China Releases GB Standards for Infant Formula FSMP and Complementary Baby Foods

On March 27, 2025, the National Health Commission and the State Administration for Market Regulation jointly released 50 national food safety standards and 9 amendment sheets. The following analyzes key revisions in the GB 25596-2025 National Food Safety Standard General Rules of Infant Formula Foods for Special Medical Purposes, GB 10769-2025 National Food Safety Standard Cereal-based Complementary Foods for Infants and Young Children, and GB 10770-2025 National Food Safety Standard Canned Complementary Foods for Infants and Young Children.

1. GB 25596-2025  National Food Safety Standard General Rules of Infant Formula Foods for Special Medical Purposes (effective on March 16, 2027)

1.1 Revision to the scope and definition

• The standard incorporates the definition of infants in its scope, explicitly stating that it applies to infant formula FSMP for infants aged 0 to 12 months.

• The standard removes the requirement for product forms (powder or liquid) to accommodate technical advancements and consumer demand for greater diversity. Besides, the term "nutritional needs" is revised to "nutritional or dietary needs" because some infant formula FSMP are designed to address dietary requirements rather than purely nutritional needs. For example, the newly introduced formula for preventing gastroesophageal reflux disease is intended to meet the dietary demands of infants with frequent gastroesophageal reflux. Additionally, to avoid confusion, the revised definition eliminates the misleading statement that "the energy and nutrients shall meet the growth and development needs for 0-to-6-month-old infants."

 1.2 Revision to technical requirements for essential nutrients

• The energy range per 100ml of the product ready for consumption is revised from 250 kJ (60 kcal)~295 kJ (70 kcal) to 250 kJ (60 kcal)~314 kJ (75 kcal).

• The energy coefficient of dietary fiber shall be calculated at 8kJ/g, instead of 50% of the carbohydrate energy coefficient in the previous standard.

• The preferred source of carbohydrates is limited to lactose (except in special cases, such as lactose intolerance), with glucose polymers no longer considered a preferred option. Besides, sucrose cannot be used as a carbohydrate source in addition to fructose.

• Nutrient requirements and testing methods for protein, fat, carbohydrates, vitamins, and minerals have been updated. Notably, choline is modified from an optional ingredient to an essential ingredient, with revised content requirements specified in the vitamin area

Examples

※N.S. stands for not specified.

 1.3 Revision to technical requirements for optional nutrients

In addition to choline being modified as an indispensable ingredient, the requirements for the content and testing methods of other optional ingredients have also been adjusted.

Examples of amendments

1.4 Limits for contaminants, mycotoxins, and microorganisms referenced to relevant standards

1.5 Revision to labeling requirements

• Expand the scope of osmolality labeling to include all infant formula FSMP products.

• For formula targeting gastroesophageal reflux disease, the label should indicate parameters such as preparation temperature, holding time, and the viscosity of the product after preparation.

1.6 Revision to Appendix A: Common Infant Formula Foods for Special Medical Purposes

• Revise the target population and key formula requirements for the common infant formula FSMP.

• Establish nutrient content requirements for extensively hydrolyzed milk protein formula, amino acid-based formula, and formula for amino acid metabolism disorders, ensuring that their nutrient levels are scientifically adjusted to meet the specific needs of their target populations. Slight adjustments are allowed for rare disease amino acid metabolic disorder formulas based on the standard.

• Specify the restricted types and levels of amino acids for the amino acid metabolic disorders formula

• Establish nutrient content requirements for premature or low birth weight infant formula, ensuring that their nutrient levels are scientifically adjusted to meet the specific needs of their target populations.

• Add six new types of infant formula FSMP as follows, to meet broader clinical needs.

1.7 Amendments to Appendix B: Requirements for Monomeric Amino Acids in Infant Formula Foods for Special Medical Purposes

2. GB 10769-2025 National Food Safety Standard Cereal-based Complementary Foods for Infants and Young Children  (effective on March 16, 2026)

2.1 Revised scope and definition

• The standard incorporates the definition of elderly infants and young children in its scope, explicitly stating that it applies to cereal-based complementary foods for infants and young children aged 6-36 months.

• The standard now includes millet as one of the main ingredients, and enhances the content requirement for main ingredients from "over 25%" to "50% or more" of total dry substance.

2.2 Amendment to product classification

Cereal-based complementary foods are still classified into four types. But for cereal-based and high-protein cereal-based complementary food types, the ready-to-eat form is introduced. In addition, teething sticks belong to other cereal-based complementary foods.

 2.3 Amendments to raw material requirements

Honey is prohibited in cereal-based complementary foods, considering its potential risks to infants and young children. Accordingly, honey has also been removed from the list of allowed sugars.

2.4 Amendments to requirements for essential nutrients

• Vitamin C is modified from an optional nutrient to an essential nutrient for cereal-based complementary foods and high-protein cereal-based complementary foods.

•  Content requirements for nutrients, including protein, Vitamin B1, and Calcium, are revised as follows:

• Specify that when cereal-based complementary foods and high-protein cereal-based complementary foods are in the ready-to-eat form(liquid or semisolid), the energy content should be ≥335kJ/100g or 80kcal/100g.

• The energy coefficient of dietary fiber shall be calculated at 8kJ/g, instead of 50% of the carbohydrate energy coefficient in the previous standard.

2.5 Amendments to requirements for optional nutrients

• Magnesium is introduced as an optional nutrient

• Iodine is removed as an optional nutrient

• Introduce the limits of the content level for some optional nutrients

Examples

2.6 Amendment to the limit for sugar

The total amount of sucrose, fructose, glucose, and glucose syrup is set at ≤0.6g/100kJ (2.5g/100kcal), which applies to all types of cereal-based complementary foods.

2.7 Limits for contaminants, mycotoxins, and microorganisms referenced to relevant standards

2.8 New packaging requirement

The use of carbon dioxide and/or nitrogen gas, compliant with national food safety standards, is allowed as a packaging medium.

3. GB 10770-2025 National Food Safety Standard Canned Complementary Foods for Infants and Young Children (effective on March 16, 2026)

3.1  Revised scope and definition

The standard incorporates the definition of elderly infants and young children in its scope, explicitly stating that it applies to canned complementary foods for infants and young children aged 6-36 months.

Scope of the standard

Definition of canned complementary foods for infants and young children

3.2 Amendments to product form

Canned complementary foods in complementary foods in granular form are revised to canned complementary foods in complementary foods in granular or tablet (block) forms. For products in this form, size restrictions (smaller than 5mm) apply to products intended for elderly infants aged 6-12 months, while no size restrictions are imposed for products designed for children aged 12 months and above.

3.3 Amendments to raw material

• The source of animal-based ingredients has been expanded to include shrimp meat and animal liver.

• Honey is prohibited in canned complementary foods, considering its potential risks to infants and young children.

3.4 Amendments to physicochemical indicators

A limit for histamine is set for products containing fish meat (no more than 10mg/100g)

3.5 Limits for contaminants, mycotoxins, and microorganisms referenced to relevant standards

3.6 Amendments to the labeling requirement

Introduce a new requirement that granule- or tablet (block)-form canned complementary foods must be labeled with the wording: "This product contains granules or tablet (block) forms; please pay attention to swallowing safety during consumption."