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 designed for infants aged 0 to 12 months with lactose intolerance.

The 15 products consist of 12 domestic formulas and 3 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

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*

*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

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

* 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

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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