SPECIAL STORY FEED & ADDITIVE MAGAZINE November 2023 63 The new 2021 Transparency Regulation also saw the creation of an EC portal (the E-Submission Food Chain Platform) where applicants can upload dossier information. Such a portal can make submissions more convenient in some respects. However, it also adds a host of GDPR requirements that developers must fulfil for smooth progression of their application. Again, failure to meet these requirements can incur costly delays to application progression. Other changes are on the horizon, too. For example, the industry is awaiting a substantial refit to Regulation (EC) No 1831/2003 to facilitate compliance with the EU Farm to Fork Strategy and the European Green Deal (currently on hold but expected to come into effect 2025 or thereafter), and updates to guidance on efficacy, user worker safety, microorganisms & Whole Genome Sequencing are on track for adoption by June 2024 — all of which could substantially impact zootechnical additive applications. Of course, such a continually evolving regulatory landscape can complicate the path to smooth regulatory approval. In the worst case, changes could mean that in-progress studies may not be suitable, requiring additional work or a repeat of the study. As a result, developers could end up wasting significant time and resources and facing delayed market entry. “There’s no doubt that unfortunately timed regulatory refits can cause upheaval for developers looking to bring new zootechnical additives to market,” said Andrew. “Developers must be able to swiftly spot signs of impending change, as well as anticipate its impact on their specific product. The problem is that doing so demands extensive regulatory knowledge, and a lot of time.” Geographical differences Compounding the problems of overwhelming documentation and shifting requirements are global and local geographical regulatory discrepancies. Feed additive regulations in Europe differ greatly from those in the US. In the US, developers have not just one but several ways to register a feed additive, each with vastly different data requirements. The Food Additive Petition (a dossier placed with the FDA) is the most similar to feed additive applications in the EU, but even here, the details are fundamentally different. As such, zootechnical feed additive producers with US approval wishing to expand into Europe may need to repeat or redesign studies to meet European requirements. Even within Europe, there are important regulatory differences, most notably between the UK and the rest of Europe. In the UK the Food Standards Agency (FSA) took over much of EFSA’s role after Brexit. While the FSA mirrored EFSA initially (owing to retained regulations) it has not evolved in line with EFSA’s regulatory changes, and the divergence is expected to continue in future. Additive developers must, therefore, ensure they are aware of these discrepancies if they are to secure and maintain access to markets in both the UK and the rest of Europe. As Andrew noted, “The regulatory differences between the UK and the rest of Europe can be frustrating for developers looking to market their products in both regions. This is particularly evident in instances where EFSA has removed the need for some studies since Brexit, as companies will still have to conduct them for UK application.” SMOOTHING THE ROUTE TO REGULATORY SUCCESS WITH THE RIGHT EXPERTISE With so many challenges on the road to European regulatory success, it’s no surprise that the chance of error is high. Those errors, even if small, can cause costly setbacks that stymie progress, slow the route to market, and ultimately, delay returns on investment. However, that’s not to say that companies can’t take steps to minimize risks. Indeed, perhaps the most important and impactful step that a zootechnical developer can take to maximize chances of regulatory success is to work with highly knowledgeable and experienced consultative partners. Doing so offers a whole host of benefits.
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