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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 3rd 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.

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