Abstract

The development of biotechnology and particularly of genetic engineering raises the question of the safety of the genetically modified organisms (GMOs) and the evaluation of any risks that they could pose to Public Health. The allergic risk is considered as a special issue which raises many concerns among consumers and regulatory committees. Indeed biotechnolgy is a possible way of creating new allergens or of unmasking hidden and therefore non bioavailable immunoreactive structures and of increasing the expression/potential of existing ones. If the inserted DNA is well characterized, one can expect that only the trait protein (and possibly the marker gene product) will be expressed and will have to be assessed for allergenicity. However, the insertion of the transgene within the plant genome is not controlled and indirect pleiotropic effect may over express one or several endogenous allergenic protein(s) or express it (them) in a modified form. Therefore there is a pressing need to assess the allergenicity of the product(s) of the introduced gene(s) but also of the whole transgenic plant or of the foods derived therefrom. If the introduced gene encodes a known allergen, the recombinant protein may be tested for allergenicity by the classical in vitro tests using sera form allergic patients. If the source of the transgene has no history of allergenicity, alternative approaches are required based on the structure and stability of the foreign protein. However they must be critically appraised and applied on a case-by-case basis. No validated methodologies exist for evaluating or predicting the allergic risk generated by indirect and unintended effects of the genetic modification. Chemical and genetic (mRNA) fingerprinting, proteomics to detect differences in total protein expression of the transgenic plant and its conventional counterpart offer a possible approach. In addition to pre-market testing, post market surveillance could bring useful informations on the occurrence of unintended effects and particularly on new allergies after exposure to GMOs in the every day life conditions.

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