已获批特殊医学用途婴儿配方食品营养成分含量与《新国标》（GB 25596-2025）比较研究
收稿日期: 2025-05-22
录用日期: 2025-09-01
网络出版日期: 2025-11-06
A comparative study on the nutritional content of approved special medical purpose infant formula food with the "New National Standard (GB 25596-2025)"
Received date: 2025-05-22
Accepted date: 2025-09-01
Online published: 2025-11-06
国家卫生健康委员会联合国家市场监督管理总局于2025年3月16日共同发布《食品安全国家标准 特殊医学用途婴儿配方食品通则》（GB 25596-2025）（简称《新国标》）。《新国标》涉及宏量营养素（蛋白质、碳水化合物和脂肪），维生素和矿物质等微量元素以及可选择成分等指标范围、含量要求及检测方法的优化调整，同时产品类别从原有6类扩增至13类，并配套相应技术指标要求。目前已获批特殊医学用途婴儿（简称特医婴）配方食品均按照《食品安全国家标准 特殊医学用途婴儿配方食品通则》（GB 25596-2010）（简称《旧国标》）要求生产。本文将重点围绕必需成分和可选择性成分的指标变化，比较研究已获批产品与《新国标》的符合程度，帮助临床儿科医师准确把握《新国标》修订的核心内容，从而为特定疾病状态婴儿提供更加科学合理的营养支持方案。
关键词： 特殊医学用途婴儿配方食品; 国家标准; 已获批; 比较研究
郭卓雨 . 已获批特殊医学用途婴儿配方食品营养成分含量与《新国标》（GB 25596-2025）比较研究[J]. 临床儿科杂志, 2025 , 43(11) : 837 -844 . DOI: 10.12372/jcp.2025.25e0568
The National Health Commission and the State Administration for Market Regulation jointly promulgated the "National Food Safety Standard: General Standard for Infant Formula for Special Medical Purposes" (GB 25596-2025, hereinafter referred to as the "New Standard") on March 16, 2025. The New Standard introduces comprehensive optimizations regarding the reference ranges, content requirements, and testing methods for macronutrients (proteins, carbohydrates, and fats), vitamins, minerals, and other optional components. Additionally, it expands the product categories from the original 6 to 13 types, with corresponding technical specifications established for each category. Currently, all approved infant formula products for special medical purposes (hereinafter referred to as "FSMP for infants") in the market are manufactured in compliance with the 2010 version of the standard (GB 25596-2010, "Old Standard"). This article will focus on analyzing the changes in mandatory and optional component requirements, while evaluating the compliance status of approved products with the New Standard. The findings aim to assist clinical pediatricians in accurately understanding the key revisions of the New Standard, thereby enabling more scientifically appropriate nutritional support plans for infants with special medical conditions.
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