At the request of the EU, Europe’s food safety regulator is set to establish safety thresholds for cereulide toxin, linked to the ongoing global baby formula recall.
The European Food Safety Authority (EFSA) announced plans to establish an “acute reference dose for cereulide in infants,” as instructed by the European Commission. Concurrently, the EFSA is tasked with gathering data on “typical and higher-end consumption levels” of infant formula. This effort aligns with a coordinated response to the recalls, involving the European Centre for Disease Prevention and Control (ECDC) and the European Commission.
EFSA intends to publish its findings on these requests by February 2. Cereulide, a toxin associated with the Bacillus cereus bacteria, can lead to vomiting, abdominal cramps, and diarrhea in infants.
Nestlé initiated the recall in Europe in December following the detection of Bacillus cereus in some of its infant formula products. This recall later expanded globally in January after Nestlé identified cereulide toxin in arachidonic acid (ARA) oil sourced from an external supplier in China.
Following Nestlé’s actions, French companies Lactalis and Danone, along with several smaller baby formula producers, joined the recall notice. Additionally, French prosecutors in Angers and Bordeaux have opened investigations due to reports of two infant fatalities linked to the affected Nestlé formulas. The French Ministry of Health confirmed these investigations last week but emphasized that no evidence currently connects the formula consumed with the infants’ symptoms.
According to EFSA’s statement, the ECDC has received reports of diarrhea cases in infants after consuming the recalled products, though no severe cases have yet been confirmed. One documented case involved an infant who tested positive for the toxin and experienced vomiting and diarrhea but made a favorable recovery.
EFSA mentioned that the potential negative health effects are rated as low to moderate, particularly impacting younger infants, especially those under six months old. However, as products are withdrawn in many countries, the risk of further exposure is diminishing.
The ECDC is actively monitoring the situation and providing scientific guidance to support national investigations. Nestlé’s initial recall involved its NAN stage 1 formula but was later expanded to include select batches of SMA, SMA Alfamino, and Beba baby milk across more than 60 countries.
As of now, Nestlé has stated, “To our knowledge, based on information we have to date, no illnesses have been confirmed in connection with the products involved in the recall.”
Privately-owned Lactalis has also recalled specific batches of its Picot infant formula across 18 countries. Recently, Danone issued a recall of its infant formula produced in Ireland after previous withdrawals in Singapore at the request of local food safety authorities.
