Cosmetics Regulatory Support in Japan


As one of the most affluent nations in Asia, Japan’s cosmetic market witnesses’ growth despite the economic fluctuations.

In Japan, cosmetic products are regulated by the Ministry of Health, Labor, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Act (PMD Act). The MHLW reviews the quasi-drugs applications and the cosmetics registrations in Japan (foreign manufacturers and importers) and evaluates their adverse effect reports.

Cosmetics Classification

The MHLW categorizes cosmetics in Japan into the following two (02) categories:

  • General Cosmetics
  • Quasi Drugs

The manufacturers/importers are required to complete their cosmetic product registration in Japan and apply for marketing approval based on the type of product.

General Cosmetics

Quasi Drugs

Perfume and Eau de Cologne

Products for preventing nausea

Makeup products

Products for treating heat rash

Skincare products

Oily skin and acne treatment products

Haircare products

Skin-whitening products

Special-purpose cosmetics (e.g., sunscreens)

Anti-aging products

Hair growth products

Notification of Cosmetic products in Japan

For a seamless market entry into the cosmetics market of Japan, manufacturers and importers need to appoint a local entity that will be in charge of all Regulatory responsibilities for the imported cosmetics in Japan. In order to achieve compliance with the MHLW, manufacturers also need to check if the cosmetic formula and the associated ingredients are in-line with the Japanese regulations.

Important Validities

If the cosmetic product is not changed or withdrawn from the Japanese market, then the notification for the cosmetic product is valid forever.

Freyr Expertise

  • Formulation Review and Product Classification
  • Safety Assessment and Toxicology Services
  • Labeling Review
  • Claims Review
  • Research and Development Solutions
  • Product Information File /Dossier/Document Compilation
  • Regulatory Intelligence
  • Region-specific Requirements Compliance/Consulting
  • Go-to-market Regulatory Support

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