Japan Cosmetic and Quasi Drugs Regulation

Overview of Japan Cosmetics Regulation

In Japan, cosmetic products are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). The PMDA is an independent agency that works together with the MHLW to assess the safety and effectiveness of quasi-drugs and cosmetics.

In November 2014, the Japanese cosmetic market experienced significant changes due to the replacement of the Japanese Pharmaceutical Affairs Law (JPAL) with the new Pharmaceutical and Medical Device Act (PMD Act). The PMD Act defines two categories of cosmetics with different requirements of regulatory compliance: cosmetics and quasi-drugs.

In the below chapters, you will find how cosmetics and quasi-drugs are regulated and what needs to do in order to comply with the law.

Cosmetics Definitions and Classifications

Cosmetic definition in Japan:  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.

Quasi drug definition in Japan:

1. 1. Preventing nausea and other discomforts.
   2. Preventing heat rash, soreness, etc.
   3. Encouraging hair growth or removing hair, or
   4. Exterminating and preventing mice, flies, mosquitoes, fleas, etc.

As defined above, the act divides cosmetics based on the functions, the following table shows the main classification of cosmetics and quasi-drugs.

How to import cosmetics to Japan

Before we talk about the procedures of the importing, it is important to arise your attention to a specific role: importers. It is crucial to understand that importers of your products shall assume all quality assurance and product liability for cosmetics, which means your primary importer will handle most of the compliance jobs locally before import products into Japan.

Therefore, picking up a right importer will be a key point to your successful importing cosmetics to Japan.

First of all, your primary importer should acquire a license called: “cosmetics manufacturing and sales license”. The sales business refers to the act of selling, renting, or lending of manufactured or imported cosmetics.

In order to obtain the license, the importer needs already built a product safety and quality management system for its company which shall be consisting of naming three persons(or one person with three titles) in charge (a Marketing Supervisor, a Quality Supervisor and a Safety Control Supervisor). Those persons have to implement a set of standards called Good Quality Practice (GQP) and a Good Vigilance Practice (GVP), as well as undertake appropriate actions for safety management.

After you appoint the importer of your products, we need to ensure that the products are in accordance with the law in Japan. This assessment is performed on samples of the products by “testing and inspection facilities” designated by the MHLW. It basically consists of checking the list of ingredients and analyzing the ingredients of cosmetics for safety.

Once the formula has been checked and products have been tested, the importer will fill three forms to competent authorities: a Manufacture and Sales of Cosmetics Notification, a Cosmetics Import Notification for Manufacture and Sales and the manufacturer’s or importer’s brand name. Those forms will be kept with a record of the testing and inspection results verifying that the product does not contain any prohibited combination.

After the three forms are prepared properly, your products will be ready for importing to Japan and the importer will handle the rest of the matters.

How to import Quasi-drugs to Japan

For the quasi-drugs are actually special functions of cosmetics in Japan, the application process for product compliance is almost the same with cosmetics but with more strict requirements on both products and your importers. You need to appoint your importer as 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 MAH must have three persons as roles of quality representative, medical safety officer, and General manager who are qualified to take responsibility for selling the quasi-medical related products in Japan.

Therefore, you should be aware that an experienced distributor for your products importing to Japan is a vital initial.

Cosmetics Labeling

All the information must be expressed in Japanese and must be clearly and explicitly listed. Labeling with false or potentially misleading expressions, and unapproved claims of effect-efficacy in labeling are prohibited. The items that should be indicated for cosmetics are as follows:

• Name and address of the importer
• Address of the office where the Marketing Supervisor serves (if this office is
• outside Japan: name and country of foreign approval holder; name and
• address of the nominated importer).
• Brand name Name for which notification has been posted for importation.
• Manufacturing number or code
• List of full ingredients (descending order by quantity)
• Expiration date
• Other items specified by the MHLW Ministerial Ordinance

Note: Ingredients’ names shall be translated into Japanese from the International Nomenclature of Cosmetic Ingredients (INCI) names as well. The Japan Cosmetic Industry Association (JCIA) offered a “List of Cosmetic Ingredient Label Names” in Japanese. This list is available in Japanese only here:
Access to Japan Cosmetics Regulatory Database. ->

Reference

List of Cosmetic Ingredient Label Names