EFSA and ECDC rapid outbreak assessment on cereulide incident: likelihood of exposure low

Key scientific findings

Reported cases

As of 13 February 2026, seven countries (Austria, Belgium, Denmark, France, Luxembourg, Spain and the United Kingdom) had reported cases under investigation involving infants with gastrointestinal symptoms who had consumed infant formula products. Investigations are ongoing to further identify cases, and assess whether recalled batches or other batches of infant formula products may have been the vehicle of illness.

Clinical condition of affected children

The joint assessment indicates that most reported cases presented mild gastrointestinal symptoms, while hospitalisations due to dehydration have also been reported. Experts note that identifying and confirming cases can be challenging because symptoms may resemble common viral gastrointestinal infections and testing for cereulide in clinical samples is not routinely available in many settings.  

Background to the recall and current risk

In December 2025, food companies in multiple countries began recalling several infant formula products after cereulide was detected in batches of infant formula containing arachidonic acid (ARA) oil supplied by a producer in China. In February, recalls were expanded following the publication of EFSA’s assessment estimating safety levels of cereulide in infant formula products.

As a result of the large-scale control measures implemented in the EU, the likelihood of exposure to contaminated products has decreased and is considered low. However, additional cases may still occur if recalled products remain in households rather than being returned.

In terms of health impact, the assessment notes that cereulide intoxication normally presents with relatively mild symptoms, but infants (under six months) may be more vulnerable because they are more sensitive to dehydration and electrolyte disturbances. Overall, the ROA assesses the impact of exposure to the toxin as low to moderate, depending on the age of the child.

Advice to consumers

Recalled products should not be given to infants or young children and should be returned to the point of sale. Consumers are advised to follow the instructions and guidance issued by national food safety authorities.

It is important to be vigilant for symptoms of vomiting and diarrhoea in infants and young children, regardless of the underlying cause. The general recommendation is to seek professional medical advice if infants or young children develop persistent or severe gastrointestinal symptoms.

More information

• EFSA provides rapid risk assessment on cereulide in infant formula
• Precautionary global recall of infant nutrition products following detection of Bacillus cereus toxin