SPECIAL STORY 62 FEED & ADDITIVE MAGAZINE November 2023 The application process involves many steps, and typically takes anywhere from 3–4 years (Figure 1). To navigate it successfully, companies must deal with three major challenges: overwhelming complexity, continual regulatory evolution, and subtle, yet critical, geographical differences. Overwhelming complexity The first challenge developers will likely face on the path to regulatory success in Europe is the huge number of guidance documents they must contend with. Simply finding feed additive regulations and guidance documents is easy enough (they are freely available online). Identifying the right, up-to-date and applicable documents, however, can be a time-intensive and error-prone process. Indeed, even with a deeply experienced regulatory team, the process can be hugely disorienting, and could lead to costly mistakes that delay market entry. As noted by Andrew Bell, Regulatory Affairs Manager at Pen & Tec Consulting, part of the Argenta Group, even in this early stage of the regulatory journey, companies can make a wrong turn that can drive costs and drastically reduce chances of application success. “Companies underestimate how easy it can be to design efficacy studies based on outdated guidance documents, only to realize the mistake too late. The time and cost impacts of having to start these studies from scratch are hard to overstate — and painful to think about.” Dynamic regulations Beyond the wealth of documentation, developers must also contend with the fact that regulations and guidance documents get revised regularly. Staying abreast of these changes, and most importantly, understanding how they might impact your application, is a substantial task. The 2021 transparency regulation (Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019) is a good example of a recent change with far-reaching impacts for feed additive developers. The new regulation introduced several changes into the General Food Law, one of the most important being a need for companies to notify EFSA prior to the commencement of any analytical studies. While this is a welcome change that guarantees all relevant studies are submitted (thereby ensuring the most appropriate decision is made with regards to authorization), failure to notify EFSA can have drastic consequences — namely, a 6-month penalty delay on dossier assessment. Such a significant penalty can draw out the application process and postpone market entry, delaying return on investment. Figure 1. Simplified overview of the application process for new zootechnical feed additives in the EU Andrew Bell Regulatory Affairs Manager Pen & Tec Consulting, part of the Argenta Group
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