Scientific and technical assistance report on the evaluation of human‐identical milk oligosaccharides (HiMOs) as novel foods

Abstract

Abstract EFSA was asked by the European Commission to provide scientific and technical assistance on the evaluation of human‐identical milk oligosaccharides (HiMOs) as novel foods (NFs). In recent years, the number of authorisations of HiMOs as NFs has markedly increased, which may lead to situations of multiple concurrent uses. Since the safety assessment of HiMOs is based on the comparison with the ‘natural’ intake of human milk oligosaccharides (HMOs), i.e. the HMO intake from human milk in exclusively breastfed infants, a scoping literature review was outsourced to update the database of mean concentrations of single and total HMOs in human milk, and relevant HMO intakes were thus updated. It is noted that in infants up to 16 weeks of age exclusively fed with infant formula, when adding all the assessed HiMOs at their highest maximum use levels across production methods, the resulting highest daily intakes of single HiMOs and the sum of HiMOs are within the natural HMO intake range. These intakes were also estimated (DietEx) for the most exposed population groups (i.e., infants and young children) considering the highest maximum use levels in those food categories with the highest contribution to the overall HiMO intake (i.e., infant and follow‐on formulae, ready‐to‐eat meals, yoghurt and cow milk). The resulting highest P95 daily HiMO intakes were unlikely to be higher than the highest mean daily HMO intakes. However, any possible higher intake would not necessarily imply a safety concern since such natural intake estimates represent an upper end of average natural intakes. It can be concluded that currently there are no safety concerns resulting from the authorised or assessed HiMO intakes from their concurrent combined uses. Nonetheless, in consideration of the increased interest in the use of HiMOs as NFs, a simplified but realistic approach for the intake assessment is proposed in the case of new HiMOs or extensions of use of already authorised HiMOs.