GB 10766-2021National food safety standard - Older infants formula (English PDF)

2.1 Older infant formula

A formula food, suitable for older infants, whose energy and nutrients can meet

the normal nutritional needs of infants aged 6 ~ 12 months.

2.3 Soy-based older infant formula

The product which, taking soybeans and soybean 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 older infants; meet their nutritional needs.

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

3.2 Sensory requirements

For the color, taste, smell, structural state, preparation of older 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 older infants.

3.3.4 Older infant formula shall not use fructose and sucrose as the source of

carbohydrates. It may add glucose polymers appropriately (wherein starch can

be added after pre-gelatinization). For milk-based older infant formula, the

source of carbohydrates shall give priority to lactose (lactose shall account for

>= 90% of carbohydrates).

3.3.6 Minerals shall meet the requirements of Table 3.

Table 3 (continued)

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.

3.8 Microbial limit

3.8.1 The limit of pathogenic bacteria for solid products shall meet the

requirements of GB 29921; other microbial indicators shall meet the

requirements of Table 6.

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.

3.10 Urease activity

The activity of urease in soy-based older 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.

4.2 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.

4.3 Packaging

It may use the carbon dioxide and (or) nitrogen, that meet the national food

safety standards, as packaging media.

Appendix A

Recommended content of essential and semi-essential amino acids in

older 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 the

older infant formula (mg/g N).

A.1.

A.3 When calculating, it may add the concentrations of tyrosine and

phenylalanine. If the ratio of methionine to cysteine is less than 2.1, it may also

add the two.

Appendix B

Monomer amino acids that can be used in older infant formula

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