Standard No.:	GB 25596-2025
English Name:	National food safety standard - General Rules for Infant Formula Food for Special Medical Purposes
Chinese Name:	食品安全国家标准 特殊医学用途婴儿配方食品通则
Professional Classification:	GB    National Standard
Source Content Issued by:	National Health Commission of the People's Republic of China, State Administration for Market Regulation
Issued on:	2025-03-16
Implemented on:	2026-3-16
Status:	to be valid
Superseding:	GB 25596-2010 National Food Safety Standard General Rules for Infant Formula Food for Special Medical Purposes
Target Language:	English
File Format:	PDF
Word Count:	6000 words
Translation Price(USD):	180.0
Delivery:	via email in 1 business day

GB 25596-2025 National food safety standard - General rules for infant formula products for special medical purposes 1 Scope This standard is applicable to infant formula products for special medical purposes consumed by infants aged 0 to 12 months. 2 Terms and definitions 2.1 infant formula products for special medical purposes formulated food specially processed and formulated to meet the special needs of infants for nutrients or diets such as eating restrictions, digestion and absorption disorders, metabolic disorders or specific disease states. Such product shall be eaten alone or in combination with other foods under the guidance of doctors or clinical nutritionists 3 Technical requirements 3.1 General requirements 3.1.1 The formula of infant formula products for special medical purposes shall be based on medical and nutritional research results, and its safety, nutritional adequacy and clinical effects need to be scientifically confirmed. 3.1.1.1 The categories of common infant formula products for special medical purposes, applicable populations with special medical conditions and the main technical requirements of the formula shall meet the requirements of Annex A. 3.1.1.2 Other infant formula products for special medical purposes with clinical needs shall meet the requirements of 3.1.1. 3.1.2 The processing of infant formula products for special medical purposes shall comply with relevant national regulations. 3.2 Raw material requirements 3.2.1 The raw materials used in the products shall meet the corresponding safety standard and/or relevant requirements. The substances with the hazards on infant nutrition and health must not be applied. 3.2.2 The raw materials and food additives used shall not contain gluten. 3.2.3 Hydrogenated oil and fat shall not be used.

Foreword i 1 Scope 2 Terms and definitions 3 Technical requirements 4 Others Annex A Common infant formula products for special medical purposes Annex B Requirements for monomeric amino acids in infant formula products for special medical purposes