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GB 25596-2025: National food safety standard - General Rules for Infant Formula Food for Special Medical Purposes Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB 25596: Historical versions
GB 25596-2025: National food safety standard - General Rules for Infant Formula Food for Special Medical Purposes---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB25596-2025 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA National Food Safety Standard – General Rules for Infant Formula Food for Special Medical Purposes Issued on. MARCH 16, 2025 Implemented on. MARCH 16, 2027 Issued by. National Health Commission of the People’s Republic of China; State Administration for Market Regulation. Table of ContentsForeword... 3 1 Scope... 4 2 Terms and Definitions... 4 3 Technical Requirements... 4 4 Others... 10 Appendix A Common Infant Formula Foods for Special Medical Purposes... 12 Appendix B Requirements for Monomeric Amino Acids that can be Used in Infant Formula Foods for Special Medical Purposes... 17ForewordThis Standard replaced GB 25596-2010 National Food Safety Standard General Rules for Infant Formula Food for Special Medical Purposes. Compared with GB 25596-2010, the major changes of this Standard are as follows. --- Modify the terms and definitions; --- Modify the essential ingredients; adjust or increase the minimum or maximum values of some nutrients; --- Change choline from an optional ingredient to an essential ingredient; --- Modify the contaminant limit indicators; --- Modify the mycotoxin limit indicators; --- Modify the microbial limit indicators; --- Modify Appendix A, adding 6 categories based on the original product categories and clarifying the technical indicators; --- Modify Appendix B. National Food Safety Standard – General Rules for Infant Formula Food for Special Medical Purposes1 ScopeThis standard applies to infant formula food for special medical purposes for infants aged 0 ~ 12 months.2 Terms and Definitions2.1 Infant formula food for special medical purposes Formulated foods are specially processed and prepared to meet the special nutritional or dietary needs of infants with restricted feeding, digestive and absorption disorders, metabolic disorders or specific disease states. Such products shall be consumed alone or in combination with other foods under the guidance of a doctor or clinical nutritionist.3 Technical Requirements3.1 General requirements 3.1.1 The infant formula food for special medical purposes shall be based on the results of medical and nutritional research; and its safety, nutritional adequacy and clinical effects shall be scientifically confirmed. 3.2 Raw material requirements 3.2.1 The raw materials used in the product shall comply with the corresponding safety standards and/or relevant regulations; and substances that endanger the nutrition and health of infants shall not be used. 3.2.2 The used raw materials and food additives shall not contain gluten. 3.2.3 Hydrogenated fats shall not be used. 3.2.4 Irradiated raw materials shall not be used. 3.3 Sensory requirements The color, taste, smell, texture and solubility of infant formula food for special medical purposes shall conform to the characteristics of the corresponding product. The product shall not contain foreign matter visible to normal vision. 3.4 Essential ingredients 3.4.1 The energy, nutrient composition and content of infant formula food for special medical purposes shall be based on the essential ingredients specified in this Standard; and shall be appropriately adjusted in accordance with the requirements of Appendix A according to the special nutritional needs of infants with special disorders, diseases or medical conditions to meet the nutritional needs of infants with special medical conditions. 3.4.4 For infant formula food for special medical purposes, except for special needs (such as lactose intolerance), lactose shall be the preferred source of carbohydrates; and glucose polymers can be appropriately added (starch can be added after pre-gelatinization). Fructose and sucrose shall not be used as the source of carbohydrates. 3.6 Other indicators They shall comply with the provisions of Table 5. 3.7 Contaminant limits It shall comply with the provisions of GB 2762. 3.8 Mycotoxin limits It shall comply with the provisions of GB 2761. 3.9 Microbial limits 3.9.1 The pathogenic bacteria limits of solid products shall comply with the provisions of GB 29921; and other microbial limits shall meet the requirements of Table 6. 3.10 Food additives and nutritional fortifiers 3.10.1 The use of food additives and nutritional fortifiers shall comply with the provisions of GB 2760 and GB 14880. 3.11 Urease activity The urease activity of products with soybeans and soybean protein products as the main protein source shall comply with the provisions of Table 7.4 Others4.1 Labels 4.1.1 Product labels shall comply with GB13432 and/or relevant provisions. The content of essential ingredients and optional ingredients shall be labeled with the content of “per 100 kilojoules (100 kJ)”. 4.1.2 The label shall clearly indicate the product category (such as lactose-free formula), the applicable population with special medical conditions and the osmotic pressure. 4.1.5 The label shall clearly indicate “Please use under the guidance of a doctor or clinical nutritionist”. 4.1.6 The label shall not contain images of infants and women, and shall not use the terms “humanized milk”, “breast-milk” or similar terms. 4.2 Instructions for use 4.2.1 The instructions and diagrams for product use, preparation, and storage conditions shall be clearly stated on the label. When the maximum surface area of the package is less than 100 cm2 or the product mass is less than 100 g, the diagram may not be marked. 4.2.2 Warnings shall be given for health hazards that may be caused by improper preparation and improper use. 4.3 Packaging Carbon dioxide and/or nitrogen that meet national food safety standards may be used as packaging media.Appendix ACommon Infant Formula Foods for Special Medical Purposes See Table A.1 for common infant formula foods for special medical purposes. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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