FSSC 22000 V5.1 and FSMA Addendum V3 aligns with FDA FSMA PCHF Rule

Foundation FSSC is pleased to announce that following the conclusion of the US Food and Drug Administration (FDA) Third-Party Food Safety Standards Alignment Pilot Program this week, FSSC 22000 certification requirements have proven to successfully align with those of the FDA Preventive Controls for Human Food (PC Human Food).

The FDA undertook the voluntary pilot program to assess whether private third-party food safety audit standards adequately cover the relevant technical components of the PC Human Food Rule. The food safety requirements of the PC Human Food Rule are one of the foundational regulations issued to implement the FDA Food Safety Modernization Act (FSMA).

The result of their evaluation show that the FDA considers FSSC 22000 Scheme V5.1 for food manufacturing, together with FSSC 22000 V5.1 FSMA PCHF Addendum Version 3, to address the current PC Human Food Rule requirements. This positive outcome of the FDA’s review provides additional confidence to those organizations relying on compliance with FSSC 22000 and the related Addendum.

A detailed article and the full results of the evaluation are available on the FDA website here.

Although the FDA states that accredited third-party certification against voluntary Schemes such as FSSC 22000 is not a substitute for FDA or state regulatory inspections for compliance with FDA regulations, the project represents progress in their public-private collaboration and the achievement of another milestone in the New Era of Smarter Food Safety Blueprint.

The alignment of FSSC 22000 Scheme V5.1 (plus the FSSC 22000 V5.1 FSMA PCHF Addendum Version 3) with FDA Food Safety Regulations is a vital next step in market acceptance and building trust for globally recognized Food Safety Schemes based on reliable third-party audits. It will be welcome news to those among the 33,000 FSSC 22000 certified organizations worldwide looking to market products within the United States. Foundation FSSC is pleased to continue collaborations with the FDA and other global regulatory organizations. Supporting the industry with additional assurance that those organizations being certified to the FSSC 22000 Scheme for food safety management systems and the related Addendum align with the Preventive Controls for Human Food Rule requirements is a big plus.
Guido Dinjens, Chief Market Officer at FSSC

The FSSC 22000 V5.1 Scheme documents and the associated FSSC 22000 V5.1 FSMA PCHF Addendum Version 3 can be downloaded for free from the FSSC website via the link below: