Cereulide is a toxin produced by Bacillus cereus. It is heat and acid stable and therefore not eliminated by standard processing steps such as pasteurisation. In infant nutrition, where safety margins are extremely small, this creates a specific analytical and regulatory challenge.
Triskelion helps you detect cereulide with validated, defensible analysis. So you can demonstrate control with confidence.
Cereulide is an emetic toxin produced by certain strains of Bacillus cereus. Unlike the bacteria itself, the toxin remains stable under heat and acidic conditions. Once formed, it can persist through processing.
Routine microbiological testing does not necessarily detect the toxin. This means that a product may comply microbiologically while still containing cereulide.
For infant nutrition manufacturers, this matters. Infants are a vulnerable population, and regulatory scrutiny is high. Even suspicion of contamination can trigger investigations, recalls or reputational impact.
Targeted analytical testing is required to assess this risk properly.
Under Regulation (EC) No 178/2002, food business operators are responsible for placing only safe food on the market. For infant formula, additional specific compositional and safety requirements apply.
Although no harmonised EU maximum level is currently set specifically for cereulide, manufacturers are expected to assess foreseeable risks under their HACCP system and general safety obligations.
Authorities may expect documented risk assessments, validated methods and evidence of control when contamination is suspected.
Cereulide risk becomes relevant when:
Working with raw materials susceptible to Bacillus cereus contamination
Producing powdered infant formula or related dry blends
Investigating unexplained complaints such as vomiting incidents
Responding to elevated Bacillus cereus counts
Managing supplier changes or new sourcing regions
Without targeted testing, uncertainty remains. And uncertainty is difficult to defend.
Triskelion offers verified cereulide analysis for infant nutrition powders and related matrices, performed in our ISO 17025 accredited laboratory in Utrecht.
Our method is based on extraction in acetonitrile and analysis by LC MS MS according to ISO 18465.
LOQ: 0.03 µg/kg
LOD: 0.01 µg/kg
Verified recoveries between 90 and 120 percent
We provide clear, technically sound reporting suitable for internal decision making and external communication.
If needed, we support interpretation, documentation and communication towards authorities or customers.
Is routine microbiological testing sufficient?
Not always. Microbiological analysis detects the organism, not necessarily the toxin. Targeted analysis is required to assess cereulide presence directly.
Is cereulide regulated in the EU?
There is currently no harmonised maximum level, but general safety obligations apply. Manufacturers must assess foreseeable risks.
Can cereulide be destroyed by processing?
Cereulide is heat and acid stable and is not eliminated by standard pasteurisation processes.
We help you assess, measure and document cereulide risk in infant nutrition products and ingredients.
Contact us for intake, method details or a tailored proposal.
