From Cereulide to Context

Why Food Safety Horizon Scanning Must Evolve

Why This Article, Why Now

This article was triggered by the recent cereulide contamination case associated with infant formula, not because cereulide itself is a new hazard, but because the event exposed a deeper, structural weakness in how food safety risks are identified.

The cereulide case demonstrated that risks can be scientifically foreseeable yet operationally invisible when horizon scanning relies primarily on keyword monitoring, named hazards, and static test expectations. The hazard existed in the scientific literature, but the context:  fat-based ingredients, upstream formation, heterogeneous powder matrices, and sampling limitations, was not systematically connected.

At PRODEEN, this gap is precisely what we set out to address. We believe the future of food safety lies not in monitoring more signals, but in reasoning combined with deep operational context. This article outlines how a next-generation, agentic architecture enables that shift and why no traditional horizon scanning solution is currently designed to do so.

The Limits of Traditional Horizon Scanning

Conventional horizon scanning approaches typically focus on:

• Monitoring known hazards and predefined keywords

• Reviewing external alerts, recalls, and publications

• Relying on expert interpretation to assess relevance

This model works when risks are already named and codified. It breaks down when:

• Hazards are discussed indirectly (e.g. toxin properties without explicit product references)

• Risk emerges from interactions between ingredients, processes, and testing strategies

• Scientific understanding advances faster than regulatory criteria or routine control programs

The cereulide case is emblematic of this limitation: the hazard was known, but its relevance to specific product designs and testing approaches was not automatically surfaced.

The PRODEEN Approach: From Signals to Reasoning

PRODEEN’s next-generation architecture moves beyond signal detection toward contextual risk reasoning.

Rather than asking:

“Is this hazard mentioned in recent alerts?”

The system asks:

“Given how this product is formulated, processed, sampled, and tested, does emerging knowledge imply a credible risk?”

To answer this, PRODEEN continuously connects:

• Internal context: formulations, ingredient functions, process steps, hold times, sampling designs, analytical methods

• External knowledge: scientific literature, regulatory communications, recall patterns, method development trends

• Domain logic: established principles from food science, microbiology, analytical chemistry, and sampling theory

This architecture is unique in that relevance is derived from reasoning, not keyword coincidence.

Logical Risk Gates: Making Foreseeability Systematic

At the heart of the PRODEEN platform are reusable logical risk gates — formalized expressions of expert judgment.

Examples include:

• Matrix–Hazard Compatibility: Do hazard properties (e.g. heat stability, lipophilicity) align with the product matrix?

• Process Persistence: Could the hazard form upstream or survive beyond final control steps?

• Sampling Representativeness: Is the sampling strategy capable of detecting localized or heterogeneous contamination?

• Method–Hazard Fit: Does testing target the hazard itself, or only a proxy?

• Consumer Exposure Alignment: Is verification aligned with how the product is actually consumed?

In the many past cases, it is proven that these gates converge to reveal a risk pathway even before a recall makes it explicit.

Alignment with Risk Governance Frameworks

This agentic, reasoning-based approach directly strengthens existing governance models. It expands HACCP and Codex concepts of reasonably foreseeable hazards by systematically linking scientific knowledge to real product contexts. Under ISO 22000, it operationalizes risk-based thinking and continual improvement through continuous reassessment of external and internal factors. From an enterprise risk management perspective, it converts weak technical signals into decision-relevant risk insights, enabling earlier escalation and more defensible governance.

A Provocation for the Testing, Inspection, and Certification Industry

The cereulide case also raises an uncomfortable but necessary question for the Testing, Inspection, and Certification (TIC) sector.

Verification against predefined standards remains essential. But when emerging risks are logically implied before they are formally codified, a purely reactive model risks lagging behind science.

PRODEEN’s architecture opens the door to a more proactive role for TIC organizations:

• Identifying where test strategies are misaligned with hazard properties

• Highlighting detection blind spots before incidents occur

• Contributing to earlier, evidence-based evolution of testing expectations

This is not about replacing independence or accreditation, but about elevating foresight as a shared responsibility.

From Cereulide to the Next Unknown Risk

The cereulide case will not be the last example of a known hazard becoming relevant in an unexpected way. As food systems grow more complex, the most consequential risks will increasingly be those that sit between disciplines, between ingredients, and between test methods.

PRODEEN was designed for this reality. By embedding scientific reasoning directly into horizon scanning, it enables organizations to move earlier, act with greater confidence, and demonstrate not just compliance but foresight.