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Abstract 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.

Abstract The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MZHG0JG and its conventional counterpart needs further assessment, except for early stand count (pre‐thinning). The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the mEPSPS and PAT proteins as expressed in maize MZHG0JG, and finds no evidence that the genetic modification would change the overall allergenicity of maize MZHG0JG. The nutritional impact of food/feed derived from maize MZHG0JG is expected to be the same as that of food/feed derived from the conventional counterpart and commercial non‐GM maize reference varieties. The GMO Panel concludes that maize MZHG0JG is nutritionally equivalent to and as safe as the conventional counterpart and 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 MZHG0JG grains into the environment, maize MZHG0JG would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MZHG0JG. In conclusion, the GMO Panel considers that maize MZHG0JG, 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 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 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.

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 threeevent 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. [ABSTRACT FROM AUTHOR]

In this opinion, the GMO Panel assessed the five-event stack maize MON 87427 ×MON 89034 × 1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five-event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five-event stack maize did not give rise to issues - based on the molecular, agronomic/ phenotypic or compositional characteristics - regarding food and feed safety and nutrition. Considering the scope of this application, the known biological function of the newly expressed proteins and the data available for the five-event stack maize and its previously assessed maize subcombinations, the GMO Panel considered that different combinations of the single events would not raise environmental concerns. The GMO Panel concludes that the five-event stack maize is as safe and as nutritious as the non-genetically modified (GM) comparator and the tested non-GM reference varieties in the context of its scope. For the 14 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 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 maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122. Since the post-market environmental monitoring plan for the five-event stack maize does not include any provisions for the 14 maize subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly. [ABSTRACT FROM AUTHOR]

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 tofood 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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 postmarket 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 FROM AUTHOR]

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 FG72 was developed by biolistic transformation to express the HPPD W336 and 2mEPSPS proteins, which confer tolerance to isoxaflutole‐ and glyphosate‐based herbicides. The molecular characterisation of soybean FG72 did not give rise to safety issues. The agronomic and phenotypic characteristics of soybean FG72 tested under field conditions revealed no biologically relevant differences between soybean FG72 and its conventional counterpart that would give rise to any food and feed or environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins HPPD W336 and 2mEPSPS, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean FG72. The nutritional characteristics of soybean FG72 is not expected to differ from that of non‐GM soybean varieties. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. 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 FG72 to bacteria have not been identified. The 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 soybean FG72 addresses the scientific comments raised by Member States and that soybean FG72, 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 Maize MON 87427 was developed by Agrobacterium tumefaciens‐mediated transformation to express the CP4 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (EPSPS) protein, in all tissues except for the male reproductive tissues, conferring tissue‐selective tolerance to glyphosate. The molecular characterisation of maize MON 87427 did not give rise to safety issues. Agronomic and phenotypic characteristics as well as compositional data of maize MON 87427 did not raise food/feed and environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein. The nutritional value of maize MON 87427 is not expected to differ from that of non‐genetically modified (GM) maize varieties. There are no indications of an increased likelihood of establishment or spread of feral maize plants. Given its intended use in food and feed, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely, but theoretically possible, horizontal gene transfer from maize MON 87427 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application for maize MON 87427. In conclusion, the EFSA Panel on Genetically Modified Organisms considers that the information available for maize MON 87427 addresses the scientific comments raised by Member States and that the maize MON 87427, as described in this application, is as safe as its conventional counterpart 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 the application.

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 FROM AUTHOR]

Cotton GHB119 was developed by Agrobacterium tumefaciens-mediated transformation. It expresses the Cry2Ae and phosphinothricin acetyltransferase ( PAT) proteins which, respectively, confer resistance to certain lepidopteran species and tolerance to glufosinate ammonium-based herbicides. The molecular characterisation of cotton GHB119 did not give rise to safety issues. The agronomic, phenotypic and compositional characteristics of cotton GHB119 tested under field conditions revealed no relevant differences between cotton GHB119 and its conventional counterpart that would give rise to any food and feed or environmental safety concern. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry2Ae and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of cotton GHB119. The nutritional characteristics of cotton GHB119 are not expected to differ from those of non- GM cotton varieties. There are no indications of an increased likelihood of establishment and spread of feral cotton GHB119 plants. 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 cotton GHB119 to bacteria have not been identified. The 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 cotton GHB119 addresses the scientific comments raised by the Member States and that cotton GHB119, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of the scope of this application. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Genetically Modified Organisms ( GMO) previously assessed the three single events that are combined to produce the three-event stack oilseed rape ( OSR) MS8 × RF3 × GT73. In this Scientific Opinion, the GMO Panel assessed the three-event stack OSR and subcombinations that have not been authorised previously (i.e. MS8 × GT73 and RF3 × GT73), independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The combination of OSR events, MS8, RF3 and GT73, in the three-event stack OSR does not raise issues relating to molecular, agronomic/phenotypic or compositional characteristics requiring further investigations. In line with previous assessments and considering the scope of this application, the GMO Panel did not find indications of safety concern for food and feed with trace levels of glyphosate oxidoreductase ( GOX)v247 protein derived from the three-event stack OSR; whereas, the GMO Panel cannot assess the safety of three-event stack OSR products rich in protein, such as rapeseed protein isolates in feed. As the risk assessment of the three-event stack OSR could not be completed for products rich in protein, such as rapeseed protein isolates, the GMO Panel is not in a position to complete the food and feed safety assessment of subcombinations within the scope of this application (i.e. MS8 × GT73 and RF3 × GT73). The two-event stack OSR MS8 × RF3 is outside the scope of this application. Considering the scope of this application, the mode of action of the introduced traits and the data available for the three-event and two-event stack OSR MS8 × RF3, the GMO Panel considered that different combinations of the events, MS8, RF3 and GT73, would not raise environmental concerns. [ABSTRACT FROM AUTHOR]

Oilseed rape MON 88302 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 EPSPS protein, which confers tolerance to glyphosate. The molecular characterisation of oilseed rape MON 88302 did not raise safety issues. Agronomic and phenotypic characteristics of oilseed rape MON 88302 tested under field conditions revealed no biologically relevant differences between oilseed rape MON 88302 and its conventional counterpart, except for days-to-first flowering. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein, and no evidence that the genetic modification might significantly change the overall allergenicity of oilseed rape MON 88302. The nutritional value of oilseed rape MON 88302 is not expected to differ from that of non-GM oilseed rape varieties. There are no indications of an increased likelihood of spread and establishment of feral oilseed rape MON 88302 plants or hybridising wild relatives, unless these plants are exposed to glyphosate. It is unlikely that the observed difference in days-to-first flowering would lead to any relevant increase in persistence or invasiveness. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from oilseed rape MON 88302 to bacteria were not identified. The post-market environmental monitoring plan is in line with the intended uses of oilseed rape MON 88302. In conclusion, the EFSA GMO Panel considers that the information available addresses the scientific requirements of the EFSA GMO Panel and the scientific comments raised by the Member States, and that oilseed rape MON 88302, as described in this application, is as safe as its conventional counterpart and non-GM commercial oilseed rape varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Soybean BPS-CV127-9 contains a single insertion locus of the csr1-2 gene. Stability of the genetic modification was demonstrated. The expression of the acetohydroxyacid synthase large sub-unit from Arabidopsis thaliana, conferring tolerance to imidazolinone herbicides, was sufficiently analysed. Bioinformatic analyses did not raise safety issues. No differences were identified in the seed composition that would require further assessment with regard to safety. Regarding agronomic and phenotypic characteristics, a difference in seed weight was identified; however, this difference does not affect the overall safety of this soybean. Although the EFSA GMO Panel cannot conclude on its forage composition, soybean forage is not expected to be imported in significant amount for feed uses. Safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins or soybean BPS-CV127-9. Compositional data indicating that soybean BPS-CV127-9 is as nutritious as non-GM soybean varieties were supported by the outcome of a chicken feeding study. There are no indications of an increased likelihood of spread and establishment of feral soybean BPS-CV127-9 plants, unless they are exposed to imidazolinone-containing herbicides. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean BPS-CV127-9 to bacteria have not been identified. Considering the scope of this application, interactions with the biotic and abiotic environment are not considered to be a relevant issue. The post-market environmental monitoring plan and reporting intervals are in line with the scope of this application. In conclusion, the EFSA GMO Panel considers that the information available for soybean BPS‑CV127-9 addresses scientific comments raised by Member States and that the soybean BPS-CV127-9, as described in this application, is as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.

Soybean FG72 was developed by biolistic transformation to express the HPPD W336 and 2mEPSPS proteins, which confer tolerance to isoxaflutole- and glyphosate-based herbicides. The molecular characterisation of soybean FG72 did not give rise to safety issues. The agronomic and phenotypic characteristics of soybean FG72 tested under field conditions revealed no biologically relevant differences between soybean FG72 and its conventional counterpart that would give rise to any food and feed or environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins HPPD W336 and 2mEPSPS, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean FG72. The nutritional characteristics of soybean FG72 is not expected to differ from that of non-GM soybean varieties. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. 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 FG72 to bacteria have not been identified. The 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 soybean FG72 addresses the scientific comments raised by Member States and that soybean FG72, 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 FROM AUTHOR]

A bstract Maize MON 87427 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) protein, in all tissues except for the male reproductive tissues, conferring tissue-selective tolerance to glyphosate. The molecular characterisation of maize MON 87427 did not give rise to safety issues. Agronomic and phenotypic characteristics as well as compositional data of maize MON 87427 did not raise food/feed and environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein. The nutritional value of maize MON 87427 is not expected to differ from that of non-genetically modified (GM) maize varieties. There are no indications of an increased likelihood of establishment or spread of feral maize plants. Given its intended use in food and feed, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely, but theoretically possible, horizontal gene transfer from maize MON 87427 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application for maize MON 87427. In conclusion, the EFSA Panel on Genetically Modified Organisms considers that the information available for maize MON 87427 addresses the scientific comments raised by Member States and that the maize MON 87427, as described in this application, is as safe as its conventional counterpart 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 the application. [ABSTRACT FROM AUTHOR]

Oilseed rape MON 88302 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 EPSPS protein, which confers tolerance to glyphosate. The molecular characterisation of oilseed rape MON 88302 did not raise safety issues. Agronomic and phenotypic characteristics of oilseed rape MON 88302 tested under field conditions revealed no biologically relevant differences between oilseed rape MON 88302 and its conventional counterpart, except for days-to-first flowering. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein, and no evidence that the genetic modification might significantly change the overall allergenicity of oilseed rape MON 88302. The nutritional value of oilseed rape MON 88302 is not expected to differ from that of non-GM oilseed rape varieties. There are no indications of an increased likelihood of spread and establishment of feral oilseed rape MON 88302 plants or hybridising wild relatives, unless these plants are exposed to glyphosate. It is unlikely that the observed difference in days-to-first flowering would lead to any relevant increase in persistence or invasiveness. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from oilseed rape MON 88302 to bacteria were not identified. The post-market environmental monitoring plan is in line with the intended uses of oilseed rape MON 88302. In conclusion, the EFSA GMO Panel considers that the information available addresses the scientific requirements of the EFSA GMO Panel and the scientific comments raised by the Member States, and that oilseed rape MON 88302, as described in this application, is as safe as its conventional counterpart and non- GM commercial oilseed rape varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application. [ABSTRACT FROM AUTHOR]

Soybean BPS-CV127-9 contains a single insertion locus of the csr1-2 gene. Stability of the genetic modification was demonstrated. The expression of the acetohydroxyacid synthase large sub-unit from Arabidopsis thaliana, conferring tolerance to imidazolinone herbicides, was sufficiently analysed. Bioinformatic analyses did not raise safety issues. No differences were identified in the seed composition that would require further assessment with regard to safety. Regarding agronomic and phenotypic characteristics, a difference in seed weight was identified; however, this difference does not affect the overall safety of this soybean. Although the EFSA GMO Panel cannot conclude on its forage composition, soybean forage is not expected to be imported in significant amount for feed uses. Safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins or soybean BPS-CV127-9. Compositional data indicating that soybean BPS-CV127-9 is as nutritious as non-GM soybean varieties were supported by the outcome of a chicken feeding study. There are no indications of an increased likelihood of spread and establishment of feral soybean BPS-CV127-9 plants, unless they are exposed to imidazolinone-containing herbicides. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean BPS-CV127-9 to bacteria have not been identified. Considering the scope of this application, interactions with the biotic and abiotic environment are not considered to be a relevant issue. The post-market environmental monitoring plan and reporting intervals are in line with the scope of this application. In conclusion, the EFSA GMO Panel considers that the information available for soybean BPS-CV127-9 addresses scientific comments raised by Member States and that the soybean BPS-CV127-9, as described in this application, is as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. [ABSTRACT FROM AUTHOR]

Abstract This Scientific Opinion reports on an evaluation of a risk assessment for the placing on the market for cultivation of genetically modified soybean 40‐3‐2, and updates the previous EFSA GMO Panel Scientific Opinion on the renewal applications for the continued marketing of soybean 40‐3‐2. The EFSA GMO Panel considered that soybean 40‐3‐2 is unlikely to raise additional environmental safety concerns compared with conventional soybean, but that the management of its cultivation could result in environmental harm under certain conditions. The Panel therefore recommended managing the use of glyphosate on soybean 40‐3‐2 in ways that result in similar or reduced environmental impacts compared with conventional soybean cultivation. There is no evidence of adverse effects on non‐target organisms (including pollinators) due to the expression of the CP4 EPSPS protein, and there are no indications of the occurrence of adverse effects on non‐target predators, herbivores and decomposers due to potential unintended changes in soybean 40‐3‐2. Owing to the lack of event‐specific data on plant‐pollinator interactions, scientific uncertainty on the occurrence of adverse effects on pollinators, due to potential unintended changes in soybean 40‐3‐2, remains, and strategies for resolving this uncertainty are discussed. The Panel recommended the deployment of case‐specific monitoring to address: (1) changes in weed community diversity; and (2) the evolution of resistance to glyphosate in weeds due to changes in herbicide and cutivation regimes. The Panel agreed with the general surveillance plan of the applicant, but requested that the Panel's proposals to strengthen general surveillance are implemented. The Panel concluded that the information available for soybean 40‐3‐2 addresses the scientific comments raised by Member States and that soybean 40‐3‐2, as described in this application, is as safe as its conventional counterpart and commercial non‐GM soybean varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation of soybean 40‐3‐2 is unlikely to have environmental effects any more adverse than those associated with conventional soybean cultivation.

Abstract This scientific opinion evaluates the risk assessment for the authorisation for (continued) marketing of genetically modified insect‐resistant and herbicide‐tolerant cotton MON 531 × MON 1445 for food and feed produced from it. Cotton MON 531 × MON 1445 was produced by conventional crossing methods, and the stack is homozygous for the newly introduced traits. The integrity and the stable co‐inheritance of the parental events were demonstrated in the stack. Molecular characterisation did not reveal safety issues. No biologically relevant differences were identified in the compositional, phenotypic and agronomic characteristics of cotton MON 531 × MON 1445 in comparison with its conventional counterpart and its composition fell within the range of non‐GM cotton varieties, except for the Cry1Ac, CP4 EPSPS and NPTII proteins. No safety issues were identified with regard to toxicity and allergenicity of food and feed produced from cotton MON 531 × MON 1445. A feeding study in catfish confirmed that toasted cottonseed meal from MON 531 × MON 1445 is as nutritious as toasted cottonseed meal from its conventional counterpart and four commercial non‐GM cotton varieties. Products from cotton MON 531 × MON 1445 do not contain viable plant parts. The insert structure in cotton MON 531 × MON 1445 may facilitate the stabilisation of the nptII gene in plasmids of environmental bacteria through double homologous recombination. However, considering the overall limited occurrence of horizontal transfer of DNA in plant material to bacteria, and the very low exposure to DNA from cotton MON 531 × MON 1445, the EFSA GMO Panel concludes that it is highly unlikely that cotton MON 531 × MON 1445 will contribute to the environmental prevalence of nptII genes. Potential interactions of cotton MON 531 × MON 1445 with non‐target organisms and the abiotic environment were not considered to be an issue because of low exposure levels. A post‐market environmental monitoring plan is not required.

Abstract This Scientific Opinion reports on an evaluation of a risk assessment for placing on the market of genetically modified maize MON 88017 for cultivation. The EFSA GMO Panel considers that maize MON 88017 is unlikely to have any adverse effect on the environment, except for the possible resistance evolution to the Cry3Bb1 protein in coleopteran target pests; resistance evolution may lead to altered pest control practices that may cause adverse environmental effects. The cultivation management of maize MON 88017 could result in environmental harm. The EFSA GMO Panel therefore recommends managing the use of glyphosate on maize MON 88017 within diversified cropping regimes that have similar or reduced environmental impacts compared with conventional maize cultivation. The EFSA GMO Panel recommends the deployment of insect resistance management strategies and case‐specific monitoring to address (1) the possible resistance evolution to the Cry3Bb1 protein in coleopteran target pests, (2) changes in botanical diversity within fields due to novel herbicide regimes, and (3) resistance evolution to glyphosate in weeds due to novel herbicide regimes. The EFSA GMO Panel agrees with the general surveillance plan of the applicant, but requests that the proposals made to strengthen general surveillance are implemented. Whilst the scope of this application only covers the cultivation of maize MON 88017, this Scientific Opinion also updates the previous EFSA GMO Panel safety evaluation of the food and feed uses, import and processing of maize MON 88017 and derived products. The EFSA GMO Panel concludes that the information available for maize MON 88017 addresses the scientific comments raised by Member States and that maize MON 88017, as described in this application, is as safe as its conventional counterpart and commercial maize varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation management of maize MON 88017 is unlikely to raise safety concerns for the environment.

Abstract This scientific opinion is an evaluation of a risk assessment for the genetically modified herbicide tolerant soybean A5547‐127 for food and feed uses, import and processing. Soybean A5547‐127 was developed through particle bombardment. It contains a single insertion site consisting of a copy of the intact pat expression cassette, encoding the PAT protein that confers tolerance to glufosinate‐ammonium containing herbicides. Other inserted sequences include two truncated parts of the beta‐lactamase (bla) gene from the transformation vector on each side of the pat expression cassette. The stability of the inserted DNA was confirmed over multiple generations. The results of the bioinformatic analyses of the insert and the flanking regions, and the levels of newly expressed protein did not raise a safety concern. The comparative analysis of compositional, phenotypic and agronomic characteristics indicated that soybean A5547‐127 is not different from its conventional counterpart (A5547), except for the newly expressed protein (PAT). The safety assessment of the PAT protein and the soybean A5547‐127 identified no concerns regarding potential toxicity and allergenicity. A feeding study on broiler chickens confirmed that seeds of soybean A5547‐127 are as nutritional as seeds of the conventional counterpart. There are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glufosinate‐ammonium containing herbicides. The risk caused by a possible transfer of the recombinant gene from soybean A5547‐127 to environmental micro‐organisms is regarded to be negligible due to the lack of any advantage that would be conferred in the context of its intended uses. The potential interactions of the GM plant with target organisms, non‐target organisms and the abiotic environment and biogeochemical cycles were not considered an issue by the EFSA GMO Panel. The monitoring plan and reporting intervals are in line with the intended uses of soybean A5547‐127. The EFSA GMO Panel considers that the information available for soybean A5547‐127 addresses the scientific comments raised by the Member States and that the soybean A5547‐127, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses.

Abstract This scientific opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified insect resistant and herbicide tolerant maize Bt11×GA21 for food and feed uses, import and processing. Conventional breeding methods were used in the production of maize Bt11×GA21 from inbred lines of the respective parental events. The structural integrity of the inserts in the single maize events as well as the phenotypes were retained in the stacked maize event. The expression levels of the Cry1Ab, PAT and mEPSPS proteins in maize Bt11×GA21 were demonstrated to be comparable with those of the single maize events. The comparative analysis of phenotypic, agronomic and compositional characteristics of this GM maize indicated equivalence with its non‐GM maize counterpart and conventional maize, except for the expression of the target proteins Cry1Ab, PAT and mEPSPS, providing resistance to certain lepidopteran pests and tolerance to glufosinate‐ammonium‐ and glyphosate‐based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11×GA21. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its non‐GM maize counterpart and conventional maize. Considering the intended uses of maize Bt11×GA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11×GA21 was required. In case of accidental release of viable maize Bt11×GA21 grains into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants, except in the presence of glufosinte‐ammonium‐ and/or glyphosate‐based herbicides.

Abstract This opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified herbicide tolerant and insect resistant maize MON89034 × NK603 for food and feed uses, import and processing. Conventional breeding methods were used in the production of maize MON89034 × NK603 from inbred lines of the respective parental events. The structural integrity of the inserts in the single events as well as the phenotypes were retained in the hybrid. The expression levels of the Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins in maize MON89034 × NK603 were demonstrated to be comparable with those of the single events. The comparative analysis of phenotypic, agronomic and compositional characteristics of this GM maize indicated equivalence with its non‐GM counterpart and conventional maize except for the expression of the target proteins, providing resistance to certain lepidopteran pests and tolerance to glyphosate herbicide. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON89034 × NK603. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to non‐GM counterpart and conventional maize. Considering the intended uses of maize MON89034 × NK603, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize MON89034 × NK603 was required. In case of accidental release of viable maize grain of MON89034 × NK603 into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants except in the presence of the herbicide. The GMO Panel concludes that maize MON89034 × NK603 is as safe as its non‐GM counterpart with respect to effects on human and animal health and the environment.

This scientific opinion reports on a risk assessment for the authorisation for (continued) marketing of genetically modified maize T25 for food and feed uses, import and processing. Maize T25 contains a single insertion locus containing a pat cassette conferring tolerance to glufosinate-based herbicides. Bioinformatic analyses, protein expression data and genetic stability studies did not raise safety issues. The compositional, agronomic and phenotypic characteristics of maize T25 grain and its conventional counterpart showed no differences that are of relevance for food/feed safety. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced PAT protein. The compositional data indicating the nutritional equivalence of maize T25 were supported by the results of the feeding studies. There was no evidence that the genetic modification might significantly change the overall allergenicity of maize T25. Considering all available information related to the agronomic and phenotypic characterisation of maize T25, the EFSA GMO Panel did not observe any enhanced fitness characteristics of maize T25 that will change its capacity to spread, establish or persist compared with non-genetically modified (GM) maize, except in the presence of glufosinate-based herbicides. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize T25 to bacteria have not been identified. The monitoring plan and reporting intervals were in line with the intended uses. The Panel concluded that maize T25, as described in the applications, is as safe as its conventional counterpart with respect to potential effects on human and animal health or the environment in the context of its intended uses for food and feed, import and processing. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MZHG0JG and its conventional counterpart needs further assessment, except for early stand count (pre‐thinning). The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the mEPSPS and PAT proteins as expressed in maize MZHG0JG, and finds no evidence that the genetic modification would change the overall allergenicity of maize MZHG0JG. The nutritional impact of food/feed derived from maize MZHG0JG is expected to be the same as that of food/feed derived from the conventional counterpart and commercial non‐GM maize reference varieties. The GMO Panel concludes that maize MZHG0JG is nutritionally equivalent to and as safe as the conventional counterpart and 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 MZHG0JG grains into the environment, maize MZHG0JG would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MZHG0JG. In conclusion, the GMO Panel considers that maize MZHG0JG, 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 FROM AUTHOR]