Analysis of 15 Approved Lactose-Free/Low-Lactose Infant Formulas for Special Medical Purposes in China

Approval status

As of now, China has officially approved 15 lactose-free/low-lactose infant formulas for special medical purposes. These are designed for infants aged 0 to 12 months with lactose intolerance.

The 15 products consist of 12 domestic formulas and three imported ones from 14 companies. Among these, Wissun International has had two formulas approved, while the other 13 companies each have had one. All 15 products are in powdered form. Notably, only one low-lactose formula for special medical purposes has been approved, which is Neng Dun by Wissun International.

The product details are as follows:

Table 1 15 approved lactose-free/low-lactose infant formulas for special medical purposes

S.N.	Applicant	Product name	Dosage form	Registration number
1	Hangzhou BEINMATE	Beinmate	Powder	国食注字TY20180001
2	Mead Johnson	An Er Bao (安儿宝)	Powder	国食注字TY20185005
3	NESTLE	An Er Ning Neng En (安儿宁能恩)	Powder	国食注字TY20195003
4	Maeil Dairies Co., Ltd	Ai Si Nuo Fu Er Jia (爱思诺赋儿嘉)	Powder	国食注字TY20195009
5	Tianjin Aumix	Li Nuo Kang Ning (力诺康宁)	Powder	国食注字TY20190006
6	Synutra International Inc.	You Bo Rui An (优博瑞安)	Powder	国食注字TY20190009
7	Beian Yeeper Dairy	Bao An Su (葆安素)	Powder	国食注字TY20210002
8	Ausnutria	Zhi Shu (稚舒)	Powder	国食注字TY20210005
9	Heilongjiang Feihe	Bei Shu Xiao (蓓舒消)	Powder	国食注字TY20210008
10	Wissun International	An Ni Er (安尼尔)	Powder	国食注字TY20210009
11	AusNuotore	AusNuotore You An Li (爱优诺优安力)	Powder	国食注字TY20220003
12	Qingdao Shengtong	Te Ai Rui An (特爱瑞安)	Powder	国食注字TY20230021
13	Wissun International	Neng Dun (能盾)	Powder	国食注字TY20230050
14	Zhejiang Kelubao	Jia Fu Bao (嘉复褓)	Powder	国食注字TY20230054
15	Shijiazhuang Junlebao	Yi An Xiao (怡安消)	Powder	国食注字TY20240015

Formula characteristics

Lactose-free or low-lactose infant formulas for special medical purposes are designed for infants with primary or secondary lactose intolerance. In these formulas, alternative carbohydrates such as – sucrose, glucose, corn syrup, dextrin, or maltodextrin – are used to replace some or all of the lactose found in regular infant formulas. This helps to manage lactose intolerance effectively while ensuring the normal growth and development of infants.

Table 2 Energy density and energy supply ratios of nutrients*

S.N.	Product name	Energy density kcal/mL	Energy supply ratio of protein	Energy supply ratio of fat	Energy supply ratio of total carbohydrate	Energy supply ratio of linoleic acid	Energy supply ratio of α-linolenic acid
1	Beinmate	0.68	9.5%	46.5%	43.6%	8.0%	0.8%
2	An Er Bao (安儿宝)	0.67	8.6%	48.1 %	43.4%	8.4%	0.7%
3	An Er Ning Neng En (安儿宁能恩)	0.67	8.3%	44.2%	47.4%	7.1%	0.6%
4	Ai Si Nuo Fu Er Jia (爱思诺赋儿嘉)	0.69	9.1%	43.0%	47.8%	8.6%	0.8%
5	Li Nuo Kang Ning (力诺康宁)	0.66	9.4%	43.5%	47.0%	5.8%	0.6%
6	You Bo Rui An (优博瑞安)	0.66	10.5%	45.7%	43.9%	8.1%	1.0%
7	Bao An Su (葆安素)	0.65	9.8%	44.5%	45.8%	8.0%	0.8%
8	Zhi Shu (稚舒)	0.69	8.8%	47.8%	43.2%	7.0%	0.8%
9	Bei Shu Xiao (蓓舒消)	0.64	8.6%	46.7%	44.0%	5.7%	0.6%
10	An Ni Er (安尼尔)	0.65	9.0%	43.3%	45.4%	5.4%	0.5%
11	AusNuotore You An Li (爱优诺优安力)	0.62	9.4%	44.1%	46.6%	7.9%	0.8%
12	Te Ai Rui An (特爱瑞安)	0.66	10.5%	45.7%	43.9%	8.1%	1.0%
13	Neng Dun (能盾)	0.65	9.3%	43.4%	47.3%	5.6%	0.6%
14	Jia Fu Bao (嘉复褓)	0.67	9.9%	45.4%	43.9%	7.4%	0.9%
15	Yi An Xiao (怡安消)	0.65	9.7%	46.4%	43.6%	6.5%	0.9%

*Energy density and nutrient energy ratios are calculated based on the product labels.

Energy density

According to GB 25596, lactose-free or low-lactose infant formulas for special medical purposes should contain 250 kJ (60 kcal) to 295 kJ (70 kcal) of energy per 100 mL in the final product ready for use. This is equivalent to an energy density of 0.6 kcal to 0.7 kcal/mL, which complies with the National Food Safety Standard – Infant Formula (GB 10765). The energy densities of the 15 approved products range from 0.62 kcal to 0.69 kcal/mL.

Protein

According to GB 25596, the protein content in these formulas should be between 0.45 g and 0.70 g per 100 kJ, which corresponds to a protein energy ratio of 7.65% to 11.9%. The protein must come from milk protein, which is recognized for its complete essential amino acid profile and easy absorption by the human body. The 15 approved products have a protein energy ratio ranging from 8.3% to 10.5%.

In terms of protein sources, these formulas primarily use a combination of whey protein isolate and casein. Whey protein isolate, a high-purity protein derived from further processing of concentrated whey, is easily digestible and absorbable. Casein, on the other hand, does not require prior denaturation for hydrolysis by caseinase and is also readily absorbed by infants. Therefore, both whey protein isolate and casein are frequently used in these formulas.

Table 3 Ingredient sources of protein

S.N.	Ingredient source	Frequency
1	Casein	10
2	Whey protein isolate	9
3	Whey protein powder	4
4	Potassium caseinate/Calcium caseinate	4
5	Whole milk powder (lactose-free)	3
6	Concentrated milk protein	2
7	Hydrolyzed casein	1

Fat

According to GB 25596, the fat content in these formulas should range from 1.05 g to 1.40 g per 100 kJ, which corresponds to a fat energy ratio of 38.85% to 51.8%. Fat plays a crucial role in providing essential nutrients for infants, supporting central nervous system development, and maintaining energy for the retina. The 15 approved products have fat energy ratios ranging from 43.0% to 47.8%.

Fat sources in these formulas typically include a mix of edible vegetable oils, such as coconut oil, maize oil, rapeseed oil, and sunflower seed oil. Coconut oil is rich in medium-chain fatty acids, which are easier for infants to digest and absorb compared to long-chain fatty acids. Maize oil, rapeseed oil, and sunflower seed oil are high in unsaturated fatty acids, providing both energy and essential fatty acids (linoleic acid and α-linolenic acid) for infants.

Table 4 Ingredient sources of fat

S.N.	Ingredient source	Frequency
1	Coconut oil	15
2	Maize oil	10
3	Rapeseed oil	8
4	Sunflower seed oil	7
5	Soybean oil	5
6	Low-erucic acid rapeseed oil	4
7	Anhydrous milk fat	3
8	1,3-dioleic acid-2-palmitic acid triglyceride*	2
9	Linseed oil	1
10	Palm oil	1

* Also used as a nutrition enhancer in the formulas

Carbohydrates

As specified in GB 25596, the carbohydrates content in these formulas should range from 2.2g to 3.3g/100kJ, which is equivalent to a carbohydrates energy ratio of 37.4% to 56.1%. The 15 approved products have carbohydrate energy ratios ranging from 43.2% to 47.8%. In formula design, a combination of glucose syrup and maltodextrin with other carbohydrates is often used to replace lactose. Maltodextrin is favored for its non-clumping properties, good solubility, and lower cost, while glucose syrup enhances product viscosity and improves texture. Both are commonly used in these formulas.

Table 5 Ingredient sources of carbohydrates

S.N.	Ingredient source	Frequency
1	Glucose syrup	10
2	Maltodextrin	9
3	Starch sugar (solid)	4
4	Solid corn syrup	3
5	Anhydrous glucose	2
6	Edible glucose	2
7	White granulated sugar	2

The above information represents CIRS Group’s statistical analysis of energy density, macronutrient energy ratios, and ingredient sources, aimed at supporting companies in their formula development efforts.

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