Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐007)

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; Broll, Hermann; Dumont, Antonio Fernández; Olaru, Irina

doi:10.2903/j.efsa.2018.5163

Cited by 3 publications

(3 citation statements)

References 4 publications

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“…The updated bioinformatic analyses confirmed the previous conclusions on the likelihood of occurrence of HGT for these events (e.g. EFSA GMO Panel, , ). It was concluded that the unlikely, but theoretically possible, horizontal transfer of recombinant genes from maize 1507 × NK603 to bacteria did not raise any environmental safety concern.…”

Section: Assessmentsupporting

confidence: 82%

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 9 NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 9 NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 9 NK603 (EFSA, 2006).

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Section: Assessmentsupporting

confidence: 82%

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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“…Therefore, there was no indication of an interaction at protein expression level. In addition, expression data from the two‐event stack maize NK603 × MON810 (EFSA, 2005c,d; EFSA GMO Panel, 2018a) and 1507 × NK603 (EFSA, 2006; EFSA GMO Panel, 2018b) were similar to those observed in each of the single maize events. This supports the conclusion that interactions affecting the expression levels of the newly expressed proteins are not expected in the four subcombinations not previously assessed and included in the scope of application EFSA‐GMO‐NL‐2015‐127.…”

Section: Assessmentmentioning

confidence: 55%

Assessment of genetically modified maize 1507 × MIR162 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐127)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2021

EFS2

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Maize 1507 × MIR162 × MON810 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: 1507, MIR162, MON810 and NK603. The GMO Panel previously assessed the four single events and six of the subcombinations and did not identify safety concerns. No new data on the single events or the six subcombinations that could lead to modification of the original conclusions on their safety were identified. 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, as described in this application, is as safe as its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable seeds 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 four 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 the four‐event stack maize. 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 the non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

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“…Therefore, there was no indication of an interaction at protein expression level. In addition, expression data from the two‐event stack maize MON 810 × NK603 (EFSA, 2005a,b; EFSA GMO Panel, 2017a, 2018b, 2021a) were similar to those observed in each of the single maize events. This supports the conclusion that interactions affecting the expression levels of the newly expressed proteins are not expected in the 9 subcombinations not previously assessed and included in the scope of application EFSA‐GMO‐NL‐2018‐150.…”

Section: Assessmentmentioning

confidence: 57%

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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Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐007)

Cited by 3 publications

References 4 publications

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Assessment of genetically modified maize 1507 × MIR162 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐127)

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)

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