CHINA – China has officially approved the use of human milk oligosaccharides (HMOs) in infant formula with two multinational corporations, IFF and DSM-Firmenich, along with local dairy giant Mengniu, receiving approvals for their 2′-fucosyllactose (2’-FL) ingredient.
However, China, as one of the most lucrative infant formula markets in the Asia-Pacific region, has been slower to allow the use of HMOs in infant formulas compared to other countries.
Chinese authorities have approved the use of these HMOs in various infant formula categories, including follow-up formula, infant formula for special medical purposes, and formulated milk powder for children.
The authorities have also set limits on the minimum and maximum amounts of HMOs that can be added to these formulas, ensuring a safe and beneficial level.
According to Cathy Yu, general manager of, the food business division at Hangzhou-based regulatory consulting firm CIR, this first wave of approvals marks a milestone, and more approvals are expected to follow now that harmonized standards for HMOs’ use in infant formulas have been established.
“I think the approval process is considered relatively quick because it is the first time that food additives made via synthetic biology technology are being approved [for use in infant formulas],” she said.
The approval process for HMOs can be divided into two parts. First, the Ministry of Agriculture and Rural Affairs (MARA) assesses the safety of genetically modified strains used in HMO fermentation. This step could take time, as MARA meets only twice a year.
“MARA only meets twice a year. It is not established which month is. You might have submitted for approval in January and the meeting might be held in July. This means that the application could be in the system for many months,” Marta Miks, senior regulatory & scientific affairs manager, at DSM Firmenich said.
“Sometimes, you could be lucky, and the meeting could be held the week after you have submitted. That’s why it’s difficult to estimate the exact timeline for this stage.”
The second part involves the China Food Safety Authority (CFSA), which conducts panel reviews and public consultations to assess the safety, tolerability, and benefits of HMOs added to infant formulas.
This part of the process aims to develop a new process to check the safety and tolerability of HMOs produced using GM organisms.
The involvement of multiple companies has helped to pave the way and address major questions raised by authorities, which should help expedite future approvals.
HMOs are the third most abundant solid component of human breast milk and serve as prebiotics, promoting the growth of beneficial bacteria in the gut.
They are known to support gut health, immune health, and cognitive development. Preparations are underway for approvals of HMOs 3′-Sialyllactose (3’-SL) and 6′-Sialyllactose (6’-SL).
This milestone paves the way for further innovation in infant formula products in the Chinese market. Infant formula companies will need to register their stage one to three infant formulas fortified with HMOs with Chinese authorities before they can be sold.
