China approves HMO 3’-SL for use in infant formula

CHINA – The Chinese authorities have approved 3’-sialyllactose (3’-SL) – a human milk oligosaccharide (HMO) – for use in infant formula for the first time.

China’s National Health Commission (NHC) has permitted the use of 3’-SL in a variety of products other than infant formula, including complementary food for toddlers, food for special medical purposes (FSMP) for infants and dairy powder for kids’ consumption.

The ingredient can be used at concentrations between 0.06 g/L and 0.28 g/L when dissolved as a powder in water.

Found naturally in human breast milk, HMOs are produced via fermentation in commercial settings. They are also seen as a point of innovation as companies seek to develop infant formulas that closely mimic human breast milk.

While 2’-FL is the most abundant HMO found in breast milk, LNnT has been shown to act as a prebiotic while 3’-SL plays a key role in brain development, synapse formation and cognitive enhancement.

Chinese dairy giant Mengniu and fellow Chinese biotech firm Meihua Holdings Group have secured the 3’-SL approvals.

 Mengniu said in a press release that the latest approval meant that it could produce variants from all three major types of HMOs – namely fucosylated, N-containing and sialylated.

The majority (35% – 50%) of HMOs found in breast milk are fucosylated ones, followed by N-containing (42% – 55%) and sialylated (12% – 14%) ones.

“The approval of 3’-SL signifies that, following the previous approvals of 2’-FL and LNnT, Mengniu has now completed a systematic layout of three key HMO representative molecules for the first time,” the company said.

The approvals also showed that Chinese companies have caught up with their Western counterparts in HMO research and production. This could potentially reduce reliance on HMO imports, said Mengniu.

“For a long time, HMO industrialization technology was in the hands of European and American giants…This series of breakthroughs not only marks a crucial leap for China in terms of developing technologies that simulate breast milk composition, allowing us to keep up with leading industry players, but also transforms the local precision nutrition industry from being dependent on raw material imports to developing our own manufacturing technology,” it said.

Mengniu began researching and developing techniques for producing HMOs a decade ago and was the first Chinese company to receive approval from the NHC to produce the HMO 2′-FL in October 2023.

 It launched its first infant formula containing HMO in China two months later. Meihua Holdings Group, on the other hand, had officially acquired the HMOs and amino acids ingredient business from Kyowa Hakko Bio last year.

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