Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Paraskevopoulos, K. M.; Ramon, Matthew; Dalmay, Tamás; Jardin, Patrick du; Casacuberta, Josep; Guerche, Philippe; Jones, Huw; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils

doi:10.2903/sp.efsa.2018.en-1466

Cited by 17 publications

(13 citation statements)

References 22 publications

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“…EFSA GMO Panel, 2010a , 2011a , b , 2015a , 2017 ), explanatory notes and statements (i.e. EFSA GMO Panel, 2010a , 2018 ; EFSA, 2010 , 2014 , 2018 , 2019a ,b) for the risk assessment of GM plants.…”

Section: Data and Methodologiesmentioning

confidence: 99%

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

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

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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.

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Section: Data and Methodologiesmentioning

confidence: 99%

“…The PAT and the CP4 EPSPS proteins were previously assessed by the GMO Panel in the context of other applications (EFSA, 2006 , 2008 , 2009b , c , d , 2011 , 2012 , 2013 , 2014 , 2015b , 2018 ) and no safety concerns for humans and animals (i.e. farmed and companion animals) were identified.…”

Section: Assessmentmentioning

confidence: 99%

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

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

Self Cite

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show abstract

“…EFSA GMO Panel, 2010a , 2011a , b , 2015 , 2017 ; EFSA Scientific Committee, 2011 ) and explanatory notes and statements (i.e. EFSA, 2010 , 2014 , 2017 , 2018 , 2019a , b ; EFSA GMO Panel, 2010b , 2018 ) for the risk assessment of GM plants.…”

Section: Data and Methodologiesmentioning

confidence: 99%

“…Molecular characterisation of maize MON 95379 was performed by next generation sequencing (NGS) and junction sequence analysis (JSA) in order to determine insert copy number and to confirm the absence of PV‐ZMIR522223 plasmid backbone and the entire PV‐ZMOO513642 plasmid, and NGS sequencing on PCR amplified fragments to determine size and organisation of the inserted sequences. Overall, the quality of the sequencing methodology and data sets was assessed by the EFSA GMO Panel and is in compliance with the requirements listed in the EFSA Technical Note (EFSA GMO Panel, 2018 ).…”

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize MON 95379 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐170)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

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Genetically modified maize MON 95379 was developed to confer insect protection against certain lepidopteran species. These properties were achieved by introducing the cry1B.868 and cry1Da_7 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 MON 95379 and its conventional counterpart needs further assessment. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Cry1B.868 and Cry1Da_7 proteins as expressed in maize MON 95379. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 95379. In the context of this application, the consumption of food and feed from maize MON 95379 does not represent a nutritional concern in humans and animals. Therefore, no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 95379 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 95379. The GMO Panel concludes that maize MON 95379 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.

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“…EFSA GMO Panel, 2010a , 2011a , b , 2015a , 2017 , EFSA Scientific Committee, 2011 ), explanatory notes and statements (i.e. EFSA GMO Panel, 2010b , 2018 ; EFSA, 2010 , 2014 , 2017 , 2018 , 2019a , b ) for the risk assessment of GM plants.…”

Section: Data and Methodologiesmentioning

confidence: 99%

Assessment of genetically modified oilseed rape MON 94100 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐169)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

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Oilseed rape MON 94100 was developed to confer tolerance to dicamba herbicide. 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 oilseed rape MON 94100 and its conventional counterpart needs further assessment, except for the levels of carbohydrates, calcium and ADF in seeds, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono‐oxygenase (DMO) protein as expressed in oilseed rape MON 94100. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of oilseed rape MON 94100. In the context of this application, the consumption of food and feed from oilseed rape MON 94100 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that oilseed rape MON 94100 is as safe as the conventional counterpart and non‐GM oilseed rape reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable oilseed rape MON 94100 seeds 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 oilseed rape MON 94100. The GMO Panel concludes that oilseed rape MON 94100 is as safe as its conventional counterpart and the tested non‐GM oilseed rape reference varieties with respect to potential effects on human and animal health and the environment.

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Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Cited by 17 publications

References 22 publications

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

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

Assessment of genetically modified maize MON 95379 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐170)

Assessment of genetically modified oilseed rape MON 94100 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐169)

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