Cosmetics Regulatory Services - Japan

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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). The MHLW reviews the quasi-drugs applications and cosmetics registration in Japan (foreign manufacturers, importers) and evaluates their adverse effect reports.

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. 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 - These 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 and promoting hair growth. Some medicated cosmetics, such as whitening, anti-aging products, and oily skin or acne treatment products, are also categorized as quasi-drugs.

According to the 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 cosmetic registration process in Japan proves to be challenging for manufacturers and importers. As a proven Regulatory partner, Freyr provides Cosmetic Regulatory services in Japan including competent product compliance check comprising of  Cosmetic product formulation review along with Cosmetic label and claims review.

Expertise

Freyr Expertise

  • Product Classification
  • Product Testing
  • Ingredient Check/Registration (as per Japan Cosmetic Industry Association (JCIA))
  • Label Compliance and Claims Review
  • Regulatory Intelligence
  • Japan Cosmetic Packaging Requirements
  • Strategic Regulatory Consulting
Freyr Advantages

ADVANTAGES

Freyr Advantages

 

Expertise in decoding cosmetic product classification

 

Accurate translation services in the local language on primary cosmetic packages

 

Aims at first-time approval to firmly establish labeling compliance

 

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