Regulation of Cosmetics in Japan

The regulatory body for cosmetics in Japan is the Ministry of Health, Labor and Welfare and the specific regulatory authority is the Bureau of Medicine and Health.

Laws that Japan Enforces for Cosmetics:

• Pharmaceutical and Medical Device Law (PMDL), 2014

Japan officially implemented the Pharmaceutical and Medical Device Law (PMDL) in 2014, which is regulated by the Ministry of Health, Labor and Welfare, and which directly replaces the Pharmaceutical Affairs Law (PAL) enacted in Japan in 1960. The PMDL must be followed for the manufacture, sale and import of cosmetic products.

Definition of Cosmetic Product

In Japan, cosmetics are defined as "substances that are applied to the body or used in a similar way to cleanse and beautify the body, to increase its charm, to change its appearance, and to keep the skin and hair healthy, and are substances that have a moderate effect on the body" .

In Japan, soap and toothpaste used for the purpose of cleaning the body are also considered cosmetics, while hair dyes, perms, acne creams, creams to prevent cracking and frostbite, and products that have antiseptic effects on the skin or mouth, including toothpaste, are called medical products.

Classification of cosmetics

Japan also has a unique classification system that generally divides beauty products into two categories: cosmetics and pharmaceutical extras. Of these, cosmetics can be divided into six other categories - perfumes and colognes, make-up products, skin care products, hair care products, special purpose cosmetics and cosmetic soaps. In addition, extra-medical products are defined as:

"Articles used to prevent nausea and other discomforts, to prevent prickly heat, soreness, etc., to promote hair growth or removal or to destroy and prevent rats, flies, mosquitoes, fleas, etc."

Pre-market Approval and Notification of Products

In Japan, a Cosmetic Manufacturing License and a Cosmetic Marketing License are required to register a cosmetic product. Of these, the Cosmetics Marketing Permit holder is required to comply with two standards: the Good Quality Practice (GQP) standard; and the Good Vigilance Practice (GVP) standard. In addition, after obtaining these two documents, the manufacturer is required to submit a Notification of Sale of Cosmetics to the county where the Cosmetics Marketing License was issued. Only after these formalities are completed can the product be officially marketed.

Claims

Japan has introduced documents to provide guidance on the regulation of cosmetic claims, such as a list of cosmetic efficacy claims, which lists 56 types of efficacy claims available for cosmetic use.

Animal experiments

Japan is phasing out animal testing for cosmetics, which is not mandatory although there are no explicit laws or regulations prohibiting animal testing. On the other hand, animal testing is mandatory for pharmaceutical products in Japan (including products classified as cosmetics in the EU).

For R&D and Further Manufacturing ONLY.