Japan Cosmetic Regulations
In Japan cosmetics are regulated under Pharmaceutical and Medical Devices Law (PMDL) formerly Pharmaceutical Affairs Law, and supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labor and Welfare (MHLW). Japan classifies cosmetics into two categories: cosmetics and quasi drugs. The regulations governing each category differ greatly.
GRP-Japan is a Market Authorized Holder (MAH) for cosmetics and can support your registration and market entry.
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| Notification No. 331 | COSMETICS STANDARDS | Ministry of Health and Welfare | The Cosmetics Standards classify which ingredients may be used for cosmetics only by the amount approved in this standard as well as a list of prohibited ingredients. | English | For Sale |
| Notification No. 1225001 | LIST OF ACTIVE INGREDIENTS IN SO-CALLED MEDICINAL COSMETICS | PMDA | The "List of Active Ingredients in so-called medicinal Cosmetics" are regulated products known as quasi-drugs. The guide list the maximum amount allowed for each ingredient in "medicinal-cosmetics". | English | For Sale |
| - | Nanotechnology Cosmetic Guideline | The 4th International Conference on Cosmetic Regulatory Cooperation | This guidance was created through ICCR work and intended to serve as an indicator when determining whether a particular substance used in cosmetics is a nanomaterial to be considered. | English | For Sale |