0, subscore: 0.00 ]: In this report the various elements of the safety and nutritional assessment procedure for genetically modified ( GM ) plant derived food and feed are discussed , in particular the potential and limitations of animal feeding trials for the safety and nutritional testing of whole GM food and feed . The general principles for the risk assessment of GM plants and derived food and feed are followed , as described in the EFSA guidance document of the EFSA Scientific Panel on Genetically Modified Organisms . In Section 0 the mandate , scope and general principles for risk assessment of GM plant derived food and feed are discussed . Products under consideration are food and feed derived from GM plants , such as maize , soybeans , oilseed rape and cotton , modified through the introduction of one or more genes coding for agronomic input traits like herbicide tolerance and/or insect resistance . Furthermore GM plant derived food and feed , which have been obtained through extensive genetic modifications targeted at specific alterations of metabolic pathways leading to improved nutritional and/or health characteristics , such as rice containing beta-carotene , soybeans with enhanced oleic acid content , or tomato with increased concentration of flavonoids , are considered . The safety assessment of GM plants and derived food and feed follows a comparative approach , ie the food and feed are compared with their non-GM counterparts in order to identify intended and unintended ( unexpected ) differences which subsequently are assessed with respect to their potential impact on the environment , safety for humans and animals , and nutritional quality . Key elements of the assessment procedure are the molecular , compositional , phenotypic and agronomic analysis in order to identify similarities and differences between the GM plant and its near isogenic counterpart . The safety assessment is focussed on ( i ) the presence and characteristics of newly expressed proteins and other new constituents and possible changes in the level of natural constituents beyond normal variation , and on the characteristics of the GM food and feed , and ( ii ) the possible occurrence of unintended ( unexpected ) effects in GM plants due to genetic modification . In order to identify these effects a comparative phenotypic and molecular analysis of the GM plant and its near isogenic counterpart is carried out , in parallel with a targeted analysis of single specific compounds , which represent important metabolic pathways in the plant like macro and micro nutrients , known anti-nutrients and toxins . Significant differences may be indicative of the occurrence of unintended effects , which require further investigation . Section 0 provides an overview of studies performed for the safety and nutritional assessment of whole food and feed . Extensive experience has been built up in recent decades from the safety and nutritional testing in animals of irradiated foods , novel foods and fruit and vegetables . These approaches are also relevant for the safety and nutritional testing of whole GM food and feed . Many feeding trials have been reported in which GM foods like maize , potatoes , rice , soybeans and tomatoes have been fed to rats or mice for prolonged periods , and parameters such as body weight , feed consumption , blood chemistry , organ weights , histopathology etc have been measured . The food and feed under investigation were derived from GM plants with improved agronomic characteristics like herbicide tolerance and/or insect resistance . The majority of these experiments did not indicate clinical effects or histopathological abnormalities in organs or it issues of exposed animals . In some cases adverse effects were noted , which were difficult to interpret due to shortcomings in the studies . Many studies have also been carried out with feed derived from GM plants with agronomic input traits in target animal species to assess the nutritive value of the feed and their performance potential Studies in sheep , pigs , broilers , lactating dairy cows , and fish , comparing the in vivo bioavailability of nutrients from a range of GM plants with their near isogenic counterpart and commercial varieties , showed that they were comparable with those for near isogenic non-GM lines and commercial varieties . In Section 0 toxicological in vivo , in silico , and in vitro test methods are discussed which may be applied for the safety and nutritional assessment of specific compounds present in food and feed or of whole food and feed derived from GM plants . 