PDF GB 25596-2025 English (GB 25596-2010: Older version)
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National food safety standard - General Rules for Infant Formula Food for Special Medical Purposes
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| GB 25596-2010 | English | 70 |
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National food safety standard - General Standard for Infant Formula for Special Medical Purposes
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GB 25596-2025: PDF in English GB 25596-2025
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 Contents
Foreword... 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... 17
National Food Safety Standard – General Rules for Infant
Formula Food for Special Medical Purposes
1 Scope
This standard applies to infant formula food for special medical purposes for infants aged 0 ~
12 months.
2 Terms and Definitions
2.1 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 Requirements
3.1 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.
3.1.1.1 The categories of common infant formula food for special medical purposes, the
applicable population with special medical conditions and the main technical requirements of
the formula shall comply with the provisions of Appendix A.
3.1.1.2 The formula of other infant formula food for special medical purposes that are clinically
needed shall meet the requirements of 3.1.1.
3.1.2 The processing of infant formula food for special medical purposes shall comply with
relevant national regulations.
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.
3.4.2 The energy contained in every100 mL of the product in the ready-to-eat state shall be in
the range of 250 kJ (60 kcal) ~314 kJ (75 kcal). Energy is calculated by multiplying the content
of protein, fat and carbohydrate in every 100 mL of product by the energy coefficient 17 kJ/g,
37 kJ/g and 17 kJ/g (the energy coefficient of dietary fiber is 8 kJ/g), and the sum them in the
kJ/100 mL, which is then divided by 4.184 to get the kcal/100 mL value.
3.4.3 The amount of protein, fat and carbohydrate contained in every 100 kJ (100 kcal) of the
product shall comply with the provisions of Table 1.
corresponding standards and relevant regulations.
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 Others
4.1 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.
4.1.3 The label of anti-reflux formula food shall indicate the product's brewing temperature,
storage time and other parameters, as well as the viscosity of the product after preparation.
4.1.4 Special medical formula foods for infants over 6 months old shall be marked with "When
infants over 6 months old with special medical conditions consume this product, supplementary
food shall be added".
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.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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