Marketing Authorization Holder (MAH)
An importer or domestic representative with a Type 1 cosmetics license must be designated as the Marketing Authorization Holder before any product enters Japan.
Compliance checkingAsia-Pacific
Japan cosmetic regulations
MHLW · Pharmaceutical and Medical Device Act (PMD Act)
Japan distinguishes between cosmetics (no active claims) and quasi-drugs (functional cosmetics with claims like whitening, anti-aging, anti-dandruff). Cosmetics are regulated under the PMD Act and the Standards for Cosmetics. Quasi-drugs require pre-market approval; standard cosmetics require notification by a licensed marketing authorization holder.
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Key facts
- Statute
- PMD Act + Standards for Cosmetics
- Local representative required
- Yes — Marketing Authorization Holder
- Quasi-drug claims
- Pre-market approval required
- Ingredient lists
- INCI + Japanese name (JAN) both used
What Japan requires
The core obligations every brand selling cosmetics in Japan must meet.
Notification (cosmetics)
Standard cosmetics require notification of product details, ingredients, and manufacturer to MHLW prior to import or sale.
Pre-market approval (quasi-drugs)
Whitening, anti-aging, anti-dandruff, anti-acne, and other functional cosmetics are classified as quasi-drugs (yakubuhin) and require approval prior to sale, including efficacy substantiation.
Labeling
All mandatory labeling text must be in Japanese. Ingredient names typically appear in Japanese (JAN) but INCI is widely accepted alongside.
How Cosmetica helps
Cosmetica coverage for Japan
Ingredient compliance checks against the Standards for Cosmetics and the positive list of UV filters and preservatives. Structured data ready for an in-Japan marketing authorization holder (MAH) to submit.
Primary sources
Always verify current requirements against the regulator's official publications. Cosmetica's analysis cites these primary sources directly in every compliance finding.