EFSA Issues Rapid Risk Assessment on Cereulide in Infant Formula Amid Recalls

The European Food Safety Authority (EFSA) has conducted a rapid risk assessment in response to the detection of cereulide—a toxin produced by Bacillus cereus—in several infant formula products, prompting recalls across multiple countries. The European Commission requested this urgent scientific advice to support risk management decisions throughout the European Union.

EFSA's scientists have established an acute reference dose (ARfD) for cereulide in infants at 0.014 μg per kilogram of body weight. This threshold is based on the critical acute adverse effect of vomiting, determined through benchmark dose modeling. Given that infants under 16 weeks metabolize substances differently than adults, an additional safety factor was applied in setting the ARfD.

To estimate short-term exposure, EFSA confirmed that a consumption value of 260 mL per kilogram of body weight is appropriate for infant formula, while 140 mL per kilogram is suitable for follow-on formula, which is typically not consumed by infants younger than 16 weeks. These values represent the higher end of typical intake to ensure a conservative assessment.

Comparing the ARfD with these consumption values, EFSA concluded that cereulide concentrations exceeding 0.054 μg/L in reconstituted infant formula and 0.1 μg/L in follow-on formula may surpass safe levels.

Consumers are advised not to feed recalled products to infants or young children and to adhere to guidance from national food safety authorities. The European Centre for Disease Prevention and Control (ECDC) recommends seeking medical advice if infants develop vomiting or diarrhea after consuming recalled formula, especially if symptoms are severe, such as dehydration or persistent vomiting. Gastrointestinal symptoms in infants can quickly lead to complications, regardless of the cause.