On October 31st, 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
Including the name, source and intended uses of the strain.
This report should be issued by an organization with qualification of strain identification.
Strain Identification Report
Growth Conditions of Strain
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.
Dossiers Related to Production Process etc.
Review of Safety Evaluation Dossiers at Home and Abroad
Approval information in other country
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 Result I or Result II, the strain can be used in health food.
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.
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