CIRS FAQ: Can FSMP Be Produced on the Same Production Line as Infant and Young Children Formula Food? Vol. 10, 2023

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

Q1: Can infant formula food for special medical purposes (FSMP) be produced on the same production line as common infant formula food?

A1: Yes. It is stipulated in the Production License Examination Rules for Food for Special Medical Purposes that food-related enterprises create specifications for food co-production and risk management. When various products are produced on the same production line, adequate food safety risk analysis should be conducted, including but not limited to food protein allergy risk analysis. Additionally, effective cleaning procedures should be developed and verified to prevent cross-contamination and make sure that product switching does not affect the subsequent batch of products, and it should meet relevant requirements for approval and registration.

At the same time, it should be noted that common infant and young children formula food should also follow relevant registration and production requirements.

Q2: What are the requirements for amino acid when it is used as an excipient for FSMP?

A2: The application of amino acids used in FSMP is relatively restricted in China since there are few regulations governing food safety for individual amino acids, and the raw material suppliers are unable to obtain the corresponding production license, which, however, is being addressed currently.

Q3: What are the legal basis for nutrition enhancers used in FSMP?

A3: According to Food Safety National Standard General Rules of Food for Special Medical Purposes (GB 29922-2013), the use of food nutrition enhancers shall comply with the provisions of GB 14880-2012 and its quality specifications shall meet the relevant standards and requirements.

Q4: What are the inspection requirements for finished products of whole nutrition formula foods for specific medical purposes?

A4: The finished products require full project testing in batches.

According to the Production License Examination Rules for Food for Special Medical Purposes, food enterprises should set up an inspection management system for finished products and conduct batch-by-batch full project inspections in accordance with national food safety standards and the technical requirements for product standards registration. And the inspections must be done in line with national food safety standards and/or relevant provisions.

Q5: What factors must I consider when choosing the factory site if I plan to produce FSMP in the future?

A5: The site selection must comply with the National Food Safety Standard – General Hygiene Practice of Food Production (GB 14881-2013).

According to the National Food Safety Standard – FSMP Good Manufacturing Practice (GB 29923-2013), the site selection and its surrounding should comply with the provisions recorded in GB 14881-2013. Specific requirements are as follows:

1. The factory should not be located in areas that significantly pollute food. If there is a significant adverse impact on food safety and food suitability in a certain location, and measures cannot be taken to improve it, it is necessary to avoid building a factory in that location;
2. The factory should not be located in areas where hazardous waste, dust, harmful gases, radioactive substances, and other diffusive pollution sources cannot be effectively removed;
3. The factory should not be located in areas prone to flood disasters. If it is difficult to avoid them, necessary protective measures should be designed; and
4. It is not advisable to locate the factory around areas where a large number of pests can breed. If it is difficult to avoid them, necessary protective measures should be designed.

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

Further Information

Vol. 01, 2023 FAQs on Health Food Registration and Filing in China

Vol. 02, 2023 The Precondition to Health Food Application in China

Vol. 03, 2023 Applicants’ Qualifications for the Registration of New Food Raw Material (Novel Food) in China

Vol. 04, 2023 Technical Requirements for New Food Additives Applications in China

Vol. 05, 2023, Can Food for Special Medical Purposes Be Entrusted to Other Enterprises for Production?

Vol. 06, 2023, Is There Any Protection Period for Newly Approved New Food Additives?

Vol. 07, 2023, Is it Possible to Keep the Health Food Formula Secret during Compliance Applications?

Vol. 08, 2023, Do Health Foods Sold on Cross-border E-commerce Platforms Need to Apply for Registration or Filing?

Vol. 09, 2023, Can We Claim New Health Functions for Products Now? Vol. 09, 2023