Scientific Opinion on an application from Pioneer Hi‐Bred International and Dow AgroSciences LLC (EFSA‐GMO‐NL‐2005‐23) for placing on the market of genetically modified maize 59122 for food and feed uses, import, processing and cultivation under Regulation (EC) No 1829/2003

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doi:10.2903/j.efsa.2013.3135

Cited by 13 publications

(8 citation statements)

References 388 publications

(630 reference statements)

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“…Due to the lack of seed germination studies, it was not possible to assess if the observed differences were related to a different germination capacity of the starting materials. A reduction in early stand count was also identified in the agronomic and phenotypic field trials performed during the comparative assessment of two events of the five-event stack maize, namely maize 59122 and GA21 (EFSA, 2007b;EFSA GMO Panel, 2013). The differences observed suggested a lower fitness of the five-event stack maize than that of its conventional counterpart (i.e.…”

Section: Persistence and Invasiveness Of The Gm Plant 32mentioning

confidence: 84%

“…Since the publication of the scientific opinions on the single maize events by the EFSA GMO Panel (EFSA, 2004(EFSA, , 2005a(EFSA, , 2007b(EFSA, , 2009bEFSA GMO Panel, 2013), no safety issue pertaining to the five single events has been reported by the applicant.…”

Section: Updated Information On Single Eventsmentioning

confidence: 99%

“…The EFSA GMO Panel regularly reviews the available publications on food allergy to maize (EFSA GMO Panel, 2013). However, to date, maize has not been considered to be a common allergenic food 29 (OECD, 2002).…”

Section: Assessment Of Allergenicity Of Gm Plant Products 28mentioning

confidence: 99%

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Scientific Opinion on an application by Syngenta (EFSA‐GMO‐DE‐2011‐99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003

2016

EFS2

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In this opinion, the EFSA GMO Panel assesses the five-event stack maize and 20 of its subcombinations independently of their origin. The EFSA GMO Panel has previously assessed the five single events that are combined to produce this five-event stack maize Bt11 9 59122 9 MIR604 9 1507 9 GA21 and did not identify safety concerns. No new data on the single events, leading to a modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the five-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the single events impacting on the food and feed safety of the five-event stack maize. Considering the scope of the application (no cultivation), routes of exposure and limited exposure levels, the Panel concludes that this five-event stack maize would not raise safety concerns in the event of accidental release of viable grains into the environment. The EFSA GMO Panel concludes that the fiveevent stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. For the 20 subcombinations, the EFSA GMO Panel followed a weight-of-evidence approach, and concluded that they are expected to be as safe as the five-event stack maize. No specific data were submitted for the subcombinations included in the scope of this application that could be produced by conventional crossing through targeted breeding approaches. In order to reduce the consequent uncertainties and to confirm assumptions made for their assessment, the EFSA GMO Panel considers that the applicant should provide relevant information, if these subcombinations were to be created via targeted breeding approaches and imported into the EU in the future. In this case, this information should focus on expression levels of the newly expressed proteins. A minority opinion expressed by an EFSA GMO Panel member is appended to this opinion.

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Section: Persistence and Invasiveness Of The Gm Plant 32mentioning

confidence: 84%

Section: Updated Information On Single Eventsmentioning

confidence: 99%

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Scientific Opinion on an application by Syngenta (EFSA‐GMO‐DE‐2011‐99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003

2016

EFS2

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“…Based on the data provided, it can be concluded that the sequence differences found in maize event DAS-59122-7 in 2016 were already present in the original material used in the risk assessment process (EFSA, 2007(EFSA, , 2008(EFSA, , 2009aEFSA GMO Panel, 2010a, 2013, 2016. Furthermore, the differences identified are located outside the coding sequences of the newly expressed proteins Cry34Ab1, Cry35Ab1 and PAT; two nucleotides are in the TA peroxidase promoter of the cry35Ab1 expression cassette and one nucleotide is in the 5 0 genomic flanking region.…”

Section: Assessmentmentioning

confidence: 97%

Risk assessment of new sequencing information on GM maize event DAS‐59122‐7

Naegeli¹,

Birch²,

Casacuberta³

et al. 2016

EFS2

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The EFSA Panel on Genetically Modified Organisms (GMO Panel) has previously assessed genetically modified (GM) maize DAS-59122-7 as a single event as well as part of several stacked events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health, and the environment. On 26 July 2016, the European Commission received from Pioneer new nucleic acid sequencing data on maize event DAS-59122-7 and updated bioinformatic analyses using the new sequencing data. The European Commission tasked EFSA to analyse these data and to indicate whether the previous conclusions of the GMO Panel on the previously assessed GM maize events remain valid. The GMO Panel used the appropriate principles described in its guidelines for the risk assessment of GM plants to analyse the received data. The new sequencing data indicated three base pair (bp) differences compared to the sequencing data originally provided; two located in a non-coding region of the insert and one located in the 5 0 genomic flanking region. These base pairs reported as differences in the new nucleic acid sequencing data on maize event DAS-59122-7 had already been present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence did not give rise to safety issues. Therefore, the GMO Panel concludes that the original risk assessment of event DAS-59122-7 as a single and as a part of stacked events remains valid.

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“…Evaluation of the systematic search and evaluation of literature Ten of the 11 relevant primary research studies identified by the applicant have already been assessed by the GMO Panel (EFSA GMO Panel, 2013) and it was concluded that none of them raised any safety concerns. The GMO Panel assessed the remaining publication, Ferreira et al (2015), in which it was reported that the agronomic and phenotypic characteristics and nutritional composition of grains and forage of maize 59122 did not differ from its non-GM comparator.…”

Section: 2mentioning

confidence: 99%

Scientific opinion on an application for renewal of authorisation for continued marketing of maize 59122 and derived food and feed submitted under articles 11 and 23 of Regulation (EC) No 1829/2003 by Pioneer Overseas Corporation and Dow AgroSciences LLC

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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Following the submission of application EFSA‐GMO‐RX‐003 under Regulation (EC) No 1829/2003 from Pioneer Overseas Corporation and Dow AgroSciences LLC, 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 insect‐resistant genetically modified maize 59122. 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 59122 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that no new hazards or modified exposure and no new scientific uncertainties were identified that would change the conclusions of the original risk assessment on maize 59122.

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Scientific Opinion on an application from Pioneer Hi‐Bred International and Dow AgroSciences LLC (EFSA‐GMO‐NL‐2005‐23) for placing on the market of genetically modified maize 59122 for food and feed uses, import, processing and cultivation under Regulation (EC) No 1829/2003

Cited by 13 publications

References 388 publications

Risk assessment of new sequencing information on GM maize event DAS‐59122‐7

Scientific opinion on an application for renewal of authorisation for continued marketing of maize 59122 and derived food and feed submitted under articles 11 and 23 of Regulation (EC) No 1829/2003 by Pioneer Overseas Corporation and Dow AgroSciences LLC

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