Chr. Hansen secures EU approval for final HMO in infant formula

By Nikki Hancocks

- Last updated on GMT

Getty | Pilin Petunyia
Getty | Pilin Petunyia

Related tags HMO Infant formula

Chr. Hansen has announced its 6’-SL HMO mix is approved for highest use levels in infant formula and follow-on formula in EU.

The bioscience company's HMO (human milk oligosaccharide) 6’-Sialyllactose sodium salt​ (6’-SL), marketed under the new trademark 'MyOli' 6’-SL HMO, is now authorised for the EU market under proprietary protection for five years. 

This EU authorisation includes the highest use level for 6’-SL in infant formula and follow-on-formula (0.70 g/L) in the EU. This is the most abundant sialylated HMO in human milk is said to provide sialic acid and support immune system development​.

Benefits attributed to 6′-SL HMO are, among others, reducing the risk of adhesion of harmful bacteria and their proteins and support to the brain development in infants, by supplying sialic acid, an essential building block for neurons.

Chr. Hansen now has EU authorization for all five HMOs in its MyOli 5 HMO Mix which contains 2'-fucosyllactose (2’-FL), 3'-fucosyllactose (3-FL), lacto-N-tetraose (LNT), 3’-sialyllactose (3’-SL) and 6'-sialyllactose (6’-SL). The firm was awarded final EU authorization of its HMOs LNT, 3-FL and 3’-SL for use in infant formula at the highest dosage levels in March of this year (2023).

The authorisations allows manufacturers 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, says: “The fact that Chr. Hansen MyOli 5 HMO Mix is now approved for use in the EU at the highest use levels is an important milestone. It means that Chr. Hansen can now supply a blend of five HMOs bringing infant nutrition solutions closer to breast milk, to the benefit of infants who cannot be breastfed for various reasons.

"The European approval is also an important step towards using HMOs at natural concentration levels in infant formula and follow-on formula.”

The catalogue of HMOs

HMOs are the third most abundant solid component of breast milk and are known in many different variations. These prebiotic compounds contribute to the development of the infant's microflora and immune system. By acting via various mechanisms, they protect against many infections and alleviate their course. They have also been shown to have anti-bacterial, anti-viral and anti-inflammatory effects.

Among the various compositional differences between human breast milk and cow milk, one of the major differences is the presence of HMOs in human milk, which are virtually absent in cow milk. 

Human breast milk contains three major HMO types: fucosylated HMOs (35%–50%), sialylated HMOs (12%–14%), and nonfucosylated neutral HMOs (42%–55%). Fucosylated HMOs include 2′-fucosyllactose (2′-FL), while non-fucosylated neutral HMOs include lacto-N-neotetraose (LNnT). The neutral HMOs account for more than 75% of the total HMOs in the human breast milk.

The amount and diversity of HMOs are determined by the genetic background, environment and lifestyle factors of the mothers.

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​.

Related topics Regulation & Policy

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