Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐123)

Naegeli, Hanspeter; Birch, Andrew Nicholas; Casacuberta, Josep M.; Schrijver, Adinda De; Gralak, Mikołaj Antoni; Guerche, Philippe; Jones, Huw; Manachini, Barbara; Messéan, Antoine; Nielsen, Elsa; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils; Sweet, Jeremy; Tebbe, Christoph C.; Visioli, Francesco; Wal, Jean‐Michel; Álvarez, Fernando; Ardizzone, Michele; Paraskevopoulos, K. M.; Broll, Hermann; Devos, Yann; Dumont, Antonio Fernández; Ruiz, José Ángel Gómez; Lanzoni, Anna; Neri, Franco Maria; Olaru, Irina; Papadopoulou, Nikoletta

doi:10.2903/j.efsa.2018.5280

Cited by 4 publications

(10 citation statements)

References 18 publications

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“…The updated bioinformatics analyses of events DP4114, MON 810, MIR604 and NK603 confirm the assessments provided in the context of previous Scientific Opinions (EFSA GMO Panel, 2018a, 2019b, 2021a,f).…”

Section: Assessmentsupporting

confidence: 74%

See 1 more Smart Citation

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)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

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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.

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Section: Assessmentsupporting

confidence: 74%

“…The GMO Panel had previously concluded that these studies are in line with Regulation (EU) No 503/2013 and do not show adverse effects related to diets incorporating the single‐event maize DP4114 (EFSA GMO Panel, 2018a), MON 810 or NK603 (EFSA GMO Panel, 2021a).…”

Section: Assessmentmentioning

confidence: 80%

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)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

Self Cite

View full text Add to dashboard Cite

show abstract

“…The GMO Panel had previously concluded that these studies are in line with Regulation (EU) No 503/2013 and do not show adverse effects related to diets incorporating the single‐event maize DP4114 (EFSA GMO Panel, 2018b), MON 89034 (EFSA GMO Panel, 2019e), MON 87411 (EFSA GMO Panel, 2018c) and DAS‐40278‐9 (EFSA GMO Panel, 2021c).…”

Section: Assessmentmentioning

confidence: 76%

“…Human and animal dietary exposure assessment to DvSnf7 dsRNA and its derived siRNAs was not conducted because these molecules are generally rapidly denaturated, depurinated and degraded shortly after ingestion, and therefore, they are considered generally not to exert any biological effects once ingested by humans and animals (EFSA GMO Panel, 2018b).…”

Section: Assessmentmentioning

confidence: 99%

“…Based on the outcome of the studies considered in the comparative analysis and molecular characterisation, no new constituents other than the newly expressed proteins have been identified in seed and forage from the four‐event stack maize, with the exception of the intended expression of DvSnf7 dsRNA and derived siRNAs, designed to control coleopteran pests via RNAi. The GMO Panel has previously assessed these compounds in the context of the single maize event MON 87411 (EFSA GMO Panel, 2018b) and concluded that no safety concerns are associated with their presence. The GMO Panel is not aware of any new information that would change its previous conclusions on the safety of these compounds.…”

Section: Assessmentmentioning

confidence: 99%

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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)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

Self Cite

View full text Add to dashboard Cite

Genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9 was developed by crossing to combine four single events: DP4114, MON 89034, MON 87411 and DAS‐40278‐9. The GMO Panel previously assessed the four single maize events and two 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 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. Therefore, no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable four‐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 eight 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 four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP4114 × MON 89034 × MON 87411 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered 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 maize varieties with respect to potential effects on human and animal health and the environment.

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Comparative safety assessment of genetically modified crops: focus on equivalence with reference varieties could contribute to more efficient and effective field trials

et al. 2023

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The initial compositional analysis of plants plays an important role within the internationally harmonized comparative safety assessment approach for genetically modified plants. Current EFSA guidance prescribes two types of comparison, namely difference tests with regard to a conventional comparator or control, and equivalence tests with regard to a collection of commercial reference varieties. The experience gained so far shows that most of the statistically significant differences between the test and control can be discounted based on the fact that they are still within equivalence limits of reference varieties with a presumed history of safe use. Inclusion of a test variety and reference varieties into field trial design, and of the statistical equivalence test would already suffice for the purpose of finding relevant parameters that warrant further assessment, hence both the inclusion of a conventional counterpart and the performance of difference testing can be omitted. This would also allow for the inclusion of safety testing regimes into plant variety testing VCU (value for cultivation and use) or other, independent variety trials.

show abstract

Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐123)

Cited by 4 publications

References 18 publications

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)

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)

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)

Comparative safety assessment of genetically modified crops: focus on equivalence with reference varieties could contribute to more efficient and effective field trials

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