To accurately address the common questions frequently encountered in the acceptance of special foods and related administrative licenses, and to effectively improve the efficiency and experience of the applicants, the Food Review Center of China's State Administration for Market Regulation issued the “Summary of Common Issues on the Acceptance Work” on October 28, 2025.
This article forms part of a series of FAQs we have translated and focuses on the latest summary of common issues on health foods acceptance in China. Other articles include FAQs on the latest summary of application issues on infant formula products and FSMPs in China.
1. For non-standardized samples, what should be noted regarding safety and health function animal study evaluation materials?
Answer: According to Article 3.4.2.3.2(2) of the Detailed Rules for the Registration, Review, and Approval of Health Foods (2016 Edition), the production and handling process of non-standardized samples, the food testing institution’s specific requirements for sample handling, and an explanation of the necessity and rationale should be provided.
2. What should be noted for human consumption evaluation materials issued by legally qualified food testing institutions?
Answer: Original documents must be within the validity period. Product name and enterprise information must match the application form, and the batch number should be one of the three specified in Section 6.5. Applicants must also submit the original ethical review approval from the testing institution’s ethics committee. If the human consumption evaluation samples cannot use the same batch as the animal safety or health function studies, provide a reason, production process, and sample consistency proof for the different batch, and a hygiene test report from the testing institutions.
3. What should be noted for qualification certificates issued by the regulatory authority of the product’s country/region or legal service institution for overseas manufacturers?
Answer: Documents must include the issuing institution’s name, manufacturer’s name and address, product name, and issuance date.
4. In renewal applications, which information should be consistent with the approved health food registration certificate?
Answer: Product name, registration number, certificate validity period, and health function.
5. What should I do if the applicant's information on the business license differs from the approved certificate?
Answer: Submit an original change certificate issued by the local market supervision authority or a complete printed report from the National Enterprise Information Publicity System, stamped with the company seal.
6. When should a renewal application be submitted?
Answer: Renewal applications should be submitted promptly to be approved for acceptance before the health food registration certificate expires.
7. How should proof of production and sales for imported health foods be provided for renewal applications?
Answer: If provincial regulatory authorities cannot verify production and sales, submit a written statement with a stamped or signed business license, import customs declaration, and sales invoice copies.
8. How do you apply to terminate an accepted health food application?
Answer:
- For the old system: submit a written termination letter.
- For the new system: submit a withdrawal application form in the system and submit paper materials to the acceptance hall; do not submit official letters directly.
9. Can materials be returned for products not approved for registration?
Answer: Applicants may, within one month of receiving the rejection notice, request the return of documents such as authorization letters from overseas applicants to domestic agents, and certificates issued by overseas institutions. Other materials and samples will not be returned.
10. If multiple products share a single original document, what should be done?
Answer: The original can be used for one product; other products can use stamped copies with a written note indicating which product holds the original.
11. How do I update contacts and contact information in the health food system?
Answer: Search “Health Food – Common Questions” on the center’s external network, find the notice on updating contacts, fill out the change application form, stamp with the company seal, and submit to the acceptance hall.
12. For product name changes in registration change applications, should the pre-change or post-change name be used?
Answer: Use the pre-change name, consistent with the approved registration certificate.
13. When changing an applicant's name or address, how should the applicant field in the application form be filled out?
Answer: It should match the latest business license.
14. To transfer supplementary materials, is it enough to stamp only the transferee’s seal?
Answer: Yes, unless regulations or review opinions specifically require stamps from both parties.
15. What should be noted when reapplying?
Answer:
- For applications that are voluntarily withdrawn: if modifications do not involve safety, health function, or quality control, the original product name should be used, with explanations and commitments indicating no substantial changes.
- For rejected products: if rejection does not involve safety, health function, or quality control, the original product name should be used, attach a copy of the rejection notice (stamped), provide detailed reasoning addressing the rejection, and submit comparison and supporting materials.
16. Other common issues in application materials:
Answer: Check the “New Review Points in Health Food Acceptance” column on the center’s external network.
17. How should health functions be filled in after the 2023 version of the “Directory of Permitted Health Functions for Non-Nutrient Supplements”?
Answer: For new products, follow the updated directory; for change, renewal, transfer, or reissue applications, maintain consistency with the approved certificate.
18. Is it still necessary to collect paper acceptance notices?
Answer: Electronic acceptance notices are available through the health food registration system. Physical notices are not required unless specifically needed, in which case a note should be attached.
19. What are the key considerations for transferring health food registration technology?
Answer: Coordinate timing of transfer and renewal applications. If the transfer is unapproved and the certificate has expired, renewal will not be accepted. Consider risks if the transfer is terminated or unapproved, including contract fulfillment. The registration certificate is an administrative permit, not a property certificate. The center does not mediate contractual disputes. For health food products with no validity period and technical requirements, additional tests may be required during certificate renewal, leading to extra costs; applicants should assess technical risks and potential costs to avoid disputes.
About CIRS Group
Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 domestic and international food companies achieve one-stop compliance solutions. CIRS offers a full range of regulatory services covering novel food applications, synthetic biology-derived foods, U.S. GRAS notice, EU novel food application, health food registration, and food for special medical purposes (FSMP).
Our food services in China include, but are not limited to:
- China FCM Testing
- China new food raw materials registration
- China new food additive registration
- China health food (dietary supplement) registration/filing
- China health food testing service
- China new food contact substance registration
- China food for special medical purpose (FSMP) registration
- China infant formula milk powder registration
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
