Allergy assessment of foods or ingredients derived from biotechnology, gene‐modified organisms, or novel foods

Abstract

The introduction of novel proteins into foods carries a risk of eliciting allergic reactions in individuals sensitive to the introduced protein and a risk of sensitizing susceptible individuals. No single predictive test exists to perform a hazard assessment in relation to allergenic properties of newly expressed proteins in gene-modified organisms (GMOs). Instead, performance of a weighted risk analysis based on the decision tree approach has been suggested. The individual steps of this analysis comprise sequence homology to known allergens, specific or targeted serum screens for immunoglobulin E (IgE) cross-reactions to known allergens, digestability studies of the proteins in simulated gastric and/or intestinal fluids, and animal studies. These steps are discussed and five examples of risk evaluation of GMOs or novel foods are presented. These include ice-structuring protein derived from fish, microbial transglutaminase, GMO-soybeans, amylase and the Nangai nut.

Studies on the Specific Degranulation of Mast Cell Sensitized by Several Allergens in Vitro

“…In recent years, new proteins have been artificially produced in special foods, such as genetically modified foods (18). Some of the new proteins might be strongly allergenic in humans (19,20).…”

Approaches to assess IgE mediated allergy risks (sensitization and cross-reactivity) from new or modified dietary proteins

“…The approaches developed for GM foods have also been used to assess the potential of new non-GM proteins or protein-enriched food products introduced onto the market for their potential to cause allergic reactions (Meredith, 2005;Poulsen, 2004;Putten et al, 2011) (see examples in the Annex). In the EU, the scientific guidance documents for GM foods have formally evolved through EFSA, and only recently has a separate EFSA panel developed specific guidance for non-GM novel foods.…”

Production of vaccines and vaccine components in corn

“…In spite of the great promise that it offers, application of biotechnology to food crops initiated concerns regarding potential toxicity of recombinant proteins and unintended (Poulsen, 2004). The first step is to perform a homology search against amino acid sequences of known allergens.…”

“…Currently, there are a number of allergen databases. Efforts are under way to unite these to create a high validity public allergen database (Poulsen, 2004 …”

“…For example, it is well established that allergens must cross link IgEs. Interestingly, IgE binding to food allergens are observed in persons who are tolerant to the given food allergen (Poulsen, 2004). Therefore a decision tree approach which integrates testing for all known parameters of allergenicity sequentially is applied to evaluate potential risks of recombinant proteins.…”