A Summary on Differences between the New and Current Version of Infant and Young Children Food Safety National Standard

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

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

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

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

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.

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Reference:

NHC Official News