Analyses of Bacillus cereus and cereulide toxin in infant formula

In recent weeks, health news has been marked by a wave of withdrawals and recalls of infant formula in many countries following the detection of a toxin called cereulide produced by Bacillus cereus.

To address this health issue, Phytocontrol laboratory supports manufacturers by carrying out cereulide toxin analysis in liquid, powdered and reconstituted milk.

Why is this toxin a concern?

Bacillus cereus is a bacterium present in the environment (soil, dust, raw materials) that can contaminate foodstuffs, including dairy-based preparations. Some strains produce cereulide, a toxin that is particularly heat-stable and difficult to eliminate even during preparation or reconstitution of milk. This toxin poses a major risk to infants.

Recent cases have shown that the toxin can be present both in an ingredient and in the product after reconstitution, which complicates its detection in the absence of specific analyses.

The regulatory framework

Bacillus cereus: Regulation (EU) 2073/2005 sets a process hygiene criterion for Bacillus cereus (presumptive) in powdered infant formula at 50 CFU/g.

Cereulide toxin: EFSA was requested to assess the risks associated with the presence of cereulide toxin in infant formula and to propose risk management criteria. It published its opinion on 2 February and lowered the ARfD to 0.014 µg/kg body weight for cereulide in infants. It concluded that cereulide concentrations in reconstituted (liquid) infant formula exceeding the thresholds below could lead to safety levels being exceeded:

• 0.054 µg/L for infant formula (stage 1)
• 0.1 µg/L for follow-on formula (stage 2)

The Phytocontrol solution

To address this issue, we support manufacturers and authorities in managing the Bacillus cereus risk and the presence of cereulide toxin in powdered and reconstituted milk.

Our LC-MS/MS analytical approach, adapted from ISO 18465:2017, guarantees excellent sensitivity, high robustness and an optimised turnaround time. We have also targeted limits of quantification lower than the regulatory requirements applicable to cereulide, reaching 0.020 µg/L for liquid and reconstituted milk.

In addition to analyses, we support you through audits aimed at updating your Food Safety Management Plan and HACCP approach, taking emerging risks into account.

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