Cosmetics Regulatory Services in Japan

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In Japan, cosmetic products are regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law (PMDL), formerly known as Pharmaceutical Affairs Law. The MHLW focuses on reviewing the applications of quasi drugs and cosmetic registration in Japan (foreign manufacturer, importer), and evaluates their adverse effect reports.

As one of the affluent nations of Asia, Japan’s cosmetic market is growing constantly. Cosmetics in Japan are broadly categorized into two categories as per the MHLW. The manufactures/importers are required to complete their cosmetic registration in Japan and apply for marketing approval based on the type of product.

  • General cosmetics – These are further classified into six categories as listed below.
    • Perfume and eau de cologne
    • Makeup products
    • Skin care products
    • Hair care products
    • Special-purpose cosmetics (including sunscreen)
    • Cosmetic soaps
  • Quasi drugs – This category includes products used for preventing nausea, heat rash and mosquitoes, and promoting hair growth. Some medicated cosmetics, such as, whitening products, anti-aging products and oily skin or acne treatment products, are also categorized under quasi drugs.

Labeling in local language on primary cosmetic packages is required for all domestic and imported products for compliant cosmetic registration in Japan. Erroneous labeling translations may lead to major reworks and at times result in significant monetary loss.

As a proven regulatory partner, Freyr has extensive experience in providing Regulatory services which also includes competent product compliance check which comprises formulation review, label review and claims review.


Freyr Expertise

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


Freyr Advantages


Expertise in decoding cosmetic product classification


Accurate translation services in local language on primary cosmetic packages


Aim at first-time approval to firmly establish labelling compliance


Qualified team of experts with hands-on experience across all cosmetic categories like skin care, hair care, infant care, oral care, and beauty products


Support for region-specific Regulatory activities


End-to-end cosmetic Regulatory consultation