A Summary on Differences between the New and Current Version of Infant and Young Children Food Safety National Standard - Regulatory News - Food & Food Contact Materials

NHC released 50 Food Safety National Standard on March 18, 2021, including new standards for infant and young children food: GB10765, GB10766 and GB10767. The transitional period is set as 2 years, and it is allowed and encouraged for enterprises to implement the new standards before the implementation date; while after the implementation date, enterprises and food safety supervision and inspection agencies must implement this standard. Products produced before the implementation date may continue to be sold within the shelf life.

In summary, the main changes in the new revisions are as follows:

Divide current GB10767 to new GB10766 and GB10767, which will be better to apply to the corresponding population;
To ensure food safety, new standards set maximum values for all the nutrients (excluding L-carnitine), or adjust the existed ones;
To ensure nutritional adequacy, new standards set minimum values for most of the nutrients, or adjust the existed ones;
Adjust some optional ingredients to mandatory ones considering the nutritional needs of infants and young children

In addition, in order to ensure food safety and the harmonization of standards, the corresponding basic standards, namely GB2762, GB2761 and GB29921, are directly referenced for the limits of contaminants, mycotoxins and pathogenic bacteria, rather than listing them separately in the new standards. However, GB29921-2013 is in the process of revision, thus, before the release of the new version, requirements on pathogenic bacteria involved in infant and young children foods shall meet the requirements of GB10765-2010 and GB10767-2010.

The detailed comparison of nutrient indexes between the new and current version are listed below, in which the index values are highlighted in red when they increase, green when they decrease, and yellow when they are newly generated.

Energy

Energy kcal/100mL	Infant food		Older infant food		Young children food
	Current	New	Current	New	Current	New
	60~70	60~70	60~85	60~75	60~85	60~80

The basis of the energy revise mainly include:

Reports from FAO suggest that a high energy intake may increase the risk of obesity and other chronic diseases;
Referring to relevant regulations of EFSA;
Considering the situation of products on the market: energy of most stage2 products are between 63-70kcal/100mL, and 97% of the stage3 products are between 60-80kcal/100mL

Protein

1. Protein content

Protein g/100kcal	Infant food		Older infant food		Young children food
Protein g/100kcal	Current	New	Current	New	Current	New
Milk base	1.88~2.93	1.8~3.0	2.9~5.0	1.8~3.5	2.9~5.0	1.8~4.0
Soy base	2.09~2.93	2.2~3.0	-	2.2~3.5	-	-

The basis of the protein revise mainly include:

Data on breast milk: the average protein concentration in Chinese breast milk was about 1.72g/100kcal;
Health outcome: intake too much protein in infants can disrupt their water balance, especially if no other fluid is replenished or water loss from the kidneys increases. In addition, high protein intake has been shown to lead to high insulin secretion, resulting in a higher Body Mass Index (BMI) in childhood, which increases the risk of obesity later in life;
Referring relevant regulations from CAC, EU and ANZ

2. Protein quality

The new GB10766 requires that, whey protein shall account for at least 40% of the total protein in milk base stage2 product, and the basis are:

Whey protein in breast milk accounts for 45-55%;
Whey protein in the selling products accounts for 40-50%

Carbohydrate

Carbohydrate g/100kcal	Infant food		Older infant food		Young children food
	Current	New	Current	New	Current	New
	9.2~13.8	9.0~14.0	-	9.0~14.0	-	7.5~15.0
Lactose/Carbohydrate	≥90%	≥90%	-	≥90%	-	≥50%

In addition, fructose and sucrose cannot be used in stage1 and stage2 products.

Vitamin

Vitamin	Infant food		Older infant food		Young children food
Vitamin	Current	New	Current	New	Current	New
Vitamin A μg RE/100kcal	59~180	60~150	75~225	75~180	75~225	75~180
Vitamin D μg/100kcal	1.05~2.51	2.0~5.0	1.05~3.14	2.0~5.0	1.05~3.14	2.0~5.0
Vitamin E mg α-TE/100kcal	0.50~5.02	0.5~5.0	0.63~NS	0.6~5.0	0.63~NS	0.6~5.0
Vitamin K1 μg/100kcal	4.2~27.2	4.0~27.0	4~NS	4.0~27.0	4~NS	4.0~27.0
Vitamin B1 μg/100kcal	59~301	60~300	46~NS	60~300	46~NS	60~300
Vitamin B2 μg/100kcal	80~498	80~500	46~NS	80~500	46~NS	80~650
Vitamin B6 μg/100kcal	35.6~188.3	35~175	46~NS	46~175	46~NS	46~175
Vitamin B12 μg/100kcal	0.105~1.506	0.10~1.50	0.17~NS	0.17~1.50	0.17~NS	0.17~2.00
Niacin (Niacinamide) μg/100kcal	293~1506	400~1500	460~NS	460~1500	460~NS	460~1500
Folic acid μg/100kcal	10.5~50.2	12~50	4~NS	10~50	4~NS	10~50
Pantothenic acid μg/100kcal	402~2000	400~2000	293~NS	400~2000	293~NS	400~2000
Vitamin C mg/100kcal	10.5~71.1	10~70	7.5~NS	10~70	7.5~NS	10~70
Biotin μg/100kcal	1.5~10.0	1.5~10.0	1.7~NS	1.7~10.0	1.7~NS	1.7~10.0
Choline mg/100kcal	7.1~50.2	20~100	7.1~50.2	20~100	7.1~50.2	20~100

The major changes can be concluded as follows:

For GB10765, changes in vitamins are mainly on increase in the minimum values and decrease in the maximum values, the basis are the latest DRIs (Dietary Reference Intakes) and breast milk data;
For GB10766 and GB10767, changes in vitamins are mainly on increase in the minimum values and generation in the maximum values, the basis are the latest DRIs and the selling products;
Choline becomes an essential nutrient in GB10765 and GB10766, and remains optional nutrient in GB10767

Mineral

Mineral	Infant food		Older infant food		Young children food
Mineral	Current	New	Current	New	Current	New
Sodium mg/100kcal	21~59	30~59	NS~84	NS~84	NS~84	NS~84
Potassium mg/100kcal	59~180	70~180	75~289	75~225	75~289	75~290
Copper μg/100kcal	35.6~121.3	60~120	29~146	35~120	29~146	29~146
Magnesium mg/100kcal	5.0~15.1	5.0~15.0	5.9~NS	5.0~15.0	5.9~NS	6.0~18.0
Iron mg/100kcal Milk base Soy base	0.42~1.51	0.42~1.50 0.63~1.50	1.05~2.09	1.0~2.0 1.5~2.0	1.05~2.09	1.0~2.5
Zinc mg/100kcal Milk base Soy base	0.50~1.51	0.50~1.50 0.75~1.50	0.4~1.3	0.50~1.50 0.75~1.50	0.4~1.3	0.40~1.30
Manganese μg/100kcal	5.0~100.4	3.0~100.0	1.05~100.4	1.0~100.0	1.05~100.4	1.0~100.0
Calcium mg/100kcal	50~146	50~146	71~NS	71~180	71~NS	71~210
Phosphorus mg/100kcal Milk base Soy base	25~100	25~100 30~100	34.7~NS	35~110 42~110	34.7~NS	35~110
Calcium/ phosphate	1:1~2:1	1:1~2:1	1.2:1~2:1	1.2:1~2:1	1.2:1~2:1	1.2:1~2:1
Iodine μg/100kcal	10.5~58.6	15~59	5.9~NS	15~59	5.9~NS	6~59
Chlorine mg/100kcal	50~159	50~159	NS~218	NS~218	NS~218	NS~218
Selenium μg/100kcal	2.01~7.95	3.0~8.6	2.01~7.95	2.0~8.6	2.01~7.95	2.0~8.6

The major changes on minerals are:

The index of iron, zinc and phosphorus for soy-based formula are supplemented, and the lower limits are higher than that of milk-based formula, which is because the inositol hexa-phosphate in soy-based formula has influence on the utilization of iron, zinc and phosphorus in vivo.
For GB10766, manganese and selenium become essential nutrients (they are still essential nutrients in GB10765, and keep optional nutrients in GB10767). The basis are the latest scientific research and international and foreign standards such as CAC, EU, Australia, New Zealand and the United States, as well as the comprehensive situation of products on the market

Optional nutrient

Optional nutrient	Infant food		Older infant food		Young children food
Optional nutrient	Current	New	Current	New	Current	New
Inositol mg/100kcal	4.2~39.7	4~40	4.2~39.7	4~40	4.2~39.7	4~40
Taurine mg/100kcal	NS~13	3.5~16.7	NS~13	3.5~16.7	NS~13	3.5~16.7
L-carnitine mg/100kcal	1.3~NS	1.3~NS	1.3~NS	1.3~NS	1.3~NS	1.3~NS
DHA mg/100kcal	NS~0.5 %TFA(Total Fatty Acid)	15~40	NS~0.5 % TFA	15~40	NS~0.5 % TFA	NS~40
ARA mg/100kcal	NS~1 % TFA	NS~80	NS~1 % TFA	NS~80	NS~1 % TFA	NS~80

As shown from the table above, the new standards make adjustments to the upper and lower limits of taurine, DHA, and ARA, and the units of DHA and ARA have changed. Besides, although the lower limit for ARA is still ‘NS’, both GB10765 and GB10766 specify that if DHA is added to the formula, at least the same amount of ARA must be added, so there is virtually no need to set it.

Summary

The revision of the standards not only refers to international and foreign standards and scientific research, but also considers the relevant situation of the current products on the market, thus reducing the difficulty of market transition to a certain extent.

In 2017, a total of 952 infant and young children formula were registered, accounting for more than 70% of all the registered products. Therefore, when the new standards are implemented in 2023, most of the registered products will be in the period of renewal of registration. For enterprises that need to adjust the product formula according to the new standards, it has not been clear that, if formula/label change application can be made at the same time as applying for the renewal registration? And for the enterprises whose certificates are still valid after 2023 while the product formula are necessary to be adjusted according to the new standards, can they apply for changes of registration? Or should they re-register? These may require official clarity.

However, it is clear that, the product must comply with the new standards after they are implemented. Therefore, enterprises in demanding should carry out product research and development tests as early as possible according to the requirements of the new national standards.

If you have any needs or questions, please contact us at service@cirs-group.com.

Reference:

NHC Official News

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