Mainland China is the most heavily regulated of Japan’s nearby export markets for a supplement, and it runs on two systems that both have to be satisfied — a product-side approval from China’s market regulator, and a facility-side registration from China’s customs authority. A third route, cross-border e-commerce, changes the picture again for smaller retail shipments. Getting the route right early avoids rebuilding a formula or a label later.
This guide covers who regulates health food in China, the registration-versus-filing choice for a Japan-made formula, the overseas manufacturer registration every factory needs with China Customs, and how the cross-border e-commerce retail route differs from a standard commercial import.
💬 Planning to bring a Japan-made supplement into mainland China? We help you see which route your ingredients actually qualify for before you commit to a formula. See Japan-made supplement OEM.
Who regulates health food, and the registration-versus-filing choice
China’s State Administration for Market Regulation (SAMR) is the product-side regulator for “health food” (保健食品), and a Japan-made formula generally follows one of two paths depending on what it contains and what it claims — full registration, or a lighter filing route limited to vitamins and minerals.
Health food in China is defined as food that claims a specific health function, or that supplements vitamins, minerals or other nutrients. A product limited to supplementing vitamins and/or minerals already listed in SAMR’s published raw-material catalogue can go through filing (备案), a simplified route that does not require the clinical-style evidence a full registration needs. A product that makes a specific health-function claim beyond vitamins and minerals — supporting immune function, joint comfort or similar — instead needs full registration (注册), evaluated on submitted evidence for that function.
| Route | Applies to | What it requires |
|---|---|---|
| Filing (备案) | Products limited to vitamins/minerals matching SAMR’s published raw-material catalogue | Simplified filing, no clinical-style functional evidence required |
| Registration (注册) | Products claiming a specific health function beyond vitamins/minerals, or using an ingredient outside the filing catalogue | Full registration with SAMR, including evidence for the claimed function |
An approved health food carries China’s health-food mark, commonly known as the “Blue Hat” (小蓝帽), on the package, together with an approval or filing number that shows whether the product was made in China or imported, and whether it went through registration or filing.
GACC overseas manufacturer registration
Before any commercial shipment can clear China Customs, the Japanese factory itself must be registered with the General Administration of Customs of China (GACC) — a facility-level requirement, separate from and in addition to SAMR’s product-level health-food approval.
China’s overseas food manufacturer registration system requires every foreign factory exporting food to China to be registered with GACC. Health food and dietary supplement manufacturers fall into the group of categories requiring “recommended registration,” meaning the application needs an inspection report and a recommendation from the competent authority in the factory’s own country, rather than the simpler self-application route open to some other food categories. GACC’s registration framework was updated by a new regulation (Decree No. 280), which took effect on 1 June 2026 and replaced the previous Decree No. 248; health food and dietary supplements remain on the list of categories requiring recommended registration under the new rule, and registrations already issued under the previous decree carry over without needing to be reapplied for.
| Step | Responsible party | Notes |
|---|---|---|
| GACC overseas manufacturer registration | The Japanese factory, via Japan’s competent authority (recommended-registration route) | Required before any commercial shipment can be customs-cleared |
| SAMR health food registration or filing | The China-side applicant (commonly the Chinese importer or a locally appointed agent) | Product-level approval, separate from the factory’s GACC registration |
💬 Not sure whether your ingredients fit SAMR’s filing catalogue or need full registration? Tell us your formula and we help you see which route applies.
Cross-border e-commerce: a separate retail route
China’s cross-border e-commerce (CBEC) retail-import channel lets a health food reach individual Chinese consumers under a lighter process than the standard commercial-import route, but only for products on the official positive list and only for personal-use quantities.
Goods sold through the CBEC retail channel — bought online by an individual consumer for personal use, rather than imported in bulk for general retail sale — are matched against a published “positive list” of eligible product categories; a product outside the list cannot use this channel at all. Health food is included in the positive list framework, but China’s own guidance on this route states that health food supplementing vitamins and minerals still needs to be filed, and other first-time-imported health food still needs to be registered, with the relevant authority — CBEC does not remove the underlying SAMR product-approval requirement, it only changes the import and retail mechanism and the applicable customs/tax treatment. CBEC-imported goods are restricted to personal use and cannot be resold as ordinary retail stock.
| Route | Who it reaches | SAMR requirement |
|---|---|---|
| Standard commercial import | General retail sale in mainland China | Full health food registration, or filing for a qualifying vitamin/mineral product |
| Cross-border e-commerce (CBEC) retail import | Individual consumers buying online, personal-use quantities, product on the positive list | Same underlying registration/filing requirement still applies; CBEC changes the import and tax mechanism, not the product-approval requirement |
Documents a Japanese factory can provide
A specification sheet, a Certificate of Analysis and evidence of GACC registration status are the documents a China-side applicant will ask for first, regardless of which route the product takes.
- Specification sheet. Full ingredient list, amount per serving, dosage form and packaging detail — needed for both the SAMR filing/registration application and general customs documentation.
- 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; commonly requested as supporting evidence in the SAMR process.
- GACC registration confirmation. Evidence that the factory itself is registered as an overseas manufacturer with GACC, without which no shipment can be customs-cleared.
- Certificate of origin. Supports customs clearance into China.
Before you ask for a quotation
- Whether your formula fits SAMR’s vitamin/mineral filing catalogue, or needs full health-food registration for a functional claim
- Confirmation that the Japanese factory is, or can become, registered with GACC as an overseas manufacturer under the recommended-registration route
- Whether you are targeting the standard commercial-import route or the cross-border e-commerce retail route, and whether your product sits on the CBEC positive list
- Which documents you need from the factory: specification sheet, CoA, Certificate of Free Sale, GACC registration confirmation, certificate of origin
💬 Ready to work out which China route fits a Japan-made supplement? Send us your product concept and target route.
Frequently asked questions
1. Can a Japan-made supplement skip SAMR approval by selling through cross-border e-commerce?
No. The cross-border e-commerce route changes how the product is imported and taxed for personal-use retail sale, but China’s own guidance still requires the underlying SAMR filing or registration for health food sold this way, and the product must also be on the CBEC positive list.
2. What is the difference between SAMR “filing” and “registration”?
Filing is a simplified route limited to products that only supplement vitamins and/or minerals already on SAMR’s published raw-material catalogue. Registration is required for a product claiming a specific health function beyond that, or using an ingredient outside the filing catalogue, and involves submitting evidence for the claimed function.
3. Does GACC registration replace the need for SAMR approval, or the other way round?
Neither replaces the other. GACC registration is a facility-level requirement for the overseas factory, needed before customs will clear any shipment. SAMR filing or registration is a separate, product-level approval. A Japan-made supplement generally needs both.
4. Did the rules for registering an overseas factory with China change recently?
Yes. A new regulation, Decree No. 280, took effect on 1 June 2026 and replaced the previous Decree No. 248. Health food and dietary supplement manufacturers remain in the category requiring recommended registration through Japan’s competent authority, and registrations already issued under the previous decree carry over.
5. Who applies for the SAMR health-food filing or registration — the Japanese factory or the China-side party?
The China-side applicant, commonly the importer or a locally appointed agent, applies for SAMR filing or registration. The Japanese factory supports the application with documents such as the specification sheet, Certificate of Analysis and Certificate of Free Sale.
Sources: State Administration for Market Regulation (SAMR), health food raw-material and health-function catalogue management measures (保健食品原料目錄與保健功能目錄管理辦法, SAMR Order No. 13, 2 August 2019) and the 2023 vitamin/mineral nutrient-supplement raw-material catalogue update, sjfg.samr.gov.cn / samr.gov.cn; SAMR health food registration service portal, zwfw.samr.gov.cn; General Administration of Customs of China (GACC), Decree No. 248 overseas food manufacturer registration framework and its 17 categories requiring recommended registration (including health food/dietary supplements), and Decree No. 280 (effective 1 June 2026, replacing Decree No. 248, same category treatment for health food), as summarised by CIRS Group and China Briefing from GACC’s published decree text; cross-border e-commerce retail-import positive list framework and continuing SAMR filing/registration requirement for health food sold via CBEC, as summarised by Lianlian Global and China Daily from official Ministry of Finance/customs announcements. Checked on 25 September 2026.