Chr. Hansen HMO secures regulatory wins across geographies

12 September 2022 10:05

Approvals from authorities across the globe bring infant formula closer to breast milk in more countries

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.

“At Chr. Hansen, we want to support healthy infant development. We are very proud to share this news on approvals in new and existing markets, so more infants can benefit from infant formula closer to breast milk,” says Jesper Sig Mathiasen, senior vice president, Chr. Hansen HMO.

The new approvals

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 up to 1.8 g/L of HMOs.

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
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.

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.

Breastfeeding is best. Chr. Hansen supports the World Health Organization (WHO) recommendation of breastfeeding exclusively for the first six months, followed by continued breastfeeding together with complementary foods.

Meet our HMO experts at NASPGHAN 2022 on October 12-15, Florida
For the first time, Chr. Hansen HMO will be present at the annual meeting of NASPGHAN, the professional society for pediatric gastroenterologists in North America. This event provides a forum for participants to learn of the latest advances in pediatric gastroenterology, hepatology and nutrition and to learn about, discuss, and debate current topics in clinical applications.

Chr. Hansen’s team of experts looks forward to discussing the science behind our unique product offering supporting infant health, including the newest 5 HMO Mix and scientific study, alongside other new topics in the world of HMOs and infant microbiome science.