11.07.22
Royal DSM recently announced that its human-identical milk oligosaccharide (HMO), branded as GlyCare, has been approved for use in infant formula and nutritional supplements in Canada.
The company reports that it holds regulatory clearance for the highest number of HMO ingredients globally, and GlyCare 2-fucosyllactose (2FL) is the only HMO permitted for use in infant and toddler products in Canada, allowing more room for innovation for brands in the early life nutrition space.
Health Canada provided the company with an approval known colloquially as a ‘letter of no objection’ for GlyCare 2FL HMO, confirming its acceptance for use in infant formulas and nutritional supplements for toddlers between the ages of one and three.
The department assessed the oligosaccharide according to its Guidelines for Safety Assessment of Novel Foods, concluding there are no allergy concerns associated with the ingredient and “there are no differences in the nutritional value of this 2FL carbohydrate compared to other carbohydrates available for consumption.”
HMOs are the third-most abundant solid component naturally found in human milk after lipids and lactose. They have been evidenced to play a role in immune support and gut health, and emerging research suggests they may also play a role in brain and cognitive development, according to DSM.
At present, six of DSM’s HMO ingredients have been approved as new food and supplement ingredients in the European Union, United Kingdom, United States, Russia, Israel, and Singapore.
DSM holds the only authorization of the oligosaccharides LNT, 6SL, 3SL, as well as a mixture product 2FL/DFL, in the European Union. It 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 and a final decision is expected to take place in six to 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.”
“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.”
The company reports that it holds regulatory clearance for the highest number of HMO ingredients globally, and GlyCare 2-fucosyllactose (2FL) is the only HMO permitted for use in infant and toddler products in Canada, allowing more room for innovation for brands in the early life nutrition space.
Health Canada provided the company with an approval known colloquially as a ‘letter of no objection’ for GlyCare 2FL HMO, confirming its acceptance for use in infant formulas and nutritional supplements for toddlers between the ages of one and three.
The department assessed the oligosaccharide according to its Guidelines for Safety Assessment of Novel Foods, concluding there are no allergy concerns associated with the ingredient and “there are no differences in the nutritional value of this 2FL carbohydrate compared to other carbohydrates available for consumption.”
HMOs are the third-most abundant solid component naturally found in human milk after lipids and lactose. They have been evidenced to play a role in immune support and gut health, and emerging research suggests they may also play a role in brain and cognitive development, according to DSM.
At present, six of DSM’s HMO ingredients have been approved as new food and supplement ingredients in the European Union, United Kingdom, United States, Russia, Israel, and Singapore.
DSM holds the only authorization of the oligosaccharides LNT, 6SL, 3SL, as well as a mixture product 2FL/DFL, in the European Union. It 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 and a final decision is expected to take place in six to 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.”
“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.”
