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

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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 chloride

GB1903.34 Zinc chloride

All

Selenium

Selenocarrageenan

GB1903.23 Selenocarrageenan

4 years and above

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 Directory

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

2020 Raw Materials Directory

Calcium

Calcium acetate

GB15572 Calcium acetate

GB1903.15 Calcium acetate

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 Directory

2020 Raw Materials 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.

If you have any needs or questions, please contact us at service@cirs-reach.com.

Reference:

SAMR Notice (2020.12.01)