The EU has agreed to introduce permanent maximum limits for cereulide — a toxin linked to recent infant formula recalls — in infant formula, follow-on formula and foods for special medical purposes intended for infants.
The measure follows a cereulide contamination incident that triggered food alerts and product recalls across Europe between December 2025 and April 2026, the European Commission informed in a statement on Friday.
The contamination was linked to the use of arachidonic acid oil imported from China as an ingredient. Arachidonic acid is a fatty acid used in some infant nutrition products.
Cereulide is a toxin produced by some strains of the bacterium Bacillus cereus, and can end up in food when there are deficiencies in the production process.
Member states endorsed strict maximum safety limits for cereulide in both dried and liquid products after a scientific assessment by the European Food Safety Authority.
Checks to begin once regulation applies
Once the regulation starts to apply, the new limits will form the basis for checks by food businesses and authorities, the Commission said.
The regulation will enter into force 20 days after it is published in the EU’s Official Journal.
