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)

Abstract

Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify 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 indicates 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 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 for which no experimental data were provided, and concludes that they 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. No post‐market monitoring of food/feed is 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 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.…”

“…On 29 August 2018, the European Food Safety Authority (EFSA) received from the European Commission (EC) application EFSA-GMO-RX-014 for the renewal of the authorisation of maize MON 88017 (Unique Identifier MON-88Ø17-3), submitted by Monsanto (hereafter referred to as 'the applicant') according to Regulation (EC) No 1829/2003 Following receipt of application EFSA-GMO-RX-014, EFSA informed the Member States (MS) and made the summary of the application available to the public on the EFSA website. 2 EFSA checked the application for compliance with the relevant requirements of Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 3 and, when needed, asked the applicant to supplement the initial application.…”

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)

“…The updated bioinformatics analyses of events MON 87427, MON 89034, MIR162 and NK603 do not reveal any new DNA sequence that could provide sufficient length and identity which could facilitate HGT by double homologous recombination, confirming the conclusions of previous Scientific Opinions (EFSA GMO Panel, ,b, ,b,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)

“…Subcombinations assessed in parallel in the context of application EFSA‐GMO‐NL‐2013‐113 (EFSA GMO Panel, ).…”

“…The applicant clarified that the 1507 maize sequence reported for the four‐event stack maize contained one silent nucleotide change in the insert sequence compared to the corrected original 1507 maize sequence (EFSA GMO Panel, ,b, ). Analysis of the new sequencing data and bioinformatic analyses performed on the new sequence does not identify any need for further safety assessment.…”