Key takeaways
- China requires registration or notification depending on the product category.
- ASEAN uses a harmonised cosmetic directive with a local responsible entity.
- Japan distinguishes cosmetics from quasi-drugs, which changes the claim set.
Asia is not one market. Japan, Korea, China and the ASEAN states each have their own notification or registration system, their own definition of a cosmetic, and their own requirements for a local entity. A single formula can be sold across the region, but a single dossier cannot.
1. China
China separates ordinary cosmetics, which are notified, from special cosmetics such as sunscreen and hair dye, which are registered. The dossier includes the formula, the testing, the safety assessment and the manufacturing licence. A local responsible entity is required, and the process is documentation-heavy.
2. Japan
Japan distinguishes cosmetics from quasi-drugs. A product making a claim about a physiological effect, such as whitening or anti-inflammatory action, may fall into the quasi-drug category with a heavier approval path. The claim set decides the category, so marketing copy should be drafted before the regulatory route is chosen.
3. Korea
Korea has a functional cosmetics category for whitening, wrinkle improvement and sun protection, with a review process. Ordinary cosmetics are notified. A local responsible seller is required, and the ingredient restrictions are specific and detailed.
4. ASEAN
The ASEAN Cosmetic Directive harmonises the requirements across member states, with a notification through a local company and a product information file. The ingredient annexes follow the EU closely. A notification in one member state does not automatically cover the others.
5. The local entity
Every system requires a local entity to hold the notification or the licence. That entity carries legal responsibility for the product in that market. A distributor can take the role, and the contract should state who holds the dossier and who responds to an enquiry.
6. The PIF
Most Asian systems require a product information file similar to the EU one: formula, safety assessment, manufacturing statement, claims evidence and labelling. A well-built EU file is the fastest route to an Asian dossier, with local additions.
7. Ingredient differences
Ingredient restrictions differ. A preservative permitted in the EU may be restricted in Japan; a colourant permitted in Korea may be prohibited in China. A global formula must be checked against the strictest of the target markets, or reformulated per market.
8. Testing
Some markets require local testing or accept foreign reports from accredited labs. China has specific requirements for testing institutions. The testing plan should be set per market, because a report that is accepted in one is not automatically accepted in another.
9. Labelling
Each market requires its own language and its own mandatory elements, including the local responsible entity’s name, the licence number in China and the functional category in Korea. The artwork is therefore per market, and the SKU count multiplies.
10. Timeline and cost
A notification in ASEAN can take weeks; a registration in China can take months. The cost per market ranges from hundreds to thousands of dollars, and the timeline is the binding constraint for a launch. Plan the regulatory calendar before the product calendar.
11. Where it fits
Asia entry runs across the brightening serum range; the claim boundary continues in the claims entry.
Reference: Asia market entry dossiers and notification records, 2025
