After weeks of global alarm over recalls of contaminated infant formula from Nestlé and other brands, the European Food Safety Authority (EFSA) has completed its urgent scientific assessment in record time and set precise limits on the presence of cereulide in infant formula for the first time.
A fundamental step that will provide European authorities with clear and uniform criteria to decide when a product must be withdrawn from the market.
The affair of contaminated formula milk
For those who haven’t followed the story, let’s briefly recap what happened. Starting from December 2025, massive recalls of infant formula began in dozens of countries, mainly involving Nestlé products (Guigoz, Nidal, SMA, Beba, Alfamino brands), but also Lactalis (Picot) and, to a more limited extent, Danone. The cause was contamination by cereulide, a toxin produced by the bacterium Bacillus cereus.
The case has taken on a very serious tone in particular in France, where two newborns who had consumed Guigoz brand milk (produced by Nestlé) died. Both had experienced severe digestive disorders before their deaths. The French judicial authorities have opened two investigations to determine whether there is a causal link between the consumption of the contaminated milk and the deaths, but at the moment this link has not been definitively established.
The source of the contamination appears to be a Chinese supplier of ARA oil (arachidonic acid), an ingredient used in premium formulas to reproduce the composition of breast milk. The fact that this supplier simultaneously supplied several large manufacturers explains why the problem quickly spread on a global scale.
The urgent request from the European Commission
Faced with this health emergency involving multiple countries and millions of potentially exposed children, the European Commission asked EFSA to provide urgent scientific advice.
The underlying problem was that until then there was no official toxicological threshold for cereulide in newborns. In the absence of reference values, the recalls were based on the principle of maximum precaution, but there was a lack of objective and shared criteria to establish when a product should actually be recalled.
The Commission asked EFSA two specific questions: to establish an acute reference dose for cereulide in infants and to define the typical consumption levels of infant formula necessary to calculate actual exposure to the toxin.
And the new thresholds arrived in record time.
The new thresholds established by EFSA
In their rapid risk assessment, published on 2 February 2026, EFSA scientists have finally provided concrete answers.
The experts proposed a “DAR (acute reference dose, ARfD) of 0.014 μg/kg body weight for cereulide in infants”. Translated into simpler terms: this is the maximum amount of toxin that a newborn can ingest in a single exposure without suffering appreciable harmful effects.
To arrive at this value, scientists identified vomiting as “the most relevant acute adverse effect” and used sophisticated mathematical models. Furthermore, they took a particularly cautious approach:
Since very young infants (under 16 weeks) metabolize substances differently from adults, EFSA has adopted a conservative approach and added an additional safety factor in the definition of the DAR – reads the press release.
This means that the youngest children, those under four months old, were protected with an even greater safety margin, precisely because their bodies are more vulnerable and less capable of metabolizing toxins.
To calculate actual exposure to the toxin, EFSA had to establish how much formula infants normally consume. The authority confirmed precautionary values based on maximum consumption:
These values represent the highest quantities that infants usually drink, thus ensuring that the assessment remains prudential and protective.
By cross-referencing the acute reference dose with consumption levels, EFSA arrived at the concrete thresholds that risk managers were looking for. The authority concluded that cereulide concentrations in reconstituted milk (ready-to-drink milk) above 0.054 μg/L for formula (for the youngest infants) and 0.1 μg/L for follow-on formula may lead to safety levels being exceeded.
These numbers now represent the official benchmarks for the European Union. Products exceeding these concentrations must be withdrawn from the market as a public health precaution.
With this scientific opinion, EFSA has provided European Union Member States with the tools to manage future cereulide-related emergencies in a more effective and harmonized way. It’s not just about closing this specific crisis, but about building a more solid prevention system.
The new thresholds will allow us to rapidly identify dangerous products through laboratory analysis, establish objective and uniform criteria for recalls across Europe, avoid both overly prudent recalls and dangerous delays and consequently better protect newborns.
