On Monday 2 February, the European Food Safety Authority (EFSA) published a rapid assessment of the risks associated with the presence of cereulide, a bacterial toxin, in certain infant formulas recalled in several European Union countries.
This report was requested by the European Commission to inform risk management decisions at EU level. Cereulide is produced by the bacterium Bacillus cereus and can cause acute gastrointestinal effects.
EFSA scientists set an acute reference dose for infants at 0.014 micrograms (μg) per kilogram of body weight. EFSA adopted a cautious approach, taking into account the specific metabolism of infants under 16 weeks of age.
The French Ministry of Agriculture has announced that the threshold has been lowered to 0.014 μg, a higher level of safety than the threshold hitherto applied (0.03 μg per kilogram of body mass).
To estimate short-term exposure, EFSA confirmed a consumption of 260 ml of preparation per kilogram of body weight over 24 hours.
For ‘follow-on’ preparations (infant formulae intended for infants over the age of six months, also known as ‘second-age milk’, which gradually replace breast milk and are essential for a diversified diet), the value adopted is 140 ml per kilogram.
On this basis, EFSA believes that concentrations in excess of 0.054 micrograms per litre may pose a risk. For ‘follow-on’ preparations, the critical threshold is set at 0.1 micrograms per litre. The products subject to the recalls must not be consumed, EFSA stresses. In the event of vomiting or diarrhoea in an infant, it is recommended to seek medical advice. The aim of this assessment is to harmonise product withdrawal decisions across the European Union.
Further details: https://aeur.eu/f/kk0 (Original version in French by Lionel Changeur)