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China Health Food Testing Service

Health foods, identified as a distinct food category with health claims, are subject to intense scrutiny by regulatory authorities and various sectors of society concerning quality, safety, and function evaluation. Testing remains the only means to confirm product compliance with relevant regulations, standards, and requirements.

China,Health,Food,Dietary,Supplement,Testing

What Are the Major Regulations and Standards concerning Health Food Testing in China?

  • GB 16740-2014 Health Food;
  • Guideline on the Inspection and Evaluation of Physicochemical and Hygienic Indicators of Health Food (2020 Version);
  • Guideline on Stability Test of Health Food;
  • Guideline on the Safety Inspection and Evaluation of Strains Used in Health Food Raw Materials (2020 Version);
  • Guideline on the Safety Toxicological Inspection and Evaluation of Health Food and Its Raw Materials (2020 Version);
  • Testing and Evaluation Methods for Health Food Functions (2023 Version);
  • Guideline on Testing and Evaluation of Health Food Functions (2023 Version);
  • Guideline on Ethical Review of Health Food Human Feeding Trials (2023 Version).

What Are the Test Requirements (for Health Food Registration and Filing) under Traditional Trade?

For health foods sold through traditional trade channels, a registration or filing application is required before market release. According to the Health Food Registration and Filing Regulation and its accompanying documents, applicants shall complete a series of safety and functional testing evaluations before submitting the registration or filing for health foods.

Test Items for Health Food Registration

  • 3-batch self-test reports;
  • 3-batch tests of functional components or characteristic ingredients, hygiene, and stability;
  • Methodological validation on functional components or characteristic ingredients test methods;
  • 1-batch toxicology tests;
  • 1-batch animal function tests and (or) human feeding trials; and
  • Other tests, if necessary (e.g., safety assessment of new health food raw materials and strain virulence test).

▶  Test Items for Health Food Filing

  • 3-batch tests of functional components or characteristic ingredients, hygiene, and stability;
  • 3-batch full-item tests that meet the product's technical requirements; and
  • If it falls into the category of domestic functional health foods, a full-item test report for raw materials used (coenzyme Q10, fish oil, melatonin, broken ganoderma lucidum spore powder, spirulina, soy protein isolate, and whey protein) shall also be provided.

Health Foods Sold on Cross-Border E-Commerce Platforms

Currently, products sold through cross-border e-commerce platforms are managed as personal items, which, when being marketed on such platforms, do not require health food registration or filing certificates. However, with the burgeoning expansion of cross-border e-commerce in China, both customs and platforms are paying increasing attention to the quality control of cross-border goods. Drawing from Tmall Global, according to the Tmall Global Technical Specifications for Pre-packaged Food Products - Supplemental Requirements for Health Foods:

  1. Health foods marketed on Tmall Global through cross-border bonded and direct mail trade models shall adhere to the technical regulations or standards of the purchasing country and meet the requirements of relevant compulsory national standards.
  2. The general safety requirements include contaminants (including mycotoxins), microorganisms, and physicochemical indicators, among others.

Table 1. Limit requirements for contaminants (including mycotoxins c) and microorganisms in health foods sold on Tmall Global (general)

S.N.

Product category

Test items

Regulatory basis

1

All samples

Lead (Pb) a

GB 16740

2

All samples

Arsenic (As) a

GB 16740

3

All samples

Mercury (Hg) a,b

GB 16740

4

Hard capsule samples

Chromium in capsules d

The section of gelatin empty capsules in Volume 4 of Pharmacopoeia of the People’s Republic of China (2020 Version).

5

All samples

Total plate count e

GB 16740

6

All samples

Coliforms

GB 16740

7

All samples

Mould and yeast

GB 16740

8

All samples

Staphylococcus aureus

GB 16740

9

All samples

Salmonella

GB 16740

Note:

a. It shall meet the requirements of GB 2762 for corresponding food categories; for foods not categorized, follow the requirements listed in Table 2 of GB 16740.

b. The total mercury test item is not required for liquid products (excluding health foods for infants and young children).

c. The limits for mycotoxins shall meet the requirements of GB 2761 for corresponding food categories.

d. The test item is for gelatin empty capsules only.

e. It is not applicable to products with final products containing active strains ( aerobic and facultative anaerobic probiotics).

f. The microbial limits shall meet the requirements of GB 29921 and relevant national food safety standards for corresponding food categories; for foods not categorized, follow the requirements listed in Table 3 of GB 16740.

In addition to meeting the aforementioned requirements, operators of cross-border health foods shall also take note that:

For conventional products, ensure that product safety indicators meet the requirements of GB 16740;

For novel products (e.g., products containing NMN), it is recommended to conduct safety assessments on the specific ingredients (e.g., NMN) in addition to ensuring that product quality complies with GB 16740. This may involve the issuance of a toxicology evaluation report and a safety assessment report.

Our services

Based on its over 10 years of experience in health food compliance service, CIRS Group is well-versed in the key points of health food testing and compliance requirements and has established long-term partnerships with numerous experienced domestic health food inspection agencies. Our team customizes experimental plans based on clients’ needs, selecting appropriate testing agencies, monitoring experiment progress, and assisting in resolving any technical issues that may arise during the experiment. CIRS Group provides our clients with the following services:

  • Health Food Registration Inspection Service;
  • Health Food Filing Inspection Service;
  • Individual Testing Service; and
  • Customized Testing Service

Other Services

Further Information

China Officially Released the Function Evaluation Methods for Health Food: Summary of Key Changes

Change of Health Food Registration Certificate in China: An Analysis of Products with No Validity Period and Technical Requirements

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