More than just testing: A layered approach to risk management for Bacillus cereus cereulide toxin

29 January 2026 | Nick Byrd, Associate Director - Technical Services and Danielle Cawdron, Chief Chemist

Recent infant formula recalls have involved several products that may contain cereulide toxin, with the source being arachidonic acid (ARA) oil.

The recall underscores the need for vigilance at every stage of production – from raw ingredients through to finished products, with careful control and verification.

Bacillus cereus cereulide toxin

Bacillus cereus (B. cereus) is a bacterium responsible for a number of outbreaks of foodborne illnesses, through the production of a heat stable, emetic toxin – cereulide. Cereulide’s high resistance to heating processes, combined with its potential to cause vomiting and gastrointestinal distress, makes it a serious concern for infants, whose digestive systems are highly sensitive.

Also due to its stability, the toxin may still be present even when B. cereus can no longer be detected. The toxin can be present in both raw ingredients and finished formula, which is why a comprehensive safety strategy must cover the entire production chain.

When it comes to testing, full coverage must be ensured, examining both raw ingredients and finished products to make sure any contamination is caught before it reaches consumers.

Even seemingly lower risk materials could pose a risk and should therefore be considered for testing. Such an integrated approach forms a safety net to protect both infants and manufacturers from the potentially serious consequences of toxin exposure.

Sensitive, quantitative, accurate determination of cereulide

The most reliable way to confirm the safety of infant formula is through laboratory testing, which must use a highly sensitive method to detect even trace amounts of cereulide that could pose a risk.

We participated with nine other international laboratories in developing and validating a sensitive and quantitative LC-MS/MS procedure to determine cereulide in a wide range of foodstuffs in a European Committee for standardisation (CEN) sponsored validation study. The method was adopted in 2017 as ISO 18465:2017 (Microbiology of the food chain – Quantitative determination of the emetic toxin (cereulide) using LC-MS/MS).

How we can help – a lab that offers more than just testing

To implement a truly effective cereulide control programme, many manufacturers are now partnering with specialised laboratories that do more than just the analytical testing – these partners provide expert guidance on risk management, hygiene practices and process controls, helping businesses evaluate the vulnerability of raw materials, production environments and finished products. By leveraging such expertise, food business operators gain access to tailored strategies for reducing contamination risk, improving facility hygiene and ensuring regulatory compliance. All while maintaining confidence in test results.

Alongside accurate, sensitive cereulide testing, our experts can help with the food safety assurance of your end-to-end supply chain, including assessing levels of natural toxicants, allergens, potential contaminants, and more. Our end-to-end support also includes microbiology services, hygiene consultancy, process control, decontamination methods, food safety and quality management systems, incident management and root cause analysis.

For existing products, product development and exploring new ingredient / product categories and manufacturing processes, we can help with optimal risk reduction strategies. We can advise on your testing and methodology requirements for your specific situation and product, and can conduct product testing, either for routine analysis, or analysis in response to a challenge or for investigations / troubleshooting.

When it comes to hygiene and preventing contamination from the food processing / production environment, we can support with hygienic design, cleaning and environmental monitoring plans (EMP). We can visit your site to provide practical support with proactive initiatives and troubleshooting alike.

For pathogens of concern, we develop, validate and help implement effective decontamination methods into client facilities. We also support clients with process control design / review, implementation and validation – from a microbiological / decontamination perspective and more broadly.

A layered approach to risk management

Beyond testing and lab partnerships, manufacturers must adopt a layered approach to risk management.

Supplier audits, verification of ingredient quality, raw material testing, and proper storage protocols all help reduce the likelihood of bacterial growth in raw materials. During production, maintaining stringent environmental and hygiene controls, monitoring temperature and moisture, and adhering to standardised processing timelines further minimise risk.

Finally, testing finished products ensures that any contamination that may have occurred prior to, or during, processing is identified and addressed before the products leave the facility. Keeping detailed records of all these steps not only supports regulatory compliance but also enables traceability and swift action in the event of a potential recall.

The recent recalls serve as a reminder that food safety is not just a technical requirement, but a commitment to protecting the most vulnerable consumers.

Through careful sourcing, rigorous in-process control, comprehensive testing of both raw ingredients and finished products, and strong collaboration with knowledgeable laboratory partners, cereulide risk can be effectively managed.

By partnering with a trusted laboratory, manufacturers don’t just respond to risk – they anticipate it.

Combining expert guidance with robust testing and proactive risk management allows businesses to safeguard quality, maintain customer trust and stay ahead of regulatory expectations. Investing in such a partnership now can prevent costly recalls tomorrow, ensuring both safety and confidence in every batch that leaves your facility.

About Danielle Cawdron

Danielle Cawdron joined Campden BRI in 2009 as a technician in the Chemistry and Biochemistry department having graduated with a Master's degree in Chemistry.

Danielle’s current role is Chromatography. Her key area of responsibility is concerned with the potential chemical migration from food contact materials into their packaged goods.

Danielle supervises all aspects of analytical and consultancy work of the group and is the primary client liaison point for all enquires relating to global legislative compliance for food contact materials as well as the practical aspects of undertaking migration testing.

Bacillus cereus and cereulide toxin

If you work with materials or products associated with the risk of cereulide contamination, or are affected by the recalls discussed, we are here to help.