Infant formula is among the most carefully regulated food products worldwide. Because it is intended for a particularly vulnerable population, maintaining strict ingredient quality and manufacturing controls is essential to protecting consumer health.
Recent food safety incidents in Europe have brought renewed attention to contamination risks in infant nutrition products. Between December 2025 and April 2026, several infant formula products were recalled across multiple countries following the detection of cereulide, a heat-stable toxin produced by certain strains of Bacillus cereus.
Investigations linked the contamination to arachidonic acid (ARA) oil used as an ingredient in affected products. On November 6, 2026, EU Member States approved a European Commission proposal to establish permanent food safety criteria for cereulide in infant formula, follow-on formula and certain foods for special medical purposes intended for infants.
Understanding the Cereulide Risk
Cereulide is a toxin produced by certain strains of Bacillus cereus. Unlike some microorganisms that can be controlled through conventional heat treatment, this toxin is highly resistant to heat and may remain active after pasteurization and sterilization.
This presents a significant challenge for infant food manufacturers. If contaminated ingredients enter the production process, conventional thermal processing may not be sufficient to eliminate the toxin.
The incident demonstrates that food safety management must extend beyond finished-product inspection. Ingredient quality, production hygiene and supplier controls are equally important.
Stronger Regulatory Requirements in Europe
The latest European regulatory initiative introduces a specific food safety criterion for cereulide in infant formula and related infant foods.
Under the approved proposal, the maximum criterion for dried products is set at 0.1 μg/kg. For liquid products, the applicable limit must be adjusted according to the manufacturer's reconstitution factor.
The designated analytical reference method is ISO 18465. The regulation will enter into force 20 days after its publication in the Official Journal of the European Union.
These developments highlight the increasing importance of scientific risk assessment, standardized analytical methods and consistent quality control throughout infant food production.
Three Priorities for Better Ingredient Management
For food manufacturers, the incident offers several important lessons.
1. Strengthen supplier qualification
Manufacturers should evaluate supplier production processes, quality management systems and historical compliance records, particularly when purchasing specialized ingredients.
2. Improve incoming material control
Raw materials should be assessed according to their potential hazards. Appropriate sampling, testing and documentation checks can help identify problems before ingredients enter production.
3. Maintain effective manufacturing hygiene and traceability
Proper temperature control, hygienic production conditions, batch identification and traceability are essential for preventing contamination and responding quickly when problems occur.
Choosing the Right Testing Technology
Different contaminants require different analytical methods. Testing strategies should be selected according to the target substance, food matrix, required detection limit and applicable regulatory standards.
For cereulide in infant formula, ISO 18465 provides the designated reference analytical method based on liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
For other food safety targets, rapid test strips and ELISA kits can provide practical screening and laboratory analysis solutions when the intended target and sample matrix are covered by validated product specifications.
Selecting an appropriate method and following validated testing procedures are essential for obtaining reliable results.
Kwinbon: Supporting Food and Feed Quality Control
Beijing Kwinbon Technology Co., Ltd. specializes in immunodiagnostic technologies, developing rapid test strips and ELISA kits for food and feed safety applications.
Its product portfolio covers a variety of testing targets, including veterinary drug residues, mycotoxins, pesticides, food additives and food adulteration.
Through continuous product development, Kwinbon supports food manufacturers, laboratories and inspection organizations in monitoring relevant food safety risks and improving routine quality control.
The recent developments in infant formula safety reinforce an important principle: reliable food safety begins with responsible ingredient sourcing, effective manufacturing controls and appropriate analytical testing.
By strengthening these practices, food manufacturers can better protect consumers and build lasting confidence in their products.
Post time: Nov-12-2026