How FSSC 22000 4.1 Certification Is More Closely Aligning with FSMA

With the introduction of the US Food Safety Modernization Act (FSMA) and as concerns continue to grow about food safety issues like food fraud, intentional adulteration and allergen cross-contamination, food and beverage companies and their suppliers who are already certified to a GFSI-recognized scheme or who are planning to become certified are eager more than ever to understand how certification to a GFSI-recognized scheme helps them achieve FSMA compliance.

The good news is that following the release of GFSI Benchmarking Requirements v7, and with the release of FSSC version 4.1, certification to FSSC 22000 v. 4.1 is a way for food and beverage companies to demonstrate their commitment to food safety and to build trust with their retailer customers.

What Is FSSC 22000?

FSSC 22000 is an ISO-based, independent scheme for the auditing and certification of food safety processes. The standard represents a comprehensive approach to food safety risk management throughout the food supply chain, designed for food and feed safety management systems. In addition, FSSC 22000 includes transportation and on site storage if part of the operation.

FSSC 22000 is recognized by the Global Food Safety Initiative (GFSI). More than 15,000 sites are FSSC 22000 certified around the world.

In 2010, the Global Food Safety Initiative (GFSI) approved the Food Safety System Certification (FSSC) 22000, which provides a framework for effectively managing food safety responsibilities. FSSC 22000 is now on version 4.1, is fully recognized by GFSI and is based on existing ISO Standards, including ISO 22000.

As a result of independent analysis by The Acheson Group, FSSC 22000 aligns with FSMA Preventive Controls for Human Food (Final Rule).  In summary, TAG found that "FSSC 22000 often exceeds FDA requirements" and "where FSSC 22000 is not exceeding, the scheme requirements are in very large measure comparable to those of the Final Rule." As a result, FSSC can demonstrate that a company has a robust food safety management system with the same preventative controls as FSMA’s HARPC.

What’s New in Version 4.1?

To help ensure further alignment with FSMA, FSSC 22000 4.1 brings an increased focus on the prevention of food fraud. The standard now requires a separate food fraud vulnerability assessment and a prevention strategy for all types of fraud, for all of your products and across your entire food supply chain – from raw materials to the finished product.

Version 4.1 also requires a separate food defense threat assessment and control plan for all types of attacks, including tampering and acts disgruntled employees in addition to FSMA’s Intentional Adulteration scope of terrorist-type "wide scale public health harms."

FSSC 22000 4.1 also includes greater scrutiny of processes related to allergan management. The standard requires a documented allergen management plan that includes:

  • Risk assessment addressing potential allergen cross contamination
  • Control measures to reduce or eliminate the risk of cross contamination
  • Validation and verification of effective implementation

FSMA, Unannounced Visits & Potential Reduction of FDA Site Audits

With Hazard Analysis Critical Control Point (HACCP) standards at its core, FSSC 22000 4.1 certification will also help bring U.S. companies into compliance with Food Safety Modernization Act (FSMA) requirements, in addition to international food safety standards under the Global Food Safety Initiative (GFSI).

Beginning January 1, 2018, all FSSC 22000 certified sites will be audited against the new version.  Under 4.1, companies will undergo a longer and more comprehensive auditing process than required previously, including the addition of unannounced audits at least once in every three-year cycle, scheduled to begin in 2019.

In the future, companies who obtain FSSC 22000 4.1 certification may find that it reduces the number of inspections by the U.S. Food and Drug Administration, though this has yet to be formally confirmed.

More Stringent Requirements on Accredited Certification Bodies for FSSC 22000

Only a third-party certification body, accredited by the FSSC 22000 and in good standing, can issue FSSC 22000 4.1 certification. A list of accredited auditors is found on the FSSC 22000 website. When evaluating an FSSC certification body, it’s always a good idea to check this site to ensure the CB continues to meet the increasingly stringent requirements placed on them to maintain their accreditation and license to deliver FSSC v4.1 certification.

LRQA is an accredited third-party certification body for FSSC 22000 and our auditors have deep industry experience. We are a market leader in certifying food and beverage industry members around the world to FSSC 22000 standards, with more than 25 years experience and clients in 120 countries.

Our team of food safety experts can assess your existing food safety programs and help you to determine the most practical route to compliance and certification under FSSC 22000 version 4.1.

Contact us to learn more about FSSC 22000 4.1 certification