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?

There are many benefits to a digital food traceability system. It plays a vital role in ensuring food safety for consumers and can help mitigate damage when outbreaks of foodborne illnesses occur. Additionally, food traceability allows businesses to easily verify their products’ status as Kosher or organic.

Some of the biggest benefits of food traceability include:

Protecting the Health of Consumers

The number one goal of food traceability is to ensure the quality of food products in order to protect consumers from foodborne illnesses. Should a foodborne illness outbreak occur, food traceability empowers businesses to identify the source of the outbreak and immediately recall all affected food products. It also provides businesses with the needed visibility to contain outbreaks within their facilities to ensure contamination does not spread to unaffected ingredients.

Ensuring Compliance

Countries around the world have regulations that govern the production, processing, and distribution of food. Failing to comply with these regulations can result in monetary fines, sanctions, and other penalties. Through food traceability, companies have better visibility over food products in their supply chain, empowering them to better maintain compliance with industry regulations and food safety standards. A lot-based, digital traceability system that provides one-up, one0down traceability, is essential for regulatory compliance for food manufacturers. It supports both mock-recalls and audits and actual rapid responses to real events. This level 3 traceability capability can also feed trace data on manufacturing conversion to level 5 farm-to-fork systems.

Growing Customer Trust

As consumers become increasingly aware of the source and quality of their food, it is more important than ever before for food manufacturers to build trust with their customers. A food manufacturer's ability to demonstrate rapid and comprehensive digital lot trace capability can help win new customers and hold on to existing ones.  In the event of an actual recall, the ability to move quickly to identify and notify customers of the specific lots of products that must be quarantined helps maintain relationships at a challenging moment.

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 January 20, 2026.

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.