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Assessment of genetically modified maize DP202216 × NK603 × DAS‐40278‐9 (application GMFF‐2022‐6232).

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Title: Assessment of genetically modified maize DP202216 × NK603 × DAS‐40278‐9 (application GMFF‐2022‐6232).
Authors: Casacuberta, Josep (AUTHOR), Barro, Francisco (AUTHOR), Braeuning, Albert (AUTHOR), de Maagd, Ruud (AUTHOR), Epstein, Michelle M. (AUTHOR), Frenzel, Thomas (AUTHOR), Gallois, Jean‐Luc (AUTHOR), Koning, Frits (AUTHOR), Messéan, Antoine (AUTHOR), Moreno, F. Javier (AUTHOR), Nogué, Fabien (AUTHOR), Savoini, Giovanni (AUTHOR), Schulman, Alan H. (AUTHOR), Tebbe, Christoph (AUTHOR), Veromann, Eve (AUTHOR), Ardizzone, Michele (AUTHOR), De Sanctis, Giacomo (AUTHOR), Dumont, Antonio Fernandez (AUTHOR), Ferrari, Arianna (AUTHOR), Gennaro, Andrea (AUTHOR)
Source: EFSA Journal. Dec2025, Vol. 23 Issue 12, p1-30. 30p.
Subject Terms: *Transgenic plants, *Herbicide tolerance of plants, *Environmental protection, *Food safety, *Transgenic organisms, Nutritional assessment
Abstract: Genetically modified maize DP202216 × NK603 × DAS 40278‐9 was developed by crossing to combine three single events: DP202216, NK603 and DAS‐40278‐9. The three‐event stack maize expresses PAT, CP4 EPSPS, CP4 EPSPS L124P, AAD‐1 and the maize endogenous protein with altered expression (EPAE) ZMM28 to confer herbicide tolerance and to provide the potential for yield enhancement (PYE) under field conditions. The GMO Panel previously assessed the three single maize events and one of the sub‐combinations and did not identify safety concerns. No new data on the single maize events or the assessed sub‐combination were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and the EPAE in the three‐event stack maize does not give rise to food and feed safety or nutritional concerns. The GMO Panel concludes that three‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM reference varieties tested and no post‐market monitoring of food/feed is considered necessary. In the case of the release of processed maize DP202216 × NK603 × DAS 40278‐9 or accidental spillage of viable GM maize grains, into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in two of the maize sub‐combinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed sub‐combination and the three‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216 × NK603 × DAS 40278‐9. The GMO Panel concludes that this three‐event stack maize and its sub‐combinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Assessment of genetically modified maize DP202216 × NK603 × DAS‐40278‐9 (application GMFF‐2022‐6232).
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  Data: <searchLink fieldCode="AR" term="%22Casacuberta%2C+Josep%22">Casacuberta, Josep</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Barro%2C+Francisco%22">Barro, Francisco</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Braeuning%2C+Albert%22">Braeuning, Albert</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22de+Maagd%2C+Ruud%22">de Maagd, Ruud</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Epstein%2C+Michelle+M%2E%22">Epstein, Michelle M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Frenzel%2C+Thomas%22">Frenzel, Thomas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gallois%2C+Jean‐Luc%22">Gallois, Jean‐Luc</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Koning%2C+Frits%22">Koning, Frits</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Messéan%2C+Antoine%22">Messéan, Antoine</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Moreno%2C+F%2E+Javier%22">Moreno, F. Javier</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nogué%2C+Fabien%22">Nogué, Fabien</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Savoini%2C+Giovanni%22">Savoini, Giovanni</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schulman%2C+Alan+H%2E%22">Schulman, Alan H.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tebbe%2C+Christoph%22">Tebbe, Christoph</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Veromann%2C+Eve%22">Veromann, Eve</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ardizzone%2C+Michele%22">Ardizzone, Michele</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22De+Sanctis%2C+Giacomo%22">De Sanctis, Giacomo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dumont%2C+Antonio+Fernandez%22">Dumont, Antonio Fernandez</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ferrari%2C+Arianna%22">Ferrari, Arianna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gennaro%2C+Andrea%22">Gennaro, Andrea</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Dec2025, Vol. 23 Issue 12, p1-30. 30p.
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  Data: *<searchLink fieldCode="DE" term="%22Transgenic+plants%22">Transgenic plants</searchLink><br />*<searchLink fieldCode="DE" term="%22Herbicide+tolerance+of+plants%22">Herbicide tolerance of plants</searchLink><br />*<searchLink fieldCode="DE" term="%22Environmental+protection%22">Environmental protection</searchLink><br />*<searchLink fieldCode="DE" term="%22Food+safety%22">Food safety</searchLink><br />*<searchLink fieldCode="DE" term="%22Transgenic+organisms%22">Transgenic organisms</searchLink><br /><searchLink fieldCode="DE" term="%22Nutritional+assessment%22">Nutritional assessment</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Genetically modified maize DP202216 × NK603 × DAS 40278‐9 was developed by crossing to combine three single events: DP202216, NK603 and DAS‐40278‐9. The three‐event stack maize expresses PAT, CP4 EPSPS, CP4 EPSPS L124P, AAD‐1 and the maize endogenous protein with altered expression (EPAE) ZMM28 to confer herbicide tolerance and to provide the potential for yield enhancement (PYE) under field conditions. The GMO Panel previously assessed the three single maize events and one of the sub‐combinations and did not identify safety concerns. No new data on the single maize events or the assessed sub‐combination were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and the EPAE in the three‐event stack maize does not give rise to food and feed safety or nutritional concerns. The GMO Panel concludes that three‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM reference varieties tested and no post‐market monitoring of food/feed is considered necessary. In the case of the release of processed maize DP202216 × NK603 × DAS 40278‐9 or accidental spillage of viable GM maize grains, into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in two of the maize sub‐combinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed sub‐combination and the three‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216 × NK603 × DAS 40278‐9. The GMO Panel concludes that this three‐event stack maize and its sub‐combinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.2903/j.efsa.2025.9746
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      – Code: eng
        Text: English
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      – SubjectFull: Transgenic plants
        Type: general
      – SubjectFull: Herbicide tolerance of plants
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      – SubjectFull: Environmental protection
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      – SubjectFull: Food safety
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      – SubjectFull: Transgenic organisms
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      – SubjectFull: Nutritional assessment
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