IFF Secures Regulatory Approval for Use of 2'-FL HMO in China

Landmark decision marks first-time approval of human milk oligosaccharide molecules for infant formula in China 

SHANGHAI, Oct. 10, 2023 /PRNewswire/ -- IFF, a global leader in food, beverage, health, biosciences and scent, today announced it is one of the first ingredients suppliers to achieve regulatory approval (NHC No. 8, 2023) for the use of its 2′-fucosyllactose (2'-FL), human milk oligosaccharide (HMO) in China for infant formula, follow-up formula and formula for special medical purposes for infants. The news is a significant milestone that signifies IFF's position as a key supplier of this vital constituent of human milk to the Chinese market.

HMOs—including 2'-FL, 3'-FL and others—have been gradually appearing in the U.S. and European markets for several years now. Their introduction to infant formula is propelled by numerous studies conducted on human milk, as well as formula containing 2'-FL, which suggested such products showed pronounced immune health benefits in infants.

China has the largest milk formula segment worldwide, representing close to 50 percent of the global market's total retail value.^[1] Until today, HMO molecules were not approved for use in infant formula in China. The announcement of the landmark decision means brand owners and infant formula producers can now look to further support families across the Asia-Pacific region, and beyond.

"The infant formula industry has eagerly awaited the approval of 2'-FL in China, since it will allow producers to formulate a new generation of products for the early-life nutrition segment," said Marcus Gliwitzki, global product manager, Health, IFF. "Today's decision will help us better serve customers in all major markets and respond to the rising global demand for infant nutrition products."

"We are thrilled to contribute to bringing infant formula closer to human milk," said Klaas Illeghems, global strategic business unit leader, INFAT^®, HMO & Biosciences, Health, IFF. "This is our first HMO ingredient for the Chinese market, and we are committed to accelerate more of our high-quality HMOs to customers soon."

This regulatory milestone marks the intersection of IFF's extensive HMO research and innovation, commercialization, and health benefit effects – via infant gut microbiome modulation – closing an important gap between human milk and infant formula.

¹ Euromonitor: Dairy Products and Alternatives: Euromonitor from trade sources/national statistics.

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