Scientific Opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 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 GMO Panel assessed the five‐event stack maize MON 87427 × MON 89034 ×1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five‐event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five‐event stack maize did not give rise to issues – based on the molecular, agronomic/phenotypic or compositional characteristics – regarding food and feed safety and nutrition. Considering the scope of this application, the known biological function of the newly expressed proteins and the data available for the five‐event stack maize and its previously assessed maize subcombinations, the GMO Panel considered that different combinations of the single events would not raise environmental concerns. The GMO Panel concludes that the five‐event stack maize is as safe and as nutritious as the non‐genetically modified (GM) comparator and the tested non‐GM reference varieties in the context of its scope. For the 14 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 combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and maize MON 87427 ×MON 89034 × 1507 × MON 88017 × 59122. Since the post‐market environmental monitoring plan for the five‐event stack maize does not include any provisions for the 14 maize subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

Assessment of genetically modified maize MON 88017 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐014)

“…The updated bioinformatic analysis for maize event MON 88017 confirms previous conclusions which 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 GMO Panel, 2017b, ). Given the results of this analysis and that the recombinant DNA in maize MON 88017 does not confer selective advantages to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT.…”

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 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).…”