The EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) today delivered Scientific Opinions on lacto-N-neotetraose (LNnT) and 2'-O-fucosyllactose (2'-FL) as novel food ingredients (NFIs).
Glycom - a Danish firm that works to synthesize and commercialise human milk oligosaccharides - developed LNnT, a synthetic tetrasaccharide, and 2'-LT, a synthetic trisaccharide, primarily for use in infant and follow-on formula.
The NDA Panel - accepting the results of a Glycom clinical trial - confirmed the safety of 2'-FL and LNnT when added alone or in combination to infant, follow-on and young child formula.
"The Panel concludes that LNnT is safe for infants (up to one year of age) when added to infant and follow-on formula, in combination with 2'-FL, at concentration up to 0.6g/L of LNnT and 1.2g/L of 2'-FL," the NDA Panel wrote.
It added that LNnT and 2'-FL safe for young children (older than one year of age) when added to follow-on and young child formula in the same concentrations.
These limits, the NDA Panel added, are "within the range of intake levels from breast milk."
The NDA Panel Scientific Opinions, delivered at the request of the European Commission (EC) following NFI applications by Glycom, took into account information from a number of sources.
Information provided on potential mutagenicity lead the NDA Panel to conclude neither of the ingredients "raise safety concerns as regards the genotoxicity."
Based on the results of a 90-day toxicity study in rats, the NDA Panel further determined a "no adverse effect level" of 2,500 milligrams (mg) per kilogram (kg) of body weight for LNnT and a 2,000mg per kg limit for 2'-FL.
The results of a double-blind, randomized, controlled clinical trial on the effects of 2'-FL consumed in combination with LNnT in infants were also accepted by the NDA Panel.