Scientific Opinion on an application by Syngenta (EFSA‐GMO‐DE‐2009‐66) for placing on the market of herbicide tolerant and insect resistant maize Bt11 × MIR162 × MIR604 × GA21 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003

,

doi:10.2903/j.efsa.2015.4297

Cited by 6 publications

(4 citation statements)

References 34 publications

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“…In addition, the data on genetic stability and protein expression from the previously assessed five subcombinations ( Table 2) do not show any evidence of interactions. Given the anticipated expression levels in the subcombinations that are similar to those measured in the singles, the five-event stack and the subcombinations already assessed (EFSA, 2005a(EFSA, , 2009b(EFSA, , 2009e, 2010a(EFSA, , 2010bEFSA GMO Panel, 2015a), this scenario is considered extremely unlikely. However, at relatively high doses, the Bt proteins might act as adjuvants (see Section 3.3.3.4).…”

Section: Risk Assessment Of the Subcombinationsmentioning

confidence: 99%

“…However, at relatively high doses, the Bt proteins might act as adjuvants (see Section 3.3.3.4). Given the anticipated expression levels in the subcombinations that are similar to those measured in the singles, the five-event stack and the subcombinations already assessed (EFSA, 2005a(EFSA, , 2009b(EFSA, , 2009e, 2010a(EFSA, , 2010bEFSA GMO Panel, 2015a), this scenario is considered extremely unlikely. However, to mitigate uncertainty, the EFSA GMO Panel has included a recommendation that, if any of the subcombinations were to be created via targeted breeding approaches and commercialised in the future, the applicant should provide relevant information including expression levels of the newly expressed proteins.…”

Section: Risk Assessment Of the Subcombinationsmentioning

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: Risk Assessment Of the Subcombinationsmentioning

confidence: 99%

Section: Risk Assessment Of the Subcombinationsmentioning

confidence: 99%

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 giving its scientific opinion to the European Commission, the Member States and the applicant, and in accordance with Articles 6(1) and 18 (1) of Regulation (EC) No 1829/2003(European Commission, 2003, EFSA has endeavoured to respect a time limit of 6 months from the acknowledgement of the valid application. As additional information was requested by the GMO Panel, the time limit of 6 months was extended accordingly, in line with Articles 6(1), 6(2), 18 (1) and 18(2 (European Commission, 2003), this scientific opinion is to be seen as the report requested under Articles 6(6) and 18(6) of that Regulation and thus will be part of the EFSA overall opinion in accordance with Articles 6(5) and 18 (5).…”

Section: Table Of Contentsmentioning

confidence: 99%

“…As additional information was requested by the GMO Panel, the time limit of 6 months was extended accordingly, in line with Articles 6(1), 6(2), 18(1) and 18 (2) of Regulation (EC) No 1829/2003. According to Regulation (EC) No 1829/2003(European Commission, 2003, this scientific opinion is to be seen as the report requested under Articles 6(6) and 18(6) of that Regulation and thus will be part of the EFSA overall opinion in accordance with Articles 6(5) and 18(5).…”

Section: Introductionmentioning

confidence: 99%

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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In this opinion, the GMO Panel assessed the four‐event stack maize Bt11 × MIR162 × 1507 × GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four‐event stack maize did not give rise to food/feed safety issues. Based on the nutritional assessment of the compositional characteristics of maize Bt11 × MIR162 × 1507 × GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non‐GM maize varieties. In the case of accidental release of viable grains of maize Bt11 × MIR162 × 1507 × GA21 into the environment, this would not raise environmental safety concerns. The GMO Panel concludes that maize Bt11 × MIR162 × 1507 × GA21 is nutritionally equivalent to and as safe as its non‐GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, 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 the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 × MIR162 × 1507 × GA21 and its subcombinations. A minority opinion expressed by a GMO Panel member is appended to this opinion.

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Evolution of risk assessment strategies for food and feed uses of stacked GM events

Kramer

Brune

McDonald

et al. 2016

Plant Biotechnology Journal

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SummaryData requirements are not harmonized globally for the regulation of food and feed derived from stacked genetically modified (GM) events, produced by combining individual GM events through conventional breeding. The data required by some regulatory agencies have increased despite the absence of substantiated adverse effects to animals or humans from the consumption of GM crops. Data from studies conducted over a 15‐year period for several stacked GM event maize (Zea mays L.) products (Bt11 × GA21, Bt11 × MIR604, MIR604 × GA21, Bt11 × MIR604 × GA21, Bt11 × MIR162 × GA21 and Bt11 × MIR604 × MIR162 × GA21), together with their component single events, are presented. These data provide evidence that no substantial changes in composition, protein expression or insert stability have occurred after combining the single events through conventional breeding. An alternative food and feed risk assessment strategy for stacked GM events is suggested based on a problem formulation approach that utilizes (i) the outcome of the single event risk assessments, and (ii) the potential for interactions in the stack, based on an understanding of the mode of action of the transgenes and their products.

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Cited by 6 publications

References 34 publications

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)

Evolution of risk assessment strategies for food and feed uses of stacked GM events

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