Detailed Rules for the Examination and Approval of Production Licenses for Foods for Special Medical Purposes.

These Detailed Rules are developed according to the Food Safety Law and the Food Production Licensing Management Measures, aiming to strengthen the safety supervision of foods for special medical purposes and effectively protect the health and safety of people.
The Detailed Rules consist of 43 articles divided into 7 chapters, imposing strict requirements on aspects such as production sites, equipment and facilities, technological processes, personnel management, and system management.
The Rules standardize the manufacturing conditions for specialized nutritional products designed for individuals with limited food intake, metabolic disorders, or specific diseases. The Rules also apply to both infant formulas for those aged 0-12 months and general FSMP products for populations over one year old. The text details rigorous oversight criteria for facility management, equipment sterilization, and raw material procurement. The document mandates that manufacturers implement comprehensive product recall systems, stability research protocols, and post-market quality tracking. Furthermore, it provides a scoring framework for inspectors to evaluate food safety incident handling and non-compliant product management to ensure strict adherence to national industrial standards.