Safety of infant milks: Contamination with cereulide. A commentary by ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology, and Nutrition).

Abstract

Since late 2025, precautionary recalls of specific infant and follow-on formula batches in Europe have occurred due to contamination with cereulide, a heat- and acid-stable emetic toxin produced by certain Bacillus cereus strains. Contamination was traced to arachidonic acid (ARA)-containing algal oil from a single supplier; no viable bacteria were detected in the affected products. The European Food Safety Authority established a conservative acute reference dose for infants, and available monitoring data indicate that detected concentrations were generally low and unlikely to pose significant health risks, although some batches may have exceeded precautionary thresholds. This commentary reviews the toxicological background, current risk assessment, analytical challenges, and clinical implications. While cereulide should not be present beyond unavoidable trace levels in infant formula, risk management must remain proportionate and avoid promoting nutritionally inadequate substitutes. Ensuring validated analytical surveillance, stringent raw material control, transparent communication, and continued provision of appropriately regulated formulas containing recommended long-chain polyunsaturated fatty acids, including docosahexaenoic acid (DHA) and ARA, is essential to safeguard infant health and maintain public confidence.