ISSUE FOCUS 38 FEED & ADDITIVE MAGAZINE September 2023 based nutritional feed additive, the public availability of safety and efficacy information, and the recognition of the approval pathway in the industry. Conventional approval timelines take around 2-3 years but can extend further if the authorities require additional clarifications, studies, or documents. Success in maneuvering through the U.S. regulatory landscape requires a thorough understanding of all potential pathways, bolstered by strategic planning and careful dossier preparation. By choosing the most suitable pathway, developers can ensure dossiers are prepared to regulatory expectations and potential delays are minimized. Notably, in contrast to the EU model, which relies heavily on written guidance, the US authorities propose a more ‘open’ approach to pre-submission engagement, encouraging developers to clarify questions and concerns before formal submission. As such, having contacts within the regulatory bodies, or working with an external party who does, is of great benefit to developers. THE REGULATORY CHALLENGES FOR PRODUCERS No matter which territory, the regulatory journey towards introducing plant-based nutritional feed additives to the market is fraught with common hurdles that developers often stumble at. UNDERSTANDING AND KEEPING UP WITH REGULATIONS Ensuring a comprehensive grasp of regulatory intricacies is essential to navigate the approval process smoothly. This knowledge must evolve in line with ever-changing regulations, which is a time-consuming endeavor. Failing to keep up with updates can result in delayed market entry or, in worst-case scenarios, the need to repeat costly and lengthy studies. CONSTRUCTING COMPREHENSIVE AND HIGH-QUALITY DOSSIERS A comprehensive dossier isn't prepared just to satisfy an item on a checklist; it's an integral element that if done well will minimize the need for regulators to ask follow-up questions and their associated delays. In contrast, a dossier that does not satisfy all requirements contributes significantly towards increased resource expenditure, cost escalation, and loss of potential earnings due to a delayed market presence. MAINTAINING REGULATORY COMPLIANCE POST-APPROVAL Plant-based nutritional additives don’t just have to earn regulatory approval — they have to maintain it. This involves making any product, label or packaging updates as required, particularly in response to changing regulations, and submitting renewal dossiers in a timely manner. Failure to do so can result in the loss of market access and therefore a loss of earn-
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