Scientific Opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Abstract

In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three‐event stack maize MON 87427 × MON 89034 × NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three‐event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three‐event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON 87427 × MON 89034 × NK603 into the environment, the three‐event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the three‐event stack maize is as safe and as nutritious as the non‐GM comparator and the tested non‐GM reference varieties in the context of its scope. The GMO Panel considered that its previous conclusions on the two‐event stack maize MON 89034 × NK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034 × NK603 and maize MON 87427 × MON 89034 × NK603. Since the post‐market environmental monitoring plan for the three‐event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

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 genetic stability of the inserted DNA over multiple generations in the five single maize events was demonstrated previously (see Table ). Integrity of the events was demonstrated in the five‐event stack maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 (Section 3.4.1.2) and the previously assessed maize subcombinations (EFSA GMO Panel, , , ). The GMO Panel finds no reasons to expect the loss of integrity of the events in the maize subcombinations not previously assessed (see Table ).…”

“…Briefly, bioinformatics searches for sequence identity with proteins eliciting celiac disease revealed partial matches with and without the Q/E‐X1‐P‐X2 motif for the Cry1A.105 protein requiring further investigation. Based on additional considerations on position and nature of amino acids flanking the QLPQ motif, such as the absence of prolines at specific positions and the charge and size of adjacent amino acids (EFSA GMO Panel, ), the sequences containing the motif do not raise concern as they fail to mimic gluten sequences. Two additional partial sequence matches lacking the motif were also identified and subjected to a HLA‐DQ‐peptide structure modelling using a publicly available crystal structure of HLA‐DQ2‐T‐cell receptor interactions as a reference , .…”

“…When newly expressed proteins with a potential adjuvant activity are expressed together, possible interactions increasing adjuvanticity and impacting the allergenicity of the GM crop are assessed. In addition, an assessment of specific newly expressed proteins in relation to their potential to cause celiac disease was also performed (EFSA GMO Panel, ).…”

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐113)

“…The updated bioinformatic analyses for maize events MON 89034, MON 88017 and 59122 do not reveal any new DNA sequence that could provide sufficient length and identity which could facilitate HGT by DHR, confirming the previous conclusions (EFSA GMO Panel, ,c).…”

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

“…The updated bioinformatic analysis for maize events MON 89034 and NK603 do not reveal any new DNA sequence that could provide sufficient length and identity which could facilitate HGT by DHR, confirming the previous conclusions (EFSA GMO Panel, ,c,d).…”