Japan is one of the world’s leading markets for cosmetic and personal care products. The Beauty and Personal Care Products Market is estimated to grow at a CAGR of 3.5% for the next five years in Japan. Along with this, Cosmetics shipments within Japan generated a market value of around 2.7 trillion Japanese yen in 2019.
Top reasons to choose Japan as your cosmetics
- Constant growth in the cosmetic market.
- High in quality, authentic and sustainable products.
- Highly popular in Asia, accounting for 90% of Japanese exports.
- Have the highest per person expenditure on cosmetics & skincare products.
- A great demand for natural & organic beauty products with Increasing health and sustainability awareness of Japanese consumers.
- The rich culture and their obsession for beauty.
- Increasing demand for denture products with the increasing aging population.
Regulatory authority for cosmetics in Japan
In Japan, cosmetics are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law. In Japan, cosmetics are supported by a series of subsidiary rules, standards, and guidance documents issued by the Ministry of Health, Labour, and Welfare (MHLW).
The Pharmaceuticals and Medical Devices Agency (PMDA) focuses on conducting on-site and document-based inspections, evaluate the adverse effect reports, and review the applications of foreign manufacturers and importers.
Types of Cosmetics
Japan regulatory classifies cosmetics broadly into two types
- Cosmetics, and
Cosmetics are defined as items having mild action on the human body and are intended to be applied 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.
In the Japanese market, cosmetics are further classified into 6 different categories
- Perfume and eau de cologne: Perfume and eau de cologne
- Makeup cosmetics: Foundation creams, lipsticks, eye makeup, and others
- Skincare cosmetics: Skin lotion, essence, skin milk, cleansing cream, and others
- Haircare products: Hair dye, shampoo, hair treatment, and others
- Special-purpose cosmetics: Sunscreen, shaving cream, and others
- Cosmetic soaps: Soaps for cosmetics
The quasi-drugs shall have mild effects on the human body, and are designated by the MHLW based on the characteristics. Generally, quasi-drugs include deodorants, depilatories, hair growth treatments, hair dyes, bath products, dentifrice, perm, and straightening products as well as medicated cosmetics.
The cosmetic products that come under quasi drugs include
- Whitening products
- Anti-aging products
- Oily skin or acne treatment products
- Anti-dandruff or anti-itching products
- Freckle-removing products
- Shaving products
- Anti-sunburn or “snow burn” products
- Anti-bactericide products
The difference between cosmetics and quasi-drugs is not clear. However, the distinction is made based on differences in the effects of the product, the nature and the number of ingredients used, the application method, and the appearance of the product.
Mainly, cosmetics and quasi-drugs ingredients have to be in compliance with Cosmetics and Japanese Standards of Quasi-drug Ingredients. The regulations governing each category differ slightly and the requirements for quasi-drugs are more strict.
Let’s see how each category of cosmetics can be marketed in Japan.
How to get the approval of cosmetics in Japan?
The approval process of cosmetics can be simplified by obtaining answers for the following questions
- How are cosmetics regulated in Japan?
- What are the regulatory requirements and processes for different categories of cosmetic products?
- What are the licenses required for registration?
- How foreign manufacturers can market their cosmetic products in Japan?
- How to import cosmetic products after obtaining the required approvals?
The cosmetics markets are generally a mixture of chemicals used to enhance the appearance and include, sunscreens, hair colors (hair Dyes), deodorants, makeup kits, suncare, skincare, body lotions, etc.
The beauty and skincare market is old in Japan, and Japan is the second-largest market for cosmetic products. after the United States.
So it's obvious to consider the Japanese market for your cosmetic products. But due to the complex approval procedures, language barriers, and low exposure to Japanese regulations, many manufacturers are intact for the Japanese market. However, understanding the core regulations would simplify the entire process and make the approval easy for foreign manufacturers.
For the registration of cosmetic products in Japan here are some salient points that need to be understood
How are these products regulated in Japan?
Japanese regulators have classified the cosmetics products as Cosmetics and Quasi-drugs, the regulations and requirements for each class of cosmetic product vary.
You need to understand the complete regulatory process applicable to your product category.
Process for foreign manufacturers
For the foreign manufacturer who likes to market their cosmetic products in Japan, they need to have a local representative, and approvals may vary compared with the domestic manufacturers.
You need to obtain the necessary certification and submit notifications to import and sell your product in Japan.
Required licenses and certifications
Since quality and safety are the high priority for the Japanese regulations, product analysis and manufacturing site inspections are important for approval.
Various factors and requirements for import
One needs to understand the requirements for the import of cosmetic products after approval. You need to obtain all notifications and license to import your cosmetic product into Japan. Gaining all approvals avoids delays.
Regulatory for labeling and import
The manufacturers who plan to market their cosmetic products in Japan need to understand the labeling and advertising guidelines and requirements before marketing and selling them into the Japanese market.
Get Details on Regulatory Process, Requirements, and Import of Cosmetic Products in Japan.
Due to the increase in interest of the manufacturers to market their cosmetic products in Japan, we are receiving an increased number of queries. We found that some of the queries were to understand the regulatory and process feasibility as the information available is not clear or incomplete.
Credevo has prepared a report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.
What would you get by downloading this report?
- Details on the regulations, requirements, and process to register the cosmetic products in Japan.
Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering cosmetic products in Japan. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared on the basis of relevant information from the public domain as of the date, however, the PMDA regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.
Step 1: Review, categorize and perform ingredient analysis for your product
The application process for marketing licenses and manufacturing licenses for quasi-drugs is the same as cosmetics. However, the requirements and regulators vary as the quasi-drugs are looked for safety and efficacy of products.
Therefore, before initiating any process of registration you need to first review your product and find the category to which your product belongs, as the requirements and regulations vary between the category of the product.
This review process can be made easier with Credevo expert reviewing your product details. If you have downloaded the above referred ‘Report on the Market Approval Process of Cosmetics in Japan’, just fill up the information below to receive a free assessment of your drug product details by Credevo experts to identify specific requirements apply for its registration.
The second step is to conduct ingredient analysis and it is performed on samples by testing and inspection facilities designated by the MHLW, owned or contracted by manufacturers/importers. It basically includes analyzing the list of ingredients whether it is in compliance with Japanese standards for cosmetics.
Step 2: Obtaining Required Licenses
The next step is obtaining the required licenses such as Cosmetic Manufacturing License and Cosmetic Marketing License from the respective regulatory authorities.
In the case of foreign manufacturers, they need to be accredited by the MHLW as an “Accredited Foreign Manufacturer”.
Marketing License holders have to implement a set of standards called
- Good Quality Practice (GQP) for maintaining the quality of products, and
- Good Vigilance Practice (GVP) for undertaking appropriate actions for safety management.
Step 3: Cosmetic & Quasi-Drug Marketing Notification Submission
After obtaining the licenses and before initiating the import & selling, manufacturers need to submit cosmetic marketing notification to the same prefecture as that which has granted the cosmetics marketing license.
- Cosmetics Import Notification for Manufacture and Sales
- Cosmetics (foreign manufacturer, importer) notification
Step 4: Import your Cosmetics and Quasi Drugs into Japan
All the requirements mentioned above have to be implemented by importers with some slight differences. An importer can handle the importation or distribution of its products by opening a local subsidiary. In this case, the local company should follow specific regulations to be an importer.
For import of cosmetics and quasi drugs into Japan, you need to obtain
- Primary distribution Approval
- Cosmetic Manufacturing License (packaging, labeling, and storage)
Labeling & Claims
Cosmetic labels are required to be in Japanese and full ingredient labeling in Japanese is mandatory on the outer package of cosmetics. Labeling with misleading expressions, and unapproved claims of functionality or efficacy are prohibited.
The Japan Cosmetic Industry Association (JCIA) has compiled a Japanese version of the “List of Cosmetic Ingredient Label Names” to be used in compliance with the PMDL’s requirements to list all ingredient names on the labeling. Companies can refer to the document to standardize the Japanese name of ingredients. If a new label name needs to be devised, a request can be filed with the JCIA.
For quasi-drugs, a label containing the name of specific ingredients prescribed by the MHLW is required. MHLW doesn’t offer a reference list of permitted or prohibited claims for quasi-drugs. The claims of quasi-drugs are based on active ingredients and can only be marked after getting approval.
E.g. Claim of Whitening efficacy with a product containing the active whitening ingredient, Claim of Anti-acne efficacy with a product containing an anti-acne active ingredient.
Approval Process for cosmetics and Quasi Drugs