CIRS FAQ: Can Approved New Food Raw Materials Be Used in FSMP? Vol. 02, 2024

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) to help you gain a clearer understanding of the current requirements in China.

Q1: Can new food raw materials approved by the former National Health and Family Planning Commission (NHFPC) be used as raw materials for FSMP?

A1: It depends. It requires a comprehensive assessment based on the official approval announcement of the raw materials, and GB 29922 or GB 25596.

The scope of use specified in the approval announcement should serve as a reference. If the announcement allows the use of one certain new food raw material in FSMP, then it can be considered as a raw material. In cases where the announcement does not explicitly specify, a specific analysis is required based on the requirements for FSMP raw materials.

Take inulin as an example. Its approved scope of use does not include infants and young children foods, as a result, it cannot be used in FSMP for children under 3. However, inulin is a type of dietary fiber ingredient, and according to GB 29922, dietary fiber can be added as an optional component to FSMP. Therefore, based on the above considerations, it can be used as a dietary fiber ingredient in FSMP for individuals over 3 years old.

Similarly, for Haematococcus pluvialis, it’s specified in the official announcement that the scope of use does not include infants and young children foods. However, due to its biological activity, it falls outside the optional ingredients listed in GB 29922 and GB 25596, and it is not recommended for addition. Therefore, it cannot be used in FSMP.

Note: Regarding the use of food raw materials, excipients, food additives, and nutrition enhancers in FSMP and the use of probiotics, click the links below to read our previous articles for more details.

• A Brief Discussion on Raw Materials of FSMP in China
• Summary and Analysis of Food Additives Permitted to be Used in FSMP
• Is There Available Food Raw Material List for FSMP, Is the Stability Test While Using Necessary for FSMP--Q&A from CIRS

Q2: Can some of the testing items for the FSMP application be self-tested, while others are entrusted?

A2: Yes, it is allowed. It is necessary to ensure consistency in testing agencies and methods for the same testing item at different times.

New applicants need to submit documentation of testing capabilities including proof of the testing personnel, equipment, and basic testing capabilities, as well as proof materials for commissioned testing institutions, including the name, legal qualifications, and commissioning contracts. Additionally, a description and list of self-testing and commissioned testing projects should be provided.

Q3: Are there any requirements for the number of batches and batch sizes for background testing of raw materials during FSMP application?

A3: It is recommended to conduct background value studies on three batches of bulk materials.

There are no specific requirements for background testing of raw materials in the relevant standards for FSMP. However, the formula development data provided in the actual application needs to be combined with the background value research data of bulk materials. Therefore, it is recommended to conduct background value studies on at least three batches of bulk materials. Applicants can choose information from three batches of bulk materials used in commercial trial production or other batch materials. The background content data should be provided by the applicant or a qualified third-party inspection agency.

Q4: Is on-site inspection mandatory when a company applies for FSMP? What are the key points?

A4: Generally, on-site inspection is required, especially for new applicants.

It is explicitly stipulated in the Administrative Measures for Food for Special Medical Purposes Registration that the review agency should conduct on-site inspection and sampling testing based on food safety risks, and carry out on-site inspection of clinical trials. According to our years of regulatory experience, on-site inspection is generally required, especially for new applicants.

The inspection accesses the applicant’s capability regarding research and development, production, and testing, and whether the application materials are consistent with the actual situation. Key inspection items include enterprise qualifications, research and development capabilities, the establishment of a production management system, production conditions, and the quality of production water.

The review agency shall complete the on-site inspection within 20 working days from the date of determining the inspection date by the applicant, and issue an inspection report. If corrective action is required for the inspected enterprise, it should be completed within 10 working days.

Click the links below to read more about the on-site inspection of FSMP and our FSMP registration service.

• What Do You Know About On-site Inspection of FSMP?
• SAMR Food for Special Medical Purpose (FSMP) Registration

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

CIRS FAQ: Is It Necessary to Establish Animal Function Evaluation Methods while Applying for New Health Functions? Vol. 01, 2024

CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Heath Food Filing? Vol. 3, 2024

CIRS FAQ: Which FSMP are Eligible for Inclusion in the Priority Review and Approval Process? Vol. 4, 2024