China Updates Health Food Functional Evaluation Requirements

Registration of health foods will no longer be contingent on proving functional efficacy and safety through mandatory human clinical trials; however, a consumption evaluation report will still be required during product re-evaluation. The functional efficacy evaluation methods laid down in the newly amended China Health Food Review and Technical Evaluation Guidance are no longer compulsory, and enterprises are free to use any appropriate methods to substantiate health food functional efficacy and safety provided the methods are scientific and approved.

On the 3^rd China Health Food Conference held in Zhuhai on Oct. 17, 2019, Li Bo, the associate researcher of China Food and Drug Verification Institute, delivered a keynote speech regarding the proposed revision to “China Health Food Review and Technical Evaluation Guidance” (it was announced invalid in 2018, click here to read more). The most significant changes to China’s health food regulatory framework are that human clinical trials will no longer be mandatory prior to the registration approval, and the scope of permitted evaluation and testing methods has greatly expanded.

With reference to the previous iteration of Administrative Measures for Registration and Filing of Health Foods, human consumption evaluation report was mandatory for health food registration, and “China Health Food Review and Technical Evaluation Guidance” specified the rules for human clinical trials. However, the requirements laid down in The Technical Evaluation guidance were overly stringent and erected an excessively high market entry barrier as many enterprises did not have the technical capacities or resources to conduct human clinical trials in line with previous standards.

As revealed by researcher Li Bo and chief of health food registration division Wan Chao, registered health food may be exempted from human trial before registration approval, but manufacturers are required to submit human consumption evaluation report after the products are sold on market. In the near future, the competent authority will soon unveil the “Guiding Principles for Health Food Human Consumption Test Review” (exposure draft), which specifies the general principle, application of ethical review, inspection procedure and etc.

Additionally, the testing methods stipulated in “China Health Food Review and Technical Evaluation Guidance” will no longer be mandatory, and manufacturers can use other testing methods if they are scientific and approved by SAMR.

Other amendments are listed below:

Functional evaluation

Correct some typo mistakes
Eliminate terminological ambiguity
Optimize some testing methods

Hygienic evaluation

As some indicators stipulated in GB 16740-2014 Health Food will be revised, the hygienic evaluation shall be detailed in corresponding updates.

Physical and chemical evaluation

Newly add the detection of prohibited components