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Abstract Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA‐GMO‐NL‐2015‐126). The applicant conducted a 90‐day feeding study on GM soybean MON 87705 and provided a proposal for post‐market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90‐day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment‐related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA‐GMO‐NL‐2015‐126 and in the supplementary toxicity study, is as safe as its non‐GM comparator and the non‐GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north‐eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether ‘very highly’ and ‘extremely’ sensitive non‐target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non‐target lepidoptera to maize MON 810 pollen is reduced to levels of no concern.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2021 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Evidence provided in the PMEM report shows that farmers growing maize MON 810 in Spain complied partially with refuge requirements, while full compliance was achieved in Portugal. Cry1Ab susceptibility tests performed on European and Mediterranean corn borer populations collected from north‐eastern Spain in 2021 indicated no symptoms of resistance evolution to maize MON 810. However, unexpected damage to maize MON 810 plants was observed in a field trial in the province of Girona (north‐eastern Spain), which may point to the presence of resistance alleles in this region. Information retrieved through farmer questionnaires and the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2021 PMEM report does not invalidate its previous conclusions on the safety of maize MON 810. The possible presence of Cry1Ab resistance alleles at frequencies leading to damage to maize MON 810 plants in Girona requires twofold actions: (1) increase monitoring efforts in this area; and (2) implement remedial measures to limit the suspected evolution and spread of resistance. As in previous years, EFSA identified shortcomings on resistance monitoring that need revision. In particular, full refuge compliance must be achieved in Spain. Moreover, the sensitivity of the monitoring plan must be increased, which can be achieved by replacing the current susceptibility assays by periodic F2 screens. EFSA also recommends the consent holder to revise the farmer questionnaires to account for the emergence of teosinte as a noxious agricultural weed in maize MON 810‐growing areas in Spain.

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA‐GMO‐NL‐2015‐126). The applicant conducted a 90‐day feeding study on GM soybean MON 87705 and provided a proposal for post‐market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90‐day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment‐related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA‐GMO‐NL‐2015‐126 and in the supplementary toxicity study, is as safe as its non‐GM comparator and the non‐GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application. [ABSTRACT FROM AUTHOR]

• Crop diversification is a dynamic pathway towards sustainable agrifood systems.• Technological and institutional barriers restrict uptake of crop diversification.• More coordination and cooperation among agrifood system stakeholders is required.• The European Crop Diversification Cluster calls for multiactor networks.European cropping systems are often characterized by short rotations or even monocropping, leading to environmental issues such as soil degradation, water eutrophication, and air pollution including greenhouse gas emissions, that contribute to climate change and biodiversity loss. The use of diversification practices (i.e., intercropping, multiple cropping including cover cropping and rotation extension), may help enhance agrobiodiversity and deliver ecosystem services while developing new value chains. Despite its benefits, crop diversification is hindered by various technical, organizational, and institutional barriers along value chains (input industries, farms, trading and processing industries, retailers, and consumers) and within sociotechnical systems (policy, research, education, regulation and advisory). Six EU-funded research projects have joined forces to boost crop diversification by creating the European Crop Diversification Cluster (CDC). This Cluster aggregates research, innovation, commercial and citizen-focused partnerships to identify and remove barriers across the agrifood system and thus enables the uptake of diversification measures by all European value-chain stakeholders. The CDC will produce a typology of barriers, develop tools to accompany actors in their transition, harmonize the use of multicriteria assessment indicators, prepare policy recommendations and pave the way for a long-term network on crop diversification.

Abstract Following a request from the European Commission; the European Food Safety Authority (EFSA) assessed the 2020 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Like previous years, there was full compliance with refuge requirement in Portugal and partial compliance with refuge requirements by Spanish farmers growing MON 810 varieties. European and Mediterranean corn borer populations collected from north‐eastern Spain during the 2020 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810. The assessment of farmer questionnaires and relevant scientific publications does not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2020 PMEM report does not invalidate previous EFSA evaluations on the safety of maize MON 810. However, as in previous years, EFSA identifies shortcomings on resistance monitoring that need revision in future reports. In particular, the monitoring plan, as implemented in 2020, is not sufficiently sensitive to detect the recommended 3% resistance allele frequency. Consequently, EFSA strongly recommends the consent holder to achieve full compliance with refuge obligations in areas where adoption of maize MON 810 is high and increase the sensitivity of the monitoring plan by performing periodic F2‐screens on corn borer populations from north‐eastern Spain. EFSA recommends revising the farmer questionnaires when new characteristics of the receiving environment emerge which are relevant for the environmental risk assessment of MON 810 such as the emergence of teosinte. EFSA encourages the Competent authorities of concerned EU Member States, the consent holder and environmental networks to engage in a dialogue to develop a framework on how to best identify and report unexpected adverse effects from the cultivation of Bt maize varieties.

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north‐eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether 'very highly' and 'extremely' sensitive non‐target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non‐target lepidoptera to maize MON 810 pollen is reduced to levels of no concern. [ABSTRACT FROM AUTHOR]

Abstract Teosinte, wild maize relatives originating from Mexico and Central America, emerged as a noxious agricultural weed in France and Spain. In 2016, the European Food Safety Authority (EFSA) issued a technical report that assessed the available scientific information on teosinte for its relevance for the environmental risk assessment (ERA) and risk management (RM) of genetically modified (GM) maize MON810, Bt11, 1507 and GA21 for cultivation. It was concluded that the impact of insect resistance and/or herbicide tolerance in GM teosinte hybrid progeny (potentially acquired through hybridisation between GM maize and teosinte) on target and non‐target organisms, the abiotic environment and biogeochemical cycles would be very low under EU conditions. Following a request of the European Commission, EFSA evaluated whether the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, or require revision in light of new scientific evidence on teosinte that has become available since the publication of EFSA (2016). A protocol was developed to clarify the interpretation of the terms of reference of the mandate and make them operational. The assessment relied on evidence retrieved via an extensive literature search and from reports of the Competent Authorities of France and Spain, and on hearing expert testimonies. A limited collection of 18 publications of varying relevance and quality was retrieved and assessed. Based on this evidence, it is concluded that the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, except those pertaining to the use of glyphosate‐based herbicides on maize GA21 which should be considered under Regulation (EC) No 1107/2009. In infested agricultural areas (especially in regions where maize MON810 is widely grown), weed management measures implemented to monitor, control and/or eradicate teosinte must remain in place, as they will contribute to further reduce the low vertical gene flow potential between GM maize and EU teosinte.

Abstract Following a request from the European Commission, the EFSA assessed the 2019 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Like previous years, there was full compliance with refuge requirement in Portugal and partial compliance with refuge requirements by Spanish farmers growing MON 810 varieties. European and Mediterranean corn borer populations collected from north‐eastern Spain during the 2019 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810. The assessment of farmer questionnaires and relevant scientific publications does not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2019 PMEM report does not invalidate previous EFSA evaluations on the safety of maize MON 810. However, as in previous years, EFSA identifies shortcomings on resistance monitoring that need revision in future reports. In particular, the monitoring plan, as implemented in 2019, is not sufficiently sensitive to detect the recommended 3% resistance allele frequency. Consequently, EFSA strongly recommends the consent holder to achieve full compliance with refuge obligations in areas where adoption of maize MON 810 is high and increase the sensitivity of the monitoring plan by performing periodic F2 screens on corn borer populations from north‐eastern Spain. EFSA recommends revising the farmer questionnaires when new characteristics of the receiving environment emerge which are relevant for the environmental risk assessment of MON 810 such as the emergence of teosinte. EFSA encourages the Competent authorities of concerned EU Member States, the consent holder and environmental networks to engage in a dialogue to develop a framework on how to best identify and report unexpected adverse effects from the cultivation of Bt maize varieties.

This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6443/full

Field cultivation of Genetically Modified (GM) Bt-plants has a potential environmental risk toward non-target Lepidoptera (NTLs) larvae through the consumption of Bt-maize pollen. The Bt-maize Cry protein targeting Lepidoptera species detrimental to the crop is also expressed in pollen which is dispersed by wind and can thus reach habitats of NTLs. To better assess the current ecological risk of Bt-maize at landscape scales, we developed a spatially-explicit exposure-hazard model considering (i) the dynamics of pollen dispersal obtained by convolving GM plants emission with a dispersal kernel and (ii) a toxicokinetic-toxicodynamic (TKTD) model accounting for the impact of toxin ingestion on individual lethal effects. We simulated the model using real landscape observations in Catalonia (Spain): GM-maize locations, flowering dates, rainfall time series and larvae emergence date of the European peacock butterfly Aglais io. While in average, the additional mortality appears to be negligible, we show significant additional mortality at sub-population level, with for instance a mortality higher than 40% within the 10m for the 10% most Bt-sensitive individuals. Also, using Pareto optimality we capture the best trade-off between isolation distance and additional mortality: up to 50 m are required to significantly buffer Bt-pollen impact on NTLs survival at the individual level. Our study clears up the narrow line between diverging conclusions: those claiming no risk by only looking at the average regional effect of Bt on NTLs survival and those pointing out a significant threaten when considering the variability of individuals mortality.

Abstract Following a request from the European Commission, the EFSA assessed the 2018 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Like previous years, there was partial compliance with refuge requirements by Spanish farmers growing MON 810 varieties. European and Mediterranean corn borer populations collected from north‐eastern Spain during the 2018 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810. The assessment of farmer questionnaires and relevant scientific publications does not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. The report does not provide information about the use of existing networks involved in environmental monitoring. Overall, EFSA concludes that the evidence reported in the 2018 PMEM report does not invalidate previous EFSA evaluations on the safety of maize MON 810. However, as in previous years, EFSA identifies shortcomings on resistance monitoring that need revision in future reports. In particular, the monitoring plan, as implemented in 2018, is not sufficiently sensitive to detect the recommended 3% resistance allele frequency. Consequently, EFSA strongly recommends the consent holder to: (1) achieve full compliance with refuge obligations in areas where adoption of maize MON 810 is high; (2) increase the sensitivity of the monitoring plan and address previously mentioned limitations for resistance monitoring; and (3) perform an F2 screen on corn borer populations from north‐eastern Spain. A fit‐for‐purpose farmer alert system may help to detect unexpected adverse effects associated with the cultivation of MON 810 varieties and be an alternative to the current farmer survey system. Moreover, relevant stakeholders should implement a methodological framework to enable making the best use of existing networks involved in environmental monitoring for the general surveillance of genetically modified plants.

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2021 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Evidence provided in the PMEM report shows that farmers growing maize MON 810 in Spain complied partially with refuge requirements, while full compliance was achieved in Portugal. Cry1Ab susceptibility tests performed on European and Mediterranean corn borer populations collected from north‐eastern Spain in 2021 indicated no symptoms of resistance evolution to maize MON 810. However, unexpected damage to maize MON 810 plants was observed in a field trial in the province of Girona (north‐eastern Spain), which may point to the presence of resistance alleles in this region. Information retrieved through farmer questionnaires and the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2021 PMEM report does not invalidate its previous conclusions on the safety of maize MON 810. The possible presence of Cry1Ab resistance alleles at frequencies leading to damage to maize MON 810 plants in Girona requires twofold actions: (1) increase monitoring efforts in this area; and (2) implement remedial measures to limit the suspected evolution and spread of resistance. As in previous years, EFSA identified shortcomings on resistance monitoring that need revision. In particular, full refuge compliance must be achieved in Spain. Moreover, the sensitivity of the monitoring plan must be increased, which can be achieved by replacing the current susceptibility assays by periodic F2 screens. EFSA also recommends the consent holder to revise the farmer questionnaires to account for the emergence of teosinte as a noxious agricultural weed in maize MON 810‐growing areas in Spain. [ABSTRACT FROM AUTHOR]

Abstract Soybean MON 87751 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON 87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87751. The nutritional impact of soybean MON 87751‐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 soybean MON 87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM soybean reference varieties tested, and no post‐market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON 87751 seeds into the environment, soybean MON 87751 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87751. In conclusion, soybean MON 87751, as described in this application, is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

Abstract 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.

Abstract Maize 4114 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate‐ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non‐genetically modified (GM) comparator(s) required further assessment. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non‐GM maize varieties and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non‐GM comparator(s) and non‐GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Abstract Following a request from the European Commission, EFSA assessed the annual post‐market environmental monitoring (PMEM) report for the 2016 growing season of the Cry1Ab‐expressing maize event MON 810 provided by Monsanto Europe S.A. Partial compliance with refuge requirements was reported in Spain, as observed in previous years. EFSA reiterates the need to achieve full compliance in areas of high maize MON 810 adoption to delay resistance evolution, and therefore advocates increasing the level of compliance in such areas. Resistance monitoring data do not indicate a decrease in susceptibility to the Cry1Ab protein in the field corn borer populations tested in the 2016 season. However, EFSA identified some methodological and reporting limitations pertaining to resistance monitoring that need improvement in future PMEM reports. No complaints related to corn borer infestation of maize MON 810 were received via the farmer alert system during the 2016 cultivation season. EFSA encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. EFSA reiterates its recommendations on the methodology and analysis of farmer questionnaires, and considers that future literature searches on maize MON 810 performed in the context of annual PMEM reports should follow the guidelines given in the 2017 EFSA explanatory note on literature searching. Moreover, EFSA encourages relevant stakeholders to implement a methodological framework that enables the use of existing networks in the broader context of environmental monitoring. EFSA concludes that no new evidence has been reported in the 2016 PMEM report that would invalidate previous EFSA evaluations on the safety of maize MON 810.

Abstract The three‐event stack cotton GHB614 × LLCotton25 × MON 15985 was produced by conventional crossing to combine three single cotton events, GHB614, LLCotton25 and MON 15985. The EFSA GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single events that could lead 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 events and of the newly expressed proteins in the three‐event stack cotton did not give rise to food and feed safety or nutritional issues. Food and feed derived from cotton GHB614 × LLCotton25 × MON 15985 are expected to have the same nutritional impact as those derived from the non‐GM comparator. In the case of accidental release of viable GHB614 × LLCotton25 × MON 15985 cottonseeds into the environment, this three‐event stack cotton would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 × LLCotton25 × MON 15985. In conclusion, the GMO Panel considers that cotton GHB614 × LLCotton25 × MON 15985, as described in this application, is as safe as the non‐GM comparator with respect to potential effects on human and animal health and the environment.

Abstract The GMO Panel was previously not in the position to complete the food/feed safety assessment of maize 5307 due to an inadequate 28‐day toxicity study necessary for an appropriate assessment of eCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed a supplementary 28‐day toxicity study in mice on the eCry3.1Ab protein (1,000 mg/kg body weight (bw) per day) to complement its scientific opinion on application EFSA‐GMO‐DE‐2011‐95 for the placing on the market of the maize 5307 for food and feed uses, import and processing. The supplementary 28‐day toxicity study did not show adverse effects. Taking into account the previous assessment and the new information, the GMO Panel concludes that maize 5307, as assessed in the scientific opinion on application EFSA‐GMO‐DE‐2011‐95 (EFSA GMO Panel, ) and in the supplementary toxicity study, is as safe and nutritious as its conventional counterpart in the scope of this application.

Abstract Maize MON 87403 was developed to increase ear biomass at early reproductive phase through the expression of a modified AtHB17 gene from Arabidopsis thaliana, encoding a plant transcription factor of the HD‐Zip II family. The molecular characterisation data and bioinformatic 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 87403 and its conventional counterpart were identified. The compositional analysis of maize MON 87403 did not identify differences that require further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the AtHB17∆113 protein, as expressed in maize MON 87403. The nutritional value of food and feed derived from maize MON 87403 is not expected to differ from that of food and feed derived from non‐genetically modified (GM) maize varieties. Based on the outcome of the studies considered in the comparative analysis and molecular characterisation, the GMO Panel concludes that maize MON 87403 is as safe and nutritious as the conventional counterpart and the non‐GM maize reference varieties tested. In the case of accidental release of viable maize MON 87403 grains into the environment, maize MON 87403 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 87403. In conclusion, the GMO Panel considers that maize MON 87403, 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.

Abstract Following the submission of application EFSA‐GMO‐RX‐007 under Regulation (EC) No 1829/2003 from Monsanto, 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 and insect‐resistant genetically modified maize NK603 x MON810. The data received in the context of this renewal application contained post‐market environmental monitoring reports, 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. Under the assumption that the DNA sequence of the events in maize NK603 x MON810 considered for renewal is identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐007 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603 x MON810.

Abstract The GMO Panel has previously assessed the single events Bt11, 59122, MIR604, 1507 and GA21 as well as different stacked events corresponding to combinations of these events and no safety concerns were identified. In its assessment of the five‐event maize stack Bt11 × 59122 × MIR604 × 1507 × GA21 (application EFSA‐GMO‐DE‐2011‐99), the GMO Panel also assessed all the subcombinations of these events not previously assessed, including some for which little or no experimental data were provided, including the three‐event stack Bt11 × 1507 × GA21. In line with Article 5 of the decision for authorisation of application EFSA‐GMO‐DE‐2011‐99, the European Commission received from Syngenta information on the levels of the newly expressed proteins in subcombination Bt11 × 1507 × GA21 and tasked EFSA to analyse these data and to indicate whether they have an impact on the previously issued opinion on the five‐event stack Bt11 × 59122 × MIR604 × 1507 × GA21 and its subcombinations. Analyses of the levels of the newly expressed proteins Cry1Ab, PAT, Cry1F and mEPSPS showed that there is no indication of an interaction between the events combined in maize Bt11 × 1507 × GA21 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel is of the opinion that the new information for maize Bt11 × 1507 × GA21 does not alter the conclusions of the scientific opinion on application EFSA‐GMO‐DE‐2011‐99.

Abstract 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.

Abstract 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.

Abstract This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non‐IgE‐mediated adverse immune reactions to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where appropriate.

Abstract Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post‐market environmental monitoring (PMEM) report for the 2015 growing season of the Cry1Ab‐expressing maize event MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data submitted to EFSA do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein during the 2015 season. However, since the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations on resistance monitoring to provide sufficient detection sensitivity. Although the farmer alert system to report complaints about product performance could complement the information obtained from the laboratory bioassays, the GMO Panel is currently not in a position to appraise its usefulness, and therefore encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance (GS) do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. The GMO Panel reiterates its previous recommendations on the analysis of farmer questionnaires, and advises the consent holder to provide more detailed information on the conducting and reporting of the literature search in future annual PMEM reports. Moreover, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring. The GMO Panel concludes that the case‐specific monitoring (CSM) and GS activities of maize MON 810 as carried out by the consent holder do not provide evidence that would invalidate previous GMO Panel evaluations on the safety of maize MON 810.

Abstract In this opinion, the GMO Panel assessed the three‐event stack oilseed rape (OSR) MON 88302 × MS8 × RF3 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the single events combined to produce this three‐event stack OSR and did not identify safety concerns; no new information that would modify the original conclusions was identified. The combination of the single OSR events and of the newly expressed proteins in the three‐event stack OSR does not give rise to food and feed safety and nutrition issues – based on the molecular, agronomic/phenotypic and compositional characteristics. In the case of accidental release of viable OSR MON 88302 × MS8 × RF3 seeds into the environment, the three‐event stack OSR would not raise environmental safety concerns. The GMO Panel therefore concluded that the three‐event stack OSR is as safe and as nutritious as its conventional counterpart and the tested non‐GM reference varieties in the context of the scope of this application. Since no new safety concerns were identified for the previously assessed two‐event stack OSR MS8 × RF3, the GMO Panel considered that its previous conclusions on this subcombination remain valid. For the two subcombinations MON 88302 × MS8 and MON 88302 × RF3 for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their different combinations would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed OSR MS8 × RF3, and OSR MON 88302 × MS8 × RF3. Since the post‐market environmental monitoring plan for the three‐event stack OSR does not include any provisions for two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

Abstract In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO) assesses the two‐event stack soybean FG72 × A5547‐127 for food and feed uses, import and processing. The EFSA GMO Panel previously assessed the two single events combined to produce the two‐event stack soybean FG72 × A5547‐127 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. The molecular, agronomic, phenotypic and compositional data on soybean FG72 × A5547‐127 did not give rise to safety concerns and no reason to expect interactions between the single events impacting on the food and feed safety of the two‐event stack soybean was identified. Although the EFSA GMO Panel cannot conclude on forage composition, soybean forage is not expected to be imported in a significant amount for use as feed. Considering the routes of exposure and limited exposure levels, the EFSA GMO Panel concludes that soybean FG72 × A5547‐127 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean FG72 × A5547‐127. The EFSA GMO Panel concludes that soybean FG72 × A5547‐127 is as safe as the non‐genetically modified (GM) comparator and non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

Abstract The EFSA Panel on Genetically Modified Organisms (GMO) has previously assessed the single events Bt11, MIR162, MIR604 and GA21 as well as different stacked events corresponding to combinations of these 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. In its assessment of the four‐event maize stack Bt11 × MIR162 × MIR604 × GA21, the GMO Panel also assessed all the subcombinations of these events not previously assessed, including some for which little or no experimental data were provided, including the two‐stack maize event Bt11 × MIR162 (application EFSA‐GMO‐DE‐2009‐66). On 8 November 2016, the European Commission received from Syngenta information on the subcombination Bt11 × MIR162. On 14 December 2016, the European Commission tasked EFSA to analyse these data and to indicate whether they have an impact on the previously issued opinion on the four‐event stack Bt11 × MIR162 × MIR604 × GA21 and its subcombinations. The GMO Panel used the appropriate principles described in its guidelines for the risk assessment of genetically modified (GM) plants to analyse the provided data. The levels of the newly expressed proteins Cry1Ab, PAT, Vip3Aa20 and PMI are similar between the two‐event stack Bt11 × MIR162 and the corresponding single events Bt11 and MIR162. Based on this analysis, there is no indication of an interaction between the events combined in maize Bt11 × MIR162 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel considers that the new information for maize Bt11 × MIR162 does not alter the conclusions of the scientific opinion on application EFSA‐GMO‐DE‐2009‐66.

Abstract Soybean DAS‐68416‐4 was developed by Agrobacterium tumefaciens‐mediated transformation to express the aryloxyalkanoate dioxygenase‐12 (AAD‐12) protein, conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and the phosphinothricin acetyltransferase (PAT) protein, conferring tolerance to glufosinate ammonium‐based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between soybean DAS‐68416‐4 and its conventional counterpart, except for ‘days to 50% flowering’. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 36%) in lectin activity in soybean DAS‐68416‐4. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition for soybean DAS‐68416‐4 as compared to its conventional counterpart and the non‐GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the two newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS‐68416‐4. Soybean DAS‐68416‐4 is as nutritious as its conventional counterpart and the non‐GM reference varieties. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS‐68416‐4 plants, unless these are exposed to the intended herbicides. The likelihood of environmental effects resulting from the accidental release of viable seeds from soybean DAS‐68416‐4 into the environment is therefore very low. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS‐68416‐4. The GMO Panel concludes that the information available addresses the scientific comments of the Member States and that soybean DAS‐68416‐4, as described in this application, is as safe as its conventional counterpart and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Abstract Cotton MON 88701 was developed through Agrobacterium tumefaciens‐mediated transformation to express the dicamba mono‐oxygenase (DMO) protein, conferring tolerance to dicamba, and the phosphinothricin N‐acetyltransferase PAT protein, conferring tolerance to glufosinate ammonium‐based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between cotton MON 88701 and its conventional counterpart. Since complete compositional results were reported for only three sites, the EFSA Panel on Genetically Modified Organisms (GMO Panel) is not in the position to complete the assessment of the compositional analysis. Moreover, as no 28‐day toxicity study in rodents on the MON 88701 DMO protein was provided, the GMO Panel is not in the position to complete the safety assessment of this protein in cotton MON 88701. Consequently, the GMO Panel cannot complete the toxicological, allergenicity and nutritional assessment of food/feed derived from cotton MON 88701. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the PAT protein newly expressed in cotton MON 88701. Considering the routes of exposure and limited exposure levels, the GMO Panel concludes that cotton MON 88701 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88701. In conclusion, in the absence of an appropriate comparative assessment and an appropriate assessment of the MON 88701 DMO protein, the GMO Panel is not in a position to complete its food/feed risk assessment of cotton MON 88701. The GMO Panel concludes that the cotton MON 88701 is unlikely to have any adverse effect on the environment in the context of the scope of the application.

Abstract Soybean DAS‐44406‐6 expresses 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (2mEPSPS), conferring tolerance to glyphosate‐based herbicides, aryloxyalkanoate dioxygenase (AAD‐12), conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and phosphinothricin acetyl transferase (PAT), conferring tolerance to glufosinate ammonium‐based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food/feed safety. The agronomic and phenotypic characteristics revealed no relevant differences between soybean DAS‐44406‐6 and its conventional counterpart, except for pod count, seed count and yield. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 31%) in lectin activity in soybean DAS‐44406‐6. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition of soybean DAS‐44406‐6 as compared to its conventional counterpart and non‐GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the three newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS‐44406‐6. Soybean DAS‐44406‐6 is as nutritious as its conventional counterpart and the non‐GM soybean reference varieties tested. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS‐44406‐6 plants, unless exposed to the intended herbicides. The likelihood of environmental effects from the accidental release of viable seeds from soybean DAS‐44406‐6 into the environment is therefore very low. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS‐44406‐6. In conclusion, the GMO Panel considers that the information available for soybean DAS‐44406‐6 addresses the scientific comments raised by Member States and that soybean DAS‐44406‐6, as described in this application, is as safe as its conventional counterpart and non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Abstract Following the submission of application EFSA‐GMO‐RX‐001 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 frame of a renewal of authorisation application of the insect‐resistant and herbicide‐tolerant genetically modified (GM) maize 1507. The data package received in the frame of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, an updated bioinformatics analysis and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed this data package for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the frame of the original application. Under the assumption that the DNA sequence of the event in maize 1507 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 for the application for renewal that would change the conclusions of the original risk assessment on maize 1507 (EFSA, , ).

Abstract 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′ 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.

Abstract Maize DAS‐40278‐9 was developed by direct Whiskers‐mediated transformation to express the aryloxyalkanoate dioxygenase‐1 (AAD‐1) protein, conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and aryloxyphenoxypropionate (AOPP) herbicides. The molecular characterisation of maize DAS‐40278‐9 did not raise safety issues. The agronomic, phenotypic and compositional characteristics of maize DAS‐40278‐9 tested under field conditions revealed no differences between maize DAS‐40278‐9 and its non‐genetically modified (GM) comparator that would give rise to food and feed or environmental safety concerns. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed protein AAD‐1, and no evidence that the genetic modification might significantly change the overall allergenicity of maize DAS‐40278‐9. The nutritional characteristics of maize DAS‐40278‐9 are not expected to differ from those of non‐GM maize varieties and no post‐market monitoring of food/feed is considered necessary. Maize DAS‐40278‐9 is as nutritious as its non‐GM comparator and other non‐GM commercial varieties. There are no indications of an increased likelihood of establishment and spread of occasional feral maize DAS‐40278‐9 plants, unless these plants are exposed to the intended herbicides. However, this will not result in different environmental impacts compared to conventional maize. Considering the scope of the application, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with the unlikely but theoretically possible horizontal gene transfer from maize DAS‐40278‐9 to bacteria were not identified. The post‐market environmental monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, the EFSA GMO Panel considers that the information available for maize DAS‐40278‐9 addresses the scientific comments raised by the Member States and that maize DAS‐40278‐9, as described in this application, is as safe as the non‐GM comparator and non‐GM maize reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Abstract Soybean DAS‐81419‐2 was developed by Agrobacterium tumefaciens‐mediated transformation. It expresses the Cry1F and Cry1Ac proteins to confer resistance to certain lepidopteran species and the PAT protein that confers tolerance to glufosinate ammonium‐based herbicides and that was used as a selectable marker gene. The molecular characterisation of soybean DAS‐81419‐2 did not give rise to safety issues. The agronomic, phenotypic and compositional characteristics of soybean DAS‐81419‐2 tested under field conditions revealed no relevant differences between soybean DAS‐81419‐2 and its conventional counterpart that would give rise to any food and feed or environmental safety concerns. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry1Ac and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS‐81419‐2. The nutritional value of soybean DAS‐81419‐2 is not expected to differ from that of non‐GM soybean varieties and no post‐market monitoring of food/feed is considered necessary. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS‐81419‐2 plants, unless these plants are exposed to glufosinate ammonium‐based herbicides or infested by insect pests that are susceptible to the Cry1F and Cry1Ac proteins. This will not result in different environmental impacts compared to conventional soybean. Considering the scope of this application, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean DAS‐81419‐2 to bacteria have not been identified. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS‐81419‐2. The GMO Panel concludes that the soybean DAS‐81419‐2 is as safe and as nutritious as its conventional counterpart and the tested non‐GM reference varieties in the context of its scope.