FSMA 204 Traceability¶
GTIN1 supports the FDA's Food Safety Modernization Act (FSMA) Section 204 requirements for enhanced food traceability. This guide covers how to set up and use GTIN1's traceability features.
What is FSMA 204?¶
The FDA Food Traceability Rule (21 CFR Part 1, Subpart S) requires certain food businesses to maintain additional traceability records for foods on the Food Traceability List (FTL). The rule took effect on January 20, 2026, and applies to manufacturers, processors, packers, and distributors who handle FTL foods.
The core requirements are:
- Assign traceability lot codes to FTL foods at each point of transformation
- Record Critical Tracking Events (CTEs) such as harvesting, receiving, transforming, and shipping
- Capture Key Data Elements (KDEs) for each CTE, including locations, dates, and lot identifiers
- Provide records to the FDA within 24 hours when requested during a foodborne illness investigation
Which Products Require Compliance?¶
FSMA 204 applies to foods on the FDA's Food Traceability List. GTIN1 supports all 16 FTL categories:
| Category | Examples |
|---|---|
| Leafy Greens | Lettuce, spinach, kale, arugula |
| Fresh-cut Fruits/Vegetables | Pre-cut salad mixes, sliced melons |
| Fresh Herbs | Cilantro, basil, parsley |
| Tomatoes | All fresh tomato varieties |
| Peppers | Bell peppers, chili peppers |
| Sprouts | Alfalfa sprouts, bean sprouts |
| Cucumbers | All fresh cucumber varieties |
| Melons | Cantaloupe, honeydew, watermelon |
| Tropical Tree Fruits | Mangoes, papayas, guavas |
| Finfish | Fresh and frozen fish (excluding shelf-stable) |
| Crustaceans | Shrimp, crab, lobster |
| Molluscan Shellfish | Oysters, mussels, clams |
| Ready-to-eat Deli Salads | Potato salad, egg salad, seafood salad |
| Nut Butters | Peanut butter, almond butter |
| Fresh and Soft Cheeses | Brie, feta, mozzarella, queso fresco |
| Shell Eggs | Table eggs in the shell |
Enabling FSMA 204 for Your Organization¶
FSMA 204 traceability features are opt-in. To enable them:
- Navigate to your organization settings.
- Enable FSMA 204 Traceability.
- Once enabled, the organization dashboard shows additional navigation items for Locations, Critical Tracking Events, and Traceability Export.
Feature gating
FSMA 204 features (locations, CTEs, traceability exports) are only accessible when FSMA is enabled for the organization. Attempting to access these pages without enabling the feature returns a 404 error.
Designating FTL Trade Items¶
After enabling FSMA 204, mark which of your trade items are on the Food Traceability List:
- Navigate to the trade item you want to designate.
- Enable FTL Item in the trade item settings.
- Select one or more FTL Categories from the list above.
FTL designation requires at least one category. GTIN1 validates this at save time: you cannot mark an item as FTL without selecting at least one category.
Once a trade item is designated as FTL, its lots have stricter validation rules: every lot must have either a harvest date or a production date recorded.
Managing Locations¶
Locations represent physical places in your supply chain where food is grown, received, transformed, or shipped. Each location is identified by a GS1 Global Location Number (GLN).
Creating a Location¶
Navigate to Locations in your organization dashboard and click Add Location.
| Field | Required | Description |
|---|---|---|
| GLN | Yes | 13-digit Global Location Number with valid check digit |
| Name | Yes | Human-readable location name |
| Location type | Yes | One of: Growing/Harvesting, Receiving, Transforming, Shipping |
| Address | No | Full street address, city, state, postal code, and country (ISO 3166-1 alpha-2) |
Location types correspond to the four types of CTEs defined by FSMA 204:
| Location Type | Used For |
|---|---|
| Growing/Harvesting | Farms, fields, orchards where food originates |
| Receiving | Warehouses, distribution centers where food arrives |
| Transforming | Processing plants where food is transformed into new products |
| Shipping | Loading docks, fulfillment centers where food is dispatched |
GLN uniqueness
Each GLN must be unique within your organization. If you operate multiple facilities at the same physical address, assign each a distinct GLN.
Locations in Digital Link URIs¶
When a lot has a growing location assigned, the location's GLN is embedded in QR codes using GS1 Application Identifier 416 (Production GLN):
This allows supply chain partners to identify the production origin directly from a scan.
Critical Tracking Events (CTEs)¶
Critical Tracking Events record what happened to a food product, where, and when. GTIN1 supports the four CTE types defined by FSMA 204.
CTE Types¶
| Event Type | Description | Required Data |
|---|---|---|
| Harvest | Food is harvested or gathered from a growing location | Location (must be Growing type), lot, date |
| Receive | Food arrives at a facility | Location, lot, date |
| Transform | Food is combined or processed into a new product | Location, output lot, input lots, date |
| Ship | Food is shipped to another party | Location, lot, date, recipient name or GLN |
Recording a CTE¶
Navigate to Critical Tracking Events in your organization dashboard, or go to a specific lot and select Record Event.
All CTEs require:
- Event type
- Event date and time
- Location where the event occurred
- Primary lot involved
Additional fields by event type:
- Harvest: The location must be a Growing/Harvesting type location.
- Transform: Specify input lots (the raw materials that were combined or processed).
- Ship: Provide the recipient's name or GLN (at least one is required).
Each CTE also has an optional Notes field for recording additional context.
Viewing CTEs¶
You can view CTEs at two levels:
- Organization-wide: See all CTEs across all lots, sorted by most recent first.
- Per lot: See the chronological chain of events for a specific lot.
The per-lot view is particularly useful for tracing the complete history of a batch through your supply chain.
GS1 Application Identifiers for Traceability¶
GTIN1 encodes traceability data in QR codes using standard GS1 Application Identifiers:
| AI | Name | Format | Example |
|---|---|---|---|
| 01 | GTIN | 14 digits | 00614524740870 |
| 10 | Batch/Lot | Up to 20 alphanumeric | LOT2026A |
| 21 | Serial Number | Up to 20 alphanumeric | SN00001 |
| 7007 | Harvest Date | YYMMDD (or YYMMDDYYMMDD for ranges) | 260115 |
| 416 | Production GLN | 13 digits | 5412345000013 |
When generating a QR code for a lot that has harvest date and growing location data, GTIN1 automatically includes AI 7007 and AI 416 in the encoded Digital Link URI:
Traceability Export¶
GTIN1 provides traceability data export in two scopes: per-lot and organization-wide.
Per-Lot Export¶
Export the complete traceability record for a single lot, including all associated CTEs and KDEs.
Organization-Wide Export¶
Export traceability data for all FTL lots in your organization, with optional date range filtering.
Export files are named using the pattern traceability_{identifier}_{date}.{format} and are delivered as a direct file download.
Export Formats¶
| Format | Best For |
|---|---|
| JSON | Integration with other systems, programmatic processing |
| CSV | Spreadsheet analysis, regulatory submissions, archival |
Traceability on the Product Page¶
When consumers or supply chain partners scan a QR code for a lot with traceability data, the hosted product page displays:
- Lot identification: Lot number, production date, expiration date
- Origin information: Growing location name and GLN (when available)
- Harvest date: When the product was harvested (for applicable products)
- Traceability completeness: Whether the lot has complete FSMA 204 data (harvest/production date and growing location)
This provides transparency to consumers while maintaining compliance with regulatory requirements.
Relationship to EPCIS¶
GTIN1's traceability features align with the GS1 EPCIS 2.0 standard. Critical Tracking Events in GTIN1 correspond to EPCIS event types:
| GTIN1 CTE | EPCIS Event Type |
|---|---|
| Harvest | ObjectEvent (ADD) |
| Receive | ObjectEvent (OBSERVE) |
| Transform | TransformationEvent |
| Ship | ObjectEvent (OBSERVE) with shipping context |
For programmatic access to traceability events, including serial number pool allocation and event capture, see the EPCIS API interactive reference. The EPCIS API provides a standards-compliant interface for systems integration, while the organization dashboard provides the human-friendly interface described in this guide.