East Asia
Manufacturing in Korea for the Japanese Market
Japan is the most demanding market on this site for quality expectation and the most particular about paperwork, and it splits products into two categories that do not exist in Korea in the same form. Getting the category right is the whole game.
The framework
- Regulator
- Ministry of Health, Labour and Welfare (MHLW) and prefectural authorities
- Governing law
- Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)
- Before you can sell
- Cosmetics: notification by the licence holder. Quasi-drugs: item-by-item approval.
- Must be established locally
- An importer holding a marketing authorisation holder licence in Japan.
- Sunscreen is
- A cosmetic, with SPF and PA labelling under an industry standard.
From formula to first shipment.
- 01
Determine cosmetic or quasi-drug
Japan splits the category. Ordinary cosmetics are notified; quasi-drugs — which include many whitening, anti-acne and deodorant products — require item-by-item approval with an approved active at an approved level. A product that is a general cosmetic in Korea may be a quasi-drug in Japan purely because of its claim.
- 02
Confirm your importer holds the right licence
Import and sale requires a marketing authorisation holder licence held by a Japanese entity, plus an import sales business licence. A Korean manufacturer cannot hold these. This is the first thing to verify about a prospective Japanese partner.
- 03
Check the formula against the Standards for Cosmetics
Japan operates a negative list of prohibited and restricted substances plus positive lists for preservatives, UV filters and colourants. Some materials routine in Korea are restricted or capped at lower levels in Japan.
- 04
Prepare Japanese ingredient naming
Ingredients are declared using the Japanese naming convention rather than INCI directly. This is a translation task with a defined reference, and it is a common source of label rework when left late.
- 05
Complete notification or approval
For cosmetics, the licence holder files the notification. For quasi-drugs, approval is obtained per item, which takes substantially longer and constrains the formula to approved actives at approved levels.
- 06
Prepare compliant labelling
Japanese language, full ingredient declaration, the licence holder details, content and required warnings.
What catches brands out here.
Whitening claims usually make it a quasi-drug
Brightening and whitening positioning is central to a lot of Korean skincare, and in Japan it generally moves the product into the quasi-drug category with an approved active requirement. Reframing the claim is sometimes cheaper than pursuing approval; deciding which is the right question to ask early.
Quality expectations exceed the legal minimum
Japanese buyers and consumers are unusually intolerant of cosmetic defects — filling variation, packaging marks, colour drift. Specifications that pass elsewhere generate returns here. Agree the acceptance criteria explicitly rather than relying on a general standard.
Ingredient naming is not a direct INCI transfer
Japanese ingredient names follow their own convention. Building the label from an INCI list without conversion produces a non-compliant pack, and it is a late and avoidable delay.
Japan is a mature K-beauty market, not an emerging one
Korean brands have been sold in Japan long enough that "Korean" alone is not a positioning. Products succeed on formulation and design rather than on origin.
We document. Your local entity registers.
- Full quantitative formula with ingredient identification suitable for Japanese naming conversion
- Raw material specifications and certificates of analysis
- Stability and challenge test reports
- Manufacturing method and facility documentation
- Tightened cosmetic acceptance specifications where the buyer requires them
- The Japanese licence holder and import licences
- Notification, or quasi-drug approval where required
- Japanese ingredient naming and label artwork
- Category determination for your specific claim set
Manufacturing through contracted Korean partners, matched to your product — every order made in Korea. Certifications depend on the selected manufacturing partner and project requirements.
Why this market
Japan is one of the largest cosmetic markets in the world and a long-standing destination for Korean products, with established retail and e-commerce routes.
The market rewards restraint: minimal formulations, precise textures and quiet design perform better than the maximalist positioning that works elsewhere.
Because the category system and language work are front-loaded, Japan suits brands committing to it properly rather than testing it opportunistically.
Selling in Japan
What is the difference between a cosmetic and a quasi-drug in Japan?
Cosmetics are notified and have wide formulation freedom within the Standards for Cosmetics. Quasi-drugs require item-by-item approval and must use approved actives at approved levels, but may carry claims that cosmetics cannot — whitening and anti-acne among them. The claim usually determines the category, not the formula.
Can we import into Japan ourselves?
Only through a Japanese entity holding the required marketing authorisation holder and import licences. A Korean manufacturer cannot hold them. In practice this means a Japanese importer or distributor partner, and confirming their licence status is the first due diligence step.
Can we use our INCI ingredient list on the Japanese label?
Not directly. Japan uses its own ingredient naming convention, and the label must follow it. The conversion is a defined task with a reference standard, but it needs to be done before artwork rather than after.
Does Japan accept Korean test reports?
Manufacturing-side documentation such as stability data, certificates of analysis and specifications is normally supplied by the manufacturer and used by the licence holder. What the licence holder needs, and in what form, is set by their own quality system, so agree the documentation list with them before production.
Sources
- Pharmaceuticals and Medical Devices Act — English information — Pharmaceuticals and Medical Devices Agency, Japan
- Ministry of Health, Labour and Welfare — Pharmaceuticals and cosmetics — Ministry of Health, Labour and Welfare, Japan
- Cosmetic Regulatory Framework in Korea — Ministry of Food and Drug Safety, Republic of Korea
Requirements differ by market and by product, and they keep changing. Cross-check the current position as your project moves, and confirm it with a qualified regulatory consultant in Japan before committing to a formula or a launch date. We review these pages against the sources above as the rules move.
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What’s Next in Beauty.
Tell us you are selling into Japan at the brief stage rather than after. It changes the formula, not just the label.
Start Your Project →This page is general information for manufacturing planning. It is not legal or regulatory advice, it has no legal effect, and no rights can be derived from it. Requirements change by market and over time — before acting on anything here, confirm the current position with the authority concerned or with qualified counsel.