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.

Appendix A

Recommended content of essential and semi-essential amino acids in

infant formula

A.1 Refer to the published representative data of essential and semi-essential

amino acids in Chinese human milk AND data on nitrogen content and/or

protein content, considering a certain range of variation, to calculate the

recommended lower limit of essential and semi-essential amino acids in infant

formula (mg/gN).

A.2 According to the low limit of each amino acid in human milk in China

(mg/gN), calculate the amino acid content per 100 kcal of infant formula, when

the protein content is the lowest (1.8 g/100 kcal); the calculation method is that.

The milligrams of amino acids per gram of nitrogen in human milk, is divide by

the nitrogen conversion factor of 6.25, then multiplied by 1.8.

Appendix B

Monomer amino acids that can be used in infant formula

The monomer amino acids, that can be used in infant formula, are as shown in Table B.1.

Table B.1 -- Monomer amino acids that can be used in infant formula

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