Assessment of genetically modified Maize MON 87429 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐161)

Abstract

Maize MON 87429 was developed to confer tolerance to dicamba, glufosinate, quizalofop and 2,4‐D herbicides. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 87429 and its conventional counterpart needs further assessment, except for the levels of phytic acid in grains, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the DMO, PAT, FT_T and CP4 EPSPS proteins as expressed in maize MON 87429. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 87429. In the context of this application, the consumption of food and feed from maize MON 87429 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 87429 is as safe as the conventional counterpart and non‐GM maize reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87429 grains into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87429. The GMO Panel concludes that maize MON 87429, as described in this application, is as safe as its conventional counterpart and the tested non‐GM maize reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 87419 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐140)

“…The applicant, instead of providing a 28‐day study with a DMO MON 87419 protein, referred to the 28‐day study with the DMO MON 87429 protein previously assessed by the GMO Panel in the frame of another application (EFSA GMO Panel, 2022a ), supporting this choice with the comparison of the physico‐chemical and functional properties of the MON 87419 DMO and MON 87429 DMO proteins. 20…”

“…Based on the above information the GMO Panel agreed with the approach of referring to the 28‐day study with the closely related DMO MON 87429 protein previously assessed (EFSA GMO Panel, 2022a), for which no adverse effects were observed up to the dose of 1,000 mg/kg bw per day in mice. Conclusion on the toxicological profile of DMO protein …”

“…In vitro protein degradation studies on PAT and DMO proteins have been previously evaluated by the GMO Panel (EFSA GMO Panel, 2017b , c , 2021b , 2022a ). The applicant provided additional studies on the PAT and DMO proteins as expressed in MON 87419 that were consistent with the outcome of previous studies on other PAT and DMO proteins (EFSA GMO Panel, 2013a ).…”

“…The study was conducted with the upper limit doses of 33%. 24 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 , b , c ). 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 33% is acceptable for this existing study.…”

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐159)

“…Vertical gene transfer from maize is limited to Zea species. Wild relatives of maize outside cultivation are not known/reported in Europe (Eastham & Sweet, 2002;EFSA, 2016EFSA, , 2022OECD, 2003;Trtikova et al, 2017). Therefore, potential vertical gene transfer is restricted to maize and weedy Zea species, such as teosintes, and/or maize-teosinte hybrids, occurring in cultivated areas (EFSA, 2016(EFSA, , 2022Le Corre et al, 2020;Trtikova et al, 2017).…”