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On Apr. 4, 2019, China SAMR opened “Health Food Toxicology Evaluation Procedure Standards” and “Health Food Strain Pathogenicity Evaluation Procedure Standard” for public feedback. The deadline for consultation is May 4, 2019.
The announcement clarified that testing reports based on “Technical Standards for Testing & Assessment of Health Food (2003)” which was abolished in Jul. 2018 (read CL news here) could not be used as technical review reference for health food registration any more. The revision to “Technical Standards for Testing & Assessment of Health Food” is still underway and will be compatible with the recent changes in the health food function adjustment.
Health Food Toxicology Evaluation Procedure Standards (draft)
The draft states that the toxicological tests are conducted in reference to GB 15193. Compared with the test items stipulated in “Technical Standards for Testing & Assessment of Health Food (2003)”, the major change is that the duration of the oral toxicity test has decreased from 30 days to 28 days.
Here are the main toxicology testing items listed in the draft:
acute oral toxicity test
genotoxicity test
28-days oral toxicity test
teratogenicity test
90-days oral toxicity test
reproductive toxicity test
toxicokinetics test
chronic toxicity test
carcinogenicity test
combination test of chronic toxicity and carcinogenicity
Health Food Strain Pathogenicity Evaluation Procedure Standard (draft)
This draft specifies the pathogenicity evaluation procedure of strains used in health food (including bacteria, filamentous fungi and yeast), active ingredients (viable organism) and strains used for fermentation in health food production.
As a new evaluation method, Health Food Strain Pathogenicity Evaluation Procedure Standard (draft) fleshes out requirements mentioned in “Rules for Application and Review of Probiotic Health Foods” and “Administrative Measures for Health Food Registration and Filing”, such as the issuance of strain identification report, strain pathogenicity and resistance report and etc.
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