Assessment of genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐144)

Abstract

Maize MON 87427 × MON 89034 × MIR162 × MON 87411 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and MON 87411. The genetically modified organism (GMO) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. 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 dsRNA 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, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. 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 the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to 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 the four‐event stack maize. 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 tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MIR162 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐025)

“…In addition, the updated bioinformatic analysis of the newly created ORFs spanning the junctions with genomic DNA confirms previous results which did not indicate sequence similarities to toxins or allergens in maize MIR162 (EFSA, 2012;EFSA GMO Panel, 2019. The updated bioinformatic analyses for event MIR162 did not reveal any DNA sequence that could provide sufficient length and identity which could facilitate horizontal gene transfer (HGT) by double homologous recombination, confirming previous conclusions (EFSA, 2012;EFSA GMO Panel, 2019. Given the results of this analysis and that the recombinant DNA in maize MIR162 does not confer selective advantages to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT.…”

“…The updated bioinformatic analyses for event MIR162 did not reveal any DNA sequence that could provide sufficient length and identity which could facilitate horizontal gene transfer (HGT) by double homologous recombination, confirming previous conclusions (EFSA, 2012; EFSA GMO Panel, 2019, 2021). Given the results of this analysis and that the recombinant DNA in maize MIR162 does not confer selective advantages to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT.…”

Strategies for the production of dsRNA biocontrols as alternatives to chemical pesticides

“…MON-87411 has been registered for cultivation in the US and elsewhere since 2015 ( Firko, 2015 ). The grain product of this crop has been registered for food and feed uses within the European Union ( Naegeli et al, 2019 ). To date, no other dsRNA-based GM crop has been commercialized.…”

Facultative symbionts are potential agents of symbiont-mediated RNAi in aphids

“…In 2018–2021, EFSA evaluated the safety of MON87411 with other GM corns for food and feed uses. EFSA concluded that MON87411 was safe, and no safety concern was identified ( EFSA Panel on Genetically Modified Organisms (GMO) et al, 2018 , 2019 , 2021 ). In 2021, the GMO safety certificate of MON87411 was approved by Ministry of Agriculture and Rural Affairs, PRC.…”