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Food allergen analysis and risk assessment has historically focused on allergen-specific methods, including submissions for exemption from mandatory allergen source labeling. However, in many cases, ingredients derived from a major food allergen or a food allergen-derived preparation under review for exemption are highly processed with a number of considerations which could render results from different methods, including allergen-specific methods, to be not fit-for-purpose in the overall characterization of the derivative and subsequent required exposure assessment. This presentation provides an overview of a risk-based framework proposed by the recent FAO/WHO Expert Consultation on Risk Assessment of Food Allergens for evaluation of potential exemptions from mandatory allergen source labeling. The framework could provide safe, broader food choices for allergic individuals, with protein characterization, total protein quantification, and exposure estimation critical for any derivative assessment. Case studies will highlight when allergen-specific methods are likely insufficient to characterize derivates that have been highly processed (e.g. hydrolyzed), with low levels of protein (e.g. highly refined oils), or are comprised of difficult matrices with extraction challenges (e.g. lecithins). In these instances, methods based on general protein or amino acid analysis may be better suited. Additional considerations include the recommendation to utilize more than one fit-for-purpose method for total protein quantification, each based on different principles, as well as assessing the impact of different fit-for-purpose extraction methods, sampling, and recovery on the overall analysis.
