Singapore - Health Products (Cosmetic Products — Asean Cosmetic Directive) Regulations – Part IV – Third Schedule – Part IV

PART IV

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 Part 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 this Part.

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 Part and which release formaldehyde must be labelled with the warning “contains formaldehyde” where the concentration of formaldehyde in the finished product exceeds 0.05%.

First column	Second column	Third column	Fourth column	Fifth column
Ref No.	Substance	Maximum authorised concentration	Other limitations and requirements	Warnings and precautions for use to be shown on label of product
1	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 those listed under reference number 1 and esters of benzoic acid	0.5 % (acid)
2	Propionic acid and its salts	2% (acid)
3	Salicylic acid and its salts (+) 1	0.5% (acid) Not to be used in preparations for children under 3 years of age, except for shampoos	Not to be used for children under 3 years of age2
1 For non-preservative usage, see reference no. 98 of Part II.
2 Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.
4	Sorbic acid (hexa-2,4-dienoic acid) and its salts	0.6% (acid)
5	Formaldehyde and paraformaldehyde (+)	0.2% (except for products for oral hygiene)	Prohibited in aerosol dispensers (sprays)
		0.1% (products for oral hygiene) expressed as free formaldehyde
7	Biphenyl-2-ol (o-phenylphenol) and its salts	0.2% expressed as phenol
8	Zinc pyrithione (+)3	Hair products: 1.0 %	Rinse off products only
		Other products: 0.5%	Not for use in products for oral care
3 For non-preservative usage, see reference no. 101 of Part II.
9	Inorganic sulphites and hydrogensulphites (+) 4	0.2% expressed as free SO2
4 For non-preservative usage, see reference no. 99 of Part II.
11	Chlorobutanol (INN)	0.5%	Prohibited in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid its salts and esters	0.4% (acid) for any one ester
		0.8% (acid) for mixtures of esters
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’-hexamethylenedioxydibenzamidine (Dibromohexamidine) and its salts ( including isethionate)	0.1%
16	Thiomersal (INN)	0.007% (of Hg) If mixed with other mercurial compounds authorised by this Directive, the maximum concentration of Hg remains fixed at 0.007%	For eye make-up and eye make-up remover only	Contains thiomersal
17	Phenylmercuric salts (including borate)	Ditto	Ditto	Contains phenylmercuric compounds
18	Undec-10-enoic acid and 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 less than 1 ppm
			— 3,3’,4,4’-Tetrachloroazoxybenzene less than 1 ppm
5 For non-preservative usage, see reference no. 100 Part II.
24	4-Chloro-m-cresol	0.2%	Prohibited in products intended to come into contact with mucous membranes
25	Triclosan (INN) (+)	0.3%
26	4-Chloro-3,5-xylenol	0.5%
27	3,3’-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1’-methylenediurea (’’Imidazolidinyl urea’’)	0.6%
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-dimethylbutan-2-one (+)	0.5%
33	1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione	0.6%
34	Benzyl alcohol (+)	1%
35	1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl)-2-pyridon and its monoethanolamine salt (+)	Rinse-off products: 1%
		For other products: 0.5%
37	6,6-Dibromo-4,4-dichloro-2,2’-methylene-diphenol: Bromochlorophen	0.1%
38	4-Isopropyl-m-cresol	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	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)
40	2-Benzyl-4-chlorophenol (Chlorophene)	0.2%
41	2-Chloroacetamide	0.3%		Contains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+)	0.3% expressed as chlorhexidine
43	1-Phenoxypropan-2-ol (+)	1.0%	Only for rinse-off products
44	Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (+)	0.1%
45	4,4-Dimethyl-1,3- oxazolidine	0.1%	pH of finished product must not be lower than 6
46	N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolinidyl-4)-N’-(hydroxymethyl) urea	0.5%
47	1,6-Di(4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate (+)	0.1%
48	Glutaraldehyde (Pentane-1,5-dial)	0.1%	Prohibited in aerosols	(sprays) Contains glutaraldehyde6
6 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
50	3-(p-Chlorophenoxy)-propane-1,2-diol (chlorphenesin)	0.3%
51	Sodium hydroxymethylamino acetate (Sodium hydroxymethylglycinate)	0.5%
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 saccharinate (+)	0.1% calculated as Benzalkonium chloride		Avoid contact with the eyes
55	Benzylhemiformal	0.15%	Only for products to be removed by rinsing
56	Iodopropynyl butyl-carbamate (IPBC) 3-iodo-2-propynylbutylcarbamate		Not to be used in oral hygiene and lip care products
		(a) rinse-off products 0.02 %	(a) Not to be used in preparations for children under three years of age, except in bath products, shower gels and shampoo	(a) Not to be used for children under three years of age
		(b) leave-on products 0.01 %, except in deodorants and antiperspirants 0.0075 %	(b) Not to be used in body lotion and body cream Not to be used in preparations for children under three years of age	(b) Not to be used for children under three years of age
57	Methylisothiazolinone (INCI)	0.01 %