China SAMR Issues Advisory on Health Food Registration

On Apr. 1st, 2020, Food Evaluation Center subordinated to SAMR released the FAQ (Frequently Asked Question) and points for attention regarding health food registration in China. Apart from the format issues, the notice also provides guidance on the following items:

• production technology

• variety, name, and standard for the food contact materials

• sensory requirements

• physical and chemical indicators

• microbiological indicator

• functional ingredient

• volume or weight variation indicator/net content and allowable negative tolerance

• quality requirements of raw and auxiliary materials

Format issues

After submitting a health food registration, dossier enterprises may receive feedback from the expert panel of the food evaluation center, offering suggestions on necessary amendments. In this case, they are not allowed to revise other contents which are not mentioned in the feedback. 

Physical and chemical indicators

• If the product is granular, then the granularity and solubility shall be stipulated based on the granular standard specified in "Chinese Pharmacopoeia," and these indicators shall be tested using three batches of products.

• If the product belongs to a solid beverage, it should follow the national standard for solid beverage and indicate the correct category name.

• If the product is a tablet, then the solubility shall be stipulated based on the troche standard specified in “Chinese Pharmacopoeia," and the solubility performance shall be tested using three batches of products.

• If the product is candy, it should follow the national standard for confectionary and indicate the correct category name.

• If the product is a medicinal liquor, it should stipulate the methanol and cyanide level (calculated as 100% alcohol) with reference to the national food safety standard.

Raw and auxiliary materials requirements

The standard of extract quality should be stipulated based on article 11.2.1 "Health Food Registration Guideline," involving raw materials sources, preparation method (extraction solvent, solvent amount, temperature, duration, times; drying method and temperature; sterilization method, parameters, etc.), extraction efficiency (scope), sensory requirements, common quality control indicators, functional ingredients, microorganism level and so on. 

Please feel free to contact ChemLinked if you need the details of the notice.