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| Main Authors: | , , |
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| Format: | Recurso digital |
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Zenodo
2026
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| Online Access: | https://doi.org/10.5281/zenodo.19661278 |
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Table of Contents:
- <p>This deliverable (D5.1) from the EPIC-SHIFT project (Grant Agreement No. 101181470) presents a comprehensive assessment of how the European Union regulatory framework influences the market access of novel foods derived from alternative protein sources (NFAPs). The report focuses on the implementation and practical implications of the Novel Food Regulation (EU) 2015/2283, complemented by the Transparency Regulation (EU) 2019/1381.</p> <p>The study combines a detailed review of regulatory requirements with qualitative insights gathered from structured interviews with 15 companies engaged in the development and authorisation of NFAPs, including proteins derived from microorganisms, algae, insects, and agri-food by-products. It evaluates administrative procedures, scientific data requirements, and the real-world experiences of applicants navigating the EU novel food approval process.</p> <p>Key findings highlight that while the EU procedure is globally recognised for its scientific rigour and high consumer protection standards, applicants face significant challenges related to regulatory complexity, interpretation of data requirements, and extended approval timelines often driven by additional data requests during risk assessment. These factors have notable implications for innovation, investment, and strategic market entry decisions, with many companies prioritising non-EU markets due to faster and more predictable regulatory pathways.</p> <p>The report identifies critical bottlenecks, including uncertainties in allergenicity assessment, toxicological testing requirements, and compliance with transparency obligations. It also underscores the heavy reliance on external regulatory expertise and the limited scope of current pre-submission support mechanisms.</p> <p>Despite these challenges, the EU framework is valued for its transparency, structured guidance, and robust scientific evaluation by the European Food Safety Authority (EFSA). The report concludes with evidence-based recommendations to improve regulatory clarity, enhance pre-submission engagement, streamline administrative processes, and support innovation in the alternative protein sector.</p> <p>Overall, this deliverable provides actionable insights for policymakers, regulators, and industry stakeholders, aiming to strengthen the efficiency and predictability of the EU novel food system while maintaining high standards of safety and public trust.</p> <p><strong>Project:</strong> EPIC-SHIFT – Horizon Europe (HORIZON-CL6-2024-FARM2FORK-01)<br><strong>Grant Agreement:</strong> 101181470</p> <p><strong>Disclaimer:</strong><br>EPIC-SHIFT is funded by the European Union. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union or Horizon Europe. Neither the European Union nor the granting authority can be held responsible for them.</p>