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


Mullins, Ewen; Bresson, Jean‐Louis; Dalmay, Tamas; Dewhurst, Ian Crawford; Epstein, Michelle M; George Firbank, Leslie; Guerche, Philippe; Hejatko, Jan; Naegeli, Hanspeter; Nogué, Fabien; Rostoks, Nils; Sánchez Serrano, Jose Juan; Savoini, Giovanni; Veromann, Eve; Veronesi, Fabio; Fernandez Dumont, Antonio; Moreno, Francisco Javier (2022). Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology. EFSA Journal, 20(1):e07044.

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?'.

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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Item Type:Journal Article, refereed, original work
Communities & Collections:05 Vetsuisse Faculty > Veterinärwissenschaftliches Institut > Institute of Veterinary Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
Scopus Subject Areas:Life Sciences > Parasitology
Life Sciences > Food Science
Life Sciences > Microbiology
Life Sciences > Animal Science and Zoology
Health Sciences > Veterinary (miscellaneous)
Life Sciences > Plant Science
Uncontrolled Keywords:Plant Science, Veterinary (miscellaneous), Animal Science and Zoology, Microbiology, Food Science, Parasitology
Language:English
Date:1 January 2022
Deposited On:07 Feb 2023 16:56
Last Modified:28 Feb 2024 02:50
Publisher:Wiley Open Access
ISSN:1831-4732
OA Status:Gold
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.2903/j.efsa.2022.7044
PubMed ID:35106091
  • Content: Published Version
  • Language: English
  • Licence: Creative Commons: Attribution-No Derivatives 4.0 International (CC BY-ND 4.0)