|Pharmaceutical and Medical Devices Law|
|Ministry of Health, Labour and Welfare (MHLW)|
|Main Supporting Rules|
|28 March 2016||Enforcement Rules of Pharmaceutical and Medical Devices Law|
|1 April 2001||Standards for Cosmetics|
|6 Nov 2013||Japanese Standards of Quasi-drug Ingredients 2006|
Japanese cosmetics are regulated under Pharmaceutical and Medical Devices Law (PMDL, formerly Pharmaceutical Affairs Law) supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfare (MHLW).
Japan legally classifies cosmetics (in the broad sense of beauty products) into two categories: cosmetics and quasi drugs. The regulations governing each category differ greatly.
Act for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical and Medical Devices
Licensing for quasi drugs
- Ministry of Health, Labour and Welfare is the competent authority regulating cosmetics and quasi drugs, which is responsible for formulating cosmetic and quasi drug regulations and standards.
- Pharmaceutical Affairs and Food Sanitation Council is MHLW’s back-up expert panel.
- Pharmaceuticals and Medical Devices Agency (PMDA) focuses on review applications of quasi drugs and cosmetics (foreign manufacturer, importer) notifications, and evaluate the adverse effect reports.
- Prefectural governments are responsible for licensing, inspection and guidance.
Japan defines cosmetics as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.” There are 6 categories in total:
Perfume and eau de cologne
Perfume and eau de cologne
Foundation creams, lipsticks, eye makeup and others
Skin care cosmetics
Skin lotion, essence, skin milk, cleansing cream and others
Hair care products
Shampoo, hair treatment and others
Special purpose cosmetics
Sunscreen, shaving cream and others
Soaps for cosmetics
Marketing license holders take full charge for ingredient safety problems. When considering selling products in Japan, they are recommended by the authority to conduct ingredients analysis to ensure conformity with Japanese cosmetic ingredient regulations although the analysis is not mandatory and there is no need to submit related reports prior to marketing. But related reports will be inspected if their products are found unsafe.
This analysis is performed on samples by “testing and inspection facilities” designated by the MHLW, owned or contracted by manufacturers/importers. The following items are to be tested:
- UV absorbents,
- Heavy metals,
- Japanese legal color index colorants,
- Prohibited ingredients.
Also, some specific tests could be performed, such as pH, viscosity, specific gravity, bacterial count, patch tests, stability tests and more. As there are numerous testing items, the MHLW provides a checklist for manufacturers/importers for confirmation.