EFSA Journal (Aug 2022)

Assessment of genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐151)

  • 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,
  • Giacomo De Sanctis,
  • Antonio Fernandez Dumont,
  • Silvia Federici,
  • Andrea Gennaro,
  • Jose Angel Gomez Ruiz,
  • Tilemachos Goumperis,
  • Dafni Maria Kagkli,
  • Anna Lanzoni,
  • Paolo Lenzi,
  • Aleksandra Lewandowska,
  • Franco Maria Neri,
  • Konstantinos Paraskevopoulos,
  • Tommaso Raffaello,
  • Franz Streissl

DOI
https://doi.org/10.2903/j.efsa.2022.7451
Journal volume & issue
Vol. 20, no. 8
pp. n/a – n/a

Abstract

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Abstract Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the five single maize events and 16 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 the 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 five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that five‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM maize varieties tested. In the case of accidental release of viable five‐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 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 subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐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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