Guidance on allergenicity assessment of genetically modified plants

EFSA J. 2017 Jun 22;15(6):e04862. doi: 10.2903/j.efsa.2017.4862. eCollection 2017 Jun.

Abstract

This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non-IgE-mediated adverse immune reactions to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where appropriate.

Keywords: GMO; allergenicity assessment; endogenous allergenicity; guidance; newly expressed proteins.