Japan and South Korea are the two Asian markets where a formulator's assumptions are most likely to be wrong. Both operate a two-tier system that separates ordinary cosmetics from a category that permits stronger claims, both maintain positive lists for the ingredient classes that matter most, and both require a locally licensed entity before a single unit can legally be placed on the market.
The commercial significance is high. Japanese and Korean consumers are sophisticated, retailers are demanding, and the markets are the source of much of the trend direction that reaches the rest of the world. A brand that can supply them has a credibility advantage everywhere else.
The cost of getting it wrong is equally high, because the categories that carry the strongest claims are precisely the ones that require approval rather than notification, and the timeline difference is measured in months rather than weeks.
This guide explains the two-tier logic in each market, the licence and responsible-entity requirements, the ingredient lists that govern the formula, and the labelling and fragrance rules that differ from the European and US conventions.
Both countries have amended their cosmetic frameworks repeatedly in recent years, including changes to functional cosmetic categories and to fragrance allergen labelling. Confirm the current position with a local regulatory agent before finalising a formula.
Why Japan and Korea treat formulation differently
Both markets inherited a regulatory philosophy in which the claim determines the category, and the category determines the pathway. A moisturiser that simply describes what it does is an ordinary cosmetic. The same moisturiser with a claim about whitening, wrinkles or protection may fall into a category that requires approval and efficacy data.
This is the opposite of the European approach, where almost everything is a cosmetic and the constraint is on the claim wording. In Japan and Korea the constraint bites earlier, on the formulation and the evidence, and it changes the cost structure of the project before the packaging is designed.
The practical consequence for a private label brand is that the market entry decision and the claim strategy are the same decision. Choosing a stronger claim commits the brand to a longer, more expensive pathway in both countries, and that trade-off should be made explicitly at brief stage rather than discovered during filing.
| Element | Japan | South Korea |
|---|---|---|
| Two tier structure | Ordinary cosmetics and quasi-drugs | Cosmetics and functional cosmetics |
| Ordinary route | Notification before marketing | Notification or report, depending on the category |
| Stronger claim route | Quasi-drug approval, supported by efficacy data | A report or a review process, depending on the claim category |
| Local party | An entity holding the manufacturing and sales licence | A registered responsible distributor |
| Ingredient control | Positive lists for UV filters, preservatives and colorants | Its own prohibited and restricted lists plus permitted sets |
| Label language | Japanese | Korean, with fragrance allergen disclosure above set thresholds |
Japan: ordinary cosmetics and quasi-drugs
Japan divides skin and hair products into ordinary cosmetics and quasi-drugs. Ordinary cosmetics are notified before marketing rather than approved, while quasi-drugs require formal approval and have to support their claims with data. Quasi-drug status is what allows a product to make certain efficacy claims that ordinary cosmetics cannot, which is why the category matters commercially.
The notification for an ordinary cosmetic is made by the entity that places the product on the Japanese market, and that entity must hold the appropriate manufacturing and sales licence. For an overseas brand this means working through a Japanese licensee, and since 2021 the framework has also required the overseas manufacturer to be registered in Japan through a domestic supervisory arrangement.
Two planning points follow. First, the licence holder is not a paperwork formality; the licence carries legal responsibility for the product in Japan, and the appointment takes time. Second, because quasi-drug approval requires efficacy data for the specific claim, a brand considering a quasi-drug positioning should decide that before the formulation is finalised, since the data package is built around the approved claim.
Korea: cosmetics and functional cosmetics
Korea operates a similar two-tier structure. Ordinary cosmetics follow a lighter route, while functional cosmetics, which include products making claims about UV protection, whitening, wrinkle improvement and a growing list of other categories, are subject to a report or review process depending on the category.
The Korean framework has been expanding the functional category over time, with claims relating to hair loss, acne-prone skin and other areas being added and adjusted. Because the list changes, a brand planning a Korea launch should verify the current treatment of its specific claim rather than relying on the understanding that applied when the product was first conceived.
Import and distribution require a locally registered responsible distributor, and that entity holds the obligations for the product on the Korean market. Labelling is in Korean and must carry the required content including the responsible distributor, the full ingredient list and any category-specific statements.
One further point is worth noting for brands with a global claims strategy: Korea has moved to prohibit animal testing for cosmetics, which aligns it with the European position and means a brand with a cruelty-free claim has a credible basis for it in this market.
Positive lists and the formula review that has to happen
The most consequential practical difference between these markets and most others is the use of positive lists for the ingredient classes that determine whether a formula works at all.
In Japan, the permitted UV filters, preservatives, colorants and other additive classes are governed by positive lists that differ appreciably from the European position. Several UV filters that are standard in Europe are not available in Japan, and some that are available in Japan are not available in Europe. The same is true for preservatives, where the approved set is narrower in some respects and different in others.
Korea maintains its own ingredient standards with prohibited and restricted substances and its own permitted lists for the same functional classes. Fragrance allergen labelling requirements have also been tightened, meaning that a fragrance composition statement is now needed at the design stage rather than only for the safety assessment.
What this means for a project is concrete. Give the formulator the target market list before the first sample, and ask specifically about the UV filters, the preservative system and the colorants. A formula built on a European preservative or filter set can be perfectly sound and still be unfilable in these markets, and discovering that after the stability study has been run wastes an entire development cycle.
Labelling and fragrance disclosure
Japanese and Korean labelling both require the full ingredient list in the local language using the recognised naming convention, the nominal content, the batch code, the date of manufacture or expiry in the prescribed format, the name and address of the responsible entity and the country of manufacture.
The details that commonly cause rework are the naming convention, which does not always follow the international nomenclature in the same form as a European label, and the treatment of fragrance. Korean rules in particular require disclosure of certain fragrance allergens above defined thresholds, which means a brand using a compounded fragrance needs a full composition statement from the fragrance house.
Because the fragrance house is a third party, this documentation is often the longest external dependency in the project. Requesting the composition and allergen statement at brief stage, rather than when the artwork is being prepared, is the single most effective schedule protection measure for these markets.
Japan also has specific requirements around the presentation of the manufacturer and the responsible entity, and around claims that could be read as medical. A Japanese label template and a Korean label template should be treated as separate deliverables rather than as translations of a European original.
Categories that require the most planning
Sunscreen products and whitening products are the two categories that most often require a change of pathway rather than a change of wording.
A sunscreen with a stated protection factor is treated as a functional product in Korea and requires the corresponding process, with the permitted filters and the test method prescribed. In Japan, sunscreens are generally handled within the cosmetic framework, but the specific protection claims that may be made and the testing behind them are prescribed, and the filters available differ from other regions.
Whitening and brightening products occupy the highest-scrutiny position in both markets, because the claim sits closest to a treatment claim. In Japan this is where quasi-drug approval becomes commercially relevant, and in Korea it is a defined functional category with its own evidentiary requirements.
Anti-wrinkle and firming claims similarly sit in the functional zone in Korea and in the quasi-drug zone in Japan, which makes an anti-ageing range the most complex product family to launch across both markets. A brand building such a range should plan separate formulations for each market rather than attempting one formula with adapted claims.
Documentation to request from the factory
The documentation set for these markets overlaps with the global core but with additional emphasis on two areas.
The global core is the full formula with concentrations and functions, stability data covering the claimed shelf life, a microbiological challenge test report, pack compatibility reports, the safety assessment for the finished formula, and current good manufacturing practice certification for the manufacturing site.
The two additional areas are the raw material documentation needed for the positive list review, which requires supplier confirmation of the specific grade and compliance status of each functional ingredient, and the fragrance composition and allergen statement from the fragrance house.
Both are supplier-side documents rather than factory documents, which is why they take longer than the factory paperwork. In our experience the fragrance disclosure is the item most likely to delay a Japanese or Korean launch, and it is worth requesting before the sample is approved.
Frequently asked questions about Japanese and Korean market entry
Can I sell in Japan or Korea from overseas without a local entity?
No. Both markets require a locally licensed entity to place the product on the market, and most brands appoint a licensee, distributor or regulatory agent for that role.
Is sunscreen treated as a cosmetic?
Not in the same way in both markets. Korea treats it as a functional cosmetic with a defined process, and Japan prescribes the claims and testing within its own framework.
Why do my EU ingredients not work?
Because both markets maintain positive lists for UV filters, preservatives and colorants that differ from the European lists. A formula review against the local lists is necessary before development rather than after.
Do I need separate labels for each market?
Yes. Japanese and Korean labels have their own required content, naming conventions and language requirements, and neither is a direct translation of a European label.
Can you supply documentation for filing in Japan and Korea?
Yes. Formula specifications, stability and challenge reports, pack compatibility reports, safety documentation and ingredient data are supplied in English, and we can obtain the fragrance composition and allergen statements your filing will require.
Next step: confirm the claim category before the formula
If you are preparing a product for Japan, Korea or both, send us the format, the claim set you intend to make and your target market, and we will advise on the category your claim falls into, review the formula against the local positive lists, and provide a costed quote. Write to capsulebiotech@163.com, message the right team on WhatsApp: Capsule Series (capsules only) +86 158-7655-5319, Cosmetics Series (serum, hair care, body care, fragrance) +86 158-7655-5319, or use the inquiry form and we will reply within one working day.
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