Infant Formulas in Europe Approved to Include a Human Milk Oligosaccharide Ingredient that Helps Close Gap between Human Breast Milk and Formula

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A new 2’-fucosyllactose (2’-FL) human milk oligosaccharide (HMO) ingredient for infant formula that is “fully identical to the 2’-FL HMO found in human milk” has, for the first time, been granted EU Novel Food regulatory approval for infant formulas in the European market. Two suppliers, DuPont Nutrition & Health (Geneva) and Inbiose (Ghent, Belgium), worked together to refine the technique for synthesizing the HMOs, and specifically the HMO 2’-fucosyllactose (2’-FL), so that these ingredients can be cost-efficient enough for commercialization.

HMOs are complex carbohydrates found in human breast milk. They are, in fact, the third-most-abundant component in breast milk after fat and lactose. HMOs represent the largest compositional gap between infant formula and human milk, which is considered the “gold standard for nourishing a baby’s growth,” the companies state. Of the more than 100 different HMOs found in human breast milk, 2’-FL is the most abundant and recent studies support its ability to help establish beneficial gut bacteria, like Bifidobacteria, in infants.

In 2016, DuPont and Inbiose entered into a joint development and licensing agreement for the exclusive rights to produce and commercialize a synthetically identical form of 2’-FL and other fucosylated HMOs for food applications. Previously, the companies state, HMOs were not available in large quantities from “extractive sources (e.g., cow’s milk),” and the few HMOs that could be chemically synthesized were too costly to produce on a large scale. In order to meet this need for large-scale HMO production, Inbiose developed a proprietary fermentation-based production method to produce specialty carbohydrates such as human milk oligosaccharides, which the companies say has now been developed to industrial levels.

The companies say that this development is significant because not ever mother is able to breastfeed. Thus, innovations in the large-scale production of HMOs can help to provide some of the health benefits-for example, helping to establish a healthy microbiota, blocking the attachment of pathogens, and providing immune development support, among others-associated with human breast milk [in infant formula], say the companies.

In the press announcement announcing the new infant formula Novel Food approval in the EU, Joeri Beauprez, chief science officer, Inbiose, explained that the company’s technology will allow for increased production of HMOs: “Our competency lies in the rapid development of cost-effective production methods for specialty carbohydrates. 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.”

Added Wim Soetaert, PhD, executive chairman, Inbiose: “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. Thanks to our successful collaboration with DuPont, our first HMO is now commercialized, with many others to come.”

DuPont, for its part, brings “decades of experience developing ingredients for infant formula” to the partnership. Said Steen Lyck, global business development leader, DuPont: “We will be the leading supplier of HMOs for infant nutrition and beyond. Our unique experience and capabilities give DuPont the ability to leverage synergies with multiple HMOs and probiotics; 2’-FL is just the beginning.” DuPont will market the ingredient under the name Care4U.

According to the companies, the ingredient is already approved for use in dietary supplements in the EU, with potential applications for digestive and immune health, as well.

The substantial equivalence dossier for 2’-FL was granted EU Novel Food approval in December 2017. Said Paul Tenning, regulatory affairs manager, EMEA, for DuPont in a press statement: “We are excited to be able to bring this important new ingredient for infants and children into the European market.”