Национальный центр контроля пищевой продукции опубликовал 12 новых часто задаваемых вопросов о пищевых продуктах специального медицинского назначения

Formula

How should the Product Priority Review and Approval Application Form be submitted in the system?

At the same time as submitting the registration application for a food for special medical purposes, the Registration Priority Review and Approval Application Form for Foods for Special Medical Purposes may be submitted; a scanned electronic copy shall be uploaded to the Foods for Special Medical Purposes Registration Application System and named as a separate file. After the product is accepted, and following formal review and a public announcement with no objections, it will be included in the priority review and approval procedure.

What materials should be provided for the osmotic pressure labeling of the product in its ready-to-eat state?

Test reports on the osmotic pressure of three batches of trial-produced products in the ready-to-eat state, tested in accordance with the National Food Safety Standard — Determination of Osmotic Pressure in Foods (GB 5009.301), shall be provided, and the labeled osmotic pressure value shall be determined based on the test results.

Production Process

What should be noted in the production process materials?

The production process text shall specify whether the material feeding process involves materials with an addition sequence or materials added in portions, and whether the production process involves storage of intermediate products; if so, corresponding validation materials shall be provided.

The description of the production premises and equipment used shall specify the division of each operation area and the compliance of the cleanliness class of each process with the National Food Safety Standard — Good Manufacturing Practice for Foods for Special Medical Purposes (GB 29923-2023), and shall list the equipment and facilities actually used for the applied product.

What should be noted for products using a dry process?

For products using a dry process, the mixing principle of the mixing equipment shall be provided, such as two-dimensional, three-dimensional, pneumatic, or twin-shaft paddle mixing, and the process flow diagram shall indicate the mixing principle, the production batch size, and a statement of the applicability of the mixing equipment's loading range.

Validation materials for the production process under three-batch commercial production conditions shall be provided, including the raw and auxiliary material feeding information for three batches of trial-produced products, validation materials for the process parameters of key steps, the mixing uniformity validation indicators together with their basis for selection and limit ranges, and the specific test results of the mixing uniformity validation indicators, the acceptance criteria, and the process validation conclusion. The raw and auxiliary material feeding information shall be provided in tabular form and shall at least include, for the three trial production batches, the feeding amount of each raw and auxiliary material, the batch numbers of the raw and auxiliary materials, the trial production date, the trial production sample batch number and theoretical yield, the actual yield, the material balance calculation, and other production information. Where sampling is involved in the mixing process, the impact of the sample amount on the mixing validation and the control measures shall be provided.

What materials should be provided for the production process design section?

If a food for special medical purposes has already been approved for registration on the same production line, and the production process and parameter design, form selection, process flow, and other aspects are basically consistent with those of the approved product, only a consistency statement regarding the process design, form selection, process flow, and other aspects needs to be submitted; the basis for the production process design, literature references, and similar materials may no longer be submitted.

Quality and Safety

What materials should be submitted regarding packaging materials and containers (migration control plan)?

Materials demonstrating compliance with the National Food Safety Standards shall be submitted for packaging materials and containers; if the same applicant already has a food for special medical purposes with the same packaging materials approved for registration, it may explain the relevant circumstances, such as compliance with the National Food Safety Standards, and may no longer provide the migration control plan and test reports for hazardous substances in the packaging materials and containers.

What issues should be noted in product test reports?

In the test reports for three batches of products, the testing basis and test conclusions shall at least include GB 29922 or GB 25596, GB 13432 or the values declared on the label, the product standard requirements, and the conformity conclusion, and the edition year of the standards shall be indicated.

For each specification of the product applied for registration, test reports for three batches of products are generally required.

What materials should be provided as proof of testing capability?

Proof materials of testing capability for the items tested in-house shall be submitted; for test items that the applicant cannot perform itself (and must commission), a statement of the testing institution qualified to conduct batch-by-batch testing shall be provided.

What materials should be provided for the stability study?

A statement on the conduct of stability testing in accordance with the Requirements for Stability Studies of Foods for Special Medical Purposes (Trial) shall be submitted, including a commitment to complete accelerated testing and to continue long-term stability studies. The storage conditions, shelf life, and use after opening the package, and other aspects of the product shall be confirmed based on the stability study results.

Others

Should a copy of the deficiency notice be attached when submitting supplementary materials?

When submitting supplementary materials, a copy of the deficiency notice shall be attached, and the electronic version shall be named as a separate file and uploaded to the registration application system.

Has the former "Food Review Center of the State Administration for Market Regulation" been renamed? What is its official website information?

The "Food Review Center of the State Administration for Market Regulation" has been renamed the "National Center for Food Safety Inspection and Testing Technology (National Center for Applied Research on Hazard Analysis and Critical Control Points for Food Safety)", and its website has changed to https://www.cfsi.net.cn.

Registration under the New National Standards

What should be noted in the registration application materials for products in the newly added categories of GB 29922-2025 and GB 25596-2025?

The specific category of the product shall be clearly defined, and the basis for the correspondence between the product technical requirements, target population, and other aspects and the corresponding product category shall be provided. The product formula, product standard requirements, test reports for three batches of trial-produced products, and other application materials shall all comply with the corresponding requirements of GB 29922-2025 and GB 25596-2025.