Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)

Abstract Maize DP4114 × MON 810 × MIR604 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: DP4114, MON 810, MIR604 and NK603. The GMO Panel previously assessed the four single maize events and one of the subcombinations and did not identify safety...

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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, Hanspeter Naegeli, Francisco Javier Moreno, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann, Fabio Veronesi, Michele Ardizzone, Antonio Fernandez Dumont, Silvia Federici, Andrea Gennaro, Jose Ángel Gómez Ruiz, Tilemachos Goumperis, Dafni Maria Kagkli, Anna Lanzoni, Paolo Lenzi, Franco Maria Neri, Nikoletta Papadopoulou, Konstantinos Paraskevopoulos, Tommaso Raffaello, Franz Streissl, Giacomo De Sanctis
Format: Article
Language:English
Published: Wiley 2022-03-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2022.7134
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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
Francisco Javier Moreno
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Michele Ardizzone
Antonio Fernandez Dumont
Silvia Federici
Andrea Gennaro
Jose Ángel Gómez Ruiz
Tilemachos Goumperis
Dafni Maria Kagkli
Anna Lanzoni
Paolo Lenzi
Franco Maria Neri
Nikoletta Papadopoulou
Konstantinos Paraskevopoulos
Tommaso Raffaello
Franz Streissl
Giacomo De Sanctis
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
Francisco Javier Moreno
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Michele Ardizzone
Antonio Fernandez Dumont
Silvia Federici
Andrea Gennaro
Jose Ángel Gómez Ruiz
Tilemachos Goumperis
Dafni Maria Kagkli
Anna Lanzoni
Paolo Lenzi
Franco Maria Neri
Nikoletta Papadopoulou
Konstantinos Paraskevopoulos
Tommaso Raffaello
Franz Streissl
Giacomo De Sanctis
author_sort EFSA Panel on Genetically Modified Organisms (GMO)
collection DOAJ
description Abstract Maize DP4114 × MON 810 × MIR604 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: DP4114, MON 810, MIR604 and NK603. The GMO Panel previously assessed the four single maize events and one of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombination 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. The GMO Panel concludes that the four‐event stack maize, is as safe as the comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombination and the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.
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spelling doaj.art-ca46049e836c45a1a2a82de43041678b2023-03-14T04:16:02ZengWileyEFSA Journal1831-47322022-03-01203n/an/a10.2903/j.efsa.2022.7134Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)EFSA Panel on Genetically Modified Organisms (GMO)Ewen MullinsJean‐Louis BressonTamas DalmayIan Crawford DewhurstMichelle M EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoHanspeter NaegeliFrancisco Javier MorenoFabien NoguéNils RostoksJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiMichele ArdizzoneAntonio Fernandez DumontSilvia FedericiAndrea GennaroJose Ángel Gómez RuizTilemachos GoumperisDafni Maria KagkliAnna LanzoniPaolo LenziFranco Maria NeriNikoletta PapadopoulouKonstantinos ParaskevopoulosTommaso RaffaelloFranz StreisslGiacomo De SanctisAbstract Maize DP4114 × MON 810 × MIR604 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: DP4114, MON 810, MIR604 and NK603. The GMO Panel previously assessed the four single maize events and one of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombination 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. The GMO Panel concludes that the four‐event stack maize, is as safe as the comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombination and the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.https://doi.org/10.2903/j.efsa.2022.7134GMOherbicide tolerantmaize (Zea mays)DP4114MON 810MIR604
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
Francisco Javier Moreno
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Michele Ardizzone
Antonio Fernandez Dumont
Silvia Federici
Andrea Gennaro
Jose Ángel Gómez Ruiz
Tilemachos Goumperis
Dafni Maria Kagkli
Anna Lanzoni
Paolo Lenzi
Franco Maria Neri
Nikoletta Papadopoulou
Konstantinos Paraskevopoulos
Tommaso Raffaello
Franz Streissl
Giacomo De Sanctis
Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)
EFSA Journal
GMO
herbicide tolerant
maize (Zea mays)
DP4114
MON 810
MIR604
title Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)
title_full Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)
title_fullStr Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)
title_full_unstemmed Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)
title_short Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)
title_sort assessment of genetically modified maize dp4114 mon 810 mir604 nk603 and subcombinations for food and feed uses under regulation ec no 1829 2003 application efsa gmo nl 2018 150
topic GMO
herbicide tolerant
maize (Zea mays)
DP4114
MON 810
MIR604
url https://doi.org/10.2903/j.efsa.2022.7134
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