According to the "Health Food Registration and Filing Management Measures" promulgated and implemented in 2016 by Order No. 22 of the State Food and Drug Administration, in Mainland China, the dual-track system of registration and filing of health foods is implemented.

　　● Health food registration means that the food and drug regulatory authority conducts a systematic evaluation and review of the safety, health function and quality controllability of the health food application for registration in accordance with legal procedures, conditions and requirements according to the registration applicant’s application. Review and decide whether to approve its registration approval process.

　　● Health food filing refers to the process by which health food manufacturers submit materials indicating product safety, health function and quality controllability to the Food and Drug Administration for archiving, disclosure, and reference in accordance with legal procedures, conditions and requirements.

　　When do I need to register and when do I need to file?

　　General regulatory standards

　　●"Health Food Registration and Filing Management Measures"

　　●Announcement of "Health Food Raw Material Catalog (1)" and "Health Function Catalogue of Allowed Health Food Claims (1)" (2016 No. 205): The source, standard basis, application scope, and application scope of the 22 nutrients involved The suitable population, daily dosage and efficacy are specified.

　　● GB 16740-2014 "National Food Safety Standard Health Food"

　　● Announcement of the General Administration on Regulating the Labeling of Health Food Function Claims (No. 23 of 2018)

　　Registration related regulations

　　●"Health Food Registration Application Service Guide"

　　● "Regulations for Health Food Registration Review and Approval"

　　Filing related regulations

　　● "Guidelines for the Filing of Health Food (Trial)"

　　●Notice of "Supplementary Materials Available for Registration of Health Food Products and Their Use Regulations (Trial)" and "Main Production Process of Health Food Registration Products (Trial)" (Food and Drug Administration Special Food Tube [2017] No. 36), involving 179 auxiliary materials.

　　In addition to the list of health food raw materials and available auxiliary materials, the following substances can also be used as raw materials for health foods, but health foods produced using these substances need to be registered.

　　● Ordinary food ingredients

　　● New food ingredients

　　● List of items that are both food and medicine

　　● List of items that can be used in health food

　　● List of fungal species that can be used in health food

　　● List of probiotic strains that can be used in health food

　　● Vitamins and mineral elements (excluding substances in the health food raw material list)

　　● Substances that need to be declared for new food ingredients