Preparatory work to support the re-evaluation of botanically defined feed flavouring additives

Abstract

In recent years, interest in the use of naturally occurring substances of botanical origin as livestock feed additives has increased significantly. Before any additive can be marketed it must undergo a rigorous scientific evaluation to demonstrate both its safety and its efficacy under Regulation (EC) No 1831/2003. EFSA has been re-evaluating all feed additives currently on the market, authorised under the previous regulatory framework such that they are harmonised with the current regulation. As part of this work, EFSA issued a tender to procure support for this re-evaluation process as there was a need to consider the completeness of data submissions related to substance identity and description, physico-chemical properties, purity and manufacturing processes. This involved examining the data required for the implementation of Regulation (EC) No 429/2008 and for compliance with EFSA guidance to form a data checklist. Twenty dossiers, containing 268 botanical preparations, were then analysed against this checklist. This involved extracting data for each botanical preparation and using this to populate a database. Bespoke software was then used to perform a gaps analysis and to generate a summary data sheet for each preparation. The summary data sheet and gaps analysis report were then submitted to EFSA. The variability in the data provided in the dossiers for all 268 botanical preparations are well reflected in the summary data sheets. Those gaps and inconsistencies in the identity and characterisation may impact on data to be provided in other sections. There is scope to improve the consistency of scientific data reporting and presentation throughout the characterisation and identity section of the dossier.