EFSA Conducts Rapid Risk Assessment of Cereulide in Infant Formula
The European Food Safety Authority (EFSA) has conducted a rapid risk assessment regarding cereulide, a toxin produced by the bacterium Bacillus cereus, found in various infant formula products. This assessment follows the detection of cereulide, which has led to recalls of these products in multiple countries.
Background of the Risk Assessment
The European Commission tasked the EFSA with providing a scientific opinion to evaluate the risks associated with cereulide in infant formula. Such assessments aim to support EU risk management decisions regarding food safety.
Key Findings from the EFSA Assessment
- Acute Reference Dose (ARfD): The EFSA established an ARfD of 0.014 μg/kg of body weight for infants. This value was determined based on the potential for vomiting, the critical acute adverse effect associated with cereulide.
- Consumption Values: For assessing acute exposure, the EFSA confirmed a consumption value of 260 ml per kilogram of body weight for infant formulas. For follow-on formulas, which are typically not consumed by infants under 16 weeks, the consumption value was set at 140 ml per kilogram.
Safety Thresholds for Cereulide
According to EFSA’s evaluation, cereulide concentrations exceeding certain thresholds in reconstituted infant formula may pose safety risks:
- 0.054 μg/L for standard infant formulas
- 0.1 μg/L for follow-on formulas
Public Health Recommendations
Pregnant women and infants should avoid consuming recalled products. Consumers are urged to adhere to guidance issued by national food safety authorities. In instances where infants exhibit vomiting or diarrhea after consuming recalled formulas, the European Centre for Disease Prevention and Control (ECDC) recommends consulting a healthcare professional. If symptoms are severe, such as persistent vomiting or dehydration, immediate medical attention should be sought.
Understanding the potential risks associated with cereulide is crucial for safeguarding infant health.
