China health food raw material update

China health food raw material update has been issued by the State Administration for Market Regulation (SAMR), along with the National Health Commission (NHC) and the National Administration of Traditional Chinese Medicine.

Adjustments have been made to:

The Catalogue of Raw Materials for Health Food & Nutritional Supplements (2023 Edition)
The Catalogue of Health Functional Claims Allowed by Health Food--Nutritional Supplements (2023 Edition)

These adjustments will take effect on October 1, 2023. If any discrepancies exist between the previously released catalog and this version, the latest version will prevail.

The Catalogue of Raw Materials for Health Food & Nutritional Supplements (2023 Edition)

1. Nutritional supplements

The Catalogue now includes 24 substances following the noteworthy addition to the catalogue of the substance DHA. Three new compounds have also been added to existing nutritional supplements:

Casein phosphopeptide+calcium (Calcium)
ferric chloride heme (Iron)
vitamin K2 (synthetic method) (Vitamin K).

Please refer to the new list of nutritional supplement ingredients below:

24 nutritional supplement ingredients

Calcium *
Magnesium *
Potassium
Manganese
Iron *
Zinc *
Selenium
Copper
Vitamin A *
Vitamin D *
Vitamin B1 *
Vitamin B2 *
Vitamin B6 *
Vitamin B12 *
Niacin (nicotinic acid) *
Folic acid *
Biotin
Choline
Vitamin C *
Vitamin K
Pantothenic acid *
Vitamin E *
β-carotene
Docosahexaenoic acid (DHA)*
Biotin
Choline
Vitamin C *
Vitamin K
Pantothenic acid *
Vitamin E *
β-carotene
Docosahexaenoic acid (DNA)*

The catalogue provides the names of the compounds corresponding to each nutrient, the standard basis, scope of use, daily dosage (including efficacy index, suitable population, lowest value, and highest value), and corresponding efficacy claims.

2. New China health food raw materials update

Two new raw materials, Soybean Protein Isolate and Whey protein, have been introduced for health food use. The documents specify the names, daily dosage (including dosage range, suitable population, unsuitable population, and precautions), and efficacy claims (Enhancing immunity) for these ingredients. Additionally, technical requirements for the ingredients are provided, including source, sensory requirements, physical and chemical indicators, landmark ingredient indicators, microbial indicators, and dosage form.

Companies can apply for notification filing for the above products from October 1, 2023.

The Catalogue of Health Functional Claims Allowed by Health Food & Nutritional Supplements (2023 Edition)

3. New health function

The health function and definition of "supplementing n-3 Polyunsaturated fatty acid" have been newly added to the catalogue.

This Catalogue specifies which substances may mention a supplement explicitly but must not describe an associated function. Only substances marked with an asterisk (*) in the table above are allowed to describe the specific function of the supplement according to the definitions in the catalogue. No deletion, addition, or merger of functional claims is permitted.

Implications

The adjustments in the catalogue and the introduction of new raw materials have implications for the health food industry. These changes will come into effect on October 1, 2023.

Application submissions to file a notification of a product containing these new raw materials, new function claims or new nutritional supplements may commence on October 1, 2023. As it can typically take between 22 and 33 months to register and between 6 and 9 months to notify or file a health food, the preparatory work to submit such dossiers may start immediately. Please contact Cisema with your health food enquiry.