On December 20, 2021, China State Administration for Market Regulation ("SAMR") opened the drafts of "Health Food Raw Materials Directory - Nutrient Supplement (2022)" and "Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplement (2022)", as well as "Health Food Raw Material Directory - Protein" for public comments. Any comment can be sent to bjspba@cfe-samr.org.cn before January 19, 2022.
1. Raw Material Directory
China adopted a dual-track system (registration/filing) of health food for market access. Compared to product registration, it takes less time and cost for enterprises to get health food filed, and only health food using the ingredients from "Health Food Raw Materials Directory" (hereafter as the "Directory") subjects to product filing. Currently, the "Directory" is composed of "Health Food Raw Materials Directory - Nutrient Supplement" and other five specified functional ingredients*. As revealed by the above drafts, a total of six new ingredients are proposed to be included in the "Directory", including two new functional ingredients for non-nutrient supplement and four new ingredients for nutrient supplement.
Note: The five specified functional ingredients refer to coenzyme Q10, reishi shell-broken spore powder, spirulina, fish oil and melatonin. At present, only Chinese domestic heath food using the five ingredients can be filed. When it comes to products imported for the first time, registration is still required. For the market access (registration or filing) for the first-imported health food using the two new functional ingredients, it will not be specified until further notification released.
Two New Functional Ingredients
According to the draft of "Health Food Raw Material Directory - Protein", soybean protein isolate and whey protein are proposed to be added.
Name | Daily consumption | Function | ||||
Consumption range | Suitable group | Unsuitable group | Notes | |||
Soybean protein isolate | 6~25g | Immunocompromised adults due to insufficient protein intake | Children, pregnant woman, lactating woman | The total daily consumption of protein for adults is recommended to be 60g, which can be adjusted within the consumption range individually. It is not recommended for people without significant lack of protein. Those who are allergic to plant protein and animal protein should take the product with caution (label the warning language for the products using soybean protein isolate and whey protein raw materials respectively).Those with renal insufficiency should take the product under the guidance of doctors. | Enhance immunity | |
Whey protein |
Note: Soy protein isolate and whey protein can be used as the raw material alone or in combination. The dosage form of health food using the two ingredients should be powder. Technical requirements for the two ingredients are specified in this draft.
Four New Ingredients for Nutrient Supplement
Compared with the current version (2020), the draft of "Health Food Raw Materials Directory - Nutrient Supplement (2022)" adds "casein phosphopeptide + calcium" as a new compound source of calcium, and "6S-5-methyltetrahydrofolate calcium", along with "(6S)-5-methyltetrahydrofolic acid, glucosamine salt" as two new compound sources of folic acid. Besides, DHA is proposed to be a new nutrient permitted for nutrient supplement.
Name | Daily consumption | Function | ||||||
Nutrient | Compound | Reference standard | Suitable for | Functional component | Suitable group | Minimum value | Maximum value | |
Calcium | casein phosphopeptide + calcium | For casein phosphopeptide: GB 31617 For calcium: refer to the relevant standard of the selected calcium | Determined by the range of selected calcium. The ratio of casein phosphopeptide + calcium is 1:5-1:20 | Ca (as ca, mg) | Determined by the range of selected calcium. | Determined by the range of selected calcium. | Determined by the range of selected calcium. | Supplement calcium |
Folic acid | 6S-5-methyltetrahydrofolate calcium | Adult | Folic acid (as folic acid, µg) | Adult | 80 | 500 | Supplement folic acid | |
(6S)-5-methyltetrahydrofolic acid, glucosamine salt | ||||||||
DHA | Docosahexaenoic acid | Follow GB 26400; EHA content: w/% ≤ 3.0 (calculated as C20H30O2, triglyceride) | People above 17 years old | DHA (as C22H32O2, triglyceride, mg) | Adult | 200 | 1000 | Supplement n-3 polyunsaturated fatty acids |
Note 1: The dosage form of nutrient supplements using DHA should be soft capsule. Only single raw material can be used in the product formulation, and shall not be compounded with other raw materials.
Note 2: The dosage form of nutrient supplements using 6S-5-methyltetrahydrofolate calcium and (6S)-5-methyltetrahydrofolic acid, glucosamine salt should be solid forms.
2. Health Function Catalogue
As DHA was listed the draft of "Health Food Raw Materials Directory - Nutrient Supplement (2022)", the draft of "Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplement (2022)" adds "supplement n-3 polyunsaturated fatty acids" as a new health function for nutrient supplement correspondingly, with other contents remained the same as the current catalogue (2020).
ChemLinked's Interpretation
Once the drafts pass the final review, health food (including nutrient supplement and non-nutrient supplement) using these six ingredients can get the health food certificate by product filing, which gives greater freedom and convenience for manufacturers in terms of health food production and market access, especially considering that soy protein isolate, whey protein and DHA have always been popular ingredients for health food in the market.
To promote the industry development and facilitate the product registration/filing of health food, China has been active on the regulatory revisions, which can be exemplified by the adjustments of the "Directory" over the years. It is expected that more ingredients will be listed in the "Directory" in the future.
Recommended foodpedia: China Health Food Regulation
For the further translation service of the drafts mentioned above or if you need any assistance related to health food filing and registration, please feel free to contact us.