China SAMR to Append Health Food Positive List with 5 New Functional Ingredients

China will take the unprecedented step of appending its health food raw materials directory (essentially a positive list of ingredients that are eligible for filing which previously only included vitamins and minerals) with several new ingredients including coenzyme Q10, melatonin, fish oil, reishi shell-broken spore powder and spirulina.

On Mar. 28, 2019, China SAMR opened 5 health food ingredients to public feedback. The ingredients are proposed to be added to the health food raw materials directory. The deadline for consultation is Apr. 30. The announcement lists the new ingredients proposed to be applied in health food and stipulates their usage as well as the technical requirements. Most importantly if the expansion in scope is approved products using these ingredients bearing the specific functional claims listed below will be eligible for health food filing.

Name	Daily usage				Function
Name	Usage level	Suitable group	Unsuitable group	Notes	Function
Coenzyme Q10	30-50mg	Adults	Children, pregnant woman, lactating woman, those with allergies	People taking pharmaceutical drugs should consult the doctor before consuming the product	Enhance immunity Antioxidation
Melatonin	1-3mg	Adults	Children, pregnant woman, lactating woman	People who work on driving, mechanical operation and dangerous operation cannot consume this product before or during the operation, and the patients having autoimmune disease (like rheumatoid) or hyperthyroidism should take the product with caution.	Sleep improvement
Fish oil	No more than 4.0g (among them, the usage amount of EPA+DHA should be no less than 1.0g	People with high blood lipids	Children, pregnant woman, lactating woman; those with bleeding tendency and patients with bleeding diseases; those with hepatic insufficiency	This product is not suitable to those who are allergic to marine products	Assist to reduce serum triglycerides
Reishi shell-broken spore powder	1-4g	those with weakened immune systems	Children, pregnant woman, lactating woman		Enhance immunity
Spirulina	3-4g	those with weakened immune systems	Children, pregnant woman, lactating woman and those with allergic constitution		Enhance immunity

*The function names in the table are compatible with the recent changes in the health food function adjustment.

At the end of 2016, former CFDA (now SAMR) unveiled the first batch of Health Food Raw Materials Directory, the food ingredients that are eligible for health food filing. Other ingredients listed below can also be used in registered health foods.

Common food (including food additives, nutritional fortification substance)
New food ingredients
Substances traditionally used as both food and Chinese medicine (87 items);
Substances allowed to be used in health food (114 items);
Probiotics allowed to be used in health food (10 items)