Recommended Addition Amount of CABIO's HMOs Products - Comprehensive Considerati

In the field of infant formula food, human milk oligosaccharides (HMOs), as an important component in breast milk, have attracted much attention in recent years. Among them, 2'-fucosyllactose (2'-FL) is not only the most concentrated component in HMOs but also highly regarded for its unique physiological functions.

Since October 7, 2023, the National Health Commission has successively issued relevant approval announcements for HMOs substances. 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose (LNnT) have been approved as new varieties of food additives. As of June 14, 2024, the Health Commission has accepted applications for 33 HMOs substances as new varieties of food additives, among which 2'-FL has the highest acceptance frequency. The approval of HMOs is an important milestone in the infant formula food market, marking the upgrading of infant formula powder quality and accelerating the process of breast milk approximation. With consumers' increasing awareness of healthy food, the application fields of HMOs will be further broadened and the market demand will continue to grow.

As a leading enterprise in the research and development and production of HMOs, CABIO will recommend a reasonable addition amount of 2'-FL for customers and the market by combining Chinese breast milk research, regulatory requirements, market application cases and clinical or efficacy studies.

 Chinese Breast Milk Research

Changes during lactation and individual differences of mothers can lead to changes in the content and composition of HMOs. According to Chinese breast milk research data, the concentration of 2'-FL during lactation fluctuates approximately between 0.935 - 2.865 g/L (Liu, Shuang, et al., Frontiers in Nutrition, 2023). This data provides a scientific basis for guiding the addition of 2'-FL in infant formula food, which should be as close as possible to this natural concentration range of breast milk to ensure the safety and effectiveness of the product.

Regulatory Requirements

At the regulatory level, different countries and regions have clear regulations on the addition amount of 2'-FL in infant formula milk powder:

| European Union | ≤1.2 g/L |

| United States | ≤2.4 g/L |

| China | 0.7 - 2.4 g/L |

（Information source: Baidu Encyclopedia）

The regulations of the European Union, the United States and China set the addition range of 2'-FL in infant formula milk powder as 1.2 g/L, 2.4 g/L and 0.7 - 2.4 g/L respectively. CABIO always strictly complies with the regulatory requirements of various countries when recommending the addition amount to ensure the compliance of the product.

Market Application Cases

In terms of market application, the addition amount of 2'-FL in products of international mainstream brands such as Danone, Nestlé and Mead Johnson is generally in the range of 1.0 - 2.0 g/L. This data not only reflects the market's recognition of 2'-FL but also provides a practical reference for application.

Clinical or Efficacy Studies

In clinical or efficacy studies, although most clinical studies focus more on safety and tolerance and there are not many dose screenings, CABIO's research has found the relationship between the dose of 2'-FL and health benefits.

CABIO studied the immunomodulatory effect of 2'-FL on healthy mice. The study found that when the dose of 2'-FL reached the human equivalent dose of 1.15 g/L, it could significantly enhance the lymphocyte transformation ability of mice; when the dose was increased to 2.0 g/L, it could comprehensively improve the immunity of mice, including NK cell activity, lymphocyte transformation ability, delayed-type hypersensitivity and carbon clearance ability. Therefore, when supplementing 2'-FL alone, increasing its dose can significantly enhance the immunity of healthy mice.

Therefore, CABIO recommends that when adding 2'-FL at a concentration below 1.15 g/L, it is better to combine it with other types of HMOs to achieve more comprehensive health benefits. However, if only 2'-FL is added alone for specific needs, a higher dose, that is, 2.0 g/L, is recommended to ensure that it can also produce significant health effects when used alone.

In conclusion, CABIO fully considers various factors such as Chinese breast milk research, regulatory requirements, market application cases and clinical or efficacy studies when recommending the addition amount of 2'-FL. We firmly believe that only a scientific, compliant and efficient addition amount can provide consumers with safer, healthier and more competitive infant formula food.