Stacked Maize Research Articles

Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS-40278-9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO-NL-2020-171).

Genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS-40278-9 was developed by crossing to combine four single events: DP4114, MON 89034, MON 87411 and DAS-40278-9. The GMO Panelpreviously assessed the four single maize events and two of the 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 four-event stack maize does not give rise to food and feed safety and nutritional concerns. Therefore, no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable four-event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panelassessed the likelihood of interactions among the single events in eight of the maize subcombinations not previously assessed and concludes that these are 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 DP4114 × MON 89034 × MON 87411 × DAS-40278-9. Post-market monitoring of food/feed is not considered necessary. The GMO Panelconcludes that the four-event stack maize and its subcombinations are as safe as its non-GM comparator and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON89034 × 1507 × MIR162 × NK603 × DAS-40278-9 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2018-151).

Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the five single maize events and 16 of the 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 the 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 five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that five‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM maize varieties tested. In the case of accidental release of viable five‐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 nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2018-150).

Maize DP4114 × MON 810 × MIR604 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: DP4114, MON 810, MIR604 and NK603. The GMO Panel previously assessed the four single maize events and one of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombination 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 four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, is as safe as the comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombination and the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize NK603 × T25 × DAS-40278-9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-164).

Maize NK603 × T25 × DAS‐40278‐9 (three‐event stack maize) was produced by conventional crossing to combine three single events: NK603, T25 and DAS‐40278‐9. The GMO Panel previously assessed the three single maize events and two of the subcombinations and did not identify safety concerns. No new data on the single maize events or the two 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 three‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the three‐event stack maize, as described in this application, is as safe as the non‐GM comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the three‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in one of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the three‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the three‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the three‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Scientific assistance on the internal review under Regulation (EC) No 1367/2006 of the Commission Implementing Decisions on genetically modified soybean MON 87751 x MON 87701 × MON 87708 x MON 89788, maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and subcombinations and maize MON 87427 × MON 89034 × MIR162 × MON 87411 and subcombinations

Following a request of the European Commission, the European Food Safety Authority (EFSA) reviewed the scientific arguments raised by the non-governmental organisation Testbiotechrequestingthe review of Commission Implementing Decisions (EU) No 2021/66, 2021/61 and 2021/65, authorising the placing on the market of products containing, consisting of or produced from the four-event stack soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 (application EFSA-GMO-NL-2016-128), the five-event stack maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and its subcombinations (application EFSA-GMO-NL-2016-134) and the four-event stack maize MON 87427 × MON 89034 × MIR162 × MON 87411 and its subcombinations (application EFSA-GMO-NL-2017-144).In relation to the four-event stack soybean and the five-event stack maize, Testbiotech argued that the risk assessment performed by the EFSA Scientific Panel on Genetically Modified Organisms (EFSA GMO Panel) is insufficientas regards molecular characterisation, comparative analyses, toxicological and allergenicity assessment and environmental assessment. For the four-event stack maize,Testbiotechclaims that the risk assessment performed by the EFSA GMO Panel is inadequateconsidering the general knowledge gaps in the assessment of RNAi-based GM plants.EFSA's assessment focuses on scientific elements and does not cover legal aspects, as they are not in EFSA's remit and not in the frame of the mandate received from the EC. The assessment of the scientific arguments provided in the technical background of the three requests does not give enough justification to support the re-examination of theEFSA GMO Panelrisk assessment conclusions and risk management recommendations.

Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-139).

Maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 (six‐event stack maize) was produced by conventional crossing to combine six single events: MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The GMO Panel previously assessed the six single maize events and 17 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 17 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 and dsRNA in the six‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as its non‐GM comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 39 maize subcombinations not previously assessed 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 the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize 1507×MIR162 ×MON810×NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2015-127).

Maize 1507 × MIR162 × MON810 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: 1507, MIR162, MON810 and NK603. The GMO Panel previously assessed the four single events and six of the subcombinations and did not identify safety concerns. No new data on the single events or the six subcombinations that could lead to modification of the original conclusions on their safety were identified. 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 four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable seeds of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the four maize subcombinations not previously assessed and concludes that these are 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 the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

INFLUENCE OF TRANSGENIC MAIZE ON BEHAVIOR OF ADULT FEMALE OF Spodoptera frugiperda (J. E. SMITH) (LEPIDOPTERA: NOCTUIDAE)

It is known that genetic manipulation of plants can cause pleiotropic effects or mutations originated from the incorporation of an exogenous gene, which may interfere with foraging of herbivores. Little is known about how herbicide-tolerant plants (singular event), insect-resistant plants (singular event), and herbicide-tolerant plus insect-resistant plants (stacked event) affect foraging of Spodoptera frugiperda. The objective of this study was to evaluate if singular and stacked maize events interfere with the quantity and quality of S. frugiperda eggs. The hybrids DKB390 (VTPRO, VTPRO2, VTPRO3), DKB390 (isogenic) and Ag 3700 RR2 were evaluated. Choice and non-choice tests for oviposition preference of S. frugiperda, in plants with and without injuries, were performed in a greenhouse. The size of egg masses and the number of hatched larvae were evaluated. Larger egg masses and higher number of hatched larvae per plant were found in transgenic plants. The conclusion was that S. frugiperda females modify their oviposition behavior in the presence of transgenic and non-transgenic maize hybrids, especially when they are injured. However, the females do not discriminate between singular or stacked hybrid for oviposition.

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize Bt11 x MIR604 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/50)

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize Bt11 x MIR604 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/50)

Genetically modified (GM) crop use in Colombia: farm level economic and environmental contributions

ABSTRACT This study assesses the economic and environmental impacts that have arisen from the adoption and use of genetically modified (GM) cotton and maize in Colombia in the fifteen years since GM cotton was first planted in Colombia in 2003. A total of 1.07 million hectares have been planted to cotton and maize containing GM traits since 2003, with farmers benefiting from an increase in income of US $301.7 million. For every extra US $1 spent on this seed relative to conventional seed, farmers have gained an additional US $3.09 in extra income from growing GM cotton and an extra US $5.25 in extra income from growing GM maize. These income gains have mostly arisen from higher yields (+30.2% from using stacked (herbicide tolerant and insect resistant cotton and +17.4% from using stacked maize). The cotton and maize seed technology have reduced insecticide and herbicide spraying by 779,400 kg of active ingredient (−19%) and, as a result, decreased the environmental impact associated with herbicide and insecticide use on these crops (as measured by the indicator, the Environmental Impact Quotient (EIQ)) by 26%. The technology has also facilitated cuts in fuel use, resulting in a reduction in the release of greenhouse gas emissions from the GM cotton and maize cropping area and contributed to saving scarce land resources.

Assessment of genetically modified maize MON87427×MON89034×MIR162×MON87411 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-144).

Maize MON 87427 × MON 89034 × MIR162 × MON 87411 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and MON 87411. The genetically modified organism (GMO) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. 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 and dsRNA in the four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to 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 the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 87427× MON 87460×MON 89034×MIR162×NK603 and subcombinations, for food and feed uses, under Regulation (EC) No1829/2003 (application EFSA-GMO-NL-2016-134).

Maize MON 87427 ×MON 87460 × MON 89034 × MIR162 × NK603 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 87427, MON 87460, MON 89034, MIR162 and NK603. The GMO Panel previously assessed the five single maize events and eleven of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 11 subcombinations that could lead to modification of the original conclusions on their safety were identified. 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 five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the five‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the five‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 14 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the five‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 87427×MON 89034×MIR162×NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2016-131).

Maize MON 87427 × MON 89034 × MIR162 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and NK603. The GMO Panel previously assessed the four single maize events and four of the subcombinations did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. 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 four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to 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 the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize Bt11×MIR162×MIR604×1507×5307×GA21 and subcombinations, for food and feed uses, under Regulation (EC) No1829/2003 (application EFSA-GMO-DE-2011-103).

Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. 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 the six‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 34 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to 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 the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON89034×1507×MON88017×59122×DAS-40278-9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No1829/2003 (application EFSA-GMO-NL-2013-113).

Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates that the combination of the single maize events and of the newly expressed proteins in the five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the five‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of the five‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 14 maize subcombinations for which no experimental data were provided, and concludes that they are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the five‐event stack maize. No post‐market monitoring of food/feed is considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON89034×1507×NK603×DAS-40278-9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No1829-2003 (application EFSA-GMO-NL-2013-112).

Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates that the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize does not give rise to food/feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations for which no experimental data were provided, and concludes that these are expected to be as safe as and nutritionally equivalent to 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 the four‐event stack maize. No post‐market monitoring for food/feed is necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize 1507×NK603 for renewal of authorisation under Regulation (EC) No1829/2003 (application EFSA-GMO-RX-008).

Following the submission of application EFSA‐GMO‐RX‐008 under Regulation (EC) No 1829/2003 from Pioneer Hi‐Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect‐resistant, herbicide‐tolerant genetically modified maize 1507 × NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioinformatic 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 × NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two‐event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 × NK603 (EFSA, 2006).

Assessment of genetically modified maize Bt11xMIR162x1507xGA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No1829/2003 (application EFSA-GMO-DE-2010-86).

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.

Assessment of genetically modified maize 1507×59122×MON810×NK603 and subcombinations, for food and feed uses, under Regulation (EC) No1829/2003 (application EFSA-GMO-NL-2011-92).

In this opinion, the GMO Panel assessed the four‐event stack maize 1507 × 59122 × MON810 × NK603 and its ten subcombinations, independently of their origin. The GMO Panel previously assessed the four single events combined in this four‐event stack maize and five of their combinations and did not identify safety concerns. No new data on the single events or their previously assessed combinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize did not give rise to food and feed safety or nutritional issues. The GMO Panel concludes that the four‐event stack maize is as safe and as nutritious as its non‐GM comparator. In the case of accidental release of viable grains of maize 1507 × 59122 × MON810 × NK603 into the environment, this would not raise environmental safety concerns. For four of the subcombinations not previously assessed, protein expression data were provided and did not indicate an interaction affecting the levels of the newly expressed proteins in these subcombinations. The five subcombinations not previously assessed are expected to be as safe as the single maize events, the previously assessed subcombinations and the four‐event stack maize. The GMO Panel considers that post‐market monitoring of maize 1507 × 59122 ×MON810 × NK603 and its subcombinations is not necessary. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 1507 × 59122 × MON810 ×NK603 and its subcombinations.

Scientific Opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three‐event stack maize MON 87427 × MON 89034 × NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three‐event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three‐event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON 87427 × MON 89034 × NK603 into the environment, the three‐event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the three‐event stack maize is as safe and as nutritious as the non‐GM comparator and the tested non‐GM reference varieties in the context of its scope. The GMO Panel considered that its previous conclusions on the two‐event stack maize MON 89034 × NK603 remain valid. For the two 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 combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034 × NK603 and maize MON 87427 × MON 89034 × NK603. Since the post‐market environmental monitoring plan for the three‐event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.