The Qualified Presumption of Safety (QPS) framework, developed by the European Food Safety Authority, provides a harmonized approach for microbial risk assessment in the European food and feed chains.

Bacteriophages were previously excluded from QPS consideration due to insufficient taxonomic resolution. However, advances in whole-genome sequencing and viral phylogeny have transformed phage classification, enabling species-level definition and regulatory reassessment.

This talk will analyze the scientific and regulatory basis for reconsidering lytic bacteriophages within the QPS framework.

Key Scientific and Regulatory Criteria (EFSA BIOHAZ Panel, 2026)

• Double-stranded DNA genome ensuring replication fidelity
• Strictly lytic lifecycle (absence of lysogeny)
• Genome-unit packaging with defined termini (no generalized transduction risk)
• Narrow host spectrum (genus-restricted specificity)
• Absence of virulence, toxin, spoilage, or antibiotic resistance genes
• Documented safe use in food or feed applications

• Bridges taxonomy, genomics, and regulatory science
• Positions phages within formal European risk assessment frameworks
• Clarifies conditions for safe translational deployment
• Connects food-chain applications with broader therapeutic strategies

Targeting Phage Therapy 2026
April 9-10, 2026
 – Valencia, Spain

www.phagetherapy-site.com