How is dsm-firmenich leading on global regulatory approvals for HMOs?

By:  Talking Nutrition Editors



  • HMOs are a vital component of human breast milk that play a fundamental role in infant health by potentially providing immune support, cognitive and gut health benefits.1–7
  • Powered by recent technological advancements and growing awareness of these unique ingredients, HMOs have been revolutionizing innovation in the early life nutrition market. dsm-firmenich has been at the forefront of developments in the space, infiltrating and expanding the HMO market on a global scale.
  • Read on to discover how recent advances led by dsm-firmenich’s expertise has driven the regulatory approval of HMOs in key markets worldwide and discover what steps the company is taking next to bring these important nutrients to children worldwide.

How are HMOs inspiring innovation in the early life nutrition market?

Breast milk is the gold standard in infant nutrition, providing ideal nourishment to support infants during the early stages of life. Human milk oligosaccharides (HMOs) comprise the third most abundant component of human milk after lipids and lactose.5,8,9 As our knowledge of the science of human milk evolves, so does infant formula, with the goal of bringing it closer to breast milk – both compositionally and functionally.

Expanding research from leading scientists in the field has revealed the potential benefits of HMOs in breastmilk and HMO-supplemented formulas. These benefits range from encouraging the growth of good bacteria in the gut, to promoting intestinal barrier health and supporting immune regulation.1–7 Together with leading clinical partners, universities and external labs, dsm-firmenich continues to spearhead research in the field to advance the industry’s understanding of HMOs and their relevance for human health.  

How has dsm-firmenich achieved approval for HMOs in Canada?

dsm-firmenich is at the forefront of advancements in the HMO field, supporting the research and development of these unique ingredients, while simultaneously providing end-to-end expertise to infiltrate HMOs into the global market. 

Most recently, dsm-firmenich’s HMO GlyCare™ 2’-fucosyllactose (2FL) has been approved in Canada for use in infant formula and nutritional supplements (toddler formula). At time of writing, this makes dsm-firmenich the only company to have obtained approval of 2FL in Canada, making the HMO and its unique health benefits accessible to infants and toddlers in the region. This great achievement is due to the company’s ability to navigate the regulatory and legal landscape worldwide and its strong commitment to make HMOs and their benefits accessible to all infants.

How is dsm-firmenich helping to shape the global HMO market?

dsm-firmenich’s goal is to promote healthier childhoods worldwide by making HMOs as widely accessible as possible. Through its science-backed GlyCare™ HMO portfolio – available for use in more than 160 countries – and customized solutions powered by expert services, the company is helping customers worldwide leverage the benefits of HMOs to launch purpose-led infant nutrition products.

With significant knowledge of different regulatory and legal landscapes worldwide, dsm-firmenich is leading the number of approvals on HMOs and is continuously expanding its global footprint to make HMOs easily available to partners across the world. Approval of 2FL in Canada is just the latest regulatory win for the company. 

Following the successful authorization of the first two manufactured HMOs, 2FL and lacto-N-neotetraose (LNnT) in several markets around the globe, dsm-firmenich has been striving towards the launch of difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose (3SL) and 6’-sialyllactose (6SL) on the global market too. At present, all six HMO products have secured market authorization as new ingredients in foods and supplements in six markets, including the European Union, United Kingdom, United States, Russia, Israel and Singapore. dsm-firmenich holds the exclusive authorization of LNT, 6SL, 3SL, and mixture product 2FL/DFL in the European Union and has market access of 2FL and exclusive market access for LNnT in Australia and New Zealand. This year dsm-firmenich has also achieved approval of LNT, 3SL and 6SL in Brazil, with pending approval of its 2FL and DFL HMOs.

What progress has dsm-firmenich made on regulatory approvals in China?

To continue making HMOs available to a global audience, dsm-firmenich is leading an effective strategy to drive forward the HMO approval process in China. To date, six of its HMO strains have received safety clearance from the Chinese Ministry of Agriculture and Rural Affairs (MARA). This was a pivotal milestone made possible by dsm-firmenich’s pioneering approach in navigating the complex regulatory steps required to obtain safety clearance in China. However, progress does not stop here. Next, dsm-firmenich will embark on a five-phase regulatory assessment of individual HMO ingredients by the China National Center for Food Safety Risk Assessment (CFSA). Completion of these steps is expected to take between six to nine months. 

How is dsm-firmenich supporting customers in the early life nutrition space?

dsm-firmenich is an experienced, purpose-led partner with global expertise that understands specific regional and market needs. dsm-firmenich brings supply chain superiority and offers a complete portfolio of nutritional ingredients and commercially available HMOs that meet the highest safety and quality requirements. We also provide customized solutions and support to help customers sustainably navigate the path to future product development.


Discover howdsm-firmenich’s HMO portfolio can support your next innovation in the early life nutrition space:

Published on

28 November 2022


5 min read

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1.     Lewis ZT, Totten SM, Smilowitz JT, Popovic M, Parker E, Lemay DG et al. Maternal fucosyltransferase 2 status affects the gut bifidobacterial communities of breastfed infants. Microbiome 2015; 3. doi:10.1186/s40168-015-0071-z.

2.     Korpela K, Salonen A, Hickman B, Kunz C, Sprenger N, Kukkonen K et al. Fucosylated oligosaccharides in mother’s milk alleviate the effects of caesarean birth on infant gut microbiota. Sci Rep 2018; 8: 13757.

3.     Smilowitz JT, Lebrilla CB, Mills DA, German JB, Freeman SL. Breast Milk Oligosaccharides: Structure-Function Relationships in the Neonate. Annu Rev Nutr 2014; 34: 143–169

4.     Chichlowski M, de Lartigue G, Bruce German J, Raybould HE, Mills DA. Bifidobacteria isolated from infants and cultured on human milk oligosaccharides affect intestinal epithelial function. J Pediatr Gastroenterol Nutr 2012; 55: 321–327.

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6.     Triantis V, Bode L, van Neerven RJJ. Immunological Effects of Human Milk Oligosaccharides. Front Pediatr 2018; 6. doi:10.3389/fped.2018.00190

7.     Plaza-Díaz J, Fontana L, Gil A. Human Milk Oligosaccharides and Immune System Development. Nutrients 2018; 10: 1038.

8.     Kunz C, Rudloff S, Baier W, Klein N, Strobel S. Oligosaccharides in Human Milk: Structural, Functional, and Metabolic Aspects. Annu Rev Nutr 2000; 20: 699–722.

9.     Carr LE, Virmani MD, Rosa F, Munblit D, Matazel KS, Elolimy AA et al. Role of Human Milk Bioactives on Infants’ Gut and Immune Health. Front Immunol 2021; 12. doi:10.3389/fimmu.2021.604080.

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