Assessment of genetically modified maize MON 87427 × MON 89034 × MIR162 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐131)

Abstract

Maize MON 87427 9 MON 89034 9 MIR162 9 NK603 (four-event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and NK603. The GMO Panel previously assessed the four single maize events and four of the subcombinations 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 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 fourevent stack maize and its subcombinations 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.This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. Assessment of maize MON 87427 3 MON 89034 3 MIR162 3 NK603 and subcombinations www.efsa.europa.eu/efsajournal 2 EFSA Journal 2019;17(7):5734 Assessment of maize MON 87427 3 MON 89034 3 MIR162 3 NK603 and subcombinations www.efsa.europa.eu/efsajournal 3 EFSA Journal 2019;17(7):5734Considering the combined events and their potential interactions, the outcome of the comparative analysis, and the routes and levels of exposure, the GMO Panel concludes that the four-event stack maize would not raise safety concerns in the case of accidental release of viable GM maize grains into the environment.Since no new safety concerns were identified for the four previously assessed subcombinations, and no new data leading to the modification of the original conclusion...

Assessment of genetically modified maize MON 89034 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐015)

“…Analyses of the amino acid sequence of the newly expressed Cry1A.105 and Cry2Ab2 proteins reveal no significant similarities to toxins, allergens or immunogenic gluten‐related epitopes. In addition, bioinformatic analyses of the newly created ORFs within the insert or spanning the junctions with genomic DNA confirm the previous conclusions indicating that the expression of an ORF showing significant similarities to toxins or allergens for the event MON 89034 is highly unlikely (EFSA, ; EFSA GMO Panel, ,c, ,b).…”

“…The updated bioinformatic analysis for maize event MON 89034 do not reveal any new DNA sequence that could provide sufficient length and identity which could facilitate HGT by double homologous recombination (HR) confirming the previous conclusions (EFSA GMO Panel, ,c, ,b). Given the results of this analysis and that the recombinant DNA in maize MON 89034 does not confer selective advantages or increased fitness to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT.…”

Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐134)

“…The GMO Panel has previously assessed the above‐mentioned additional information on MON 87427, MON 89034, MIR162 and NK603 in the context of another application under Regulation (EU) 503/2013 (EFSA GMO Panel, ). The additional histopathology provided for the 90‐day study on maize MON 87460 showed sporadic histopathological findings compatible with the spontaneous background pathology of rats of this strain and age.…”

“…Therefore, there was no indication of an interaction at protein expression level. In addition, expression data from the two‐event stack maize MON 89034 × NK603 (EFSA GMO Panel, ), the three‐event stack MON 87427 × MON 89034 × NK603 (EFSA GMO Panel, ) and the four‐event stack MON 87427 × MON 89034 × MIR162 × NK603 (EFSA GMO Panel, ) were similar to those observed in each of the single maize events or showed in general the expected higher levels for CP4 EPSPS. This supports the conclusion that interactions affecting the expression levels of the newly expressed proteins are not expected in the 14 subcombinations not previously assessed and included in the scope of application EFSA‐GMO‐NL‐2016‐134.…”

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)

“…The GMO Panel has previously assessed the above‐mentioned additional information on MON 87427, MON 89034 and MIR162 in the context of another applications under Regulation (EU) 503/2013 (EFSA GMO Panel, ,b_AP131). The conclusion was that these studies are in line with the requirements of Regulation (EU) 503/2013 and that there are no indications of adverse effects related to the 90‐day administration to rats of diets including up to 41.5% grains from maize MON87427, MON89034 and MIR162.…”