Cosmetics Regulations & Registration Process in Japan

In Japan, cosmetics have to meet the requirements and standards before they can be brought into the market.

It is important to be aware of these regulations in order to be compliant and to sell cosmetic products in Japan. The guide discusses cosmetics regulations and registration in Japan, and the main requirements for market entry.

Highlights of the Cosmetics Market in Japan

The Japanese cosmetics market ranks as the fourth largest globally, comprising around 3,000 companies, with skincare being the largest product segment.

• The revenue in the cosmetics market is estimated to reach US$7.92 billion.
• An annual growth rate of 3.12% (CAGR 2025–2030) is estimated.

Cosmetic Regulations in Japan

The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical Medical Device Agency (PMDA) are the regulatory authorities that govern the cosmetic sector in Japan.

Cosmetics are regulated under the Pharmaceutical and Medical Devices Law. The applications made to the PMDA are forwarded to the MHLW in most cases, and a decision is made. PMDA and MHLW therefore work together for the processing of applications for licensing or approvals.

Also Read: Medical Device Regulations and Registration Process In Japan

Roles and Responsibilities of Cosmetics Authority in Japan

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.

Cosmetics Classification in Japan

According to Article 2.3 of the Pharmaceutical Affairs Law, cosmetics are products that have a mild effect and are used for cleaning, beautifying, improving appearance, and maintaining healthy skin and hair.

General Cosmetics

General cosmetics are those that are used for the purpose of cleaning, beautifying, or maintaining healthy skin and hair. They do not normally need to be individually approved. However, they must meet the Standards for Cosmetics, labelling and notification requirements.

They are classified into the following categories:

General Cosmetic Categories	Examples
Perfume and Eau de Cologne	Perfumes, Eau de Cologne
Skin Care Cosmetics	Skin lotions, cleansing creams, Facial creams, Skin milk
Makeup Cosmetics	Foundation, Lipstick, Eye makeup
Hair Care Cosmetics	Shampoo, Hair dyes, Hair treatment products
Special Purpose Cosmetics	Sunscreens, Shaving creams
Cosmetic Soaps	Cosmetic soaps

Quasi-Drugs

Quasi-drugs are products containing approved active ingredients that offer particular functional benefits in addition to the cosmetic function. They might need further regulatory review or approval before being marketed, depending on the product.

Cosmetics Regulations & Registration Process in Japan

In Japan, cosmetic registration is divided depending on the type of product that has to be registered – general cosmetic or quasi-drug cosmetic. The general steps in the overall process are as follows:

Step 1. Determine the Product Classification

Identify if the product is a general cosmetic or a quasi-drug. The classification will be based on the intended use, ingredients, formulation, and claims of the product.

Step 2. Review Ingredients for Compliance

Check the ingredients of the product with the MHLW Standards for Cosmetics. Make sure that all ingredients meet restrictions and safety requirements.

Step 3. Get the Required Licenses

Cosmetic manufacturers or importers are required to secure the proper license prior to marketing the product in Japan. Foreign firms must employ a Japanese Marketing Authorization Holder (MAH) to handle the regulatory duties.

Step 4. Submit Product Notifications

If necessary, acquire the necessary licenses, and notify the competent authority for the product before marketing the cosmetic product in Japan.

Step 5. Prepare Compliant Labels

Make sure the product label meets Japanese labelling regulations. Information that is required to be provided shall be in Japanese; Cosmetic claims shall conform to the PMD Act.

Step 6. Carry out the Importation and Market the Product

After compliance with applicable regulations, the product can be imported and marketed in Japan, after having fulfilled the licensing, notification and labeling obligations.

Step 7. Maintain Post-Market Compliance

Good Quality Practice (GQP) and Good Vigilance Practice (GVP) are expectations of Marketing Authorization Holders (MAHs). They also oversee product quality, safety surveillance, and regulatory reporting.

Also Read: Nutraceutical Regulations & Registration Process in Japan

Licensing Requirements for Cosmetics in Japan

The manufacturers/importers have to acquire two licenses-

• Cosmetic manufacturing license (5 years validity)
• Cosmetic marketing license (5 years validity)

This license is valid for five years.

Accredited Foreign Manufacturer

Foreign manufacturers exporting cosmetics or quasi-drugs to Japan may need accreditation from the MHLW. This accreditation is granted under the Accredited Foreign Manufacturer scheme.

Before applying, the Japanese Marketing Authorization Holder (MAH) must obtain a Business Number. This requires submitting a Business Number Registration Form.

The applicant must then submit:

• An Application for Accreditation to the Minister (in duplicate)
• An Application for Accreditation Examination to the PMDA Chief Executive

Both applications are submitted to the Administrative Division II of the PMDA’s Office of Review Administration.

Documents Required for Accreditation

Applicants should prepare the following documents:

• Curriculum vitae of the responsible person at the manufacturing site
• Manufacturing process documents and list of products intended for export to Japan
• Details of the manufacturing building and facilities
• Radiopharmaceutical facility information (where applicable)
• Copy of a valid manufacturing or marketing license issued by the competent authority in the country of origin, where applicable

Cosmetic Labeling Requirements in Japan

Cosmetic labeling in Japan is regulated under the Pharmaceutical and Medical Devices (PMD) Act. All mandatory labeling information must be provided in Japanese.

Cosmetic labels should include:

• Product name
• Brand name
• Name and address of the manufacturer or importer
• Net quantity or weight
• Manufacturing code or batch number
• Country of origin
• Full ingredient list designated by the MHLW
• Storage and usage precautions
• Expiration date (where required)
• Contact information

Import Requirements for Cosmetics in Japan

Companies importing cosmetics into Japan must meet the applicable licensing, notification, and documentation requirements. These requirements must be completed before products can be marketed or distributed.

Importers responsible for marketing cosmetics generally require a Primary Distributor’s License. Businesses involved in packaging, labeling, or storage must also hold a Cosmetic Manufacturing License for those activities.

Documents Required for a Primary Distributor’s License

The application generally includes:

• Corporate registration certificate (for corporations)
• Duty specification list
• Medical certificate of the applicant
• Qualification documents of the Marketing Supervisor and employment contract
• Good Quality Practice (GQP) documentation
• Good Vigilance Practice (GVP) documentation
• Business premises and warehouse floor plans

Documents Required for a Cosmetic Manufacturing License

Applicants should submit:

• Manufacturing facility overview
• Manufacturing facility floor plan
• Qualification documents of the responsible engineer and employment contract
• Testing laboratory agreement, where applicable

Fees for Cosmetic Registration in Japan

The review fee depends on the product category and application type.

Cosmetic Type	Review Fee
Quasi-drugs – New active ingredient	310,100 Yen
Quasi-drugs – New dosage form	258,900 Yen
Other quasi-drugs	66,600 Yen
General Cosmetics	66,600 Yen

Note: The above fees are indicative and may change. Please refer to the official PMDA or MHLW guidance before making any payment.

Cosmetic Advertising and Claims in Japan

Cosmetic advertisements in Japan must comply with the Pharmaceutical and Medical Devices (PMD) Act.

The following claims are prohibited:

• Claims that exceed the permitted scope of cosmetic products under the PMD Act
• False or misleading claims about safety, efficacy, ingredients, or product properties
• Claims that encourage excessive consumption or misuse of the product
• Statements such as “recommended by doctors” or similar endorsements without regulatory authorization
• Expressions that may mislead or cause unnecessary concern among consumers

Timeline for Cosmetic Registration in Japan

The timeline for cosmetic registration depends on several factors. These include the product classification, licensing status, and completeness of the submitted documentation.

Activity	Typical Timeline
Product classification	1–2 weeks
Ingredient compliance review	2–4 weeks
License preparation	Varies
Product notification	A few weeks
Overall market entry	Approximately 3–6 months*

Note: Timelines may vary depending on the product type, regulatory pathway, and documentation submitted. Quasi-drugs generally require a longer review period than general cosmetics.

PMS Requirements for Cosmetics in Japan

Companies marketing cosmetics in Japan must establish systems for post-market surveillance in accordance with Good Quality Practice (GQP) and Good Vigilance Practice (GVP) requirements.

These systems help companies:

• Maintain product quality
• Monitor product safety after commercialization
• Record and investigate consumer complaints
• Evaluate adverse events and product risks
• Report significant safety issues to the MHLW, where required
• Conduct product recalls or corrective actions when necessary

Maintaining effective GQP and GVP systems helps ensure continued compliance with Japan’s cosmetics regulations.

Conclusion

To make a product’s market entry, it is important to know the rules applicable to that country. Here at Artixio, our regional experts can guide you through these rules and provide Regulatory Affairs Consulting Services in Japan. Our regional experts in Japan can assist you in document preparation, faster Japanese cosmetic market entry, consultation with PMDA, local representation, and more. Reach out through info@artixio.com.

FAQs

1. Do all cosmetics have to be approved by PMDA in Japan?

No, there is no need to obtain product approval prior to sale in Japan for general cosmetics. But companies should abide by the laws and regulations regarding licensing, notifying, labeling, and safety. Quasi drugs must be approved by the regulatory authorities for commercial use.

2. Can overseas cosmetic manufacturers sell directly in Japan?

No. Japanese Marketing Authorization Holder (MAH) must be appointed by overseas manufacturers to market cosmetics in Japan. The MAH will be accountable for compliance aspects, notifications, and post-market duties.

3. What happens if a cosmetic contains a restricted ingredient?

Japanese market may not be available for products containing prohibited/ restricted ingredients. Manufacturers should compare their formulations to the standards of the MHLW, and adjust them, if needed, prior to registration or import.

4. Is it possible to sell the same cosmetic product in Japan without modification?

Not always. Ingredients, authorised claims, labelling and classification may vary from other markets. Products that have met U.S. FDA or EU requirements may need to be reformulated or relabelled for Japan.

5. Do all imported cosmetics get checked before they enter Japan?

Products brought in may be subject to customs and regulatory examination to ensure that they meet the import requirements and the PMD Act. If necessary, the authorities will ask for more documents.

6. Can cosmetic claims be translated directly from other markets?

Acceptable claims in other countries may not be found acceptable in Japan. There may be claims in cosmetics that are outside the scope of the PMD Act, such as therapeutic or medicinal claims, that typically would require the cosmetic product to be regulated as a quasi-drug.

7. Are ingredient names required to be listed in Japanese?

Yes. Cosmetic labels must be presented in Japanese, and the required ingredient declaration must be included in the label in Japan. The ingredient name(s) should conform to the Japanese labelling requirements.

8. What does PMDA mean?

PMDA stands for the Pharmaceuticals and Medical Devices Agency. It is Japan’s regulatory agency responsible for reviewing applications, conducting inspections, monitoring product safety, and supporting the Ministry of Health, Labour and Welfare (MHLW) in regulating cosmetics, pharmaceuticals, medical devices, and quasi-drugs.