By: Talking Nutrition Editors
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 continues to spearhead research in the field to advance the industry’s understanding of HMOs and their relevance for human health.
DSM 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’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 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.
DSM’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 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 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 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 has also achieved approval of LNT, 3SL and 6SL in Brazil, with pending approval of its 2FL and DFL HMOs.
To continue making HMOs available to a global audience, DSM 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’s pioneering approach in navigating the complex regulatory steps required to obtain safety clearance in China. However, progress does not stop here. Next, DSM 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.
DSM is an experienced, purpose-led partner with global expertise that understands specific regional and market needs. DSM 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 how DSM’s HMO portfolio can support your next innovation in the early life nutrition space:
28 November 2022
5 min read
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