EU Proposes Maximum Limits for Cereulide in Infant Formula
The European Commission is seeking feedback on a draft regulation that would set limits for cereulide toxin infant formulas. Cereulide is a heat-stable toxin produced by the microorganism Bacillus cereus that is able to survive pasteurization and typical food processing conditions.
The draft regulation would amend Regulation (EC) No. 2073/2005 on the microbiological criteria for foods to establish a Maximum Limit (ML) of 1 microgram per kilogram (µg/kg) cereulide in dried (powdered) infant formulas, follow-on formulas, and infant foods for special medical purposes. In liquid products, the ML should be adjusted by the manufacturer’s reconstitution factor to ensure compliance with the limit of 0.1 µg/kg in corresponding dried forms.
The European Commission is accepting public comments on the draft regulation through September 29, 2026.
Draft Regulation Responds to Global Food Safety Incident, Recalls
The draft regulation was prompted by a global food safety incident that occurred in early 2026, in which infant formula recalls spanning 99 countries were initiated due to potential cereulide toxin contamination. Affected products were produced by Nestlé, Danone, Lactalis Nutrition Santé, and other brands. The source of contamination was determined to be arachidonic acid oil (AHA oil) from a common Chinese supplier. The World Health Organization (WHO) reported that, in January and February of 2026, at least 144 suspected and confirmed cases of illness associated with cereulide-contaminated products were identified in ten countries.
Immediately following the global contamination event, the European Commission increased controls on imports of AHA oil from China used in the manufacture of infant formula. The European Food Safety Authority (EFSA) also established an acute reference dose (ARfD) for cereulide in infants and determined concentrations of the toxin in infant formula that pose a potential safety concern.
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