Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants
Abstract This statement supplements and updates the GMO Panel guidance document on allergenicity of genetically modified (GM) plants published in 2017. In that guidance document, the GMO Panel considered that additional investigations on in vitro protein digestibility were needed before providing an...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-01-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2021.6350 |
| _version_ | 1811242736679911424 |
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| author | EFSA Panel on Genetically Modified Organisms (GMO) Hanspeter Naegeli Jean‐Louis Bresson Tamas Dalmay Ian Crawford Dewhurst Michelle M Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Francisco Javier Moreno Ewen Mullins Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Antonio Fernandez Dumont |
| author_facet | EFSA Panel on Genetically Modified Organisms (GMO) Hanspeter Naegeli Jean‐Louis Bresson Tamas Dalmay Ian Crawford Dewhurst Michelle M Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Francisco Javier Moreno Ewen Mullins Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Antonio Fernandez Dumont |
| author_sort | EFSA Panel on Genetically Modified Organisms (GMO) |
| collection | DOAJ |
| description | Abstract This statement supplements and updates the GMO Panel guidance document on allergenicity of genetically modified (GM) plants published in 2017. In that guidance document, the GMO Panel considered that additional investigations on in vitro protein digestibility were needed before providing any additional recommendations in the form of guidance to applicants. Thus, an interim phase was proposed to assess the utility of an enhanced in vitro digestion test, as compared to the classical pepsin resistance test. Historically, resistance to degradation by pepsin using the classical pepsin resistance test has been considered as additional information, in a weight‐of‐evidence approach, for the assessment of allergenicity and toxicity of newly expressed proteins in GM plants. However, more recent evidence does not support this test as a good predictor of allergenic potential for hazard. Furthermore, there is a need for more reliable systems to predict the fate of the proteins in the gastrointestinal tract and how they interact with the relevant human cells. Nevertheless, the classical pepsin resistance test can still provide some information on the physicochemical properties of novel proteins relating to their stability under acidic conditions. But other methods can be used to obtain data on protein's structural and/or functional integrity. It is acknowledged that the classical pepsin resistance test is embedded into international guidelines, e.g. Codex Alimentarius and Regulation (EU) No 503/2013. For future development, a deeper understanding of protein digestion in the gastrointestinal tract could enable the framing of more robust strategies for the safety assessment of proteins. Given the high complexity of the digestion and absorption process of dietary proteins, it is needed to clarify and identify the aspects that could be relevant to assess potential risks of allergenicity and toxicity of proteins. To this end, a series of research questions to be addressed are also formulated in this statement. |
| first_indexed | 2024-04-12T13:55:22Z |
| format | Article |
| id | doaj.art-f4d16a0e2a744b14bd4709bc0f211882 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-12T13:55:22Z |
| publishDate | 2021-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-f4d16a0e2a744b14bd4709bc0f2118822022-12-22T03:30:23ZengWileyEFSA Journal1831-47322021-01-01191n/an/a10.2903/j.efsa.2021.6350Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plantsEFSA Panel on Genetically Modified Organisms (GMO)Hanspeter NaegeliJean‐Louis BressonTamas DalmayIan Crawford DewhurstMichelle M EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoFrancisco Javier MorenoEwen MullinsFabien NoguéNils RostoksJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiAntonio Fernandez DumontAbstract This statement supplements and updates the GMO Panel guidance document on allergenicity of genetically modified (GM) plants published in 2017. In that guidance document, the GMO Panel considered that additional investigations on in vitro protein digestibility were needed before providing any additional recommendations in the form of guidance to applicants. Thus, an interim phase was proposed to assess the utility of an enhanced in vitro digestion test, as compared to the classical pepsin resistance test. Historically, resistance to degradation by pepsin using the classical pepsin resistance test has been considered as additional information, in a weight‐of‐evidence approach, for the assessment of allergenicity and toxicity of newly expressed proteins in GM plants. However, more recent evidence does not support this test as a good predictor of allergenic potential for hazard. Furthermore, there is a need for more reliable systems to predict the fate of the proteins in the gastrointestinal tract and how they interact with the relevant human cells. Nevertheless, the classical pepsin resistance test can still provide some information on the physicochemical properties of novel proteins relating to their stability under acidic conditions. But other methods can be used to obtain data on protein's structural and/or functional integrity. It is acknowledged that the classical pepsin resistance test is embedded into international guidelines, e.g. Codex Alimentarius and Regulation (EU) No 503/2013. For future development, a deeper understanding of protein digestion in the gastrointestinal tract could enable the framing of more robust strategies for the safety assessment of proteins. Given the high complexity of the digestion and absorption process of dietary proteins, it is needed to clarify and identify the aspects that could be relevant to assess potential risks of allergenicity and toxicity of proteins. To this end, a series of research questions to be addressed are also formulated in this statement.https://doi.org/10.2903/j.efsa.2021.6350allergenicity assessmentpepsin testin vitro digestionprotein safetynewly expressed proteinsGMO |
| spellingShingle | EFSA Panel on Genetically Modified Organisms (GMO) Hanspeter Naegeli Jean‐Louis Bresson Tamas Dalmay Ian Crawford Dewhurst Michelle M Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Francisco Javier Moreno Ewen Mullins Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Antonio Fernandez Dumont Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants EFSA Journal allergenicity assessment pepsin test in vitro digestion protein safety newly expressed proteins GMO |
| title | Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants |
| title_full | Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants |
| title_fullStr | Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants |
| title_full_unstemmed | Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants |
| title_short | Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants |
| title_sort | statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants |
| topic | allergenicity assessment pepsin test in vitro digestion protein safety newly expressed proteins GMO |
| url | https://doi.org/10.2903/j.efsa.2021.6350 |
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