EU authorities have determined the likelihood of exposure to baby formula contaminated with the cereulide toxin to be “low” following widespread recalls across Europe.
Manufacturers, including Nestlé, Danone and Lactalis, have withdrawn formula since December over the potential contamination with cereulide, a toxin linked to the bacterium Bacillus cereus that can cause vomiting, abdominal cramps and diarrhoea in babies.
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The European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) have issued a joint assessment, bringing together the latest epidemiological and microbiological evidence.
“The assessment concludes that, given the large-scale recalls, the current likelihood of exposure to contaminated infant formula is low,” the agencies said in a joint statement yesterday (19 February).
However, they warned “additional cases may still occur if recalled products remain in households rather than being returned.”
Investigators have traced the source of the toxin to an arachidonic acid (ARA) oil ingredients supplier in China.
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By GlobalDataThe first major recall was initiated by Nestlé in Europe in December, after cereulide was detected in some batches of its formula.
The Swiss group expanded the recall globally in January, when French rivals Lactalis and Danone, along with smaller producers, also pulled products from the market.
By 13 February, seven countries – Austria, Belgium, Denmark, France, Luxembourg, Spain and the UK – had reported cases under investigation involving infants with gastrointestinal symptoms after consuming infant formula products.
Investigations are ongoing to identify more cases and determine whether recalled or other batches of formula caused illness.
According to the joint EFSA-ECDC assessment, most reported cases involved “mild” gastrointestinal symptoms, though some infants were hospitalised for dehydration.
Experts caution that identifying and confirming cases is difficult because symptoms resemble common viral gastric infections and testing for cereulide is not routinely available in many clinical settings.
Nestlé, Lactalis and Danone are all under investigation by the Paris prosecutor’s office in connection with the cereulide-linked infant-formula recall. Smaller baby-powder makers Babybio – owned by Vitagermine – and La Marque en Moins are also being investigated.
All the firms could face fines if accusations against them are upheld, according to a statement issued last Friday (13 February).
France’s Ministry of Health, Families, Autonomy and Persons with Disabilities said in January it was aware of two deaths but had found no evidence linking the babies’ symptoms to the formula they consumed.
On 11 February, the same Ministry said three deaths had been reported, still with no causal link established.
In parallel, 24 families in France are taking legal action against the government over alleged failures in managing the recall, represented by lawyer Nathalie Goutaland. At least two families say their children suffered vomiting and diarrhoea after consuming Guigoz milk, a Nestlé-produced formula.
Meanwhile, the UK Health Security Agency said it has received 36 “clinical” notifications of children with symptoms consistent with cereulide toxin poisoning in connection with the global recall.
Following a request from the European Commission for a “rapid risk assessment,” EFSA issued advice on 2 February setting a threshold for cereulide at 0.014 micrograms per kilogram of body mass, matching the level established by France a week earlier. That led to further recalls of formula across the bloc.
