At the request of the EU, Europe’s food-safety regulator plans to set safety thresholds for the cereulide toxin, which is at the root of the global baby formula recall.
The European Food Safety Authority (EFSA) said it will look to establish an “acute reference dose for cereulide in infants”, as instructed by the European Commission.
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At the same time, the EFSA has been asked to provide data on “typical and higher-end consumption levels” of infant formula as it coordinates a response to the recalls with the European Centre for Disease Prevention and Control (ECDC), and the EC.
EFSA added in a statement that it will aim to publish its response to those two requests on 2 February.
Cereulide, a toxin associated with the Bacillus cereus bacteria, can cause vomiting, abdominal cramps and diarrhoea in babies.
Nestlé initiated the recall in Europe in December after the detection of the Bacillus cereus bacteria in some of its infant-formula products.
It was then expanded worldwide early in January after Nestlé identified the presence of the cereulide toxin in an ingredient from an external supplier – arachidonic acid (ARA) oil, which was later linked to a source in China.
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By GlobalDataFrench peers Lactalis and Danone then joined the recall notice, along with a host of smaller baby formula producers.
Meanwhile, French prosecutors in Angers and Bordeaux have launched investigations after receiving reports that two infants had died from the consumption of the Nestlé formulas in question.
France’s Ministry of Health, Families, Autonomy and Persons with Disabilities, through its Health Crisis Centre, confirmed the investigations last week but said there was as yet no evidence of a link between the formula eaten by the babies and their symptoms.
According to the EFSA statement, the ECDC has received reports of diarrhoea in infants after being fed the recalled products, although no “severe” cases have been reported so far.
In one documented case, an infant who consumed formula from a recalled batch tested positive for the toxin and developed vomiting and diarrhoea, with a “favourable” recovery.
“The possible negative health effects are considered low to moderate and depend on the infant’s age, with neonates and infants under six months more at risk of severe disease,” the EFSA said. “As the products are being withdrawn and recalled in many countries, the likelihood of further exposure is decreasing.”
The ECDC is currently monitoring the situation and providing “scientific advice and guidance” to support national investigations.
Nestlé’s initial precautionary recall revolved around its Nan stage 1 formula but was expanded to select batches of SMA, SMA Alfamino and Beba baby milk earlier this month taking in more than 60 countries.
“To our knowledge, based on information we have to date, no illnesses have been confirmed in connection with the products involved in the recall,” a Nestlé spokesperson said last week.
Privately owned Lactalis has issued a recall for certain batches of its Picot infant formula encompassing 18 countries.
A week ago, Danone issued a European recall of infant-formula made at a site in Ireland after initially withdrawing product in Singapore at the request of the local food-safety regulator.
