Regulations for Cosmetics in Japan are governed by Ministry of Health, Labour and Welfare (MHLW) and an independent agency Pharmaceutical and Medical Devices Agency (PMDA). In this article, we aim to provide overview of regulations for cosmetics in Japan.
Japan Cosmetic Market Highlights
Japanese market is 3rd largest beauty market worldwide.
Total 14% of revenue is to be generated till 2021 by the source of online sales
Japan is one of the leading cosmetic market in world for cosmetic products having its largest segment in skin care cosmetics.
Japanese market is expected to grow annually by 2.83% (CAGR 2021-2025).
Definition of Cosmetics in Japan
COSMETICS are “Substances which possess mild actions and can be applied to human body by the source of sprinkling, rubbing or similar methods for the purpose of cleaning, increasing attractiveness, beautifying themselves and for altering the appearance for keeping the hairs and skin in good condition”.
Japan cosmetics are broadly classified in two ways-
General cosmetics are further divided to-
Perfume And Eau De Cologne
Eau De Colognes And Perfumes
Skin Care Cosmetics
Skin Milk, Cleansing Creams, Skin Lotion And Facial Creams
Foundation Cream, Eye Makeup, Lipstick And Others
Hair Care Cosmetics
Shampoo, Hair Dyes, And Producs For Hair Treatments
Special Purpose Cosmetics
Shaving Cream, Sunscreen And Others
Soaps For Cosmetics
What are Quasi Drugs?
They are the products which are used for-
· Preventing Nausea:
· Mosquitoes And Heat Rashes:
· Products For Promoting Hair Growth:
· Medicated Cosmetics-Skin Whitening Products, Anti-Ageing Products, Acne Prone Or Oily Skin Treatment Products Are Categorized Under Quasi Drugs.
Quasi drugs are further divided as-
Deodorants, hair growth treatment, depilatories, hair dyes, permanent waving agents, bath products, dentifrices and medicated cosmetics.
Anti-itching and anti-dandruff products
Oily skin products
Anti-sunburn or (snow burn) products
Freckle removing products
Products to prevent chapping and roughness of the skin.
What are Competent Regulatory Authorities in Japan?
Japanese cosmetics are regulated by Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical devices Law. All the series of subsidiary rules, safety standards and documents of guidance issued by MHLW.
Pharmaceutical and Medical Devices Agency (PMDA)- It is an independent agency which-
Conducts on-site and document-based studies for the safety and effectiveness of quasi drugs and cosmetics:
Evaluates the adverse effects in ingredients or products of cosmetics:
Give review for the applications of importers and foreign manufacturers.
How to Market Cosmetics in Japan?
Analysis For Product Ingredients-
Ingredient analysis is important before the registration of any cosmetics for the safety and efficacy of cosmetics or quasi drugs.
The process of registration is same for both but the regulators and requirements may vary for cosmetics and quasi drugs.
The manufacturers or importers have their own or contracted testing and inspection facilities which are designated by MHLW helps them to perform the ingredient analysis on product samples.
Ingredient analysis can be done on heavy metals, harsh preservatives, legal colors and perfumes, UV protecting agents, etc. Some other basic tests such as microbial tests, pH, viscosity and stability tests.
The manufacturers/importers have to acquire for two licenses-
Cosmetic manufacturing license (5 years validity)
Cosmetic marketing license (5 years validity)
Foreign manufacturers have to be ascribed by MHLW as an “Accredited Foreign Manufacturer”.
Cosmetic Safety and Quality
Good Quality Practice(Gqp) And Good Vigilance Practice
The cosmetics to be marketed are properly assess the cosmetics production its safety and quality standards by the marketing license holders. They must have the systems which are capable for providing the report on consumer requirements and should have collection of information related to safety of products, examine the harmful effects of product and evaluates its safety and if license holder detect any kind of harmful effect in the product, they must report safety issue to MHLW. GQP and GVP is responsible for the safety control and marketing quality of cosmetics and quasi drugs.
Before entering to market and selling the product the manufacturer/importers have to submit notification. This step can be done after obtaining cosmetic license.
Domestic manufacturer needs to submit only COSMETIC MARKETING NOTIFICATION to the same regulatory officials as granted the cosmetics marketing license. While foreign manufacturer has to submit COSMETICS (foreign manufacturer, importer) NOTIFICATION along with marketing notification.
Cosmetic and Quasi Drug Import
Manufacturer or importer are required to obtain PRIMARY DISTRIBUTOR’S LICENSE for cosmetics, this license is used for the renting, selling and lending of imported or manufactured cosmetics.
Any distributor engaging with the labeling, packaging and storage of imported or manufactured product has to obtain COSMETIC MANUFACTURING LICENSE (packaging, labelling and storage).
How Cosmetics are Labelled?
Labeling requirements are implemented according to Pharmaceutical Affairs Act-
Labelling of cosmetics is mandatorily expressed in Japanese language, outer packaging requires obligatory full ingredient list. Misleading or false expressions and unapproved claims with safety and efficacy effect in labeling is prohibited.
Quasi drugs which have claims should depend on the active ingredient in it and should be approved by MHLW. For the approval of quasi drugs MHLW allow for product effectiveness result that has to be recognized thus companies name them as medicated cosmetics.
Labeling items to be indicated on cosmetics are,
Name of the product
Name and address of the manufacturer or importer
Quantity or weight of the product
Manufacturing code or number
Ingredient list designated by MHLW
Any specific precautions on its storage and use
Expiration date as designated by MHLW
What are Prohibited Claims in Advertisement?
A. Names other than names included in the PMDL Article 12, 18, and 22
B. If the scope is exceeded than given in the article 1,3 (3) of “ENFORCEMENT RULE OF PHARMACEUTICAL ACT”
C. Misleading or false claims related to safety, efficacy, ingredients, amount, and property of cosmetics and quasi drugs
D. Claims which cause the overconsumption and misuse of product
E. Claims which include “recommended by doctors, cosmetologists, etc.
F. The claims creating uncomfortable expressions.
Information provided above are some examples of prohibited claims in advertisements.
Artixio provides regulatory services for cosmetics in Japan. For any queries regarding Japan cosmetic market, please write to us at firstname.lastname@example.org.