Scientific Opinion on the application (EFSA‐GMO‐BE‐2012‐110) for the placing on the market of tissue‐selective herbicide‐tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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doi:10.2903/j.efsa.2015.4130

Cited by 7 publications

(5 citation statements)

References 22 publications

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“…The studies on resistance to degradation of the Cry3Bb1 and CP4 EPSPS proteins by pepsin have been previously assessed by the GMO Panel (EFSA GMO Panel, 2009, 2015c.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 49mentioning

confidence: 99%

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Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate‐containing herbicides by the expression of a CP4 5‐enolpyruvylshikimate‐3‐phosphate synthase (cp4 epsps) gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411 did not identify differences that required further assessment except for palmitic acid levels in grains from not treated maize MON 87411. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry3Bb1 and CP4 EPSPS proteins, as expressed in maize MON 87411 and found no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87411. The nutritional impact of maize MON 87411‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that maize MON 87411, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the 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 87411 grains into the environment, maize MON 87411 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 87411. The GMO Panel concludes that maize MON 87411, 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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“…The studies on resistance to degradation of the Cry3Bb1 and CP4 EPSPS proteins by pepsin have been previously assessed by the GMO Panel (EFSA GMO Panel, 2009, 2015c.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 49mentioning

confidence: 99%

“…Effects of temperature and pH on CP4 EPSPS and Cry3Bb1 proteins have been previously evaluated by the EFSA GMO Panel (EFSA GMO Panel, 2009, 2015b, 2015c, 2017a. No new studies were provided in the context of this application.…”

Section: Influence Of Temperature and Ph On Newly Expressed Proteinsmentioning

confidence: 99%

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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“…In vitro protein degradation studies on proteins PAT and CP4 EPSPS expressed in MON 87429 were previously evaluated by the GMO Panel (EFSA GMO Panel, 2015a , 2018 , 2021 ) The applicant provided additional studies on the DMO protein as expressed in MON 87429 that were consistent with the outcome of previous studies on other DMO proteins (EFSA GMO Panel, 2013 ). Briefly, the resistance to degradation by pepsin of the DMO protein was measured in solutions containing pepsin and the test protein at pH 1.2.…”

Section: Assessmentmentioning

confidence: 84%

“…The GMO Panel conducted its assessment in line with the principles described in Regulation (EU) No 503/2013, its applicable guidelines (i.e. 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%

“…The effects of temperature and pH on PAT and CP4 EPSPS proteins expressed in MON 87429 were previously evaluated by the GMO Panel (EFSA GMO Panel, 2015a , 2018 , 2021 ). The applicant provided additional studies on the DMO protein as expressed in MON 87429 that were consistent with the outcome of previous studies on other DMO proteins (EFSA GMO Panel, 2013 ).…”

Section: Assessmentmentioning

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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Scientific Opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Naegeli

Birch²,

Casacuberta³

et al. 2017

EFS2

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In this opinion, the GMO Panel assessed the five‐event stack maize MON 87427 × MON 89034 ×1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five‐event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five‐event stack maize did not give rise to issues – based on the molecular, agronomic/phenotypic or compositional characteristics – regarding food and feed safety and nutrition. Considering the scope of this application, the known biological function of the newly expressed proteins and the data available for the five‐event stack maize and its previously assessed maize subcombinations, the GMO Panel considered that different combinations of the single events would not raise environmental concerns. The GMO Panel concludes that the five‐event stack maize is as safe and as nutritious as the non‐genetically modified (GM) comparator and the tested non‐GM reference varieties in the context of its scope. For the 14 maize subcombinations for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and maize MON 87427 ×MON 89034 × 1507 × MON 88017 × 59122. Since the post‐market environmental monitoring plan for the five‐event stack maize does not include any provisions for the 14 maize subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

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Scientific Opinion on the application (EFSA‐GMO‐BE‐2012‐110) for the placing on the market of tissue‐selective herbicide‐tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Cited by 7 publications

References 22 publications

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

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

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