EFSA Panel on Genetically Modified Organisms (GMO); Draft Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed

The weight-of-evidence, case-by-case approach is considered the most appropriate way of assessing the allergenicity of genetically modified (GM) food and feed. This scientific opinion discusses various aspects to increase the strength and accuracy of this approach, including the latest developments pertaining to clinical aspects of allergic reactions, structural aspects of GM food and feed and in silico approaches, as well as IgE binding studies and cell-based methods, profiling techniques and animal models. In this context, conclusions and recommendations are provided to update and complement current risk assessment strategies for the allergenicity assessment of newly expressed protein(s) and whole GM food and feed. In summary, it is recommended that with regard to the search for sequence homology and structural similarities, the local alignment method with a known allergen with a threshold of 35% sequence identity over a window of at least 80 amino acids is considered a minimal requirement. When IgE binding tests are considered necessary, e.g. when there is sequence homology and/or structure similarity with known allergens, the use of individual sera from allergic individuals rather than pooled sera is recommended. In addition to the pepsin resistance test, it is recommended that the resistance to digestion of the newly expressed proteins is evaluated using other in vitro digestibility tests mimicking physiological conditions of humans. Finally, when the recipient of the introduced gene is allergenic, in order to compare the allergenicty of the whole GM plant with that of its appropriate comparator(s), it is recommended that relevant characterised endogenous allergens are included in the comparative compositional analysis of the GM plant and its appropriate comparator(s). Proposals for the use of additional testing that may improve the weight-of-evidence approach and 1 On request of EFSA, Question No EFSA-Q-2005-125, adopted on 30 June 2010. 2 Panel members: Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal. Opinion is shared by all members of the Panel. Correspondence: gmo@efsa.europa. eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on “The assessment of allergenicity of genetically modified foods” for the preparation of this Draft Scientific Opinion: Rob Aalberse, Hans Christer Andersson, Philippe Eigenmann, Ralf Einspanier, Karin Hoffmann-Sommergruber, Gijs Kleter, Ilona Kryspin-Sorensen, Martinus Lövik, Clare Mills, Jean-Marie Saint-Remy, Willem Seinen, Daniel Soeria-Atmadja (until September 2009), Ingrid Van der Meer, Jean-Michel Wal (Chair) and John Warner (until September 2008); the following experts for their contribution on specialised issues: Dominique Kaiserlian (January 2007), Jean-Paul Lallès (July 2008), Gabriel Peltre (July 2007), André Penninks (January 2007); and EFSA’s staff members Ellen Van Haver and Antonio Fernandez Dumont for the support provided to this EFSA scientific output. Assessment of allergenicity of GM plants and microorganisms and derived food and feed 2 EFSA Journal 2010; 8(7):1700 suggestions for further evaluation of new promising methods that are as yet in an early phase of development are also addressed.