European Commission grants milk oligosaccharide ingredient Novel Food approval
The European Commission (EC) has granted Novel Food approval for 2’-fucosyllactose (2’-FL), a human milk oligosaccharide (HMO) ingredient for infant formula in the European market.
The European Commission (EC) has granted Novel Food approval for 2’-fucosyllactose (2’-FL), a human milk oligosaccharide (HMO) ingredient for infant formula in the European market. There are more than 100 HMOs found in human breast milk, with 2’-FL being the most abundant. HMOs are the third-most-abundant solid component in human milk, after fat and lactose, and these complex carbohydrates represent the largest compositional gap between human milk and infant formula. HMOs are believed to exert numerous important physiological functions for babies, including facilitating the establishment of a healthy microbiota, blocking the attachment of pathogens, and promoting immune-system development.
In 2015, the EC requested that the European Food Safety Authority (EFSA) carry out a risk assessment on the ingredient to determine if it could qualify for approval as a Novel Food. The EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) concluded that 2’-FL is safe for infants (up to one year of age) when added to infant and follow-on formulas, and when added to other foods at the uses and use levels proposed by the applicant.
In 2016, Inbiose and DuPont Nutrition & Health 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. 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.
DuPont press release