Regulatory Harmonization Needs for Farm-to-Fork Bacteriophage Applications in South American Food Systems

Bacteriophage-based bioproducts are increasingly recognized as targeted tools to reduce foodborne pathogens and antimicrobial resistance (AMR) pressures across the farm-to-fork continuum. However, their adoption in South America remains limited due to fragmented regulatory pathways and inconsistent evidence requirements. This review aims to (i) analyze the current scientific and technological landscape of bac-teriophage applications in South American food systems, (ii) identify key regulatory challenges affecting their classification, authorization, and implementation, and (iii) discuss the need for harmonized international guidance, particularly through Codex Alimentarius, to support the safe and effective integration of phage-based bioprod-ucts across the farm-to-fork continuum. The results indicate a growing but uneven body of applied research, together with an expanding yet geographically concentrated patent and biotechnology landscape. Despite this progress, regulatory frameworks remain inconsistent, particularly in relation to classification, labeling, safety requirements, monitoring, and mechanisms for updating phage formulations. Addressing these gaps requires harmonized, risk-proportionate guidance that clearly defines product categories and claims, es-tablishes genomic safety standards and performance endpoints, and includes re-quirements for traceability and post-market surveillance. In this context, a Codex Alimentarius “New Work” on phage-based bioproducts could provide an interna-tional framework to support safe implementation, reduce regulatory uncertainty, and facilitate trade across global food systems.