Publication of a toxicological study: a milestone for Jennewein Biotechnologie for the GRAS approval of the HMO-mix

Rheinbreitbach (ots) - Jennewein Biotechnology announces another milestone in
the Worldwide approval of a new product generation, the "HMO-Mix". The data of
the toxicological study, with the title "A Safety Evaluation of Mixed Human Milk
Oligosaccharides in Rats", was recently accepted for publication by the renowned
journal "Food and Chemical Toxicology".

After the EU Novel Food Dossier was submitted to the European Commission in
August 2019, the way is now clear for the GRAS (General Regarded As Safe)
decision at the US FDA.(Food and Drug Administration).

The study examined the tolerability of a mixture of human milk oligosaccharides
(HMOs) as a foodstuff. The HMO mix consists of the five most common HMOs
2'-fucosyllactose, 3-fucosyllactose, lacto-N-tetraose, 3'-sialyllactose and
6'-sialyllactose. The results show that the consumption of the HMO-Mix is well
tolerated and harmless, even in high doses. The study was carried out in
accordance with the internationally recognized OECD guidelines

Proof of the safety of the product was also a prerequisite for the "Growth and
Tolerance" study currently being carried out by Jennewein Biotechnologie. In
this study, baby food with the HMO Mix is being used in a concentration, such as
the individual HMOs that can also be found in breast milk. One aspect of this
clinical study is the evaluation of the positive effects of the HMOs on the gut
microbiome of the participating babies who consumed the baby food with HMOs,
compared to a control group that consumes conventional baby food or a group of
breastfed children.

"In 2015 Jennewein Biotechnologie introduced 2'-fucosyllactose onto the Infant
Food Market. With the commercialization of the 5 HMO Mix for baby food and its
use in natural concentration there is a revolution of the baby food market in
sight" said CEO Dr. Stefan Jennewein." By supplementing Infant Formula with HMOs
in their natural concentration, they can completely replace artificial
prebiotics such as GOS and FOS," Dr. Jennewein concludes

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 health and development. HMOs are prebiotics, 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 formulas around the
world now contain 2?-fucosyllactose (e.g. Abbott Similac).

About Jennewein Biotechnologie:

Jennewein Biotechnologie is a leading international industrial biotechnology
company with a range of products in the field of complex oligosaccharides (HMOs)
and rare monosaccharides.The company manufactures an extensive portfolio of
innovative HMO products, such as 2?-fucosyllactose, 3-fucosyllactose 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
The European Food Safety Authority (EFSA) under the Novel Food Regulation.

Contact:

For further information, please contact:
Dr. Bettina Gutierrez
bettina.gutierrez@jennewein-biotech.de
+49 22224 98810 797

Additional content: https://www.presseportal.de/pm/77411/4486968
OTS: Jennewein Biotechnologie GmbH

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