Kasim Allel

Bacteriophage-based products are gaining attention as effective tools to reduce harmful germs in food and combat antimicrobial resistance throughout the food production process. However, in South America, their use is still limited because of complicated regulations and inconsistent evidence requirements. This review aims to (i) explore the current scientific and technological landscape of using bacteriophages in South American food systems, (ii) identify main regulatory challenges that impact their classification, approval, and use, and (iii) highlight the need for consistent international guidelines, especially from Codex Alimentarius, to help safely and effectively incorporate phage-based products in food. Research on phage-based products is growing, but it is not consistent across different regions. There are more patents and advancements in biotechnology, but they are limited to certain areas. Although progress is being made, the regulatory frameworks are still unclear, especially when it comes to how these products are classified, labeled, and monitored for safety. To address these gaps, risk-based guidelines are needed. These should define product categories and claims, set safety standards, and include rules for tracking products and monitoring them after they hit the market. Creating a new Codex Alimentarius project on phage-based products could help establish global guidelines that promote safe use, reduce uncertainty in regulations, and improve trade in food markets around the world.

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.

Background. The United Nations General Assembly High-level Meeting on Antimicrobial Resistance (UNGA HLM-AMR) committed to a target that 70% of global human antibiotic use (ABU) should be from the Access group of the WHO AWaRe system. Methods. We used 2019 IQVIA MIDAS global ABU Quarterly value sales, volumes (kg/SU) and average ex-manufacturer prices to evaluate price per daily defined dose (DDD) by AWaRe group across countries. IQVIA MIDAS volumes/value data reflect public, private, or mixed sectors. We estimated potential national pharmaceutical expenditure savings if i) the UNGA 70% Access target was met, and ii) national ABU aligned with the WHO Model List of Essential Medicines (EML). We evaluated 7-day treatment prices for common oral and parenteral antibiotics across AWaRe groups. We measured affordability in middle-income countries (MICs) by income group, as the percentage of the population at risk of falling below national poverty lines if paying out-of-pocket, using income distributions and generalised beta distributions of the second kind. Prices were reported in 2019 international dollars (I$). Results. Volume-weighted ex-manufacturer prices per DDD were lower for Access (I$1.2, IQR I$0.7) than Watch (I$2.6, IQR I$2.1) and highest (I$83.8, IQR I$80.9) for Reserve antibiotics. Lower prices were seen in high-income countries for Access antibiotics. Meeting the 70% Access target could save countries I$0.1 million-I$4.9 billion annually. Global savings could reach I$10.4 billion if only WHO EML-listed antibiotics were used. Seven-day parenteral meropenem could put 7% (IQR 9%) of the population in MICs at risk of impoverishment. Conclusion. Antibiotic policies focused on achieving the UNGA-AMR 70% Access target could generate significant potential national and global expenditure savings.