FSMA 204 Food Compliance: Modernize Your Food Safety Efforts

Meet FSMA 204 compliance requirements for safety and traceability, mitigate risks, prevent tampering, and guarantee product quality across your supply chain

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FMSA: What is the Food Safety Modernization Act?

FDA

Embracing a New Era of Smarter Food Safety

The  Food Safety Modernization Act (FSMA) sets forth requirements for any company that manufactures, processes, packs, or holds foods on the Food Traceability List (FTL). These entities must establish and maintain comprehensive records that contain Key Data Elements (KDEs) and Critical Tracking Events (CTEs), which are the building blocks of food traceability.

Who Is Affected?

Farms, manufacturers, distributors, retail food establishments, and restaurants are affected. These entities must comply with traceability requirements, including recording Critical Tracking Events (CTEs) and Key Data Elements (KDEs). CTEs typically occur during growing and processing, including the physical movement of items and quality inspections. KDEs provide the granular details for traceability, including time, location, lot code, and unit measurements. FSMA compliance also involves providing traceability information electronically to the FDA within 24 hours of an official request.

Deadline for Compliance

The deadline for full compliance with FSMA regulations is January 2026.

Please note that all FSMA requirements and statements come from the FDA. For detailed information about FSMA 204 guidelines, visit the official FDA website here. 

 

Meet FSMA 204 Compliance Requirements

Meet the Increasing Demands from Consumers

Serialized digital product traceability in your food and beverage supply chain meets consumer expectations for product information and provides numerous benefits, including:

  Smart Labels

  Reducing Food Tampering

  Anti-Diversion

  Improved Inventory Management

  Increased Brand Protection

  Regulatory and Customer Compliance



At rfxcel, we understand the complexities of FSMA 204 compliance and are dedicated to supporting your journey toward food safety excellence. Our innovative traceability solutions, coupled with advanced data management capabilities, empower your business to achieve and maintain FSMA 204 compliance quickly and completely.

  Comprehensive traceability solutions tailored to the food and beverage industry.

  Expertise in regulatory compliance, including FSMA.

  Innovative technologies for efficient traceability and data management.

  Scalable solutions that can be customized to your business needs.

  A proven track record and industry leadership in traceability.

Events and Resources

View all upcoming events and Food Safety Supply Chain Resources

 

Webinars and Resources

 

Traceability Plan

  • Required for all persons covered by the rule

  • Description of the procedures you use to maintain the required records, including the format and location of the records

  • Description of the procedures you use to identify foods on the FTL that you manufacture, process, pack or hold

  • Description of how you assign traceability lot codes to foods on the FTL, if applicable

  • Statement identifying a point of contact for questions regarding your traceability plan and records

  • If you grow or raise a food on the FTL (other than eggs), a farm map showing the areas in which you grow or raise such foods

    • The farm map must show the location and name of each field (or other growing area) in which you grow a food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area

  • You must update your traceability plan as needed to ensure that the information reflects your current practices and to ensure you are in compliance with the rule

  • You must retain your previous traceability plan for 2 years after

Critical Tracking Event: Harvesting (Raw agricultural commodities (RACs)

Key Data Elements Required:

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Commodity and, if applicable, variety of the food

  • Quantity and unit of measure of the food

  • Location description for the farm where the food was harvested

    • Name of the field or other growing area from which the food was harvested (must correspond to the name used by the grower), or

    • Other information identifying the harvest location at least as precisely as field or growing area name

  • Date of harvesting

Critical Tracking Event: Cooling

Key Data Elements Required:  

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Commodity and, if applicable, variety of the food

  • Quantity and unit of measure of the food

  • Location description for where you cooled the food

  • Date of cooling

  • Location description for the farm where the food was harvested

 

Critical Tracking Event: Initial Packing

Key Data Elements Required:  

(KDEs must be linked to the traceability lot you assign for the food that you pack)

  • Commodity and, if applicable, variety of the food received

  • Date you received the food

  • Quantity and unit of measure of the food received

  • Location description for the farm where the food was harvested

    • Name of the field or other growing area from which the food was harvested (must correspond to the name used by the grower), or

    • Other information identifying the harvest location at least as precisely as field or growing area name

Critical Tracking Event: Shipping

Key Data Elements Required:  

(KDEs must be linked to the traceability lot for the food)

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Location description for the location from which you shipped the food

  • Date you shipped the food

  • Location description for the traceability lot code source or the traceability lot code source reference

Critical Tracking Event: FTL food(s) used as ingredient(s)

Key Data Elements Required: (KDEs must be linked to the new traceability lot for the food)

  • Traceability lot code for the food

  • Product description for the food to which the traceability lot code applies

  • For each traceability lot used, the quantity and unit of measure of the food used from that lot

Critical Tracking Event: - New food produced

Key Data Elements Required:(KDEs must be linked to the new traceability lot for the food)

  • New traceability lot code for the food

  • Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference

  • Date transformation was completed

  • Product description for the food

  • Quantity and unit of measure of the food

 Critical Tracking Event: Receiving

Key Data Elements Required:(KDEs must be linked to the traceability lot for the food)

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate previous source (other than a transporter) for the food

  • Location description for where the food was received

  • Date you received the food

  • Location description for the traceability lot code source or the traceability lot code source reference

 Critical Tracking Event: Shipping

Key Data Elements Required:(KDEs must be linked to the traceability lot for the food)

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Location description for the location from which you shipped the food

  • Date you shipped the food

  • Location description for the traceability lot code source or the traceability lot code source reference

Receiving KDEs (KDEs must be linked to the traceability lot for the food)

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate previous source (other than a transporter) for the food

  • Location description for where the food was received

  • Date you received the food

  • Location description for the traceability lot code source or the traceability lot code source reference

Shipping KDEs (KDEs must be linked to the traceability lot for the food)

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Location description for the location from which you shipped the food

  • Date you shipped the food

  • Location description for the traceability lot code source or the traceability lot code source reference

Receiving KDEs (KDEs must be linked to the traceability lot for the food)

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate previous source (other than a transporter) for the food

  • Location description for where the food was received

  • Date you received the food

  • Location description for the traceability lot code source or the traceability lot code source reference

Shipping KDEs (KDEs must be linked to the traceability lot for the food)

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Location description for the location from which you shipped the food

  • Date you shipped the food 

 

Note: if Food Retailers manufacture foods that are on the FTL (e.g. Ready-to-eat deli salads, etc.), also see Food Manufacturers requirements

 

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