Growing global attention on Bacillus cereus and its emetic toxin, cereulide, is continuing to reshape the food safety landscape for infant nutrition manufacturers. Following a series of precautionary formula recalls across multiple EU Member States, the European Food Safety Authority (EFSA) has released a rapid risk assessment establishing the first-ever acute reference dose (ARfD) for cereulide in infants.
This update summarizes the implications for manufacturers, ingredient suppliers and brand owners as risk assessment expectations and scientific benchmarks continue to evolve.
New benchmark for cereulide risk management
EFSA has defined an ARfD of 0.014 μg/kg body weight, reflecting the heightened vulnerability of infants, particularly those under 16 weeks of age. This ARfD is grounded in benchmark dose modelling, with emesis identified as the critical endpoint, supported by in vivo toxicological data and human case evidence.
To ensure conservative protection of the most sensitive population, EFSA applied an overall uncertainty factor of 300 to account for interspecies variability, human variability and additional uncertainties related to infant susceptibility. This represents a significant new scientific reference point for exposure assessments within the EU risk assessment framework.
Consumption values driving exposure calculations
Infant consumption volumes vary substantially with age. EFSA's assessment relies on the latest EU menu dietary consumption data to estimate peak exposures.
Key consumption benchmarks:
- Infant formula (0–4 months): 260 mL/kg bw/day (P95) – representing the highest‑risk population
- Follow-on formula (4–12 months): 140 mL/kg bw/day (P95)
- Foods for special medical purposes (FSMPs): in the absence of dedicated consumption data, EFSA recommends applying the same age-specific intake levels as above
These values form the basis for determining cereulide concentrations at which acute exposure may exceed the ARfD.
Cereulide concentrations associated with potential ARfD exceedance
Using the new ARfD and age-specific formula consumption, EFSA has modelled cereulide concentrations in liquid, ready-to-consume formula at which acute exposure could exceed the ARfD:
- Infant formula: > 0.054 μg/L
- Follow-on formula: > 0.10 μg/L
These values provide a risk-based reference for exposure assessment, supporting manufacturers in evaluating ingredient sourcing and finished product safety.
Analytical and Ingredient Considerations
Recent investigations cited by EFSA have identified certain lipid ingredients, including arachidonic acid (ARA) oils, as potential contributing factors in contamination events. Given the toxin's thermostability and resistance to digestive breakdown, early detection and robust analytical verification are critical.
EFSA underscores two key points impacting laboratory surveillance:
- LC-MS/MS remains the reference method for cereulide quantification
- Extraction efficiency from powdered formula matrices may be limited without pre‑hydration, requiring method optimization to avoid underestimating contamination
These insights reinforce the need for enhanced vigilance at both ingredient and finished product stages.
What this means for industry
As scientific understanding of cereulide risks advances, manufacturers and suppliers should reassess existing control measures in light of EFSA's newly established ARfD and exposure modelling outcomes.
Recommended next actions
- Reevaluate internal specification limits using EFSA's ARfD-based exposure assessment approach
- Strengthen supplier approval processes, particularly for ingredients identified as potentially higher risk such as ARA oils.
- Verify that analytical methods can reliably detect cereulide at levels relevant to EFSA's exposure scenarios (around 0.05 μg/L in liquid matrices)
- Update HACCP plans to reflect emerging cereulide hazards and their unique stability characteristics
- Prepare for the potential incorporation of EFSA's conclusions into future EU guidance or national risk management measures.
- Implement robust environmental and product monitoring, incorporating B. cereus, qualitative identification of genetic hazard "ces" gene and cereulide toxin quantification
Supporting safe, high-quality infant nutrition
The publication of EFSA's ARfD marks a pivotal step in strengthening the scientific basis for cereulide risk assessment in Europe. As the scientific and regulatory environment continues to evolve, staying ahead of these developments is essential to protecting vulnerable consumers and maintaining brand trust.
If you would like further support, including our cereulide testing services (Infant and Baby Milk Formula Safety Testing | SGS), we are ready to assist.
For further information, please contact:
Anna Theil-Gangl
Global Head of Food Business Development
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