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 | |
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.
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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