DuPont and Inbiose infant formula HMO gains EU approval

DuPont and Inbiose infant formula HMO gains EU approval

The ingredient 2’-Fucosyllactose (2’-FL) is to be marketed by DuPont under the brand name CARE4U, having already been approved for use in dietary supplements.

DuPont have earmarked the HMO as a core ingredient in potential applications for the future that are related to digestion and immune health.

The substantial equivalence dossier for 2’-FL received EU Novel Food approval in December 2017,​” said Paul Tenning, DuPont’s regulatory affairs manager, EMEA.

We are excited to be able to bring this important new ingredient for infants and children into the European market.​”

2016 agreement

News of regulatory approval for 2’FL means the firms’ joint development and licensing agreement to produce and commercialise 2’-FL, agreed back in 2016 are on track.

This agreement, which also looks to develop other fucosylated HMOs, combines Inbiose’s carbohydrate production platform with DuPont’s industrial-scale fermentation facilities.

“After many years of research and 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 Professor Wim Soetaert, Inbiose’s executive chairman.

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

Cost-effective HMO production

HMOs are a group of unique oligosaccharides found in mother’s milk, with 2’-FL being the single most abundant HMO.

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

Inbiose, a Belgium-based biotechnology company, believe its fermentation-based production method is now industrial-level ready to produce 2’-FL that is identical to the 2’-FL HMO found in human milk.

Our competency lies in the rapid development of cost-effective production methods for specialty carbohydrates,​” said Joeri Beauprez, Inbiose CSO.

Through our platform technology, we will continue to excel in the production of such ingredients, making these ingredients and their health benefits available to society at large.​”

According to market research firm Innova, digestive/gut health was the primary claim associated with infant formula launches in 2015.

It was also featured in 58% of all launches in the market as the past five years have seen the use of prebiotics in infant formulas dramatically increase.

EFSA confirmation

The ball began rolling in 2015, after The European Food Safety Authority (EFSA) confirmed the safety of two synthetic oligosaccharides, opening the door for their use in infant and follow-on formula.

The EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) delivered Scientific Opinions on 2′-O-fucosyllactose (2′-FL)​ and lacto-N-neotetraose (LNnT)​ as novel food ingredients (NFIs).

Along with its purported prebiotic functions, 2’-FL is thought to offer protection against infection by diarrhoea-causing pathogens, ease inflammation, and promote brain function development that includes learning and memory abilities.