South Korea regulates supplements more formally than most of its neighbours, with a dedicated category — “health functional food” — sitting alongside ordinary food. A Japan-made product can usually go to Korea by either route, and the choice changes what you can claim, what has to be registered before the goods ever ship, and who is responsible for that registration.
This guide covers who regulates supplements in Korea, the health functional food category and its two ingredient routes, the foreign manufacturing facility registration every shipment depends on, and what a Korean label must say.
💬 Planning to bring a Japan-made supplement into South Korea? We help you work out whether health functional food or general food fits your product. See Japan-made supplement OEM.
Who regulates supplements, and the two category routes
Korea’s Ministry of Food and Drug Safety (MFDS) regulates supplements either as “health functional food,” a dedicated legal category with its own act, or as general food — and a Japan-made product can usually be planned toward either, depending on the claim you want to make.
Health functional food is defined under Korea’s Health Functional Food Act as food manufactured or processed to supplement nutrients or provide a recognised functional benefit, using ingredients from an approved list. General food, by contrast, follows Korea’s ordinary food-safety and labelling rules and historically could not carry a function claim at all — though Korea has since opened a “general food with function claim” route, described below, that narrows the gap for a subset of ingredients.
| Route | What it allows | Governing framework |
|---|---|---|
| Health functional food | A function claim using a notified or individually recognised functional ingredient | Health Functional Food Act and Health Functional Food Code, MFDS |
| General food (no claim) | Ordinary food sale, no function claim | Korea’s general food-safety and labelling rules |
| General food with function claim | A limited function claim, for specified approved functional ingredients, without full health-functional-food registration | MFDS Q&A framework introduced in 2021, alongside ordinary food rules |
Functional ingredients: notified versus individually recognised
A health functional food product can only claim a function using an ingredient that is either on MFDS’s published list of notified functional ingredients or individually recognised for that specific applicant’s product.
Notified functional ingredients are published by MFDS with set standards and specifications; any manufacturer or distributor can use one of these ingredients, formulated to the published standard, for its own health functional food. Individually recognised ingredients follow a separate path: a business submits its own safety and functionality data, and if MFDS issues a recognition certificate, only that company may use the ingredient under the certificate — it is not automatically open to other applicants. A Japan-made formula built entirely around notified ingredients (many vitamins and minerals fall in this group) has a more predictable route into Korea than one relying on a novel or Japan-specific ingredient that has no Korean recognition yet.
💬 Not sure whether your ingredients are already notified in Korea, or would need individual recognition? Tell us your formula and we help you see where it sits.
Foreign manufacturing facility registration and import declaration
Every shipment depends on two separate steps completed before the goods arrive — registering the Japanese factory as a foreign food facility with MFDS, and filing an import declaration for the specific shipment.
Under Korea’s Imported Food Act, registration of the overseas manufacturing facility with MFDS is mandatory and must be completed before any import declaration can be filed; this registration identifies the actual factory, separately from whoever imports and sells the product in Korea. Once the facility is registered, the importer files an import declaration for each shipment, and the product goes through document review, and in many cases inspection, before customs release. This applies to health functional food and to general food imports alike — the facility registration step is a food-wide requirement, not specific to the health-functional-food category.
| Step | Who is responsible | When |
|---|---|---|
| Foreign manufacturing facility registration | The Japanese factory (or its representative), registered with MFDS | Before any shipment can be declared for import |
| Import declaration | The Korea-side importer | For each shipment, at the time of import |
| Health functional food ingredient status | Notified list, or individual recognition held by a specific applicant | Fixed before the product formula is finalised for the Korean market |
Korean labels
An imported supplement needs a Korean-language label before sale, whether printed on the original pack or added afterward as a compliant sticker.
MFDS requires prepackaged food, including health functional food, to carry Korean-language labelling showing the product name, ingredient list, manufacturing and expiry (or quality-retention) dates, net contents, the responsible business’s identity and address, and any required nutrition or safety information. A sticker or supplementary label is acceptable if it is durable, not easily removable, and does not obscure the original label; Korean and other-language text may appear together, but the required elements must be in Korean. A health functional food label must also carry the required disclaimer that the product is not a medicine used for disease prevention or treatment, and it may state only the function recognised for its ingredient — not a broader wellness claim.
Documents a Japanese factory can provide
A specification sheet, a Certificate of Analysis and evidence supporting the ingredient’s functional status are the documents most useful to a Korean importer working through either route.
- Specification sheet. Full ingredient list, amount per serving, dosage form and packaging detail.
- Certificate of Analysis (CoA). Batch-specific test results confirming the product matches specification.
- Certificate of Free Sale. Confirms the product is legally sold as a food in Japan, useful supporting evidence for the Korean importer’s own registration and declaration work.
- Certificate of origin. Supports customs clearance into Korea.
Before you ask for a quotation
- Whether you are aiming for the health functional food route, the general food route, or the general-food-with-function-claim route
- Whether your functional ingredients are already on MFDS’s notified list, or would need individual recognition
- Confirmation that the Japanese factory can be registered with MFDS as a foreign food facility before shipment
- Dosage form and packaging, and how the required Korean-language elements will fit
- Which documents you need from the factory: specification sheet, CoA, Certificate of Free Sale, certificate of origin
💬 Ready to move a Japan-made supplement toward the South Korea market? Send us your product concept and preferred category route.
Frequently asked questions
1. Does a Japan-made supplement have to be “health functional food” to be sold in Korea?
No. It can also be sold as general food without a function claim, or — for certain approved functional ingredients — under Korea’s general-food-with-function-claim route, which is simpler than full health-functional-food registration.
2. What is the difference between a notified and an individually recognised functional ingredient?
A notified ingredient is on MFDS’s published list with set standards, and any business can use it if it meets that standard. An individually recognised ingredient is approved for one specific applicant’s own submitted data, and only that applicant may use it under the recognition.
3. Who registers the Japanese factory with MFDS — us or the factory?
The overseas manufacturing facility itself is the one registered with MFDS as a foreign food facility, and this must happen before any shipment can be declared for import into Korea.
4. Can I use an English-only label for a Japan-made supplement sold in Korea?
No. Korean-language labelling is required for the core elements before sale, though it can be added as a compliant sticker and can appear alongside other languages.
5. Does a health functional food label need to say it is not a medicine?
Yes. Korean rules require the label to state that the product is not a pharmaceutical product for disease prevention or treatment, and to limit the function claim to the ingredient’s recognised function.
Sources: Ministry of Food and Drug Safety (MFDS), Health Functional Food Act and Health Functional Food Code, definitions of notified and individually recognised functional ingredients, mfds.go.kr; MFDS, Imported Food Safety / foreign food facility registration requirement before import declaration, mfds.go.kr; MFDS, Foods Labeling Standards, Korean-language labelling requirements for imported prepackaged food, mfds.go.kr; general-food-with-function-claim route introduced via MFDS Q&A, 2021, as summarised by ChemLinked. Checked on 25 September 2026.