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On October 31^st, 2020, the State Administration for Market Regulation (SAMR) issued Guideline for Safety Inspection and Evaluation of Strains Used as Health Food Raw Materials (2020 version) (hereinafter referred to as “the Guideline”). It specifies the pathogenicity (virulence) testing methods of bacteria, filamentous fungi (except fruiting bodies) and yeasts used in health food, and how to determine whether these strains can be used in health food.

In the article, the following questions will be answered:

What is the application scope of the Guideline?
What dossiers should be provided before testing?
What are the detection methods?
How to judge whether the strain can be used in health food according to the test results?

1. Application Scope

The guideline is applicable for the pathogenicity test and evaluation of strains intended to be used in health food (including strains used as health food raw materials directly, or used for producing health food raw materials).
The guideline is not applicable for the pathogenicity test and evaluation of genetically modified microbial strains and the strains that are not habitually used in China.

2. Dossier Requirements

S. N.	Dossier	Notes
1	Basic Information	Including the name, source and intended uses of the strain.
2	Strain Taxonomic Report	This report should be issued by an organization with qualification of strain identification.
3	Strain Identification Report	Generally, the test report should indicate the specific species to which the strain belongs. When the functional component of health food is live strain, the test report should indicate the specific strain to which the strain belongs.
4	Growth Conditions of Strain	/
5	If refers to Mutagenized Strain	Detailed mutation method and Genetic Stability Research Report of at least 100 generations of strains (no less than 7 days between generations) shall be provided.
6	Dossiers Related to Production Process etc.	/
7	Review of Safety Evaluation Dossiers at Home and Abroad	/
8	Approval information in other country	/
9	Other Information to Be Explained	/

3. Evaluation Method

Complete Genome Sequencing

Gene sequencing
Gene sequencing analysis

Animal pathogenicity test: the test report shall be issued by qualified test agency.
Toxigenic test: the content of toxic active metabolites can be detected according to the GB test methods or the standard test methods specified by international organizations/relevant countries.

4. Results Analysis

When the results comply with Res ult I or Result II, the strain can be used in health food.	Result I The result of animal pathogenicity test shows no pathogenicity of the strain. The result of toxigenic test shows that the strain did not produce toxic active metabolites in any of the tested cultures. Based on the current knowledge, no known virulence/pathogenic genes (or key genes and gene clusters of toxin synthesis) were found in genome-wide sequence analysis.
	Result II Virulence/pathogenic genes (or key genes and gene clusters of toxin synthesis) were found in genome-wide sequence analysis. However, The result of animal pathogenicity test shows no pathogenicity of the strain. or, Toxic active metabolites were detected in toxigenic test, but their levels were low, and long term intake had no effect on human health. Combined with the using history at home and abroad, it could be considered that it can be used in health food.
When the results comply with Result III, the strain cannot be used in health food.	Result III The result of animal pathogenicity test shows pathogenicity of the strain. or, The strain can produce high levels of known toxic metabolites, and long-term intakes may affect human health.

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Analysis on Guideline for Safety Inspection and Evaluation of Strains Used as Health Food Raw Materials (2020 version)