Assessment of genetically modified maize MIR604 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐013)

Organisms, EFSA Panel on Genetically Modified; Veronesi, F.; Álvarez, Fernando; Ardizzone, Michele; Raffaello, Tommaso; Naegeli, Hanspeter; Bresson, Jean‐Louis; Dalmay, Tamás; Dewhurst, Ian Crawford; Epstein, Michelle M.; Firbank, Leslie George; Guerche, Philippe; Hejátko, Jan; Moreno, F. Javier; Mullins, Ewen; Nogu, Fabien; Rostoks, Nils; Serrano, Jose Juan Sánchez; Savoini, G.; Veromann, Eve

doi:10.2903/j.efsa.2019.5846

Cited by 5 publications

(9 citation statements)

References 8 publications

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“…The assessment of the Cry1F, Cry1A.105, 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 ( 2019d , g , 2021c , d ). Based on additional considerations on 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, 2017a ), the relevant peptides containing the motif do not raise concern as they fail to mimic gluten sequences.…”

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

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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.

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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

View full text Add to dashboard Cite

show abstract

“…The assessment of the Cry1F, Cry35Ab1, 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 (2019a,c, 2020and 2021d. Based on additional considerations on position and nature of amino acids flanking the motifs, such as the presence of two 19 Although animals used in a toxicology study are of the same strain, from the same supplier and are closely matched for age and body weight at the start of the study, they exhibit a degree of variability in the parameters investigated during the study.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 20mentioning

confidence: 99%

“…A 90‐day study on maize MIR604 has been previously assessed by the GMO Panel in the context of the single‐event renewal application dossier (EFSA GMO Panel, 2019a), and was not consider adequate because it was not possible to confirm the adequacy of the control material (i.e. to exclude it was a negative segregant, EFSA GMO Panel, 2011a; EFSA Scientific Committee, 2011); upon EFSA’s request to fulfil the requirements of Regulation (EU) No 503/2013, the applicant provided a new 90‐day toxicity study on maize MIR604.…”

Section: Assessmentmentioning

confidence: 99%

“…The assessment of the Cry1F, Cry35Ab1, 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 (2019a,c, 2020 and 2021d,e). Based on additional considerations on 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, 2017b), the relevant peptides containing the motif do not raise concern as they fail to mimic gluten sequences.…”

Section: Assessmentmentioning

confidence: 99%

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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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“…The PAT and PMI proteins were previously assessed by the GMO Panel in the context of other applications and no safety concerns for humans and animals (i.e. farmed and companion animals) were identified (EFSA GMO Panel, 2012, 2015b, 2020). These proteins have been extensively characterised (see MC section).…”

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize DP915635 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐172)

Mullins,

Bresson,

Dalmay

et al. 2024

EFS2

Self Cite

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Genetically modified maize DP915635 was developed to confer tolerance to glufosinate herbicide and resistance to corn rootworm pests. These properties were achieved by introducing the ipd079Ea, mo‐pat and pmi expression cassettes. 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 DP915635 and its conventional counterpart needs further assessment, except for the levels of crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD079Ea, PAT and PMI proteins expressed in maize DP915635. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize DP915635. In the context of this application, the consumption of food and feed from maize DP915635 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP915635 is as safe as the conventional counterpart and non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP915635 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 DP915635. The GMO Panel concludes that maize DP915635 is as safe as its conventional counterpart 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 MIR604 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐013)

Cited by 5 publications

References 8 publications

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)

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)

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 DP915635 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐172)

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