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Machine-translated versions are also available in all EU languages on the EFSA website
EFSA provides rapid risk assessment
Multi-country recalls of several infant formula products are ongoing following the detection of cereulide – a toxin produced by the bacterium Bacillus cereus. The European Commission asked EFSA to deliver urgent scientific advice to support risk management decisions across the EU.
In its rapid risk assessment, EFSA’s scientists established an acute reference dose (ARfD1) for cereulide in infants and established cereulide concentrations in infant formula of potential safety concern. This advice is intended to help EU risk managers determine when products should be withdrawn from the market as a precautionary public health measure.
Key scientific findings:
A health-based guidance value for infants
EFSA’s scientists proposed an ARfD of 0.014 μg/kg body weight for cereulide in infants. Emesis (vomiting) is the critical acute adverse effect used to set the ARfD, which was derived using benchmark dose modelling. Because very young infants (below 16 weeks) metabolise substances differently from adults, EFSA took a cautious approach and added an extra safety factor when setting an ARfD.
Consumption values used to estimate acute exposure
For infant formula, EFSA confirmed that a value of 260 mL per kilogram of body weight remains appropriate for estimating short-term (24-hour) exposure. For follow-on formula – which is generally not consumed by infants younger than 16 weeks – EFSA confirmed a value of 140 mL per kilogram of body weight for the same purpose. These values are based on the higher end of what infants typically drink, so that the assessment stays conservative.
Concentrations that may lead to exceedance of the ARfD
By comparing the ARfD with these high consumption values, EFSA concluded that cereulide concentrations in reconstituted (liquid) infant formula above:
· 0.054 μg/L for infant formula, and 
· 0.1 μg/L for follow-on formula, 
may lead to safe levels being exceeded.
Public health advice and recommendations
Recalled products should not be given to infants or young children. Consumers are advised to follow the instructions and guidance issued by national food safety authorities. 
For infants who develop vomiting or diarrhoea after consuming infant formula included in the recall, the European Centre for Disease Prevention and Control (ECDC) recommends seeking medical advice from a healthcare professional, such as a paediatrician, or, if the symptoms are severe (e.g., dehydration or persistent vomiting), at an emergency department. Gastrointestinal symptoms in infants can rapidly lead to complications, regardless of the underlying cause.
More information:
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