Jennewein Biotechnologie obtains US-FDA GRAS status on alternative 2'-fucosyllactose fermentation strain

Rheinbreitbach (ots) - Jennewein Biotechnologie GmbH, Rheinbreitbach, the
leading manufacturer of human milk oligosaccharides (HMOs), announces that the
U.S. Food and Drug Administration (FDA) issued a "no question" response letter
to Jennewein's supplement of its GRAS Notice GRN571, thereby acknowledging that
the HMO 2'-fucosyllactose, a key ingredient in advanced baby formula, made by an
alternative bacterial production strain is also Generally Recognized As Safe
(GRAS).

In its November 6., 2016 response to GRN 571, FDA had no question on the safety
of 2'-fucosyllactose being produced by an Escherichia coli strain bearing a high
temperature induced lactase activity to remove residual lactose from the
manufacturing process. In their recent letter of November 08, 2019, FDA also had
no question regarding the safety of 2'-fucosyllactose being produced by an E.
coli strain that does not possess said high-temperature expressed lactase
activity. The letter responding to the supplement to GRN571 will be publicly
accessible at www.fda.gov/grasnoticeinventory.

The CEO of Jennewein Biotech, Stefan Jennewein, stated: "We are pleased by the
FDA's letter which provides Jennewein Biotech with an option to use different
bacterial strains in manufacturing and offering 2'-fucosyllactose in the US,
thereby securing supply of the US market with 2'-fucosyllactose at reasonable
costs for our customers".

About HMOs:

Human milk oligosaccharides (HMOs) are complex sugar molecules that are only
present in breast milk. Excluding water, they are the third most abundant
constituent of human milk after fats and lactose. More than 200 structurally
different HMOs have been identified.

The most abundant HMO is 2'-fucosyllactose, which is produced by about 80% of
all lactating mothers at concentrations of up to 3 g/L. Scientific studies have
shown that HMOs, and 2?fucosyllactose in particular, have a positive impact on
infant development. HMOs are prebiotic, i.e. they specifically promote the
growth of beneficial microorganisms, and at the same time they inhibit the
growth of pathogens by directly and indirectly preventing colonisation.
Jennewein Biotechnologie launched 2'-fucosyllactose onto the global baby food
market in 2015, and several infant milk formula around the world now contain
2'-fucosyllactose.

About Jennewein Biotechnologie:

Jennewein Biotechnologie is a leading international industrial biotechnology
company with a range of products in the field of human milk oligosaccharides
(HMOs) and rare monosaccharides such as L-Fucose and Sialic acid. The company
manufactures an extensive portfolio of innovative HMO products, such as
2'fucosyllactose, 3'-fucosyllactose, Lacto-N-neotetraose, and lacto-N-tetraose.
These rare sugars are used in the food industry (particularly infant milk
formulas), the pharmaceutical industry, and the cosmetic industry. The
manufacturing process involves state-of-the-art fermentation techniques. In
2015, the US Food and Drug Administration (FDA) granted Jennewein Biotechnologie
a license to market 2'-fucosyllactose in the USA. This was followed in 2017 by
European Union marketing authorisation under the Novel Food Regulation.

Contact:
Dr. Bettina Gutierrez
bettina.gutierrez@jennewein-biotech.de
+49 2224 98810 797

Additional content: https://www.presseportal.de/pm/77411/4449177
OTS: Jennewein Biotechnologie GmbH

Original-Content von: Jennewein Biotechnologie GmbH, übermittelt durch news aktuell