With a growing interest in the development of genetically modified crop pla
nts there is a need for appropriate approaches to safety assessment. Among
the issues that have to be addressed is consideration of whether the produc
ts of novel genes have the potential to cause allergic sensitization. Resul
ting from a collaboration between the International Food Biotechnology Coun
cil and the International Life Sciences Institute recommendations have been
made for a step-wise approach to the assessment of allergenic potential ba
sed upon considerations of serological identity, and sequence or structural
homology, with known allergens and examination of the stability of the tes
t protein in a simulated gastric fluid. In parallel there has been interest
in the development of animal models, which would permit a more direct eval
uation of potential allergenic activity. Progress in these areas is reviewe
d briefly in the context of what is known of food allergy and some of the i
mportant issues. which must be addressed in designing safety assessment str
ategies identified. (C) 2001 Elsevier Science Ireland Ltd. All rights reser
ved.