Assessment of soy leghemoglobin produced from genetically modified , under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-162).

Genetically modified strain MXY0541 was developed to produce soy leghemoglobin by introducing the coding sequence encoding leghemoglobin from soybean (). The molecular characterisation data and bioinformatic analyses do not raise any safety concerns. The safety of soy leghemoglobin as a food additive has already been assessed by the EFSA FAF Panel (EFSA-Q-2022-00031).

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 and 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.

Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-NL-2015-126) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788.

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA-GMO-NL-2015-126). The applicant conducted a 90-day feeding study on GM soybean MON 87705 and provided a proposal for post-market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90-day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment-related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days.

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.

Assessment of the 2020 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 2020 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Like previous years, there was full compliance with refuge requirement in Portugal and partial compliance with refuge requirements by Spanish farmers growing MON 810 varieties. European and Mediterranean corn borer populations collected from north-eastern Spain during the 2020 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810.

Update of environmental risk assessment conclusions and risk management recommendations of EFSA (2016) on EU teosinte.

Teosinte, wild maize relatives originating from Mexico and Central America, emerged as a noxious agricultural weed in France and Spain. In 2016, the European Food Safety Authority (EFSA) issued a technical report that assessed the available scientific information on teosinte for its relevance for the environmental risk assessment (ERA) and risk management (RM) of genetically modified (GM) maize MON810, Bt11, 1507 and GA21 for cultivation. It was concluded that the impact of insect resistance and/or herbicide tolerance in GM teosinte hybrid progeny (potentially acquired through hybridisation between GM maize and teosinte) on target and non-target organisms, the abiotic environment and biogeochemical cycles would be very low under EU conditions.

Assessment of the 2019 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 EFSA assessed the 2019 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Like previous years, there was full compliance with refuge requirement in Portugal and partial compliance with refuge requirements by Spanish farmers growing MON 810 varieties. European and Mediterranean corn borer populations collected from north-eastern Spain during the 2019 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810.

Managing resistance evolution to transgenic maize in corn borers in Spain.

Since 1998, genetically engineered maize varieties expressing the insecticidal Cry1Ab protein (i.e. event MON 810) have been grown in the European Union (EU), mainly in Spain.

A spatiotemporal dataset for integrated assessment and modelling of crop-livestock integration with the MAELIA simulation platform.

The general purpose of the primary and secondary data available in this article is to support an integrated assessment of scenarios of crop-livestock integration at the territorial level i.e. of exchanges between arable and livestock farms.

EFSA is working to advance the environmental risk assessment of genetically modified crops to better protect butterflies and moths.

This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.

Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology.

Synthetic Biology (SynBio) is an interdisciplinary field at the interface of engineering and biology aiming to develop new biological systems and impart new functions to living cells. EFSA has been asked by the European Commission to evaluate SynBio developments in agri-food with the aim of identifying the adequacy of existing guidelines for risk assessment and determine if updated guidance is needed. The scope of this opinion covers the molecular characterisation and environmental risk assessment of such genetically modified plants obtained through SynBio, meant to be for cultivation or food and feed purposes.

Assessment of the 2018 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 EFSA assessed the 2018 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Like previous years, there was partial compliance with refuge requirements by Spanish farmers growing MON 810 varieties. European and Mediterranean corn borer populations collected from north-eastern Spain during the 2018 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810.

When the average hides the risk of Bt-corn pollen on non-target Lepidoptera: Application to Aglais io in Catalonia.

Field cultivation of Genetically Modified (GM) Bt-plants has a potential environmental risk toward non-target Lepidoptera (NTLs) larvae through the consumption of Bt-maize pollen. The Bt-maize Cry protein targeting Lepidoptera species detrimental to the crop is also expressed in pollen which is dispersed by wind and can thus reach habitats of NTLs. To better assess the current ecological risk of Bt-maize at landscape scales, we developed a spatially-explicit exposure-hazard model considering (i) the dynamics of pollen dispersal obtained by convolving GM plants emission with a dispersal kernel and (ii) a toxicokinetic-toxicodynamic (TKTD) model accounting for the impact of toxin ingestion on individual lethal effects.

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-121).

Soybean MON 87751 was developed through -mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from . The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety.

Assessment of genetically modified cotton GHB614 × T304-40 × GHB119 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-122).

The three‐event stack cotton GHB614 × T304‐40 × GHB119 was produced by conventional crossing to combine three single events, GHB614, T304‐40 and GHB119. The genetically modified organisms (GMO) Panel previously assessed the three single cotton events and did not identify safety concerns. No new data on the single cotton events that could lead to modification of the original conclusions on their safety were identified.

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008).

Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 × NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant.

Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants.

As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has mandated EFSA to develop a technical note to the applicants on, and checking of, the quality of the methodology, analysis and reporting covering complete sequencing of the insert and flanking regions, insertion site analysis of the GM event, and generational stability and integrity. This Technical Note puts together requirements and recommendations for when DNA sequencing is part of the molecular characterisation of GM plants, in particular for the characterisation of the inserted genetic material at each insertion site and flanking regions, the determination of the copy number of all detectable inserts, and the analysis of the genetic stability of the inserts, when addressed by Sanger sequencing or NGS.

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2010-86).

In this opinion, the GMO Panel assessed the four-event stack maize Bt11 × MIR162 × 1507 × GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified.

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2015-124).

Maize MON 87411 was developed to confer resistance to corn rootworms ( spp.) by the expression of a modified version of the gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate-containing herbicides by the expression of a CP4 5-enolpyruvylshikimate-3-phosphate synthase () gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety.

Annual post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in 2016.

Following a request from the European Commission, EFSA assessed the annual post-market environmental monitoring (PMEM) report for the 2016 growing season of the Cry1Ab-expressing maize event MON 810 provided by Monsanto Europe S.A. Partial compliance with refuge requirements was reported in Spain, as observed in previous years.

Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-123).

Maize 4114 was developed through -mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from , and tolerance to the herbicidal active ingredient glufosinate-ammonium by expression of the PAT protein derived from . The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non-genetically modified (GM) comparator(s) required further assessment.

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2011-94).

The three-event stack cotton GHB614 × LLCotton25 × MON 15985 was produced by conventional crossing to combine three single cotton events, GHB614, LLCotton25 and MON 15985. The EFSA GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single events that could lead to modification of the original conclusions on their safety were identified.

Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-DE-2011-95) for the placing on the market of genetically modified maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG taking into consideration an additional toxicological study.

The GMO Panel was previously not in the position to complete the food/feed safety assessment of maize 5307 due to an inadequate 28-day toxicity study necessary for an appropriate assessment of eCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed a supplementary 28-day toxicity study in mice on the eCry3.

Assessment of genetically modified maize MON 87403 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-BE-2015-125).

Maize MON 87403 was developed to increase ear biomass at early reproductive phase through the expression of a modified gene from , encoding a plant transcription factor of the HD-Zip II family. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87403 and its conventional counterpart were identified.