From contamination to recall: why proactive supplier oversight could reshape food safety in the supply chain

When cereulide contamination was found in a single raw material used across several of the world's largest infant formula manufacturers, the result was a recall spanning more than 60 countries. This article explores what happened, how a single supplier blind spot cascaded through a global supply chain, and why the incident is prompting a fundamental rethink of how the food and beverage industry approaches supplier oversight and proactive risk management. 

A single ingredient, a global crisis

The recall, which has now expanded to more than 60 countries and affected products from several of the world's largest infant nutrition manufacturers, stems from the contamination of a single raw material: arachidonic acid (ARA) oil. ARA is a fatty acid routinely added to infant formula to mirror the nutritional profile of human breast milk, and it is sourced from a relatively small number of specialist suppliers worldwide. 

Cereulide, a heat-stable toxin produced by certain strains of Bacillus cereus, was detected in ARA oil from a single supplier. Because that supplier's product was used across multiple manufacturers and brands, the contamination cascaded rapidly through the global infant formula supply chain. Health authorities across Europe have since reported cases of symptoms consistent with cereulide exposure in infants and the impact on parental confidence has been significant. EFSA has since published a rapid risk assessment establishing an acute reference dose for cereulide in infants, a threshold that did not previously exist. 

The scale of this recall underscores a structural reality that food safety professionals have long understood: in a globally consolidated supply chain, a single point of failure at the ingredient level can have consequences that are extraordinarily difficult to contain once a product has reached the market. 

The supplier blind spot 

For many food and beverage manufacturers, supplier quality management remains one of the most challenging aspects of their food safety programs. Internal production processes are typically well-documented and closely monitored through HACCP plans, environmental monitoring and routine testing. The challenge intensifies when control extends beyond the factory walls and into the supplier network, where visibility is often limited and assurance relies heavily on certificates of analysis, periodic audits, and trust. 

The infant formula crisis illustrates what happens when that trust is misplaced or when monitoring systems are insufficient to catch contamination before products enter production.The gap between contamination entering the supply chain and the first public recalls has prompted significant scrutiny from regulators and consumer advocacy groups, with questions raised about the speed and transparency of the response. 

Across the food and beverage industry, organisations are grappling with increasingly complex, globalised supply chains where a single ingredient may pass through multiple intermediaries before reaching the manufacturer. The more concentrated the supplier base for a critical ingredient, as is the case with ARA oil, the greater the systemic risk when something goes wrong. 

From reactive to proactive: rethinking food safety systems 

The traditional approach to food safety management tends to be reactive by design. Contamination is detected, a root cause analysis is conducted, corrective actions are implemented, and (in the worst cases) a recall is issued. Each of these steps is essential, but they all occur after the problem has already materialized. For a product as sensitive as infant formula, where the end consumer cannot advocate for themselves and where even mild illness can escalate quickly, the gap between contamination and detection carries a disproportionately high level of risk. 

What the industry increasingly needs is the ability to identify and act on risk signals earlier in the process. This means moving beyond periodic supplier audits and certificates of analysis toward continuous, data-driven supplier quality monitoring that can flag deviations, trend anomalies, and emerging risks in something closer to real time. 

Several elements are critical to making this shift. Supplier performance data, non-conformance records, audit findings, complaint trends, and incoming goods inspection results all contain early warning signals, but only if they are captured systematically and analysed together rather than sitting in separate systems or spreadsheets. When these data points are unified on a single platform, patterns become visible that would otherwise remain hidden. 

Traceability is equally fundamental. The ability to trace an ingredient from its origin through every stage of production to the finished product should be viewed as more than a tickbox exercise, but a way to help organisations mitigate upstream supplier risks. 

The regulatory landscape is shifting

Regulators are also responding. EFSA's rapid risk assessment on cereulide in infant formula has established a science-based threshold for when products should be withdrawn, a standard that simply did not exist before this crisis. This is likely to be a catalyst for tighter regulatory expectations around monitoring for cereulide and microbial toxin contamination more broadly. 

The regulatory direction of travel across Europe and globally is increasingly toward placing responsibility on manufacturers to demonstrate proactive risk management rather than simply reacting to incidents. The expectation is shifting from "can you prove this product is safe?" to "can you demonstrate that your systems are designed to prevent unsafe products from reaching the market in the first place?" 

For food safety and quality professionals, the infant formula recall is a stark reminder that supplier quality management deserves the same rigour, investment and strategic attention as internal quality management. The most robust HACCP plan in the world cannot compensate for a contaminated raw material that enters the facility undetected. 

Moving forward with confidence

The global infant formula recall will be studied and referenced for years to come, and rightly so. It has exposed vulnerabilities in global food supply chains that are not unique to infant nutrition, and it has reinforced the critical importance of robust, integrated quality and food safety management systems that extend beyond the factory floor and deep into the supplier network.