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China Updates Raw Material Directory and Function Claims for Nutrient Supplements

β-Carotene is added as a nutrient for health food filing. Its corresponding raw materials, reference standards and daily consumption, etc. are added. Except for claiming supplementing a certain kind of nutrient, health food filing products can also claim the functions of such nutrient according to Appendix D in GB 28050. For example, a calcium health food product can claim “Calcium helps strengthen bone and teeth.” etc. in addition to supplementing calcium.

On December 1st, 2020, State Administration for Market Regulation ("SAMR"), National Health Commission ("NHC") and National Administration of Traditional Chinese Medicine released the Health Food Raw Material Directory - Nutrient Supplement (2020) and Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplement (2020). Both regulations will come into force on Mar. 1st, 2021, replacing the Health Food Raw Materials Directory (1st Batch) and the Health Function Catalogue (1st batch) released in 2016.

2100903-食品合规BANNER.gifHealth Function Catalogue

Compared with the 2016 catalogue, two major changes in the 2020 health function catalogue are:

1. A new nutrient β-carotene

2. New interpretation on health functions

The interpretation on functions will work as function claims for corresponding nutrients. Health food labels are allowed to take one or more sentences from the interpretation as standard function claims. However, business operators should not delete, add, modify words in the standard function claims, or combine different sentences as one.

Part of the function interpretation (function claims) are as follows:

Health Function

Interpretation (Function claims)

Supplement calcium

  • Calcium is the major component of human bone and teeth. Many physiological functions need the participation of calcium.

  • Calcium is the major element of bone and teeth and it helps maintain bone mineral density.

  • Calcium helps the growth of bone and teeth.

  • Calcium helps strengthen bone and teeth.

Supplement vitamin A

  • Vitamin A helps maintain scotopic vision.

  • Vitamin A helps maintain skin and mucosa health.

Raw Material Directory

On the basis of 2016 raw material directory, the 2020 raw material directory:

1. Updates reference standards for some raw materials (e.g. GB 1903.14 for calcium citrate instead of GB 17203);

2. Supplements compound sources for current nutrients; and

3. Adds the allowed compound sources for the new nutrient β-carotene.

Information of new materials added in the directory are as follows:

Nutrient

Compound

Reference standard

Suitable for

Calcium

Calcium citrate malate

GB 1903.18

People above 4 years old

Magnesium

Magnesium gluconate

GB 1903.29

All

Potassium

Potassium gluconate

GB 1903.41

All

 

Iron

Ferric pyrophosphate

GB 1903.16

All

Ferric citrate

GB 1903.37

All

Sodium ferrous citrate

NHC Notification No.8 in 2018

All

Zinc

Zinc acetate

GB 1903.35

All

Zinc chloride

GB 1903.34

All

 

Selenium

Selenium carrageenan

GB 1903.23

People above 4 years old

Substance selenoprotein

GB 1903.28

People above 4 years old

Choline

Choline chloride

GB 1903.36

All

Pantothenic acid

Sodium D-pantothenate

GB 1903.32

All

 

 

 

β-Carotene

 

 

 

β-Carotene

GB 8821

Adults

GB 28310

Adults

GB 31624

Adults

Notification No.6 in 2012 of National Health and Family Planning Commission

Adults


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