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

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

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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.

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7

Review of Safety Evaluation Dossiers at Home and Abroad

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8

Approval information in other country

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9

Other Information to Be Explained

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When the results comply with Result 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.