Rapid risk assessment on acute reference dose (ARfD) of cereulide in infants and information on acute consumption of infant formulae

EFSA has received a request for a rapid risk assessment for cereulide from the European Commission. Cereulide is a heat-stable emetic toxin produced by <i>Bacillus cereus</i>, recently detected in infant formulae from multiple manufacturers. This led to precautionary recalls across several countries. EFSA was requested to determine the acute reference dose (ARfD) for cereulide in infants, based on available toxicological data, and provide information on the acute consumption of infant formulae from EFSA's food consumption database. From the available toxicological data, emesis was considered as the critical endpoint for the acute effects of cereulide. A study in adult Asian house shrews was considered as the most appropriate for benchmark dose (BMD) modelling, and a BMDL₁₀ of 4.2 μg/kg body weight (bw), corresponding to a 10% increased risk of emesis, was derived. An ARfD of 0.014 μg/kg bw was then derived by applying a default uncertainty factor (UF) of 100 and an additional UF of 3 for reduced xenobiotic metabolism and renal excretion in infants. Available consumption data confirmed EFSA's previous recommendation to use a high consumption value of 260 mL/kg bw for estimating acute exposure to cereulide via infant formulae. When assessing acute exposure from follow-on formulae, a P95 consumption value of 140 mL/kg bw was considered more appropriate. Cereulide concentrations above 0.054 μg/L and 0.1 μg/L in reconstituted infant formulae and follow-on formulae, respectively, may therefore exceed the derived ARfD.