SPECIAL STORY FEED & ADDITIVE MAGAZINE November 2023 61 example, certain studies used for the approval of a product in one species, such as those related to characterization or user/worker safety, can be reused for extension to another species, meaning one successful product approval can open the door to further product approvals requiring less time and fewer resources. What’s more, zootechnical additive authorizations are holder-specific, with the successful applicant receiving exclusive rights to the additive for ten years. Accordingly, companies that invest in bringing an innovative zootechnical feed additive to market can rest assured that their revenues and profits will be better protected. But while zootechnical additives have clear and numerous benefits, bringing them to market in Europe is no easy feat. Developers must contend with complex regulations that can quickly overwhelm even the most well-prepared companies. NAVIGATING EUROPE’S ROCKY REGULATORY LANDSCAPE The Feed Additives Regulation (Regulation (EC) No 1831/2003) is the key overarching regulation that establishes the procedure for feed additive authorization in Europe, with Commission Regulation (EC) 429/2008 providing more detailed rules on how to apply those regulations. Given that such regulations are not entirely prescriptive, EFSA provides a series of documents offering guidance on all aspects of the application — from the design of characterization and efficacy studies, through to additional information on how to conduct statistical analyses, build a robust dossier, and correctly submit it. Functional group Examples Digestibility enhancers Gut flora stabilizers Substances that favorably affect the environment Physiological condition stabilizers “Other” Enzymes, enzyme preparations, and live yeasts that improve digestibility of diet through direct action on feed materials “Probiotic” bacteria and yeasts that positively impact gut flora Products that reduce greenhouse gas emissions from animals Products that help to reduce stress indicators or affiliated markers (e.g., immune system regulation, inflammation, body condition) Products that improve production parameters (e.g., by increasing weight gain, lowering feed: gain ratio), modify physiological parameters (e.g., reducing urinary pH), or support reproductive performance (e.g., through antioxidant effects) Table 1. The zootechnical food additives category can be further divided into five functional groups, accounting for the variety of effects of zootechnical additives
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