Six Raw Materials Including DHA are Expected to be added into Health Food (Dietary Supplement) Filing Scope in China

On 20 December 2021, State Administration for Market Regulation (SAMR) issued three drafts related to health food filing, including Health Food Raw Materials Directory of Nutrition Supplement (2022 version) (Draft). Compared with current regulations, the four important changes in the drafts are as follows:

1) “DHA” is added into the “Directory of Nutrition Supplement”. As the function of this nutrient ("supply n-3 polyunsaturated fatty acids") is within the scope of “supply nutrients”, CIRS expects that overseas enterprises can also apply for the filing of DHA products in the future.

2) The combination of “Casein phosphopeptides+ Calcium” becomes the new source compounds of calcium.

3) “6S-5-methyltetrahydrofolate calcium” and “(6S)-5-methyltetrahydrofolic acid, glucosamine salt” become the new source compounds of folic acid. However, the suitable crowds of the two compounds are limited to adults, and pregnant women and lactating mothers are classified as unsuitable crowds.

4) Soybean protein isolate and whey protein are expected to be the available raw materials for health food filing, and the health function is enhancing immune. Similar to the filing of Coenzyme Q10, CIRS expects that the filing scope of health food made of the two raw materials only includes the domestic products in China, and overseas products still need to apply for health food registration.

Specific analysis are as follows:

1. Changes in the Directory of Nutrition Supplement

• Add one new nutrient: DHA

The suitable crowds of the new nutrient “DHA” are adults, and the dosage form is limited to soft capsules. In addition, when filing the products with DHA, other active ingredients are not permitted to add in the products at the same time.

Name	Nutrients	DHA
	Name of the Compounds	Docosahexaenoic acid oil
	Standard Basis	GB 26400; EPA content (count as C20H30O2 triglyceride), w/%≤3.0
	Application Scope	People over 17 years old
Daily Intake	Functional Component	DHA (count as C22H32O2 triglyceride, mg)
	Suitable Crowds	Adults
	Minimum	200 mg
	Maximum	1000 mg
Function		Supply n-3 polyunsaturated fatty acids

• Add new compounds of Calcium and Folic Acid

Compared with the current directory, more compounds will be available for Calcium and folic acid in the draft, as shown in the table below.

It is worth noting that for the two new compounds of folic acid: 1) The dosage form is limited to solid preparations when filing; 2) The suitable crowds are limited to adults, which means, children, adolescent, pregnant women and lactating mothers are classified as unsuitable crowds.

Nutrients	New Compounds	Standard Basis	Application Scope
Calcium	Casein phosphopeptides+ Calcium	Casein phosphopeptides: GB 31617 Calcium: shall comply with the standards of calcium used	Need to be determined by the application scope of calcium used. The ratio of casein phosphopeptides+ calcium is 1:5 -1:20.
Folic Acid	6S-5-methyltetrahydrofolate calcium	NHC Notice of No.13, 2017	Adults
	(6S)-5-methyltetrahydrofolic acid, glucosamine salt	NHC Notice of No.8, 2017

2. Changes in the Directory of Functional Health Food

Since June 1, 2021, according to regulations of Health Food Raw Materials Directory of Coenzyme Q10, Melatonin, Fish Oil, Broken Ganoderma Lucidum Spore Powder and Spirulina, domestic product applicants can apply for filing of health foods that use one of these five substances as single active ingredient, but overseas applicants still need to apply for registration.

SAMR issued Health Food Raw Materials Directory of Protein (Draft) this time, which intends to add soybean protein isolate and whey protein into the directory. Similar to the filing of Coenzyme Q10, CIRS expects that the filing scope of health food made of the two raw materials only includes the domestic products in China, and overseas products still need to apply for health food registration.

Name	Daily Intake				Functions
	Intake Scope	Suitable Crowds	Unsuitable Crowds	Notes
Soybean protein isolate	6-25 g	People with low immunity due to insufficient protein intake	Children, adolescent, pregnant women, lactating women	The total daily intake of protein for adults is recommended to be 60 g, which can be adjusted within the intake scope according to individual daily intake. It is unsuitable for people without significant protein deficiency. Use with caution for people who are allergic to plant protein (the note should be marked for the products with soybean protein isolate as raw material). Use with caution for people who are allergic to animal protein (the note should be marked for the products with whey protein as raw material). People with renal insufficiency should use the products under the guidance of doctors.	Enhancing immune
Whey protein

Note: Soybean protein isolate and whey protein can be used as single active ingredient, and the two raw materials can also be used in combination.

CIRS Comments

On 20 December 2021, SAMR issued three drafts, including Health Food Raw Materials Directory of Nutrition Supplement (2022 version) (Draft), Health Function Directory of Allowing Nutrition Supplement Claims (2022 version) (Draft) and Health Food Raw Materials Directory of Protein (Draft) for public comments. The public comment period will end on 19 January 2022. Compared with current regulations, the scope of health food filing is further expanded in the drafts, which provides more opportunities of health food companies. If you have any needs or questions, please contact us at service@jianzaoshiwang.cn.

CIRS Food Division Technical Team has prepare a guideline on health food exportation to China, which focuses on the updates of health food regulations in China. If you are interested, please click to know more info.

Reference

SAMR Notice (2021.12.20)