Innovative infant nutrition: Kyowa Hakko’s 2’-FL HMO clears EU regulatory hurdles

08 Aug 2024 --- Kyowa Hakko Bio’s 2’-Fucosyllactose (2’-FL) human milk oligosaccharide (HMO) receives approval as a novel food ingredient by the EU’s European Commission (EC). 

The Kirin Holdings Company subsidiary says the approval allows its 2’-FL HMO ingredient—its third EC-approved HMO—to be incorporated into several food categories, including infant formula, follow-on formula, foods for medical purposes and food supplements, across 27 EU member states.

HMOs are complex carbohydrates essential for the development of infants, which are only found in human breast milk. The company can begin including its 2’FL ingredient in formulations starting on 19 August of this year.

“To be approved by the European Commission, the novel food must undergo a safety assessment by the European Food Safety Authority (EFSA) as needed,” the company reveals. “Kyowa Hakko Bio received a positive opinion on the safety of its 2’-FL from EFSA in November 2023 and it has now been approved as a novel food.”

Latest HMO developments
Kyowa Hakko began commercial production of its HMO ingredients, which include 2’-FL, 3’-Sialyllactose sodium salt (3’-SL) and 6’- Sialyllactose sodium salt (6’-SL) in November 2022 at its newly constructed production facility in Thailand. The EC has already approved its 3’-SL and 6’-SL HMOs.

Additionally, the company partnered with the Singapore Ministry of Trade and Industry’s Agency for Science, Technology and Research to advance knowledge and understanding of HMOs’ health benefits and drive innovation in the space.

“As 3’-SL and 6’-SL had been previously approved, now we are ready to supply all three HMOs — 2’-FL, 3’-SL and 6’-SL — in the EU area,” the company underscores. “We will continue to expand the availability of HMOs in countries and regions where applications for new ingredients have been approved.”