EFSA sets safety thresholds for cereulide in infant formula amid ongoing recalls

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The European Food Safety Authority (EFSA) has issued a rapid risk assessment on cereulide in infant formula, as precautionary recalls linked to the toxin continue across multiple countries.

Cereulide is produced by the bacterium Bacillus cereus and can cause acute gastrointestinal symptoms, including vomiting and diarrhoea. A number of infant nutrition products have been recalled since December 2025 as a preventive public health measure.

The assessment was requested by the European Commission, which asked EFSA to provide urgent scientific advice to support risk management decisions across the EU, including when products should be withdrawn from the market.

EFSA’s scientists have proposed an acute reference dose (ARfD) of 0.014 micrograms per kilogram of body weight for cereulide in infants. Vomiting was identified as the critical acute adverse effect and used to derive the ARfD through benchmark dose modelling.

Because infants under 16 weeks metabolise substances differently from adults, EFSA applied an additional safety factor to ensure a conservative level of protection.

For infant formula, EFSA confirmed that a consumption value of 260ml per kilogram of body weight remains appropriate for estimating short-term (24 hour) exposure. For follow-on formula, which is generally not consumed by infants younger than 16 weeks, a value of 140ml per kilogram of body weight was confirmed.

EFSA said these intake values reflect the higher end of typical consumption, ensuring the assessment remains precautionary.

By comparing the ARfD with these consumption values, EFSA concluded that cereulide concentrations in reconstituted formula above 0.054 micrograms per litre for infant formula, and 0.1 micrograms per litre for follow-on formula may lead to the ARfD being exceeded.

EFSA reiterated that recalled products should not be given to infants or young children, and consumers should follow instructions issued by national food safety authorities.

For infants who develop vomiting or diarrhoea after consuming affected products, the European Centre for Disease Prevention and Control (ECDC) advises seeking medical advice from a healthcare professional, such as a paediatrician.

In cases of severe symptoms, including dehydration or persistent vomiting, emergency medical care is recommended, as gastrointestinal illness in infants can rapidly lead to complications.