ISSUE FOCUS 48 FEED & ADDITIVE MAGAZINE February 2025 ples to the EURL-FA and arrange a fee-payment following their administrative guidance. 2. Dossier preparation and submission In the dossier, applicants must provide detailed information supporting the characterization, safety and efficacy of the microorganism. A dossier comprises three sections: • Identity and Characterization: Information about the quality of the product, impurities, stability and methods of analysis must be provided, alongside detailed descriptions of the manufacturing processes to demonstrate batch consistency. • Safety: The safety of the microorganism strain needs to be evaluated for animals, humans and the environment. If the strain qualifies for Qualified Presumption of Safety (QPS) status, meaning there is already an existing knowledge of the safety profile, then a full assessment won’t be required, streamlining the process. User worker safety data also needs to be provided. • Efficacy: All relevant information must be provided for all studies, including detailed descriptions of study designs and evidence of compliance with appropriate animal welfare regulations. All studies must follow current EFSA efficacy requirements. Additionally, according to article 39 of EU regulation 2019/1318, applicants must create both a confidential and non-confidential version of each annex of the dossier with proper justification for each confidentiality request. 3. Risk assessment After the full dossier is submitted and validated by EFSA, the scientific assessment starts. During this, scientific officers can request additional information, stopping the clock until the applicant submits responses and outstanding data. 4. Post-adoption phase EFSA adopts a scientific opinion and, if positive, the draft authorization is discussed by the Standing Committee on Plants, Animals, Food and Feed. The authorization is then published in the EU Official Journal and the feed additive is listed in the EU Register of feed additives. In the best-case scenario, microorganism approval will take around 2-4 years, but it can be much longer if applicants don’t adopt a strategic and well-informed approach from the outset. CHANGES IN THE MICROORGANISMS EFSA GUIDANCE EFSA’s previous guidance on microorganisms, released in 2018, provided a foundational framework for assessing microorganisms used in feed additives, focusing primarily on bacteria, yeasts, and filamentous fungi. The guidance highlighted key principles such as the need for thorough characterization of microorganisms, rigorous safety evaluations for both animals and humans, and comprehensive environmental risk assessments. While this framework has served the industry well, it had certain constraints. Notably, the scope of the guidance was somewhat limited, primarily addressing established microorganism categories without fully accounting for emerging groups. As demands for new and diverse microorganisms in animal feed have grown, these gaps in the regulatory framework have become more apparent. In response, EFSA has updated its draft guidance: Scope Expansion One of the most notable updates to the regulations is the inclusion of new microorganism categories. For the first time, viruses (including bacteriophages) and microalgae are now specifically included. Additionally, the new draft guidance introduces updated protocols for evaluating genetically modified microorganisms (GMMs) and production strains. Standardization of Characterization Methods EFSA has now standardized the approach to characterizing microorganisms. Whole Genome Sequencing (WGS) must be used to identify bacteria, yeasts, filamentous fungi, and viruses at the species level. For microalgae and other protists, taxonomic
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