Post-market Environmental Monitoring 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 the 2022 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU.

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

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.

Challenges for the Post-Market Environmental Monitoring in the European Union Imposed by Novel Applications of Genetically Modified and Genome-Edited Organisms.

Information on the state of the environment is important to achieve the objectives of the European Green Deal, including the EU's Biodiversity Strategy for 2030. The existing regulatory provisions for genetically modified organisms (GMOs) foresee an obligatory post-market environmental monitoring (PMEM) of potential adverse effects upon release into the environment. So far, GMO monitoring activities have focused on genetically modified crops. With the advent of new genomic techniques (NGT), novel GMO applications are being developed and may be released into a range of different, non-agricultural environments with potential implications for ecosystems and biodiversity. This challenges the current monitoring concepts and requires adaptation of existing monitoring programs to meet monitoring requirements. While the incorporation of existing biodiversity monitoring programs into GMO monitoring at the national level is important, additional monitoring activities will also be required. Using case examples, we highlight that monitoring requirements for novel GMO applications differ from those of GM crop plants previously authorized for commercial use in the European Union.

Safety Assessment RP1232 Genetically Modified GHB811 Cotton

Following the submission of application RP652 to the Food Standards Agency (FSA) under assimilated Regulation (EC) No. 1829/2003 from Syngenta Crop Protection NV/SA, represented by Syngenta Limited (Bracknell, UK), FSA/FSS (Food Standards Scotland) have undertaken a safety assessment on genetically modified MIR162 maize. To support the safety assessment by FSA/FSS, the Advisory Committee on Novel Foods and (ACNFP) provided advice to FSA/FSS on the data submitted for the renewal of authorisation for the genetically modified maize MIR162, as outlined in this document. The advice of the ACNFP has been taken into account in this safety assessment which represents the opinion of FSA/FSS on the safety of genetically modified MIR162 maize. MIR162 maize is modified to express the Vip3a20 and PMI proteins; Vip3Aa20 – a variant of a protein from the soil bacterium Bacillus thurigiensis – is an insecticidal protein, active against certain lepidopteran pests of maize, including Spodoptera frugiperda (Fall armyworm) and Helicoverpa zea (Corn earworm). PMI (phosphomannose isomerase – from E. coli strain K-12) catalyses the reversible interconversion of mannose and fructose, and enables the plant to use mannose as a primary carbon source. It is used as a selectable marker in the development of MIR162 maize. MIR162 maize has previously been authorised for food and feed uses and is most commonly used as animal feed. The scope of this application is for the renewal of the authorisation for placing on the market of food and feed products containing, consisting of, or produced from genetically modified MIR162 maize. This also includes products other than food or feed. The application does not cover cultivation and therefore no MIR162 maize will be grown in the UK. In providing its advice on the safety of MIR162 maize for food and feed, the ACNFP considered data provided as part of application RP652 (post-market environmental monitoring reports, evaluation of systematic literature searches, additional studies performed by or on behalf of the applicant, and updated bioinformatics analyses), additional information provided by the applicant, and analyses and reports from outside contractors. The ACNFP assessed these data for possible new hazards, modified exposures, or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application (EFSA GMO Panel 2012). FSA/FSS concludes, based on ACNFP advice, that there is no evidence in the renewal application RP652 for new hazards, modified exposures, or new scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified maize MIR162 (EFSA GMO Panel 2012).

Safety Assessment RP652 Genetically Modified MIR162 Maize

“Following the submission of application RP652 to the Food Standards Agency (FSA) under assimilated Regulation (EC) No. 1829/2003 from Syngenta Crop Protection NV/SA, represented by Syngenta Limited (Bracknell, UK), FSA/FSS (Food Standards Scotland) have undertaken a safety assessment on genetically modified MIR162 maize. To support the safety assessment by FSA/FSS, the Advisory Committee on Novel Foods and (ACNFP) provided advice to FSA/FSS on the data submitted for the renewal of authorisation for the genetically modified maize MIR162, as outlined in this document. The advice of the ACNFP has been taken into account in this safety assessment which represents the opinion of FSA/FSS on the safety of genetically modified MIR162 maize. MIR162 maize is modified to express the Vip3a20 and PMI proteins; Vip3Aa20 – a variant of a protein from the soil bacterium Bacillus thurigiensis – is an insecticidal protein, active against certain lepidopteran pests of maize, including Spodoptera frugiperda (Fall armyworm) and Helicoverpa zea (Corn earworm). PMI (phosphomannose isomerase – from E. coli strain K-12) catalyses the reversible interconversion of mannose and fructose, and enables the plant to use mannose as a primary carbon source. It is used as a selectable marker in the development of MIR162 maize. MIR162 maize has previously been authorised for food and feed uses and is most commonly used as animal feed. The scope of this application is for the renewal of the authorisation for placing on the market of food and feed products containing, consisting of, or produced from genetically modified MIR162 maize. This also includes products other than food or feed. The application does not cover cultivation and therefore no MIR162 maize will be grown in the UK. In providing its advice on the safety of MIR162 maize for food and feed, the ACNFP considered data provided as part of application RP652 (post-market environmental monitoring reports, evaluation of systematic literature searches, additional studies performed by or on behalf of the applicant, and updated bioinformatics analyses), additional information provided by the applicant, and analyses and reports from outside contractors. The ACNFP assessed these data for possible new hazards, modified exposures, or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application (EFSA GMO Panel 2012). FSA/FSS concludes, based on ACNFP advice, that there is no evidence in the renewal application RP652 for new hazards, modified exposures, or new scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified maize MIR162 (EFSA GMO Panel 2012).”

Safety Assessment RP212 Genetically Modified Soybean 40-3-2

Following the submission of application RP212 to the Food Standards Agency (FSA) under assimilated Regulation (EC) No. 1829/2003 from Bayer CropScience Ltd, FSA/FSS (Food Standards Scotland) have undertaken a safety assessment on genetically modified soybean 40-3-2. To support the safety assessment by FSA/FSS, the Advisory Committee on Novel Foods and Processes (ACNFP) provided advice to FSA/FSS on the data submitted for the renewal of authorisation for the genetically modified soybean 40-3-2, as outlined in this document. The advice of the ACNFP has been taken into account in this safety assessment which represents the opinion of FSA/FSS on the safety of genetically modified soybean 40-3-2. Soybean 40-3-2 is modified to express the CP4 EPSPS (5-enolpyruvylshikimate 3-phosphate synthase) protein from the CP4 strain of Agrobacterium tumefaciens, which has a lower binding affinity with glyphosate, conferring tolerance to glyphosate herbicides. Soybean 40-3-2 has previously been authorised for food and feed uses and is most commonly used as a source of protein in animal feed. The scope of this application is for the renewal of the authorisation for placing on the market of food and feed products containing, consisting of, or produced from genetically modified soybean 40-3-2. This also includes products other than food or feed. The application does not cover cultivation and therefore no soybean 40-3-2 will be grown in the UK. In providing its advice on the safety of soybean 40-3-2 for food and feed, the ACNFP considered data provided as part of application RP212 (post-market environmental monitoring reports, evaluation of systematic literature searches, additional studies performed by or on behalf of the applicant, and updated bioinformatics analyses), additional information provided by the applicant, and analyses and reports from outside contractors. The ACNFP assessed these data for possible new hazards, modified exposures, or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application (or the first renewal in 2012). FSA/FSS concludes, based on ACNFP advice, that there is no evidence in the renewal application RP212 for new hazards, modified exposures, or new scientific uncertainties that would change the conclusions of the original risk assessments on genetically modified soybean 40-3-2 (EFSA GMO Panel 2010, UK-ACNFP 1995).

Safety Assessment RP188 Genetically Modified Soybean A5547-127

Following the submission of application RP188 to the Food Standards Agency (FSA) under assimilated Regulation (EC) No. 1829/2003 from BASF Plc (United Kingdom), FSA/FSS (Food Standards Scotland) have undertaken a safety assessment on genetically modified soybean A5547-127. To support the safety assessment by FSA/FSS, the Advisory Committee on Novel Foods and Processes (ACNFP) provided advice to FSA/FSS on the data submitted for the renewal of authorisation for the genetically modified soybean A5547-127, as outlined in this document. The advice of the ACNFP has been taken into account in this safety assessment which represents the opinion of FSA/FSS on the safety of genetically modified soybean A5547-127. Soybean A5547-127 is modified to express the PAT (phosphinothricin acetyltransferase) protein from the soil bacteria Streptomyces viridochromogenes to confer resistance to glufosinate ammonium herbicide. The PAT protein prevents glufosinate ammonium herbicide from inhibiting the glutamate synthase enzyme, which is essential for nitrogen metabolism in plants. Soybean A5547-127 has previously been authorised for food and feed uses and is most commonly used as a source of protein in animal feed. The scope of this application is for the renewal of the authorisation for placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127. This includes food, feed, and products other than food or feed. The application does not cover cultivation and therefore no soybean A5547-127 will be grown in the UK. In providing its advice on the safety of soybean A5547-127 for food and feed, the ACNFP considered data provided as part of application RP188 (post-market environmental monitoring reports, evaluation of systematic literature searches, additional studies performed by or on behalf of the applicant, and updated bioinformatics analyses), additional information provided by the applicant, and analyses and reports from outside contractors. The ACNFP assessed these data for possible new hazards, modified exposures, or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application (EFSA GMO Panel 2011). FSA/FSS concludes, based on ACNFP advice, that there is no evidence in the renewal application RP188 of new hazards, modified exposures, or new scientific uncertainties that would change the conclusions of the original risk assessment of genetically modified soybean A5547-127 (EFSA GMO Panel 2011).

Safety Assessment RP608 Genetically Modified GHB614 Cotton

“Following the submission of application RP608 to the Food Standards Agency (FSA) under assimilated Regulation (EC) No. 1829/2003 from BASF Agricultural Solutions Seed US LLC, (New Jersey, USA), FSA/FSS (Food Standards Scotland) have undertaken a safety assessment on genetically modified GHB614 cotton. To support the safety assessment by FSA/FSS, the Advisory Committee on Novel Foods and Processes (ACNFP) provided advice to FSA/FSS on the data submitted for the renewal of authorisation for the genetically modified cotton GHB614, as outlined in this document. The advice of the ACNFP has been taken into account in this safety assessment which represents the opinion of FSA/FSS on the safety of genetically modified GHB614 cotton. Cotton is primarily used worldwide for its lint, however raw, unprocessed cottonseed may be fed to ruminants as meal, or the seed can be processed into oil. Cottonseed oil has been in use since the 19th century and is considered to be a premium quality oil. GHB614 cotton is modified to express the 2mEPSPS (5-enolpyruvylshikimate 3-phosphate synthase) protein. The 2mepsps gene sequence has been modified by introducing two mutations to the epsps gene from maize which decreases the binding affinity of glyphosate, conferring tolerance to glyphosate herbicides. GHB614 cotton has previously been authorised for food and feed uses and is most commonly used as animal feed. The scope of this application is for the renewal of the authorisation for placing on the market GHB614 cotton products for food and feed uses, import, and processing. The application does not include cultivation and therefore no GHB614 cotton will be grown in the UK. In providing its advice on the safety of GHB614 cotton for food and feed, the ACNFP considered data provided as part of application RP608 (post-market environmental monitoring reports, evaluation of systematic literature searches, additional studies performed by or on behalf of the applicant, and updated bioinformatics analyses), additional information provided by the applicant, and analyses and reports from outside contractors. The ACNFP assessed these data for possible new hazards, modified exposures, or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application (EFSA GMO Panel 2009). FSA/FSS concludes, based on ACNFP advice, that there is no evidence in the renewal application RP608 for new hazards, modified exposures, or new scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified cotton GHB614 (EFSA GMO Panel 2009).”

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 MON 89034 × 1507 × NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (application GMFF-2022-3670).

Following the submission of dossier GMFF-2022-3670 under Regulation (EC) No 1829/2003 from Corteva Agriscience Belgium BV and Bayer Agriculture BV, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant and insect-resistant genetically modified maize MON 89034 × 1507 × NK603, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and a search for additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × NK603 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-3670 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × NK603.

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2022-9170).

Following the joint submission of dossier GMFF-2022-9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.V., the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant and insect resistant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations.

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 maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2022-9450).

Following the submission of dossier GMFF-2022-9450 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect protected genetically modified maize MON 810, for food and feed uses (including pollen), excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 810 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in dossier GMFF-2022-9450 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 810.

Assessment of the 2021 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU.

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

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 oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-024).

Following the submission of application EFSA-GMO-RX-024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of EFSA was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant genetically modified oilseed rape MS8, RF3 and MS8 × RF3, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in oilseed rape MS8, RF3 and MS8 × RF3 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-024 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8 × RF3.