Several European countries have reported possible illnesses in relation to a recall of contaminated infant formula.
Global recalls of formula products from Nestlé, Lactalis, Danone and others are ongoing following the detection of cereulide – a toxin produced by Bacillus cereus. The toxin can cause nausea, vomiting, and stomach pain, 30 minutes to six hours after ingestion. Cereulide was found in arachidonic acid (ARA) oil, a raw material from a Chinese supplier.
Cereulide toxin analysis in fecal samples is not part of routine diagnostics in clinical microbiological laboratories. Belgium is the only country that has reported positive fecal samples.
In Belgium, five infants have tested positive based on clinical samples. All of them consumed the recalled infant formula. Of these formula samples, three out of five were positive.
A moderate risk
Spain reported eight cases with vomiting and a history of consuming affected products. Five of them required hospitalization but no suspected cases have been lab-confirmed.
In France, of 11 hospitalized infants, five consumed recalled formula but this information is unknown for six cases. All infants have recovered and were sent home.
Danish authorities have received reports of infants who developed diarrhea following consumption of recalled products, but it is not known if there is any link between illness and the products. Samples have not been investigated for the presence of the toxin.
The Dutch Food and Consumer Product Safety Authority (NVWA) has received 11 reports of children who became ill after drinking infant formula. Swiss authorities said reports of illness have been received and they are trying to clarify if there is a connection with recalled products.
The UK Health Security Agency (UKHSA) previously said it was investigating 36 reports of illness connected to infant formula recalls. These reports are clinical notifications where children who have consumed recalled batches have symptoms consistent with cereulide toxin poisoning.
According to the European Centre for Disease Prevention and Control (ECDC), recalled products are widely distributed and the likelihood of exposure to a contaminated batch is moderate to high for infants drinking formula. The impact of exposure to the toxin and development of gastrointestinal symptoms is low to moderate depending on the age of the child.
The ECDC and the European Food Safety Authority (EFSA) are working on an outbreak assessment, which should be published later this month.
Specalised Nutrition Europe (SNE) welcomed the action thresholds for cereulide in infant formula, follow-on formula and foods for special medical purposes for infants and young children developed by EFSA.
The group, which represents the specialized nutrition sector, said it would support efforts to establish a uniform analytical methodology for detecting cereulide across EU countries.
Call for formula data and experts
In other news, the World Health Organization (WHO) and UN Food and Agriculture Organization (FAO) have issued a call for experts and data covering the microbiological risk assessment of powdered infant formula.
The Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) was asked to conduct a risk assessment on spore-forming pathogens, including Clostridium botulinum and Bacillus cereus, in powdered infant formula. The meeting will also estimate the burden of disease caused by pathogens and their toxins attributable to such formula as well as the prevalence and levels of contamination of formula with these pathogens from production to consumption.
FAO and WHO want scientists who can participate in this work. Selection of experts will begin on March 15 and will continue until enough qualified candidates are identified.
Data will be used in the development of scientific advice which will guide the revision of Codex documents. One request is for sampling plans and testing methods for monitoring spore-forming and environmental pathogens including bacterial toxins. The deadline for submission of relevant information is May 15, 2026.
