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%.

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

ANNEX VI – PART 1

LIST OF PRESERVATIVES ALLOWED

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
1 Benzoic acid (CAS No. 65-85-0), and its Rinse off products, except
sodium salt (CAS No 532-32-1) 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 0.5 % (acid)
under reference number 1 and esters of
benzoic acid
2 Propionic acid and its salts 2% (acid)
3 Salicylic acid and its salts (+)(1) 0.5% (acid) Not to be used in - Not to be used for
preparations for children children under three
under three years of age, years of age (2)
except for shampoos
4 Sorbic acid (hexa-2,4-dienoic acid) and its salts 0.6% (acid)

5 Formaldehyde and paraformaldehyde(+) (7) 0.2% (except for products Prohibited in aerosol
for oral hygiene) dispensers (sprays)
0.1% (for oral hygiene)
expressed as free
formaldehyde
6 Entry moved or deleted

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
7 Biphenyl-2-ol (o-phenylphenol) and its salts 0.2% expressed as phenol
8 Zinc pyrithione (+)(3) (CAS No 13463-41-7) Hair products; 1.0 % Rinse off products only.
Other products; 0.5% Not for use in products for
oral hygiene
9 Inorganic sulphites and hydrogensulphites(+) (4) 0.2% expressed as free SO2
10 Entry moved or deleted
11 Chlorobutanol (INN) 0.5% Prohibited in aerosol - Contains chlorobutanol
dispensers (sprays)
12 4-Hydroxybenzoic acid and its Methyl- and 0.4% )as acid) for single
Ethyl- esters, and their salts (INCI) ester
4-Hydroxybenzoic acid; CAS No. 99-96-7; 0.8% )as acid) for mixtures
Methylparaben; CAS No. 99-76-3; of esters
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. 26112-07-
2;
calcium paraben; CAS No. 69959-44-0;

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
12a Butyl 4-hydroxybenzoate and its salts Propyl 4- 0,14 % (as acid) for the sum Not to be used in leave-on For leave-on products
hydroxybenzoate and its salts of the individual products designed for designed for children under
Butylparaben; CAS No. 94-26-8; concentrations 0,8 % (as application on the nappy three years of age: “Do not
Propylparaben; CAS No. 94-13-3 acid) for mixtures of area of children under three use on the nappy area”’
substances mentioned in years of age.
sodium propylparaben; CAS No. 35285-69-9
entry 12 and 12a, where the
sodium butylparaben; CAS No. 36457-20-2 ;
sum of the individual
potassium butylparaben; CAS No. 38566-94-8; concentrations of butyl- and
potassium propylparaben; CAS No. 84930-16- propylparaben and their
5; salts does not exceed
0,14 %
13 3-Acetyl-6-methylpyran-2,4 (3H)-dione 0.6% (acid) Prohibited in aerosol
(Dehydroacetic acid) and its salts dispensers (sprays)
14 Formic acid and its sodium salt 0.5% (expressed as acid)
15 3,3'-Dibromo-4,4'-hexamethylenedioxydi- 0.1%
benzamidine (Dibromohexamidine) and its salts
( including isethionate)
16 Thiomersal (INN) 0.007% (of Hg) For eye make-up and eye - Contains thiomersal
If mixed with other mercurial make-up remover only
compunds authorized by this
Directive, the maximum
concentration of Hg remains
fixed at 0.007%
17 Phenylmercuric salts (including borate) 0.007% (of Hg) For eye make-up and eye - Contains phenylmercuric
If mixed with other mercurial make-up remover only compounds
compunds authorized by this
Directive, the maximum
concentration of Hg remains
fixed at 0.007%

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
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’,4,4’-

Tetrachloroazobenzene < 1
ppm; 3,3’,4,4’-Tetra-
chloroazoxybenzene < 1
ppm
24 4-Chloro-m-cresol 0.2% Prohibited in products
intended to come into
contact with mucous
membranes

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
25 5-Chloro-2- (2,4- dichlorophenoxy) phenol (a) Toothpastes Hand (a) 0,3 %
(INCI) soaps Body
Triclosan (INN) soaps/Shower gels
Deodorants (non-spray)
CAS No. 3380-34-5
Face powders and
blemish concealers Nail
products for cleaning
the fingernails and
toenails before the
application of artificial
nail systems
(b) Mouthwashes (b) 0,2 %’
26 4-Chloro-3,5-xylenol 0.5%
27 3,3’-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin- 0.6%
4-yl)-1,1’-methylenediurea (“Imidazolidinyl
urea”)
28 Poly(1-hexamethylenebiguanide hydrochloride) 0.3%
29 2-Phenoxyethanol 1.0%
30 Hexamethylenetetramine (methenamine) (INN) 0.15%
31 Methenamine 3-chloroallylochloride (INNM) 0.2%
32 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3- 0.5%
dimethylbutan-2-one) (+)

33 1,3-Bis(hydroxymethyl)-5,5- 0.6%
dimethylimidazolidine-2,4-dione)
34 Benzyl alcohol(+) (8) 1%
35 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2 1% Rinse-off products
pyridon and its monoethanolamine salt (+) 0.5% For other products

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
36 Entry deleted
37 6,6-Dibromo-4,4-dichloro-2,2’-methylene- 0.1%
diphenol (Bromochlorophen)
38 4-Isopropyl-m-cresol 0.1%

39 Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)- 0,0015 % (of a mixture in Rinse-off products

one and 2-Methylisothiazol-3(2H)-one (INCI) the ratio 3:1 of 5-chloro- 2-
methylisothiazol 3(2H)-one
and 2-methylisothiazol-3
Methylchloroisothiazolinone (and)
(2H)-one)’
Methylisothiazolinone(9)
CAS No. 26172-55-4, 2682-20-4, 55965-84-9

40 2-Benzyl-4-chlorophenol (chlorophene) 0.2%

41 2-Chloroacetamide 0.3% - Contains
chloroacetamide
42 Chlorhexidine (INN) and its digluconate, 0.3% expressed as
diacetate and dihydrochloride (+) chlorhexidine
43 1-Phenoxypropan-2-ol(+) (10) 1.0% Only for rinse-off products

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
44 Alkyl (C12-22) trimethyl ammonium bromide and 0.1%
chloride) (+)
Behentrimonium chloride (11), CAS No. 17301-
53-0,
cetrimonium bromide, CAS No. 57-09-0,
cetrimonium chloride (12), CAS No. 112-02-7,
laurtrimonium bromide, CAS No. 1119-94-4,
laurtrimonium chloride, CAS No. 112-00-5,
steartrimonium bromide, CAS No. 1120-02-1,
steartrimonium chloride (12) CAS No. 112-03-8,
45 4,4-Dimethyl-1,3-oxazolidine 0.1% The pH of the finished
product must not be lower
than 6
46 N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3- 0.5%
dioxo-2,5-imidazolinidyl-4)-N'-(hydroxymethyl)
urea)
47 1,6-Di(4-amidinophenoxy)-n-hexane 0.1%
(Hexamidine) and its salts (including
isethionate and p-hydroxybenzoate (+)
48 Glutaraldehyde (Pentane-1,5-dial) 0.1% Prohibited in aerosols - Contains glutaraldehyde
(sprays) (where glutaraldehyde
concentration in the
finished product exceeds
0.05%)
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

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
50 3-(p-Chlorophenoxy)-propane-1,2-diol 0.3%
(chlorphenesin)
51 Sodium hydroxymethylamino acetate (Sodium 0.5%
hydroxymethylglycinate
52 Silver chloride deposited on titanium dioxide 0.004% calculated as AgCl 20% AgCl (w/w) on TiO2
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 0.1% calculated as - Avoid contact with the
saccharinate(+) (13) Benzalkonium chloride eyes
55 Benzylhemiformal 0.15% Only for products to be
removed by rinsing

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
56 Iodopropynyl butylcarbamate (IPBC); (a) rinse-off Not to be used in oral (a) Not to be used for
3-Iodo-2-propynylbutylcarbamate CAS No: products: 0.02 % hygiene and lip care children under three
55406-53-6 (b) leave-on products years of age (**)
products: 0.01 % (a) Not to be used in (b) Not to be used for
except in preparations for children children under three
deodorants & under three years of age, years of age (***)
antiperspirants: except in bath
0.0075 % 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.

57 2-Methyl-2H-isothiazol- 3-one (INCI) 0.01 %’

Methylisothiazolinone(14)
CAS No.2682-20-4

58 Ethyl Lauroyl Arginate HCl (INCI) (+) (6) Ethyl-Ν 0.4% Not to be used in lip products,
α -dodecanoyl- L-arginate hydrochloride CAS oral products and spray
No 60372-77-2 products.

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 Annex VI – Part 1 – List of preservatives allowed for use in cosmetic products

Reference Substance Maximum authorized Limitations and Conditions of use and

Number concentration requirements warnings which must be
printed on the label
a b c d e
59 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, 0,2 %, corresponding to Not to be used in
monohydrate and 1,2,3-Propanetricarboxylic 0,0024 % of silver oral products and
acid, 2-hydroxy-,silver(1+) salt, monohydrate eye products”
(INCI)
Citric acid (and) Silver citrate

(1) For non-preservative usage see Annex III. Part 1, entry 98

(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, entry 207
(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, entry 54
(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, which might be used for children under three years of age.
(***) Solely for products which might be used for children under three years of age

Revised as per August 2015 ASEAN Cosmetic Documents 164