DHA and Two Proteins Added into Health Food Raw Materials Directory in China

On 14 June 2023, State Administration for Market Regulation (SAMR) issued four new regulations:

• Health Food Raw Materials Directory of Nutrition Supplements (2023 Version);
• Health Function Directory of Allowing Nutrition Supplement Claims (2023 Version);
• Health Food Raw Materials Directory - Soy Protein Isolate; and
• Health Food Raw Materials Directory - Whey Protein.

They will take effect from October 1, 2023. Compared with the current regulations, there are six major changes in the new ones. Details are as follows:

1) “DHA” has been added to the “Raw Materials Directory of Nutrition Supplements”. As the function of this nutrient (“supplying n-3 polyunsaturated fatty acids”) is within the scope of “supply nutrients”, CIRS believes that overseas enterprises can also apply for the filing of DHA products.

2) The combination of “Casein phosphopeptides+ Calcium” is added as a new source compound of calcium.

3) “Hemin chloride” is added as a new source compound of iron.

4) The “Vitamin K2 (synthesis method)” is added as a new source compound of Vitamin K.

5) The new health function “supply n-3 polyunsaturated fatty acids” and its interpretations have been added to the “Function Directory of Nutrition Supplements”.

6) Soy protein isolate and whey protein are newly available raw materials for health food filing, and their health function is to enhance immunity. Similar to the filing of Coenzyme Q10, CIRS expects that the filing scope of health food made of the two raw materials will only be applicable for domestic products, while overseas products will still be required to apply for health food registration.

Specific analyses are as follows:

1. Changes to the Raw Materials Directory of Nutrition Supplements

Addition of one new nutrient: DHA

The suitable use group of the newly approved nutrient, DHA, is limited to adults.

Considering that the DHA is classified as a nutrition supplement, and its function described in the Health Function Directory (2023 Version) is supplying n-3 polyunsaturated fatty acids, which is within the scope of “supplying vitamins, minerals, and/or other nutrients”, CIRS believes that overseas enterprises can also apply for the filing of DHA products.

Name	Nutrients	DHA
	Name of the Compounds	Docosahexaenoic acid oil
	Standard Basis	Raw Material Technical Requirements for DHA Algal Oil *
	Applicable Scope	Adults
Daily Intake	Functional Component	DHA (counted as C22H32O2 triglyceride, mg)
	Suitable Crowds	Adults
	Minimum	200 mg
	Maximum	1000 mg
Function		Supplying n-3 polyunsaturated fatty acids

*See Annex: Raw Material Technical Requirements for DHA Algal Oil of Health Food Raw Materials Directory of Nutrition Supplements (2023 Version)

Addition of new source compounds of Calcium, Iron, and Vitamin K

Compared with the current Directory, more compounds will be available for Calcium, Iron, and Vitamin K:

Nutrients	New Compounds	Standard Basis	Applicable Scope
Calcium	Casein phosphopeptides + Calcium	Casein phosphopeptides: GB 31617; Calcium: shall comply with the standards of the calcium used	Shall be determined by the applicable scope of the calcium used. The ratio of casein phosphopeptides and calcium shall be within [1:5 -1:20].
Iron	Hemin chloride	GB 1903.52	All groups
Vitamin K	Vitamin K2 (synthesis method)	NHC Notice of No.9, 2020	All groups

The standard basis of 13 compounds have been added/updated

Compared with the current Directory, the standard basis of 13 compounds have been newly added/updated:

Nutrients	Compounds	Current Directory	Directory (2023 Version)
Calcium	calcium dihydrogen phosphate	GB25559	GB1886.333
	tricalcium orthophosphate	GB25558	GB1886.332
Potassium	dipotassium hydrogen phosphate	GB25561	GB1886.334
	potassium dihydrogen phosphate	GB25560	GB1886.337
Iron	Ferrous fumarate	Chinese Pharmacopoeia	GB1903.46; Chinese Pharmacopoeia
	Ferrous lactate	GB6781	GB1903.47
Zinc	Zinc citrate	Chinese Pharmacopoeia	GB 1903.49; Chinese Pharmacopoeia
	Zinc citrate (trihydrate)	NHFPC Notice of No.5, 2013	NHFPC Notice of No.5, 2013; GB 1903.49
Vitamin D	Vitamin D3	Chinese Pharmacopoeia	GB1903.50; Chinese Pharmacopoeia
Vitamin B12	Cyanocobalamin	Chinese Pharmacopoeia	GB1903.43; Chinese Pharmacopoeia
Niacin (or Nicotinic acid)	Nicotinamide	Chinese Pharmacopoeia	GB1903.45; Chinese Pharmacopoeia
Choline	Choline bitartrate	National Drug Standards WS-10001-(HD-1250)-2002	GB 1903.54; National Drug Standards WS-10001-(HD-1250)-2002
Pantothenic acid	Calcium D-pantothenate	Chinese Pharmacopoeia	GB1903.53; Chinese Pharmacopoeia

2. Changes to the Function Directory of Nutrition Supplements

Compared with the current Function Directory, the definition of health function is revised from “supplying vitamins and/or minerals” to “supplying vitamins, minerals, and/or other nutrients”.

A new remark, supplying n-3 polyunsaturated fatty acids, corresponding to the new nutrient “DHA” has been added. The interpretation of the new health function is presented below:

Health Function	Interpretation
Supplying n-3 polyunsaturated fatty acids	1. The n-3 polyunsaturated fatty acids provide essential fatty acids; 2. The intake of n-3 polyunsaturated fatty acids in the diet shall account for [0.5% - 2%] of the total energy; 3. Help to maintain healthy blood lipids (triglycerides) levels.

3. Changes to the Raw Materials Directory of Functional Health Food

Since June 1, 2021, according to regulations of Health Food Raw Materials Directory - 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 the single active ingredient, but overseas applicants will still need to apply for registration.

SAMR issued Health Food Raw Materials Directory - Soy Protein Isolate, and Health Food Raw Materials Directory - Whey Protein this time, adding soybean protein isolate and whey protein into the Directory, and the details are shown in the following table. Similar to the filing of Coenzyme Q10, CIRS expects that the filing scope of health food made of the two raw materials will only be applicable for domestic products, while overseas products will still be required to apply for health food registration.

Name	Daily Intake				Functions
	Intake Scope	Suitable Crowds	Unsuitable Crowds	Notes
Soybean protein isolate	Protein 6-25 g	People with low immunity due to insufficient protein intake	Teenagers and children	The total daily intake of protein for adults is recommended to be 60 grams (g), which can be adjusted within the intake scope according to individual daily intake. It is not suitable for people without significant protein deficiency. It is not suitable for people who are allergic to plant protein. People with renal insufficiency should use it with caution. Pregnant women and breastfeeding women should use the products under professional guidance.	Enhancing immune
Whey protein				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 not suitable for people without significant protein deficiency. It is not suitable for people who are allergic to animal protein. People with renal insufficiency should use it with caution. Pregnant women and breastfeeding women should use the products under professional guidance.

CIRS Comments

The inclusion and revision of the Health Food Raw Materials Directory of Nutrition Supplements (2023 Version) mentioned above provide more options for enterprises to select raw materials and suppliers. The expansion of the Health Function Directory of Allowing Nutrition Supplement Claims (2023 Version) also enables enterprises to make appropriate functional claims, which shows a positive significance for product promotion. Moreover, soy protein isolate and whey protein become newly available raw materials for health food filing, whose filing scope of health food made of the two raw materials is expected to be applicable for domestic products only.

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Reference

SAMR Notice (2023.06.14)