SAMR Blue Hat Approval for Domestic and Imported Supplements — Your Trusted Domestic Responsible Agent in China
China offers significant opportunities for overseas supplement, nutrition, functional food and nutraceutical brands. However, products marketed as dietary supplements, food supplements, health supplements, natural health products or nutraceuticals in other countries may not automatically fall into the same regulatory category in China.
Before entering China through general trade, offline retail, domestic e-commerce platforms, cross-border e-commerce (CBEC), or local OEM/ODM manufacturing, companies need to determine whether their product is subject to China health food registration, China health food filing, or another food compliance pathway.
REACH24H provides end-to-end support for China health food registration and filing, including product classification, registration/filing pathway assessment, formula and claim review, testing strategy, dossier preparation, SAMR submission support, Chinese labeling review, GACC-related import compliance assessment and post-approval maintenance.
What Is Health Food in China and What Is the Blue Hat?
In China, health food refers to food that claims and delivers specific health functions or is intended to supplement vitamins, minerals or other nutrients. Health food is not intended to treat diseases, and its label, instructions and advertising must not claim disease prevention or therapeutic effects.
A health food product approved through registration or filing may bear the dedicated health food logo commonly known as the “Blue Hat” mark. In business discussions, terms such as Blue Hat registration, Blue Hat filing or China Blue Hat approval are often used. From a regulatory perspective, however, companies should distinguish between health food registration, health food filing, health food registration certificate and health food filing certificate.
Market Entry Strategy: CBEC vs. Blue Hat Certification
For foreign supplement brands, choosing the right China market entry pathway is a strategic decision. Many companies first test market demand through cross-border e-commerce (CBEC) and later consider general trade, domestic e-commerce, offline retail or local manufacturing once the product has proven commercial potential.
Option A: Cross-Border E-Commerce (CBEC)
CBEC may provide a different market entry route for eligible products sold directly to Chinese consumers through approved cross-border e-commerce channels. However, CBEC does not automatically exempt a product from all product compliance obligations.
Advantages: Fast market entry (2–4 months); no SAMR Blue Hat registration or filing required; original foreign packaging permitted; lower initial investment.
Limitations: Cannot be sold in physical retail stores or domestic e-commerce platforms; no specific health function claims allowed; per-transaction purchase volume limits apply (5,000 RMB per transaction, 26,000 RMB per person per year).
Option B: General Trade with Blue Hat Certification
If your business goal is long-term China market expansion through general trade, domestic e-commerce, pharmacies, supermarkets, distributor networks or offline retail, you may need to obtain Blue Hat approval through health food registration or health food filing.
Advantages: Access to all sales channels; ability to make SAMR-approved health function claims; higher consumer trust; no purchase volume limits.
Limitations: Longer timeline (6 months to 3+ years); significant testing and dossier preparation costs; compliant Chinese physical labeling required.
China Health Food Registration vs Filing: Which Path Applies?
China adopts a dual-track management system for health food: registration and filing. The applicable route should be determined based on the product’s raw materials, health function claims, dosage form, daily intake, target population, manufacturing location, import status and intended sales channel.
Health food registration generally applies to health food products using raw materials outside the Health Food Raw Material Directory, as well as first-time imported health food products, except those intended to supplement vitamins, minerals and other nutrients listed in the Health Food Raw Material Directory.
Health food filing generally applies to domestic health food products using raw materials listed in the Health Food Raw Material Directory and meeting the applicable filing technical requirements. It also applies to first-time imported health food products intended to supplement vitamins, minerals and other nutrients, provided that the relevant nutrients are included in the Health Food Raw Material Directory.
| Product scenario | Likely regulatory pathway |
|---|---|
| Domestic health food using raw materials outside the Health Food Raw Material Directory | Health food registration |
| First-time imported health food, except eligible nutrient supplement products | Health food registration |
| Domestic health food using raw materials listed in the Health Food Raw Material Directory and meeting applicable filing technical requirements | Health food filing |
| First-time imported health food intended to supplement vitamins, minerals and other nutrients listed in the Health Food Raw Material Directory | Imported health food filing |
| Overseas dietary supplements already sold abroad but not matching China’s filing directory or technical requirements | Registration or further pathway assessment required |
| Ordinary food, solid beverage, compressed candy or tea product wishing to claim health functions | Health food registration/filing assessment required |
| CBEC product moving to general trade or offline retail in China | Blue Hat pathway assessment recommended |
| Overseas brand planning China OEM/ODM production | Domestic vs imported pathway comparison required |
REACH24H helps companies determine the most appropriate route before formula finalization, sample production, testing or China market launch.
China Health Food Registration
Health food registration is an administrative approval process. It involves a systematic technical review of materials related to product safety, health function and quality controllability.
Registration is generally required for health food products using raw materials outside the Health Food Raw Material Directory and for first-time imported health food products that are not eligible for imported health food filing.
Compared with filing, registration usually involves more complex technical evaluation. It may require safety assessment, health function evaluation, human consumption studies where applicable, stability testing, hygiene testing, functional or marker ingredient testing, production process validation and a complete registration dossier.
Typical Products Requiring Registration
China health food registration may apply to:
Functional supplements with specific health function claims;
Products using raw materials outside the Health Food Raw Material Directory;
First-time imported functional health food products;
Products involving complex formulas, novel functional positioning or non-standard ingredients;
Products planning to move from cross-border e-commerce to general trade or offline channels;
Products marketed overseas as dietary supplements, food supplements, nutraceuticals, health supplements or natural health products but not eligible for China filing.
Domestic vs Imported Health Food Registration
| Item | Domestic health food registration | Imported health food registration |
|---|---|---|
| Typical applicant | A legally registered legal person or other organization in China | Overseas manufacturer of the marketed health food |
| Applicable product | Domestic health food using raw materials outside the Health Food Raw Material Directory | First-time imported health food, except eligible nutrient supplement products |
| Registration number format | 国食健注G + 4-digit year code + 4-digit serial number | 国食健注J + 4-digit year code + 4-digit serial number |
| Certificate validity | 5 years | 5 years |
| Key challenges | Formula rationale, functional claim support, testing strategy, production process, quality control | Overseas qualification documents, proof of overseas sale, notarized translations, China agent arrangement, Chinese label conversion |
| Early-stage focus | Ingredient feasibility, claim feasibility, dosage form, testing plan | Import status, overseas manufacturer qualification, evidence of overseas marketing, China market access strategy |
For companies exporting finished food products to China, health food registration may also need to be assessed together with China food import compliance and GACC overseas manufacturer registration.
China Health Food Filing
Health food filing is a record-filing process in which the filing applicant submits materials indicating the product’s safety, health function and quality controllability to the competent authority for record filing, publication and future inspection.
Filing is generally more streamlined than registration, but it is not a simple online upload. The product must still meet the applicable requirements on raw materials, function claims, dosage forms, excipients, technical specifications, labeling, instructions and testing.
Official references on health food filing and eligible raw materials include the Health Food Raw Material Directory - Nutrient Supplements, the Health Food Registration and Filing Product Data Query and the imported health food filing information page.
Domestic Health Food Filing
Domestic health food filing generally applies to health food products produced in China using raw materials listed in the Health Food Raw Material Directory and meeting the applicable filing technical requirements.
For overseas brands considering local manufacturing, OEM or ODM production in China, domestic filing may be worth evaluating if the formula, ingredients, dosage form, function claim, daily intake and product technical requirements fit the filing route.
Imported Health Food Filing
Imported health food filing generally applies to first-time imported health food products intended to supplement vitamins, minerals and other nutrients, provided that the relevant nutrients are listed in the Health Food Raw Material Directory and the product meets applicable filing requirements.
For imported health food filing, the filing applicant should be the overseas manufacturer of the marketed health food. According to the SAMR government service platform, imported health food filing materials are received by the Center for Food Evaluation of SAMR, and the filing result is an imported health food filing certificate.
Additional documentation may be required, such as overseas manufacturer qualification documents, proof of overseas sale, original overseas labels and instructions, Chinese translations, notarized documents and China agent documents.
Domestic vs Imported Health Food Filing
| Item | Domestic health food filing | Imported health food filing |
|---|---|---|
| Applicable product | Domestic products using raw materials listed in the Health Food Raw Material Directory and meeting filing technical requirements | First-time imported health food intended to supplement vitamins, minerals and other nutrients listed in the Health Food Raw Material Directory |
| Filing applicant | Health food manufacturer in China; original registration holder may also act as filing applicant where applicable | Overseas manufacturer of the marketed health food |
| Handling authority | Provincial-level market regulation authorities | Center for Food Evaluation of SAMR |
| Filing number format | 食健备G + 4-digit year code + 2-digit provincial administrative division code + 6-digit serial number | 食健备J + 4-digit year code + 00 + 6-digit serial number |
| Common documents | Filing form, applicant qualification, formula, production process, test reports, label and instructions, product technical requirements | Domestic filing documents plus overseas qualification, proof of overseas sale, original label/instructions, Chinese translation, notarization and agent documents |
| Key challenges | Directory applicability, dosage form, excipient compliance, test report consistency, label consistency | Overseas documents, notarization and translation, Chinese label conversion, China agent arrangement, document consistency |
Registration or Filing? Key Questions for Overseas Companies
Overseas supplement brands should not assume that a product sold as a dietary supplement, food supplement or health supplement in another country can be directly filed or registered in China.
Before selecting the pathway, companies should assess:
Is the product a health food, ordinary food, Food for Special Medical Purpose (FSMP), medicine, or another regulated category in China?
Are all active ingredients included in the Health Food Raw Material Directory?
Does the product meet the applicable filing technical requirements?
Is the product a nutrient supplement or a functional health food?
Is the product being imported for the first time?
Is the product manufactured overseas or through China OEM/ODM?
Are the intended health function claims permitted in China?
Does the dosage form meet filing or registration requirements?
Are the daily intake level, target population and unsuitable population compliant?
Can the existing overseas label be converted into a compliant Chinese label?
Will the product be sold via CBEC, general trade, domestic e-commerce, pharmacies, supermarkets or offline retail?
REACH24H can help review the product at the concept, formula, sample or market-entry stage to reduce the risk of choosing the wrong regulatory route.
China Health Food Registration and Filing Process
1. Product classification and pathway assessment
We assess whether the product should be managed as health food, ordinary food, FSMP, medicine or another category in China. We then determine whether registration, filing or another compliance route applies.
2. Formula, ingredient and claim review
We review the formula, raw materials, excipients, dosage form, daily intake, target population, unsuitable population and intended claims against China’s health food requirements.
3. Regulatory feasibility and gap analysis
We identify potential issues before formal testing or dossier preparation, such as non-listed ingredients, claim mismatch, dosage form limitations, excessive nutrient levels, missing overseas documents, label inconsistency or insufficient scientific support.
4. Testing strategy and sample preparation
We help design the required testing plan and coordinate with qualified testing institutions where needed, covering hygiene testing, stability testing, functional or marker ingredient testing, safety evaluation and health function evaluation.
5. Dossier preparation
We support the preparation of registration or filing documents, including formula materials, production process information, product technical requirements, test reports, label and instruction drafts, R&D rationale, safety and function evaluation materials and other supporting documents.
6. Submission and authority communication
We assist with online system preparation, submission support, technical review communication, supplementary material preparation and response to authority comments.
7. Approval, filing completion and post-market compliance
After approval or filing completion, we help companies maintain compliance throughout the product lifecycle, including label updates, advertising review, certificate renewal, change registration, filing changes, import compliance and channel compliance.
What Documents Are Commonly Required?
Actual document requirements depend on the product type, formula, function, origin, manufacturing model and applicable route. Common document categories include:
For Health Food Registration
Applicant qualification documents;
Product R&D report;
Formula and ingredient rationale;
Production process and process validation materials;
Product technical requirements;
Safety evaluation materials;
Health function evaluation materials;
Human consumption study materials, where applicable;
Hygiene, stability and marker ingredient test reports;
Label and instruction drafts;
Packaging material information;
Overseas manufacturer qualification documents for imported products;
Proof of overseas sale or safety history for imported products;
Chinese translations and notarized documents where required.
For Health Food Filing
Filing form;
Applicant qualification documents;
Formula and production process materials;
Raw material and excipient compliance explanation;
Product technical requirements;
Label and instruction drafts;
Full-item test reports;
Product name search materials;
Overseas manufacturer qualification documents for imported products;
Proof of overseas sale and original overseas label/instructions for imported products;
Chinese translations, notarization and agent documents where required.
Timeline and Cost Factors
There is no single timeline or cost that applies to all China health food registration and filing projects. The overall project timeline and budget may be affected by:
Whether the product follows registration or filing;
Whether it is domestic or imported;
Whether ingredients are included in the Health Food Raw Material Directory;
Whether the product meets the applicable filing technical requirements;
Whether the product involves functional claims, new functions, special ingredients or complex formulas;
Whether human consumption studies or additional safety studies are required;
Sample preparation and production scale;
Testing institution schedule;
Overseas document preparation, notarization and translation;
Technical review comments and supplementary material requirements;
Label, claim or formula adjustment during the project.
REACH24H: One-Stop China Health Food Registration & Filing Services
REACH24H provides regulatory and technical support across the full lifecycle of China health food registration and filing, from initial concept assessment through post-market compliance.
Product Pathway Assessment: We determine whether your product requires health food registration, health food filing, ordinary food compliance, FSMP registration, or another regulatory route — and whether CBEC or general trade is the right entry strategy.
Formula & Claim Compliance Review: We assess ingredients, active substances, excipients, dosage form, daily intake, target population, unsuitable population, and intended health claims against China's requirements.
Domestic Responsible Agent (DRA) Services: As your independent, qualified DRA in China, we submit applications, communicate with SAMR, and manage your certificates — independently of your distributors.
GACC Overseas Manufacturer Registration: We handle GACC Decree 280 facility registration for overseas supplement manufacturers, ensuring your products can clear Chinese customs without disruption.
Testing Strategy & Coordination: We design appropriate testing strategies and coordinate with SAMR-designated testing institutions, covering hygiene, stability, functional, and safety evaluation testing.
Dossier Preparation & Submission Support: We prepare complete registration or filing dossiers and manage the full SAMR submission process, including responding to authority comments.
Imported Health Food Support: We assist overseas companies with foreign manufacturer qualification documents, proof of overseas sale, Chinese translations, notarization, and all import-related compliance requirements.
Post-Approval Compliance: We support label review, advertising compliance, e-commerce content review, filing changes, registration changes, certificate renewal, technology transfer, and CBEC-to-general-trade transition.
Why Choose REACH24H?
With more than a decade of experience in food regulatory compliance, REACH24H has supported thousands of food companies worldwide in entering target markets, including Fortune Global 500 companies. We also work with embassies, consulates, business associations, and industry organizations as a trusted market access service provider.
Decades of Food Compliance Expertise
Our food compliance team combines expertise in food science, toxicology, chemistry, biology, nutrition, and regulatory affairs. REACH24H also has toxicology professionals with credentials such as DABT, ERT, and DCST, enabling us to support safety assessment, dossier preparation, and technical responses during the SAMR review process.
Global Service Network
With 9 global branches and over 300 in-house specialists, we have served over 15,000 enterprises including 103 Fortune Global 500 firms, delivering prompt cross-border regulatory support.
Trusted Technical Communication Channel
We maintain steady professional contact with China’s regulators and technical bodies such as SAMR, NHC and CFSA expert panels. We help clients prepare technical documents, reply to supplementary material requests and resolve review-related scientific and regulatory questions.
Frequently Asked Questions
A: Health food registration is an administrative approval process involving technical evaluation of product safety, health function and quality controllability. Health food filing is a record-filing process where the filing applicant submits materials indicating the product’s safety, health function and quality controllability for filing, publication and future inspection.
Products using raw materials outside the Health Food Raw Material Directory and certain first-time imported products usually require registration. Products using listed raw materials and eligible imported nutrient supplement products may follow the filing route, provided that applicable filing technical requirements are met.
A: No. Some first-time imported health food products intended to supplement vitamins, minerals and other nutrients may be subject to imported health food filing if the relevant nutrients are included in the Health Food Raw Material Directory and the product meets China’s filing requirements. Other imported health food products, especially functional products, usually require registration or further pathway assessment.
A: Not necessarily. A product sold overseas as a dietary supplement, food supplement or health supplement must be assessed under China’s health food rules. The formula, nutrient source, dosage form, claim, daily intake, target population, label and overseas documentation must all be reviewed before determining whether filing is possible.
A: “Blue Hat” is a common market term referring to the dedicated logo for registered or filed health food products in China. Depending on the product, Blue Hat approval may be achieved through health food registration or health food filing. Companies should use the official terms “health food registration certificate” or “health food filing certificate” in regulatory documents.
A: Cross-border e-commerce retail import and general trade import follow different regulatory logic. If a product plans to move from CBEC to general trade, offline retail or domestic e-commerce platforms, the company should reassess whether health food registration or filing is required, and review Chinese labeling, advertising claims and import compliance.
A: In most cases, overseas test reports cannot directly replace China-required testing. Existing overseas data may support the scientific rationale, but the need for China-based testing should be assessed based on the product type, function, formula and applicable requirements.
A: No. Health food products must not claim disease prevention or treatment. Labels, instructions, advertising and online sales content should remain consistent with the registered or filed content and comply with China’s health food labeling and advertising requirements.
A: Companies should start the assessment before finalizing the China-market formula, producing application samples, designing Chinese labels, or deciding between CBEC, general trade and local manufacturing. Early assessment can reduce reformulation, repeated testing and launch delays.
Related Services
Official References
Plan Your China Health Food Market Access Strategy
Whether you are exporting a finished supplement to China, evaluating imported nutrient supplement filing, developing a functional health food product, or considering China OEM/ODM manufacturing, REACH24H can help you identify the right regulatory pathway and prepare for compliant market entry.
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