dsm-firmenich has recently disclosed that its Escherichia coli K-12 DH1 MDO strain for 2’-Fucosyllactose (2’-FL) production has received safety clearance from the Indonesia Biosafety Clearing House. This approval secures market access for dsm-firmenich’s 2’-FL human milk oligosaccharide (HMO) ingredient, commercially known as GLYCARE® 2FL 9000 used in flavored liquid milk drinks for children aged 3 and older.[1]
The commission also found that dsm-firmenich’s 2’-FL ingredient does not show any potential to cause allergies, is classified as a non-toxic substance, and is safe for consumption as a food ingredient.
Elaine Tan, Regulatory Affairs Manager for APAC at dsm-firmenich said, “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.”
Anita Wichmann, Lead Expert in Regulatory Affairs for Early Life Nutrition, Medical Nutrition and HMOs at dsm-firmenich said, “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.”
Human milk oligosaccharides (HMOs) including 2’FL, are a key component of human breast milk—the gold standard for infant nutrition. A growing body of evidence demonstrates that these ingredients can support the gut microbiota, digestive health, and immunity of infants, children, and adults.[2],[3],[4],[5]
[1] In line with good manufacturing practice (GMP) levels (i.e. no minimum or maximum level).
[2] 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 116, no. 8 (2016): 1356-1368.
[3] Bajic, D. et al. “HMOs exert marked bifidogenic effects on children’s gut microbiota ex vivo, due to age-related Bifidobacterium species composition.” Nutrients 15, no. 7 (2023): 1701.
[4] Schalich, KM. et al. “A human milk oligosaccharide prevents intestinal inflammation in adulthood via modulating gut microbial metabolism.” MBio 15, no. 4 (2024): e00298-24.
[5] Bajic, D. et al. “HMOs Impact the Gut Microbiome of Children and Adults Starting from Low Predicted Daily Doses.” Metabolites 14, no. 4 (2024): 239.
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