The European Food Safety Authority (EFSA) has introduced acute safety thresholds for cereulide toxin concentrations in infant formula. This response follows a major global recall of several infant formula products contaminated with cereulide, a bacterial toxin known to cause vomiting and stomach discomfort shortly after consumption.
Risk Assessment Following Global Recalls
The recall originated after Nestlé detected cereulide in arachidonic acid (ARA) oil used in their formula, which led to precautionary recalls by other manufacturers such as Danone, Lactalis Nutrition Santé, and Hochdorf Swiss Nutrition AG. The contamination source has been traced to AHA oil supplied from China.
EFSA’s Safety Thresholds and Exposure Estimates
EFSA has set an acute reference dose (ARfD) of 0.014 micrograms per kilogram of body weight (μg/kg BW) for cereulide in infants. The organization confirmed consumption values of 260 milliliters per kilogram of body weight (mL/kg BW) for standard infant formulas and 140 mL/kg BW for follow-on formulas, which are typically not fed to infants younger than 16 weeks.
By correlating these consumption rates with the ARfD, EFSA determined that cereulide concentrations surpassing 0.054 μg per liter in infant formula and 0.1 μg per liter in follow-on formula may exceed safe exposure levels.
Health Reports and Ongoing Investigations
The UK Food Standards Agency verified cereulide presence in Nestlé and Danone products linked to the recall. European health authorities such as the European Centers for Disease Control have noted diarrhea cases in infants who consumed recalled formula, with at least one infant confirmed to have the toxin detected and has since recovered.
Although serious illness cases have not been conclusively associated with the contaminated formulas, French authorities are investigating two infant deaths involving recalled Nestlé and Lactalis products. Meanwhile, claims about connections between the contaminated formula and meningitis in the UK have been denied by both the manufacturer and health officials.
As of early February 2026, the UK Health Security Agency is investigating 36 cases exhibiting symptoms consistent with poisoning from the cereulide toxin.