A quiet revolution in infant food safety unfolded in February 2026

EFSA Establishes an Acute Reference Dose for Cereulide in Infants

A quiet revolution in infant food safety unfolded in February 2026. The European Food Safety Authority (EFSA) published a landmark rapid risk assessment establishing the first-ever acute reference dose (ARfD) for careline in infants. This development follows multi-country recalls of infant formula products after detecting this bacterial toxin across multiple manufacturers.

Cereulide represents a heat-stable toxin produced by specific strains of Bacillus cereus bacteria. Unlike many food contaminants, heating does not destroy this toxin. It causes sudden nausea, vomiting, and abdominal pain within thirty minutes to six hours after ingestion. For vulnerable infants, these symptoms can rapidly lead to dehydration and electrolyte imbalances requiring medical intervention.

The European Commission requested EFSA’s urgent scientific advice to support risk management decisions across the European Union. National authorities needed clear guidance on when contaminated products warranted withdrawal from markets. EFSA responded with comprehensive toxicological evaluation and consumption data analysis, delivering critical thresholds that now guide regulatory action.

The Scientific Foundation of the Acute Reference Dose

EFSA’s scientists established an ARfD of 0.014 micrograms per kilogram of body weight for cereulide in infants . This value represents the amount of cereulide an infant can ingest within twenty-four hours without appreciable health risk.

The derivation process involved sophisticated toxicological modelling. Researchers identified emesis (vomiting) as the critical acute adverse effect for setting the ARfD. They used benchmark dose modelling on a study involving adult Asian house shrews, deriving a BMDL10 of 4.2 micrograms per kilogram body weight corresponding to a ten percent increased risk of vomiting .

From this point, EFSA applied multiple safety factors. The standard default uncertainty factor of 100 accounts for interspecies differences and human variability. Critically, EFSA added an additional safety factor of three specifically for infants below sixteen weeks. These youngest consumers metabolise substances differently from adults, with reduced xenobiotic metabolism and renal excretion capabilities requiring extra protection .

Consumption Values Underpinning the Assessment

EFSA confirmed appropriate consumption values for estimating acute exposure . For infant formula, a value of 260 millilitres per kilogram of body weight remains appropriate for twenty-four-hour exposure estimates. This figure represents the higher end of typical infant consumption, ensuring the assessment remains conservative and protective.

For follow-on formula, which infants generally consume after introducing complementary foods around six months, EFSA confirmed a value of 140 millilitres per kilogram of body weight for the same purpose . These values draw from EFSA’s comprehensive food consumption database, reflecting real-world feeding patterns across European populations.

Critical Concentration Thresholds

By comparing the ARfD with high consumption values, EFSA derived actionable concentration thresholds . Cereulide concentrations in reconstituted (liquid) infant formula above 0.054 micrograms per litre may lead to safe levels being exceeded. For follow-on formula, concentrations above 0.1 micrograms per litre trigger similar concern.

These thresholds provide European risk managers with clear scientific benchmarks for determining when products require withdrawal from markets as precautionary public health measures . National authorities now possess objective criteria for evaluating test results and making consistent regulatory decisions across member states.

The Context of Global Recalls

This scientific work responds to real-world crisis. Multi-country recalls of infant nutrition products began in December 2025 and continued through January 2026 after detecting cereulide in ingredients from common suppliers . Major manufacturers including Nestlé, Danone, and Lactalis initiated precautionary withdrawals across more than sixty countries .

The contamination originated in a raw material ingredient known as ARA oil, used extensively in infant formula production . Austrian authorities detected concerning concentrations in recent samples, with levels exceeding the newly established ARfD multiple times, prompting further recalls .

Tragically, French authorities have opened two criminal investigations following the deaths of two infants who consumed recalled formula. While investigators have not yet established causal links to cereulide, these events underscore the critical importance of robust food safety systems .

Public Health Implications

The health risks require careful communication. For infants developing vomiting or diarrhoea after consuming formula included in recalls, ECDC recommends seeking medical advice from healthcare professionals. Severe symptoms including dehydration or persistent vomiting warrant emergency department attention, as gastrointestinal symptoms in infants can rapidly lead to complications regardless of underlying cause .

Parents should follow instructions and guidance issued by national food safety authorities, ceasing use of recalled products immediately . Consumer organisations emphasise that clear, binding limits should ultimately become EU law, eliminating uncertainty in evaluating contaminants in food .

Integration with Food Safety Management Systems

Food safety management systems must now address these new thresholds. Organizations producing infant formula require robust processes controlling Bacillus cereus throughout supply chains. This includes raw material monitoring, environmental surveillance, and finished product testing aligned with the new safety criteria.

ISO 22000 provides the framework for systematic food safety management addressing hazards like cereulide. The standard’s risk-based approach requires organizations to identify potential hazards, determine acceptable levels, and implement controls preventing contamination. Certification against ISO 22000 demonstrates commitment to internationally recognized food safety practices.

For organizations navigating these complex requirements, Global Standards offers expert guidance. Our lead auditors certified from CQI IRQA approved bodies bring authoritative expertise to food safety management system implementation. The CQI IRQA certification represents global recognition of auditing excellence, ensuring our auditors possess current knowledge of standards and best practices.

We help organizations achieve ISO 22000 Certification through comprehensive support. Our approach integrates hazard analysis, prerequisite programs, and HACCP principles into cohesive management systems. We guide clients through gap analysis, documentation updates, and implementation verification. We ensure food safety controls align with current regulatory expectations including emerging requirements like cereulide thresholds.

The Role of Prerequisite Programs

Effective control of Bacillus cereus begins with robust prerequisite programs. These foundational conditions and activities maintain a hygienic environment throughout the food chain. For infant formula production, critical controls include raw material specifications, supplier approval programs, environmental monitoring, and sanitation procedures.

The updated ISO 22002-x:2025 series of prerequisite program standards provides detailed guidance for specific food chain sectors. These standards, now elevated from Technical Specifications to full International Standards, incorporate lessons learned from years of implementation while addressing emerging hazards including toxin-producing bacteria.

FSSC 22000 incorporates these prerequisite program standards alongside ISO 22000 requirements and additional scheme requirements. Organizations certified under this scheme demonstrate comprehensive food safety management aligned with GFSI benchmarking requirements.

Analytical Challenges and Solutions

Detecting cereulide at concentrations below 0.054 micrograms per litre presents analytical challenges. Laboratories require sensitive methods capable of quantifying such low levels reliably. Validated analytical techniques including LC-MS/MS enable accurate measurement, but not all laboratories possess this capability.

Food business operators must ensure their testing programmes utilize competent laboratories with appropriate analytical scope. This includes participation in proficiency testing schemes and adherence to international standards for laboratory competence.

Supply Chain Implications

The cereulide incident highlights supply chain vulnerability. Contamination originating in a single raw material ingredient affected multiple manufacturers across dozens of countries. This demonstrates how hazards propagate through interconnected food systems, requiring collaborative approaches to risk management.

Organizations must strengthen supplier approval and monitoring programmes. This includes auditing suppliers’ food safety management systems, verifying raw material testing, and maintaining clear specifications for hazard control. Contractual arrangements should clearly allocate responsibility for food safety and specify corrective actions when problems arise.

Regulatory Landscape Evolution

EFSA’s ARfD establishment represents a pivotal regulatory development. For the first time, a health-based guidance value exists specifically for cereulide in infants. This provides foundation for potential future binding limits under EU food safety legislation .

The European Commission requested this scientific advice explicitly to support risk management decisions. National authorities now apply these thresholds when evaluating test results and determining appropriate regulatory responses. Harmonised application across member states promotes consistent consumer protection and reduces trade disruption.

Future Directions

The scientific work continues. EFSA’s rapid risk assessment acknowledges uncertainties and data gaps requiring further research. Ongoing studies may refine the ARfD as additional toxicological data becomes available. Meanwhile, the precautionary approach embodied in the additional safety factor for young infants ensures protection while science advances.

Food safety management systems must remain adaptable to evolving scientific understanding. Organizations should monitor regulatory developments and adjust controls accordingly. Proactive engagement with emerging requirements positions organizations for compliance while demonstrating commitment to consumer protection.

ISO 22000 certification provides framework for this adaptability. The standard’s emphasis on continuous improvement and management review ensures systems evolve alongside scientific and regulatory developments. Organizations maintaining certification demonstrate ability to incorporate new requirements systematically.

Global Standards supports organizations through this evolution. Our CQI IRQA certified lead auditors understand both current requirements and emerging trends. We help clients interpret new scientific findings and translate them into practical control measures. Contact us today to discuss how we can support your food safety management journey. The safety of the most vulnerable consumers depends on robust systems and continuous vigilance.