DuPont Nutrition & Biosciences has published the results of its safety assessment on the biotechnologically produced human milk oligosaccharide (HMOs), 3-Fucolsyllactose (3-FL).
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 colonisation 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.
The results of this study will 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 standardised 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.