EU imposes new toxin threshold following worldwide infant formula recalls

04 February 2026

The European Food Safety Authority (EFSA) has introduced a new maximum safe daily intake level for cereulide, a toxin produced by Bacillus cereus. This decision follows recalls of infant formula in more than 60 countries. Cereulide can cause vomiting, nausea and diarrhoea, and can have important risks for young children.

Manufacturers Nestlé, Lactalis and Danone began recalling products only in January, after detecting traces of the toxin in December. The European Commission then asked EFSA to provide urgent scientific advice and propose a unified European safety threshold. EFSA has now set an “acute reference dose” for children under 16 weeks at 0.014 micrograms of cereulide per kilogram of body weight per day. France has already aligned its own national limit with this stricter threshold.

French authorities are investigating the deaths of two infants in January who had consumed Guigoz formula produced by Nestlé, even if contamination has not yet been confirmed to be linked with the recalled products in any case. Nestlé has identified arachidonic acid (ARA) oil as the source of contamination. French investigators are now focusing their search on a supplier based in China.