China’s Food and Health Food regulation is administered by the State Administration for Market Regulation (SAMR), with responsibilities distributed across state, provincial, municipal, and county-level authorities. The National Health Commission (NHC) approves new additives, ingredients, and contact materials, while the General Administration of Customs (GAC) enforces compliance for imported products.
Products are classified as Foods or Health Foods. Health Foods require registration or filing approval, and successful applicants receive the Blue Hat certification.
Freyr provides Regulatory expertise across classification, dossier preparation, label and claims review, and submissions to Chinese authorities, ensuring compliant market entry.
Understanding the Regulatory Framework for Foods and Health Foods in China
China applies a structured Regulatory framework to ensure consumer safety, fair trade, and transparency across foods and health foods. Oversight is shared between:
State Administration for Market Regulation (SAMR) – Administers food and health food regulation, manages registration and filing approvals, and enforces compliance nationwide.
National Health Commission (NHC) – Reviews and authorizes new additives, novel ingredients, and food contact materials.
General Administration of Customs (GAC) – Ensures imported foods and health foods meet China’s regulatory requirements and oversees customs clearance. Manages overseas manufacturer registration under GAC Decree 248 and import food compliance requirements under GAC Decree 249.
Provincial, municipal, and county authorities – Handle local implementation, inspections, and market surveillance under SAMR’s guidance.
Product Categories Under Chinese Regulation
1. General Foods
General foods are everyday consumables intended for the general public, ranging from raw agricultural produce to processed snacks, beverages, and dairy.
Categories: Defined across 18 trade types by the General Administration of Customs (GAC), including meat, aquatic products, grains, and processed foods.
Regulations: Governed by national food safety standards (GB standards). Fortification with approved nutrients is permitted, but general foods cannot carry functional, physiological, or health-related claims.
2. Foods for Special Dietary Use (FSDU)
Foods for Special Dietary Uses (FSDU) are specific categories of foods intended to meet the nutritional requirements of particular population groups, as defined under applicable GB standards. Classification should be assessed on a product-specific basis. These must comply with GB standards but do not require SAMR registration or Blue Hat certification.
3. Special Foods
Products targeting vulnerable demographics or demanding clinical nutrition. These require strict pre-market authorization before commercial import. They are divided into three (3) highly regulated categories:
A. Health Food (Functional Food): Regulated by SAMR Health Food Rules. Intended for specified groups to help regulate body functions, but not to treat diseases.
- Nutrient Supplements: Vitamins and minerals designed to supplement a regular diet.
- Functional Health Foods: Products with approved functional claims (e.g., "helps enhance immunity," "helps improve sleep").
B. Foods for Special Medical Purposes (FSMP): Specially processed and formulated to meet nutritional needs of consumers with clinical conditions, digestive disorders, or metabolic diseases.
C. Infant Formula: Specially formulated foods designed to satisfy the nutritional requirements of infants and young children.
What is Registration vs Filing for Health Foods in China?
Health Foods must undergo either Registration or Filing before market entry; two (2) distinct approval pathways that differ in scope, requirements, and timelines.
Filing vs Registration Comparison Guide
| Pathway | Applies To | Timeline | Key Requirements | Outcome |
|---|---|---|---|---|
| Registration | Products with new ingredients or functional claims not listed in the official catalog | 12–24 months | Full technical dossier in Chinese, safety evaluation, clinical/functional testing | Approval grants Blue Hat certification |
| Filing | Products using listed ingredients (e.g., vitamins, minerals) | Typically, several months, depending on dossier completeness and authority review timelines. | Simplified dossier, compliance with SAMR directory | Approval grants Blue Hat certification |
What is Blue Hat Registration?
Blue Hat Registration is the result of SAMR’s approval process for Health Foods. Upon successful completion of the applicable Registration or Filing procedure, eligible Health Foods are authorized to use the Blue Hat certification mark in accordance with SAMR requirements.
- Symbol of Compliance: The Blue Hat logo indicates that the product has completed the applicable Health Food Registration or Filing process with SAMR.
- Consumer Trust: It reassures buyers that functional claims are officially validated.
- Market Access: Without the Blue Hat, Health Foods cannot legally be marketed or sold in China.
Step By Step Registration and Filing Process for Health Foods in China
STEP 01
DETERMINE
PATHWAY
PATHWAY
Identify whether the product requires Registration (new ingredients or novel claims) or Filing (listed vitamins and minerals).
STEP 02
PREPARE TECHNICAL
DOSSIER
DOSSIER
Compile documents in Chinese, including product formula, manufacturing process, safety data, and labeling information.
STEP 03
CONDUCT REQUIRED
TESTING
TESTING
Submit samples for required testing at qualified laboratories recognized in accordance with applicable Chinese regulatory requirements.
STEP 04
SUBMIT APPLICATION
TO SAMR
TO SAMR
File the dossier through SAMR's online portal, pay fees, and provide supplementary materials if requested.
STEP 06
RECEIVE
APPROVAL
APPROVAL
If successful, the product is granted Blue Hat certification, authorizing market entry and health claim use.
STEP 05
UNDERGO AUTHORITY
REVIEW
REVIEW
SAMR reviews the dossier, test results, and compliance with GB standards; queries may be raised for clarification.
Click here to view the full list of documents required for Registration and Filing.
Foods in China
For Foods (general food products), there is no Registration or Filing pathway under SAMR. Instead, compliance is based on GB standards (China's national food safety standards).
Key Documentation Checklist:
Product formula and ingredient list
Ingredient specifications (purity, source, technical data)
Manufacturer business license and qualification documents
Label samples (Chinese, GB-compliant)
Packaging artwork (final design meeting GB rules)
Stability data (shelf-life, storage conditions)
Testing reports from accredited labs (chemical, microbiological, heavy metals)
📌 Foods for Special Dietary Uses (FSDU) — such as infant formula or medical foods follow stricter GB standards, requiring nutritional adequacy and additional stability/nutritional studies.
Post-Approval Compliance in China
Approval is not the end of the regulatory journey. After obtaining Health Food Registration/Filing approval or placing a compliant food product on the Chinese market, companies must maintain ongoing obligations to stay market-ready:
Renewal & Validity — Approvals must be renewed if product composition, claims, or labeling change.
Label Updates — Labels must be revised whenever GB standards or SAMR rules are updated.- Advertising & Claims Control — Functional claims must match those approved; disease-treatment claims are prohibited.
Periodic Testing — Shelf-life, safety, and efficacy data may need re-submission to confirm ongoing compliance.
Imported Food Facility Registration — Where applicable, overseas manufacturers must maintain registration with GAC in accordance with Decree 248 and comply with relevant import requirements under Decree 249.- Market Surveillance — Provincial and municipal authorities conduct inspections; non-compliance can trigger fines, recalls, or blacklisting.
How Can Freyr Help?
China Food Product Classification- Health Food Formulation Review/Ingredients Assessment
- Health Food Labeling Review
- Health Food Claims Review
- Registration Support for all Applicable Categories
- Claims Consultation and Substantiation
- Gap Analysis
- Health Food Dossier Compilation
- Health Food Regulatory Intelligence
- Go-to-market Regulatory Support
- Food Registration in China
- Food Product Notification in China
Why Choose Freyr?
End-to-end Regulatory consultation
Market-specific Regulatory consulting and advice
A structured and cost-effective approach ensuring speed to market
An extensive partnership network across the globe
Strong relationship with various HAs
Ready to Validate Your Product for the China Market?
Don't guess on compliance. Let our local regulatory experts analyze your formulation.
Frequently Asked Questions (FAQs)
Clear answers to common queries on China’s food and health food registration process, designed to help you navigate compliance with confidence.
Do all Foods require SAMR approval?
No. General Foods only need to comply with GB standards. Only Health Foods require Registration or Filing with SAMR.
What types of products qualify as Health Foods?
Nutrient supplements (vitamins, minerals) and functional foods with approved claims such as “enhances immunity” or “improves sleep.”
Can Foods carry health claims?
No. General Foods cannot carry functional or physiological claims. Only Health Foods with Blue Hat certification can legally make such claims.
What is required for imported Foods?
Where applicable, overseas manufacturers must be registered with GAC under Decree 248 and comply with import requirements under Decree 249, in addition to meeting relevant GB standards and labeling requirements.
What documents are critical for Health Food Registration?
Application form, product formula, manufacturing process, safety evaluation reports, functional/clinical testing, label samples, GMP/ISO certificates, and novelty evidence.
What documents are critical for China Health Food Filing?
Application form, product formula & ingredient list (matching SAMR catalog), quality & safety testing reports, label samples, manufacturer qualifications, and proof of catalog compliance.
What is the Blue Hat logo’s significance?
It signals SAMR approval, validates functional claims, and is mandatory for Health Foods to be marketed in China.
What are the penalties for non compliance?
Penalties include fines, recalls, suspension of licenses, blacklisting of manufacturers, and import bans. Severe violations can lead to reputational damage and permanent exclusion from the Chinese market.
How are claims monitored after approval?
Advertising and labeling must strictly match SAMR approved claims. Misleading or disease treatment claims can trigger enforcement actions.
Who enforces compliance in China?
SAMR leads nationwide enforcement, provincial and municipal authorities conduct inspections, and GAC enforces compliance at ports for imported products.
