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Œ-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Œ‑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Œ-fucosyllactose onto the 
global baby food market in 2015, and several infant milk formulas around the 
world now contain 2Œ-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Œ‑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Œ-fucosyllactose in the 
USA. This was followed in 2017 by The European Food Safety Authority (EFSA) 
under the Novel Food Regulation.

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

Source: Jennewein Biotechnologie GmbH

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