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)

Abstract

Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the five single maize events and 16 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to the modification of the original conclusions on their safety. 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 five‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM maize varieties tested. In the case of accidental release of viable five‐event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as 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 maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9. 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 maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO‐NL‐2020‐171)

“…The updated bioinformatic analyses for maize events DP4114, MON 89034, MON 87411 and DAS‐40278‐9 confirm the assessments provided in the context of previous Scientific Opinions (EFSA GMO Panel, 2021b, 2022a,b).…”

“…The assessment of the Cry1F, Cry1A.105, Cry35Ab1, Cry3Bb1, PAT and PMI proteins revealed partial matches containing the Q/E‐X1‐P‐X2 motif and required further investigations. Several of these partial matches have been previously assessed by the EFSA GMO Panel (2019f, 2021b,d, 2022a,b). Based on additional considerations on the position and nature of amino acids flanking the motifs, such as the presence of two consecutive prolines and the charge and size of adjacent amino acids (EFSA GMO Panel, 2017), the relevant peptides containing the motif do not raise concern as they fail to mimic gluten sequences.…”

Risk assessment of additional information on maize MIR162

“…However, the specific combination of the genetic regions leading to this effect has not been adequately identified and characterised. Syngenta also pointed out that as part of the sequencing and bioinformatics analysis assessed by the GMO panel, the molecular characterisation of the MIR162 insertion was not shown to interrupt any known endogenous gene (EFSA GMO Panel, 2022a , b ).…”

“…Two of the scientific opinions in Table 1 were adopted recently. The opinion on application EFSA‐GMO‐NL‐2018‐151 for the five‐event stack maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 and subcombinations was adopted on 4 July 2022 (EFSA GMO Panel, 2022a ). The opinion on application EFSA‐RX‐GMO‐RX025 for the renewal of maize MIR162 was adopted on 1 September 2022 (EFSA GMO Panel, 2022b ).…”

“…Following the provisions of Regulation (EC) No 1829/2003, 1 the public was requested to comment on the scientific opinions after they were published. On 21 September 2022, the European Commission (EC) asked EFSA to assess whether the scientific comments received for the five‐event stack maize contain new information that might change the conclusions of EFSA GMO Panel ( 2022a ) (‘ request 1 ’). 2 On 10 November 2022, the EC asked EFSA to assess whether the scientific comments received for the renewal application contain new information that might change the conclusions of EFSA GMO Panel ( 2022b ) (‘ request 2 ’).…”