The European Food Safety Authority (EFSA) published on February 2, 2026, a rapid risk assessment on cereulide — a toxin produced by Bacillus cereus bacteria — in response to global recalls of certain infant formulas following the detection of this substance in affected products. The goal is to support decision-makers in managing risks and to protect public health, especially those who are most vulnerable: infants.
What is cereulide and why does it matter
Cereulide is a heat-stable, emetic toxin produced by certain strains of Bacillus cereus, a bacterium commonly found in the environment and in various foods. This toxin can cause nausea, vomiting, and gastrointestinal discomfort in consumers, and in infants — due to their low body weight and developing immune system — the risks can be more serious.
The detection of cereulide has triggered recalls in more than 60 countries worldwide of various batches of infant formula produced by several manufacturers, including Nestlé, Danone, and Lactalis, as a precautionary measure.
Rapid risk assessment: key findings
Establishing a reference safety dose
EFSA has proposed an acute reference dose (ARfD) for cereulide in infants of 0.014 micrograms per kilogram of body weight. This represents the maximum amount that can be ingested over a short period (up to 24 hours) without a significant risk to health being expected.
This limit is considered protective, as it is derived through scientific analyses that include metabolic variability in infants under 16 weeks and the application of additional safety factors.
Filling a gap: why this assessment was necessary
Until recently, there was no clearly established threshold at the European Union level for cereulide concentrations in infant formulas. In the context of product recalls and growing concerns among authorities and parents, the European Commission requested that EFSA conduct an urgent assessment to help decision-makers determine when a product should be withdrawn from the market based on the actual health risk.
Exposure thresholds and recommendations
EFSA compared the ARfD with high-consumption scenarios for infant formula and identified levels of cereulide in the reconstituted liquid that could lead to exceeding the reference dose:
- >0.054 μg/L in infant formula
- >0.10 μg/L in follow-on formulas
These values help authorities determine when it is necessary to withdraw a product to protect consumers.
Messages for parents and authorities
• Parents and caregivers:
Recalled or potentially contaminated formulas should not be given to children. If digestive symptoms appear after consumption, prompt medical consultation is recommended.
• Public authorities:
EFSA’s assessment provides a solid scientific basis for decisions regarding product withdrawal and public communication on food safety.
Conclusion
The rapid risk assessment conducted by EFSA on cereulide in infant formulas provides an essential tool for protecting children’s health and for harmonizing food safety standards across the EU. In a context of international product recalls, this assessment helps clarify risk thresholds and supports informed decision-making by both authorities and manufacturers.
Source EFSA