Guide to Food Traceability

The food manufacturing industry is a complex one, and one that faces many unique challenges. Of these challenges, ensuring food safety is perhaps the greatest concern for food and beverage manufacturers. Not only does food safety help to ensure the protection of consumers’ health, but it is also necessary for to ensure compliance with FDA regulations and maintain a good reputation with customers. Here, we will take a look at everything you need to know about food traceability, including why it’s important, the challenges food manufacturers face, and the FDA regulations that mandate food traceability.

What is Food Traceability?

Food traceability is the ability to track the movement of specific lots of food products through all stages of production, processing, and distribution. For a purchased product, it involves recording and documenting information such as supplier lot, date of manufacture, and country of origin. For produced products, a lot number is created which links back to all the source lots of purchased ingredients or WIP lots used in manufacturing. Products must be traceable from the receipt through multiple levels of production, and to shipments, be they to distribution facilities or to end customers.

This information allows for greater transparency and accountability in the food supply chain, helping to ensure food safety, quality, and authenticity. Traceability systems can help in quickly identifying and addressing any issues or incidents related to food safety or quality.

Why is Food Traceability Important?

Food traceability is important because it allows businesses and regulators to track the journey of food products from source to consumption. This visibility helps quickly identify and isolate contamination issues, reducing the risk of widespread foodborne illness and helping to public health. It also improves supply chain accountability, supports compliance with food safety regulations and builds consumer trust by delivering greater transparency about where food comes from and how it is handled.

Benefits of Food Traceability Solutions

A digital food traceability solution delivers value far beyond basic compliance and recall readiness. It strengthens food safety, improves operational control and helps build long-term trust with consumers and partners. Some of the key benefits include:

• Improved Food Safety and Consumer Protection - Traceability allows you to quickly identify the source of contamination and remove affected products from circulation. This helps prevent foodborne illness outbreaks from spreading and helps protect consumers from unsafe products.
• Faster, More Targeted Recalls - Instead of broad, costly recalls, traceability enables you to pinpoint exactly which lots or batches are impacted. This reduces waste, limits financial impact and minimizes disruption to your supply chain.
• Stronger Regulatory Compliance - With clear visibility across production and distribution, you can more easily meet local and global food safety regulations. Digital traceability also supports audit readiness, mock recalls and rapid response to compliance requirements.
• Greater Supply Chain Visibility - End-to-end tracking gives you a clearer view of how ingredients and products move through your supply chain. This improves coordination, reduces uncertainties and helps confirm consistent product quality.
• Enhanced Product Quality Control - Traceability makes it easier to monitor inputs, processes and outputs at every stage of production. This helps you maintain consistent quality standards and quickly identify where issues originate.
• Verification of Product Claims - A strong traceability system helps you confirm and validate product attributes such as organic, non-GMO, Kosher or sustainably sourced claims, supporting transparency and certification requirements.
• Increased Customer Trust and Brand Protection - When you can quickly trace and respond to issues, you demonstrate accountability and transparency. This helps strengthen customer confidence and helps protect your brand reputation during both everyday operations and crisis events.
• Reduced Waste and Operational Costs - By identifying affected products precisely, you can avoid unnecessary disposal of safe inventory. Better visibility also helps optimize production and inventory management, reducing inefficiencies across the supply chain. 

Key Aspects of Food Traceability

Food traceability is built on a set of core capabilities that confirm every product can be tracked, verified and managed throughout the supply chain. These key aspects work together to create visibility and accountability from farm to finished product:

• End-to-End Product Tracking - The ability to follow food products from raw materials through processing, distribution and final delivery delivers full visibility at every stage of the supply chain.
• Lot and Batch Identification - Products are assigned unique lot or batch numbers that allow them to be grouped, tracked and traced accurately throughout production and distribution.
• Data Capture and Recordkeeping - Accurate, real-time data collection at each stage of the supply chain confirms that critical information—such as origin, processing steps and handling conditions—is consistently recorded.
• Supply Chain Integration - Traceability systems connect suppliers, manufacturers, distributors and retailers, enabling seamless information sharing across all stakeholders.
• Regulatory Compliance and Reporting - Systems are designed to meet global food safety standards and support audit readiness, reporting requirements and rapid recall capabilities.
• Real-Time Visibility and Monitoring - Digital traceability solutions provide up-to-date insights into product movement and status, helping businesses respond quickly to issues or disruptions. 

Critical Tracking Events (CTEs)

Critical Tracking Events (CTEs) are the key points in the food supply chain where products are created, transformed, moved or otherwise changed in a way that must be recorded for traceability. These events form the backbone of a reliable traceability system.

Common CTEs include:

• Receiving - Recording when raw materials or ingredients arrive at a facility, including supplier information, time of receipt and condition of goods.
• Transformation / Production - Capturing when ingredients are combined, processed, or changed into new products, including formulation, batch creation and processing details.
• Packaging and Labeling - Documenting when products are packaged and assigned lot codes, expiration dates and other identifying information.
• Shipping and Distribution - Tracking when finished goods leave a facility, including destination, carrier details and shipment timing.
• Storage and Holding - Monitoring products while they are held in warehouses or cold storage, including environmental conditions and inventory movement.
• Receiving at Next Point in the Chain - Recording when products are received by distributors, retailers or further processors, confirming continuity of traceability across the supply chain. 

FDA Food Traceability Requirements

In the United States, the Food & Drug Administration (FDA) is responsible for protecting public health by ensuring the safety of the nation’s food products. While the FDA has created and deployed a number of regulations to help guide the food industry, the one that pertains to food traceability falls under the Food Safety Modernization Act (FSMA).

FSMA Traceability

FSMA is a United States law that was signed in 2011 with the aim of ensuring the safety of the U.S. food supply by shifting the focus from responding to contamination to preventing it. The FSMA gives the FDA new authority to regulate the way foods are grown, harvested, and processed. It also requires food facilities to implement preventive controls to minimize the risk of foodborne illnesses.

Section 204 (d) of the FSMA, Enhancing Tracking and Tracing of Food and Recordkeeping, pertains to the food tracking traceability requirements that food industry companies must comply with by July 20, 2028.

Per section 204 (d), the FDA was tasked with developing and testing methods and technologies, in conjunction with the food industry, for food traceability and tracking.

Section 204 (d) also required the FDA to designate foods for which additional recordkeeping requirements are necessary, which was finalized in 2022 when the FDA published its Food Traceability Final Rule.

The requirements covered in section 204 (d) of the FSMA are as follows:

Record Keeping and Reporting Requirements

Section 204 (d) mandates that certain entities in the supply chain must maintain records pertaining to the production, distribution, and handling of food products. All records must be maintained for two years and in a manner that allows for the rapid and effective tracing of the origin and movement of food products. Manufacturers must also be able to provide records to the FDA within 24 hours if requested.

Traceability Requirements

Section 204 (d) mandates the establishment of a procedure for tracking the history, location, and distribution of food products across all stages of the supply chain, from production to consumption. This is intended to enable the rapid identification recall of contaminated food. One of the primary requirements for food manufacturers, under section 204 (d), is to assign a traceability lot code to food on the Food Traceability List.

Collaboration and Consideration

Section 204 (d) also requires the full disclosure of traceability methods. Various stakeholders within the food supply chain are required to maintain records that contain key data elements (KDEs) associated with critical tracking events (CTEs), which are defined as pivotal checkpoints in the food supply chain. Examples of CTEs can include manufacturing, receiving, holding, repackaging, exporting, and recalling.

Pilot Projects and Rulemaking

As mentioned previously, per section 204 (d), the FDA is conducting pilot programs to help develop more advanced procedures for maintaining food traceability. Based on their findings, the FDA is authorized to issue regulations to establish traceability for specific food products.

FDA Food Traceability List

The FDA Food Traceability List includes all foods for which the FDA has determined additional recordkeeping requirements are needed to ensure the protection of public health.

Here is a condensed version of the FDA’s Food Traceability List and what’s included in each section.

The complete Food Traceability List can be found on the FDA’s website.

Maintain Food Traceability with the Plex Smart Manufacturing Platform

The Plex Smart Manufacturing Platform™ by Rockwell Automation provides the functionality that food manufacturers and suppliers need to maintain compliance with the FSMA.

With the Plex Smart Manufacturing Platform, food manufacturers can take advantage of the following features to obtain real-time food traceability across processes:

• Lot Traceability and Management
• Supplier Management
• Quality Control and Testing
• Comprehensive Reporting and Documentation
• Recall Management

Learn more about building a digital strategy for FSMA and food traceability compliance with the Plex Smart Manufacturing Platform.