EFSA after infant formula recalls: acute reference dose for cereulide of 0.014 µg/kg bw — risk above 0.054 µg/L in reconstituted infant formula
On 2 February 2026 the European Food Safety Authority (EFSA) published a rapid risk assessment of cereulide — a Bacillus cereus toxin detected in infant formulae from several manufacturers, which triggered recalls in many countries. The values are meant to help risk managers decide when to withdraw a product from the market.
- The assessment was prepared urgently at the request of the European Commission. Emesis was considered the critical acute effect; a study in adult Asian house shrews was judged most appropriate for benchmark dose modelling, giving a BMDL10 of 4.2 µg/kg body weight (a 10% increased risk of emesis).
- The acute reference dose (ARfD) of 0.014 µg/kg bw was derived by applying the default uncertainty factor of 100 and an additional factor of 3, because infants below 16 weeks of age metabolise and excrete foreign substances more slowly.
- For short-term exposure EFSA confirmed a high consumption value of 260 mL/kg bw for infant formula, and for follow-on formula used 140 mL/kg bw (95th percentile).
- The comparison shows that cereulide concentrations above 0.054 µg/L in reconstituted infant formula and above 0.1 µg/L in follow-on formula may lead to the ARfD being exceeded. According to EFSA, these values are intended to help EU risk managers determine when products should be withdrawn from the market as a precautionary measure.
Source: EFSA — EFSA provides rapid risk assessment on cereulide in infant formula (2.02.2026)