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Food Chem Toxicol. 2019 May 4;129:405-423. doi: 10.1016/j.fct.2019.04.052. [Epub ahead of print]

The relevance of a digestibility evaluation in the allergenicity risk assessment of novel proteins. Opinion of a joint initiative of COST action ImpARAS and COST action INFOGEST.

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TNO, Utrechtseweg 48, Zeist, the Netherlands. Electronic address:
National Food Institute, Technical University of Denmark, DK-2800, Kgs. Lyngby, Denmark. Electronic address:
STLO, INRA-Agrocampus Ouest, 35042 Rennes, France. Electronic address:
Agroscope, Schwarzenburgstr. 161, 3003, Bern, Charlotte, Switzerland. Electronic address:
University of Salzburg, Department of Biosciences, Hellbrunnerstraße 34, 5020 Salzburg, Austria. Electronic address:
INRA UR1268 BIA, Rue de la Géraudière, BP 71627, 44316 Nantes, France. Electronic address:
School of Food Science and Nutrition, University of Leeds, LS2 9JT, UK. Electronic address:
TNO, Utrechtseweg 48, Zeist, the Netherlands. Electronic address:
UMR Service de Pharmacologie et Immunoanalyse, Laboratoire d'Immuno-Allergie Alimentaire, CEA, INRA, Université Paris-Saclay, F-91191, Gif-sur-Yvette Cedex, France. Electronic address:
Institute of Food Sciences, CNR, Via Roma 64, 83100 Avellino, Italy. Electronic address:
Agroscope, Schwarzenburgstr. 161, 3003 Bern, Switzerland. Electronic address:
Institute of Risk Assessment Sciences, Utrecht University, Yalelaan 104, 3584CM, Utrecht, the Netherlands. Electronic address:
Section of Paediatrics, Imperial College London, London, United Kingdom. Electronic address:
Institute of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. Electronic address:
Department of Dermatology, Experimental Allergy Laboratory, Medical University of Vienna, Waehringer Guertel 18-20 room 4P9.02, 1090, Vienna, Austria. Electronic address:


The current allergenicity assessment of novel proteins is based on the EFSA GMO guidance. Recently, EFSA launched a new guidance document on allergenicity assessment of GM plants (2017). This document describes, amongst other topics, the new scientific and regulatory developments on in vitro protein digestibility tests. The EFSA GMO Panel stated that for in vitro protein digestibility tests, additional investigations are needed before any additional recommendation in the form of guidance can be provided. To this end, an interim phase is considered necessary to evaluate the revisions to the in vitro gastrointestinal digestion test, proposed by EFSA. This prompted the establishment of a joint workshop through two COST Action networks: COST Action ImpARAS and COST Acton INFOGEST. In 2017, a workshop was organised to discuss the relevance of digestion in allergenicity risk assessment and how to potentially improve the current methods and readouts. The outcome of the workshop is that there is no rationale for a clear readout that is predictive for allergenicity and we suggest to omit the digestion test from the allergenicity assessment strategy for now, and put an effort into filling the knowledge gaps as summarized in this paper first.


Allergenicity risk assessment; Food allergy; Food digestion; In vitro protein digestibility tests; Novel proteins

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