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On 1 December 2020, State Administration for Market Regulation (SAMR) issued Health Food Raw Materials Directory of Nutrition Supplement (2020 version) (hereinafter referred to as “2020 Raw Materials Directory”) and Health Function Directory of Allowing Nutrition Supplement Claims (2020 version) (hereinafter referred to as “2020 Health Function Directory”), which will be formally implemented on 1 March 2021.

Compared with Health Food Raw Materials Directory (the first batch) (hereinafter referred to as “Current Raw Materials Directory”) and Health Function Directory of Allowing Health Food Claims (the first batch) (hereinafter referred to as “Current Health Function Directory”), the changes are as follows:

1. Changes in Raw Materials Directory

Add one new nutrient

Compared with the Current Raw Materials Directory, the nutrients in the 2020 Raw Materials Directory have increased from 22 to 23. The new nutrient--β-carotene, was originally a kind of compounds in the nutrient “vitamin A”. Now it is also used as a new type of nutrient, and standard basis, suitable crowds and daily intake of different β-carotene are specified.

Name				Daily Intake
Nutrients	Compounds	Standard Basis	Application Scope	Functional Component	Suitable Crowds	Minimum	Maximum	Function
β-carotene	β-carotene	GB 8821 β-carotene	Adults	β-carotene (mg)	Adults	1.5	5	Supplement β-carotene
		GB 28310 β-carotene (fermentation)	Adults		Adults	1.5	5
		GB 31624 Natural carotene	Adults		Adults	1.5	7
		NHC Notice of No.06, 2012	Adults		Adults	1.5	5

Supplement new compounds of 8 existing nutrients

Compared with the Current Raw Materials Directory, new compounds have been added for 8 existing nutrients in the 2020 Raw Materials Directory, as follows:

Nutrients	New Compounds	Standard Basis	Application Scope
Calcium	Calcium citrate malate	GB1903.18 Calcium citrate malate	4 years and above
Magnesium	Magnesium gluconate	GB1903.29 Magnesium gluconate	All
Potassium	Potassium gluconate	GB1903.41 Potassium gluconate	All
Iron	Ferric pyrophosphate	GB1903.16 Ferric pyrophosphate	All
	Ferric citrate	GB1903.37 Ferric citrate	All
	Sodium ferrous citrate	NHC Notice of No.08, 2018	All
Zinc	Zinc acetate	GB1903.35 Zinc acetate	All
Zinc	Zinc chloride	GB1903.34 Zinc chloride	All
Selenium	Selenocarrageenan	GB1903.23 Selenocarrageenan	4 years and above
Selenium	Selenoprotein	GB1903.28 Selenoprotein	4 years and above
Choline	Choline chloride	GB1903.36 Choline chloride	All
Pantothenic acid	D-Sodium pantothenate	GB1903.32 D-Sodium pantothenate	All

Add the standard basis of 5 compounds

Nutrients	Compounds	Current Raw Materials Directory	2020 Raw Materials Direc tory
Iron	Ferrous Succinate	National Drug Standard WS1-(X-005)-2001Z	National Drug Standard WS1-(X-005)-2001Z; GB 1903.38
Selenium	Selenious Yeast	National Drug Standard WS1-(x-005)-99Z	National Drug Standard WS1-(x-005)-99Z; GB1903.21
Vitamin A	Retinyl acetate	GB14750	GB14750; GB1903.31
Vitamin B1	Thiamine mononitrate	Chinese Pharmacopoeia	Chinese Pharmacopoeia; GB1903.20
Biotin	D- Biotin	National Drug Standard WS-10001-(HD-1052)-2002	National Drug Standard WS-10001-(HD-1052)-2002; GB1903.25

Update the standard basis of 3 compounds

Nutrients	Compounds	Current Raw Materials Directory	202 0 Raw Materials Directory
Calcium	Calcium acetate	GB15572 Calcium acetate	GB1903.15 Calcium acetate
Calcium	Calcium citrate	GB17203 Calcium citrate	GB1903.14 Calcium citrate
Zinc	Zinc citrate trihydrate	NHC Notice of No.09, 2013	NHC Notice of No.05, 2013

Modify the calculation method of Vitamin K2’ functional component

Nutrients	Compounds	Current Raw Materials Di rectory	2020 Raw Materia ls Directory
Vitamin K	Vitamin K2 (fermentation)	Vitamin K (count as phylloquinone, µg)	Vitamin K2 (count as 7-Menadione, µg)

2. Changes in Health Function Directory

Add the interpretations of health function for 15 nutrients, which can be marked on the label of health food

Compared with the Current Health Function Directory, the interpretations of health functions have been added for 15 nutrients in the 2020 Health Function Directory.

Type	Nutrients
15 nutrients with interpretations of health function	Calcium, magnesium, iron, zinc, vitamin A, vitamin D, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin (niacinamide), folic acid, vitamin C, pantothenic acid, vitamin E
8 nutrients without interpretations of health function	Biotin, choline, potassium, manganese, selenium, copper, vitamin K, β-carotene

Interpretations of health function shall be marked in accordance with GB28050 Appendix D. One or more corresponding standard terms of nutrient functional claims in the definition can be used on the label of health foods. No form of modification, addition, or combination of functional claims may be made.

The interpretations of health functions are as follows:

Functions	Interpretations
Supplement Calcium	Calcium is the major component of human bone and tooth; many physiological functions require the participation of calcium. Calcium is the major component of bone and tooth, and it maintains bone density. Calcium helps development of bone and tooth. Calcium makes the bone and tooth firmer.
Supplement Magnesium	Magnesium is an essential component for energy metabolism, tissue formation and bone growth.
Supplement Iron	Iron is an important component for RBC formation. Iron is an essential element for RBC formation. Iron is essential for production of hemoglobin.
Supplement Zinc	Zinc is an essential element for children growth. Zinc helps improve appetite. Zinc helps maintain skin health.
Supplement Vitamin A	Vitamin A helps maintain the scotopia (darkness visual acuity). Vitamin A helps maintain health of skin and mucosa.
Supplement Vitamin D	Vitamin D facilitates absorption of calcium. Vitamin D is good to bone and tooth health. Vitamin D helps with formation of bones.
Supplement Vitamin B1	Vitamin B1 is an indispensable component for energy metabolism. Vitamin B1 helps maintain normal physiological function of neural system.
Supplement Vitamin B2	Vitamin B2 helps maintain the health of skin and mucosa. Vitamin B2 is an indispensable component for energy metabolism.
Supplement Vitamin B6	Vitamin B6 helps with metabolism and use of protein.
Supplement Vitamin B12	Vitamin B12 helps with formation of RBC.
Supplement Nicotinic acid	Nicotinic acid helps maintain the health of skin and mucosa. Nicotinic acid is an indispensable component for energy metabolism. Nicotinic acid helps maintain the health of neural system.
Supplement Folic acid	Folic acid helps with development of brain and neural system for embryo. Folic acid helps with the formation of RBC. Folic acid helps with the development of embryo.
Supplement Vitamin C	Vitamin C helps maintain the health of skin and mucosa. Vitamin C helps maintain the health of bones and gum. Vitamin C facilitates absorption of iron. Vitamin C has anti-oxidation efficacy.
Supplement Pantothenic acid	Pantothenic acid is essential for energy metabolism and tissue formation.
Supplement Vitamin E	Vitamin E has anti-oxidation efficacy.

Add “supplement β-carotene” in health function notes

Compared with the Current Health Function Directory, the health function in the 2020 Health Function Directory remained unchanged, but “supplement β-carotene” has been added in the notes.

CIRS Comments

Compared with the Current Raw Materials Directory, one nutrient (β-carotene) has been added in the 2020 Raw Materials Directory, in addition, 8 nutrients added new compounds, and 5 existing compounds added standard basis, which provide more choices for companies to choose raw materials and suppliers. Besides, the interpretations of health function have been added in the 2020 Health Function Directory. Companies can use one or more corresponding nutrient functional claim standard terms in the definition on the label of health foods, which has a positive significance for product promotion.

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Reference:

SAMR Notice (2020.12.01)

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Nutrient Supplements can Label Function Interpretation-2020 Raw Materials Directory of Nutrient Supplement Issued