In 2023, Japan ranked among the top cosmetics markets, known for its advanced skincare technology, high-quality products, and sophisticated consumer preferences. The market in Japan is characterized by a strong emphasis on skincare, makeup, hair care, and fragrance, with a diverse range of domestic and international brands. The Japanese cosmetics market is highly competitive, with both domestic and international brands vying for market share. Domestic brands such as Shiseido, Kao Corporation, and Kanebo have longstanding reputations for quality and innovation, while international brands like L'Oréal, Estée Lauder, and Procter & Gamble also enjoy strong brand recognition and consumer trust.
Highlights of the Cosmetic Market in Japan
The Japanese cosmetics market ranks as the third-largest globally.
Online sales are projected to contribute to 14% of total revenue by 2021.
Renowned for its skincare offerings, Japan leads the global cosmetic industry in this segment.
The Japanese cosmetic market anticipates an annual growth rate of 2.83% from 2021 to 2025, reflecting steady expansion.
Cosmetic Regulations in Japan
Regulation of cosmetics in Japan is overseen by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA). The regulation of cosmetics are covered under Pharmaceutical Affairs Law (Law No.145 of 1960). The regulatory framework ensures the safety, efficacy, and quality of cosmetics to protect consumer health.
The Pharmaceutical and Medical Devices Agency (PMDA) is an autonomous organization responsible for:
Undertaking both on-site and document-based examinations to assess the safety and efficacy of quasi drugs and cosmetics.
Assessing adverse effects associated with ingredients or products used in cosmetics.
Reviewing applications submitted by importers and foreign manufacturers.
Pharmaceutical and Medical Devices Agency (PMDA) Definition of Cosmetics in Japan
As per Article 2.3 of Pharmaceutical Affairs Law, the 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”.
Pharmaceutical and Medical Devices Agency (PMDA) Categorization of Cosmetics in Japan
In Japan, cosmetics are categorized into two main groups:
General Cosmetics: These include everyday beauty products such as skincare, haircare, makeup, and fragrances. General cosmetics are widely available and are typically used for personal grooming and enhancing appearance. The General Cosmetics are sub-divided into following categories
General Cosmetic Categories | Examples |
Perfume And Eau De Cologne | Eau De Colognes And Perfumes |
Skin Care Cosmetics | Skin Milk, Cleansing Creams, Skin Lotion And Facial Creams |
Makeup Cosmetics | 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 |
Cosmetic Soaps | Soaps For Cosmetics |
Quasi-Drugs: Quasi-drugs are a category of products that fall between cosmetics and pharmaceuticals, encompassing items such as medicated skincare products, hair growth treatments, and anti-dandruff shampoos. Quasi-drugs are cosmetic products that contain active ingredients with medicinal properties and are intended to have therapeutic effects on the skin or hair. These products undergo stricter regulatory requirements and are often used for treating specific skin or hair conditions, such as acne, aging, or hair loss.
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.
License Requirements
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.
Notification Requirements
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
Brand name
Quantity or weight of the product
Manufacturing code or number
Origin country
Ingredient list designated by MHLW
Any specific precautions on its storage and use
Expiration date as designated by MHLW
Contact information
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.
Navigating the regulatory landscape of cosmetics in Japan, overseen by the Pharmaceutical and Medical Devices Agency (PMDA), requires adherence to stringent standards for safety and efficacy. Understanding the categorization of cosmetics and the regulatory responsibilities is essential for successful market entry and compliance.
At Artixio, we specialize in regulatory affairs and offer comprehensive support to companies seeking to navigate the complex regulatory requirements in Japan and other markets. Our team of experts provides guidance and assistance throughout the regulatory process, ensuring compliance with PMDA regulations and facilitating market access for cosmetic products.
For tailored regulatory solutions and expert assistance with PMDA compliance, contact Artixio at info@artixio.com. Our dedicated team is here to support your regulatory needs and help you achieve success in the Japanese cosmetics market.
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