DSM’S HMO (2FL) gains regulatory approval for early life nutrition in Canada

Hørsholm, Denmark

Royal DSM, a global science-based company active in Health, Nutrition and Bioscience, today announced that its human-identical milk oligosaccharide (HMO) GlyCare™ 2’-fucosyllactose (2FL) has been approved in Canada for use in infant formula and nutritional supplements (toddler formula). DSM holds regulatory clearance for the highest number of HMO ingredients and markets globally and, GlyCare™ 2FL, as the only HMO permitted in both infant and toddler formula products in Canada, opens up new opportunities for early life nutrition brands to innovate and support the health and development of children worldwide. 

Following DSM’s submission for regulatory approval in 2021, Health Canada has issued a ‘letter of no objection’ for GlyCare™ 2FL HMO, confirming the acceptability for its use as an ingredient in infant formulas and nutritional supplements for toddlers aged one to three years of age. The department conducted a comprehensive assessment of the oligosaccharide according to its Guidelines for the Safety Assessment of Novel Foods. It concluded that ‘there are no allergy concerns associated with the 2FL ingredient’ and ‘there are no differences in the nutritional value of this 2FL carbohydrate compared to other carbohydrates available for consumption’ – making its inclusion safe in early life nutrition solutions. 

HMOs are the third most abundant solid component naturally found in human milk, after lipids and lactose. Growing evidence shows that HMOs have important immunity and gut health benefits and a potential role in brain and cognitive development – creating increasing demand for these ingredients in the early life nutrition space. With the widest portfolio of commercially available HMOs and the world’s only dedicated large-scale HMO production facility, DSM brings supply chain superiority and assurance of quality as a trusted source of HMOs for infants, children and adults. The new regulatory win adds to recent approvals that DSM has gained in several other important markets. At present, six of its HMO products have secured market authorization as new ingredients in foods and supplements in the European Union, United Kingdom, United States, Russia, Israel and Singapore. To date, DSM holds the exclusive authorization of LNT, 6SL, 3SL, as well as a 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. In addition, DSM is filing for approval of its 2FL and LNnT HMOs in China – this is progressing well, with a final decision estimated to take between six and nine months. 

“As a purpose-driven leader in the early life nutrition space, we’re committed to providing the best nutrition to all infants that don’t enjoy the privilege of being breast fed,” says Christoph Röhrig, Head of HMO Regulatory at DSM. “Breast milk is the gold standard for infant nutrition, so we strive to develop formulas that are as similar to breast milk in composition and functionality as possible. Not too long ago though, HMOs were only available to breast fed infants. Recent technological advances now allow for the development and addition of HMOs to infant and toddler formula products. The market for these bioactive compounds is fast growing, as their potential role in infant development and overall human health is becoming increasingly recognized.” 

Marta Miks, Senior Regulatory & Scientific Affairs Manager at DSM continues: “DSM already leads in the number of regulatory approvals for HMOs worldwide, but we’re thrilled by the recent approval of 2FL in Canada because it means that more infants can access the unique health benefits provided by these important ingredients. Our progress in this space doesn’t stop there though. We continue to advance scientific understanding of these unique ingredients through a rich program of preclinical and clinical studies, alongside a network of more than 40 research and strategic partners across the world.”

To learn more about DSM’s portfolio of next generation HMOs and the research behind these unique ingredients, visit: https://www.dsm.com/human-nutrition/en/products/hmos/hmos-for-early-life.html