[FAQs] Latest Summary of Application Issues on Infant Formula Products in China

To accurately address the common questions frequently encountered in the acceptance of special foods and related administrative licenses, and to effectively improve applicants’ efficiency and experience, the Food Review Center of the 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 application of infant formula products in China. Other articles include FAQs on health food acceptance in China, and a summary of application issues on FSMP.

1. What should be noted when the application type for infant formula product registration is “deregistration and re-registration”?

Answer: When the application type is deregistration and re-registration, the correct application entry must be selected in the system. Ensure that the material type shown in the system is “Registration Application Form (Deregistration and Re-registration)”. The paper version of the deregistration application form must be submitted at the same time.

2. What are the requirements for affixing official seals on application materials?

Answer: Except for the registration application form and the test report issued by the inspection institution, all application materials must be stamped – either page by page or across the binding seam – with the applicant’s official seal or stamp. For overseas applicants without an official seal, the seal of their Chinese representative office or domestic agent must be used. The seal must be stamped on the text portion. All seals must comply with national regulations on official seals and have legal validity. For details, refer to “Items and Requirements for Application Materials for Infant Formula Product Registration (Trial) – 2017 Revision”.

3. What should be noted when filling in the application form for infant formula product registration?

Answer: The applicant's name, address, and legal representative information must match the latest applicant qualification documents. For change and renewal applications, the product name, product validity period, registration certificate number, and other information must be consistent with the approved certificate.

4. What should be noted regarding time limits when submitting change or renewal applications for infant formula product registration?

Answer:

• Change registration must be submitted and accepted within the validity period of the certificate.
• Renewal registration must be submitted and accepted six months before the certificate expires.

5. For infant formula registration, which materials must be submitted in the original form?

Answer: All materials not explicitly specified as copies must be submitted as originals. Example: If the trademark owner is not the applicant, original documents proving the applicant’s legal right to use the trademark must be provided. Product test reports must be submitted as originals.

6. What should be noted regarding supporting documents when applying to change registration for infant formula products?

Answer: For changes to the applicant’s name or production address, original change certification documents issued by the local competent governmental authority must be submitted. Copies of business licenses (before and after the change) cannot be used as substitutes.

7. What qualification documents (copies) must be submitted for the renewal registration of infant formula product formulas?

Answer:

• For domestic products, copies of the applicant’s latest business license and production license.
• For imported products, copies of the GACC list of overseas dairy manufacturers registered in China, and the authorization letter (the authorization letter must be within its validity period).

8. What should be noted when uploading electronic versions of infant formula product registration materials?

Answer: Copies and electronic files must be made from originals, and their content must be complete, clear, and consistent with the originals. The applicant is responsible for the authenticity, completeness, and legality of all materials and bears corresponding legal responsibility. All application materials must be stamped page by page or across the binding seam before being scanned and uploaded to the infant formula product formula registration system.

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.