127 results on '"Hejatko J"'
Search Results
2. Automated Detection and Segmentation of Grain Spikes in Greenhouse Images Using Shallow and Deep Learning Neural Networks: A Comparison of Six Methods
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Hejatko J, Henke M, Gladilin E, Narisetti N, and Ullah S
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Artificial neural network ,Computer science ,business.industry ,Deep learning ,Greenhouse ,Pattern recognition ,Segmentation ,Artificial intelligence ,business - Abstract
Image-based plant phenotyping is the major approach to quantitative assessment of important plant properties. For automated analysis of a large amount of image data from high-throughput greenhouse measurements, efficient techniques for image segmentation are required. However, conventional approaches to whole plant and plant organ segmentation are hampered by high variability of plant and background illumination, and naturally occurring changes in geometry and colors of growing plants. Consequently, application of advanced machine learning techniques for automated image segmentation is required. Here, we investigate six advanced neural network (NN) methods for detection and segmentation of grain spikes in RGB images including three detection deep NNs (SSD, Faster-RCNN, YOLOv3/v4), two deep (U-Net, DeepLabv3+) and one shallow segmentation NNs. Our experimental results show superior performance of deep learning NNs that achieve in average more than 90% accuracy by detection and segmentation of wheat as well as barley and rye spikes. However, different methods demonstrate different performance on matured, emergent and occluded spikes. In addition to comprehensive comparison of six NN methods, a GUI-based tool (SpikeApp) provided with this work demonstrates the application of detection and segmentation NNs to fully automated spike phenotyping. Further improvements of evaluated NN approaches are discussed.
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- 2021
3. Assessment of genetically modified maize MON 88017 × MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐017)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, and Raffaello, T
- Abstract
Following the submission of application EFSA‐GMO‐RX‐017 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA 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 and herbicide‐tolerant genetically modified maize MON 88017 × MON 810, 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, and updated bioinformatic analysis. 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 88017 × MON 810 considered for renewal are identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐017 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 88017 × MON 810.
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- 2021
4. Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐002)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, JL, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, and Raffaello, T
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Following the submission of application EFSA‐GMO‐RX‐002 under Regulation (EC) No 1829/2003 from Monsanto Company, the Panel on Genetically Modified Organisms of EFSA (GMO) 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 GT73. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in oilseed rape GT73 considered for renewal of authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐002 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT73.
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- 2020
5. Assessment of genetically modified soybean A2704-12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-009)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J-L, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogue, F, Rostoks, N, Serrano, JJS, Savoini, G, Veromann, E, Veronesi, F, Alvarez, F, Ardizzone, M, Papadopoulou, N, Paraskevopoulos, K, University of Zurich, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, UAR 1171 Soutien aux Projets Européens, and Institut National de la Recherche Agronomique (INRA)
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0106 biological sciences ,[SDV]Life Sciences [q-bio] ,Veterinary (miscellaneous) ,Plant Science ,TP1-1185 ,010501 environmental sciences ,01 natural sciences ,Microbiology ,A2704‐12 ,[SDV.IDA]Life Sciences [q-bio]/Food engineering ,[SDV.BV]Life Sciences [q-bio]/Vegetal Biology ,[SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering ,TX341-641 ,0105 earth and related environmental sciences ,2. Zero hunger ,renewal ,A2704-12 ,Nutrition. Foods and food supply ,Chemical technology ,fungi ,Regulation (EC) No 1829/2003 ,10079 Institute of Veterinary Pharmacology and Toxicology ,Scientific Opinion ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,Articles 11 and 23 ,Soybean ,010606 plant biology & botany ,Food Science - Abstract
International audience; Following the submission of application EFSA-GMO-RX-009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.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 genetically modified soybean A2704-12, for food and feed uses, import and processing, 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. In addition, the applicant provided sequence data on the soybean A2704-12 event using material from a commercial variety currently on the market and intended to be marketed in the coming years. 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. The GMO Panel concludes that there is no evidence in the renewal application EFSA-GMORX-009 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean A2704-12.
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- 2020
6. Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-NL-2009-75) for placing on the market of genetically modified oilseed rape Ms8 x Rf3 x GT73 and subcombinations; which have not been authorised previously (i.e. Ms8 x GT73 and Rf3 x GT73) independently of their origin; for food and feed uses; import and processing; with the exception of isolated seed protein for food; under Regulation (EC) No 1829/2003); taking into consideration additional information
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, JL, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Ardizzone, M, Lanzoni, A, and Paraskevopoulos, K
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Subcombinations Ms8 × Rf3 and Ms8 × GT73 ,040301 veterinary sciences ,Veterinary (miscellaneous) ,TP1-1185 ,Plant Science ,010501 environmental sciences ,01 natural sciences ,Microbiology ,0403 veterinary science ,Import and processing ,oilseed rape Ms8 × Rf3 × GT73 ,TX341-641 ,0105 earth and related environmental sciences ,2. Zero hunger ,Nutrition. Foods and food supply ,GMO ,Chemical technology ,fungi ,Glyphosate oxidoreductase (GOXv247) protein ,04 agricultural and veterinary sciences ,Scientific Opinion ,Food and feed safety ,Oilseed rape Ms8 × Rf3 × GT73 ,Animal Science and Zoology ,Parasitology ,28‐day toxicity study ,subcombinations Ms8 × Rf3 and Ms8 × GT73 ,Food Science - Abstract
The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73 according to the scope as defined in the application EFSA‐GMO‐NL‐2009‐75, and was not in the position to complete the safety assessment of products rich in protein, such as rapeseed protein isolates or products of this nature in animal feeding. Following a mandate from the European Commission, the GMO Panel assessed a 28‐day toxicity study in mice with the glyphosate oxidoreductase (GOXv247) protein, provided to complement information related to application EFSA‐GMO‐NL‐2009‐75 for the placing on the market of oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The 28‐day toxicity study on Escherichia coli‐ produced GOXv247 protein did not show adverse effects in mice, at the gavage doses up to 1000 mg/kg body weight (bw) per day. Taking into account its previous assessment on EFSA‐GMO‐NL‐2009‐75 and the outcome of the 28‐day toxicity study in mice with the GOXv247 protein provided in this mandate, the GMO Panel, based on a weight of evidence approach, concludes that food and feed containing, consisting and produced from genetically modified oilseed rape Ms8 × Rf3 × GT73 and its sub combinations Ms8 × GT73 and Rf3 × GT73, are as safe as its conventional counterpart, according to the scope as defined in the application EFSA‐GMO‐NL‐2009‐75., This publication is linked to the following EFSA Journal articles: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6199/full
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- 2020
7. Assessment of genetically modified maize MZIR098 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2017‐142)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, De Sanctis, G, Devos, Y, Dumont, AF, Gennaro, A, Gómez Ruiz, JÁ, Lanzoni, A, Neri, FM, Papadopoulou, N, Paraskevopoulos, K, Raffaello, T, University of Zurich, Orthopaedic Surgery Department, Sant Rafael Hospital, European Food Safety Authority (EFSA), Tuscia University, Center for Nanotechnology Innovation, @NEST (CNI), National Enterprise for nanoScience and nanoTechnology (NEST), Scuola Normale Superiore di Pisa (SNS)-Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP)-Istituto Italiano di Tecnologia (IIT)-Consiglio Nazionale delle Ricerche [Pisa] (CNR PISA)-Scuola Normale Superiore di Pisa (SNS)-Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP)-Istituto Italiano di Tecnologia (IIT)-Consiglio Nazionale delle Ricerche [Pisa] (CNR PISA), Universität Zürich [Zürich] = University of Zurich (UZH), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Earlham Institute [Norwich], Centre for Ecology and Hydrology [Bangor] (CEH), Natural Environment Research Council (NERC), Institut Jean-Pierre Bourgin (IJPB), and AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
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MZIR098 ,[SDV.BIO]Life Sciences [q-bio]/Biotechnology ,040301 veterinary sciences ,Veterinary (miscellaneous) ,[SDV]Life Sciences [q-bio] ,2405 Parasitology ,Context (language use) ,mCry3A ,Plant Science ,TP1-1185 ,010501 environmental sciences ,Biology ,01 natural sciences ,Microbiology ,0403 veterinary science ,Environmental safety ,1110 Plant Science ,TX341-641 ,maize (Zea mays) ,1106 Food Science ,0105 earth and related environmental sciences ,2. Zero hunger ,Maize (Zea mays) ,Genetically modified maize ,PAT Proteins ,Animal health ,business.industry ,Nutrition. Foods and food supply ,GMO ,Chemical technology ,2404 Microbiology ,Regulation (EC) No 1829/2003 ,04 agricultural and veterinary sciences ,10079 Institute of Veterinary Pharmacology and Toxicology ,eCry3.1Ab ,Biotechnology ,3401 Veterinary (miscellaneous) ,Scientific Opinion ,PAT Requestor: Competent Authority of Germany ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,1103 Animal Science and Zoology ,business ,PAT ,Food Science ,eCry31Ab - Abstract
© 2020 European Food Safety Authority., Maize MZIR098 was developed to confer tolerance to glufosinate‐ammonium‐containing herbicides and resistance to certain coleopteran pests. 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 MZIR098 and its conventional counterpart needs further assessment, except for neutral detergent fibre (NDF) in grains, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the eCry3.1Ab, mCry3A and PAT proteins as expressed in maize MZIR098, and finds no evidence that the genetic modification would change the overall allergenicity of maize MZIR098. In the context of this application, the consumption of food and feed from maize MZIR098 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MZIR098 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 MZIR098 grains into the environment, maize MZIR098 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MZIR098. In conclusion, the GMO Panel considers that maize MZIR098, as described in this application, is as safe as its conventional counterpart and the non‐GM maize reference varieties tested with respect to potential effects on human and animal health and the environment.
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- 2020
8. Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, De Sanctis, G, Dumont, A, Devos, Y, Gennaro, A, Gómez Ruiz, JÁ, Lanzoni, A, Neri, FM, Papadopoulou, N, Paraskevopoulos, K, and Raffaello, T
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fungi ,food and beverages - Abstract
Soybean MON 87705 × MON 87708 × MON 89788 (three‐event stack soybean) was produced by conventional crossing to combine three single soybean events: MON 87705, MON 87708 and MON 89788. This combination is intended to alter the fatty acid profile in the seed (in particular increasing the levels of oleic acid) and tolerance to glyphosate‐based and dicamba herbicides. The Genetically Modified Organisms Panel previously assessed the three single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the three‐event stack soybean does not give rise to food and feed safety and nutritional concerns. In the case of accidental release of viable three‐event stack soybean seeds into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and the reporting intervals are in line with the intended uses of soybean MON 87705 × MON 87708 × MON 89788. Considering the altered fatty acid profile of the three‐event stack soybean, a proposal for post‐market monitoring needs to be provided by the applicant. The GMO Panel notes that in the context of this application EFSA‐GMO‐NL‐2015‐126 the applicant did not provide a 90‐day study on MON 87705 soybean in line with the applicable legal requirements. Therefore, the GMO Panel is not in the position to finalise the risk assessment of soybean MON 87705 × MON 87708 × MON 89788 under the current regulatory frame.
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- 2020
9. Assessment of genetically modified maize MON 88017 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐014)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, and Raffaello, T
- Abstract
Following the submission of application EFSA‐GMO‐RX‐014 under Regulation (EC) No 1829/2003 from Monsanto Company 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 and herbicide‐tolerant genetically modified maize MON 88017, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 88017 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐014 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 88017.
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- 2020
10. Assessment of genetically modi¿ed oilseed rape MS11 for food and feed uses; import and processing; under Regulation (EC) No 1829/2003 (application EFSA-GMO-BE-2016-138)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, De Sanctis, G, Devos, Y, Fernandez‐Dumont, A, Gennaro, A, Gómez Ruiz, JÁ, Lanzoni, A, Neri, FM, Papadopoulou, N, Paraskevopoulos, K, Institut Jean-Pierre Bourgin (IJPB), and AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
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[SDV.BIO]Life Sciences [q-bio]/Biotechnology ,040301 veterinary sciences ,Veterinary (miscellaneous) ,Context (language use) ,TP1-1185 ,Plant Science ,010501 environmental sciences ,Biology ,01 natural sciences ,Microbiology ,0403 veterinary science ,Environmental safety ,TX341-641 ,0105 earth and related environmental sciences ,2. Zero hunger ,Barnase ,Nutrition. Foods and food supply ,business.industry ,GMO ,Chemical technology ,Oilseed rape (Brassica napus) ,Regulation (EC) No 1829/2003 ,04 agricultural and veterinary sciences ,Environmental exposure ,Hybrid seed ,Biotechnology ,Genetically modified organism ,Barstar ,oilseed rape (Brassica napus) ,PAT/bar ,Animal Science and Zoology ,Parasitology ,MS11 ,business ,Food Science - Abstract
© 2020 European Food Safety Authority., Oilseed rape MS11 has been developed to confer male sterility and tolerance to glufosinate‐ammonium‐containing herbicides. Based on the information provided in the application and in line with the scope of application EFSA‐GMO‐BE‐2016‐138, the genetically modified organism (GMO) Panel concludes that 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 characteristics tested between oilseed rape MS11 and its conventional counterpart needs further assessment. No conclusions can be drawn for the compositional analysis due to the lack of an appropriate compositional data set. No toxicological or allergenicity concerns are identified for the Barnase, Barstar and PAT/bar proteins expressed in oilseed rape MS11. Owing to the incompleteness of the compositional analysis, the toxicological, allergenicity and nutritional assessment of oilseed rape MS11 cannot be completed. In the case of accidental release of viable oilseed rape MS11 seeds into the environment, oilseed rape MS11 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the scope of the application. Since oilseed rape MS11 is designed to be used only for the production of hybrid seed, it is not expected to be commercialised as a stand‐alone product for food/feed uses. Thus, seeds harvested from oilseed rape MS11 are not expected to enter the food/feed chain, except accidentally. In this context, the GMO Panel notes that, oilseed rape MS11 would not pose risk to humans and animals, while the scale of environmental exposure will be substantially reduced compared to a stand‐alone product.
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- 2020
11. Assessment of genetically modified soybean SYHT0H2 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE- 2012-111)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, Dumont, AF, Devos, Y, Gennaro, A, Gómez Ruiz, JÁ, Lanzoni, A, Neri, FM, Paraskevopoulos, K, Gastroenterology, Hepatology and Nutrition Division, CHU Sainte Justine [Montréal], European Food Safety Authority (EFSA), Tuscia University, Center for Nanotechnology Innovation, @NEST (CNI), National Enterprise for nanoScience and nanoTechnology (NEST), Scuola Normale Superiore di Pisa (SNS)-Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP)-Istituto Italiano di Tecnologia (IIT)-Consiglio Nazionale delle Ricerche [Pisa] (CNR PISA)-Scuola Normale Superiore di Pisa (SNS)-Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP)-Istituto Italiano di Tecnologia (IIT)-Consiglio Nazionale delle Ricerche [Pisa] (CNR PISA), Universität Zürich [Zürich] = University of Zurich (UZH), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Earlham Institute [Norwich], Centre for Ecology and Hydrology [Bangor] (CEH), Natural Environment Research Council (NERC), Institut Jean-Pierre Bourgin (IJPB), AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and University of Zurich
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0106 biological sciences ,[SDV.BIO]Life Sciences [q-bio]/Biotechnology ,2405 Parasitology ,Plant Science ,01 natural sciences ,Genetically modified soybean ,Mesotrione ,chemistry.chemical_compound ,1110 Plant Science ,AvHPPD‐03 ,TX341-641 ,media_common ,2. Zero hunger ,0303 health sciences ,Animal health ,GMO ,2404 Microbiology ,Regulation (EC) No 1829/2003 ,food and beverages ,Genetically modified organism ,3401 Veterinary (miscellaneous) ,soybean (Glycine max) ,Veterinary (miscellaneous) ,TP1-1185 ,Biology ,SYHT0H2 ,Microbiology ,03 medical and health sciences ,Environmental safety ,Glufosinate-ammonium ,media_common.cataloged_instance ,European union ,1106 Food Science ,030304 developmental biology ,PAT Proteins ,business.industry ,Nutrition. Foods and food supply ,Chemical technology ,fungi ,10079 Institute of Veterinary Pharmacology and Toxicology ,Biotechnology ,Scientific Opinion ,chemistry ,Soybean (Glycine max) ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,1103 Animal Science and Zoology ,business ,PAT ,010606 plant biology & botany ,Food Science ,AvHPPD-03 ,PAT Requestor: Competent Authority of Germany Question number: EFSA-Q-2012-00753 - Abstract
© 2020 European Food Safety Authority., The scope of application EFSA‐GMO‐DE‐2012‐111 is for food and feed uses, import and processing of genetically modified (GM) soybean SYHT0H2 in the European Union. Soybean SYHT0H2 was developed to confer tolerance to the herbicidal active substances mesotrione and other p‐hydroxyphenylpyruvate dioxygenase (HPPD)‐inhibiting herbicides and glufosinate ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues except for sequence similarity of AvHPPD‐03 to bacterial haemolysins that was considered in food/feed safety assessment. The outcome of the comparative analysis (agronomic/phenotypic and compositional characteristics) did not need further assessment except for the changes in seed levels of α‐tocopherol and γ‐tocopherol that were assessed for food and feed relevance. The GMO Panel does not identify toxicological and allergenicity concerns for the AvHPPD‐03 and PAT proteins expressed in soybean SYHT0H2 and finds no evidence that the genetic modification would change the overall allergenicity of soybean SYHT0H2. The nutritional impact of food/feed from soybean SYHT0H2 is expected to be the same as that of food/feed from the conventional counterpart and commercial non‐GM soybean reference varieties. The GMO Panel concludes that soybean SYHT0H2 is as safe as and nutritionally equivalent to the conventional counterpart and the tested non‐GM soybean reference varieties, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean SYHT0H2 grains into the environment, soybean SYHT0H2 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean SYHT0H2. In conclusion, the GMO Panel considers that soybean SYHT0H2, as described in this application, is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.
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- 2020
12. Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, De Sanctis, G, Devos, Y, Dumont, AF, Gennaro, A, Gómez Ruiz, JÁ, Lanzoni, A, Neri, FM, Papadopoulou, N, Paraskevopoulos, K, and Raffaello, T
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fungi ,food and beverages - Abstract
Soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 (four‐event stack soybean) was produced by conventional crossing to combine four single events: MON 87751, MON 87701, MON 87708 and MON 89788. The GMO Panel previously assessed the four single events and did not identify safety concerns. No new data on the single events have been identified that would 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 and allergenicity assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the four‐event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack soybean, as described in this application, is as safe as and nutritionally equivalent to the non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable seeds of the four‐event stack soybean 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 the four‐event stack soybean. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack soybean is as safe as the non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.
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- 2019
13. Assessment of genetically modified maize MIR604 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐013)
- Author
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Veromann, E, Savoini, G, Veronesi, F, Álvarez, F, Ardizzone, M, Raffaello, T, and University of Zurich
- Subjects
0106 biological sciences ,Veterinary (miscellaneous) ,Renewal ,2405 Parasitology ,TP1-1185 ,Plant Science ,010501 environmental sciences ,01 natural sciences ,Microbiology ,1110 Plant Science ,TX341-641 ,1106 Food Science ,0105 earth and related environmental sciences ,2. Zero hunger ,Nutrition. Foods and food supply ,Chemical technology ,2404 Microbiology ,fungi ,Regulation (EC) No 1829/2003 ,MIR604 ,10079 Institute of Veterinary Pharmacology and Toxicology ,Maize ,3401 Veterinary (miscellaneous) ,Scientific Opinion ,570 Life sciences ,biology ,Articles 11 and 23 ,Animal Science and Zoology ,Parasitology ,1103 Animal Science and Zoology ,010606 plant biology & botany ,Food Science - Abstract
Following the submission of application EFSA‐GMO‐RX‐013 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the EFSA Panel on Genetically Modified Organisms (GMO) 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 genetically modified maize MIR604, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MIR604 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐013 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR604.
- Published
- 2019
14. Assessment of genetically modified maize MON 89034 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐015)
- Author
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, and Raffaello, T
- Subjects
fungi - Abstract
Following the submission of application EFSA‐GMO‐RX‐015 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA, the EFSA Panel on Genetically Modified Organisms (GMO Panel) 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 genetically modified maize MON 89034, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 89034 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐015 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034.
- Published
- 2019
15. Assessment of genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐144)
- Author
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, De Sanctis, G, Fernandez Dumont, A, Gennaro, A, Gómez Ruiz, JÁ, Lanzoni, A, Neri, FM, Papadopoulou, N, and Paraskevopoulos, K
- Abstract
Maize MON 87427 × MON 89034 × MIR162 × MON 87411 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and MON 87411. The genetically modified organism (GMO) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA 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, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.
- Published
- 2019
16. Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐UK‐2006‐34) for authorisation of food and feed containing, consisting of and produced from genetically modified maize 3272
- Author
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Sánchez Serrano, JJ, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, Lanzoni, A, Gómez Ruiz, JÁ, De Sanctis, G, Fernández Dumont, A, Gennaro, A, Neri, FM, and University of Zurich
- Subjects
040301 veterinary sciences ,Veterinary (miscellaneous) ,2405 Parasitology ,TP1-1185 ,Plant Science ,Genetically modified crops ,010501 environmental sciences ,Biology ,01 natural sciences ,Microbiology ,0403 veterinary science ,Fodder ,1110 Plant Science ,TX341-641 ,European commission ,maize (Zea mays) ,1106 Food Science ,0105 earth and related environmental sciences ,2. Zero hunger ,Genetically modified maize ,Nutrition. Foods and food supply ,GMO ,business.industry ,Chemical technology ,2404 Microbiology ,Authorization ,10079 Institute of Veterinary Pharmacology and Toxicology ,04 agricultural and veterinary sciences ,Food safety ,food and feed safety ,Genetically modified organism ,Biotechnology ,3401 Veterinary (miscellaneous) ,Scientific Opinion ,thermotolerant alpha‐amylase ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,1103 Animal Science and Zoology ,business ,Food Science - Abstract
Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified (GM) maize 3272 (EFSA‐GMO‐UK‐2006‐34). The applicant conducted new agronomic, phenotypic and compositional analysis studies on maize 3272 and assessed the allergenic potential of AMY797E protein, addressing elements that remained inconclusive from previous EFSA opinion issued in 2013. The GMO Panel is of the opinion that the agronomic and phenotypic characteristics as well as forage and grain composition of maize 3272 do not give rise to food and feed safety, and nutritional concerns when compared to non‐GM maize. Considering the scope of this application and the characteristics of the trait introduced in this GM maize, the effect of processing and potential safety implications of specific food or feed products remain to be further investigated. Regarding the allergenic potential of AMY797E protein and considering all possible food and feed uses of maize 3272, the Panel concludes that the information provided does not fully address the concerns previously raised by the Panel in 2013. Owing to the nature and the knowledge available on this protein family, it is still unclear whether under specific circumstances the alpha‐amylase AMY797E has the capacity to sensitise certain individuals and to cause adverse effects. To further support the safety of specific products of maize 3272, the applicant provided thorough information relevant for the allergenicity assessment of dried distiller grains with solubles (DDGS), which is the main product of interest for importation into the EU. Having considered the information provided on this product, the Panel is of the opinion that under the specific conditions of use described by the applicant, DDGS produced from maize 3272 does not raise concerns when compared to DDGS from non‐GM maize.
- Published
- 2019
17. Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J-L, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Serrano, JJS, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, Papadopoulou, N, Paraskevopoulos, K, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, UAR 1171 Soutien aux Projets Européens, Institut National de la Recherche Agronomique (INRA), and University of Zurich
- Subjects
oilseed rape ,040301 veterinary sciences ,[SDV]Life Sciences [q-bio] ,Veterinary (miscellaneous) ,Renewal ,2405 Parasitology ,T45 ,TP1-1185 ,Plant Science ,010501 environmental sciences ,01 natural sciences ,Microbiology ,0403 veterinary science ,1110 Plant Science ,articles 11 and 23 ,TX341-641 ,1106 Food Science ,0105 earth and related environmental sciences ,2. Zero hunger ,renewal ,Nutrition. Foods and food supply ,Chemical technology ,2404 Microbiology ,Regulation (EC) No 1829/2003 ,10079 Institute of Veterinary Pharmacology and Toxicology ,04 agricultural and veterinary sciences ,3401 Veterinary (miscellaneous) ,Scientific Opinion ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,1103 Animal Science and Zoology ,Oilseed rape ,Food Science - Abstract
Following the submission of application EFSA-GMO-RX-012 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified oilseed rape T45, 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 sequence of the event in oilseed rape T45 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-012 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape T45.
- Published
- 2019
18. Assessment of genetically modified maize MON89034x1507xNK603xDAS-40278-9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No1829-2003 (application EFSA-GMO-NL-2013-112)
- Author
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EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel), Naegeli, H, Bresson, J-L, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Serrano, JJS, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, Dumont, AF, Gennaro, A, Ruiz, JAG, Lanzoni, A, Neri, FM, Papadopoulou, N, and Ramon, M
- Abstract
Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates that the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize does not give rise to food/feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations for which no experimental data were provided, and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. No post‐market monitoring for food/feed is necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.
- Published
- 2019
19. Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)
- Author
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J-L, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Serrano, JJS, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, and Paraskevopoulos, K
- Subjects
fungi - Abstract
Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, 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 sequence of the event in soybean MON 89788 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐011 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 89788.
- Published
- 2018
20. Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)
- Author
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EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel), Naegeli, H, Bresson, J-L, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Serrano, JJS, Savoini, G, Veromann, E, Veronesi, F, Álvarez, F, Ardizzone, M, Paraskevopoulos, K, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, UAR 1171 Soutien aux Projets Européens, Institut National de la Recherche Agronomique (INRA), and University of Zurich
- Subjects
0106 biological sciences ,Veterinary (miscellaneous) ,[SDV]Life Sciences [q-bio] ,2405 Parasitology ,Renewal ,TP1-1185 ,Plant Science ,Cotton ,010501 environmental sciences ,01 natural sciences ,Microbiology ,LLCotton25 ,1110 Plant Science ,TX341-641 ,1106 Food Science ,0105 earth and related environmental sciences ,renewal ,Nutrition. Foods and food supply ,Gmo ,Chemical technology ,2404 Microbiology ,Regulation (EC) No 1829/2003 ,10079 Institute of Veterinary Pharmacology and Toxicology ,3401 Veterinary (miscellaneous) ,Scientific Opinion ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,Articles 11 and 23 ,1103 Animal Science and Zoology ,010606 plant biology & botany ,Food Science - Abstract
Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. 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. In addition, the applicant provided sequence data on the LLCotton25 event using the material from a commercial variety that, according to the applicant, may be imported into the EU at the time of this renewal application. 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. The GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐010 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on LLCotton25.
- Published
- 2018
21. Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-133)
- Author
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EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J-L, Dalmay, T, Dewhurst, IC, Epstein, MM, Firbank, LG, Guerche, P, Hejatko, J, Moreno, FJ, Mullins, E, Nogué, F, Rostoks, N, Serrano, JJS, Savoini, G, Veromann, E, Veronesi, F, Devos, Y, Ardizzone, M, Neri, FM, Papadopoulou, N, De Sanctis, G, Dumont, AF, Gennaro, A, Ruiz, JAG, Paraskevopoulos, K, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, UAR 1171 Soutien aux Projets Européens, and Institut National de la Recherche Agronomique (INRA)
- Subjects
0106 biological sciences ,herbicide tolerance ,[SDV]Life Sciences [q-bio] ,Veterinary (miscellaneous) ,TP1-1185 ,Plant Science ,010501 environmental sciences ,01 natural sciences ,Microbiology ,Herbicide tolerance ,[SDV.IDA]Life Sciences [q-bio]/Food engineering ,[SDV.BV]Life Sciences [q-bio]/Vegetal Biology ,TX341-641 ,[SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering ,maize (Zea mays) ,0105 earth and related environmental sciences ,2. Zero hunger ,Maize (Zea mays) ,Nutrition. Foods and food supply ,GMO ,Chemical technology ,MZHG0JG ,Regulation (EC) No 1829/2003 ,Scientific Opinion ,Animal Science and Zoology ,Parasitology ,010606 plant biology & botany ,Food Science - Abstract
The scope of application EFSA-GMO-DE-2016-133 is for food and feed uses, import and processing ofgenetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed toconfer tolerance to the herbicidal active substances glyphosate and glufosinate-ammonium. Themolecular characterisation data and bioinformatic analyses do not identify issues requiring food/feedsafety assessment. None of the identified differences in the agronomic/phenotypic and compositionalcharacteristics tested between maize MZHG0JG and its conventional counterpart needs furtherassessment, except for early stand count (pre-thinning). The GMO Panel does not identify safetyconcerns regarding the toxicity and allergenicity of the mEPSPS and PAT proteins as expressed inmaize MZHG0JG, andfinds no evidence that the genetic modification would change the overallallergenicity of maize MZHG0JG. The nutritional impact of food/feed derived from maize MZHG0JG isexpected to be the same as that of food/feed derived from the conventional counterpart andcommercial non-GM maize reference varieties. The GMO Panel concludes that maize MZHG0JG isnutritionally equivalent to and as safe as the conventional counterpart and non-GM maize referencevarieties tested, and no post-market monitoring of food/feed is considered necessary. In the case ofaccidental release of viable maize MZHG0JG grains into the environment, maize MZHG0JG would notraise environmental safety concerns. The post-market environmental monitoring plan and reportingintervals are in line with the intended uses of maize MZHG0JG. In conclusion, the GMO Panel considersthat maize MZHG0JG, as described in this application, is as safe as its conventional counterpart andthe tested non-GM maize reference varieties with respect to potential effects on human and animalhealth and the environment.
- Published
- 2018
22. LysF1 sh3b domain structure
- Author
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Benesik, M., primary, Novacek, J., additional, Janda, L., additional, Dopitova, R., additional, Pernisova, M., additional, Melkova, K., additional, Tisakova, L., additional, Doskar, J., additional, Zidek, L., additional, Hejatko, J., additional, and Pantucek, R., additional
- Published
- 2017
- Full Text
- View/download PDF
23. Crystal structure of the receiver domain of the histidine kinase CKI1 from Arabidopsis thaliana complexed with Mg2+ and BeF3-
- Author
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Otrusinova, O., primary, Demo, G., additional, Padrta, P., additional, Jasenakova, Z., additional, Pekarova, B., additional, Gelova, Z., additional, Szmitkowska, A., additional, Kaderavek, P., additional, Jansen, S., additional, Zachrdla, M., additional, Klumpler, T., additional, Marek, J., additional, Hritz, J., additional, Janda, L., additional, Iwai, H., additional, Wimmerova, M., additional, Hejatko, J., additional, and Zidek, L., additional
- Published
- 2017
- Full Text
- View/download PDF
24. Crystal structure of D1050A mutant of the receiver domain of the histidine kinase CKI1 from Arabidopsis thaliana
- Author
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Otrusinova, O., primary, Demo, G., additional, Kaderavek, P., additional, Jansen, S., additional, Jasenakova, Z., additional, Pekarova, B., additional, Janda, L., additional, Wimmerova, M., additional, Hejatko, J., additional, and Zidek, L., additional
- Published
- 2017
- Full Text
- View/download PDF
25. Crystal Structure of Histidine-containing Phosphotransfer Protein AHP2 from Arabidopsis thaliana
- Author
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Degtjarik, O., primary, Dopitova, R., additional, Puehringer, S., additional, Weiss, M.S., additional, Janda, L., additional, Hejatko, J., additional, and Kuta-Smatanova, I., additional
- Published
- 2015
- Full Text
- View/download PDF
26. Apical-basal polarity: why plant cells don't stand on their heads
- Author
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Friml, J., Benfey, P.N., Benkova, E., Bennett, M., Berleth, T., Geldner, N., Grebe, M., Heisler, M., Hejatko, J., Jurgens, G., Laux, T., Lindsey, K., Lukowitz, W., Luschnig, C., Offringa, R., Scheres, B.J.G., Swarup, R., Torres-Ruiz, R., Weijers, D., Zazimalova, E., Pattern and polarity in Arabidopsis root development, and Dep Biologie
- Subjects
International (English) ,Life sciences - Published
- 2006
27. Crystal structure of the receiver domain of the histidine kinase CKI1 from Arabidopsis thaliana complexed with Mg2+
- Author
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Marek, J., primary, Klumpler, T., additional, Pekarova, B., additional, Triskova, O., additional, Horak, J., additional, Zidek, L., additional, Dopitova, R., additional, Hejatko, J., additional, and Janda, L., additional
- Published
- 2011
- Full Text
- View/download PDF
28. Crystal structure of the receiver domain of the histidine kinase CKI1 from Arabidopsis thaliana
- Author
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Marek, J., primary, Klumpler, T., additional, Pekarova, B., additional, Triskova, O., additional, Horak, J., additional, Zidek, L., additional, Dopitova, R., additional, Hejatko, J., additional, and Janda, L., additional
- Published
- 2011
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29. Structure of CKI1RD, the receiver domain of the histidine kinase CKI1 fromArabidopsis thaliana
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Marek, J., primary, Klumpler, T., additional, Pekarova, B., additional, Borkovcova, P., additional, Hejatko, J., additional, and Janda, L., additional
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- 2008
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30. Effects of Conditional IPT-Dependent Cytokinin Overproduction on Root Architecture of Arabidopsis Seedlings
- Author
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Kuderova, A., primary, Urbankova, I., additional, Valkova, M., additional, Malbeck, J., additional, Brzobohaty, B., additional, Nemethova, D., additional, and Hejatko, J., additional
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- 2008
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31. Cloning, purification, crystallization and preliminary X-ray analysis of the receiver domain of the histidine kinase CKI1 from Arabidopsis thaliana
- Author
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Klumpler, T., Pekarova, B., Marek, J., Borkovcova, P., Janda, L., and Hejatko, J.
- Subjects
3. Good health - Abstract
Acta crystallographica / F 65, 478-481 (2009). doi:10.1107/S1744309109012032, Published by Blackwell, Oxford [u.a.]
32. Epigenetics and plant hormone dynamics: a functional and methodological perspective.
- Author
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Rudolf J, Tomovicova L, Panzarova K, Fajkus J, Hejatko J, and Skalak J
- Subjects
- Plant Development genetics, Gene Expression Regulation, Plant, Plants genetics, Plants metabolism, Plant Growth Regulators metabolism, Epigenesis, Genetic
- Abstract
Plant hormones, pivotal regulators of plant growth, development, and response to environmental cues, have recently emerged as central modulators of epigenetic processes governing gene expression and phenotypic plasticity. This review addresses the complex interplay between plant hormones and epigenetic mechanisms, highlighting the diverse methodologies that have been harnessed to decipher these intricate relationships. We present a comprehensive overview to understand how phytohormones orchestrate epigenetic modifications, shaping plant adaptation and survival strategies. Conversely, we explore how epigenetic regulators ensure hormonal balance and regulate the signalling pathways of key plant hormones. Furthermore, our investigation includes a search for novel genes that are regulated by plant hormones under the control of epigenetic processes. Our review offers a contemporary overview of the epigenetic-plant hormone crosstalk, emphasizing its significance in plant growth, development, and potential agronomical applications., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Experimental Biology.)
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- 2024
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33. Primary multistep phosphorelay activation comprises both cytokinin and abiotic stress responses: Insights from comparative analysis of Brassica type-A response regulators.
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Mala KLN, Skalak J, Zemlyanskaya E, Dolgikh V, Jedlickova V, Robert HS, Havlicková L, Panzarova K, Trtilek M, Bancroft I, and Hejatko J
- Abstract
Multistep phosphorelay (MSP) signaling integrates hormonal and environmental signals to control both plant development and adaptive responses. The type-A RESPONSE REGULATORs (RRAs), the downstream members of the MSP cascade and cytokinin primary response genes are supposed to mediate primarily the negative feedback regulation of (cytokinin-induced) MSP signaling. However, the transcriptional data suggest the involvement of RRAs in stress-related responses as well. By employing evolutionary conservation with the well-characterized Arabidopsis thaliana RRAs, we identified 5 and 38 novel putative RRAs in Brassica oleracea and Brassica napus, respectively. Our phylogenetic analysis suggests the existence of gene-specific selective pressure, maintaining the homologs of ARR3, ARR6, and ARR16 as singletons during the evolution of Brassicaceae. We categorized RRAs based on the kinetics of their cytokinin-mediated upregulation and observed both similarities and specificities in this type of response across Brassicaceae species. Using bioinformatic analysis and experimental data demonstrating the cytokinin and abiotic stress responsiveness of A. thaliana-derived TCSv2 reporter, we unveil the mechanistic conservation of cytokinin- and stress-mediated upregulation of RRAs in Brassica rapa and Brassica napus. Notably, we identify partial cytokinin dependency of cold stress-induced RRA transcription, thus corroborating the role of cytokinin signaling in the crop adaptive responses., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Experimental Biology.)
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- 2024
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34. Assessment of genetically modified maize DP910521 (application GMFF-2021-2473).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Naegeli H, Moreno FJ, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Dumont AF, Gennaro A, Gómez Ruiz JÁ, Grammatikou P, Goumperis T, Lenzi P, Lewandowska A, Camargo AM, Neri FM, Piffanelli P, Raffaello T, and Xiftou K
- Abstract
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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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35. Assessment of genetically modified maize MON 95275 (application GMFF-2022-5890).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Naegeli H, Moreno FJ, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Silvia F, Dumont AF, Gennaro A, Gómez Ruiz JÁ, Grammatikou P, Goumperis T, Kagkli DM, Lenzi P, Lewandowska A, Camargo AM, Neri FM, Piffanelli P, Raffaello T, and Xiftou K
- Abstract
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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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36. New developments in biotechnology applied to microorganisms.
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Mullins E, Bresson JL, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Cocconcelli PS, Glandorf D, Herman L, Jimenez Saiz R, Ruiz Garcia L, Aguilera Entrena J, Gennaro A, Schoonjans R, Kagkli DM, and Dalmay T
- Abstract
EFSA was requested by the European Commission (in accordance with Article 29 of Regulation (EC) No 178/2002) to provide a scientific opinion on the application of new developments in biotechnology (new genomic techniques, NGTs) to viable microorganisms and products of category 4 to be released into the environment or placed on the market as or in food and feed, and to non-viable products of category 3 to be placed on the market as or in food and feed. A horizon scanning exercise identified a variety of products containing microorganisms obtained with NGTs (NGT-Ms), falling within the remit of EFSA, that are expected to be placed on the (EU) market in the next 10 years. No novel potential hazards/risks from NGT-Ms were identified as compared to those obtained by established genomic techniques (EGTs), or by conventional mutagenesis. Due to the higher efficiency, specificity and predictability of NGTs, the hazards related to the changes in the genome are likely to be less frequent in NGT-Ms than those modified by EGTs and conventional mutagenesis. It is concluded that EFSA guidances are 'partially applicable', therefore on a case-by-case basis for specific NGT-Ms, fewer requirements may be needed. Some of the EFSA guidances are 'not sufficient' and updates are recommended. Because possible hazards relate to genotypic and phenotypic changes introduced and not to the method used for the modification, it is recommended that any new guidance should take a consistent risk assessment approach for strains/products derived from or produced with microorganisms obtained with conventional mutagenesis, EGTs or NGTs., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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37. Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sanchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Afonso A, Lenzi P, Papadopoulou N, and Raffaello T
- Abstract
EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation 'on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625'. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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38. Cytokinins regulate spatially specific ethylene production to control root growth in Arabidopsis.
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Yamoune A, Zdarska M, Depaepe T, Rudolfova A, Skalak J, Berendzen KW, Mira-Rodado V, Fitz M, Pekarova B, Nicolas Mala KL, Tarr P, Spackova E, Tomovicova L, Parizkova B, Franczyk A, Kovacova I, Dolgikh V, Zemlyanskaya E, Pernisova M, Novak O, Meyerowitz E, Harter K, Van Der Straeten D, and Hejatko J
- Abstract
Two principal growth regulators, cytokinins and ethylene, are known to interact in the regulation of plant growth. However, information about the underlying molecular mechanism and positional specificity of cytokinin/ethylene crosstalk in the control of root growth is scarce. We have identified the spatial specificity of cytokinin-regulated root elongation and root apical meristem (RAM) size, both of which we demonstrate to be dependent on ethylene biosynthesis. Upregulation of the cytokinin biosynthetic gene ISOPENTENYLTRANSFERASE (IPT) in proximal and peripheral tissues leads to both root and RAM shortening. By contrast, IPT activation in distal and inner tissues reduces RAM size while leaving the root length comparable to that of mock-treated controls. We show that cytokinins regulate two steps specific to ethylene biosynthesis: production of the ethylene precursor 1-aminocyclopropane-1-carboxylate (ACC) by ACC SYNTHASEs (ACSs) and its conversion to ethylene by ACC OXIDASEs (ACOs). We describe cytokinin- and ethylene-specific regulation controlling the activity of ACSs and ACOs that are spatially discrete along both proximo/distal and radial root axes. Using direct ethylene measurements, we identify ACO2, ACO3, and ACO4 as being responsible for ethylene biosynthesis and ethylene-regulated root and RAM shortening in cytokinin-treated Arabidopsis. Direct interaction between ARABIDOPSIS RESPONSE REGULATOR 2 (ARR2), a member of the multistep phosphorelay cascade, and the C-terminal portion of ETHYLENE INSENSITIVE 2 (EIN2-C), a key regulator of canonical ethylene signaling, is involved in the cytokinin-induced, ethylene-mediated control of ACO4. We propose tight cooperation between cytokinin and ethylene signaling in the spatially specific regulation of ethylene biosynthesis as a key aspect of the hormonal control of root growth., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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39. 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).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Camargo AM, Goumperis T, Lenzi P, Piffanelli P, and Raffaello T
- Abstract
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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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40. Assessment of genetically modified maize MON 89034 × 1507 × NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (application GMFF-2022-3670).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Camargo AM, Goumperis T, Lenzi P, Piffanelli P, and Raffaello T
- Abstract
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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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41. Assessment of genetically modified maize MON 94804 (application GMFF-2022-10651).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Gennaro A, Gómez Ruiz JÁ, Grammatikou P, Goumperis T, Jacchia S, Lenzi P, Lewandowska A, Camargo AM, Neri FM, Piffanelli P, Raffaello T, and Xiftou K
- Abstract
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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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42. Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-159).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, Camargo AM, De Sanctis G, Federici S, Fernandez A, Gennaro A, Gómez Ruiz JÁ, Goumperis T, Grammatikou P, Kagkli DM, Lenzi P, Neri FM, Papadopoulou N, and Raffaello T
- Abstract
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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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43. Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2022-9450).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, M Camargo A, Goumperis T, Lenzi P, Piffanelli P, and Raffaello T
- Abstract
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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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44. Hormone-regulated expansins: Expression, localization, and cell wall biomechanics in Arabidopsis root growth.
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Samalova M, Melnikava A, Elsayad K, Peaucelle A, Gahurova E, Gumulec J, Spyroglou I, Zemlyanskaya EV, Ubogoeva EV, Balkova D, Demko M, Blavet N, Alexiou P, Benes V, Mouille G, and Hejatko J
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- Biomechanical Phenomena, Meristem metabolism, Hormones metabolism, Cell Wall metabolism, Plant Roots metabolism, Gene Expression Regulation, Plant, Arabidopsis metabolism, Arabidopsis Proteins genetics, Arabidopsis Proteins metabolism
- Abstract
Expansins facilitate cell expansion by mediating pH-dependent cell wall (CW) loosening. However, the role of expansins in controlling CW biomechanical properties in specific tissues and organs remains elusive. We monitored hormonal responsiveness and spatial specificity of expression and localization of expansins predicted to be the direct targets of cytokinin signaling in Arabidopsis (Arabidopsis thaliana). We found EXPANSIN1 (EXPA1) homogenously distributed throughout the CW of columella/lateral root cap, while EXPA10 and EXPA14 localized predominantly at 3-cell boundaries in the epidermis/cortex in various root zones. EXPA15 revealed cell-type-specific combination of homogenous vs. 3-cell boundaries localization. By comparing Brillouin frequency shift and AFM-measured Young's modulus, we demonstrated Brillouin light scattering (BLS) as a tool suitable for non-invasive in vivo quantitative assessment of CW viscoelasticity. Using both BLS and AFM, we showed that EXPA1 overexpression upregulated CW stiffness in the root transition zone (TZ). The dexamethasone-controlled EXPA1 overexpression induced fast changes in the transcription of numerous CW-associated genes, including several EXPAs and XYLOGLUCAN:XYLOGLUCOSYL TRANSFERASEs (XTHs), and associated with rapid pectin methylesterification determined by in situ Fourier-transform infrared spectroscopy in the root TZ. The EXPA1-induced CW remodeling is associated with the shortening of the root apical meristem, leading to root growth arrest. Based on our results, we propose that expansins control root growth by a delicate orchestration of CW biomechanical properties, possibly regulating both CW loosening and CW remodeling., Competing Interests: Conflict of interest statement. None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of American Society of Plant Biologists.)
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- 2023
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45. Assessment of genetically modified cotton COT102 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2017-141).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Naegeli H, Moreno FJ, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Fernández A, Gennaro A, Gómez Ruiz JÁ, Goumperis T, Kagli DM, Lenzi P, Lewandowska A, Camargo AM, Neri FM, Papadopoulou N, and Raffaello T
- Abstract
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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
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46. Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2018-149).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Federici S, Fernandez A, Gennaro A, Gómez Ruiz JÁ, Goumperis T, Kagkli DM, Lenzi P, Camargo AM, Neri FM, and Raffaello T
- Abstract
Genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 was developed by crossing to combine six single events: Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the GMO Panel previously assessed the 6 single maize events and 27 out of the 56 possible 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 six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that six-event stack maize, as described in this application, 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 six-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 29 of the maize subcombinations not previously assessed and covered by the scope of this application 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 maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21. The GMO Panel concludes that six-event stack maize and the 30 subcombinations covered by the scope of the application are 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
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47. 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).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, Camargo AM, Fernandez A, Goumperis T, Lenzi P, Lewandowska A, Raffaello T, and Streissl F
- Abstract
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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
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48. iReenCAM: automated imaging system for kinetic analysis of photosynthetic pigment biosynthesis at high spatiotemporal resolution during early deetiolation.
- Author
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Balakhonova V, Dobisova T, Benedikty Z, Panzarova K, Pytela J, Koci R, Spyroglou I, Kovacova I, Arnaud D, Skalak J, Trtilek M, and Hejatko J
- Abstract
Seedling de-etiolation is one of the key stages of the plant life cycle, characterized by a strong rearrangement of the plant development and metabolism. The conversion of dark accumulated protochlorophyllide to chlorophyll in etioplasts of de-etiolating plants is taking place in order of ns to µs after seedlings illumination, leading to detectable increase of chlorophyll levels in order of minutes after de-etiolation initiation. The highly complex chlorophyll biosynthesis integrates number of regulatory events including light and hormonal signaling, thus making de-etiolation an ideal model to study the underlying molecular mechanisms. Here we introduce the iReenCAM, a novel tool designed for non-invasive fluorescence-based quantitation of early stages of chlorophyll biosynthesis during de-etiolation with high spatial and temporal resolution. iReenCAM comprises customized HW configuration and optimized SW packages, allowing synchronized automated measurement and analysis of the acquired fluorescence image data. Using the system and carefully optimized protocol, we show tight correlation between the iReenCAM monitored fluorescence and HPLC measured chlorophyll accumulation during first 4h of seedling de-etiolation in wild type Arabidopsis and mutants with disturbed chlorophyll biosynthesis. Using the approach, we demonstrate negative effect of exogenously applied cytokinins and ethylene on chlorophyll biosynthesis during early de-etiolation. Accordingly, we identify type-B response regulators, the cytokinin-responsive transcriptional activators ARR1 and ARR12 as negative regulators of early chlorophyll biosynthesis, while contrasting response was observed in case of EIN2 and EIN3, the components of canonical ethylene signaling cascade. Knowing that, we propose the use of iReenCAM as a new phenotyping tool, suitable for quantitative and robust characterization of the highly dynamic response of seedling de-etiolation., Competing Interests: Authors ZB, KP, JP, RK and MT were employed by company Photon Systems Instruments. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Balakhonova, Dobisova, Benedikty, Panzarova, Pytela, Koci, Spyroglou, Kovacova, Arnaud, Skalak, Trtilek and Hejatko.)
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- 2023
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49. Risk assessment of additional information on maize MIR162.
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Gennaro A, Neri FM, and Papadopoulou N
- Abstract
The European Commission requested the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to assess new scientific information on maize MIR162, and to indicate whether the previous conclusions on the safety of maize MIR162 as a single event and as a part of stacked events remain valid. The new information is included in a European patent that reports a decrease in male fertility in some MIR162 inbred lines, pointing to a potential link between such decrease and the Vip3 protein expressed by maize MIR162. The EFSA GMO Panel evaluated the data provided by the patent owner and found scarce support for a causal link between Vip3 and decreased fertility. The general hypothesis of an association between event MIR162 and altered fertility could not be confirmed. The EFSA GMO Panel conducted the safety assessment based on the conservative assumption that such an association exists. The EFSA GMO Panel concluded that a decrease in male fertility would have no impact on the previous conclusions on maize MIR162 and stacked events containing MIR162., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
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50. Assessment of genetically modified maize GA21 × T25 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-137).
- Author
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Serrano JJS, Savoini G, Veromann E, Veronesi F, Álvarez F, Ardizzone M, De Sanctis G, Devos Y, Federici S, Fernandez Dumont A, Gennaro A, Gómez Ruiz JÁ, Goumperis T, Kagkli DM, Lanzoni A, Lenzi P, Camargo AM, Neri FM, Papadopoulou N, Paraskevopoulos K, Raffaello T, and Streissl F
- Abstract
Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panel previously 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 Panel concludes 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 Panel concludes 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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)
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- 2023
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