[Updated] China Appends Soybean Protein Isolate and Whey Protein into Health Food Raw Materials Directory

Update in October:

On September 29, 2023, SAMR released the "Dosage Forms and Technical Requirements for Health Food Filing Using Soybean Protein Isolate/Whey Protein as the Raw Material".

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On June 14, an official notice was released jointly by China's State Administration for Market Regulation (SAMR), National Health Commission (NHC), and National Administration of Traditional Chinese Medicine (NATCM), announcing the revision and formulation of the four documents below, which will take effect on October 1, 2023.

Major Content

Detailed revisions and impact analysis of the first two amendments abut nutrient supplements can be read at ChemLinked news: China SAMR Expands Raw Material Directories and Function Claims for Health Food (Nutrient Supplement). Requirements for soybean protein isolate and whey protein are listed below.

1. Soybean Protein Isolate

• Consumption range: Protein 6-25g

• Suitable group: Immunocompromised adults due to insufficient protein intake

• Unsuitable group: Children

• Function: Enhancing immunity

• Notes: The total daily consumption of protein for adults is recommended to be 60g; the daily consumption of soybean protein isolate can be adjusted within the consumption range individually. It is not recommended for people without significant lack of protein. People who are allergic to plant protein shall not use it. People with renal insufficiency should take the product with caution. Pregnant women and nursing mothers are advised to consult clinicians and/or nutrition professionals.

2. Whey Protein

• Consumption range: Protein 6-25g

• Suitable group: Immunocompromised adults due to insufficient protein intake

• Unsuitable group: Children

• Function: Enhancing immunity

• Notes: The total daily consumption of protein for adults is recommended to be 60g; the daily consumption of whey protein can be adjusted within the consumption range individually. It is not recommended for people without significant lack of protein. Those who are allergic to animal protein shall not use it. Those with renal insufficiency should take the product with caution. Pregnant women and nursing mothers are advised to consult clinicians and nutrition professionals.

Impact analysis

Up until now, SAMR has approved seven ingredients with corresponding functions through notices. They are coenzyme Q10, melatonin, fish oil, reishi shell-broken spore powder, spirulina, and the two ingredients released this time (soybean protein isolate and whey protein). Since they are not vitamins nor minerals, they are outside the “Health Food Raw Materials Directory - Nutrient Supplement”.

Please note that at present, the supervision of health food added with these functional ingredients as raw materials is subject to two situations. Locally produced products can obtain the “blue hat” certificate via filing, while imported products can only get the certificate through registration. Read more explanations here: Filing Requirements for Health Food Using Coenzyme Q10 and Other Functional Ingredients. Differences between filing and registration are analysed in the following part.

Therefore, in this piece of news, for overseas stakeholders who wish to use soybean protein isolate and whey protein as ingredients in health foods with immunity-enhancing function, a "blue hat" certificate must be obtained, with registration as the only method to gain it.

Summary: China’s dual track system and its relation with raw material and product claims

All health food products, whether imported or locally produced, must obtain a “blue hat” certificate before being traded on the market. At present, there are two ways to get the “blue hat” certificate, registration and filing.

Generally, only products whose raw material and auxiliary materials fall into government’s recognized ingredient list and usage limit can obtain the “blue hat” certificate through filing. Since such ingredients are recognized safe with approved functions, the application undergone through filing will save lots of cost and time than registration. Another thing worth mentioning is that most of this kind of products are vitamin and mineral supplements, so they can only bear claims like “This product supplements Vitamin D. Vitamin D can help the absorption of Calcium.”

Table 1: Situations subject to filing

For imported products want to be claimed with functions like “enhancing immunity system”, “helping sleep”, etc., they shall obtain the “blue hat” certificate through registration. In this case, stakeholders can use a wide range of ingredients (not only limited to the raw materials listed in the positive list released by the government) and do researches and developments to prove the product function. But compared to filing, applications undergone through registration system will cost more expense, time and effort. Due to the lack of existing function evaluation regulation, the registration process of imported health food is suspended for years. Therefore, at present, we still recommend overseas enterprises to get vitamin and mineral supplements approved through filing, by meeting the aforementioned requirements, which is also quick to obtain the approval and enter the market.

Table 2: Situations subject to registration

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