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The Latest Developments of HMOs in China: Regulations and The Market

The Latest Developments of HMOs in China: Regulations and The Market

With the recent approval of human milk oligosaccharides (HMOs) by the National Health Commission (NHC) in China, the demand for HMOs in the Chinese market is expected to skyrocket, leading to a potential boom for related raw material suppliers.

Currently, the approval status of HMOs in China and internationally is as follows:

In an announcement on October 7th, China NHC approved several food additives, including two types of HMOs: 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose. These two HMOs can be used in infant formula milk powder, modified milk powder for children, and infant foods for special medical use.

Since 2016, China has issued six acceptance notices for 2'-FL and published five opinions on "public solicitation of new varieties of food nutrient fortifiers, including 2'-FL," which standardized the dosage, scope of application, and quality specifications of 2'-FL as a nutrient fortifier. In 2021, the NHC began accepting and approving applications for genetically modified microbial food additive varieties, laying the foundation for the compliant use of HMOs produced through genetically engineered microbial fermentation in China. On May 4th, 2023, the application for 6'-sialyllactose sodium salt as a new food additive variety started to be accepted, which could be approved soon as well.

2'-FL for use in infant formula products was approved by the US FDA in 2014, and in 2015 by the European Food Safety Authority. Currently, 7 types of 2'-FL HMOs have been approved for use in infant formula in Europe and the United States. Additionally, regulatory permits for 2'-FL have been granted in Canada, Brazil, Singapore, Malaysia, Vietnam, Australia, and New Zealand. Furthermore, 3 types of 6'-SL have been approved by the US FDA, and 1 has been approved by the European Union. According to incomplete statistics, products containing HMOs have been produced and sold in 45 countries and regions worldwide since 2016.

Dairy companies and raw material suppliers have responded swiftly accordingly.

Following the announcement, multiple brands of infant formula powder containing HMO ingredients quickly emerged in the market. Companies such as Yili, Junlebao, and Feihe almost simultaneously launched advertisements for the "HMOs formula," each claiming to be the "first" in China. Yili's subsidiary, Yili Jinlingguan, introduced the "Zhenhupuicui" children's growth formula milk powder, Junlebao introduced the "Quanwei Ai Weilai" milk powder with added HMO ingredients, and Feihe launched the "Xingfeifan Zhuorui Stage 4" HMO formula.

China infant milk podwers with HMOs 2023

According to data from BlueWeave Consulting, the global HMO market was valued at $199 million in 2022, and during the forecast period of 2023-2029, it is expected to grow at a robust compound annual growth rate of 22.9%, reaching $843 million by 2029. In this report, the Asia-Pacific region is predicted to have the highest compound annual growth rate, and China, with its vast market, is seen as a significant growth pole.

Currently, the main suppliers of HMOs are still international giants such as CHR. Hansen, Friesland, DSM, Finmenich. The price of conventional HMO raw materials is approximately 1,000 yuan per kilogram. In the recent approval by the NHC, Mengniu Group's self-developed HMO 2'-FL received approval, making it the only domestic company among the first approved enterprises.

In China, there are relatively few companies capable of synthesizing and producing HMOs. Representative examples include Hengrui Biology(恒鲁生物), Yixi Biology(一兮生物), and Zhino Technology(芝诺科技). Yixi Biology, as a leading domestic company with industrial-scale production capabilities for HMOs, has achieved low-cost production through integrated processes from carbon sources, strains, and culture media to sugar activation, transformation, and process modules under mass production conditions. Currently, Yixi Biology is the first in China to industrialize HMO biosynthesis and has built a production line with an annual capacity of 300 tons in 2022.

Reminder: if you have any comments/doubts on the content, or need any technical support in submitting relevant new novel food ingredients/food additives in China, free to reach out.

Relevant Reading: This Month at China: Food Regulatory Updates in September 2023