Core Points - The 2025 draft guidelines for the production licensing review of special medical purpose formula foods have been publicly solicited for opinions by the State Administration for Market Regulation [1] - Special medical purpose formula foods are designed to meet the specific nutritional needs of individuals with dietary restrictions, digestive absorption disorders, metabolic disorders, or specific disease states [1] - The new draft clarifies the types of special medical foods, the qualifications and responsibilities of company leaders, food safety directors, and food safety personnel, and establishes a dynamic management mechanism for food safety risk prevention [1] Group 1 - The draft specifies the requirements for clean and quasi-clean working areas, including maintaining dryness during the production of solid products to prevent microbial growth and contamination [1] - To ensure product uniformity and sterilization effectiveness, the draft introduces monitoring requirements for key equipment operation status, fault alarms, and effective manual monitoring measures [1] Group 2 - The draft emphasizes the management of allergen risks, clarifying special requirements for the storage and labeling of allergenic substances to avoid contamination [2] - It also mandates stricter raw material management, requiring companies to establish monitoring mechanisms for risk substances in raw materials and implement risk monitoring or inspection measures [2] - Additionally, there are enhanced requirements for the on-site audit of suppliers of food packaging materials and associated containers to ensure effective traceability [2]
事关特殊医学用途配方食品 新版细则向社会征求意见
Yang Shi Xin Wen·2025-11-03 11:51