Q&A on Registration of FSMP Under the New National Standard

On March 18, the State Administration for Market Regulation (SAMR) released the Q&A on the Registration of Foods for Special Medical Purposes under the New National Standards. The document aims to guide enterprises in conducting compliant applications and efficient registration in accordance with two national food safety standards: General Principles for Foods for Special Medical Purposes (GB 29922—2025) and Foods for Special Medical Purposes for Tumor Complete Nutrition (GB 31662—2025), thereby ensuring a smooth and orderly market supply transition.

1. When can applicants submit registration applications according to the new standard, and when must production comply with the new standard?

From the date of issuance of the new standard, applicants may submit registration (including change) applications according to the new standard. Once registered, products can be produced in accordance with the formula, production process, and technical requirements of the new standard. From the date of implementation of the new standard, manufacturers shall produce in accordance with the technical requirements registered under the new standard. Products produced under the previous standard, General Standard for Foods for Special Medical Purposes (GB 29922-2013), may be sold until the end of their shelf life. Considering the time required for supplementary materials and review procedures, applicants intending to change registration according to the new standard are advised to submit their change applications as early as possible.

2. When submitting a registration application according to the new standard, which cases are handled as changes, and which as new product registration?

For FSMPs already registered, adjustments to product formula, label/instructions, or product category according to the new standard are generally handled as change registration. Examples include revising energy and other nutrient labeling values based on the new dietary fiber energy coefficients, or adjusting labeling values due to changes in units for docosahexaenoic acid and arachidonic acid. If adjustments involve both formula and production process and effectively constitute a new product formula, the original product registration should be canceled, and a new product registration application should be submitted.

3. For already registered products applying for registration (including changes) under the new standard, what materials are required, is stability study submission necessary, and is on-site inspection and sampling needed?

Applicants shall submit materials in accordance with the FSMP Registration Application Materials Items and Requirements (Trial, 2017 Revised Edition). Materials unchanged from previous registration do not need to be resubmitted but should be clearly indicated. The product development report should detail the R&D justification for adjustments to formula, production process, etc., and describe the differences before and after the adjustments.

Applicants should conduct stability studies following the FSMP Stability Study Requirements (Trial, 2017 Revised Edition) and retain records for review. Regulatory authorities will organize on-site inspections and sampling based on food safety risk. For already registered FSMPs applying for registration under the new standard without substantial changes in production process, on-site inspection and sampling are generally not required.

4. Which products can apply for a change in product category under the new standard?

Products already registered under GB 29922-2013 that meet the technical requirements of newly added categories in the new standard may apply for a category change, with supporting evidence provided.

5. For partially modified total nutrition formula foods, what materials should be provided regarding formula design and applicable special medical conditions?

Applicants should comprehensively evaluate clinical usage scenarios, target populations, and non-applicable populations (contraindicated or to be used with caution), and provide the rationale for energy and macronutrient adjustments. Risk information for applicable and non-applicable populations, as well as clinical usage or research materials, should be added to the label/instructions.

6. Can partially modified total nutrition formula foods follow the FSMP Total Nutrition Formula Registration Guidelines?

Partially modified total nutrition formula foods belong to newly added categories in GB 29922-2025 and cannot follow the FSMP Total Nutrition Formula Registration Guidelines.

7. For extensively hydrolyzed whey protein formulas for children aged 1–10, what materials should be provided regarding applicable special medical conditions?

To ensure safety, nutritional adequacy, and clinical effect, extensively hydrolyzed whey protein formulas for children aged 1–10 with food protein allergies generally require clinical trial data of the registered product or hydrolyzed protein used. For gastrointestinal dysfunction in children aged 1–10, clinical usage evidence may be provided based on changes in gastrointestinal symptoms.

8. Which categories of products under the new standard require clinical trials?

Products designed for specific disease populations generally require clinical trials for the registered product.

9. What are the requirements for registering tumor total nutrition formula foods?

Applicants must comply with GB 31662-2025 Foods for Special Medical Purposes for Tumor Complete Nutrition. Clinical trials are generally required for the registered product. Application materials must follow the FSMP Registration Management Measures and FSMP Registration Application Materials Items and Requirements (Trial, 2017 Revised Edition).

10. What conditions must application materials meet for registration under the new standard?

For registration under the new standard, product formula, product standard requirements, and test reports of three trial batches must comply with GB 29922-2025. Products considered “clinically urgently needed and not yet approved” may apply for priority review procedures under the FSMP Registration Management Measures.

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