China Issues a Q&A Document for the Product Registration of Infant FSMP Under the New GB Standard (GB 25596-2025)

On April 23, 2025, China's State Administration for Market Regulation (SAMR) published a Q&A document to explain the registration requirements of infant foods for special medical purposes (FSMP) under the new GB standard, "GB 25596-2025 National Food Safety Standard General Rules of Infant Formula Foods for Special Medical Purposes". The new 2025 GB standard, promulgated on March 27, 2025, will come into effect on March 16, 2027. It has made several key revisions, including the amendments to the technical requirements for essential and optional nutrients. (Read more at: China Releases GB Standards for Infant Formula FSMP and Complementary Baby Foods )

The Q&A document answers the following five questions. The full text is translated below for reference only.

Content of the Q&A Document

1. When can applicants submit registration applications according to the new national standard (GB 25596-2025)? When must production be organized according to the new GB standard?

From the date the new GB standard is published (March 27, 2025), applicants can submit applications for product registration (including alteration registration) according to the new GB standard. Once registration is obtained, manufacturers can produce according to the technical requirements (e.g., requirements for formula and production process) specified in the new standards.

From the implementation date of the new GB standard (March 16, 2027), manufacturers must organize production according to the technical requirements registered under the new GB standard. Products previously produced according to the "GB 25596-2010 National Food Safety Standard General Rules of Infant Formula Foods for Special Medical Use" can be sold until the end of their shelf life.

2. When applicants submit registration applications according to the new GB standard, under what circumstances are they handled as alteration registration? Under what circumstances are they handled as new product registrations?

For already registered infant formula foods for special medical purposes, if the applicant only adjusts the formula according to the new GB standard, it will generally be handled as an alteration registration.

If adjustments are made simultaneously to the product formula, production process, etc., essentially constituting a new product formula, it will be handled by canceling the original product registration and applying for a new product registration.

3. For infant FSMP that have already been registered, what application materials need to be provided when applying for registration (including alteration registration) according to the new GB standard?

For already registered infant FSMP, when the applicant applies for registration (including alteration registration) according to the new GB standard, materials should be submitted according to the "Items and Requirements for Application Materials for Registration of Formula Foods for Special Medical Purposes (Trial) (2017 Revised Edition)". Materials that have not changed do not need to be submitted again, and this should be stated.

The product R&D report should detail the research and justification for adjustments to the product formula, production process, etc., as well as the differences before and after the adjustments.

4. For products that have already been registered, is it necessary to submit stability study materials when applying for registration (including alteration registration) according to the new GB standard?

Applicants should organize and conduct stability studies in accordance with the requirements outlined in the "Requirements for Stability Studies of Formula Foods for Special Medical Purposes (Trial) (2017 Revised Edition)" and retain records for inspection.

5. For products that have already been registered, is it necessary to conduct on-site production inspections and sample testing when applying for registration (including alteration registration) according to the new GB standard?

The review agency will organize on-site production inspections and sample testing for the applicant based on food safety risk evaluation. For already registered infant FSMP, if the applicant is only applying for registration (including alteration registration) according to the new GB standard and the production process has not undergone substantial changes, on-site production inspections and sample testing will generally no longer be conducted.

For further consulting and registration service, please email [email protected].