A Structured Analytical Framework to Facilitate EU Food Exports to the USA: A Case Study Analyzing Barriers and Support Strategies.

Exporting food products from the European Union (EU) to the United States of America (USA) involves navigating complex regulations and procedural barriers that hinder market access. Italian food businesses (FBs), particularly small and medium-sized enterprises (SMEs), often face difficulties accessing clear guidance, as national procedures are scattered across multiple sources. This paper proposes a structured three-step analytical framework to support EU FBs: product-specific analysis, identification of relevant EU and USA legislation, comparative legislative analysis via concordance tables, and identification of procedures to integrate into the Food Safety Management System. The framework was applied to an Italian medium-sized FB exporting pork-based pasta sauce to the USA. Beyond the specific case study, the proposed analytical framework was designed to be transferable and adaptable to other food categories and destination markets, providing a structured methodological tool to support regulatory alignment. In this sense, the framework can be considered product-independent but process-specific. As such, it can support both FBs and Competent Authorities in conducting risk-based assessments of regulatory equivalence and export compliance. Results indicated the need for Sanitation Standard Operating Procedures (SSOPs), thermal process validation, direct verification activities, and pre-shipment review. Findings emphasize that operational and procedural barriers disproportionately affect SMEs, highlighting the importance of targeted support to facilitate market access and strengthen certification systems.