ZMUni Compliance Centre

On April 30, 2024, the China State Administration for Market Regulation (SAMR) issued a regulation specifying the filing requirements for health food containing three ingredients: Ginseng, American Ginseng, and Lingzhi. The regulation stipulates five key aspects, including auxiliary materials usage, product dosage forms, product processing, product technical requirements, and others. It came into effect on May 1, 2024.

Prior to this, in December 2023, SAMR issued a relevant announcement, including Ginseng, American Ginseng, and Lingzhi in the Health Food Raw Materials Directory.

So far China has published several directories of health food ingredients eligible for the filing process:

Health Food Raw Materials Directory of Nutrition Supplements (2023 Edition);

Health Food Raw Materials Directory - Coenzyme Q10;

Health Food Raw Materials Directory - Broken Ganoderma Lucidum Spore Powder;

Health Food Raw Materials Directory - Spirulina;

Health Food Raw Materials Directory - Fish Oil;

Health Food Raw Materials Directory - Melatonin;

Health Food Raw Materials Directory - Soy Protein Isolate;

Health Food Raw Materials Directory - Whey Protein;

Health Food Raw Materials Directory - Ginseng;

Health Food Raw Materials Directory - American Ginseng;

Health Food Raw Materials Directory - Lingzhi;

It is worth noting that currently, the scope of imported health food products eligible for filing/notification is limited to those listed in the Health Food Raw Materials Directory of Nutrition Supplements (2023 Edition), which includes supplementary vitamins, minerals, and other nutrients like DHA Algae Oil. Other imported health food products still need to go through the registration process.