Hydroxybenzoic acid; CAS No. 99-96-7; Methylparaben; CAS No. 99-76-3; potassium ethylparaben; CAS No. 36457-19-9; potassium paraben; CAS No. 16782-08-4 sodium methylparaben; CAS No. 5026-62-0; sodium ethylparaben; CAS No. 35285-68-8; ethylparaben; CAS No. 120-47-8; sodium paraben; CAS No. 114-63-6; potassium methylparaben; CAS No. 26112-072; calcium paraben; CAS No. 69959-44-0;
0.4% (as acid) for single
ester 0.8% (as acid) for mixtures of esters
Revised January 2015
(CAS No 13463-41-7)
Conditions of use and
warnings which must be printed on the label e
Hair products; 1.0 %
Other products; 0.5%
Rinse off products only.
Not for use in products for oral hygiene
Prohibited in aerosol dispensers (sprays)
- Contains chlorobutanol
ASEAN Cosmetic Documents156
Annex VI Part 1 List of preservatives allowed for use in cosmetic products
Reference Number
Substance
Maximum authorized concentration
Limitations and requirements
12a
Butyl 4-hydroxybenzoate and its salts Propyl 4hydroxybenzoate and its salts Butylparaben; CAS No. 94-26-8; Propylparaben; CAS No. 94-13-3 sodium propylparaben; CAS No. 35285-69-9 sodium butylparaben; CAS No. 36457-20-2 ; potassium butylparaben; CAS No. 38566-94-8; potassium propylparaben; CAS No. 84930-165;
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.
13
3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydroacetic 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'-hexamethylenedioxydi0.1% benzamidine (Dibromohexamidine) and its salts ( including isethionate)
16
Thiomersal (INN)
0.007% (of Hg)
For eye make-up and eye If mixed with other mercurial make-up remover only compunds authorized by this Directive, the maximum concentration of Hg remains fixed at 0.007%
- Contains thiomersal
17
Phenylmercuric salts (including borate)
0.007% (of Hg)
For eye make-up and eye If mixed with other mercurial make-up remover only compunds authorized by this Directive, the maximum concentration of Hg remains fixed at 0.007%
- Contains phenylmercuric compounds
Revised January 2015
Conditions of use and
warnings which must be printed on the label e For leave-on products designed for children under three years of age: Do not use on the nappy area
ASEAN Cosmetic Documents157
Annex VI Part 1 List of preservatives allowed for use in cosmetic products
Reference Number
Substance
Maximum authorized concentration
Limitations and requirements
18
Undec-10-enoic acid and its salts (+)
0.2% (acid)
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) (+)(5)
0.2%
Purity criteria: 3,3,4,4Tetrachloroazobenzene <1
ppm; 3,3,4,4-Tetrachloroazoxybenzene < 1 ppm
24
4-Chloro-m-cresol
0.2%
Prohibited in products intended to come into contact with mucous membranes
Revised January 2015
Conditions of use and
warnings which must be printed on the label e
ASEAN Cosmetic Documents158
Annex VI Part 1 List of preservatives allowed for use in cosmetic products
Reference Number
Substance
Maximum authorized concentration
Limitations and requirements
25
5-Chloro-2- (2,4- dichlorophenoxy) phenol
(INCI) Triclosan (INN) (+) CAS No. 3380-34-5
(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
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 (a) Rinse-off products (b) Leave on products other than for oral care use.
0.1% calculated as Benzalkonium chloride 0.15%
Conditions of use and
warnings which must be printed on the label e
- Avoid contact with the
eyes Only for products to be removed by rinsing
ASEAN Cosmetic Documents162
Annex VI Part 1 List of preservatives allowed for use in cosmetic products
hygiene and lip care products (a) Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoos. (b) Not to be used in body lotion and body cream (*) Not to be used in preparations for children under three years of age.
56
Iodopropynyl butylcarbamate (IPBC);
3-Iodo-2-propynylbutylcarbamate CAS No: 55406-53-6
57
2-Methyl-2H-isothiazol- 3-one (INCI)
Methylisothiazolinone(14) CAS No.2682-20-4
58
Ethyl Lauroyl Arginate HCl (INCI) (+)(6)Ethyl-
-dodecanoyl- L-arginate hydrochloride CAS No 60372-77-2 EC No 434-630-6
Revised January 2015
(a) (b)
Conditions of use and
warnings which must be printed on the label e (a) Not to be used for children under three years of age (**) (b) Not to be used for children under three years of age (***)
0.01 %
0.4%
Not to be used in lip products,
oral products and spray products.
ASEAN Cosmetic Documents163
Annex VI Part 1 List of preservatives allowed for use in cosmetic products
Reference Number a 59
Substance
b 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-,silver(1+) salt, monohydrate (INCI) Citric acid (and) Silver citrate EC No. 460-890-5
Maximum authorized concentration c 0,2 %, corresponding to 0,0024 % of silver
Limitations and requirements d Not to be used in oral products and eye products
Conditions of use and
warnings which must be printed on the label e
(1)For non-preservative usage see Annex III. Part 1, entry98
(2)Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin (3)For non-preservative usage see Annex III. Part 1, entry 101 (4)For non-preservative usage see Annex III. Part 1, entry 99 (5)For non-preservative usage see Annex III. Part 1, entry 100 (6)For non-preservative usage see Annex III. Part 1, entry207 (7)For non-preservative usage see Annex III. Part 1, entry13 (8)For non-preservative usage see Annex III. Part 1, entry 45 (9)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. (10) For non-preservative usage see Annex III. Part 1, entry54 (11) For use other than as a preservative, see Annex III, No 287 (12) For use other than as a preservative, see Annex III, No 286. (13)For non-preservative usage see Annex III. Part 1, entry 65 (14)Methylisothiazolinone is also regulated in entry 39 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 (*) Concerns any products aimed to be applied on a large part of the body (**) Solely for products, other than bath products/shower gels and shampoo, whichmight be used for children under three years of age. (***)Solely for products which might be used for children under three years of age
