Considering multi-country recalls of infant formula products following the detection of cereulide, a toxin produced by some strains of Bacillus cereus, the European Food Safety Authority (EFSA) established the acute reference dose for cereulide in infants. On the basis of infant formula consumption, the EFSA also defined the cereulide concentrations in infant formula of potential safety concern. These data will help EU risk managers determine when products should be withdrawn from the market as precautionary health measure.