国家卫生健康委近日会同市场监管总局发布了32项食品安全国家标准和2项标准修改单，其中，新修订 的《食品安全国家标准 保健食品良好生产规范》（GB 17405-2025）是保健食品生产规范自1998年发布 后，27年来首次更新。作为强制性国家标准，也是保健食品注册和备案管理、生产许可审查、生产企业 监督检查中食品安全管理的基础文件，新标准针对保健食品的特殊性，以《食品安全国家标准 食品生 产通用卫生规范》（GB 14881）框架为基础，充分考虑现行保健食品监管要求，突出保健食品生产过 程的原则性、通用性要求，进一步明确细化规定了保健食品生产的相关安全要求和管理准则。新标准要 求，相关技术指标需与保健食品注册或备案相关技术要求一致，便于企业执行，并衔接保健食品监管要 求。 强化保健食品的食品属性 依据相关规定，保健食品剂型形态主要包括片剂、粉剂、颗粒剂、硬胶囊剂、软胶囊剂、口服液、丸 剂、膏剂、酒剂、茶剂等剂型，以及饮料、饼干类、糖果类、糕点类、液体乳类等食品形态。此外，在 已获批准注册的保健食品中，还有滴剂、奶粉类、醋类、果冻类、粥类等少量其他剂型形态。 保健食品剂型形态多样，不同剂型形态生产情况差异较大。且随 ...

Core Viewpoint - The newly revised "National Food Safety Standard for Good Manufacturing Practices of Health Food" (GB 17405-2025) has been officially released, marking the first update in 27 years, introducing stricter and more detailed requirements for health food production [1][2][3]. Group 1: Key Changes in the New Standard - The new standard expands from 10 chapters to 14 chapters, adding informative appendices and significantly revising various aspects such as site selection, factory environment, facilities, raw materials, and production process safety controls [1][2]. - The terminology has been updated to reflect food attributes more accurately, changing "general production area" and "clean area" to "general operation area" and "clean operation area" [2]. Group 2: Implementation and Impact - The implementation of the new standard aims to enhance production processes, ensure corporate responsibility, and improve product quality, thereby fostering innovation within the health food industry [3][4]. - The standard establishes a comprehensive control system covering the entire production chain from raw materials to finished products, enhancing safety measures and management requirements [4][5]. Group 3: Industry Implications - The new standard raises industry entry barriers, compelling companies to strengthen their quality management systems, while providing clear production guidelines for compliant enterprises [6]. - For consumers, the new standard is expected to enhance safety assurance in health food products, ensuring that consumers can purchase and consume these products with confidence [6].

9月25日，国家卫生健康委与国家市场监督管理总局联合修订的《食品安全国家标准保健食品良好生产 规范》（以下简称《生产规范》）（GB 17405—2025）正式发布。这是标准继1998年出台后，27年来 首次更新。这项强制性国家标准针对保健食品生产的各个环节提出了更为严格、细致的要求。新标准与 修订前相比内容调整较大，标准文本从原先的10个章节增加到14个章节，并增加了资料性附录。《生产 规范》对原标准中选址及厂区环境、厂房和车间、设施与设备、保健食品原料、辅料及食品相关产品、 生产过程的食品安全控制、验证和检验要求等多项内容进行修订，增加食品安全管理、产品召回及追溯 管理要求及不同类别保健食品作业区划分指南。 《生产规范》的发布，进一步贯彻落实"最严谨的标准"要求，一方面，保持与GB 14881的协同性，有 助于规范保健食品生产企业生产流程，落实企业主体责任，贴合保健食品生产企业实际需求，提升生产 效率与产品质量，激发企业创新活力与内生动力；另一方面，有助于完善特殊食品标准体系，强化特殊 食品安全基础标准供给，将标准与保健食品监管原则紧密衔接，构建起更为完善的监管链条，为行业健 康发展提供技术支撑。 "食品安 ...

Core Viewpoint - The newly revised "National Food Safety Standard for Good Manufacturing Practices of Health Food" (GB 17405—2025) has been officially released, marking the first update in 27 years since its initial introduction in 1998. The new standard imposes stricter and more detailed requirements across all production stages of health food [1][5]. Group 1: Key Changes in the Standard - The new standard has expanded from 10 chapters to 14 chapters, including additional informative appendices [1]. - Significant revisions have been made to various aspects such as site selection, factory environment, facilities and equipment, raw materials, production processes, and food safety control measures [4][6]. - The terminology has shifted from "general production area" and "clean area" to "general operation area" and "clean operation area," aligning with food-related expressions [4]. Group 2: Implementation and Impact - The release of the new standard aims to enhance the production processes of health food companies, ensuring compliance with the most rigorous standards and improving product quality and safety [5][7]. - The standard establishes a comprehensive control system from raw materials to finished products, enhancing safety measures throughout the production chain [6]. - The introduction of a "verification" chapter solidifies product safety and ensures that the entire production process is controllable [7]. Group 3: Industry Implications - The new standard raises the entry barriers for the health food industry, compelling companies to strengthen their quality management systems [7]. - It provides clear production guidelines for compliant companies, fostering healthy competition within the industry [7]. - Consumers will benefit from enhanced safety assurances, allowing them to purchase and consume health food products with greater confidence [7].