GB 10765-2021National food safety standard - Infant formula (English PDF)

2.1 Infant formula

A formula food, suitable for normal infants, whose energy and nutrients can meet the normal nutritional needs of infants aged 0 ~ 6 months.

2.1.1 Milk-based infant formula

The product which, taking milk and milk protein products as the main source of protein, by adding appropriate amount of vitamins, minerals and (or) other raw materials, is processed and produced by only the physical methods.

3.1 Raw material requirements

3.1.1 The raw materials, which are used in the product, shall comply with the corresponding safety standards and/or relevant regulations. It shall ensure the safety of infants; meet their nutritional needs. It shall not use the substances that endanger the nutrition and health of infants.

3.1.2 The raw materials and food additives used shall not contain gluten.

3.1.3 Hydrogenated grease shall not be used.

3.1.4 Raw materials, that have been irradiated, shall not be used.

3.2 Sensory requirements

For the color, taste, smell, structural state, preparation of infant formula, they shall conform to the characteristics of the corresponding product. There shall be no foreign objects, which are visible with normal eyesight.

3.3 Essential ingredients

3.3.1 All the necessary ingredients in the product are necessary for the growth and development of infants.

3.4 Optional ingredients

3.4.1 In addition to the essential ingredients in 3.3, if one or more of the ingredients in Table 4 is added to the product OR it is declared in the label, its content shall meet the requirements in Table 4.

3.9 Food additives and nutritional fortifiers

3.9.1 The use of food additives and nutritional fortifiers shall comply with the provisions of GB 2760 and GB 14880.

3.9.2 The quality of food additives and nutritional fortifiers shall comply with the corresponding standards and (or) relevant regulations.

3.10 Urease activity

The activity of urease in soy-based infant formula shall meet the requirements in Table 7.

4.1 Labels

4.1.1 The product label shall comply with GB 13432 and/or relevant regulations.

For the content label of essential and optional ingredients, it shall add the indication of "100 kilojoule (100 kJ)" content.

4.1.2 In the label, it shall indicate the product category, attributes (such as milk-based or soy-based products, as well as product status), applicable age.

4.1.3 For the infant formula, it shall be indicated that: "The most ideal food for infants aged 0 ~ 6 months is breast milk. This product can be used, when breast milk is insufficient or absent."

4.2 Instructions for use

4.2.1 For the information on product use, preparation instructions, illustrations, storage conditions, it shall be clearly stated on the label. When the maximum surface area of the package is less than 100 cm², OR the mass of the product is less than 100 g, the illustration may not be indicated.

4.2.2 The instructions shall give warnings about the health hazards, that may be caused by improper preparation and improper use. […]