EFSA Press release, 15 December 2006
Today EFSA launched a public consultation on the use of animal feeding trials to assess the safety and nutritional value of GM food or feed. EFSA's GMO Panel discussed the different types of scientific tests available including the use of animal feeding trials and made a number of recommendations. This work aims at providing further guidance on risk assessment approaches for GM food and feed, which may also be relevant for other areas of food and feed safety assessment. Views of all stakeholders and interested parties are now being sought before final recommendations are agreed.
The risk assessment of GM plants and derived food/feed is based on comparison with non-GM counterparts. The GMO Panel considers that a comparative approach following international risk assessment standards using molecular, compositional and other analyses [see note 1 below] remains an appropriate basis for determining whether animal feeding studies are needed.
The Panel recommends that any risk assessment of GM food/feed should first consider whether initial studies using in silico [see note 2 below] and in vitro [see note 3 below] approaches may answer some of the safety questions and indicate whether there is a need for subsequent in vivo [see note 4 below] studies, such as animal feeding trials. This report discusses in depth the strengths and weaknesses of repeated dose animal feeding trials for the risk assessment of whole GM food or feed. Such feeding trials on the whole food or feed should be considered in cases of substantial differences between the GM plant and its conventional counterpart or where there are indications for the potential occurrence of unintended effects. In addition, the Panel considered when livestock feeding studies are needed for the safety and nutritional evaluation of feed derived from GM plants.
The Panel made a number of recommendations to help improve the scientific basis for assessing the safety and nutritional aspects of whole foods, such as further development of in silico and in vitro tests as well as recommendations for appropriate design of in vivo tests.
Comments are invited by 31 January 2007 on the consultation paper on animal feeding trials, which is available on the EFSA website at: http://www.efsa.europa.eu/en/science/gmo/gmo_consultations/gmo_AnimalFeedingTrials.html
 See the Guidance Document of the GMO Panel for the risk assessment of GM plants and derived food and feed (http://www.efsa.europa.eu/en/science/gmo/gmo_guidance/660.html)
 Data generated and analysed using modelling and information technology approaches.
 Study in the laboratory usually involving isolated organs, tissues, cells or cellular fractions.
 Study performed on a living organism.