Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)

Abstract Genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 was developed by crossing to combine four single events: DP4114, MON 89034, MON 87411 and DAS‐40278‐9. The GMO Panel previously assessed the four single maize events and two of the subcombinations and did not identify s...

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Main Authors: 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, Francisco Javier Moreno, Hanspeter Naegeli, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann, Fabio Veronesi, Michele Ardizzone, Ana Martin Camargo, Giacomo De Sanctis, Antonio Fernandez Dumont, Andrea Gennaro, Jose Ángel Gómez Ruiz, Tilemachos Goumperis, Dafni Maria Kagkli, Franco Maria Neri, Nikoletta Papadopoulou, Tommaso Raffaello, Franz Streissl
Format: Article
Language:English
Published: Wiley 2022-11-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2022.7619
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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
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Michele Ardizzone
Ana Martin Camargo
Giacomo De Sanctis
Antonio Fernandez Dumont
Andrea Gennaro
Jose Ángel Gómez Ruiz
Tilemachos Goumperis
Dafni Maria Kagkli
Franco Maria Neri
Nikoletta Papadopoulou
Tommaso Raffaello
Franz Streissl
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
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Michele Ardizzone
Ana Martin Camargo
Giacomo De Sanctis
Antonio Fernandez Dumont
Andrea Gennaro
Jose Ángel Gómez Ruiz
Tilemachos Goumperis
Dafni Maria Kagkli
Franco Maria Neri
Nikoletta Papadopoulou
Tommaso Raffaello
Franz Streissl
author_sort EFSA Panel on Genetically Modified Organisms (GMO)
collection DOAJ
description Abstract Genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 was developed by crossing to combine four single events: DP4114, MON 89034, MON 87411 and DAS‐40278‐9. The GMO Panel previously assessed the four single maize events and two of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations 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 in the four‐event stack maize does not give rise to food and feed safety and nutritional concerns. Therefore, no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable four‐event stack 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 eight of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.
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spelling doaj.art-1446c1b7365f44db8d307f77266072382022-12-22T04:35:53ZengWileyEFSA Journal1831-47322022-11-012011n/an/a10.2903/j.efsa.2022.7619Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)EFSA Panel on Genetically Modified Organisms (GMO)Ewen MullinsJean‐Louis BressonTamas DalmayIan Crawford DewhurstMichelle M EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoFrancisco Javier MorenoHanspeter NaegeliFabien NoguéNils RostoksJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiMichele ArdizzoneAna Martin CamargoGiacomo De SanctisAntonio Fernandez DumontAndrea GennaroJose Ángel Gómez RuizTilemachos GoumperisDafni Maria KagkliFranco Maria NeriNikoletta PapadopoulouTommaso RaffaelloFranz StreisslAbstract Genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 was developed by crossing to combine four single events: DP4114, MON 89034, MON 87411 and DAS‐40278‐9. The GMO Panel previously assessed the four single maize events and two of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations 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 in the four‐event stack maize does not give rise to food and feed safety and nutritional concerns. Therefore, no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable four‐event stack 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 eight of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.https://doi.org/10.2903/j.efsa.2022.7619genetic engineeringherbicide tolerantinsect resistantmaize (Zea mays)import and processing
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
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Michele Ardizzone
Ana Martin Camargo
Giacomo De Sanctis
Antonio Fernandez Dumont
Andrea Gennaro
Jose Ángel Gómez Ruiz
Tilemachos Goumperis
Dafni Maria Kagkli
Franco Maria Neri
Nikoletta Papadopoulou
Tommaso Raffaello
Franz Streissl
Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)
EFSA Journal
genetic engineering
herbicide tolerant
insect resistant
maize (Zea mays)
import and processing
title Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)
title_full Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)
title_fullStr Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)
title_full_unstemmed Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)
title_short Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)
title_sort assessment of genetically modified maize dp4114 mon 89034 mon 87411 das 40278 9 and subcombinations for food and feed uses under regulation ec no 1829 2003 application efsa gmo nl 2020 171
topic genetic engineering
herbicide tolerant
insect resistant
maize (Zea mays)
import and processing
url https://doi.org/10.2903/j.efsa.2022.7619
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