Foods for Special Medical Purposes (FSMP) Testing Service

Foods for Special Medical Purposes (FSMP), as a food category catering to the nutritional needs of individuals with specific medical conditions, are subject to rigorous scrutiny from regulatory authorities and the wider community regarding their quality, safety, and stability. Testing and experimentation stand as the sole method to ensure compliance relevant regulations, standards and requirements.

Main regulations and standards for FSMP testing

• National Food Safety Standard - General Rules for Foods for Special Medical Purposes (GB 29922);
• National Food Safety Standard - General Rules for Infant Formula for Special Medical Purposes (GB 25596);
• Requirements for Stability Study of Foods for Special Medical Purposes (Trial);
• Clinical Trial Quality Management Specification for Foods for Special Medical Purposes (Trial);
• Technical Guidelines for Clinical Trials of Specific Nutritionally Complete Food - Diabetes;
• Technical Guidelines for Clinical Trials of Specific Nutritionally Complete Food - Kidney Disease; and
• Technical Guidelines for Clinical Trials of Specific Nutritionally Complete Food - Tumor.

According to the Administrative Measures on Foods for Special Medical Purposes Registration and its supporting documents, applicants are required to conduct a series of quality/stability assessments before submitting a registration application.

FSMP registration test items

Full-item test of three batches of products meeting product technical requirements;

Stability tests

• Accelerated testing for three batches of products;
• Long-term testing for three batches of products;
• Influencing factor testing for one batch of products;
• Stability tests after opening the packaging for one batch of products (selectively designed based on product characteristics, packaging, and usage conditions).

In addition, clinical trial reports are required for specific nutritionally complete foods.

Our service

With over a decade of expertise in FSMP compliance service, CIRS Group is well-versed in the key testing points and regulatory requirements regarding this field and has forged long-term partnerships with multiple domestic FSMP testing institutions with extensive experience. Our professional team provides tailored experimental plans based on clients’ needs, selects suitable testing institutions, tracks experiment progress in real-time, and helps to resolve any technical issues that may arise during the process. CIRS Group offers the following services to our clients:

• One-stop FSMP registration and testing service (program design, process tracking, report review, etc.)
• Single-item testing service
• Customized testing service