Expanding into Japan’s flourishing cosmetics market can be a game-changer for your brand. However, understanding stringent cosmetic regulatory landscape of Japan requires expertise and precision. At Freyr, we streamline your journey, ensuring your cosmetic products meet all the regulatory requirements of the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Act (PMD Act).

Japan’s Cosmetic Classification: Simplified for Success

Japan classifies cosmetics into two main categories, each with its distinct requirements:

General Cosmetics

  • Includes perfumes and eau de cologne, makeup, skincare, haircare, and special purpose cosmetics (including sunscreens).
  • Requires a simple Cosmetic Marketing Notification for market entry.

Quasi-Drugs

  • Encompasses products like anti-nausea remedies, hair growth treatments, whitening, and anti-aging products.
  • Cosmetic product registration is applicable to approval for compliance.

Essential Labeling for Seamless Compliance

All cosmetic products, whether domestic or imported, must feature Japanese cosmetic labeling on the primary packaging. Accurate translation is crucial to avoid costly reworks and regulatory setbacks.

Freyr: Your Trusted Partner in Japan

Decoding Japan’s cosmetic regulations can be challenging, but with Freyr, you have a reliable partner. Our comprehensive services include:

Our Expertise Includes:

Why Choose Freyr for Japan?

  • Decoding Complexity

    Japanese cosmetic classifications and cosmetic regulations.

  • Diverse Expertise

    Experience across skincare, haircare, infant care, oral care, and beauty products.

  • Strategic Alliances

    Leverage our network with organizations like the Japan Cosmetic Industry Association.

  • Local Partnership

    Acting as your operational partner within Japan for full regulatory compliance for cosmetics.

  • Comprehensive Support

    From regulatory consultations to end-to-end Cosmetic product registration.

  • Stay Ahead

    Receive timely updates on evolving Japan's Cosmetic regulations.

Ready to conquer the Japanese market? Partner with Freyr for streamlined cosmetic product registration in Japan and focus on what you do best—innovating beauty.

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Frequently Asked Questions – Cosmetics in Japan

What are the main categories of cosmetics under Japanese law?
Japan divides cosmetics into General Cosmetics (makeup, skincare, perfumes, etc.) and Quasi-Drugs (products with specific functional claims like hair growth, whitening, anti-aging). The regulatory requirements differ depending on the category.
What regulatory act governs cosmetics in Japan?
Cosmetic regulation in Japan is governed by the Pharmaceutical and Medical Devices Act (PMD Act), administered through the Ministry of Health, Labour and Welfare (MHLW).
What is required to launch a general cosmetic product in Japan?
For general cosmetics, you need to submit a Cosmetic Marketing Notification. Labeling in Japanese and accurate translations are essential.
What extra steps are needed for a “quasi-drug” product?
Quasi-drugs have more stringent requirements, including product registration/approval with the authorities, since they make functional claims such as whitening, hair growth, or other therapeutic/benefit claims.
What labeling requirements must imported cosmetic products meet?
All cosmetic products—domestic or imported—must have Japanese cosmetic labeling on the primary packaging. Translation accuracy is crucial to avoid regulatory setbacks.
What are “special purpose cosmetics” in the context of Japanese regulation?
These are cosmetics with functions beyond basic beautification—examples include sunscreens, teeth-whitening, or anti-aging products. Depending on the claims, some may be classified as quasi-drugs.
How often do cosmetic regulations change in Japan—and how do I stay updated?
Regulations evolve periodically through amendments by MHLW or updates to classification or labeling norms. Working with a local partner or regulatory intelligence provider like Freyr helps you stay ahead of changes.
What are common pitfalls companies face when registering cosmetics in Japan?
  • Misclassifying the product (leading to wrong regulatory path)
  • Errors in translation or labeling
  • Using prohibited or restricted ingredients without proper approval
  • Underestimating time needed for quasi-drug approval versus general cosmetic notification.
How long does the cosmetic registration or notification process take in Japan?
The timeline depends on whether the product is a general cosmetic (notification) or quasi-drug (more rigorous registration). The quasi-drug approval process takes more time due to safety and efficacy data requirements. (Exact times vary case by case.)
How can Freyr help with navigating cosmetic regulations in Japan?
Freyr offers end-to-end support: regulatory consultation, classification advice, aligning with regulatory bodies such as the Japan Cosmetic Industry Association, and ensuring full compliance with MHLW standards.