China Official FAQs on Filing Products with DHA Algae Oil, Soy Protein Isolate, or Whey Protein as Raw Materials

On March 7, 2024, the Center for Food Evaluation (CFE) issued Q&As on filing products with DHA algae oil, soy protein isolate, or whey protein as raw materials. Details are as follows.

Q1: For filing products with DHA algae oil as a raw material, how to set the technical requirements range?

A1: For filing products adding DHA, a nutrient supplement raw material, the efficacy component range should be between 80% to 120% of the indicated amount, while also complying with the daily consumption amount for adults.

Q2: When filing a functional health food product with soy protein isolate and/or whey protein as raw materials, how should the health function be labeled?

A2: The filed product should be labeled as “aiding in enhancing immunity”, according to the health functions listed in the health food raw material directory, and the adjusted health claims in the current directory of health functions available to be claimed for health food. For other functional raw materials included in the health food raw material directory, the same practice should be applied when labeling the health functions while filing.

Q3: When filing a product with DHA algae oil as a raw material, can I choose a specific group such as “people aged 4-17”, “pregnant women”, or “lactating mothers” as the unsuitable population?

A3: Currently, such practice is not allowed. All the above-mentioned three groups can be listed as unsuitable population during filing. If not listed, the precautions should bear a statement that “It is recommended that people aged 4-17, pregnant women, and lactating mothers consult with clinical doctors and nutrition professionals, etc.”

Q4: How to file a product with soy protein isolate and/or whey protein as raw materials if the excipients used are not included in the official announcement?

A4: If the excipients used are not listed in the official announcement but are included in the Available Excipients for Health Food Filing Product and the Use Requirements (2021 Edition), the filing should follow the requirements for products included in the health food raw material directory. The applicant should also provide materials demonstrating product safety and health functions, including the following:

1. Supporting data for the safety and function evaluation of the product, including toxicological evaluation tests and function evaluation tests for the finalized product (including all excipients), or literature data for products with same formulas;
2. The basis for using the excipients, process necessity, research tests for maintaining product stability, ensuring that there are no chemical changes with packaging materials directly in contact with the product, and not affecting product detection, preparation molding, and stability (including experimental data, indicator selection, etc.); and
3. A commitment letter from the filer ensuring that the use of the excipients will guarantee the safety of the product.

Q5: When filing for products with soy protein isolate and/or whey protein as raw materials that require compatibility with other substances, what are the requirements for providing materials on approved products with the same formula raw materials types and health functions?

A5: Materials for the same type of formula raw materials refer to the exact names and categories of raw materials listed under the “Ingredients” section on the labels and instructions of the approved product, and the filed product should not add or remove any names and categories. Materials for the same health functions refer to those listed under the “Health Function” section of the approved product’s label and instructions, which should at least include the efficacy listed in the raw material directory.

Q6: When soy protein isolate and/or whey protein need to be compounded with vitamins and minerals, what would be the available excipients if the vitamins and minerals require pre-treatment?

A6: If it requires pre-treatment such as premixing, encapsulation, microencapsulation, etc., the range of permissible excipients for pre-treatment is the same as the requirements for pre-treatment excipients of vitamins and minerals in currently filed nutrient supplement products.

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Further information

FAQ - Compilation of Common Questions Regarding Health Food in China