The European Food Safety Authority (EFSA) has established an acute reference dose (ARfD) for cereulide in infants and determined concentrations of the toxin in infant formula that poses a potential safety concern.

The rapid risk assessment was published in light of a global recall of infant formula products contaminated with cereulide, a toxin produced by the bacteria Bacillus cereus that can cause sudden nausea, vomiting, and stomach pain 30 minutes to six hours after ingestion. Beginning with Nestlé after the company found the toxin in arachidonic acid (ARA) oil used in its formula products, brands Danone, Lactalis Nutrition Santé, and Hochdorf Swiss Nutrition AG also issued precautionary recalls soon after. AHA oil originating from a supplier in China is the source of contamination.

EFSA Sets Safety Thresholds for Cereulide in Infant Formula

Responding to this large-scale food safety incident, EFSA proposed an ARfD of 0.014 micrograms per kilogram of bodyweight (μg/kg BW) for cereulide in infants based on the critical acute adverse effect of vomiting.

For infant formula, EFSA confirmed that a value of 260 milliliters (mL)/kg BW remains appropriate for estimating short-term (24-hour) exposure. For follow-on formula, which is typically not consumed by infants younger than 16 weeks, EFSA confirmed a value of 140 mL/kg BW.

By comparing the ARfD with these high consumption values, EFSA concluded that cereulide concentrations in reconstituted (liquid) infant formula above the following values may lead to safe levels being exceeded: 0.054 μg/liter (L) for infant formula and 0.1 μg/L for follow-on formula. 

The risk assessment can be read here.

Confirmed and Unconfirmed Illnesses from Cereulide-Tainted Formula

The UK Food Standards Agency (FSA) recently confirmed the presence of cereulide in Nestlé and Danone infant formula products. Investigations by the agency pointed to AHA oil sourced from a single supplier based in China as the cause of contamination.

The European Centers for Disease Control (ECDC) has received several reports of diarrhea in infants following consumption of recalled products. In one case, an infant who had consumed formula from a recalled batch tested positive for the toxin and developed vomiting and diarrhea. The infant is now recovered.

Although no cases of serious illness have been confirmed in association with recalled Nestlé, Danone, Lactalis, or Hochdorf formula products, the deaths of two infants who consumed recalled Nestlé and Lactalis products are under investigation by French authorities. “To date, no causal link has been scientifically established," said the French Health Ministry.

In the UK, a mother asserted that her hospitalized baby had contracted meningitis from the consumption of recalled Nestlé infant formula. Nestlé said it is "categoric that there is no link between the recall and meningitis" and that "cereulide does not cause or transmit meningitis.” The UK Health Security Agency (UKHSA) said there are no confirmed cases of foodborne illness associated with the recalled formula.