Chr. Hansen higher dose HMOs get Novel Food approval in EU  

By Nikki Hancocks

- Last updated on GMT

Getty | Pilin Petunyia
Getty | Pilin Petunyia

Related tags Novel foods HMOs Infant formula

Chr. Hansen has been awarded Final EU authorization of HMOs LNT, 3-FL and 3’-SL for safe use in infant formula at the highest dosage levels.

Following last May’s positive EFSA assessment of the Denmark-based bioscience firm's HMOs lacto-N-tetraose (LNT),  3-fucosyllactose (3-FL) and 3’-sialyllactose (3’-SL), these three HMOs are now approved in EU for safe use in infant formula and several other categories at the highest dosage levels approved in the HMO market.  

The authorisation will allow Chr. Hansen customers to use higher concentrations of HMOs in their infant formula, making formulations closer to nature and the levels in mother’s milk. 

Jesper Sig Mathiasen, senior vice president, Chr. Hansen HMO, said: “We are pleased to share the news on these three EU approvals, as more infants that cannot be breastfed can now benefit from infant formula with HMOs in concentrations closer to nature and the structural variations. These approvals will pave the way for bringing Chr. Hansen’s 5 HMO Mix into infant formula at the highest concentrations and closer to nature, also in the EU.”

Health benefits of HMOs

HMOs are the third most abundant solid component of breast milk with many different variations. The benefits stem from the structural diversity of HMOs. The HMOs LNT, 3-FL and 3’-SL are identified in significant amounts in breast milk.  

In addition to these three variations, Chr. Hansen’s 5 HMO mix also includes 2’-FL (2'Fucosyllactose), the most abundant HMO in breast milk of most women, and 6’-SL (6′-Sialyllactose), the most abundant sialylated HMO in human milk which is said to provide sialic acid and support immune system development​.

Health effects and research highlights   

Chr. Hansen’s team of scientists continue their work to unlocking more unique health benefits of HMOs.

Their research suggests LNT contributes to the benefits of breastfeeding for infants​, and a well-balanced gut microbiome by helping to limit the growth of undesired microorganisms.
Studies indicate that 3-FL increases in concentration over the course of lactation​, and thereby becomes the most abundant HMO in human breast milk over time.

And 3'-SL is said to provide sialic acid, a nutrient that is needed for healthy development. It further interacts with immune cells, supporting their maturation and contributing to a balanced immune response​.

Previous and new dosage allowances 

HMOs

Chr Hansen’s approval

Previously

3′-SL

Infant formula max level: 0,23 g/L in the final product ready for use

                                                                        Follow-on formula max level: 0,28 g/L in the final product ready for use

Infant formula max level: 0,2 g/L in the final product ready for use

                                                                        Follow-on formula max level: 0,15 g/L in the final product ready for use

LNT

Infant formula max level: 1,82 g/L in the final product ready for use

                                                                        Follow-on formula max level: 1,82 g/L in the final product ready for use

Infant formula max level: 0,8 g/L in the final product ready for use

                                                                        Follow-on formula max level: 0,6 g/L in the final product ready for use

3-FL

Infant formula max level: 0,90 g/L in the final product ready for use

                                                                        Follow-on formula max level: 1,20 g/L in the final product ready for use

Infant formula max level: 0,85 g/L in the final product ready for use

                                                                        Follow-on formula max level: 0,85 g/L in the final product ready for use

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