Infant Formula: EU Cuts Safe Toxin Limit in Half Amid New Recalls

The European Food Safety Authority (EFSA) has halved the permitted limit for the toxin cereulide in infant formula. This decision triggered additional product recalls by French manufacturers. Cereulide—linked to vomiting and diarrhea—was found in ingredients supplied by a Chinese factory to major infant formula producers, including Nestlé, Danone, and Lactalis. Following detections across multiple countries, the European Commission requested EFSA’s scientific advice on a safe exposure threshold. EFSA proposed a new limit of 0.014 micrograms per kilogram of infant body weight. France adopted this level immediately, lowering its previous limit of 0.03 µg/kg. As a result, companies Popote and Vitagermine withdrew certain formulas yesterday morning. Recalls began in mid-December with Nestlé—the largest—and continued with Danone and Lactalis. Nestlé emphasized its zero-tolerance policy for cereulide and confirmed withdrawals even below the new limit. Danone and Nestlé welcomed EFSA’s guidance; Lactalis stated no further recalls are planned. French authorities identified Chinese firm Cabio Biotech as the producer of contaminated arachidonic acid (ARA) oil. While EFSA opinions are not legally binding, EU member states typically follow them when deciding on recalls or sales restrictions.