Post-market Environmental Monitoring Plan Research Articles

Assessment of genetically modified maize DP51291 (application GMFF-2021-0071).

Genetically modified maize DP51291 was developed to confer control against susceptible corn rootworm pests and tolerance to glufosinate-containing herbicide; these properties were achieved by introducing the ipd072Aa, pmi and mo-pat expression cassettes. 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 DP51291 and its conventional counterpart needs further assessment, except for phosphorus in forage and manganese, proline, oleic acid (C18:1) and linoleic acid (C18:2) in grain, which do not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD072Aa, PAT and PMI proteins as expressed in maize DP51291 and finds no evidence that the genetic modification would change the overall allergenicity of maize DP51291. In the context of this application, the consumption of food and feed from maize DP51291 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP51291 is as safe as its conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP51291 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP51291. The GMO Panel concludes that maize DP51291 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize DP910521 (application GMFF-2021-2473).

Genetically modified (GM) maize DP910521 was developed to confer resistance against certain lepidopteran insect pests as well as tolerance to glufosinate herbicide; these properties were achieved by introducing the mo-pat, pmi and cry1B.34 expression cassettes. The molecular characterisation data and bioinformatic analyses did not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP910521 and its conventional counterpart needs further assessment except for the levels of iron in grain, which do not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Cry1B.34, PAT and PMI proteins as expressed in maize DP910521. The GMO panel finds no evidence that the genetic modification impacts the overall safety of maize DP910521. In the context of this application, the consumption of food and feed from maize DP910521 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP910521 is as safe as its conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of maize DP910521 material into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP910521. The GMO Panel concludes that maize DP910521 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 95275 (application GMFF-2022-5890).

Genetically modified maize MON 95275 was developed to confer protection to certain coleopteran species. These properties were achieved by introducing the mpp75Aa1.1, vpb4Da2 and DvSnf7 expression cassettes. The molecular characterisation data and bioinformatic analyses reveal similarity to known toxins, which was further assessed. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 95275 and its conventional counterpart needs further assessment. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Mpp75Aa1.1 and Vpb4Da2 proteins and the DvSnf7 dsRNA and derived siRNAs as expressed in maize MON 95275 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 95275. In the context of this application, the consumption of food and feed from maize MON 95275 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 95275 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of maize MON 95275 material into the environment, this 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 95275. The GMO Panel concludes that maize MON 95275 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 94804 (application GMFF-2022-10651).

Genetically modified (GM) maize MON 94804 was developed to achieve a reduction in plant height by introducing the GA20ox_SUP suppression cassette. The molecular characterisation and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the agronomic/phenotypic and compositional differences identified between maize MON 94804 and its conventional counterpart needs further assessment, except for ear height, plant height and levels of carbohydrates in forage, which do not raise safety or nutritional concerns. The Panel on Genetically Modified Organisms (GMO Panel) does not identify safety concerns regarding the toxicity and allergenicity of the GA20ox_SUP precursor-miRNA and derived mature miRNA as expressed in maize MON 94804 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 94804. In the context of this application, the consumption of food and feed from maize MON 94804 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 94804 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 94804 grains into the environment, this 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 94804. The GMO Panel concludes that maize MON 94804 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-159).

Genetically modified maize DP202216 was developed to confer tolerance to glufosinate-ammonium-containing herbicides and to provide an opportunity for yield enhancement under field conditions. These properties were achieved by introducing the mo-pat and zmm28 expression cassettes. 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 DP202216 and its comparator needs further assessment, except for the levels of stearic acid (C18:0), which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the PAT and ZMM28 proteins as expressed in maize DP202216, and finds no evidence that the genetic modification would change the overall allergenicity of maize DP202216. In the context of this application, the consumption of food and feed from maize DP202216 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP202216 is as safe as the comparator and non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP202216 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216. The GMO Panel concludes that maize DP202216 is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize DP915635 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-172).

Genetically modified maize DP915635 was developed to confer tolerance to glufosinate herbicide and resistance to corn rootworm pests. These properties were achieved by introducing the ipd079Ea, mo-pat and pmi expression cassettes. 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 DP915635 and its conventional counterpart needs further assessment, except for the levels of crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD079Ea, PAT and PMI proteins expressed in maize DP915635. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize DP915635. In the context of this application, the consumption of food and feed from maize DP915635 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP915635 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP915635 grains into the environment, this would not raise environmental safety concerns. The post market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP915635. The GMO Panel concludes that maize DP915635 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize DP23211 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-163).

Genetically modified maize DP23211 was developed to confer control of certain coleopteran pests and tolerance to glufosinate-containing herbicide. These properties were achieved by introducing the pmi, mo-pat, ipd072Aa and DvSSJ1 expression cassettes. 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 DP23211 and its conventional counterpart needs further assessment, except for those in levels of histidine, phenylalanine, magnesium, phosphorus and folic acid in grain, which do not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD072Aa, PAT and PMI proteins and the DvSSJ1 dsRNA and derived siRNAs newly expressed in maize DP23211, and finds no evidence that the genetic modification impacts the overall safety of maize DP23211. In the context of this application, the consumption of food and feed from maize DP23211 does not represent a nutritional concern in humans and animals. Therefore, no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP23211 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP23211. The GMO Panel concludes that maize DP23211 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.

Assessment of genetically modified cotton COT102 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2017-141).

Genetically modified cotton COT102 was developed to confer resistance against several lepidopteran species. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the differences in the agronomic-phenotypic and compositional characteristics between cotton COT102 and its non-GM comparator needs further assessment, except for levels of acid detergent fibre, which do not raise safety or nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Vip3Aa19 and APH4 proteins as expressed in cotton COT102 and finds no evidence that the genetic modification would change the overall allergenicity of cotton COT102. In the context of this application, the consumption of food and feed from cotton COT102 does not represent a nutritional concern for humans and animals. The GMO Panel concludes that cotton COT102 is as safe as the non-GM comparator and non-GM cotton varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable cotton COT102 seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton COT102. The GMO Panel concludes that cotton COT102 is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 87419 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-140).

Genetically modified maize MON 87419 was developed to confer tolerance to dicamba- and glufosinate-based herbicides. These properties were achieved by introducing the dmo and pat expression cassettes. 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 MON 87419 and its conventional counterpart needed further assessment, except for the levels of arginine and protein in grains which did not raise safety and nutritional concerns. The GMO Paneldoes not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono-oxygenase (DMO) and phosphinothricin N-acetyltransferase (PAT) proteins as expressed in maize MON 87419. The GMO Panelfinds no evidence that the genetic modification impacts the overall safety of maize MON 87419. In the context of this application, the consumption of food and feed from maize MON 87419 does not represent a nutritional concern in humans and animals. The GMO Panelconcludes that maize MON 87419 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87419 grains into the environment, this 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 87419. The GMO Panelconcludes that maize MON 87419 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize GA21×T25 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-137).

Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panelpreviously assessed the two single maize events and did not identify safety concerns. No new data on the single maize events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in maize GA21 × T25 does not give rise to food and feed safety and nutritional concerns. The GMO Panelconcludes that maize GA21 × T25, as described in this application, is as safe as its conventional counterpart and the non-GM reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable maize GA21 × T25 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize GA21 × T25. Post-market monitoring of food and feed is not considered necessary. The GMO Panelconcludes that maize GA21 × T25 is as safe as its conventional counterpart and the non-GM reference varieties tested, with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified oilseed rape GT73 for placing on the market of isolated seed protein for food under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-026/2).

Genetically modified oilseed rape GT73 was developed to confer herbicide tolerance; this property was achieved by introducing the single insert containing one copy of goxv247 and the CP4 epsps expression cassettes. The scope of the application EFSA-GMO-RX-026/2 is for the modification of the terms of the authorisation regarding the placing on the market of isolated seed protein from oilseed rape GT73 for food. Considering previous opinions on this event of the GMO Panel, the molecular characterisation data do not identify issues requiring additional food safety assessment. Based on previous assessments, no biologically relevant differences were identified in the compositional, agronomic and phenotypic characteristics of oilseed rape GT73 compared with its conventional counterpart, except for the newly expressed proteins. No new agronomic, phenotypic and compositional data in support of the comparative analysis were considered necessary in the context of this application. The GMO Paneldid not identify indications of safety concern regarding toxicity, allergenicity or adjuvanticity related to the presence of the newly expressed proteins CP4 EPSPS and GOXv247 in oilseed rape GT73. Therefore, the GMO Panelconcludes that in the context of this application, the consumption of oilseed rape GT73 does not represent any nutritional concern and is as safe as the conventional counterpart. No post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable oilseed rape GT73 into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape GT73. The GMO Panelconcludes that oilseed rape GT73 is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment. These conclusions also apply to the placing on the food market of isolated seed protein produced from oilseed rape GT73.

Assessment of genetically modified maize MON 95379 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-170).

Genetically modified maize MON 95379 was developed to confer insect protection against certain lepidopteran species. These properties were achieved by introducing the cry1B.868 and cry1Da_7 expression cassettes. 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 MON 95379 and its conventional counterpart needs further assessment. The GMO Paneldoes not identify safety concerns regarding the toxicity and allergenicity of the Cry1B.868 and Cry1Da_7 proteins as expressed in maize MON 95379. The GMO Panelfinds no evidence that the genetic modification impacts the overall safety of maize MON 95379. In the context of this application, the consumption of food and feed from maize MON 95379 does not represent a nutritional concern in humans and animals. Therefore, no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 95379 grains into the environment, this 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 95379. The GMO Panelconcludes that maize MON 95379 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified Maize MON 87429 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-161).

Maize MON 87429 was developed to confer tolerance to dicamba, glufosinate, quizalofop and 2,4-D herbicides. 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 MON 87429 and its conventional counterpart needs further assessment, except for the levels of phytic acid in grains, which do not raise nutritional and safety concerns. The GMO Paneldoes not identify safety concerns regarding the toxicity and allergenicity of the DMO, PAT, FT_T and CP4 EPSPS proteins as expressed in maize MON 87429. The GMO Panelfinds no evidence that the genetic modification impacts the overall safety of maize MON 87429. In the context of this application, the consumption of food and feed from maize MON 87429 does not represent a nutritional concern in humans and animals. The GMO Panelconcludes that maize MON 87429 is 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 MON 87429 grains into the environment, this 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 87429. The GMO Panelconcludes that maize MON 87429, 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.

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

Genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS-40278-9 was developed by crossing to combine four single events: DP4114, MON 89034, MON 87411 and DAS-40278-9. The GMO Panelpreviously assessed the four single maize events and two of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the four-event stack maize does not give rise to food and feed safety and nutritional concerns. Therefore, no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable four-event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panelassessed the likelihood of interactions among the single events in eight of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP4114 × MON 89034 × MON 87411 × DAS-40278-9. Post-market monitoring of food/feed is not considered necessary. The GMO Panelconcludes that the four-event stack maize and its subcombinations are as safe as its non-GM comparator and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

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

Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the five single maize events and 16 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to the modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that five‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM maize varieties tested. In the case of accidental release of viable five‐event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified oilseed rape MON 94100 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-169).

Oilseed rape MON 94100 was developed to confer tolerance to dicamba herbicide. 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 oilseed rape MON 94100 and its conventional counterpart needs further assessment, except for the levels of carbohydrates, calcium and ADF in seeds, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono‐oxygenase (DMO) protein as expressed in oilseed rape MON 94100. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of oilseed rape MON 94100. In the context of this application, the consumption of food and feed from oilseed rape MON 94100 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that oilseed rape MON 94100 is as safe as the conventional counterpart and non‐GM oilseed rape reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable oilseed rape MON 94100 seeds into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape MON 94100. The GMO Panel concludes that oilseed rape MON 94100 is as safe as its conventional counterpart and the tested non‐GM oilseed rape reference varieties with respect to potential effects on human and animal health and the environment.

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

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

The post-market environmental monitoring of GM maize in the EU has a limited capacity to identify adverse effects

The EU legislation requests post-market environmental monitoring (PMEM) of a genetically modified (GM) organism even if its pre-market risk assessment indicated negligible risks. It has been claimed that the monitoring of the only currently commercially cultivated GM plant in the EU, Bt MON810 maize, has not revealed any adverse effects. However, the implementation of its PMEM has been criticised repeatedly by the European Food Safety Authority (EFSA).Although EFSA agreed with the monitoring plan consisting of four tools, as proposed by the company which markets MON810, in practice PMEM has relied on famers’ questionnaires, a farmers’ complaint system, and a literature survey. The fourth approach, environmental surveillance networks, has not been utilised yet. Furthermore, PMEM requires that farmers plant a refuge of non-Bt maize in order to sustain the efficiency of the plant in combating the targeted pest.This paper aims to contribute to improved PMEM by means of a critical evaluation of its implementation in the Czech Republic based on interviews and a questionnaire survey of farmers who cultivated MON810. The results indicate that a quarter of the farmers who were surveyed did not comply with the refuge requirement. Moreover, farmers often lacked the knowledge, time, and motivation to observe and report the potential impacts of Bt maize on biodiversity, which is supposed to be monitored by the PMEM farmers’ questionnaire.The findings of this study compound the previous criticism and suggest that the current practice of PMEM limits its aim of detecting unanticipated adverse effects of MON810 maize cultivation on human and animal health and the environment. The PMEM plan should be revised before the approval process of the application for the renewal of the authorisation for MON810 cultivation in the EU continues.

Assessment of genetically modified soybean GMB151 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2018-153).

Soybean GMB151 was developed to confer tolerance to 4‐hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides and resistance to nematodes. 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 soybean GMB151 and its conventional counterpart needs further assessment, except for palmitic acid and heptadecenoic acid in seeds and carbohydrate and crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the HPPD‐4 and Cry14Ab‐1 proteins as expressed in soybean GMB151, and finds no evidence that the genetic modification would change the overall allergenicity of soybean GMB151. In the context of this application, the consumption of food and feed from soybean GMB151 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean GMB151 is as safe as the conventional counterpart and non‐GM soybean reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean GMB151 seeds into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean GMB151. The GMO Panel concludes that soybean GMB151 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.

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

Maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 (six‐event stack maize) was produced by conventional crossing to combine six single events: MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The GMO Panel previously assessed the six single maize events and 17 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 17 subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the six‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as its non‐GM comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 39 maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the six–event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.