‍China SAMR Approval of Health Food & Supplements Whitepaper

‍China SAMR Approval of Health Food & Supplements Whitepaper

China’s market for health food and dietary supplements continues to expand, but manufacturers must navigate a complex regulatory framework before products can be imported or sold in mainland China. Products categorized as “health food” are subject to specific requirements under China’s Food Safety Law and must undergo either a filing or registration process with the State Administration for Market Regulation (SAMR).

This whitepaper provides an overview of the regulatory environment governing health food products in China. It explains the classification of health foods, the approval pathways available to manufacturers, and the key documentation, testing, and compliance requirements involved in the SAMR filing and registration processes.

Why This Topic Matters

China’s health food regulatory framework has evolved significantly in response to food safety concerns and growing consumer demand. Following major food safety incidents, including the 2008 melamine crisis, the Chinese government strengthened oversight through the Food Safety Law, first implemented in 2009 and later revised to introduce stricter pre-market approval requirements for health food and other special food categories.

At the same time, the health food sector has grown rapidly. According to data referenced in the whitepaper, the number of health food filings and registrations increased significantly between 2018 and 2022, with filings and registrations more than doubling over that period.

For international manufacturers, these developments create both opportunity and regulatory complexity. Companies entering the Chinese market must understand product classification, regulatory responsibilities, and approval timelines in order to avoid delays and ensure compliance.

What You Will Learn in This Whitepaper

This whitepaper explains the key regulatory considerations for health food manufacturers entering the Chinese market.

Key topics include:

• The regulatory framework governing health foods in China
• The role of authorities such as SAMR and the Center for Food Evaluation (CFE)
• Product classification and the definition of health food in China
• Differences between the filing and registration pathways
• Testing requirements and documentation preparation
• The role of a China Responsible Agent in the approval process
• Post-market obligations and certificate renewal requirements.

China’s Regulatory Framework for Health Foods

Health food products in China fall under the broader category of special foods, which are regulated by the State Administration for Market Regulation (SAMR). The regulatory system includes several authorities responsible for supervision, technical evaluation, and policy implementation.

Key regulatory bodies include:

• State Administration for Market Regulation (SAMR) — responsible for market supervision, product safety oversight, and approval processes for health foods
• Special Food Safety Supervision Department — responsible for supervision and enforcement relating to health food, infant formula, and food for special medical purposes
• Center for Food Evaluation (CFE) — conducts technical evaluation of health food filing and registration applications.

The regulatory framework is supported by national laws, technical standards, and administrative measures governing product safety, labeling, ingredient use, and market supervision.

Classification of Health Food in China

Under Chinese regulations, health foods are defined as food products that claim specific health functions or supplement vitamins and minerals while supporting normal physiological functions. These products are not permitted to claim therapeutic effects or treatment of diseases.

Health foods are typically categorized into two main groups:

Nutritional Supplements

Nutritional supplements are products designed to provide vitamins or minerals that support nutritional intake. These products may contain single or multiple permitted ingredients and must comply with the official list of allowable substances defined by Chinese authorities.

Food with Specific Health Functions

Products in this category may claim certain functional health benefits, such as supporting immunity, improving sleep quality, or regulating physiological functions. However, these claims must align with the official list of approved health function claims defined by Chinese regulators.

The whitepaper also discusses recent updates to the catalogue of allowable health function claims and the requirements for functional testing or human trials associated with certain claims.

Filing & Registration Pathways

Before a health food product can be imported or marketed in China, manufacturers must complete either a filing (notification) process or a registration process with SAMR.

The appropriate pathway depends on the ingredients and claims associated with the product.

Filing Pathway

The filing process generally applies to products that meet predefined regulatory criteria, including:

• active ingredients listed in the official Health Food Raw Materials Directory
• permitted excipients listed in the filing catalogue
• approved dosage forms such as tablets, capsules, oral liquids, granules, or powders.

Filing certificates are valid indefinitely once issued.

Registration Pathway

Registration is required for products that:

• contain ingredients not listed in the official raw materials catalogue
• make specific functional health claims not eligible for filing
• are being introduced into the Chinese market for the first time in certain categories.

Registration certificates are valid for five years and must be renewed before expiry.

Key Steps in the SAMR Approval Process

The whitepaper outlines the major steps involved in obtaining filing or registration approval.

Typical steps include:

1. Appointment of a China Responsible Agent
2. Preparation and review of application documentation
3. Delivery of product samples for laboratory testing
4. Safety, stability, and functional testing in accredited laboratories
5. Submission of the application to SAMR
6. Technical review by the Center for Food Evaluation
7. Administrative approval and certificate issuance.

The timelines differ depending on the approval pathway. Filing procedures generally take several months, while registration procedures involving functional testing and technical review can take significantly longer.

Testing & Documentation Requirements

Health food applications require extensive documentation and product testing to demonstrate compliance with Chinese regulatory standards.

Typical application materials include:

• product formula documentation
• manufacturing process descriptions
• testing reports for safety and stability
• product labels and packaging documentation
• product technical requirements
• proof that the product has been marketed in its country of origin for at least one year.

Testing may include active ingredient analysis, hygiene testing, stability testing, and functional evaluation depending on the product category.

Post-Market Compliance & Surveillance

Regulatory responsibilities continue after a product receives approval.

Manufacturers must implement post-market compliance activities including:

• maintaining production quality management systems
• conducting periodic internal inspections
• cooperating with regulatory inspections conducted by Chinese authorities
• monitoring product safety and compliance with labeling and technical requirements.

Authorities may conduct on-site inspections, sampling inspections, and regulatory reviews to ensure ongoing compliance with food safety standards.

Who Should Read This Whitepaper

This whitepaper is particularly relevant for:

• Manufacturers of dietary supplements and health food products planning to enter the Chinese market
• Regulatory affairs professionals responsible for SAMR approvals
• Quality and compliance teams managing regulatory documentation and testing
• Market-entry teams evaluating regulatory timelines and approval pathways
• Companies exporting nutritional supplements or functional food products to China.