She said the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is committed to continuing the feed additive re-evaluation process (Regulation (EC) No 1831/2003], which is likely to be finalized in 2016.
“In addition, we started to work on the assessment of botanicals used in feed - definitely a challenging task - and we will soon identify if our guidance documents need to be updated, and define a list of priorities.
In July, we will also have the first plenary after the [FEEDAP] Panel renewal and we will then have to set up the new working groups,” said Tiramani.
Article 7(6) of Regulation (EC) No 1831/2003 requires EFSA to publish detailed guidance to assist applicants in the preparation and presentations of applications.
The Feed unit has release several such supporting documents in the last 18 months. October 2013 saw it publish guidelines outlining what evidence is needed for the renewal of approval of a feed additive - the FEEDAP Panel said dossiers should show the additive has not been changed or altered in composition, purity or activity since it was originally authorized.
The Panel also released guidance in May 2014 aimed at providing applicants with up-to-date data on how to conduct the safety assessment of Bacillus-based products.
Workload pressures
EFSA’s 2014 Activity Report, published last month, showed its target for scientific evaluation of all products, substances and claims subject to authorization could not be reached last year mainly because of “delays in adoption of opinions related to feed additive applications due to the high workload of the panel.”
Tiramani said the time it takes to process a particular mandate depends on many factors such as the quality of the dossier, in terms of the amount and quality of the data available, as well as how convoluted the process of collecting, collating and analyzing information received from stakeholders is.
“The mandates involving dossiers from consortia can also be time consuming for the same reasons; an additional factor that can impact on the length and complexity of the discussion is related to the coordination with other different units and Panels that are carrying out assessments on the same subject,” she added.
The Feed Unit has been charged with establishing a task force aimed at coordinating and harmonizing the assessments of the same active ingredients and substances across different EFSA panels.
Reliance on external experts
EFSA recently used consultants in the initial phase of the botanical feed additives assessment.
“Given the large number of dossiers submitted for re-evaluation, EFSA identified a need to procure support for the preparatory phase, namely data management involving the preparation of summary data sheets for botanical and technological feed additives. This activity, which did not include any risk assessment, was outsourced through EFSA’s grant and procurement scheme,” said Tiramani.
According to the FEEDAP Panel, in terms of botanical based substances, the issue of identification is complicated as they 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.
Consultants at the University of Hertfordshire, who were awarded the tender for the preparatory phase of the botanical feed additives assessment program, 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 are now being used by the FEEDAP Panel.
Conflict of interest
When it was put to her that there is a perception that the management of the conflict of interest in EU institutions policy makes it difficult to recruit scientific experts for working groups, Tiramani said:
“We need to acknowledge that a lot of research nowadays, even in the public sector, may be partially supported by private funding. Luckily, having an interest does not necessarily mean having a conflict of interests.
EFSA has a robust policy on independence, which has been described as one of the most sophisticated in Europe by the European Court of Auditors. It takes into consideration the interests in the context of the role that an expert will assume, the work that he/she will carry out and the remit of the scientific group.
Nevertheless, no-one employed by industry or as a full-time consultant can be an expert on an EFSA panel or working group.”
Future challenges
The FEED unit, in collaboration with the application helpdesk, will be engaging with feed industry stakeholders at a technical meeting in Barcelona next month in order to allow an exchange of views on scientific issues related to the preparation, submission and the risk assessment of applications on feed additives.
“All participants and stakeholders will have the opportunity to provide feedback on their past experiences in risk assessment of feed additives as well as discuss future challenges,” said Tiramani.