Preparatory work to support the re‐evaluation of technological feed additives (OC/EFSA/FEED/2013/01)

Abstract

Technological feed additives are intended to improve or favourably affect the characteristics of feed but have generally no direct biological effect on animal production. The authorisation procedure for feed additives including technological additives is established by Regulation (EC) No 1831/2003. Article 10 of the Regulation sets the principles of the re-evaluation of feed additives which are already on the market in the EU and/or which were authorised under the previous regulatory framework. The aim of the re-evaluation is to ensure that all feed additives in the EU market are evaluated under the same safety standards taking into consideration the most recent data. The scientific evaluation is carried out by the Scientific Panel on Additives and Products or Substances used in Animal Feed of the European Food Safety Authority with the support of the FEED Unit. The evaluation is based on the data contained in the dossiers submitted for the re-evaluation. In 2013 EFSA launched a procurement call for the provision of summary data sheets as part of the preparatory work with regard to the re-evaluation of technological feed additives. The analysis of the data contained in the dossiers focused on the identification of gaps between the available information and the data requirements set in the applicable legislation and guidance documents. During the second year of the framework contract, 14 dossiers were analysed with respect to the requirements for technological additives. Fourteen summary data sheets and 8 lists of missing information were elaborated in line with EFSA's requirements. With regard to the completeness of the information, gaps have been identified in all three main sections (identity, safety and efficacy) in all of the dossiers reviewed. Such gaps might delay the evaluation process preventing risk assessors to conclude on all aspects of the safety and efficacy of the additives.