1. What is the purpose of formulating and revising the series standards of infant formula foods?

Breast milk is the most ideal food for infants, but when a small number of lactating mothers cannot breastfeed due to diseases, insufficient milk secretion, or no milk secretion, formula foods are needed to provide nutrients for the growth and development of infants and young children. Infant formula food is important source,or even the only source of nutrients for infants and young children who can’t be breastfeeded. The formulation, revision and implementation of infant formula food series standards is an important means to ensure the safety and nutritional adequacy of infant formula foods, guiding and standardizing the technical requirements for scientific production of food production enterprises, and are also an important basis for supervision and law enforcement by regulatory authorities.
At present, the series of infant formula food standards in my country include "Infant Formula Food" (GB 10765-2021, hereinafter referred to as GB10765), "Older Infant Formula Food" (GB 10766-2021, hereinafter referred to as GB10766), and "Child Formula Food" ( GB 10767-2021, hereinafter referred to as GB10767) and "General Rules of Infant Formulas for Special Medical Purposes" (GB 25596-2010, hereinafter referred to as GB25596).
This question and answer content is only applicable to GB 10765, GB 10766 and GB 10767, GB 25596 is not involved.

2. What is the background of the revision of the infant formula food series standards?

The Party Central Committee and the State Council attach great importance to the safety of infant formula foods. In the "Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening Reform and Strengthening Food Safety Work", "National Nutrition Plan (2017-2030)" and other documents, it is clearly stated that standards should be strengthened. Driven by innovation, we will speed up the revision and improvement of the national food safety standards for infant formula milk powder.
Since the 2010 version of the infant formula food series standards were released, they have played an important role in regulating and guiding my country's infant formula food manufacturers and ensuring the safety of infant formula foods. In recent years, with the continuous in-depth research on breast milk ingredients, nutritional requirements for infants and young children, and infant formula foods in various countries, the International Codex Alimentarius Commission, tEuropean Union, Australia and New Zealand and other international organizations and countries (regions) have successively revised standards for infant formula foods. In order to better meet the nutritional and health needs of China's infants and young children, the National Health Commission has further revised and improved the current series of infant formula food standards.

3. What are the revised principles of the infant formula food series standards?

The standard revision work follows the following principles: First, adhere to the legislative purpose of the "Food Safety Law of the People's Republic of China", fully guarantee the safety of infant formula foods, and ensure the nutrition and health of infants and young children; Second, fully implement the requirements of the "most rigorous standard" and fully consider the scientificity, rationality and standardization of standards; Third, absorb the latest research results of infant nutrition at home and abroad, and fully consider the growth and development characteristics of infants and young children in China and the nutrient requirements; Fourth, scientifically learn from the standard management experience of international organizations and major developed countries, comprehensively consider China's national conditions, the statusof production enterprises and the nutrient content distribution of marketed products; Fifth, adhere to openness and transparency, conduct in-depth research and extensively collect opinions and suggestions from industries, research institutes, regulatory agencies, and consumers.

4. What are the main changes in the revision of infant formula food series standards?

First, follow the trend of the Codex Alimentarius Commission standard revision, the "Older Infants and Young Children Formula Food" (GB 10767-2010) is divided into two standards, GB10766 and GB10767; Second, to ensure infant formula food for nutritional effectiveness, the minimum value of nutrient content in the product has been revised or increased; Third, to fully protect the safety of infant nutrition, the maximum value of nutrient content in the product has been revised or increased; Fourth, adjust selected part of the ingredients in 2010 standard to essential ingredients; Fifth, the limit requirements for pollutants, mycotoxins and pathogenic bacteria are uniformly quoted from the relevant basic standards to reflect the coordination between standards.

5. How to define infant formula food?

This revision of the standard clarified the concepts of milk-based and soy-based formulas for infants and older infants. Two products with different substrates should use milk and milk protein products (milk-based), or soybean and soy protein products (soy-based) as the main protein sources, and the two cannot be mixed. For infant formula foods, they can be used alone or at the same time; when used alone, they are milk-based infant formula foods or soy-based infant formula foods. Regardless of milk-based or soy-based products, it means that the main source of protein in the product should be milk and milk protein products, or soy and soy protein.
In addition, with the continuous improvement of food production, processing technology and consumer demand for product diversification, this revision cancels the requirements for product form in the 2010 version of the standard.

6. What are the revisions of macronutrient (ie: protein, carbohydrate and fat)?

based on the latest scientific evidence, referring to the revision trend of international standards, and combining the nutrient requirements of infants and young children in China, the macronutrients are revised: First, the protein content requirements in formula foods for older infants and young children have been adjusted, and add requirements for the content of lactalbumin in infant formula; Second, the requirements for carbohydrate content in Older infant formulas have been adjusted to be consistent with the requirements of infant formula; Third, requirements for lactose content in old infant and young children’s formulas have been increased and clarified limitation of adding sucrose in infant and older infant formulas. Through amendments, the requirements for the content and quality of macronutrients in the product will be further improved.

7. What are the requirements for fructose and sucrose in GB10765 and GB10766?

GB 10765 and GB 10766 revised the requirements for fructose and sucrose. The new standard stipulates that infant and older infant formulas should not use fructose, sucrose, and fructose and/or sucrose-containing raw materials as the main source of carbohydrates.

8. What are the revisions of vitamins and minerals?

The revision of the vitamin and mineral content values in the standard mainly includes: First, the minimum value of some indicators is set to ensure the adequacy of nutrient intake; Second, maximum value of some indicators is set to ensure the nutrient intake Safety; Third, consider the influence of soy-based infant formula food on the absorption and utilization of iron, zinc and phosphorus, and increase the separate regulations on the content of iron, zinc and phosphorus in sy-based products.

9. What are the amendments to adjust from optional ingredients to essential ingredients? 

Choline, selenium and manganese play an important role in the growth and development of infants and young children. based on the actual addition of the above-mentioned nutrients in the current market products in my country, choline in infant and older infant formulas is adjusted from optional ingredients to essential ingredients. Manganese and selenium in older infant formula are adjusted from optional components to essential components.

10. What are the requirements for the available strains of infant formula foods? 

If the manufacturer adds strains to infant formula food, the number of viable bacteria in the product should be ≥106 CFU/g(mL), and the strain (strain number) should comply with the original Ministry of Health, the former National Health and Family Planning Commission, and the National Health Commision List of strains allowed to be used in foods for infants and young children.

11. What are the limit requirements for contaminations, mycotoxins and pathogenic bacteria?

In the newly revised standard, relevant content that has been covered in the basic standards of other national food safety standards has been deleted, such as contaminations, mycotoxins, pathogenic bacteria limit indicators, etc. The relevant technical requirements should comply with the corresponding national food safety standards Contamination in Food Limits of Foods (GB 2762), Limits of Mycotoxins in Foods (GB 2761) and Limits of Pathogenic Bacteria in Foods (GB 29921).
The Limitation of Pathogenic Bacteria in Food (GB 29921-2013) is currently in the process of revision. Before the new version of the standard is released, the limit requirements for pathogenic bacteria involved in the series of infant formula food standards should meet the requirements of Infant Formula (GB 10765) -2010) and "Older Infant and Young Children Formula Food" (GB 10767-2010); New version of the standard will be followed after released.

12. What are the requirements for using both nutritional fortifiers and novel food ingredients in infant formula foods?

Infant formula foods are allowed to add galactooligosaccharides and other substances that are both nutritional fortifiers and novel food ingredients. If it is for the purpose of nutritional fortification, its use should meet the requirements of the "Standard for the Use of Food Nutrition Enhancers" (GB 14880); if it is used as a food ingredient, it should meet the requirements of the announcement of novel food ingredients.

13. What are the implementation requirements of the standard?

The transition period for the implementation of the series of infant formula food standards has been set with reference to the provisions of the previous version of the standard, taking into account the actual needs of the supervision and registration of infant formula food, and the comprehensive factors are set to 2 years. The series of infant formula food standards are mandatory national food safety standards. Before the implementation date of the series of standards, food production and business units are allowed and encouraged to implement this standard. After the implementation date of this series of standards, food production and business units, food safety regulatory agencies and inspection agencies shall implement this standard. Foods that have been produced before the implementation date can continue to be sold during the warranty period.

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