Current Situation of Regulations and Application Requirements on Probiotic Health Food in China

In recent years, scientific research on probiotics has been advanced. The application of probiotics in health food is also very extensive, and the market scale has been gradually expanding. Chinese government issued probiotic health food review regulations in 2001 and 2005, and released the latest draft in 2019. CIRS here makes a systematic introduction and analysis on the current situation of regulations and application requirements on probiotic health food.

1. Current Situation of Regulations on Probiotic Health Food

Note: ①The feedback of the Draft was released on 2019.07.15, and it is planned to adopt 4 suggestions; ②Because the regulations will be updated, the definition and application requirements of probiotic health foods in the article are referred to the Draft. The final requirements are subject to the formal version. CIRS will continue to pay attention to the release of the formal version.

2. Application Requirements on Probiotic Health Food

2.1 Definition of Probiotics and Probiotic Health Food

Probiotics refer to living microorganisms which are beneficial to human health when ingested in sufficient quantities.

Probiotic Health Food refers to a kind of microbial products which take probiotics as the main functional ingredients and add necessary excipients. They are beneficial to human health when ingested in sufficient quantities.

The key points:

(1) Probiotics are required to be living microorganisms. Health food produced by dead microorganisms and microbial metabolites does not belong to probiotic health food.

(2) According to the Draft, the viable counts per species in probiotic health food shall not be less than 106CFU/mL(g) during the shelf life. However, the current detection technology is difficult to detect the viable counts per species, so the provision may be adjusted in the future.

2.2 Cultures Available in Probiotic Health Food

①List of Probiotics Available in Health Food

②List of Cultures Available in Food, and approved new food raw materials of edible cultures

③List of Cultures Available in Infant Food

The key points:

(1) The biological, genetic and functional characteristics of the culture (strain) used in the probiotic health food should be specific and stable, and the culture (strain) and its metabolites shall be non-toxic and harmless.

(2) Genetically modified culture and its metabolites shall not be used in health food.

2.3 The Requirements on Application Materials

In addition to the application materials in the Administrative Measures on Health Food Registration and Filing and other relevant regulations, the following materials shall be provided:

(1) The application basis, raw material inspection report, etc. of the culture.

(2) The genus name, species name and strain number of the culture. The genus name and species name shall have the corresponding Latin name.

(3) Culturing conditions (medium, temperature, etc.).

(4) Sources and safety materials of strains (domestic and/or overseas).

(5) Culture identification report (include the phenotypic characteristics and the identification results on strain level based on genotyping).

(6) Safety evaluation report of the culture (strains), such as pathogenicity test, drug resistance test, etc.

(7) The preservation method of the culture.

(8) The domestication methods, domestication agents, etc. (for domesticated culture)

(9) The research report, scientific literature, etc. that are related to probiotic functions (on strain level).

If the above materials involve technology and trade secrets, they can be provided directly by the culture producers to the relevant national administrative department.

The key points:

① Compared with the Application and Review of Probiotic Health Food (Trial), the Draft adds “application basis, raw material inspection report, etc. of the culture”.

② Supplement “The research report, scientific literature, etc. that related to probiotic functions (on strain level)”.

③ The genus name, species name and strain number of the culture shall be provided. And the label and instructions shall indicate the Chinese name of the culture and strain number, which imply that enterprises cannot change the raw material supplier after the declaration of probiotics health food.

④ It is required that culture identification report should include the phenotypic characteristics and the identification results on the strain level based on genotyping.

2.4 Test items

Test items of culture (strain)
Test items	Notes
Culture identification	/
Safety evaluation of culture (strain), such as pathogenicity test, drug resistance test, etc.	The current regulation requires culture virulence test. According to the feedback of public comments on Toxicological Assessment Procedure of Health Food (Draft), it is planned to modify the virulence test to pathogenicity test. And the Pathogenicity Assessment Procedure of Strains for Health Food (Draft) has been issued for public comments.
Test items of final product
Test items	Notes
Functional components and hygiene self-test for at least 3 batches of finished products	If the documents for small scale and pilot process study are not integrated, self-test for 10 batches are required.
Methodology validation of Functional component tests	/
Functional component tests, hygiene test and stability test for 3 batches of finished products	Accelerated tests are not allowed for the products containing living microorganisms. Short-term or long-term tests should be conducted according to the length of the shelf life. (According to registered probiotic health foods in China, the shelf life of liquid milk/ beverage products are mostly within 30 days. The shelf life of tablet/ powder/ granule products are mostly between 18-24 months, thus, the period of stability test of these products will be significantly longer.)
Toxicology test	The batch of the sample used in the toxicology test shall be the same as that used in the functional test, and it shall be one of the three batches of samples used in the hygienic test. If the shelf life is shorter than the entire test period, a different batch of sample is allowed, but the reason should be explained, and the test report including all items listed in the product technical requirements of the new batch samples should be provided.
Animal function test	Whether the tests need to be carried out depends on the specific function. After the abolition of the technical specifications (2003), SAMR has not issued new functional evaluation method. According to the past situation, “enhancing immune” only needs animal function test, while “regulating gastrointestinal tract flora”, “facilitating feces excretion”, “facilitating digestion”, etc. need animal function test and crowd feeding evaluation test.
Crowd feeding evaluation test

3. Conclusion

Since 1996, more than 130 probiotic health foods have obtained health food registration approval (For more information about probiotic health food, please click How many probiotic health foods have been registered in China?). Compared with other health foods, the regulations and technical standards of probiotic health foods are in the stage of update and improvement, and more application materials and test items are required as well, which makes test period longer and application more difficult. Therefore, understanding the application requirements and test items of probiotic health foods are important for saving time.

On the other hand, National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products issued the second batch of public bidding for the research on the health food raw material directory in September 2018, involving 9 common probiotics (Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve, Bifidobacterium adolescentis, Bifidobacterium animalis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus), indicating that the 9 probiotics may be used as raw materials for health food filing products in the future. However, the final result depends on whether the research results can meet the expectations. Besides, it would be a long time for the official release of relevant policies.

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