Abstract:Introduction: 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. Methods: 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. Results: 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. Conclusions: 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.
