Navigating the FDA’s New Food Traceability Rule: A Guide for Food and Beverage Organizations
- On July 3, 2024
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- batch traceability, Critical Tracking Events, Electronic Traceability Plan, ERP for Food Manufacturers, FDA Food Traceability Rule, Food and Beverage Industry, Food Manufacturing Compliance, Food Safety Compliance, Food Safety Modernization Act, Food Supply Chain, Food Traceability List, Food Traceability Requirements, FSMA Compliance, Key Data Elements, Softengine Batch Traceability
The FDA has introduced a new Food Traceability Rule as part of its ongoing efforts to enhance food safety and protect consumers. Effective January 20, 2026, this regulation requires food and beverage restaurants and manufacturers to implement extensive traceability measures. The FDA Food Traceability Rule, effective January 2026, requires manufacturers to track food items on the Food Traceability List (FTL). Key Data Elements (KDEs) and Critical Tracking Events (CTEs) must be recorded to ensure food safety compliance. Here’s what manufacturers need to know about the new rule and how tools like Softengine Batch Traceability can help ensure compliance and operational success. Keep reading today’s blog in our food and beverage insights center to learn just what navigating the FDA’s new food traceability rule entails for your organization!
Understanding the New Food Traceability Rule
Key Requirements
Food Traceability List (FTL)
The rule mandates tracking of specific food items, including fresh fruits and vegetables, shell eggs, nut butters, cheeses, and seafood products. Each item on the Food Traceability List (FTL) must have a documented origin.
Key Data Elements (KDEs) and Critical Tracking Events (CTEs)
Restaurants must maintain Key Data Elements (KDEs) for each Critical Tracking Event (CTEs), such as receiving, transforming, and shipping food items. This includes details like the product’s source, acceptance date and location, and traceability lot-code information.
Electronic Traceability Plan
Restaurants must develop a plan detailing procedures for maintaining traceability records, including the assignment of traceability lot codes and the format and location of records.
Timely Data Provision
In case of a foodborne illness outbreak, manufacturers must provide traceability records to the FDA within 24 hours or another agreed-upon reasonable time.
Who Must Comply
- Food and beverage selling restaurants with annual sales exceeding $250,000 must comply.
- Restaurants with sales between $250K and $1M have simplified reporting requirements, potentially allowing the use of receipts and invoices instead of electronic records.
- Restaurants exceeding $1M in sales must maintain electronic records.
Implementing Batch Traceability for Compliance
To meet the new FDA requirements, food and beverage manufacturers and restaurants need robust systems for tracking and maintaining detailed records. Softengine Batch Traceability provides a comprehensive solution for manufacturers to meet the new food traceability requirements. This ERP for food manufacturers simplifies tracking and maintaining records.
How Softengine Batch Traceability Works:
Centralized Record Keeping
Softengine’s system maintains Key Data Elements (KDEs) for each Critical Tracking Event (CTEs) in a centralized, easily accessible format. This ensures that all necessary information is available and up-to-date.
Visual Batch Tracking
The batch tracing tool provides a visual representation of the entire production and supply chain. It shows dependencies and the lifecycle of finished goods and components, making it easier to track each item from origin to end-user.
Detailed Transaction Records
The system captures detailed information about each transaction in the supply chain, from production orders and goods receipts to shipping and invoicing. This level of detail is crucial for meeting the FDA’s stringent traceability requirements.
Search and Reporting Functions
Softengine’s tool allows users to search for items, batches, and documents quickly. The trace results feature provides a hierarchical list of business partners, documents, and item batches, facilitating efficient investigation in case of quality issues or regulatory inquiries.
Production Chain to Batch Tracing
Below you can see a use case of producing peanut butter and how our Softengine Batch Trace solution checks every batch in the three production stages in a simplified, visual manner!
Benefits of Batch Traceability:
- Enhanced Compliance: By maintaining accurate and detailed records, manufacturers can comply with the FDA’s new traceability requirements and avoid potential fines or shutdowns.
- Improved Food Safety: Quick identification of contaminated batches helps prevent foodborne illness outbreaks, protecting both customers and the manufacturer’s reputation.
- Operational Efficiency: Automating traceability processes reduces manual record-keeping efforts, allowing staff to focus on core business operations.
- Streamlined Investigations: In case of a reported issue, the batch tracing tool simplifies root cause analysis, enabling faster resolution and corrective actions.
Preparing for 2026: Steps for Food and Beverage Manufacturers and Restaurants
Assess Current Systems
Evaluate your current record-keeping and traceability processes. Identify any gaps in compliance with the new FDA requirements.
Implement Technology Solutions
Invest in an ERP system with batch tracing functionality, such as Softengine Food One ERP, to automate and streamline traceability processes.
Train Staff
Ensure your team understands the new requirements and how to use the batch tracing system effectively.
Collaborate with Suppliers
Work closely with your supply chain partners to ensure they are also compliant and can provide the necessary traceability data.
Develop a Traceability Plan
Create a detailed plan outlining your procedures for maintaining records, assigning lot codes, and responding to FDA inquiries.
Navigating the FDA’s New Food Traceability Rule
The FDA’s new Food Traceability Rule represents a significant step towards improving food safety and traceability in the food and beverage industry. By understanding the requirements and implementing robust traceability solutions like Softengine’s Batch Traceability, manufacturers can ensure compliance, enhance food safety, and streamline their operations. Start preparing today to meet the January 2026 compliance deadline and secure your business’s future success.
Softengine is Here to Help!
Partnering with Softengine for your ERP implementation not only streamlines the data migration process but also ensures a seamless transition to your new ERP platform. Our team’s expertise, dedication, and commitment to customer success make us the ideal partner for organizations seeking to unlock the full potential of their ERP investment and scaling in the digital economy. Contact us to learn more about how our clients utilize ERP to enhance and scale their organizations, and see our solutions in action for yourself!
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