Nutrient Supplements Can Label Function Interpretation! New Health Food Raw Materials Directory and Function Directory for Comments - Regulatory News - Food & Food Contact Materials

On 2 December 2019, State Administration for Market Regulation (SAMR) issued Raw Materials Directory of Nutrition Supplement Health Food (Draft) (2019 version) (hereinafter referred to as “Raw Materials Directory (Draft)”) and Health Function Directory of Allowing Nutrition Supplement Health Food Claims (Draft) (2019 version) (hereinafter referred to as “Health Function Directory (Draft)”) for public comments. The public comment period will end on 31 December 2019.

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

One new nutrient

Compared with the Current Raw Materials Directory, the nutrients in the Raw Materials Directory (Draft) 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- standard basis, suitable crowds and daily intake of different β-carotene are specified.

Name			Daily Intake
Nutrients	Standard Basis	Application Scope	Functional Component	Suitable Crowds	Minimum	Maximum	Function
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

Supplement new compounds of 7 existing nutrients

Compared with the Current Raw Materials Directory, new compounds have been added into 7 existing nutrients in the draft, 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
Iron	ferric pyrophosphate	GB1903.16 ferric pyrophosphate	All
Iron	ferric citrate	GB1903.37 ferric citrate	All
Zinc	zinc acetate	GB1903.35 zinc acetate	All
Selenium	Selenocarrageenan	GB1903.23 Selenocarrageenan	4 years and above
Folic Acid	(6S)-5-methyltetrahydrofolic acid, glucosamine salt	NHC Notice of No.08, 2017	Except pregnant women, lactating women; Dosage form is limited to solid preparation
Choline	Choline chloride	GB1903.36 Choline chloride	all

Update the standard basis of 2 compounds

Nutrients	Compounds	Current Raw Materials Directory	Draft
Calcium	Calcium acetate	GB15572 Calcium acetate	GB1903.15 Calcium acetate
Calcium	Calcium citrate	GB17203 Calcium citrate	GB1903.14 Calcium citrate

Modify the calculation method of Vitamin K2’ functional component

Nutrients	Compounds	Current Raw Materials Directory	Draft
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, which can be marked on the label of health food

Compared with the Current Health Function Directory, the interpretations of health functions are added in the Health Function Directory (draft) . 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 d 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 Function Directory, the Health Function Directory (Draft) remains unchanged, but “supplement β-carotene” is added in the notes.

CIRS Comments

Compared with the Current Raw Materials Directory, the Raw Materials Directory (Draft) added 1 nutrient (β-carotene), and 7 nutrients added new compounds, and 5 existing compounds added standard basis, which provides more space for companies to choose raw materials and suppliers. Besides, the interpretation of health functions has been added in the draft, 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.

Reference

SAMR Notice: http://www.samr.gov.cn/hd/zjdc/201912/t20191202_308960.html

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