Evaluation of the Allergenicity of Novel Proteins

The article addresses the challenge of evaluating the allergenicity of novel proteins in new foods, including genetically modified plants, alternative nutritional sources, and populations without prior exposure. It describes a weight-of-evidence framework that combines historical safe use, allergenicity of the gene source, amino acid sequence comparisons with known allergens, protein stability tests under heat and pepsin digestion, and exposure level assessment. The authors also discuss supplementary in vitro IgE-binding tests to detect potential cross-reactivity with existing allergens. The paper highlights that no allergies linked to GM plant proteins have been reported since their commercialization in the 1990s, demonstrating the sensitivity and robustness of current assessment strategies.