INFORM April 2026

38 INFORM APRIL 2026 , VOL. 37, NO. 4

RAPID RISK ASSESSMENT ON ACUTE REFERENCE DOSE OF CEREULIDE IN INFANTS Regulatory Review features updates on regulatory matters concerning oils- and fats-related industries. European Food Safety Authority (EFSA)

• A high consumption value of 260 mL/kg body weight is considered the most appropriate for estimating acute exposure to cereulide via infant formulae (liquid). This is consistent with the previous recommendation of EFSA to assess dietary exposure of infants below 16 weeks of age. • When assessing acute exposure from follow-on formula (liquid), which are typically not consumed by infants below 16 weeks of age, a P95 consumption value of 140 mL/kg body weight is considered more realistic. • Cereulide concentrations above 0.054 μg/L and 0.1 μg/L in reconstituted infant formula and follow-on formula, respectively, may exceed the derived ARfD. This article is an excerpt from the EFSA Journal titled, “Rapid risk assessment on acute reference dose (ARfD) of cereulide in infants and information on acute consumption of infant formulae” and published here in accordance with the Creative Commons license.

and high consumption values derived in this rapid risk assessment, cereulide concentrations in final reconstituted infant formula above 0.054 μg/L may exceed the derived ARfD. For reconstituted follow on formula, cereulide concentrations above 0.1 μg/L may exceed the derived ARfD. An extensive literature search of toxicological data for cereulide in animals and humans as well as in vitro evidence and a review of previous assessments provided a basis to identify emesis as the critical effect. • BMD modelling of the data from the critical study resulted in a BMDL10 of 4.2 μg/kg bw for increased risk of emesis. • An ARfD of 0.014 μg/kg bw was established by applying the default UF of 100 and an additional UF of 3 to account for differences in xenobiotic metabolism and renal excretion between adults and infants.

The European Commission asked the European Food Safety Authority to urgently establish a scientific safety threshold, known as an acute reference dose (ARfD), to guide governments and producers on when products should be pulled from shelves. Recent detection of cereulide, a heat-stable emetic toxin produced by Bacillus cereus , in infant formula from multiple manufacturers have led to precautionary recalls across several European Union Member States. Given the heightened vulnerability of infants to this toxin and the absence of regulatory thresholds, it is critical that Member States have a scientifically established ARfD for cereulide to inform harmonized risk management decisions. Due to uncertainty regarding extraction of cereulide from powder formula with the current extraction protocols, these final considerations focus on liquid reconstituted formula. By calculating the ratio between the ARfD