China SAMR Expands Raw Material Directories and Function Claims for Health Food (Nutrient Supplement)

On June 14, 2023, SAMR, NHC and NATCM jointly issued a notice announcing four regulations related to raw materials and function claims for health food (nutrient supplement). They are Health Food Raw Materials Directory - Nutrient Supplement (2023), Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplement (2023), Health Food Raw Material Directory - Soy Protein Isolate, and Health Food Raw Material Directory - Whey Protein. The new regulations will take effect on October 1, 2023, and supersede previous regulations.

This article focuses on the first two regulations regarding nutrient supplement. For information about the regulations concerning soy protein isolate and whey protein as health food raw materials, please refer to ChemLinked News.

1. Health Food Raw Materials Directory - Nutrient Supplement (2023)

China adopts a dual-track system for health food for market access, which means health foods are subject to either registration or filing under different conditions. Compared to registration, it takes less time and cost for enterprises to get health food filed. Nutrient supplements such as vitamin/mineral supplements are subject to filing, and shall only use raw materials from the specified directory. Compared to current version, the new 2023 version has the following revisions:

Adding "casein phosphopeptide + calcium" as a new compound source of calcium.
Adding "hemin chloride" as a new compound source of iron.
Adding "Vitamin K2 (synthesis method)" as a new compound source of Vitamin K.
Adding "docosahexaenoic acid (DHA)" as a new nutrient.

Detailed use requirements are as follows:

Name of raw materials				Daily dosage				Function
Nutrient	Compound	Reference standard	Application scope	Functional component	Suitable group	Min value	Max value
Calcium	casein phosphopeptide + calcium	Casein phosphopeptide: GB 31617 Calcium: refer to the relevant standard of the selected calcium	Determined by the selected calcium. The ratio of casein phosphopeptide and calcium is 1:5-1:20	Ca (as ca, mg)	Lactating women	200	1,000	Supplement calcium
Iron	Hemin chloride	GB 1903.52 Hemin Chloride	All ages	Fe (as Fe, mg)	Lactating women	5.5	20.0	Supplement iron
Vitamin K	Vitamin K2 (synthesis method)	NHC Notification No.9 of 2020	All ages	Vitamin K2 (as menaquinone-7, μg)	Lactating women	15	100	Supplement Vitamin K
DHA	Docosahexaenoic acid	Technical requirements for DHA Algae Oil (see attachment of this regulation) *	Adult	DHA (as C₂₂H₃₂O₂, triglyceride, mg)	Adult	200	1,000	Supplement n-3 polyunsaturated fatty acids

*Notes: For DHA algae oil added with Vitamin C or Vitamin E as an antioxidant, the filed product added with such DHA algae oil should clearly state "This product contains Vitamin C or Vitamin E". Besides, when Vitamin C or Vitamin E are added only as subsidiary materials of DHA algae oil, their function claims shall not be claimed.

2. Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplement (2023)

This catalogue specifies the allowed function claims for nutrient supplement based on the nutrients specified in Health Food Raw Materials Directory - Nutrient Supplement, and provides interpretations of each function claim. As DHA is newly added as a nutrient, this catalogue adds the function claim and its interpretation of DHA correspondingly.

Function claim

Interpretation

Supplement n-3 polyunsaturated fatty acids

1. n-3 polyunsaturated fatty acids provide essential fatty acid for human body.

2. n-3 polyunsaturated fatty acids in the diet should account for 0.5%-2% of the total energy.

3. Helps maintain healthy levels of blood lipids (triglycerides).

With the implementation of updated catalogue of raw materials and function claims for nutrient supplement, enterprises are given greater convenience on the production and market access, especially for DHA supplement products which may enter the Chinese market with lower entry barrier. For English version of these regulations, please contact us for translation services.