Kezzler and GS1 logos.

SMEs test new digital traceability model for FDA FSMA 204 compliance in Mexico

NORWAY – A new pilot initiative in Mexico is testing how smaller food businesses can meet stricter U.S. traceability requirements using global data standards and cloud-based infrastructure. 

 

Kezzler and GS1 Mexico have announced a joint program aimed at helping small and medium-sized enterprises (SMEs) comply with the U.S. Food and Drug Administration’s FSMA Section 204.

 

Pilot focused on regulatory readiness

 

The initiative targets businesses that supply or plan to supply products listed under the FDA’s Food Traceability List (FTL). These products fall under expanded record-keeping requirements designed to improve how food is tracked across supply chains.

 

Under the pilot, selected GS1 Mexico members will test a structured approach to capturing and sharing traceability data. The goal is to simplify how companies align with the rule, which requires firms to maintain detailed records of how food moves through production, processing, and distribution.

 

Alejandro Trejo of GS1 Mexico stated that traceability has shifted from a market-driven feature to a compliance requirement. He explained that while FSMA defines what data must be captured, GS1 standards provide a common system for implementing those requirements across different systems and trading partners.

 

Bridging the technology gap for SMEs

 

The program addresses a persistent challenge, many SMEs lack the internal systems needed to manage complex traceability data. The pilot introduces a shared infrastructure model, reducing the need for individual companies to invest heavily in standalone IT systems.

 

Frederic Clulow, General Manager for Kezzler in the U.S., said the collaboration is designed to make compliance more accessible. By centralizing data handling and interpretation, the system allows smaller companies to participate in digital supply chains without building their own end-to-end platforms.

 

How the system works

 

The pilot uses Kezzler’s cloud-based platform, which acts as a central repository using EPCIS (Electronic Product Code Information Services) standards. Participating companies submit Key Data Elements tied to Critical Tracking Events, such as shipping, receiving, and product transformation.

 

The platform aggregates and standardizes this data, creating a continuous record of a product’s movement. This record, often referred to as a product genealogy, allows companies to trace items across multiple stages of the supply chain.

 

In practical terms, this means a food product can be tracked from its origin through processing and distribution using a consistent digital format. The system also enables reporting and analytics, which companies can use to respond to regulatory inquiries or internal audits.

 

Standards as the backbone of traceability

 

The pilot relies on GS1 identification systems, including Global Trade Item Numbers (GTINs) for products and Global Location Numbers (GLNs) for facilities. These identifiers ensure that data shared between supply chain partners is consistent and interoperable.

 

GS1 Mexico noted that standardized identifiers and data formats are essential for enabling rapid tracebacks during food safety investigations. Without them, data fragmentation can slow down response times and complicate compliance efforts.

 

Industry moves towards digitized systems

 

The launch of this pilot comes as companies across North America prepare for FSMA 204 enforcement timelines.

 

Originally set to take effect on  January 20, 2026, the FDA thought it wise to give businesses more time to fully implement the final rule’s requirements, shifting the new date to July 20, 2028.

 

As the industry moves toward digitized food safety systems,  regulators expect faster access to traceability records during outbreaks or recalls.

 

Other regions are also advancing traceability requirements. The European Union is expanding digital product passport initiatives, while several Asian markets are introducing stricter import traceability rules. These developments are increasing pressure on exporters and suppliers to adopt standardized digital systems.

 

For SMEs, the challenge is not only regulatory compliance but also maintaining access to international markets where traceability requirements are becoming more aligned.

 

Expanding access to digital supply chains

 

By combining GS1 standards with a centralized data platform, the Kezzler–GS1 Mexico pilot presents one model for integrating smaller businesses into global traceability systems. The approach reduces the need for fragmented tools and enables data sharing across multiple stakeholders.

 

The results of the pilot are expected to inform how similar programs could be scaled across other regions and sectors, particularly for companies operating in export-oriented supply chains.

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