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

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, Cristoph; Visioli, Francesco; Wal, Jean‐Michel; Álvarez, Fernando; Ardizzone, Michele; Sanctis, Giacomo De; Dumont, Antonio Fernández; Lanzoni, Anna; Papadopoulou, Nikoletta; Paraskevopoulos, K. M.

doi:10.2903/j.efsa.2018.5347

Cited by 5 publications

(6 citation statements)

References 11 publications

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“…The GMO Panel had previously concluded that these studies are in line with Reg (EU) No 503/2013 and do not show adverse effects related to diets incorporating the single‐event maize crops (MON 87427, MON 87460 and MON 89034 in EFSA GMO Panel (2019a); MON 87411 in EFSA GMO Panel (2018a,b,c).…”

Section: Assessmentmentioning

confidence: 72%

“…The applicant clarified that the 1507 maize sequence reported for the six‐event stack maize contained one silent nucleotide change in the insert sequence compared to the corrected original 1507 maize sequence (EFSA GMO Panel, 2018b, 2018c, 2019d, 2019e). Analysis of the new sequencing data and bioinformatic analyses performed on the new sequence does not identify any need for further safety assessment (EFSA GMO Panel, 2017d).…”

Section: Assessmentmentioning

confidence: 99%

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Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐139)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2021

EFS2

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Maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 (six‐event stack maize) was produced by conventional crossing to combine six single events: MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The GMO Panel previously assessed the six single maize events and 17 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 17 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 and dsRNA in the six‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as its non‐GM comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the six‐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 39 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 six–event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐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: Assessmentmentioning

confidence: 72%

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐139)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2021

EFS2

Self Cite

View full text Add to dashboard Cite

show abstract

“…The applicant clarified that the 1507 maize sequence reported for the five‐event stack maize contained one silent nucleotide change in the insert sequence compared to the corrected original 1507 maize sequence (EFSA GMO Panel, ,b). Analysis of the new sequencing data and bioinformatic analyses performed on the new sequence does not identify any need for further safety assessment.…”

Section: Assessmentmentioning

confidence: 97%

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐113)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify 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 indicates 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 the five‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of the five‐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 14 maize subcombinations for which no experimental data were provided, and concludes that they are expected to be as safe as and nutritionally equivalent to 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 the five‐event stack maize. No post‐market monitoring of food/feed is 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 reference varieties with respect to potential effects on human and animal health and the environment.

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“…The applicant clarified that the maize 1507 sequence reported for the five‐event stack maize contained one silent nucleotide change in the insert sequence compared to the corrected original sequence (EFSA GMO Panel, 2017b ), that has already been assessed in the frame of previous applications (EFSA GMO Panel, 2018a , b , 2019b , c , 2021b ). Analysis of the new sequencing data and bioinformatic analyses performed on the new sequence does not identify any need for further safety assessment (EFSA GMO Panel, 2017b ).…”

Section: Assessmentmentioning

confidence: 99%

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)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

Self Cite

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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.

show abstract

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

Cited by 5 publications

References 11 publications

Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐139)

Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐139)

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐113)

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)

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