Safety clearance received for dsm-firmenich’s 2’-FL HMO ingredient

In a recent press release, dsm-firmenich declared that the company's 2’-FL HMO ingredient which utilizes Escherichia coli K-12 DH1 MDO strain for 2’-Fucosyllactose (2’-FL) production, received safety clearance from the Indonesia Biosafety Clearing House. The 2’-FL human milk oligosaccharide (HMO) ingredient is better known as Glycare 2FL 9000 and can be found in flavored liquid milk beverages.

The Indonesia Biosafety Clearing House also determined that the ingredient did not show any potential to cause allergies, is classified as a non-toxic substance, and is safe for consumption as a food ingredient. HMOs such as 2'FL are Important constituents in human breast milk and there is a growing body of research^1-4 showing that ingredients such as these may help with digestive health, immunity in infants, children, and adults, and gut microbiota support.

“This safety clearance is a significant step forward in dsm-firmenich’s mission to improve access to HMOs worldwide, with ingredients from our Glycare HMO portfolio now available for use in more than 165 countries,” said Elaine Tan, regulatory affairs manager for the Asia-Pacific team at dsm-firmenich.

“Emerging evidence shows a myriad of health benefits provided by HMOs in early life nutrition, through childhood and beyond,” said Anita Wichmann, lead expert in regulatory affairs for early life nutrition, medical nutrition and HMOs at dsm-firmenich. “The newly secured market access for Glycare 2FL 9000 opens new opportunities for innovators in Indonesia to harness these benefits in nutritional solutions that support the gut health of children and adults.”

References

1. Elison, E. et al. “Oral supplementation of healthy adults with 2′-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota.”British Journal of Nutrition, 2016, 116, no. 8: 1356-1368. DOI:10.1017/S0007114516003354
2. Bajic, D.; Wiens, F.; Wintergerst, E.; Deyaert, S.; Baudot, A.; Van den Abbeele, P. HMOs Exert Marked Bifidogenic Effects on Children’s Gut Microbiota Ex Vivo, Due to Age-Related Bifidobacterium Species Composition. Nutrients 2023, 15, 1701. https://doi.org/10.3390/nu15071701
3. Schalich, KM. et al. "A human milk oligosaccharide prevents intestinal inflammation in adulthood via modulating gut microbial metabolism." MBio 2024, 15, no.: e00298-24. https://doi.org/10.1128/mbio.00298-24
4. Bajic, D.; Wiens, F.; Wintergerst, E.; Deyaert, S.; Baudot, A.; Abbeele, P.V.d. HMOs Impact the Gut Microbiome of Children and Adults Starting from Low Predicted Daily Doses. Metabolites 2024, 14, 239. https://doi.org/10.3390/metabo14040239