East Asia · Japan
What does it take to sell cosmetics in Japan? Entry route, responsibility, labeling
No pre-market approval for cosmetics: the licensed MAH files a 化粧品製造販売届 (notification) pe…; Responsible person: A Japan-licensed 製造販売業者 (Marketing Authorization Holder) mu…; Labeling: Full ingredient list in Japanese using JCIA 表示名称 ….
Latest change 2025-05-21 — PMD Act amendment (Act No. 37 of 2025) promulgated and phased in from 2025-11-20 and 2026-05-01, tightening MAH governance, quality and supply obligations (largely pharma-focused); separately MHLW's 2025-03-10 notice rewrote the 特記表示 (highlighted-ingredient) rules so that the ingredient's purpose must be stated. Source
Factory-side digest; the official text prevails; not legal advice.
- Authority
- Ministry of Health, Labour and Welfare (MHLW) with PMDA; prefectural governments issue licences
- Main regulation
- Act No. 145 of 1960 (renamed PMD Act 2014); latest amendment Act No. 37 of 2025 · Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)
- In force
- 1961-02-01
- Market entry
- No pre-market approval for cosmetics: the licensed MAH files a 化粧品製造販売届 (notification) per product before sale, whereas products with medicinal claims are 医薬部外品 (quasi-drugs) needing MHLW approval.
- Responsible person
- A Japan-licensed 製造販売業者 (Marketing Authorization Holder) must hold the product notification and bear full responsibility, and imported goods also need a licensed 製造業者 for labelling/storage.
- Safety file
- No statutory PIF; the MAH must ensure conformity with 化粧品基準 and the GQP/GVP ordinances and keep quality and safety records.
- Labeling
- Full ingredient list in Japanese using JCIA 表示名称 (mandatory since 2001-04-01) plus product name, MAH name/address, contents and lot; a highlighted ingredient (特記表示) must state its purpose (2025-03-10 notice); no fragrance-allergen labelling rule in force.
- Animal testing
- No statutory ban and no requirement for cosmetics; quasi-drug approvals may still rely on animal data.
- Ingredient lists
- 化粧品基準 (Standards for Cosmetics, MHW Notification No. 331 of 2000, last amended 2024-07-12): negative list plus positive lists for preservatives, UV filters and tar colours.
- Notes
- Consultancy claims that Japan will mandate fragrance-allergen labelling from May 2026 could not be verified on MHLW's site and should be treated as unconfirmed; MHLW also introduced electronic export certificates for cosmetics on 2026-07-27 (ChemLinked).
- Look up this inventory here
- 日本 · Standards for Cosmetics — appended tables
- Official text
- https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/keshouhin/index.html
Changes 2025–2026
- Japan promulgates PMD Act amendment (Act No. 37 of 2025)
Phased in from 2025-11-20 and 2026-05-01, the amendment strengthens MAH quality/safety governance and supply obligations; the cosmetics-specific 2025 change was MHLW's 2025-03-10 notice rewriting the 特記表示 highlighted-ingredient rules to require the ingredient's purpose on packs and ads. Source
FAQ
Does Japan require notification or registration before sale?
No pre-market approval for cosmetics: the licensed MAH files a 化粧品製造販売届 (notification) per product before sale, whereas products with medicinal claims are 医薬部外品 (quasi-drugs) needing MHLW approval.
Is a local responsible person mandatory in Japan?
A Japan-licensed 製造販売業者 (Marketing Authorization Holder) must hold the product notification and bear full responsibility, and imported goods also need a licensed 製造業者 for labelling/storage.
What are the labeling requirements in Japan?
Full ingredient list in Japanese using JCIA 表示名称 (mandatory since 2001-04-01) plus product name, MAH name/address, contents and lot; a highlighted ingredient (特記表示) must state its purpose (2025-03-10 notice); no fragrance-allergen labelling rule in force.
What changed recently in Japan cosmetic regulation?
2025-05-21 PMD Act amendment (Act No. 37 of 2025) promulgated and phased in from 2025-11-20 and 2026-05-01, tightening MAH governance, quality and supply obligations (largely pharma-focused); separately MHLW's 2025-03-10 notice rewrote the 特記表示 (highlighted-ingredient) rules so that the ingredient's purpose must be stated.
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