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Featureinternational regulationsLatest NewsRegulations26/10/2022Japan Standards for Cosmetics

It is of great significance to stay abreast of cosmetic regulations and updates before entering markets in different countries.  ZMUni has sorted out important regulations from major markets. This article is Japan Standards for Cosmetics.

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.

 

  1. 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 a property similar to these substances, or any of the materials listed in Appendix 1.

 

  1. Limitation on the 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 incorporated in a cosmetic, the amount of such ingredient contained shall be under the values in the column of the maximum amount of ingredient per 100 g of the said Appendix.

 

  1. Limitation on the inclusion of preservatives, UV absorbers, and tarcolors

Any and all preservatives (meaning materials incorporated in cosmetics for the purpose of inhibiting the 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.

 

Appendix 1

  1. 6-Acetoxy-2,4-dimethyl-m-dioxane
  2. Antihistamines except those of aminoether type (such asdiphenhydramine)
  3. Hormones and those derivatives except estradiol, estrone andethinylestradiol
  4. Vinyl chloridemonomer
  5. Methylenechloride
  6. Bismuth compounds other than bismuthoxychloride
  7. Hydrogenperoxide
  8. Cadmiumcompounds
  9. Sodiumperborate
  10. Chloroform
  11. Progrenoloneacetate
  12. Dichlorophene
  13. Mercury and itscompounds
  14. Strontiumcompounds
  15. Sulfamide and itsderivatives
  16. Seleniumcompounds
  17. Nitrofuran type compounds
  18. Hydroquinonemonobenzylether
  19. Halogenatedsalicylanilide
  20. Vitamin L1 and VitaminL2
  21. Bithionol
  22. Pilocalpine
  23. Pyrogallol
  24. Inorganic fluorinecompounds
  25. Pregnanediol
  26. Local anesthetics such asprocaine
  27. Hexachlorophen
  28. Boric acid
  29. Formalin
  30. Methylalcohol

 

Appendix 2

  1. The ingredients restricted in all types of cosmetics
Ingredient name Maximum amount of ingredient per 100 g
Aluminum chlorhydroxy allantoinate Cantharides tincture, ginger tincture or capsicum tincture

Phenyl salicylate

Polyoxyethylene laurylether (8-10E.O.)

1.0 g

1.0 g as total

1.0 g

2.0 g

 

  1. The ingredients restricted according to types or intended purposes of cosmetics
Ingredient name Maximum amount of ingredient per 100 g
Aerosol agents

Zirconium

Prohibited
Cosmetics to be washed away immediately after use such as soap or shampoo

Thiram

 

0.50 g

Cosmetics other than those washed away immediately after use such as soap or shampoo

Undecylenic acid monoethanolamide Thiram

Zinc p-phenolsulfonate

2-(2-Hydroxy-5-methylphenyl) benzotriazole Sodium lauroyl sarcosinate

 

 

Prohibited 0.30g

2.0 g

7.0 g Prohibited

Cosmetics used in cephalic, mucosa part or the oral cavity, and cosmetics used in other parts, containing lower aliphatic monoalcohols (exclude those containing the said alcohols added to dissolve ingredients in the said cosmetics)

Estradiol, estrone and ethinylestradiol

 

 

20000 IU as total

Cosmetics other than those used in cephalic, mucosa part or the oral cavity, containing no lower aliphatic monoalcohols (include those containing the said alcohols added to dissolve ingredients in the said cosmetics )

Estradiol, estrone and ethinylestradiol

 

 

50000 IU as total

Cosmetics used in only cephalic part

Aminoether type antihistamines

0.010 g
Cosmetics other than those used only in cephalic part

Aminoether type antihistamines

 

Prohibited

Toothpaste

Diethylene glycol

Sodium lauroyl sarcosinate

Prohibited

0.50 g

Compounds to be used with the purpose of emulsifying beewax or white beewax

Sodium pyroborate

0.76 g ( limited not to greater than 1/2 amount of beewax and white beewax)
Compounds to be used for purposes other than emulsifying beewax or white beewax Prohibited

 

Sodium pyroborate

 

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

 

Ingredient name

 

Maximum amount (g) of ingredient per 100 g

Cosmetics not used for mucosa and to be

washed away

Cosmetics not used for mucosa and not to

be washed away

Cosmetics that may be used for mucosa
Jujube Extract (*2) 5.0
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 was extracted from ” Jujube” defined in Japanese pharmacopoeia with 30% (w/v) ethanol water solution.

 

Appendix 3

  1. The ingredients restricted in all types of cosmetics
Ingredient name Maximum amount (g) of

ingredient per 100 g

Benzoic acid 0.2
Benzoate 1.0 as total
Alkyldiaminoethylglycine hydrochloride 0.20
Photosensitizing dyes 0.0020 as total
Chlorcresol 0.50
Chlorobutanol 0.10
Salicylic acid 0.20
Salicylate 1.0 as total
Sorbic acid and sorbate 0.50 as total
Dehydroacetic acid and dehydroacetate 0.50 as total
Trichlorohydroxydiphenylether (Triclosan) 0.10
p-Oxybenzoic acid esters and their sodium salts 1.0 as total
Phenoxyethanol 1.0
Phenol 0.10
Sodium lauryldiaminoethylglycine 0.030
Resorcin 0.10

 

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

 

 

Ingredient name

Maximum amount (g) of ingredient

per 100g

Cosmetics not used for mucosa and to be washed

away

Cosmetics not used for mucosa and not to be washed

away

 

Cosmetics that may be used for mucosa

Zinc, ammonia, and silver substituted zeolite(*4) 1.0 1.0
Pantothenyl ethylether benzoate 0.30 0.30
Isopropylmethylphenol 0.10 0.10
Cetylpyridinium chloride 5.0 1.0 0.010
Benzalkonium chloride 0.050 0.050
Benzethonium chloride 0.50 0.20
Chlorhexidine hydrochloride 0.10 0.10 0.0010
o-Phenyl phenol 0.30 0.30
Sodium o-phenylphenate 0.15 0.15
Silver-Copper Zeolite(*5) 0.5 0.5
Chlorhexidine gluconate 0.050 0.050
Cresol 0.010 0.010
Chloramine T 0.30 0.10
Chlorxylenol 0.30 0.20 0.20
Chlorphenesin 0.30 0.30
Chlorhexidine 0.10 0.050 0.050
1,3-Dimethylol-5, 5-dimethylhydantoin 0.30
Alkylisoquinolinium bromide 0.050 0.050
Thianthol 0.80 0.80
Thymol 0.050 0.050 ○ (*2)
Trichlorocarbanilide 0.30 0.30
p-Chlorphenol 0.25 0.25
Halocarban 0.30 0.30
Hinokitiol 0.10 0.050
Zinc pyrithione 0.10 0.010 0.010
Piroctone olamine 0.05 0.05
Iodopropynyl butylcarbamate(*6) 0.02 0.02 0.02
Polyaminopropyl biguanide 0.1 0.1 0.1
Methyl isothiazolinone 0.01 0.01
Methylchloro isothiazolinone and methyl isothiazolinone solution(*3) 0.10
N,N”-Methylenebis[N’-(3-hydroxymethyl-2,5-dioxo-4-imidazolidinyl)urea] 0.30
p-Dimethylaminostyryl heptyl methyl thiazolium iodide 0.0015 0.0015

 

(*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 can be contained in cosmetics used for mucosa and only for the oral cavity.

(*3) It indicates the aqueous solution containing 1.0 – 1.3% of 5-chloro-2-methyl-4- isothiazolin-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.

(*6)It is prohibited to be contained in aerosol agents.

 

Appendix 4

  1. The ingredients restricted in all types of cosmetics
Ingredient name Maximum amount (g) of

ingredient per 100g

Homomenthyl salicylate 10
2-Cyano-3,3-diphenyl prop-2-enoic acid 2-ethylhexyl ester (octocrylene) 10
Glyceryl mono-2-ethylhexanoate di-p-methoxycinnamate 10
Tris-Biphenyl Triazine 10.0
p-Aminobenzoic acid and its esters 4.0 as total
4-tert-Butyl-4’-methoxy dibenzoylmethane 10

 

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

 

 

 

Ingredient name

Maximum amount (g) of

ingredient per 100g

Cosmetics not used for  mucosa and to be washed away Cosmetics not used for  mucosa and not to be   washed

away

 

Cosmetics that may be used for  mucosa

4- (2-b-glucopyranosiloxy) propoxy-2-hydroxybenzophenone 5.0 5.0
Octyl salicylate 10 10 5.0
Methyl-2, 5-diisopropylcinnamate 10 10
2-[4-(diethylamino)-2-hydroxybenzyl] benzoic acid hexylester 10.0 10.0
Cinoxate 5.0 5.0
Dihydroxydimethoxybenzophenone 10 10
Sodium dihydroxydimethoxybenzophenone disulfonate 10 10
Dihydroxybenzophenone 10 10
Dimethicodiethyl-benzal malonate 10.0 10.0 10.0
1- (3, 4-dimethoxyphenyl)-4, 4-dimethyl-1, 3-pentanedione 7.0 7.0
Dimethoxybenzylidenedioxo-imidazolidine 2-ethylhexyl propionate 3.0 3.0
Tetrahydroxybenzophenone 10 10 0.050
Terephthalylidene dicamphor sulfonic acid 10 10
2,4,6-Tris [4-(2-ethylhexyloxycarbonyl) anilino] -1,3,5-triazine 5.0 5.0
Methylbis(trimethylsiloxy)silyl isopentyl trimethoxycinnamonate 7.5 7.5 2.5
Drometrizole trisiloxane 15.0 15.0
Amyl p-dimethylaminobenzoate 10 10
2-Ethylhexyl p-dimethylaminobenzoate 10 10 7.0
Isopropyl p-methoxycinnamate and diisopropyl cinnamate ester mixture(*2) 10 10
2-Ethylhexyl p-methoxycinnamate 20 20 8.0
2,4-Bis-[{4-(2-ethylhexyloxy)-2-hydroxy}-phenyl]-6-(4-methoxyphenyl)-

1,3,5-triazine

3.0 3.0
2-Hydroxy-4-methoxybenzophenone 5.0 5.0
Hydroxymethoxybenzophenone sulfonate and its trihydrate 10(*3) 10(*3) 0.10(*3)
Sodium hydroxymethoxybenzophenone sulfonate 10 10 1.0
Phenylbenzimidazole sulfonic acid 3.0 3.0
Ferulic acid 10 10
2,2’-methylenebis(6-(2H-benzotriazole-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol 10.0 10.0
2-Methylphenyl 4-methoxycinnamate 10.0 10.0

(*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 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.

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