FSMA Rules and EU Food Safety Regulations: Differences and Opportunities

Introduction: The EU REG.CE N. 178/2002 and the United States Food Safety Modernization Act (FSMA) have revolutionized food safety in Europe and the U.S. Fifteen years after publication of the European Hygiene Package, many small businesses still struggle to adapt hygienic standard based preventive procedures. The Preventive Controls Rule has yet to be fully implemented in the U.S.; but required food safety plans that include a hazard analysis and preventive controls approaches will require strong management and record keeping procedures to ensure a chain of accountability.

Purpose: This study compared the European Hygiene Package and the Preventive Controls Rule for Human Foods and their implementation.

Methods: A sample of 180 Italian food companies were selected that were subject to European regulations, had registered as a food processing facility with the FDA for export to the U.S., and had a Preventive Controls qualified individual in place.

Results: A number of major differences were found between the two regulations. These differences included the design of the Hazard Analysis and Critical Control Points program, which is by production phase in Europe rather than by single ingredient or process point, as in the U.S. The approach to setting critical limits are, also, different (single point vs average values).

Significance: European food processing facilities face a number of new challenges in implementing food safety rules that take different approaches to achieving the same goal.