保健食品生产规范更新
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保健食品生产规范27年来首次更新 强制性国家标准为行业划下安全红线
Zhong Guo Chan Ye Jing Ji Xin Xi Wang· 2025-10-21 22:14
Core Viewpoint - The National Health Commission and the State Administration for Market Regulation have released 32 national food safety standards and 2 amendments, with the revised "National Food Safety Standard for Good Manufacturing Practices of Health Foods" (GB 17405-2025) marking the first update in 27 years since its initial release in 1998, emphasizing the importance of food safety management in health food production [1] Group 1: New Standards and Regulations - The new standard is a mandatory national standard that serves as a foundational document for the registration, filing management, production licensing review, and supervision of health food production [1] - It incorporates general hygiene requirements from GB 14881 while addressing the specificities of health food production, thereby clarifying safety requirements and management guidelines [1][2] Group 2: Diverse Forms of Health Foods - Health foods come in various forms, including tablets, powders, granules, capsules, liquids, and more, with the industry expected to continue evolving to meet changing consumer demands [2] - The standard combines general principles and targeted requirements to create a comprehensive production guideline for health foods [2] Group 3: Enhanced Food Attributes - The new standard replaces terms like "general production area" and "clean area" with "general operation area" and "clean operation area," reinforcing the food attributes of health foods [3] Group 4: Comprehensive Control System - The new standard establishes a full-chain control system covering raw materials, production, verification, and traceability, aimed at reducing product quality risks and ensuring product efficacy stability [4] - It specifies that raw materials and auxiliary materials must meet technical requirements and safety standards, with particular emphasis on non-purified fermentation products [4] Group 5: Production Process Management - The standard outlines clear requirements for material balance management and cleaning procedures, emphasizing the importance of quantifying risks in the production process [5] - It mandates that health food manufacturers develop a scientific material balance management system to optimize quality, compliance, and costs [5] Group 6: Verification and Quality Control - The new standard includes a verification chapter to ensure the stability of production processes and the controllability of product quality, supporting deviation management and continuous improvement [6] - Outgoing inspections are crucial for confirming product quality, requiring checks on key indicators such as efficacy components and microbial standards [6] Group 7: Recall and Traceability Management - The new standard also stipulates requirements for product recall and traceability management, aligning with GB 14881 regulations [7]