特殊医学用途配方食品原料法规标准管理现状及进展
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山东省食品药品检验研究院,山东省特殊医学用途配方食品质量控制工程技术研究中心,国家市场 监管重点实验室(肉及肉制品监管技术),产业技术基础公共服务平台,山东 济南 250101

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田洪芸 女 正高级工程师 研究方向为食品加工与安全 E-mail:sdsythy@126.com

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R155

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Current status of regulations and standards for materials of formula foods for special medical purposes
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Shandong Institute of Food and Drug Control, Shandong Research Center of Engineering and Technology for Quality Control of Food for Special Medical Purposes, Key Laboratory of Supervising Technology for Meat and Meat Products for State Market Regulation, Industrial Technology Foundation Public Service Platform, Shandong Ji’nan 250101, China

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    摘要:

    我国对特殊医学用途配方食品实行注册管理,原料合规使用是产品配方设计时最基础的要求。特殊医学用途配方食品涉及的原料种类较多,涉及的原料标准及相关规定分布较为分散,使用时易出现理解充分或执现偏差问题,产品注册审评时因原料不合规被不予注册的情形相对较多。本文就我国现阶段食品原材料监管的相关法律法规进行梳理,同时根据产品注册和食品安全标准的要求,对特医食品原料使用原则和要求进行汇总分析,并对相关原料标准的修订进展进行总结和分析,旨在为原料的使用提供指导,促进产品注册的顺利进行,助推我国特医食品产业的高质量发展。

    Abstract:

    Our country implements the registration management to the special medicine food, the product formula design time raw material compliance use is the most important premise. The variety of raw materials involved in special medical purpose formula food is relatively large, and the corresponding standards and related regulations are relatively scattered, resulting in understanding and easy deviation in implementation by manufacturers, and the situation that products are not registered due to non-compliance of raw materials is relatively more during the registration and of products.In this paper, the current stage of our food raw material supervision of the relevant laws and regulations to sort out,at the same time, according to the requirements of registration and food safety standards for raw materials, the principles and basis for the use of raw materials for special medical food products, and the development of related standards were summarized and analyzed,the purpose is to provide guidance for the use of raw materials, promote the smooth implementation of product registration, and promote the high-quality development of our country’s specialty food industry.

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田洪芸,李恒,陆垣宏,张然,吴珍珍,胡梅,胡明燕,王骏.特殊医学用途配方食品原料法规标准管理现状及进展[J].中国食品卫生杂志,2025,37(4):361-366.

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  • 收稿日期:2024-08-15
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  • 在线发布日期: 2025-07-11
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