Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐150)

Abstract

Maize DP4114 × MON 810 × MIR604 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: DP4114, MON 810, MIR604 and NK603. The GMO Panel previously assessed the four single maize events and one of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombination were identified that could lead to 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 four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, is as safe as the comparator and the selected non‐GM reference varieties. 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 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 subcombination and the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference 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.…”

Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)

“…The results of the updated bioinformatic analyses to assess the interruption of maize endogenous genes confirmed previous results indicating that a possible genomic deletion or rearrangement happened at the insertion site, and a predicted maize E3 ubiquitin ligase gene was interrupted by event MON 810 (EFSA GMO Panel, 2009, 2012, 2021a, 2021b, 2022).…”

Assessment of genetically modified maize GA21 × T25 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐137)

“…The two studies were conducted with two upper limit doses of 50% 28 and 41.5%. 29 Since 2019, a 50% maize incorporation rate is used as the high dose (EFSA, 2014 ; Steinberg et al., 2019 , 2020 ; EFSA GMO Panel, 2021b , c , 2022a , 2022c ). While the GMO Panel is reviewing the evidence regarding test diets incorporating up to 50% and the potential to induce nutritional imbalance, currently the Panel considers that the upper limit of 41.5% is acceptable for the existing study.…”