3-FL demonstrates safe use for food and dietary supplements: Study

By Danielle Masterson contact

- Last updated on GMT

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Related tags: microbiome, Gut health, Infant formula, HMO, Prebiotic, Probiotics, Dupont

DuPont Nutrition & Biosciences continues its foray into digestive health by ramping up research on human milk oligosaccharides (HMOs).

The company recently published the results of its safety assessment on the biotechnologically-produced 3-Fucosyllactose (3-FL) HMO. 

3-FL is a highly abundant complex carbohydrate and is one of over 130 HMOs currently identified in human milk. They promote bacterial growth, especially bifidobacteria genus, in the gut, which helps improve metabolic activity, increase pathogen resistance and modulates immune responses. The antimicrobial protection and prebiotic functions of the product allow HMOs to be used in various applications, including infant formula and dietary supplements. 

The study 

Using standardized testing protocols for new ingredients, the research team tested the safety of this new ingredient for early life nutrition. Researchers produced 3-FL by fermentation and then assessed for acute oral toxicity, in vitro​ and in vivo​ of genetic toxicity, and included a sub chronic rodent feeding study. 


The results found that sub-chronic dietary exposure of rats to 3-FL did not produce any statistical or biologically relevant differences in growth, food intake or efficiency, clinical observations, or clinical or anatomic pathology changes. The evidence from these studies support the safe use of 3-FL produced using biotechnology as a nutritional ingredient in foods and dietary supplements.

“This is an important milestone for the launch of Care4U 3-FL, the next HMO from DuPont. A robust safety assessment has been completed for 3-FL demonstrating the safe use as a nutritional ingredient in foods,” ​said Ratna Mukherjea, Ph.D., technical fellow and global R&D leader for HMO. “We continue to innovate in Early Life Nutrition by providing ingredients such as HMOs and probiotics to support good nutrition in the First 1000 Days.”

HMO is one piece of DuPont’s digestive health puzzle 

This latest study props up past research which suggested that commercially-produced HMOs can replicate some of the health-promoting effects of the HMOs present in human milk. In 2018, DuPont launched 2’-fucosyllactose (2’-FL) in 2018 under the name CARE4U for infant nutrition and dietary supplements. 

DuPont is already a key player in probiotics, with an operation in Rochester, New York, the world’s largest probiotics fermentation plant. 

The HMO market 

According to Grandview Research, the global HMO market size was estimated at $19.3 million in 2019. As the industry works to manufacture a breastmilk substitute that’s as close to nature as possible, the market is expected to expand at a CAGR of 23% during the forecast period. 

Grandview points to increasing concerns among consumers regarding gut health and the growing consumption of dietary supplements​ as reasons behind the growth. 

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Source: Food and Chemical Toxicology
Vol 134, Dec 2019, 110818 https://doi.org/10.1016/j.fct.2019.110818
“Safety assessment of the biotechnologically produced human-identical milk oligosaccharide 3-Fucosyllactose (3-FL)”
Authors: J. Pitt et al.

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