%0 Journal Article %T Environmental risk assessment of genetically modified plants - concepts and controversies %A Angelika Hilbeck %A Matthias Meier %A J£¿rg R£¿mbke %A Stephan J£¿nsch %A Hanka Teichmann %A Beatrix Tappeser %J Environmental Sciences Europe %D 2011 %I BioMed Central %R 10.1186/2190-4715-23-13 %X Implementation of the current ERA concept of GM crops in the EU is based on an interpretation of the EU regulations that focuses almost exclusively on the isolated bacteria-produced novel proteins with little consideration of the whole plant. Therefore, testing procedures for the effect assessment of GM plants on non-target organisms largely follow the ecotoxicological testing strategy developed for pesticides. This presumes that any potential adverse effect of the whole GM plant and the plant-produced novel compound can be extrapolated from testing of the isolated bacteria-produced novel compound or can be detected in agronomic field trials. This has led to persisting scientific criticism.Based on the EU ERA framework, we present an improved ERA concept that is system oriented with the GM plant at the centre and integrates a procedure for selection of testing organisms that do occur in the receiving environment. We also propose a hierarchical testing scheme from laboratory studies to field trials and we illustrate the outcomes for three different crop case examples.Our proposed concept can alleviate a number of deficits identified in the current approach to ERA of GM plants. It allows the ERA to be tailored to the GM plant case and the receiving environment.In most countries of the world, genetically modified (GM) organisms are subject to regulation. In Europe and all countries that are signatories to the Cartagena Protocol, environmental risk assessment (ERA) is required for the regulatory approval of GM organisms (GMO) (CBD 2000, Annex II; 6; 1, Annex III) [1].ERA as defined in the European Union (EU) legislation has to evaluate the 'risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose' (EC 2001, Annex II) [2]. In addition, potential cumulative long-term effects have to be analysed. The EU Directive 2001/18 (EC 2001, Annex II) [2] further describes t %U http://www.enveurope.com/content/23/1/13