The following Q&A was released by the State Administration for Market Regulation of China on December 7, 2023.
1. How should the range values for product technical requirements be set when filing products using DHA algal oil as raw materials?
As a nutritional supplement ingredient, the range of active ingredients in the filed product with DHA should be 80-120% of the indicated amount of active ingredients in the product, while also complying with the recommended daily intake for adults.
2. When filing products using DHA algal oil as raw materials, is it permissible to select a specific group such as "4-17 years old," "pregnant women," or "nursing mothers" as an unsuitable population?
Currently, it is not allowed to select a specific group or two groups such as "4-17 years old," "pregnant women," or "nursing mothers" as unsuitable populations. When filing the product, the groups "4-17 years old," "pregnant women," and "nursing mothers" can be listed as unsuitable populations. If "4-17 years old," "pregnant women," and "nursing mothers" are not listed as unsuitable populations, the precautions should include the statement "It is recommended to consult clinical doctors, nutrition professionals, etc., for the 4-17 years old, pregnant women, and nursing mothers."
3. When soy protein isolate and/or whey protein are combined with vitamin and mineral complexes, what is the range of permissible auxiliary ingredients if vitamin and mineral complexes require pre-processing?
When soy protein isolate and/or whey protein needs to be combined with vitamin and mineral complexes, if pre-processing such as pre-mixing, encapsulation, microencapsulation, etc., is required for the vitamin and mineral complexes, the permissible range of auxiliary ingredients for pre-processing should be the same as the current requirements for pre-processing auxiliary ingredients of nutritional supplement products when filing.
4. When filing products with soy protein isolate and/or whey protein, if compatibility with other nutrients is required, what are the data requirements for providing information on approved products with the same formulation ingredients and the same health claims?
When soy protein isolate and/or whey protein needs to be combined with nutrients, it is required to provide data on approved products with the same formulation ingredients and the same health claims. The data for the same formulation ingredients refers to the exact same ingredient names and types as stated in the label instructions of the approved products under the "Ingredients" section, without adding or removing any ingredient names or types from the approved products. The data for the same health claims refers to including at least the effects mentioned in the efficacy catalog of the approved products under the "Health Claims" section.
5. When filing for products using soy protein isolate and/or whey protein as raw materials, how can one apply for filing using auxiliary ingredients that are not included in the published list of permissible auxiliary ingredients?
For products using soy protein isolate and/or whey protein as the ingredient, if the auxiliary ingredients used are not included in the published list of permissible auxiliary ingredients and are also not covered in the "List of Permissible Auxiliary Ingredients and Their Usage Regulations for Health Food Filing Products (2021 Edition)," the following information should be provided under the section "Other Materials Demonstrating Product Safety and Health Functions":
-Data supporting the safety and functional evaluation of the product: This includes toxicological and functional evaluation test data for the finalized product (including all auxiliary ingredients) or literature data for products with the same formulation.
-Research data (including experimental data and indicator selection) on the basis for using the auxiliary ingredient, the necessity in the manufacturing process, maintaining product stability, ensuring no chemical changes with packaging materials in direct contact with the product, and not affecting product testing, formulation molding, and stability.
-A commitment from the applicant to ensure that the use of the auxiliary ingredient guarantees the safety of the product.
6. When filing for functional health food products using soy protein isolate and/or whey protein as raw materials, how should the health claims be labeled?
When filing for functional health food products using soy protein isolate and/or whey protein as raw materials, the registered product should be labeled with the health claims based on the published efficacy in the Health Food Raw Materials Catalog and adjusted health claims from the newly released catalog of permitted health claims. In this case, the health claim should be labeled as "helps enhance immune function." For other functional ingredients listed in the Health Food Raw Materials Catalog, the health claims should also be labeled according to the same principle during product registration.
