Bacteriophages as Food Biocontrol Agents: A One Health Framework for Manufacturing Quality, Regulatory Governance,...

Bacteriophages are emerging as viable food safety tools, yet their global implementation is hindered by regulatory fragmentation and a lack of harmonized data standards. This review addresses the gap between scientific maturity and governance readiness by evaluating manufacturing quality, safety requirements, and international oversight frameworks.

A narrative review was conducted through a structured search of databases including PubMed, Scopus, Web of Science, and Google Scholar (up to December 2025). We analyzed scientific research and publicly available regulatory documents from agencies such as the FDA, EFSA, USDA, Health Canada, and FSANZ to identify authorization routes and manufacturing standards.

Commercial phage products are primarily approved as processing aids in jurisdictions like the United States, Canada, and Australia/New Zealand. We identified convergent technical requirements across these regions, including genomic integrity (absence of toxins and antimicrobial resistance genes), purity, potency, and matrix-validated efficacy. However, significant gaps remain in unified terminology, environmental risk assessment, and post-market monitoring for resistance emergence.

To facilitate global adoption, a One Health-oriented governance cycle is proposed. This includes establishing interoperable phage seed banks, standardized dossier formats, and adaptive lifecycle controls (phagovigilance) to ensure long-term efficacy and public trust.