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Cosmetic Regulatory Services Japan - Overview

Freyr's Cosmetic Regulatory Services, with 2300+ global Regulatory professionals, ensures cosmetic product registration compliance for your products in Japan. We excel in navigating Japan's Regulatory landscape governed by the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Act. Specializing in quasi-drugs and cosmetic registrations, our experts handle adverse effect reports. In Japan's dynamic cosmetic market, compliance involves categorization and registration based on the product type. Trust Freyr for comprehensive support in Japan's thriving cosmetic industry.

The Ministry of Health, Labour, and Welfare (MHLW) classifies cosmetic products into two (02) categories, which are as follows:

  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, cosmetic product registration is applicable to 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.

How can Freyr help?

Freyr Advantages


Cosmetic Product Registration in Japan - Freyr Advantages


Expertise in decoding cosmetic product classification and providing the best assistance in cosmetics Regulatory services in Japan.


Accurate translation services in the local language on primary cosmetic packages.


Aims at first-time approval to firmly establish labeling compliance.


A qualified team of experts with hands-on experience across all 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.