A spokesperson for the Parma headquartered agency told FeedNavigator: “There is an added level of complexity in the data required for the submission of botanically derived feed additives, particularly when it comes to substance identity and description.
Given the large number of dossiers submitted to EFSA for evaluation, containing 286 botanical preparations in total, the Authority identified a need to procure support for the preparatory phase of the risk assessment, namely data management which involves the preparation of summary data sheets.”
This activity, he said, was outsourced to the University of Hertfordshire, following a tender process.
EFSA has been re-evaluating all feed additives currently on the market, authorized under the previous regulatory framework, such that they are harmonized with the current regulation.
Complex chemical mixtures
The Authority says that, in terms of botanical based substances, the issue of identification is complicated as botanicals are complex chemical mixtures and the exact nature of the mixture can vary with species, variety or cultivar, the part of the plant used and, in some instances, its place of origin.
“To complicate matters further, the formulation of botanical substances into preparations for market can be done via a variety of different manufacturing processes which is often dependent on the physico-chemical properties of the botanical substance, including for example, steam distillation, infusion, hydro-alcoholic extraction or super critical carbon dioxide extraction.
The specific manufacturing process used often affects the composition of the preparation,” notes the experts in the commissioned report.
Data sheet work
The consultants at the University of Hertfordshire examined 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 reviewed against this checklist.
They said this analysis involved extracting data for each botanical preparation and using this to populate a database. The academics then employed customized software to perform a gaps analysis and to generate a summary data sheet for each preparation, which were sent to EFSA.
“Those data sets will be used by the FEEDAP Panel when they soon begin assessing botanically derived feed additives,” said the EFSA spokesperson.
Standardized templates
The university based team, in their report, said the variability in the data provided in the dossiers for all 268 botanical preparations is well reflected in the summary data sheets: “Those gaps and inconsistencies in the identity and characterization 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 identity and characterization section.”
The authors suggest discrepancies in data between different parts of the dossier can be eliminated or minimized by more robust and thorough checking prior to submission.
“Additionally, standardized templates would also help improve consistency in both content and format across dossiers,” they added.
The EFSA spokesperson told us it is always looking at ways to encourage consistency in the way data are presented by applicants in dossiers, which may include the use of standardized templates in some areas.
“But there is also a balance to strike to ensure that dossier preparation does not become overly burdensome for applicants. EFSA has adopted a series of guidance documents to assist applicants in the preparation of dossiers but ultimately the data requirements that applicants must follow for the evaluation of feed additives are set out in Regulation (EC) No 1831/2003 and in the implementing Regulation (EC) No 429/2008,” he added.