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

Research output: Contribution to journalJournal article – Annual report year: 2019Researchpeer-review



  • Author: Verhoeckx, Kitty

    Netherlands Organisation for Applied Scientific Research

  • Author: Bøgh, Katrine Lindholm

    Research group for Food Allergy, National Food Institute, Technical University of Denmark, Kemitorvet, 2800, Kgs. Lyngby, Denmark

  • Author: Dupont, Didier

    Institut National de la Recherche Agronomique

  • Author: Egger, Lotti


  • Author: Gadermaier, Gabriele

    University of Salzburg

  • Author: Larré, Colette

    Institut National de la Recherche Agronomique

  • Author: Mackie, Alan

    University of Leeds

  • Author: Menard, Olivia

    Netherlands Organisation for Applied Scientific Research

  • Author: Adel-Patient, Karine

    ComUE Paris-Saclay

  • Author: Picariello, Gianluca


  • Author: Portmann, Reto


  • Author: Smit, Joost

    Utrecht University

  • Author: Turner, Paul

    Imperial College London

  • Author: Untersmayr, Eva

    Medical University of Vienna

  • Author: Epstein, Michelle

    Medical University of Vienna

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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.

Original languageEnglish
JournalFood and Chemical Toxicology
Pages (from-to)405-423
Publication statusPublished - 2019
CitationsWeb of Science® Times Cited: No match on DOI

    Research areas

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

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