FSSC 22000 vs FSMA comparison

The Role of FSSC 22000 in meeting the requirements of the Food Safety Modernization Act (FSMA).

As the dates for the publication of the final rules of the Food Safety Modernization Act (FSMA) in the US approaches, the question of how FSSC 22000 can contribute to meeting the requirements of FSMA will be revisited.

The implementation of the new law represents a huge change in the way the Food and Drug Administration (FDA) will regulate food manufacturers and foreign suppliers. The legislation which will potentially impact food suppliers all over the world, shifts the focus of the regulator from reacting to a food safety incident to prevention, and in developing these Preventive Controls (PC)  they will require that firms take corporate responsibility for the safety of their products and that of their supply chain.

The proposed PC Rule outlines the elements of a modern hazard control (HARPC) based food safety management system and requires companies to provide proof of their food safety management activities. Obligations will include providing documented proof of monitoring, validation and verification to show that hazards are managed and firms will need to ensure that their preventive controls are based on a scientifically grounded understanding of the hazards being controlled.  Manufactures will be required to verify the compliance of both its domestic and foreign suppliers and the FDA will extend its oversight to importers of foreign food and food ingredients into the USA.  With an estimated 160,000 domestic and 180,000 registered foreign food suppliers, the FDA will need to leverage existing components of the food system to help them in meeting these national standards.

Many of the requirements outlined by the PC Rule for food safety management are reflected in the food safety management system of the ISO 22000 family of Standards.  As FSSC 22000 is based on ISO 22000 with ISO 22003 and sector specific pre requisite programs, many of the requirements outlined in the initial PC rule for food safety management are met by FSSC 22000.

With 10, 000 certified facilities in 148 countries worldwide, FSSC 22000 is currently relied upon by the world's major food manufacturers to provide evidence of good food safety management across the global supply chain. Companies certified to FSSC 22000 will therefore be meeting many of the requirements of a food safety management system sought in FSMA.  In combination with its ISO family of standards, and pre requisite programs, FSSC 22000 provides a robust and flexible food safety management system for manufacturers and suppliers throughout world. While remaining flexible, FSSC 22000 is applicable to all organizations regardless of size, and calls for compliance with all applicable statutory and regulatory food safety requirements.

A side by side comparison of FSSC 22000 with the initial FSMA PC rules was conducted by the independent TAG Group and shows how the initial FSMA requirements for a food safety management approach are met by FSSC 22000.  In their summary of the comparison TAG states;

“FSSC 22000 often exceeds FDA requirements, either by being clearer about the specific expectations or by applying the requirements more broadly within a facility (e.g., strong sanitation requirements including documentation regardless of whether it is a PRP or operational PRP). A facility that has FSSC 22000 certification is in an excellent place with regard to compliance with PC rules as currently written. Any additional requirements added in the final rule can be easily added to the FSSC 22000 standard within the existing framework”; in: DRAFT: FSSC 22000- FSMA Comparison by The Acheson Group.

While we await the final rules we remain confident that with so many common goals and that FSSC 22000 can help meet the requirements of FSMA for both domestic and foreign suppliers.


FSMA: The new legislation (Sec. 103) Mandatory preventive controls (PC) for food facilities will require industry to do establish a food safety management program that will:

Evaluate hazards that could affect food safety; 

Identify and implement preventive controls to prevent hazards; 

Monitor controls and maintain monitoring records; and

Conduct verification activities

FSMA also requires appropriate Prevention Standards which include specifications for


Training for supervisors and employees

Environmental controls and monitoring

Food allergen controls 

Recall contingency plan 

Good Manufacturing Practices (GMPs)

Supplier verification activities

With ISO 22000, FSSC 22000 requires that the establishment of a well-documented Food Safety Management System. Essential elements complimentary to the requirements of FSMA include the need to effectively communicate food safety issues up and down the supply chain and to demonstrate conformity through effective documentation.

The FSSC 22000 management system requires:

A Hazard Analysis and Critical Control Plan developed to identify, prevent and eliminate food safety hazards,

Controlling, monitoring, verification and documentation.

Establishing and maintaining and internal audit program.

Continually updating and improving the FSMS

Communication and operations affecting food safety.

Effective sector specific Prerequisite Programs  will ensure a clean sanitary environment and detail specific requirements for sector specific prevention standards.