On April 23, the State Administration for Market Regulation (SAMR) of China issued the Q&A on the Registration of Foods for Special Medical Purposes Infant Formula under the New National Standard (hereinafter referred to as the “Q&A”). The purpose of the Q&A is to facilitate the re-registration process following the promulgation of the National Food Safety Standard: General Rules for Food for Special Medical Purpose Infant Formula (GB 25596—2025) (hereinafter referred to as the “New National Standard”), guide enterprises in the standardized submission of applications, and ensure a smooth market transition.

I. When can applicants submit registration applications in accordance with the New National Standard? When must production comply with the New National Standard?

From the date of promulgation of the New National Standard, applicants may submit product registration applications (including applications for change) based on the New National Standard. Upon obtaining registration approval, production shall be organized in accordance with the technical requirements, such as product formula and production process, as specified under the New National Standard.

From the date of implementation of the New National Standard, production enterprises shall organize production in accordance with the technical requirements registered under the New National Standard. Products manufactured in compliance with the National Food Safety Standard: General Rules for Special Medical Purpose Infant Formula (GB 25596—2010) before the implementation date, may continue to be marketed until the expiration of their shelf life.

II. When submitting registration applications under the New National Standard, what circumstances should be handled as a change to a registration, and what should be handled as new product registrations?

For products that have already obtained a registration, where only the product formula is adjusted in accordance with the New National Standard, applications should, in principle, be handled as a change of registration.

Where adjustments involve both the product formula and other elements such as the production process, resulting in a substantial modification of the product, the original registration must be cancelled, and a new product registration must be applied for.

III. What application materials are required for registration (including changes) under the New National Standard for already registered FSMP infant formulas?

For food for special medical purpose (FSMP) infant formulas that have already obtained registration, applicants submitting applications under the New National Standard (including changes) must prepare materials in accordance with the Items and Requirements for Registration Application Materials for Foods for Special Medical Purposes (Trial) (2017 Revision). Materials that have not undergone any changes need not be resubmitted, but must be clearly indicated.

The product development report must provide detailed explanations regarding the research, justification for adjustments to the product formula and production process, and the differences before and after such adjustments.

IV. Is it necessary to submit stability study data for products applying for registration (including changes) under the New National Standard?

Applicants must conduct stability studies in accordance with the Stability Study Requirements for Foods for Special Medical Purposes (Trial) (2017 Revision) and retain relevant records for future verification.

V. Are production site inspections and sample testing required for products applying for registration (including changes) under the New National Standard?

The review authority shall, based on food safety risk assessments, organize production site inspections and sample testing of applicants. For FSMP infant formulas that have already obtained registration, where the applicant only applies for registration (including changes) under the New National Standard and the production process has not undergone substantive changes, production site inspections and sample testing are generally not required.

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