Allergenicity assessment of novel proteins expressed in genetically modified organisms

Abstract

To ensure the safety of developing or importing genetically modified organisms (GMOs), Korea has enacted the “LMO Act.” Accordingly, the safety of using GMOs as food or feed is evaluated in accordance with the concept of “substantial equivalence” proposed by OECD. The allergenicity of GMOs is assessed as a part of their safety evaluation. The methods of allergenicity assessment have been discussed by various international organizations, such as the OECD, FAO, and WHO. The main methods used for the allergenicity assessment of proteins newly expressed in GMOs include assessment of the physicochemical stability of these proteins, evaluation of their amino acid homology with existing allergenic proteins, and serum screening. In this study, we describe guidelines and related studies for the allergenicity assessment of GM crops.