新版特医食品生产许可审查细则征求意见 对原料安全要求更严格

Core Viewpoint - The State Administration for Market Regulation (SAMR) is revising the production licensing review guidelines for special medical purpose formula foods, aiming to enhance the classification and safety management of these products for specific patient groups [1][2]. Group 1: Product Classification - The new guidelines significantly refine product categories, increasing the number of types from 27 to 46 [2]. - Full nutritional formula foods are now categorized based on age groups: suitable for ages 1 to 10, suitable for ages over 10, and specific nutritional adjustment formulas [4]. Group 2: Targeted Nutrition - The revised guidelines allow for more targeted selection of special medical purpose foods based on individual diseases and conditions, under medical guidance [6]. Group 3: Regulatory Oversight - SAMR has approved 236 products from 71 domestic companies and 32 products from 14 foreign companies [7]. - The new guidelines impose stricter requirements on raw material safety and key production process monitoring, ensuring higher safety standards compared to regular food products [8]. Group 4: Raw Material Management - Companies must establish monitoring mechanisms for risk substances in raw materials and ensure compliance with national standards during transportation [8]. - There are specific requirements for the inspection of raw materials, particularly those containing milk, to prevent contamination [10]. Group 5: Equipment and Hygiene Monitoring - The guidelines require production companies to equip critical machinery with operational monitoring and fault alarm functions to ensure compliance with technical requirements [12][13]. - Companies must implement hygiene monitoring systems for production environments, personnel, and equipment [10]. Group 6: Allergen Control - The new guidelines specify measures to manage allergenic substances during production, including the segregation of raw materials that contain allergens [14][16]. - Enhanced requirements for companies producing special medical foods to prevent cross-contamination with allergenic materials have been established [16].