New regulatory approvals of Chr. Hansen’s Human Milk Oligosaccharides for infant formula by authorities in Europe, USA, Canada and Israel are paving the way for more market entries and higher usage levels across the globe. The new regulatory wins add to recent approvals in important markets like Australia and New Zealand. Further, Chr. Hansen is filing for approval of HMOs in China.

The new approvals:
EUROPE - Positive EFSA opinion on higher usage levels
The European Food Safety Authority has published the assessment of Chr. Hansen’s HMOs lacto-N-tetraose (LNT), 3-fucosyllactose (3-FL) and 3’-sialyllactose (3’-SL), each with a positive opinion for safe use in infant formula and follow-on formula, food for infants and young children, food for special medical purposes and food supplements.

The positive opinion is a significant milestone on Chr. Hansen’s path to Novel Food approval for HMOs in the EU and supports the addition of higher concentrations of HMOs (LNT up to 1.8 g/L).

NORTH AMERICA - FDA’s GRAS recognition in new food categories
Chr. Hansen has received “no questions” letters from the US Food and Drug Administration regarding the Generally Recognized as Safe (GRAS) notices for the use of its HMO ingredients, 2’-fucosyllactose (2’-FL), 6’-sialyllactose (6’-SL), 3’-sialyllactose (3’-SL) and, most recently, lacto-N-tetraose (LNT) in several additional food categories, such as formula for young children, meal replacement drinks, breakfast bars and sports drinks. This adds to the existing infant formula GRAS status.

Approval by Health Canada - Letter of no objection issued
Health Canada has issued a “letter of no objection” for Chr. Hansen’s 2′-fucosyallactose (2′-FL), confirming the acceptability of its use as a food ingredient for infant and toddler formula.

ISRAEL - Expanding HMO approvals
With its 2′-fucosyallactose (2′-FL) already approved in Israel, the Israeli Ministry of Health has now further granted regulatory approval of Chr. Hansen’s HMO’s 3-FL, LNT, 3’-SL and 6’-SL as new food ingredients for use in infant as well as follow-on formula.

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