The first Japan decision is category, not label copy. Cosmetics and quasi-drugs (医薬部外品) have different ingredient lists, approval paths, and advertising limits. CSCL Class I chemicals are automatically out of cosmetics.
Japan cosmetics under the PMD Act
Japan regulates cosmetics and quasi-drugs under the PMD Act. Cosmetics must meet the Standards for Cosmetics (MHLW Notification No. 331 of 2000, as amended); quasi-drugs need pre-market approval.
Who should care
Brands entering Japan, especially those used to EU “cosmetic” claims. Whitening, anti-acne, hair-growth, and similar claims often sit in quasi-drug territory.
Official sources
SME: first 5 things
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1
Decide cosmetic vs quasi-drug first
Claim and ingredient, not marketing preference, drive the path.
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2
Appoint a Marketing Authorization Holder
A Japan MAH is required to manufacture/import and sell.
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3
Screen against the Standards for Cosmetics
Positive/negative lists and restrictions are in the official notification, not a blog table.
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4
Watch CSCL Class I chemicals
If a substance is designated Class I, the Standards forbid it in cosmetics.
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5
Japanese-language labeling
Mandatory particulars must be in Japanese and not misleading.
Obligation map
Common pitfalls
- Exporting an EU cosmetic claim set unchanged into Japan
- Ignoring quasi-drug approval lead time
- Missing CSCL Class I knock-on bans (e.g. PFAS-related designations)
- English-only labels on the Japanese market
More context
What this page covers
Framework hub. Check the current MHLW notification text and any CSCL Cabinet Order before freeze of formula.
Recent regulatory updates
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Always confirm requirements against official publications before decisions.