ISSUE FOCUS FEED & ADDITIVE MAGAZINE September 2023 37 Fortunately, there are actions developers can take to streamline the path to regulatory success. The first being to understand the regulatory landscapes they face. DECIPHERING THE REGULATORY FRAMEWORK IN THE EU In the EU, the approval and ongoing market access of plant-based additives is governed by regulations that focus on the rigorous assessments of quality, safety, and efficacy. At the helm of the regulatory framework is the European Food Safety Authority (EFSA), which undertakes an independent, detailed scientific review of the submitted dossier before reporting findings and offering advice to the European Member States and European Commission. Together, the EU Member States and European Commission then assess the EFSA’s findings and original submissions to decide whether the product is approved. This process typically takes 2–3 years. However, the authorization timeline can be drastically extended. To minimize approval timelines, the importance of compiling a comprehensive and high-quality dossier cannot be overstated. EU Regulations and EFSA guidance documents are not merely suggestions, but detailed and stringent frameworks that must be cautiously followed. Any gaps in information or lapses in adherence can result in a “stop-the-clock” approach, which elongates the approval timeline. While the EFSA provides written guidance to aid dossier creation, there are many nuances that developers have to get to grips with that even those working in regulatory roles can find challenging. And that’s not all. Developers of plant-based nutritional additives also face the dynamic nature of EU regulations. Frequent changes, such as the enforcement of the Transparency Regulation in 2021 often introduce new hurdles. For example, since the 2021 update, developers must notify the ESFA of studies involving any analytical work conducted for the registration of a feed additive prior to their commencement. Failure to do so results in a 6-month penalty period levied on the review of the application.1 As explained by Laura Payo Lewis, Regulatory Affairs Director, Animal Nutrition at Pen & Tec Consulting, Part of the Argenta Group, staying abreast of regulatory changes is paramount. “Developers need to ensure they’re receiving regulatory news as it’s released. This is the best way to prepare for any changes and avoid penalties for failing to adapt to new regulations.” “Staying on top of regulatory updates, and what they mean for your organization is difficult and time consuming. For example, by June 2024, the EFSA is expected to release the update of four pieces of guidance, one which will impact developers in the planning of efficacy studies for plant-based nutritional additives, and another which will impact the requirements for demonstrating safety for the users handling the additives. At Pen & Tec Consulting, we proactively track and share how we expect regulatory changes to impact developers on our website, and with our subscribers via email.” NAVIGATING THE REGULATORY LANDSCAPE IN THE US The regulatory landscape in the US is different to that in Europe, but no less complex. There are multiple approval pathways, including: 1. GRAS (Generally Recognized as Safe): The GRAS route offers two possibilities to developers. The first involves self-determining a substance as GRAS, while the second involves submitting a GRAS determination to the FDA for review. The latter, requiring FDA approval, typically carries greater weight with industry stakeholders and regulators. 2. FAP (Food Additive Petition): FAP is an application process to the FDA for approval of a new food additive. The petition must present convincing evidence of the safety of the substance. 3. AAFCO New Ingredient Determination (American Association of Food Control Officials): The third major pathway involves a new ingredient determination made by AAFCO, an authoritative assembly providing guidance on animal feed ingredients. When selecting the regulatory approval pathway, developers should consider the nature of their plant-
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