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Background: Previously on June 14, 2023, China's State Administration for Market Regulation (SAMR), National Health Commission (NHC), and National Administration of Traditional Chinese Medicine (NATCM) jointly issued a notice announcing four documents related to raw materials and function claims for nutrient supplements. They are:
The new instruments will take effect on October 1, 2023. Read ChemLinked analysis at China SAMR Expands Raw Material Directories and Function Claims for Health Food (Nutrient Supplement) and China Appends Soybean Protein Isolate and Whey Protein into Health Food Raw Materials Directory. |
To propel the implementation of using the health food raw material approved in June, SAMR drafted four supporting documents and opened them for public consultation on July 5, 2023. The four supporting documents are:
Dosage and Technical Requirements for Filed Health Food Products with Soy Protein Isolate or/and Whey Protein as Raw Material (Draft),
Drafting Instruction of “Dosage and Technical Requirements for Filed Health Food Products with Soy Protein Isolate or/and Whey Protein as Raw Material” (Draft),
Interpretation of “Health Food Raw Material Directory - Soy Protein Isolate” and “Health Food Raw Material Directory - Whey Protein” (Draft),
Interpretation of “Health Food Raw Materials Directory - Nutrient Supplement (2023)” (Draft).
Major Content
1. “Dosage and Technical Requirements for Filed Health Food Products with Soy Protein Isolate or/and Whey Protein as Raw Material (Draft)” and its drafting instruction
1.1 Permitted raw material
When filing a health food product containing soy protein isolate, whey protein, a combination of soy protein isolate and whey protein, or any of these ingredients together with other vitamins and minerals listed in the “Health Food Raw Material Directory”, the product type should be powder form. The main production processes include crushing, sieving, mixing, filling products into containers, and packaging.
1.2 Corresponding auxiliary materials
Permitted auxiliary materials are listed accordingly based on the different combination of raw materials. For example, if the health food is subject to filing, and whey protein or together with other vitamins and minerals listed in the “Health Food Raw Material Directory” is used as raw material, then the auxiliary materials permitted to be used in this situation include soy lecithin, lecithin, fructooligosaccharides, silica, D-mannitol, maltodextrin, xylitol, citric acid, isomaltooligosaccharide, milk powder, stevioside, vitamin C, glucose, vitamin E, and edible flavors.
1.3 Requirements for product instruction
The active ingredient should at least contain protein as one of the indicators. If other ingredients (vitamins or/and minerals) are contained in the product as the raw material, then the relevant nutrients shall also be remarked as the active ingredient.
The recommended daily intake and consumption method is as follows: for products in powder, the maximum daily consumption is 35g.
For products packaged in large quantities, the filling limit for each package is 800g, which means not exceeding one-month dosage in principle.
1.4 Technical requirements
Technical requirements are clarified for the test method of active ingredient, the conversion factor of nitrogen to protein, and physicochemical indicators. For example, for products containing soy protein isolate as a raw material, the conversion factor of nitrogen to protein is 6.25. For products containing whey protein as a raw material, the conversion factor of nitrogen to protein is 6.38. For products containing both soy protein isolate and whey protein as raw materials, the conversion factor of nitrogen to protein is 6.25.
2. Interpretation of “Health Food Raw Material Directory - Soy Protein Isolate” and “Health Food Raw Material Directory - Whey Protein”(Draft)
2.1 Additional documents
For products containing soy protein isolate or/and whey protein as raw material together with other vitamins and minerals listed in the “Health Food Raw Material Directory”, the applicant should provide the result of product safety evaluation test. Such product shall only bear the function claim “enhancing immunity”. Besides, the applicant should also provide a commitment letter, stating the responsibility for the safety, efficacy, and quality control of the product.
2.2 The explanation of unsuitable consumer groups
If the filed product does not exclude pregnant and lactating women from the unsuitable consumer group, the precautions for the product should include an advisory note stating that “Pregnant and lactating women are advised to consult with clinical physicians or nutrition professionals.”
2.3 Product name
When using soy protein isolate or whey protein as the sole raw material, the product name shall be “XXX (trade name) + soy protein isolate powder” or “XXX (trade name) + whey protein powder”
When using both soy protein isolate and whey protein as the raw material, the product name can be “XXX (trade name) + soy protein isolate whey protein powder” or “XXX (trade name) + whey protein soy protein isolate powder” (the raw material with larger use amount shall rank first).
For products containing vitamins and/or minerals listed in the “Health Food Raw Material Directory” as raw material other than soy protein isolate and/or whey protein, the product name shall not contain the relevant nutrient.
2.4 Quality control of raw material
The applicant shall provide a full-item test report of raw materials and explain the supplier, quality standard, and the source of the raw material.
3. Interpretation of “Health Food Raw Materials Directory - Nutrient Supplement (2023)”(Draft)
3.1 Explanation for filed health food containing casein phosphopeptide + calcium
The instrument in June adds "casein phosphopeptide + calcium" into the raw material directory. It means casein phosphopeptide can be used together with other compounds allowed to be claimed with “supplement calcium”. The ratio of casein phosphopeptide (use amount) and calcium (label value) should be within the range of 1:5 to 1:20.
3.2 Explanation for filed health food containing DHA algae oil
3.2.1 Use of raw material
It is recommended to use DHA algal oil as the sole raw material for filed health food. If DHA does need to be compounded with other nutrients listed in the “Health Food Raw Material Directory” as raw material, the applicant should provide toxicological evaluation test data, research & development information, as well as a commitment letter, stating the responsibility for the safety, efficacy, and quality control of the product.
3.2.2 Function claim
DHA algae oil is allowed to be claim with the function “supplementing n-3 polyunsaturated fatty acids”. When DHA is compounded with other nutrients, the claimed health function should be arranged in the descending order of nutrient efficacy as listed in the “Health Food Raw Material Directory”. For example, the claimed health function can be “supplementing calcium and n-3 polyunsaturated fatty acids”, or “supplementing multiple vitamins and n-3 polyunsaturated fatty acids”.
3.2.3 Commercialized DHA algae oil
When DHA algal oil is used as a health food raw material, commercialized ingredient (such as oily and powdery ingredients) may be used. Antioxidants or diluents necessary for the production process of DHA algal oil may be added as auxiliary materials.
For commercialized ingredient added with Vitamin C or Vitamin E as a necessary antioxidant, the filed product added with such DHA algae oil should clearly state "This product contains Vitamin C or Vitamin E". Besides, the actual addition amount of antioxidant shall be explained in the product processing material. However, when Vitamin C or Vitamin E is added only as necessary auxiliary material, their function claims shall not be claimed.
3.2.4 Unsuitable consumer group
For filed health food in which DHA algal oil is used as a raw material, the target consumer group should be listed as “adults”. If the product does not exclude the age group of “4-17 years old”, “pregnant women”, or “lactating women” as unsuitable consumer group, the precautions for the product should include a specific description stating: “The group of 4-17 years of age/pregnant women/lactating women are advised to consult with clinical physicians or nutrition professionals.”
3.2.5 Product name
When using DHA algal oil as a single raw material for product filing, the product name should be “trademark + DHA + attribute name” or “trademark + DHA algal oil + attribute name” (if the material is in oil form), such as “brand name + DHA tablets” or “brand name + DHA algal oil tablets” (if the material is in oil form).
When DHA is compounded with other nutrients, the product name should still comply with the current naming rules for health food. For product names that may cause ambiguity when compounded with other nutrients, the nutrient order should be adjusted. For example, when compounded with vitamin C, the product name should be “brand name + DHA vitamin C tablets” instead of “brand name + vitamin C DHA tablets”.
Feedbacks can be sent to [email protected] prior to August 4, 2023.
For more consulting or product registration/filing service, please email [email protected].
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