Toxicological Study on HMO-mix: A Milestone for Jennewein Biotechnologie for the GRAS Approval

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).