Interpretation | Main Changes of Infant Formula Food Series Standards (2021 Version)

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On March 18, 2021, the National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) issued 3 new national standards for infant formula food, which will be implemented on February 22, 2023. This time SAMR splits the current "National Food Safety Standard, older infant and Young Children Formula" (GB 10767-2010) into "National Food Safety Standard, older infant Formula" (GB 10766-2021) and "National Food Safety Standard, Young Children Formula" (GB 10767-2021), which makes the standards more scientific. Foodmate will sort out and analyze the main changes of the new national standard for the industry's reference. We will examine the differences between the old and new versions in terms of definitions, raw materials, indicators, etc.

I. Main changes in "National Food Safety Standard, Infant Formula Food" (GB 10765-2021)

1.Terms and definitions

The definition of "infant" is deleted, and the definition of "infant formula" is added; milk and milk protein products, soy and soy protein products as "main raw materials" has been changed to "main protein sources".
Delete the description of "suitable for normal infants, and its energy and nutrients can meet the normal nutritional needs of infants aged 0-6 months".

2.Raw material requirements

Change "glutenin" to "gluten" in the description of “The raw materials and food additives that should not be contain used in infant formula food.”

3.Essential ingredients

(1)Energy value calculation
The energy coefficient of dietary fiber has been revised from "calculated at 50% of the energy coefficient of carbohydrates" to "8kJ/g".
(2) Carbohydrate source
The preferred carbohydrate source of milk-based infant formula is changed from "lactose, lactose and glucose polymer" to "lactose"; glucose polymer was changed from being the preferred carbohydrate of milk-based infant formula to the carbohydrate source of infant formula, of which the addition requirement is "appropriate addition"; a new substance "sucrose" is added to the carbohydrate source that cannot be used in infant formula.
(3)Protein, fat and carbohydrates
Adjust the protein and fat values, expand the limit range of protein in milk-based infant formula, change the limit range of protein in soy-based infant formula.
The new national standard also raised the upper limit of fat, and updated the detection methods of linoleic acid and linolenic acid in fat;
Add a new calculation method for whey protein content;
Delete the calculation requirement of lactose in milk-based products in total carbohydrates, as well as the percentage content of lactose that does not apply to soy-based formula food instructions.
(4) Vitamins
The choline is changed from an optional component to an essential component, and the content value is increased.
(5) Minerals
Add the content requirements for the three indicators of iron, zinc and phosphorus in the soybean-based formula;
Delete the limited conditions of “magnesium is only applicable to the milk-based infant formula”.

4.Optional ingredients

Adjust the values of inositol, taurine, docosahexaenoic acid, and eicosatetraenoic acid;
Add L-carnitine detection method.

5.Urease activity

Update the detection method of urease activity, from the recommended standard to the mandatory standard.

6.Other requirements

Delete the labeling requirements for formula foods that can be consumed by infants over 6 months of age.

7.Appendix A Recommended content of essential and semi-essential amino acids in infant formula

Adjust the content of all essential and semi-essential amino acids.

8.Appendix B Monomer amino acids that can be used in infant formula

Newly add the source of monomer amino acid compounds and the requirement of "non-edible animal and plant raw materials shall not be used as the source of monomer amino acid".

II Main changes in "National Food Safety Standard, Older Infant Formula Food" (GB 10766-2021)

1.expression of standard scope

Reset the indicators to make the nutritional intake of older infant more scientific, and make it clear that this standard is applicable to formula foods for older infant aged 6-12 months.

2.Terms and definitions

Add description of older infant formula. It is clear that older infant formula is divided into milk-based and soy-based, and cannot be used as a protein source at the same time.
The description of "liquid or powdered" is deleted, and the organizational state of the product is no longer specified.

3.Raw material requirements

Added a description that the raw materials and food additives should not contain gluten.

4.Essential ingredients

The upper and lower limits of the protein value of older infant formula were decreased. Add “the content of whey protein in milk-based older infant formula ≥40%”.
Newly add the requirements of the α-linolenic acid and the ratio of linoleic acid and α-linolenic acid. The upper and lower limits of fat in older infant formula have been raised.
It is stipulated that fructose and sucrose cannot be used as carbohydrate sources in older infant formulas. Newly add the lactose is the first choice as the source of carbohydrates in milk-based older infant formula, and the carbohydrate content of lactose should be ≥ 90%.
The minimum value of vitamins is limited; the maximum value is specified for nutrients without maximum value. In addition, in view of the fact that the addition rate of choline in older infant formulas on the market is more than 90%, and the scientific research evidence that choline is beneficial to vision and mental development, choline has been changed from an optional ingredient to an essential ingredient, and the value range of it is expanded.
Subdivide the indicators of iron, zinc and phosphorus in soybean-based and milk-based products.
Adjust the minimum values of some minerals.
Change the manganese and selenium in older infant formula from optional ingredients to essential ingredients.

5.Optional ingredients

Choline is changed from optional ingredients to essential ingredients.
Add the detection method of L-carnitine. Adjust the addition value of inositol, taurine, docosahexaenoic acid (DHA) and eicosatetraenoic acid (AA).
Clarified the value range of DHA and AA. In addition, since the addition amount of AA must not be less than DHA, the lower limit is determined by the amount of DHA added, so the lower limit of AA is not limited.

6.Other indicators

Newly add the requirement of impurity, which is "limited to milk-based follow-up infant formula";
Delete the description of impurity "not applicable to products with added vegetables and fruits"
The impurity unit of liquid products is modified from "mg/kg" to "mg/8L".

7.Urease activity

Update the detection method of urease activity, from the recommended standard to the mandatory standard.

8.Other aspects

In terms of labeling, the content of essential ingredients has been added to the label. The image of babies and women cannot be displayed on the label, and "human emulsification", "breast emulsification" or similar terms cannot be used.
In terms of packaging materials, carbon dioxide and nitrogen should meet the corresponding national food safety standards.
Added appendix A (Recommended values of essential and semi-essential amino acids in older infant formula) and appendix B (Monomeric amino acids that can be used in older infant formula), and clarify the source of monomer amino acid compounds.

III Main changes in "National Food Safety Standard, Young Children Formula" (GB 10767-2021)

1.expression of standard scope

It is clearly stated that this standard is applicable to formula foods consumed by children aged 12-36 months.

2.Terms and definitions

The "main raw material" is changed to the "main protein source", and it was clearly stated that milk and milk protein products and/or soy and soy protein products are the main protein sources.
The description of the state of "liquid or powdered" infant formula food is deleted, and the requirement of product state is adjusted from powdered products to solid products.

3.Essential ingredients

Compared with the old version, GB 10767-2021 has adjusted and updated the limits and detection methods of energy, protein, fat, vitamins, minerals, etc., and added the requirement for carbohydrates.
Decrease the maximum energy value from 355kJ (85kcal) to 334kJ (80kcal).
The requirements and calculation formula for "carbohydrates" have been added, and the content can be calculated based on the corresponding energy, protein, and fat. Increase the ratio of lactose to carbohydrates.
Both the maximum and minimum protein values are adjusted down.
Add the maximum value of linoleic acid.
Newly add the requirements of the α-linolenic acid and the ratio of linoleic acid and α-linolenic acid.
Increase the maximum and minimum fat values.
Adjust the values of a number of vitamin;
Add the conversion formula of dl-α-tocopherol, and delete the conversion description of the equivalent of polyunsaturated fatty acids and α-tocopherol.
Adjusted the maximum or minimum values of some minerals, except for sodium, calcium-phosphorus ratio and chlorine, all component values have been adjusted.

4.Optional ingredients

Adjusted the requirements for optional ingredients, including selenium, choline, manganese, inositol, taurine and other indicators;
Add detection method for L-carnitine;
The expressions of docosahexaenoic acid and eicosatetraenoic acid have been adjusted from the percentage of total fatty acids to specific milligrams.

5.Urease activity

The requirement for urease activity is adjusted from "products containing soybean ingredients" to "products using soybeans or soybean products as protein sources".
Update the detection method of urease activity, from the recommended standard to the mandatory standard.

6.other aspects

The expression of requirements for packaging materials has been adjusted from "food grade or purity ≥99.9%" to "in compliance with national food safety standards".

IV Summary

This revision is based on domestic survey and research data and combined with the revision trend of international standards to further refine product standards and formulate separate standards for older infant foods. The nutrient indicators are adjusted according to the latest scientific evidence, which fully guarantees the effectiveness and safety of the indicators and is consistent with the international revision trend. At the same time, the conflicts between the previous different cited standards have been resolved, and the revised standard system has become more rigorous. In addition, considering the requirements of infant formula milk powder product formula registration, the standard transition period is 2 years. According to the "Questions and Answers on Infant Formula Food Series Standards" issued by NHC, food businesses are encouraged to implement the standards in advance.

Please note: Original English article of Business Division of Food Safety and Regulatory Compliance of Global Foodmate, please indicate the source from the Global Foodmate if reprint.

Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net

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