FSMA (USA) Versus Hygiene Package (EU): Differences and Opportunities

Introduction:  The EU REG. CE N. 178/2002 and US FSMA are two rules that have revolutionized food safety in Europe and America. In Europe, 15 years after the publication of the Hygiene Package, many small businesses are struggling to adapt to hygienic standards-based preventive procedures. As a result, the member states, characterized by SME, are projected towards forms of simplified application of HACCP. What will happen in the US? Currently, the Food Safety Plan and the HARPC, seem to require management-rich procedures that are very redundant, but necessary to ensure the chain of accountability.

Purpose:  We proposed to analyze the differences between the two regulations and their implementation by analyzing the path that a manufacturing company must follow to comply with the respective regulations in the EU and US.

Methods:  Data was gathered from 180 Italian manufacturing companies, subject to European legislation, and registered with FDA for export to the US, which by June 2016 to December 2016, had qualified a PCQI for the design of their Food Safety Plan according to PCHF.

Results:  Different approaches in the design of HACCP (per phase in EU, for single ingredient in US), different concept of critical limits (points in the EU, average values in the US), introduction of the "correction", zoning in sanitation procedures, weekly frequencies document review, and introduction of the concept of " food safety culture"on FSMA, are some of the major differences found.

Significance:  Not only American companies but, also, European companies will confront a great challenge. We illustrate our solution and our consultancy approach for making this integration for European SME possible.