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)

Abstract

Maize MON 87427 ×MON 87460 × MON 89034 × MIR162 × NK603 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 87427, MON 87460, MON 89034, MIR162 and NK603. The GMO Panel previously assessed the five single maize events and eleven of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 11 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 five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the five‐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 five‐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 14 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 five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the five‐event stack maize. 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 reference varieties with respect to potential effects on human and animal health and the environment.

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

“…The genetic stability of the inserted DNA over multiple generations in the four single maize events was demonstrated previously (see Table ). Integrity of the events was demonstrated in the four‐event stack maize MON 87427 × MON 89034 × MIR162 × MON 87411 (Section 3.4.1.2) and the previously assessed maize subcombinations (EFSA GMO Panel, ,b, ,b). The GMO Panel finds no reasons to expect the loss of integrity of the events in the maize subcombinations not previously assessed (see Table ).…”

“…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.…”

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

“…The assessment of the Cry2Ab2 and Cry1Ac identified no perfect or relevant partial matches with known coeliac disease peptide sequences. The assessment of the Cry1A.105 revealed partial matches which have been previously evaluated by the GMO Panel (EFSA GMO Panel, ). Therefore, no indications of safety concerns were identified by the GMO Panel.…”