Cosmetics

Regulatory experts with specialized knowledge provide end-to-end support.

Cosmetic Product Registration In Japan - Overview

In Japan, cosmetic products are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Act (PMD Act).

As one of the most affluent nations in Asia, Japan’s cosmetic market witnesses’ growth despite economic fluctuations. The MHLW categorizes cosmetics in Japan into two (02) categories.

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: Cosmetic Marketing Notification

Quasi-Drugs: Quasi-Drug Marketing Approval

The MHLW classifies cosmetic products into two (02) categories, which are:

  1. General Cosmetics.
  2. Quasi-Drugs.

General cosmetics: As per the Japanese cosmetic regulations, cosmetics are further classified into five (05) categories as listed below:

  • Perfume and eau de cologne.
  • Makeup Products.
  • Skincare Products.
  • Haircare Products.
  • Special purpose Cosmetics (including Sunscreens).

Quasi-Drugs: This category includes products used for preventing nausea, heat rash, and mosquitoes, as well as products that promote hair growth. Some medicated cosmetics, such as whitening, anti-aging products, and oily skin or acne treatment products, are also categorized as quasi-drugs.

In Japan, medicated cosmetic product registration is applicable to approval of quasi-drugs, whereas, for general cosmetics, a simple notification is sufficient.

According to Japanese cosmetic labeling regulations, labeling in the local language on the primary cosmetic package is mandatory for all domestic and imported products. Erroneous labeling translations may lead to major reworks and result in significant monetary loss.

The Japanese cosmetics registration process proves to be challenging for manufacturers and importers. As a proven Regulatory partner, Freyr provides cosmetics regulatory services in Japan, including competent product compliance checks comprising of cosmetic product formulation review along with cosmetic label and claims review. Additionally, Freyr can also perform a cosmetics product notification of the general category of cosmetics.

Freyr Expertise

  • Regulatory Intelligence Support
  • Regulatory Due Diligence Support
  • Marketing Authorization Holder (MAH) Services for Cosmetics and Quasi-Drugs
  • Translation Services
  • Distributor Identification and Related Services

Freyr Advantages

  • Expertise in decoding cosmetic product classification and providing the best assistance in Cosmetics Regulatory services in Japan.
  • Support our clients to comply cosmetics, packages and labels with Japanese regulations with our expertise
  • A qualified team of experts with hands-on experience across cosmetic categories like skincare, haircare, infant care, oral care, and beauty products.
  • Support for region-specific Regulatory activities.
  • End-to-end Cosmetic Regulatory consultation, including Cosmetic product registration in Japan.
  • End-to-end Quasi-Drug Regulatory consultation, including Quasi-Drug product registration in Japan.
  • We act as your local operating partner in Japan, ensuring full compliance with all Japanese regulations.
  • Benefit from our extensive partnership network partnerships with key organizations like the Japan Cosmetic Industry Association.
  • Stay ahead of Japan's cosmetic regulations with our expert updates.