After weeks of alarm and recalls involving dozens of countries around the world, it is now the European Food Safety Authority (EFSA) that has officially intervened on the issue of infant formula contaminated by the cereulide toxin.
The European agency has not yet issued a definitive judgment on the risk, but clarified the health picture and announced the start of a crucial scientific evaluation which will serve to establish when and under what conditions contaminated products must be withdrawn from the market.
For those who have not followed the story, we remind you that the infant formula recalls began in December 2025 and, within a few weeks, involved dozens of countries in Europe and beyond. Those interested were several lots belonging to international brands – Nestlé first and foremost, but also Lactalis and, to a more limited extent, Danone – distributed through a global supply chain based on common suppliers of raw materials.
According to the information available so far, the problem appears to be linked to a single Chinese supplier of ARA oil, the arachidonic acid used in high-end formulas to reproduce the lipid composition of breast milk.
EFSA’s intervention
Weeks after the start of the first recalls, EFSA has released a communication that takes stock of the situation regarding food safety. The Authority clarifies the nature of the toxin involved, the possible effects on the health of newborns and, above all, explains which scientific steps are still necessary to define shared safety thresholds at European level.
EFSA reports that cereulide is a toxin produced by the bacterium Bacillus cereus which can cause sudden gastrointestinal symptoms. Complaints typically occur between 30 minutes and six hours after ingestion and include nausea, vomiting and stomach pain. In younger infants, however, the consequences can be more serious. The toxin can alter the body’s salt balance and lead to complications such as dehydration. Possible health effects are considered mild to moderate, but are highly dependent on the age of the child: newborns and children under six months are most at risk of developing severe symptoms.
A particularly critical aspect is that cereulide is a thermostable toxin, i.e. it is not inactivated by normal heating or preparation processes of infant formula. This means that, once present in the product, the risk cannot be eliminated at a domestic level.
ECDC has received reports of incidents of diarrhea in infants after consuming the recalled products. Investigations are ongoing in several countries and, so far, no serious cases directly attributed with certainty to this contamination have been reported. In France, two criminal investigations have been opened following the death of two newborns but the causal link with the contaminated milk is still being investigated by the judicial authorities.
In one documented case, an infant who consumed formula from a recalled batch tested positive for the toxin and developed vomiting and diarrhea, with a subsequent full recovery.
However, EFSA is keen to clarify an important aspect: vomiting and diarrhea in newborns are common symptoms that can be caused by many different factors, including viral infections such as norovirus. Not all cases of gastrointestinal disorders are therefore necessarily linked to milk contamination.
There are no official limits for cereulide
The central issue, underlined by the European Authority, is that there is currently no official toxicological threshold for cereulide. In the absence of a reference value, the recalls that have taken place so far are based on the maximum precaution principle.
Precisely to fill this gap, the European Commission has formally instructed EFSA to provide a scientific opinion that allows it to establish when the presence of the toxin represents a concrete risk to health and when the obligation to withdraw the products is triggered.
In particular, EFSA will:
This step is crucial because even relatively low concentrations of contaminant can result in significant exposure in younger children.
EFSA, ECDC and the European Commission are working in close coordination to ensure an effective response to this multi-country alert. ECDC is continuously monitoring the situation, providing scientific advice to national investigations and facilitating the timely exchange of information between Member States.
Information on actions taken on food safety is shared through the Rapid Alert System for Food and Feed (RASFF), the European Union platform dedicated to exchanging information on food-related risks.
Recommendations for parents
The European authority provides clear indications for those who find themselves facing this situation. The products recalled from the market must not be administered to infants or young children under any circumstances.
For infants who develop vomiting or diarrhea after consuming the infant formula included in the recall, ECDC recommends consulting a pediatrician immediately. If the symptoms are severe – for example in case of dehydration or persistent vomiting – you need to go to the emergency room. Gastrointestinal symptoms in newborns can quickly escalate into serious complications, regardless of the underlying cause.
Consumers must carefully follow the instructions and guidelines issued by national food safety authorities and verify the batch numbers of the products in their possession through official channels.
EFSA then highlights a positive fact: considering that the products have been recalled in many countries, the probability of further exposure to the toxin is progressively decreasing. Global recalls are limiting the circulation of contaminated batches and reducing the number of children potentially exposed.
However, what happened has highlighted the fragility of the global supply chain of ingredients for infant nutrition. When a single raw material supplier simultaneously supplies multiple large international brands, a problem at the source can quickly spread globally, making late or piecemeal recalls particularly dangerous.
With this intervention, EFSA does not close the emergency, but lays the scientific foundations to prevent similar crises from happening again, defining for the first time clear and harmonized criteria for the management of the risk linked to cereulide in newborns.
This scientific opinion will be fundamental to define more precise and uniform safety standards at European level. EFSA has announced that the document will be published on its website in the week starting 2 February 2026.
