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

**Authors:** Andrea Gori, Valentina Garretto, Paola Vannucci, Gaetano Liuzzo, Giovanni Munaò, Lara Tinacci, Roberta Nuvoloni, Andrea Armani

PMC · DOI: 10.3390/foods15040761 · Foods · 2026-02-19

## TL;DR

This paper introduces a framework to help EU food businesses, especially SMEs, navigate regulatory barriers when exporting to the USA.

## Contribution

The novel contribution is a structured, transferable analytical framework for regulatory alignment in food exports.

## Key findings

- The framework identified SSOPs, thermal validation, and pre-shipment review as critical for compliance.
- Operational barriers disproportionately impact SMEs, requiring targeted support for market access.
- The framework is adaptable to different food categories and destination markets.

## Abstract

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.

## Full-text entities

- **Diseases:** SSOPs (MESH:D000073818), injury to (MESH:D014947), Swine Vesicular Disease (MESH:D013555)
- **Chemicals:** water (MESH:D014867), FSIS (-), ATP (MESH:D000255)
- **Species:** Clostridium botulinum (species) [taxon 1491], Homo sapiens (human, species) [taxon 9606], Clostridium sporogenes (species) [taxon 1509]

## Full text

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## Figures

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## References

87 references — full list in the complete paper: https://tomesphere.com/paper/PMC12940801/full.md

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Source: https://tomesphere.com/paper/PMC12940801