ISSUE FOCUS 50 FEED & ADDITIVE MAGAZINE February 2025 bacteriophages should be conducted using a curated, up-to-date database, and the search should be no older than two years from the date of submission. ENVIRONMENTAL RISK ASSESSMENT When it comes to environmental risk assessment, the regulations now have a specific focus on microbiome interactions and the potential for horizontal gene transfer between microorganisms. QPS strains are excluded from additional environmental assessments, streamlining the process for microorganisms that have already been deemed safe. For GMMs, a comparative analysis with their non-modified parental strains is required to ensure that the modifications don’t introduce environmental risks. IMPACT ON THE GUT MICROBIOMES A significant new addition to the draft guidance is the need to assess microorganisms' potential adverse effects on gut microbiomes. EFSA now stipulates that developers should assess for potential risks such as dysbiosis (a disruption in the gut’s microbiota) and the shedding of pathogens, acknowledging that microorganisms used in feed additives could influence the overall health of animal microbiomes. KEY TAKEAWAYS: PRACTICAL IMPLICATIONS OF EFSA’S NEW DRAFT GUIDANCE The updates in the new draft guidance will have several important practical implications for applicants: Opportunities and Challenges for Innovative Products Different microorganism product categories, such as viruses, bacteriophages, and microalgae, now feature more prominently in the framework, offering new opportunities for innovative feed additives. However, pioneer products may still face challenges due to their novelty. Enhanced Regulatory Scrutiny in Antimicrobial and Antimycotic Resistance Clearer guidance on how to interpret antimicrobial and antimycotic resistance could help to better predict regulatory outcomes. Time to Perform Studies The regulations now require additional testing in several areas, where some tests need to be conducted within a specific time window. For example, WGS must now be carried out within two years of the application submission date, which demands more careful planning and can add complexity to existing programs. Susceptibility Testing In cases where some references — such as cutoff values for susceptibility testing — don’t apply across all bacterial, yeast, and fungal species, applicants may justify deviations from the guidance that EFSA will assess on a case-by-case basis. Since this leaves room for the interpretation of the authority, applicants need to clearly understand
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