MRO Magazine

Jennewein Biotechnologie’s conclusion that its 2’-Fucosyllactose is GRAS for use in infant formula and toddler nutrition is accepted by US FDA

December 22, 2015
By Business Wire News


Jennewein Biotechnologie GmbH, today announces that it has received acknowledgement from the U.S. Food and Drug Administration (“FDA”) that it has no questions at this time regarding Jennewein’s conclusion that its biotechnological produced human milk oligosaccharide (HMO) 2’-Fucosyllactose is generally recognized as safe (“GRAS”) for use in Infant and Toddler nutrition. FDA based its notification (GRN 571) on information provided by Jennewein Biotechnologie as well as other information available to the FDA. Jennewein 2’-Fucosyllactose represents the very first HMO being produced by a bacterial fermentation process and entering the market in the US.

Besides the US FDA confirmed GRAS evaluation for use in Infant and Toddler nutrition; Jennewein Biotechnologie performed also two additional self-affirmed GRAS evaluation for its 2’-Fucosyllactose for us in General Nutrition and for us in Medical Nutrition and Dietary Supplements products.

“Receiving this positive acknowledgement from FDA regarding our GRAS notification represents a major milestone for our many years of HMO research. Interestingly our processing aid use for the production, the bacterium Escherichia coli was originally isolated from the feces of a healthy breast fed infant in 1885 by the German pediatrician Theodor Escherich while seeking underlying causes for the much higher survival rates of breastfed compared to formula-fed infants at that time. This research not only led to the isolation of E. coli but also to the discovery of the human milk oligosaccharides (including 2’-Fucosyllactose) in human milk and the recognition of beneficial microorganisms (microbiota). Our research comes full circle by using the very same organism for the production of the first biotechnological produced commercial HMO for use in infant formula” stated Stefan Jennewein.

About 2’-Fucosyllactse

2’-Fucosyllactose represents the most abundant human milk oligosaccharide (HMO). 2’-Fucosyllactose is however lacking in cow’s milk and therefore also in current infant formula. Several beneficial function have been attributed to 2’-Fucosyllactose, besides its prebiotic functions 2’-Fucosyllactose offers protection against infection by diarrhea-causing pathogens, attenuates inflammation, and promotes brain development in terms of learning and memory. These functional benefits underlie the great demand for 2’-Fucosyllactose as a functional ingredient in infant formula and therapeutic nutrition products. Thus far, the inclusion of 2’-Fucosyllactose into infant formula or other nutrition products was limited due to the lack of a scalable and cost effective production process.

About Jennewein Biotechnologie

Jennewein Biotechnologie is a leading company specializing in the development of novel production processes and the production of scarce functional monosaccharides and oligosaccharides for nutritional and pharmaceutical applications. The company produces human-milk-oligosaccharides for the use as functional food ingredients.


Further information can be found on the company website.

Jennewein Biotechnologie
Amélie Jennewein
Tel.: +49-(0)2224-989.4502