EU Assessment Confirms Safety of Isomalto-Oligosaccharide as a Novel Food

In a recent development, the European Food Safety Authority (EFSA) has conducted an evaluation regarding the safety of expanding the use of isomalto-oligosaccharide (IMO) as a novel food. The assessment, carried out by the EFSA Panel on Nutrition, Novel Foods, and Food Allergens (NDA), has provided valuable insights into the safety considerations associated with the utilization of IMO in the food industry.

On February 5, 2024, the EFSA released a scientific opinion based on their evaluation of the safety of isomalto-oligosaccharide as a novel food. Isomalto-oligosaccharide is a type of glucose oligomer with degrees of polymerization ranging from 3 to 9. The applicant intends to extend the current uses of IMO as an ingredient in various foods and incorporate it into food supplements targeting individuals above 10 years of age.

The evaluation conducted by the expert panel concluded that, under the proposed conditions of use, isomalto-oligosaccharide as a novel food is deemed safe. The applicant provided comprehensive information regarding the manufacturing process, composition, and specifications of IMO, which did not raise any safety concerns. Additionally, a tolerability study was conducted on adult volunteers, administering doses of up to 120g/day of IMO. The results of the study provided reassurance that IMO is well-tolerated at these doses.

Conservative intake estimates were calculated for the current authorized uses of IMO as well as the proposed new uses, including its incorporation into food supplements. The highest intake estimate for adolescents reached 112g/day at the 95th percentile, which slightly exceeds the demonstrated tolerability dose of 120g/day. However, considering the source, production process, and available nutritional and toxicological data, the expert panel concluded that the proposed conditions of use do not raise safety concerns.

The recent evaluation conducted by the EFSA NDA panel reaffirms the safety of isomalto-oligosaccharide as a novel food when used under the recommended conditions. This assessment provides valuable scientific insights for the European Commission and food industry stakeholders, assuring the general population that the expanded use of isomalto-oligosaccharide as a novel food is safe.

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