Cosmetics and Quasi drugs approval in Japan

Japan is one of the world’s leading markets for cosmetic and personal care products. The experts expect the beauty and personal care products market to grow at a CAGR of 3.5% for the next five years. Along with this, Cosmetics shipments within Japan generates a market value of around 2.7 trillion Japanese yen.  Due to this market size, many global manufacturers show interest to register and market their products in Japan.

Cosmetics and Quasi drugs approval in Japan

Top reasons to choose Japan market for your cosmetic products

  • 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, the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law regulates cosmetics. Series of subsidiary rules, standards, and guidance documents issued by the Ministry of Health, Labour, and Welfare (MHLW) support cosmetics.

The Pharmaceuticals and Medical Devices Agency (PMDA) conducts on-site and document-based inspections evaluates the adverse effect reports and reviews the applications of foreign manufacturers and importers.

Types of Cosmetics in Japan

Japan regulatory classifies cosmetics broadly into two types

  • Cosmetics, and
  • Quasi-drugs

Cosmetics

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.

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

Quasi-drugs

The quasi-drugs products have mild effects on the human body, and the MHLW designates 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 differences in the effects of the product, nature, the number of ingredients used, the application method, and the product appearance.

Mainly, cosmetics and quasi-drug ingredients have to comply 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.


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Let’s see how you can market each category of cosmetics in Japan.

How to get the approval of cosmetics in Japan?

To market the cosmetic products in Japan, one needs to know answers to 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?

Lets see how you can market your cosmetic product in Japan stepwise.

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.

The next step is to conduct ingredient analysis on samples by testing at the facilities designated by the MHLW, owned or contracted by manufacturers/importers. It includes analyzing the list of ingredients whether it complies 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 the manufacturers obtain the license and before initiating the import & selling, they need to submit cosmetic marketing notification to the same prefecture as granted the cosmetics marketing license.

  1. Cosmetics Import Notification for Manufacture and Sales
  2. 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 the import of cosmetics and quasi-drugs into Japan, you need to obtain

  • Primary distribution Approval 
  • Cosmetic Manufacturing License (packaging, labeling, and storage)

Labeling & Claims

For Cosmetics

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 use this 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. Companies can refer to the document to standardize the Japanese name of ingredients. The companies can also file a request with the JCIA to revise a new label name.

Quasi-drugs

For quasi-drugs, a label shall contain 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 claim made for quasi-drugs depends on active ingredients. The sponsor can market the product only after 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


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