Cereulide in infants: Efsa establishes acute reference dose

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The toxin, produced by the bacterium Bacillus cereus, has been found in various baby foods in several European countries

The acute reference dose (DAR) for cereulide toxin in infants is 0.014 μg/kg body weight, as proposed by scientists at the European Food Safety Authority (EFSA) in their opinion published on 2 February.

© Lucio Rossi for Efsa, Studio Valle Progettazioni, Art & Build, Manens -Tifs, Pool Engineering, Art Ambiente Risorse and Territorio

The document was drafted following a request from the European Commission for urgent scientific advice in light of recalls of various baby foods in several countries due to the discovery of a toxin produced by the bacterium Bacillus cereus. EFSA’s opinion will be used to support risk management decisions to be taken across the European Union.

To establish the DAR, EFSA scientists used reference dose modelling and considered emesis (vomiting) as the most relevant acute adverse effect.

The value per kilogram of body weight for estimating short-term exposure (24 hours) was 260 ml for infant formula and 140 ml for follow-on formula, based – according to EFSA in a note – on the “maximum amount that infants usually drink, so that the assessment remains precautionary”.

Scientists at the European Food Safety Authority then compared DAR with these consumption values, concluding that “cereulide concentrations in reconstituted infant formula (liquid) above 0.054 μg/L and 0.1 μg/L in follow-on formula may lead to safety levels being exceeded”.

For infants who develop vomiting or diarrhoea after consuming infant formula affected by the current recalls, the European Centre for Disease Prevention and Control (ECDC) recommends consulting a paediatrician or other similar healthcare professionals and, in case of severe symptoms such as dehydration or persistent vomiting, seeking emergency medical attention.

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