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 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. |
Appendix 1
| 1. | 6-Acetoxy-2,4-dimethyl-m-dioxane |
| 2. | Antihistamines except those of aminoether type (such as diphenhydramine) |
| 3. | Hormones and those derivatives except estradiol, estrone and ethinylestradiol |
| 4. | Vinyl chloride monomer |
| 5. | Methylene chloride |
| 6. | Bismuth compounds other than bismuth oxychloride |
| 7. | Hydrogen peroxide |
| 8. | Cadmium compounds |
| 9. | Sodium perborate |
| 10. | Chloroform |
| 11. | Progrenolone acetate |
| 12. | Dichlorophene |
| 13. | Mercury and its compounds |
| 14. | Strontium compounds |
| 15. | Sulfamide and its derivatives |
| 16. | Selenium compounds |
| 17. | Nitrofuran type compounds |
| 18. | Hydroquinone monobenzylether |
| 19. | Halogenated salicylanilide |
| 20. | Vitamin L1 and Vitamin L2 |
| 21. | Bithionol |
| 22. | Pilocalpine |
| 23. | Pyrogallol |
| 24. | Inorganic fluorine compounds |
| 25. | Pregnanediol |
| 26. | Local anesthetics such as procaine |
| 27. | Hexachlorophen |
| 28. | Boric acid |
| 29. | Formalin |
| 30. | Methyl alcohol |
Appendix 2
| Ingredient name | Maximum amount of ingredient per 100 g |
| Aluminum chlorhydroxy allantoinate | 1.0 g |
| Cantharides tincture, ginger tincture or capsicum tincture | 1.0 g as total |
| Phenyl salicylate | 1.0 g |
| Polyoxyethylene laurylether (8-10E.O.) | 2.0 g |
2. The ingredients restricted according to types or intended purposesof cosmetics
| Ingredient name | Maximum amount of ingredient per 100 g | |
| Aerosol agents | Prohibited | |
| Zirconium | ||
| Cosmetics to be washed away immediately after use such as soap or shampoo | 0.50 g | |
| Thiram | ||
| Cosmetics other than those washed away immediately after use such as soap or shampoo | Prohibited | |
| Undecylenic acid monoethanolamide | ||
| 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 (exclude those containing the said alcohols added to dissolve ingredients in the said cosmetics) | 20000 IU as total | |
| Estradiol, estrone and ethinylestradiol | ||
| 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 ) | 50000 IU as total | |
| Estradiol, estrone and ethinylestradiol | ||
| Cosmetics used in only cephalic part | 0.010 g | |
| Aminoether type antihistamines | ||
| Cosmetics other than those used only in cephalic part | Prohibited | |
| Aminoether type antihistamines | ||
| Toothpaste | 0.50 g | |
| Sodium lauroyl sarcosinate | ||
| Compounds to be used with the purpose of emulsifying beewax or white beewax | 0.76 g ( limited not to greater than 1/2 amount of beewax and white beewax) | |
| Sodium pyroborate | ||
| Compounds to be used for purposes other than emulsifying beewax or white beewax | Prohibited | |
| Sodium pyroborate | ||
3. The ingredients restricted according to types of cosmetics (*)
| 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 | |
| Thioctic acid | 0.01 | 0.01 | |
| Ubidecarenone | 0.03 | 0.03 | |
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 |
2. 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 |
| 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 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 |
| p-Aminobenzoic acid and its esters | 4.0 as total |
| 4-tert-Butyl-4'-methoxy dibenzoylmethane | 10 |
2. 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-β-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 | |
| (*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. |
| Evaluation and Licensing Division. Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare |