Analysis of Bacillus cereus and cereulide toxin in infant formula

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

To address this health issue, the Phytocontrol laboratory is supporting manufacturers by analysing for the toxin cereulide in liquid, powdered and reconstituted milk.

Why is this toxin a cause for concern?

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

Recent cases have revealed that the toxin can be present in both the ingredient and the reconstituted product, making it difficult to detect without specific analyses.

Regulatory framework

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

Cereulide toxin: The EFSA was asked 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 for cereulide in infants to 0.014 µg/kg body weight. It concluded that cereulide concentrations in reconstituted infant formula (liquid) above the thresholds below could lead to safety levels being exceeded:

• 0.054 µg/L for infant formula (first-stage milk)
• 0.1 µg/L for follow-on formula (second-stage milk)
  
  

The Phytocontrol solution

In response to this issue, we support manufacturers, producers and authorities in controlling the risk of Bacillus cereus and the presence of the cereulide toxin in powdered and reconstituted milk.

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

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

Need technical, regulatory or pricing information? Our customer service team is available from 8:00 a.m. to 6:30 p.m. Monday to Friday.

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