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)

Abstract

Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been 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 four‐event stack maize does not give rise to food/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 for which no experimental data were provided, 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. No post‐market monitoring for food/feed is necessary. The GMO Panel concludes that the four‐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 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 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐139)

“…The updated bioinformatic analyses for events MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122 confirm the assessments provided in the context of previous applications (EFSA GMO Panel, 2019b,c,d,e,g)…”

“…The applicant clarified that the 1507 maize sequence reported for the six‐event stack maize contained one silent nucleotide change in the insert sequence compared to the corrected original 1507 maize sequence (EFSA GMO Panel, 2018b, 2018c, 2019d, 2019e). Analysis of the new sequencing data and bioinformatic analyses performed on the new sequence does not identify any need for further safety assessment (EFSA GMO Panel, 2017d).…”

Assessment of genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐151)

“…The applicant clarified that the maize 1507 sequence reported for the five‐event stack maize contained one silent nucleotide change in the insert sequence compared to the corrected original sequence (EFSA GMO Panel, 2017b ), that has already been assessed in the frame of previous applications (EFSA GMO Panel, 2018a , b , 2019b , c , 2021b ). Analysis of the new sequencing data and bioinformatic analyses performed on the new sequence does not identify any need for further safety assessment (EFSA GMO Panel, 2017b ).…”