Cargando…
Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788
The European Commission mandated EFSA to complement its original scientific opinion on soybean MON 87769 × MON 89788 (EFSA‐GMO‐NL‐2010‐85) considering additional information on the human nutritional assessment of refined bleached deodorised oil produced from the two‐event stack soybean (RBD GM‐oil)...
Autores principales: | , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114199/ https://www.ncbi.nlm.nih.gov/pubmed/34012490 http://dx.doi.org/10.2903/j.efsa.2021.6589 |
_version_ | 1783691013132386304 |
---|---|
author | Naegeli, Hanspeter Bresson, Jean Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Mullins, Ewen Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Frenzel, Thomas Gómez Ruiz, Jose Ángel |
author_facet | Naegeli, Hanspeter Bresson, Jean Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Mullins, Ewen Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Frenzel, Thomas Gómez Ruiz, Jose Ángel |
collection | PubMed |
description | The European Commission mandated EFSA to complement its original scientific opinion on soybean MON 87769 × MON 89788 (EFSA‐GMO‐NL‐2010‐85) considering additional information on the human nutritional assessment of refined bleached deodorised oil produced from the two‐event stack soybean (RBD GM‐oil). The assessment was mainly based on a replacement scenario with a list of target foods where RBD GM‐oil is intended to be added. Intake estimations for several fatty acids present in the RBD GM‐oil, in particular γ‐linolenic acid (GLA), stearidonic acid (SDA) and linoleic acid (LA) were based on the consumption of the corresponding foods that are likely to be displaced. The assessment of LA considered the established adequate intake of 4% of total energy intake (E%) and that LA deficiency has not been observed with intakes > 1 E%. The assessment of GLA and SDA was conducted using maximum doses without adverse effects from intervention human studies as reference (4.2 grams/day for SDA and 2.8 grams/day for GLA) since no tolerable upper intake levels are set for these fatty acids. The decrease observed in the levels of LA in RBD GM‐oil as compared to oil from conventional soybean does not represent a nutritional concern as intakes were in all cases above 1 E%. For GLA, all intake estimations were below the reference dose indicating no safety concern. SDA intake estimations do not pose any safety concerns based on the overly conservative nature of the estimates, the absence of toxicological hazards and the rapid metabolism of SDA in humans. The GMO Panel concluded that the consumption of soybean MON 87769 × MON 89788 and their derived products, in particular its RBD oil, does not represent a nutritional concern in humans. A post‐market monitoring plan is recommended to confirm the predicted consumption and the application of conditions of uses considered during the pre‐market risk assessment. |
format | Online Article Text |
id | pubmed-8114199 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-81141992021-05-18 Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788 Naegeli, Hanspeter Bresson, Jean Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Mullins, Ewen Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Frenzel, Thomas Gómez Ruiz, Jose Ángel EFSA J Scientific Opinion The European Commission mandated EFSA to complement its original scientific opinion on soybean MON 87769 × MON 89788 (EFSA‐GMO‐NL‐2010‐85) considering additional information on the human nutritional assessment of refined bleached deodorised oil produced from the two‐event stack soybean (RBD GM‐oil). The assessment was mainly based on a replacement scenario with a list of target foods where RBD GM‐oil is intended to be added. Intake estimations for several fatty acids present in the RBD GM‐oil, in particular γ‐linolenic acid (GLA), stearidonic acid (SDA) and linoleic acid (LA) were based on the consumption of the corresponding foods that are likely to be displaced. The assessment of LA considered the established adequate intake of 4% of total energy intake (E%) and that LA deficiency has not been observed with intakes > 1 E%. The assessment of GLA and SDA was conducted using maximum doses without adverse effects from intervention human studies as reference (4.2 grams/day for SDA and 2.8 grams/day for GLA) since no tolerable upper intake levels are set for these fatty acids. The decrease observed in the levels of LA in RBD GM‐oil as compared to oil from conventional soybean does not represent a nutritional concern as intakes were in all cases above 1 E%. For GLA, all intake estimations were below the reference dose indicating no safety concern. SDA intake estimations do not pose any safety concerns based on the overly conservative nature of the estimates, the absence of toxicological hazards and the rapid metabolism of SDA in humans. The GMO Panel concluded that the consumption of soybean MON 87769 × MON 89788 and their derived products, in particular its RBD oil, does not represent a nutritional concern in humans. A post‐market monitoring plan is recommended to confirm the predicted consumption and the application of conditions of uses considered during the pre‐market risk assessment. John Wiley and Sons Inc. 2021-05-12 /pmc/articles/PMC8114199/ /pubmed/34012490 http://dx.doi.org/10.2903/j.efsa.2021.6589 Text en © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Naegeli, Hanspeter Bresson, Jean Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Mullins, Ewen Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Frenzel, Thomas Gómez Ruiz, Jose Ángel Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788 |
title | Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788 |
title_full | Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788 |
title_fullStr | Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788 |
title_full_unstemmed | Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788 |
title_short | Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788 |
title_sort | statement complementing the efsa scientific opinion on application (efsa‐gmo‐nl‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean mon 87769 × mon 89788 |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114199/ https://www.ncbi.nlm.nih.gov/pubmed/34012490 http://dx.doi.org/10.2903/j.efsa.2021.6589 |
work_keys_str_mv | AT statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT naegelihanspeter statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT bressonjeanlouis statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT dalmaytamas statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT dewhurstiancrawford statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT epsteinmichellem statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT firbanklesliegeorge statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT guerchephilippe statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT hejatkojan statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT morenofranciscojavier statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT mullinsewen statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT noguefabien statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT rostoksnils statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT sanchezserranojosejuan statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT savoinigiovanni statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT veromanneve statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT veronesifabio statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT frenzelthomas statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 AT gomezruizjoseangel statementcomplementingtheefsascientificopiniononapplicationefsagmonl201085forauthorisationoffoodandfeedcontainingconsistingofandproducedfromgeneticallymodifiedsoybeanmon87769mon89788 |