Chr. Hansen HMOs get Novel Food approval in EU  

Chr. Hansen HMOs get Novel Food approval in EU  
Press Release | 2月 28. 2023 08:12 GMT

Final EU authorization of 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 Chr. Hansen’s HMOs lacto-N-tetraose (LNT),  3-fucosyllactose (3-FL) and 3’-sialyllactose (3’-SL), these three important Human Milk Oligosaccharides 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.  

“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,” says Jesper Sig Mathiasen, senior vice president, Chr. Hansen HMO.   

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 (all included in Chr. Hansen’s 5 HMO Mix together with 2’FL and 6’-SL) are identified in significant amount in breast milk.  

Health effects and research highlights  
Chr. Hansen’s team of scientists and other scientists continue unlocking more unique health benefits of HMOs. In relation to the three newly approved ones, early science shows:  

  • LNT: Contributes to the benefits of breastfeeding for infants (Walsh et al., 2020), and a well-balanced gut microbiome by helping to limit the growth of undesired microorganisms (Hill et al., 2021)
  • 3-FL: Increases in concentration over the course of lactation (Thum et al., 2021), and thereby becomes the most abundant HMO in human breast milk over time (Samuel et al., 2019; Thum et al., 2021) 
  • 3'-SL: Provides sialic acid, a nutrient that is needed for healthy development (Wang, 2012). It further interacts with immune cells, supporting their maturation and contributing to a balanced immune response (Triantis et al., 2018)   

Chr. Hansen's 5 HMO Mix
In addition to the newly approved LNT, 3-FL and 3’-SL, Chr. Hansen’s 5 HMO mix also includes 2’-FL, the most abundant HMO in breast milk of most women (Thum et al. 2021), and 6’-SL, which is expected to provide sialic acid and support immune system development (Wang et al. 2012 and Triantis et al. 2018).

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

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