Summary
- Cereulide has no established safety limits, leaving regulators and manufacturers unable to judge when low‑level detections pose a risk.
- Experts are urging regulators to set preliminary exposure thresholds, with EFSA now set to develop the first guidance for infants.
- The absence of clear limits has contributed to widespread infant formula recalls, as some countries default to zero‑tolerance policies.
A leading microbiologist is urging regulators to establish safety benchmarks for cereulide, the toxin behind an international infant formula recall.
Professor Monika Ehling-Schulz, who co-developed the ISO method for detecting cereulide, told us the toxin remains unregulated nearly a decade after the standard was published.
With no agreed‑upon exposure limits currently defined, food safety authorities and manufacturers cannot determine when cereulide levels become unsafe – particularly when contamination levels are low.
“The problem with cereulide is that we don’t have established reference doses that are considered safe,” she told us. “We haven’t defined what maximum levels could be tolerated in any type of food, particularly infant formula.”
This means that some countries default to a zero‑tolerance approach – triggering recalls even when the detected levels may be far below those ever linked to illness.
‘Low levels’ of exposure offer little clarity
In the ongoing infant formula recall, some recall notices reference ‘low levels’ of cereulide being detected – but in the absence of recognised maximum levels, it’s unclear what this signifies.
“Nobody knows what this ‘low’ concentration actually means, because the limit [for cereulide] has not been defined yet,” Ehling-Schulz said. “This is why this is a very unusual situation – no one can conclusively say what’s safe and isn’t safe.”
What needs to happen next is for regulators to set formal cereulide limits.
“It’s hard to comply with the rules if the rules do not exist,” Ehling-Schulz told us. “We really have to define the maximum levels for cereulide.”
These safety limits must be grounded in solid data, but with very few cereulide contamination events having occurred over the years, that evidence is sparse. And when cereulide has been detected in food, the levels have typically been high rather than low, meaning the toxin’s presence clearly posed a risk despite the lack of a benchmark.
“We have to start somewhere,” Ehling-Schulz insisted. “We should have sufficient data that we can start working to define the limits for cereulide. Now is the time – because we can see what happens [with the infant formula recalls] if we don’t have limits.”
We have to gather whatever is known from routine analysis or from incidents – put all data on the table – and then bring the relevant stakeholders together to establish science-based maximum levels for foods.
Dr Monika Ehling-Schulz
EU begins work on first‑ever cereulide thresholds
The wheels are in motion to define cereulide limits in the EU, Ehling-Schulz told us.
EFSA has secured a mandate by the European Commission to provide scientific advice on the contamination threshold above which products should be recalled.
The advice will be published on EFSA’s website next week (w/c February 2).
“I hope that a foundation will be established that provides better guidance for authorities, consumers, and industry – even if it’s based on a preliminary limit,” Ehling-Schulz said.
Danone, Nestlé facing $1bn+ combined losses - Barclays
Nestlé was the first company embroiled in what is now a multi-national, multi-company infant formula recall.
Shares of the Swiss major have tumbled nearly 8% since January 5, when the company launched its official public recall after it found cereulide from a third-party supplied ARA oil ingredient had contaminated some of its formula products.
The company recalled products in more than 60 countries but played down fears of financial damage, stating that recalled batches represent less than 0.5% of its annual group sales.
But Barclays estimates losses could top 1 billion Swiss franks (around$1.29bn), with Danone facing a $100m hit.
Still, investors aren’t rushing to downgrade the two food majors; with Nestlé receiving a ‘neutral’ rating from Jefferies and Barclays, and Danone retaining its ‘buy’ rating from both JP Morgan and UBS.
