Cosmetics and Quasi-drug Notification in Japan

In Japan, beauty products are classified into two types: cosmetics and quasi-drugs. Cosmetics are products that have mild action on the human body and are applied by rubbing, sprinkling, or other methods, which aim to clean, beautify, and increase attractiveness, alter the appearance, or keep the skin or hair in good condition. The Ministry of Health, Labor, and Welfare (MHLW) under Pharmaceutical and Medical Device Law (the “PMDL”), formerly known as the Pharmaceutical Affairs Law (the “PAL”) regulates cosmetics.

Cosmetic Notification in Japan

Under the provisions of the revised PAL, which went into effect as of June 1, 2009, when importing and distributing cosmetics, the importer must obtain a cosmetics manufacturing and sales license (化粧品製造販売許可) and a cosmetic manufacturer's license (化粧品製造許可). After that, the importer must submit 3 notifications to the proper administrative agency before initiating the product importation. They are the Manufacture and Sales of Cosmetics Notification, Cosmetics Import Notification for Manufacture and Sales, Manufacturer's or importer's brand name. These notifications must either be accompanied by an ingredient list from the importer's supplier or manufacturer, or, if this list cannot be obtained, a record of the testing and inspection results confirming the product does not contain any prohibited ingredient combinations. The importer is responsible for the safety of the product.

Quasi-drug Registration in Japan

The PAL defines quasi-drug as an item for the purpose of: (1) Preventing nausea and other discomfort. (2) Preventing heat rash, soreness, etc. (3) Encouraging hair growth or removing hair, or (4) Exterminating and preventing mice, flies, mosquitoes, fleas, etc. Among the quasi-drugs are deodorants, depilatories, hair growth treatments, hair dyes, perm and straightening products, as well as medicated cosmetics, such as whitening products, anti-aging products and oily skin or acne treatment products.

A pre-market approval of all quasi-drugs is required by the Pharmaceutical and Food Safety Bureau of the MHLW applies according to Article 14 of the PAL. A foreign manufacturer must appoint a drug marketing authorization holder (MAH) in Japan who performs all procedures with the MHLW on behalf of the applicant for the application of the marketing approval. The information required for the marketing approval for a quasi-drug is similar to that of a new drug product.

Who Shall Register?

• Cosmetics manufacturer or distributors who export cosmetics to JP
• Importers/primary distributor of cosmetics in Japan;

Our Services

CIRS China can act as a technical provider for foreign and domestic cosmetic manufacturers or distributors who want to export cosmetics to Japan to notify cosmetics or quasi-drug in Japan so as to comply with the Japanese cosmetics and quasi-drug regulations.

Our services include:

JP Cosmetics and Quasi-drug Notification	Formula and label review Testing required for the notification; Dossier preparation for notification;