FSSC 22000 V5.1 and the FDA FSMA Preventive Controls for Human Food Rule

FDA's Voluntary Pilot Program

Buyers and other stakeholders along the food supply chain often rely on third-party audits to assess the quality and safety of a product. In conjunction with the Food Safety Modernization Act (FSMA), third-party audits are allowed by the US Food and Drug Administration (FDA) for supplier verification. While third-party audits to FSSC 22000, combined with the FSSC FSMA PCHF Addendum V3, are not a substitute for FDA or state regulatory inspections for compliance with FDA regulations, they assist towards meeting those requirements.

Under its recent pilot program, the FDA went one step further by assessing select third-party food safety standards regarding their alignment with the stringent requirements set in the Preventive Controls for Human Food Rule (PCHF) or Produce Safety Rules (PSR). Although the specific elements of third-party food safety standards and FSMA-implementing regulations may not be identical, alignment indicates that the third-party standards are addressing relevant technical components of PCHF.

FDA reviewed FSSC 22000 Scheme V5.1 and the FSSC FSMA PCHF Addendum V3. After comparing over 560 provisions of FSMA PCHF, they determined that the FSSC certification standards (plus the FSSC FSMA Addendum) align with applicable FDA regulations.

Assurance through Alignment

For importers, distributors, retail, and food service buyers, the FSSC 22000 Scheme alignment confirms that their supply chain has a robust food safety management system and meets GFSI benchmarking requirements. The FSSC FSMA PCHF Addendum is also of assistance to foreign suppliers and importers in meeting their obligations under the FDA Foreign Supplier Verification Rule.

The evaluation aims to further assure importers and receiving facilities that supplier audit standards adequately address crucial food safety requirements set forth by the FDA.

Certification to FSSC 22000 V5.1, along with the FSSC FSMA PCHF Addendum, is a valuable opportunity for all manufacturers, including small and medium-sized food businesses, to demonstrate compliance with food safety requirements through an ISO-based system.

With the alignment of prominent third-party food safety standards with FSMA regulations, consumers worldwide can be assured that their food is produced and distributed with the highest level of safety and compliance.