Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology
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...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-01-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7044 |
| _version_ | 1797904051057197056 |
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| author | EFSA Panel on Genetically Modified Organisms (GMO) Ewen Mullins Jean‐Louis Bresson Tamas Dalmay Ian Crawford Dewhurst Michelle M Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Hanspeter Naegeli Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Antonio Fernandez Dumont Francisco Javier Moreno |
| author_facet | EFSA Panel on Genetically Modified Organisms (GMO) Ewen Mullins Jean‐Louis Bresson Tamas Dalmay Ian Crawford Dewhurst Michelle M Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Hanspeter Naegeli Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Antonio Fernandez Dumont Francisco Javier Moreno |
| author_sort | EFSA Panel on Genetically Modified Organisms (GMO) |
| collection | DOAJ |
| description | 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?’. |
| first_indexed | 2024-04-10T09:42:42Z |
| format | Article |
| id | doaj.art-f99592a6d08942eb84b4722105e33efb |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-10T09:42:42Z |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-f99592a6d08942eb84b4722105e33efb2023-02-17T06:41:45ZengWileyEFSA Journal1831-47322022-01-01201n/an/a10.2903/j.efsa.2022.7044Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnologyEFSA Panel on Genetically Modified Organisms (GMO)Ewen MullinsJean‐Louis BressonTamas DalmayIan Crawford DewhurstMichelle M EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoHanspeter NaegeliFabien NoguéNils RostoksJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiAntonio Fernandez DumontFrancisco Javier MorenoAbstract 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?’.https://doi.org/10.2903/j.efsa.2022.7044Allergenicity assessmentprotein safetynewly expressed proteinsinnovative proteinsGMObiotechnology |
| spellingShingle | EFSA Panel on Genetically Modified Organisms (GMO) Ewen Mullins Jean‐Louis Bresson Tamas Dalmay Ian Crawford Dewhurst Michelle M Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Hanspeter Naegeli Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Antonio Fernandez Dumont Francisco Javier Moreno Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology EFSA Journal Allergenicity assessment protein safety newly expressed proteins innovative proteins GMO biotechnology |
| title | Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology |
| title_full | Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology |
| title_fullStr | Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology |
| title_full_unstemmed | Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology |
| title_short | Scientific Opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology |
| title_sort | scientific opinion on development needs for the allergenicity and protein safety assessment of food and feed products derived from biotechnology |
| topic | Allergenicity assessment protein safety newly expressed proteins innovative proteins GMO biotechnology |
| url | https://doi.org/10.2903/j.efsa.2022.7044 |
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