Chr. Hansen HMOs get Novel Food approval in EU  

Chr. Hansen HMOs get Novel Food approval in EU  
Press Release | feb. 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.  


Chr. Hansen es una empresa global y diferenciada de biociencia que desarrolla soluciones con ingredientes naturales para las industrias de alimentación y nutrición, farmacéutica y agrícola. En Chr. Hansen, nos encontramos en una posición privilegiada para impulsar el cambio positivo mediante soluciones microbianas. Desde hace casi 150 años, trabajamos para facilitar la agricultura sostenible, alimentos mejores y una vida más sana para más personas de todo el mundo. Nuestras plataformas de tecnología microbiana y fermentativa, incluida nuestra amplia colección de unas 40.000 cepas microbianas, tienen potencial para marcar un antes y un después. Al satisfacer las necesidades de los clientes y las tendencias internacionales, seguimos revelando el poder de las bacterias beneficiosas para responder a dificultades globales, como el desperdicio de alimentos, la salud en el mundo y el uso excesivo de antibióticos y plaguicidas. Como empresa de biotecnología más sostenible del mundo, llegamos a más de mil millones de personas cada día. Con el respaldo de nuestro legado de innovación y curiosidad para impulsar la ciencia, nuestro propósito de cultivar un mundo mejor naturalmente, «Grow a better world. Naturally», está en la esencia de todo lo que hacemos.

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