Cosmetics PDF

Original: Japanese
Provisional Translation
Standards for Cosmetics
(Ministry of Health and Welfare Notification No.331 of 2000)
In accordance with the provisions of Article 42, Paragraph 2 of the Pharmaceutical Affairs
Law (Law No.145 of 1960), the Standards for Cosmetics are hereby established as follows
and shall be applied from April 1, 2001, and the Quality Standards for Cosmetics (Ministry of
Health and Welfare Notification No.321 of August 1967) and the Japanese Standards for
Cosmetic Ingredients (Ministry of Health and Welfare Notification No.322 of August 1967)
shall be abolished on March 31, 2001; provided, however, that any medical drug ingredients
which are also cosmetic ingredients that have actually been approved pursuant to Article 14,
Paragraph 1 of the said law at the time of application of this notification or which are also
cosmetic ingredients listed in the Appendix of the Ministry of Health and Welfare Notification
No.15 of February 1961 (Re: Designation of Cosmetic Ingredients that must be Approved for
Each Item in Accordance with the Provisions of Article 14, Paragraph 1 of the Pharmaceutical
Affairs Law) may, regardless of the provisions of section 2 below, be used as cosmetic
ingredients only if used in the amount for which the cosmetic ingredient was approved or the
amount of the cosmetic ingredient as listed in the said Appendix, as the case may be; and
provided further, that any cosmetics manufactured or imported on or before March 31, 2001,
shall be treated as though this notification were not established.
Standards for Cosmetics
1.
General provisions
Ingredients of cosmetics, including any impurities contained therein, shall not contain
anything that may cause infection or that otherwise makes the use of the cosmetics a
potential health hazard.
2.
Prohibition of inclusion of ingredients other than preservatives, UV absorbers and tar

colors
Cosmetics shall not contain any medical drug ingredients (excluding those used only as
additives and those listed in Appendix 2-1 through 4), or any ingredients that do not
meet the Standards for Biological Materials (Ministry of Health, Labour and Welfare
Notification No.210 of 2003), Class I Specified Chemical Substances provided in the
Law Concerning the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. Article 2, Paragraph 2 (Law No.117 of 1973), or Class II Specified
Substances provided in the same law Article 2, paragraph 3 or the materials that are
determined by the Minister of Health, Labour and Welfare and have property similar to
these substances, or any of the materials listed in Appendix 1.
3.
Limitation on inclusion of ingredients other than preservatives, UV absorbers and tar

colors
If any of the materials listed in the section of ingredient names of Appendix 2 is
1
incorporated in a cosmetic, the amount of such ingredient contained shall be under the
values in the column of maximum amount of ingredient per 100 g of the said Appendix.
4.
Limitation on inclusion of preservatives, UV absorbers and tar colors

Any and all preservatives (meaning materials incorporated in cosmetics for the purpose
of inhibiting growth of microorganisms in such cosmetics) incorporated in cosmetics
shall be among those listed in Appendix 3.
Any and all UV absorbers (meaning materials that specifically absorb ultraviolet rays
and that are incorporated in cosmetics for the purpose of protecting skin or hair from
adverse effects of ultraviolet rays) incorporated in cosmetics shall be among those listed
in Appendix 4.
The provisions of Article 3 of the Ministerial Ordinance for the Designation of Tar
Colors That May Be Used in Medical Drugs, Etc. (Ministry of Health and Welfare
Ordinance No.30 of 1966) shall be applied mutatis mutandis to tar colors incorporated
in cosmetics; provided, however, that Red No.219 and Yellow No.204 may be
incorporated only in cosmetics applied to hair and nails.
5.
Glycerin mixed with cosmetics should contain diethylene glycol less than 0.1g per 100g
glycerin.
Appendix 1
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
6-Acetoxy-2,4-dimethyl-m-dioxane
Antihistamines except those of aminoether type (such as diphenhydramine)
Hormones and those derivatives except estradiol, estrone and ethinylestradiol
Vinyl chloride monomer
Methylene chloride
Bismuth compounds other than bismuth oxychloride
Hydrogen peroxide
Cadmium compounds
Sodium perborate
Chloroform
Progrenolone acetate
Dichlorophene
Mercury and its compounds
Strontium compounds
Sulfamide and its derivatives
Selenium compounds
Nitrofuran type compounds
Hydroquinone monobenzylether
Halogenated salicylanilide
Vitamin L1 and Vitamin L2
Bithionol
Pilocalpine
Pyrogallol
Inorganic fluorine compounds
Pregnanediol
Local anesthetics such as procaine
Hexachlorophen
Boric acid
Formalin
Methyl alcohol
Appendix 2
1.
The ingredients restricted in all types of cosmetics

Ingredient name
Maximum amount of ingredient per 100 g
Aluminum chlorhydroxy allantoinate
1.0 g
Cantharides tincture, ginger tincture or capsicum
1.0 g as total
tincture
Phenyl salicylate
1.0 g
Polyoxyethylene laurylether (8-10E.O.)
2.0 g
2.
The ingredients restricted according to types or intended purposes of cosmetics

Ingredient name
Maximum amount of ingredient per 100 g
Aerosol agents
Prohibited
Zirconium
Cosmetics to be washed away immediately after
0.50 g
use such as soap or shampoo
Thiram
Cosmetics other than those washed away
immediately after use such as soap or shampoo
Undecylenic acid monoethanolamide
Prohibited
Thiram
0.30g
Zinc p-phenolsulfonate
2.0 g
2-(2-Hydroxy-5-methylphenyl) benzotriazole
7.0 g
Sodium lauroyl sarcosinate
Prohibited
Cosmetics used in cephalic, mucosa part or the
oral cavity, and cosmetics used in other parts,
containing lower aliphatic monoalcohols
20000 IU as total
(exclude those containing the said alcohols
added to dissolve ingredients in the said
cosmetics)
Estradiol, estrone and ethinylestradiol
Cosmetics other than those used in cephalic,
mucosa part or the oral cavity, containing no
lower aliphatic monoalcohols (include those
50000 IU as total
containing the said alcohols added to dissolve
ingredients in the said cosmetics )
Estradiol, estrone and ethinylestradiol
Cosmetics used in only cephalic part
0.010 g
Aminoether type antihistamines
Cosmetics other than those used only in cephalic
Prohibited
part
Aminoether type antihistamines
Toothpaste
Diethylene glycol
Prohibited
Sodium lauroyl sarcosinate
0.50 g
Compounds to be used with the purpose of
0.76 g ( limited not to greater than 1/2
emulsifying beewax or white beewax
amount of beewax and white beewax)
Sodium pyroborate
Compounds to be used for purposes other than
Prohibited
emulsifying beewax or white beewax
4
Sodium pyroborate
3.
The ingredients restricted according to types of cosmetics (*1)
Maximum amount (g) of ingredient per 100 g

Ingredient name
Cosmetics not used

Cosmetics not used
Cosmetics that may
for mucosa and to be for mucosa and not to
be used for mucosa
washed away
be washed away
5.0
Jujube Extract(*2)
Thioctic acid
0.01
0.01
Ubidecarenone
0.03
0.03
(*1) Blank indicates that it is prohibited to be used, and indicates that there is no upper
limit for the amount of ingredient.
*
( 2) It extracted from " Jujube" defined in Japanese pharmacopoeia with 30% (w/v) ethanol
water solution.
Appendix 3
1.

Ingredient name
Benzoic acid
Benzoate
Alkyldiaminoethylglycine hydrochloride
Photosensitizing dyes
Chlorcresol
Chlorobutanol
Salicylic acid
Salicylate
Sorbic acid and sorbate
Dehydroacetic acid and dehydroacetate
Trichlorohydroxydiphenylether (Triclosan)
p-Oxybenzoic acid esters and their sodium salts
Phenoxyethanol
Phenol
Sodium lauryldiaminoethylglycine
Resorcin
Maximum amount (g) of

ingredient per 100 g
0.2
1.0 as total
0.20
0.0020 as total
0.50
0.10
0.20
1.0 as total
0.50 as total
0.50 as total
0.10
1.0 as total
1.0
0.10
0.030
0.10
2.
Ingredient name
Zinc, ammonia and silver substituted zeolite(*4)

Pantothenyl ethylether benzoate
Isopropylmethylphenol
Cetylpyridinium chloride
Benzalkonium chloride
Benzethonium chloride
Chlorhexidine hydrochloride
o-Phenyl phenol
Sodium o-phenylphenate
Silver-Copper Zeolite(*5)
Chlorhexidine gluconate
Cresol
Chloramine T
Chlorxylenol
Chlorphenesin
Chlorhexidine
1,3-Dimethylol-5, 5-dimethylhydantoin
Alkylisoquinolinium bromide
Thianthol
Thymol
Trichlorocarbanilide
p-Chlorphenol
Halocarban
Hinokitiol
Zinc pyrithione
Piroctone olamine
Iodopropynyl butylcarbamate(*6)
Polyaminopropyl biguanide
Methyl isothiazolinone
Methylchloro isothiazolinone and methyl isothiazolinone solution(*3)
N,N-Methylenebis[N-(3-hydroxymethyl-2,5-dioxo-4-imidazolidinyl)urea]
p-Dimethylaminostyryl heptyl methyl thiazolium iodide
Maximum amount (g) of ingredient

per 100g
Cosmetics Cosmetics
not used for not used for Cosmetics
mucosa and mucosa and that may be
used for
to be
not to be
mucosa
washed
washed
away
away
1.0
1.0
0.30
0.30
0.10
0.10
5.0
1.0
0.010
0.050
0.050
0.50
0.20
0.10
0.10
0.0010
0.30
0.30
0.15
0.15
0.5
0.5
0.050
0.050
0.010
0.010
0.30
0.10
0.30
0.20
0.20
0.30
0.30
0.10
0.050
0.050
0.30
0.050
0.050
0.80
0.80
0.050
0.050
(*2)
0.30
0.30
0.25
0.25
0.30
0.30
0.10
0.050
0.10
0.010
0.010
0.05
0.05
0.02
0.02
0.02
0.1
0.1
0.1
0.01
0.01
0.10
0.30
0.0015
0.0015
(*2) It can be contained in cosmetics used for mucosa and only for oral cavity.
(*3) It indicates the aqueous solution containing 1.0 - 1.3% of 5-chloro-2-methyl-4isothiazolin-3-one and 0.30 - 0.42% of 2-methyl-4-isothiazolin-3-one.
(*4) It indicates the compound containing 0.2 - 4.0% as silver and 5.0 - 15.0% as zinc when
it is exposed to strong heat.
(*5) It indicates the compound containing 2.7 - 3.7% as silver and 4.9 - 6.3% as copper when
it is exposed to strong heat.
(*6It is prohibited to be contained in aerosol agents.
6
Appendix 4
1.

Ingredient name
Homomenthyl salicylate
2-Cyano-3,3-diphenyl prop-2-enoic acid 2-ethylhexyl ester (octocrylene)
Glyceryl mono-2-ethylhexanoate di-p-methoxycinnamate
p-Aminobenzoic acid and its esters
4-tert-Butyl-4-methoxy dibenzoylmethane

ingredient per 100g
10
10
10
4.0 as total
10
2.

ingredient per 100g
Cosmetics
Cosmetics
not used
not used
Cosmetics
for
that may
for
mucosa
be used
mucosa
and not to
for
and to be
be
mucosa
washed
washed
away
away
5.0
5.0
10
10
5.0
10
10
10.0
10.0
5.0
5.0
10
10
10
10
10
10
10.0
10.0
10.0
7.0
7.0
3.0
3.0
10
10
0.050
10
10
5.0
5.0
7.5
7.5
2.5
15.0
15.0
10
10
10
10
7.0
10
10
20
20
8.0
Ingredient name
4- (2--glucopyranosiloxy) propoxy-2-hydroxybenzophenone
Octyl salicylate
Methyl-2, 5-diisopropylcinnamate
2-[4-(diethylamino)-2-hydroxybenzyl] benzoic acid hexylester
Cinoxate
Dihydroxydimethoxybenzophenone
Sodium dihydroxydimethoxybenzophenone disulfonate
Dihydroxybenzophenone
Dimethicodiethyl-benzal malonate
1- (3, 4-dimethoxyphenyl)-4, 4-dimethyl-1, 3-pentanedione
Dimethoxybenzylidenedioxo-imidazolidine 2-ethylhexyl propionate
Tetrahydroxybenzophenone
Terephthalylidene dicamphor sulfonic acid
2,4,6-Tris [4-(2-ethylhexyloxycarbonyl) anilino] -1,3,5-triazine
Methylbis(trimethylsiloxy)silyl isopentyl trimethoxycinnamonate
Drometrizole trisiloxane
Amyl p-dimethylaminobenzoate
2-Ethylhexyl p-dimethylaminobenzoate
Isopropyl p-methoxycinnamate and diisopropyl cinnamate ester mixture(*2)
2-Ethylhexyl p-methoxycinnamate
2,4-Bis-[{4-(2-ethylhexyloxy)-2-hydroxy}-phenyl]-6-(4-methoxyphenyl)3.0
1,3,5-triazine
2-Hydroxy-4-methoxybenzophenone
Hydroxymethoxybenzophenone sulfonate and its trihydrate

10(*3)
Sodium hydroxymethoxybenzophenone sulfonate
10
Phenylbenzimidazole sulfonic acid
3.0
Ferulic acid
10
2,2-methylenebis(6-(2H-benzotriazole-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol 10.0
3.0
5.0
10(*3)
10
3.0
10
10.0
5.0
0.10(*3)
1.0
(*2) It indicates the compound containing 72.0 - 79.0% of isopropyl p-methoxycinnamate,
15.0 - 21.0% of ethyl 2,4-diisopropyl cinnamate and 3.0 - 9.0% of methyl
2,4-diisopropyl cinnamate.
(*3) It is calculated as the total amount of hydroxymethoxybenzophenone sulfonate.
Evaluation and Licensing Division

Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare

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Original: Japanese

Prohibition of inclusion of ingredients other than preservatives, UV absorbers and tar

Limitation on inclusion of ingredients other than preservatives, UV absorbers and tar

Limitation on inclusion of preservatives, UV absorbers and tar colors

The ingredients restricted in all types of cosmetics

The ingredients restricted according to types or intended purposes of cosmetics

The ingredients restricted according to types of cosmetics (*1)

Maximum amount (g) of ingredient per 100 g

Cosmetics not used

The ingredients restricted in all types of cosmetics

Maximum amount (g) of

The ingredients restricted according to types of cosmetics (*1)

Zinc, ammonia and silver substituted zeolite(*4)

Maximum amount (g) of ingredient

The ingredients restricted in all types of cosmetics

Maximum amount (g) of

The ingredients restricted according to types of cosmetics (*1)

Hydroxymethoxybenzophenone sulfonate and its trihydrate

Evaluation and Licensing Division

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