ISSUE FOCUS FEED & ADDITIVE MAGAZINE February 2025 47 the feed additive to) can place the feed additive on the market, ensuring better protection of revenues and profits. While microorganisms have demonstrated clear benefits in feed applications, the regulatory pathway to approval for microorganisms has remained complex and challenging. Now, a significant regulatory shift is approaching, with new draft guidance from the European Food Safety Authority (EFSA) set for public consultation until February 7 and final implementation by June 2025. “This revision represents more than just procedural updates, it fundamentally expands the scope of microorganism regulations while simultaneously introducing more rigorous assessment criteria,” says Flavia De Marta, Business Development Manager at Argenta. “For developers navigating this evolving landscape, understanding these imminent changes is crucial for ensuring compliance.” Here, we examine the critical updates in EFSA's draft guidance, their implications for product development strategies, and steps developers should take to better prepare for the new requirements. UNDERSTANDING THE EFSA EVALUATION PROCESS There are three main bodies involved in the microorganism approval process: EFSA, the EU reference laboratories for feed additives (EURL-FA), and the European Commission (EC). EFSA’s role is to provide scientific advice to support the authorization of feed additives. It examines the efficacy and safety data of the additive to determine whether it has harmful effects on humans, animals, or the environment. The EURL-FA evaluates testing methods to ensure they are fit for official controls. If EFSA’s opinion is favorable, the EC prepares a draft regulation to authorize the additive, which is then discussed and endorsed by Member states.1 When submitting a request to EFSA for evaluation of a microorganism, there are four main stages: 1. Pre-submission phase • Notification of studies: applicants must provide EFSA with details of relevant studies, including the type of study and start date, before they conduct them. The penalty for not doing so is a six-month delay in the application process. • EURL-FA samples: applicants must send samFunctional Group Definitions Digestibility enhancers Gut-flora stabilizers Substances that favorably affect the environment Physiological condition stabilizers Other zootechnical additives Substances which, when fed to animals, increase the digestibility of the diet Microorganisms or other chemically defined substances, which, when fed to animals, have a positive effect on gut flora Products that reduce greenhouse gas emissions from animals Substances (or, when applicable, microorganisms) that, when fed to animals in good health, favorably affect their physiological condition, including their resilience to stress factors. Products that improve production parameters, modify physiological parameters, or support reproductive performance Table 1. The five functional groups of zootechnical feed additives
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