ABSTRACT
Biotechnology can introduce dietary proteins that are considered novel and for which there is little to no prior consumption. The expectation from a regulatory standpoint is that the novel protein be assessed for potential allergenicity before it can enter the food supply by way of a biotech crop or novel food product. For the first generation of biotech protein products, food allergy has been assessed through a weight-of-evidence approach. The approach utilizes the data from the characterization studies to build an overall conclusion of risk. In practical terms, this means that no single study would discount the possibility that a protein is safe. This chapter outlines details of protocols that offer standardized approaches to allergy characterization for GM or novel proteins intended for use in food. It addresses how the data from characterization studies of biotech proteins rely on allergen identity and how this data is built into a thorough risk assessment of allergenic potential.
