The Feedap panel (Feed Additives)/EFSA has adopted an updated version of its guidance for the renewal of feed additives authorisations. This draft document is open to public consultation until 26 January, before final adoption, probably around March 2020.
According to the Regulation 1831/2003, feed additives authorisations are time-limited. They have to be renewed every ten years, on the basis of an application, which has to be tabled at least 1 year in advance of the authorisation’s expiry date.
Back in 2013, the Feedap has produced a guidance to help applicants preparing properly the technical dossier required for renewal and so to pass smoothly the assessment. Based on the experience acquired on the dossiers that already had to go through this process, the panel decided to update and clarify its expectations as far as coming renewal dossiers are concerned.
Without precluding on the possible modifications to the draft that could result from the public consultation, one can already take stock of some general orientations. The overall principle is that dossiers need to be upgraded to most up-to-date scientific knowledge and to state-of-the art of current evaluation practices, as they are notably detailed in the six topic-specific guidances that Feedap adopted between 2017 and 2019. Some of them will obviously trigger additional studies to maintain status quo of authorisation.
The focus is of course particularly placed on the safety section of the dossier, but the identity aspects are relevant as well. The efficacy part is not subject to particular requirements, unless the characteristics of the product or its conditions of use have evolved, or if the applicant sees a need to bring additional or new elements. The guidance is also calling for some market production and consumption data, which might create some further hurdle. The users/workers safety is also gaining increasing attention though, in absence of an updated guidance in this area, it will require more individual expertise.
The impact of these requirements might be quite variable, depending on each dossier’s history and content: was it a re-authorisation or a new application, early re-authorisation versus more recent ones, dossier prepared on a very generic basis versus a more specific approach, etc. Practically, the upgrading work could range from a limited update on specific aspects to an extensive almost de-novo dossier. In all cases, the new guidance requests that it must be a “stand-alone” document allowing EFSA to perform its assessment.
While at the time of the re-authorisation dossiers in 2010, the setting up of consortia came up as a golden route, to smoothen the process and limit individual burden, the current data requirements for the assessment and individual product positioning, will probably call for further strategic reflection at individual company level. Getting the right picture in this reflection might get even more delicate, depending on the nature and extend of the modifications that might come as a result of a possible revision of the Regulation 1831/2003.
While a significant number of additives are not out of the re-authorisation process yet, the renewal is profiling very concretely for a number of additives that went through, and it would be unwise to underestimate potential burden. In this context, for timely preparation and tabling of the dossier, one could suggest that renewal projects should be started at least 3 years ahead of the authorisation expiry date, including proper strategic reflection and integration of the new requirements. SERRPA is available to provide support to individual and collective endeavors in this area.