EFSA evaluates safety of human-identical milk oligosaccharides as novel foods

The European Food Safety Authority (EFSA) has just published its scientific and technical assistance report regarding the safety of human-identical milk oligosaccharides (HiMOs) as novel foods. This evaluation comes amid a notable increase in the approval of HiMOs, which has raised concerns about their concurrent use across various food products.    

HiMOs, which are chemically identical to the oligosaccharides present in human breast milk, have become increasingly popular due to their potential to replicate the beneficial effects of their natural counterparts, particularly in promoting healthy gut microbiota in infants. In recent years, there has been a significant rise in applications for HiMOs, which are produced either synthetically or through precision fermentation using microbial derivatives. Several HiMOs have already received authorization for use in a variety of products, including infant formula, follow-on formula, dairy-based foods and beverages, cereals and cereal bars, pasta dishes, specialized medical foods, and dietary supplements.    

The recent evaluation has prompted EFSA to raise two important points with the European Commission. First, the updated EFSA Dietary Exposure tool indicates higher intake estimates for HiMOs compared to older assessment methods, sometimes surpassing those from human milk. Second, the growing number of HiMO applications could lead to situations where multiple HiMOs are used concurrently in various foods. While individual HiMO intakes may not exceed those from human milk, the cumulative intake could surpass it. Therefore, EFSA highlights how it is essential to evaluate the authorized use of HiMOs and their combined intake holistically, potentially revising assessments to ensure safety and adequacy.    

To assess the safety of HiMOs, EFSA conducted a literature review to update the database on the concentrations of oligosaccharides in human milk. This review indicates that even when combining the highest levels of authorized HiMOs in infant formula, the total intake remains within the natural range found in breast milk. This conclusion was reached after careful consideration of the most exposed population groups, including infants and young children, where the highest projected daily intakes were calculated.    

In conclusion, the current assessment indicates that authorized HiMO intakes from various food products do not pose safety concerns. As the market for these compounds expands, EFSA will continue to adapt its methods to monitor the impact of HiMOs, ensuring that their increasing use aligns with health and safety standards across the European Union.      

 

Source:  

EFSA