Allergenicity assessment of new or modified protein-containing food sources and ingredients.

The growing world population, changing dietary habits, and increasing pressure on agricultural resources are drivers for the development of novel foods (including new protein sources as well as existing protein sources that are produced or used in an alternative way or in a different concentration). These changes, coupled with consumer inclination to adopt new dietary trends, may heighten the intake of unfamiliar proteins, or escalate consumption of specific ones, potentially amplifying the prevalence of known and undiscovered food allergies. Assessing the allergenicity of novel or modified protein-based foods encounters several challenges, including uncertainty surrounding acceptable risks and assessment criteria for determining safety. Moreover, the available methodological tools for gathering supportive data exhibit significant gaps. This paper synthesises these challenges, addressing the varied interpretations of "safe" across jurisdictions and societal attitudes towards allergenic risk. It proposes a comprehensive two-part framework for allergenicity assessment: the first part emphasises systematic consideration of knowledge and data requirements, while the second part proposes the application of a generic assessment approach, integrating a Threshold of Allergological Concern. This combined framework highlights areas that require attention to bridge knowledge and data gaps, and it delineates research priorities for its development and implementation.

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Copyright © 2024. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Declaration of Competing Interest ☐ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ☒ The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Rene Crevel reports financial support and travel were provided by International Life Sciences Institute Europe ILSI. Geert Houben reports financial support was provided by International Life Sciences Institute Europe ILSI. Rene Crevel reports a relationship with AllPreT Horizon Europe Marie Curie Doctoral Training Network Project that includes: board membership and travel reimbursement. Geert Houben reports a relationship with Netherlands Organization for Applied Scientific Research that includes: employment. Ross Yarham reports a relationship with InBio that includes: employment. Katrine Lindholm Bogh reports a relationship with Technical University of Denmark National Food Institute that includes: employment. Neil Buck reports a relationship with General Mills Inc that includes: employment. Melina Galano reports a relationship with DSM Food Specialties BV that includes: employment. Kitty Verhoeckx reports a relationship with University Medical Centre Utrecht that includes: employment. I have received fees through René Crevel Consulting Ltd for risk assessment of the proposed use of various proteins by Meatable B.V. , Upfield B.V. and Mozza Inc. - R.C. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.