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Food Chem Toxicol. 2017 Mar;101:139-148. doi: 10.1016/j.fct.2017.01.014. Epub 2017 Jan 19.

Assessment of endogenous allergenicity of genetically modified plants exemplified by soybean - Where do we stand?

Author information

European Food Safety Authority, Parma, Italy.
INRA-CEA, Gif sur Yvette Cedex, France.
Institute of Food Science Research, CIAL (CSIC-UAM), Madrid, Spain.
Norwegian Institute of Public Health, Oslo, Norway.
School of Biological Sciences, Manchester Academic Health Sciences Centre, Manchester Institute of Biotechnology, The University of Manchester, Manchester, United Kingdom.
Department of Pathophysiology and Allergy Research, Medical University of Vienna, Vienna, Austria.
European Food Safety Authority, Parma, Italy. Electronic address:


According to EU regulation, genetically modified (GM) plants considered to be allergenic have to be assessed concerning their endogenous allergens before placement on the EU market, in line with the international standards described in Codex Alimentarius. Under such premises, a quantitative relevant increase in allergens might occur in GM plants as an unintended effect compared with conventionally produced crops, which could pose a risk to consumers. Currently, data showing a connection between dose and allergic sensitisation are scarce since the pathophysiological mechanisms of sensitisation are insufficiently understood. In contrast, data on population dose-distribution relationships acquired by oral food challenge are available showing a connection between quantity of allergenic protein consumed and the population of allergic individuals experiencing reactions. Soybean is currently the only recognised allergenic GM food by law for which EFSA has received applications and was therefore taken as an example for defining an assessment strategy. Identification of potential allergens, methodology for quantification as well as risk assessment considerations, are discussed. A strategy is proposed for the identification, assessment and evaluation of potential hazards/risks concerning endogenous allergenicity in food derived from plants developed by biotechnology. This approach could be expanded to other allergenic foods in the future, whenever required.


Endogenous allergenicity; Food allergy; GMO; Genetically modified plants; Soybean

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