3-FL is one of over 130 HMOs currently identified in human milk. These complex carbohydrates are indigestible and therefore function as a prebiotic by promoting early microbial colonization of the gut. This, in turn, provides benefits related to immunity, digestion and potentially cognitive health – benefits that begin in infancy but have a lifelong impact on human health.

This new safety study supports past research which indicated that commercially produced HMOs can mimic some of the health-promoting effects of the HMOs present in human milk. DuPont has been a pioneer in the field of HMOs and launched 2’-fucosyllactose (2’-FL) in 2018 under the name CARE4U™ for infant nutrition and dietary supplements. The important results of this current study help DuPont continue to build the framework for the upcoming launch of CARE4U™ 3-FL.

To investigate safety of this new ingredient for early life nutrition, 3-FL was produced 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. These are standardized testing protocols for all new ingredients.

The results showed that subchronic 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 weight of 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 Human Milk Oligosaccharides. “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.”