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

from CIRS by

China,Health,Food,Filing,Material,Function,Protein

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.

If you need any assistance or have any questions, please get in touch with us via service @hfoushi.com.

Reference

SAMR Notice (2023.06.14)

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