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Journal Articles EFSA Journal Year : 2021

Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology

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Ewen Mullins
  • Function : Author
Jean‐louis Bresson
  • Function : Author
Tamas Dalmay
  • Function : Author
Ian Crawford Dewhurst
  • Function : Author
Michelle M Epstein
  • Function : Author
Leslie George Firbank
  • Function : Author
Philippe Guerche
Jan Hejatko
  • Function : Author
Hanspeter Naegeli
  • Function : Author
Fabien Nogué
Nils Rostoks
  • Function : Author
Jose Juan Sánchez Serrano
  • Function : Author
Giovanni Savoini
  • Function : Author
Eve Veromann
  • Function : Author
Fabio Veronesi
  • Function : Author
Antonio Fernandez Dumont
  • Function : Author
Francisco Javier Moreno
  • Function : Author

Abstract

This Scientific Opinion addresses the formulation of specific development needs, including research requirements for allergenicity assessment and protein safety, in general, which is urgently needed in a world that demands more sustainable food systems. Current allergenicity risk assessment strategies are based on the principles and guidelines of the Codex Alimentarius for the safety assessment of foods derived from 'modern' biotechnology initially published in 2003. The core approach for the safety assessment is based on a 'weight-of-evidence' approach because no single piece of information or experimental method provides sufficient evidence to predict allergenicity. Although the Codex Alimentarius and EFSA guidance documents successfully addressed allergenicity assessments of single/ stacked event GM applications, experience gained and new developments in the field call for a modernisation of some key elements of the risk assessment. These should include the consideration of clinical relevance, route of exposure and potential threshold values of food allergens, the update of in silico tools used with more targeted databases and better integration and standardisation of test materials and in vitro/in vivo protocols. Furthermore, more complex future products will likely challenge the overall practical implementation of current guidelines, which were mainly targeted to assess a few newly expressed proteins. Therefore, it is timely to review and clarify the main purpose of the allergenicity risk assessment and the vital role it plays in protecting consumers' health. A roadmap to (re)define the allergenicity safety objectives and risk assessment needs will be required to inform a series of key questions for risk assessors and risk managers such as 'what is the purpose of the allergenicity risk assessment?' or 'what level of confidence is necessary for the predictions?'.
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hal-03749940 , version 1 (11-08-2022)

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Ewen Mullins, Jean‐louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michelle M Epstein, et al.. Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology. EFSA Journal, 2021, 20 (1), ⟨10.2903/j.efsa.2022.7044⟩. ⟨hal-03749940⟩
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