12 July, 2023
dsm-firmenich, the leading innovator in health, nutrition and beauty, today confirmed plans to expand its human milk oligosaccharide (HMO) portfolio in China with two new ingredient submissions to the China National Center for Food Safety Risk Assessment (CFSA) and National Health Committee (NHC). The company* has submitted Nutrition Fortifier (NF) dossiers for its GlyCare™ 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL) ingredients – joining the registration process of its 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) HMOs.
The HMO production strains of dsm-firmenich’s 3’-SL and 6’-SL have already received safety clearance confirmed by the Chinese Ministry of Agriculture and Rural Affairs (MARA) in September 2021. In the next stage, both 3’-SL and 6’-SL NF dossiers will go through a rigorous multi-phase regulatory assessment by CFSA to achieve food additive registration for early life nutrition (ELN) use in China. This development follows the 2021 submission of dsm-firmenich’s 2’-FL and LNnT HMOs as food additives for infant nutrition in China, which are now in the final stages of the food additive approval process.
“The authorization process in China is stringent and highly challenging to navigate, comprising multiple rounds of technical review by scientific and regulatory experts, as well as a rigorous approval process that safeguards the safety and benefit of nutrition fortifiers intended for infants and young children. We continue to take positive strides in the region – first with the favorable progression of our 2’-FL and LNnT nutrition fortifier regulatory submissions, and now the submission of 3’-SL and 6’-SL,” comments Annette Lau, Global Regulatory Affairs Manager ELN at dsm-firmenich.
“Successfully breaking into complex markets, like China, highlights our teams’ unmatched multidisciplinary teamwork, cross-regional approach, regulatory expertise and their unbreakable commitment to advancing the HMO space. This latest progress is set to create significant innovation opportunities in the early life nutrition landscape – and, ultimately, make the unique benefits of HMOs accessible to more infants and young children globally.”
HMOs are powerful emerging ingredients, and important components of human breast milk, that play fundamental roles in infant nutrition and health by supporting gut health, immune function and potentially cognitive development.1,2,3,4 dsm-firmenich has additional HMOs in the approvals system in China. As a pioneer in HMO research, development and manufacturing, the company continues to drive a new era in HMO innovation, with plans to expand its offering in the early life nutrition and dietary supplement categories across multiple regions worldwide. Currently, dsm-firmenich’s science-backed GlyCare™ HMO portfolio is available for use in more than 160 countries worldwide – leading in market access and the number of HMO approvals globally.
Discover more about the promising science-based benefits of HMOs and how dsm-firmenich’s industry-leading portfolio can elevate your offering. Visit "The Human Nutrition - Hmos for early life" website.
*Glycom A/S is ultimately controlled by DSM-Fimenich AG, registered in Kaiseraugst, Switzerland.
About dsm-firmenich
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.
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Forward-looking statements
This press release may contain forward-looking statements with respect to dsm-firmenich’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of dsm-firmenich and information currently available to the company. dsm-firmenich cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. dsm-firmenich has no obligation to update the statements contained in this press release, unless required by law. The English language version of this press release prevails over other language versions.
1. Sprenger N, Tytgat HLP, Binia A, Austin S, Singhal A. Biology of human milk oligosaccharides: From basic science to clinical evidence. J Hum Nutr Diet. 2022 Apr;35(2):280-299. doi: 10.1111/jhn.12990.
2. Puccio G, Alliet P, Cajozzo C, Janssens E, Corsello G, Sprenger N et al. (2017). Effects of infant formula with human milk oligosaccharides on growth and morbidity: a randomized multicenter trial. J Pediatr Gastroenterol Nutr 64(4):624-631. DOI:10.1097/MPG.0000000000001520.
3. Berger B, Porta N, Foata F, Grathwohl D, Delley M, Moine D, et al. (2020). Linking human milk oligosaccharides, infant fecal community types, and later risk to require antibiotics. mBio 11(2):e03196-19 [18pp]. DOI:10.1128/mBio.03196-19.
4. Vandenplas Y, Żołnowska M, Berni Canani R, Ludman S, Tengelyi Z, Moreno-Álvarez A, et al. (2022). Effects of an extensively hydrolyzed formula supplemented with two human milk oligosaccharides on growth, tolerability, safety and infection risk in infants with cow’s milk protein allergy: a randomized, multi-center trial (CINNAMON Study Investigator Group). Nutrients 14(3):530 [14pp]. DOI:10.3390/nu14030530.
