Scientific Opinion on application (EFSA-GMO-UK-2008-60) for placing on the market of genetically modified herbicide tolerant maize GA21 for food and feed uses, import, processing and cultivation under Regulation (EC) No 1829/2003 from Syngenta Seeds

,

doi:10.2903/j.efsa.2011.2480

Cited by 13 publications

(2 citation statements)

References 372 publications

(541 reference statements)

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“…A 90‐day study on maize GA21 performed in 2005 had been previously assessed by the GMO Panel in the context of the single‐event applications (EFSA, 2007 ; EFSA GMO Panel, 2011c ) and no adverse effects related to the administration of the GM diet had been identified. In the context of the assessment of this six‐event stack maize, EFSA asked for additional information to confirm the adherence of this study to requirements of Regulation (EU) 503/2013, OECD TG 408 ( OECD, 1998 ), EFSA Scientific Committee ( 2011 ) and EFSA ( 2014 ).…”

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)

Mullins¹,

Bresson²,

Dalmay³

et al. 2023

EFS2

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Genetically modified maize Bt11 9 MIR162 9 MIR604 9 MON 89034 9 5307 9 GA21 was developed by crossing to combine six single events: Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the GMO Panel previously assessed the 6 single maize events and 27 out of the 56 possible 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 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 six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that six-event stack maize, as described in this application, 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 six-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 29 of the maize subcombinations not previously assessed and covered by the scope of this application 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 maize Bt11 9 MIR162 9 MIR604 9 MON 89034 9 5307 9 GA21. The GMO Panel concludes that six-event stack maize and the 30 subcombinations covered by the scope of the application are 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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Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)

Mullins¹,

Bresson²,

Dalmay³

et al. 2023

EFS2

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“…Search terms and databases were not consistently used throughout the reports. Therefore, the applicant performed a systematic search of studies published between 1 June 2005 and 30 June 2016, relevant to the food/feed and environmental safety assessments of event maize GA21 and mutated 5-enol-pyruvyl-shikimate-3-phosphate-synthase (mEPSPS) protein, covering the authorisation period, and following the principles outlined in the EFSA guidance on the application of systematic review methodology for food and feed safety assessment (EFSA, 2010).…”

Section: Systematic Search and Evaluation Of Literaturementioning

confidence: 99%

Assessment of genetically modified maize GA21 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐005)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant genetically modified maize GA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatics 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. Under the assumption that the DNA sequence of the event in maize GA21 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-005 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize GA21.

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EFSA’s scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead

et al. 2013

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Genetically modified organisms (GMOs) and derived food and feed products are subject to a risk analysis and regulatory approval before they can enter the market in the European Union (EU). In this risk analysis process, the role of the European Food Safety Authority (EFSA), which was created in 2002 in response to multiple food crises, is to independently assess and provide scientific advice to risk managers on any possible risks that the use of GMOs may pose to human and animal health and the environment. EFSA's scientific advice is elaborated by its GMO Panel with the scientific support of several working groups and EFSA's GMO Unit. This review presents EFSA's scientific activities and highlights its achievements on the risk assessment of GMOs for the first 10 years of its existence. Since 2002, EFSA has issued 69 scientific opinions on genetically modified (GM) plant market registration applications, of which 62 for import and processing for food and feed uses, six for cultivation and one for the use of pollen (as or in food), and 19 scientific opinions on applications for marketing products made with GM microorganisms. Several guidelines for the risk assessment of GM plants, GM microorganisms and GM animals, as well as on specific issues such as post-market environmental monitoring (PMEM) were elaborated. EFSA also provided scientific advice upon request of the European Commission on safeguard clause and emergency measures invoked by EU Member States, annual PMEM reports, the potential risks of new biotechnology-based plant breeding techniques, evaluations of previously assessed GMOs in the light of new scientific publications, and the use of antibiotic resistance marker genes in GM plants. Future challenges relevant to the risk assessment of GMOs are discussed. EFSA's risk assessments of GMO applications ensure that data are analysed and presented in a way that facilitates scientifically sound decisions that protect human and animal health and the environment.

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Scientific Opinion on application (EFSA-GMO-UK-2008-60) for placing on the market of genetically modified herbicide tolerant maize GA21 for food and feed uses, import, processing and cultivation under Regulation (EC) No 1829/2003 from Syngenta Seeds

Cited by 13 publications

References 372 publications

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)

Assessment of genetically modified maize GA21 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐005)

EFSA’s scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead

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