France Implements Stricter Cereulide Toxin Limits in Infant Formula Amid Global Recalls

France Tightens Infant Formula Regulations

France has announced new, more stringent limits on the acceptable level of cereulide toxin in infant formula. Effective January 31, the maximum permissible level of cereulide has been reduced to 0.014 micrograms per kilogram of body weight (µg/kg), a significant decrease from the previous limit of 0.03 µg/kg. This measure by the French farm ministry aims to enhance infant protection following a series of global product recalls and an ongoing investigation into infant deaths.

Global Recalls and Contamination Source

The decision by French authorities comes in the wake of extensive product recalls across more than 60 countries. Major infant formula manufacturers, including Nestlé, Danone, and Lactalis, have been impacted by the contamination concerns. The source of the contamination has been traced to a single compromised ingredient: arachidonic acid (ARA) oil, supplied by Chinese firm Cabio Biotech.

Cereulide, a toxin produced by the bacterium Bacillus cereus, can cause symptoms such as nausea, vomiting, and diarrhea. In young infants, it can also lead to changes in salt balance and dehydration.

Investigation into Infant Deaths and Regulatory Response

French authorities have initiated an investigation into the deaths of two infants in December and January who were suspected of having consumed contaminated powdered milk. While investigations are ongoing, no direct causal link between the deaths and the recalled products has been scientifically established at this stage. One of the infants, from Pessac, was reportedly fed with Nestlé's Guigoz brand formula.

The incident has highlighted a previous lack of a specific European Union threshold for cereulide in infant formula. The European Commission has since requested the European Food Safety Authority (EFSA) to establish a standard for cereulide in children's products, with an opinion expected on February 2, 2026. Consumer advocacy group Foodwatch filed a criminal complaint on January 29 on behalf of eight families, alleging delays in public warnings. Nestlé has stated that it acted responsibly and transparently, and that no medical reports have confirmed a link between illnesses and their products.

Impact and Future Outlook

The tightening of regulations in France, which anticipates new scientific recommendations, is expected to lead to further product withdrawals in the coming days. This event underscores the complexities of the global infant nutrition supply chain and the critical need for robust safety standards to protect vulnerable populations.