Home Authority & Legal Europe: EU approves first infant milk formula ingredient by DuPont, Inbiose

Europe: EU approves first infant milk formula ingredient by DuPont, Inbiose

DuPont Nutrition & Health and Inbiose NV celebrated regulatory approval of their first human milk oligosaccharide (HMO) ingredient for infant formula in the European market.

HMOs, complex carbohydrates found in breast milk, are an important breakthrough innovation in infant formula, developing a product with more of the health benefits associated with human milk.

There are more than 100 HMOs found in human breast milk, with 2’-fucosyllactose (2’-FL) being the most abundant.

In 2016, the two companies announced a joint development and licensing agreement for the exclusive rights to produce and commercialize 2’-FL and other selected fucosylated HMOs for food applications.

“After many years of critical research and significant investment, we are delighted to see the first of our range of human milk oligosaccharides becoming commercially available, thus addressing a major gap in the nutritional composition of infant formula,” said Wim Soetaert, Inbiose executive chairman.

“Thanks to our successful collaboration with DuPont, our first HMO is now commercialized, with many others to come.”

2’-fucosyllactose, which will be marketed by DuPont under the brand name CARE4U, is already approved for use in dietary supplements, with potential applications related to digestion and immune health.

Producing and selling specialty carbohydrates

Until recently, complex carbohydrates such as HMOs were not available in larger quantities from extractive sources (e.g., cow’s milk), and the few that could be chemically synthesized were prohibitively expensive.

Inbiose developed a proprietary platform technology to produce specialty carbohydrates such as human milk oligosaccharides.

This fermentation-based production method has now been developed to industrial levels, allowing the large-scale production of 2’-FL that is fully identical to the 2’-FL HMO found in human milk.