Chr. Hansen eyes innovative HMO launches after string of international approvals

13 Sep 2022 --- Denmark-based Chr. Hansen has received regulatory approvals for human milk oligosaccharides (HMOs) for infant formula by authorities across the EU, US, Canada and Israel. The developments are paving the way for more global market entries and higher usage levels, the company notes.

NutritionInsight speaks to Chr. Hansen’s senior vice president Jesper Sig Mathiasen on the impact of these approvals, as well the short and long-term strategy the company envisions. 

“The approvals further pave the path toward allowing infant formula brands to include more HMOs in infant formula products in increased dosages, in both existing and new countries. HMOs form the third largest component of breastmilk. Their inclusion is also very supportive in infant formula,” he says. 

“We are in close partnership with infant formula producers in the respective markets to support them in innovative launches with HMOs.”

Chr. Hansen says it supports the World Health Organization recommendation of breastfeeding exclusively for the first six months.Global approvals
In the US, Chr. Hansen has received “no questions” letters from the US Food and Drug Administration regarding 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. 

The categories include formula for young children, meal replacement drinks, breakfast bars and sports drinks, which add to the existing infant formula GRAS status.

“These market approvals are a strong part of our HMO strategy, to drive market growth and enable our customers to expand geographically and to increase the dosage of HMOs in infant formula,” Mathiasen highlights. 

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

In Israel, the company’s 2’-FL was already approved, but the government’s health ministry has now 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.

Marking milestones
According to Mathiasen, the European Food Safety Authority has published the assessment of Chr. Hansen’s HMOs LNT, 3-FL and 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,” notes the company. 

“HMOs penetration is increasing into infant formula across all markets globally. The largest Infant formula markets are China, the US and EU, where the US were the first to approve also more complex blends, such as Chr. Hansen’s 5 HMO mix with five different HMOs,” Mathiasen says. 

China has not yet approved HMOs, but the process of regulatory approvals for HMOs has been initiated, and regulatory approval is expected, he adds. 

“Australia and New Zealand have approved Chr. Hansen 2’-FL, which is a substantial step for the entire Asia Pacific region, as many countries are supplied from this market,” he concludes.

By Andria Kades