What is the EFSA cereulide guidance? Summary
- EFSA proposes new cereulide safety thresholds for infants and formula
- Recalls followed contamination concerns involving major infant formula manufacturers
- EFSA sets intake limit of 0.014 micrograms per kilogram
- New thresholds flag risks above specified levels in formula products
- Guidance offers regulators clarity on withdrawals and manufacturer compliance monitoring
Following two months of contamination worries and precautionary recalls, the European Food Safety Authority (EFSA) has stepped in with guidance. The agency is proposing maximum thresholds for the toxin cereulide in infants and in infant formula.
Infant formula contamination? Catch me up
Some of the biggest names in infant formula are facing severe disruptions amid concerns that their products are contaminated with cereulide – a toxin linked to nausea and vomiting.
Cereulide is produced by certain bacteria of the Bacillus cereus group. If the spores germinate, and the bacteria multiply, it can lead to the development of cereulide in food.
Nestlé, Danone and Lactalis are among those to have issued precautionary recalls, suggesting the contamination came from an arachidonic acid (ARA) oil supplier. ARA oil is added to infant formula to support brain and retina development.
The voluntary recalls have been just that – voluntary – because at a European level, no established safety limits exist. That means regulators and manufacturers have been unable to judge when low-level detections pose a risk. Until now.
Maximum safe intake in babies
In response to a request from the European Commission, EFSA has determined how much cereulide babies can safely consume in a short period of time. The safe level is known as the acute reference dose (ARfD).
The outcome? According to EFSA, infants should not consume more than 0.014 micrograms of cereulide per kilogram of body weight.
That estimate is based on earlier research, which allowed EFSA to calculate the dose of cereulide associated with a 10% increased risk of vomiting. The agency then applied safety margins, acknowledging that infants process chemicals more slowly than adults, to arrive at a safe intake level.
Infant formula and follow-on formula: new thresholds
How does this new limit translate to infant formula?
EFSA’s calculations suggest for infant formula, cereulide levels above 0.054 micrograms per litre could exceed the safe limit.
In follow-on formula, the threshold is 0.1 micrograms per litre.
Anything above these levels poses a risk of acute effects, such as vomiting, in infants.
These thresholds were calculated by applying the ARfD to the amount of formula babies typically consume in a day: 260 ml per kilogram of body weight for standard infant formula, and 140 ml per kilogram for follow-on formula.
Clarity for regulators and manufacturers at last
That no maximum threshold for cereulide has existed to date is an oversight, suggests leading microbiologist prof Monika Ehling-Schulz, who co-developed the ISO method for detecting the toxin almost a decade ago.
Just last week, the leading microbiologist was urging that maximum levels to be defined, conscious that without a regulatory standard, “no one can conclusively say what’s safe and isn’t safe”.
Now that EFSA has published new guidelines, EU risk managers will be able to more easily determine when products should be withdrawn from the market.
The new guidance also provides clarity for manufacturers, who conduct their own safety and quality checks before products go to market. It’s still unclear whether any company has breached these proposed limits, but we’ll be monitoring developments.
