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3. Humoral and cellular immune response in Wistar Han RCC rats fed two genetically modified maize MON810 varieties for 90 days (EU 7th Framework Programme project GRACE)

Author

Tulinská, Jana, Adel-Patient, Karine, Bernard, Hervé, Líšková, Aurélia, Kuricová, Miroslava, Ilavská, Silvia, Horváthová, Mira, Kebis, Anton, Rollerová, Eva, Babincová, Júlia, Aláčová, Radka, Wal, Jean-Michel, Schmidt, Kerstin, Schmidtke, Jörg, Schmidt, Paul, Kohl, Christian, Wilhelm, Ralf, Schiemann, Joachim, and Steinberg, Pablo

Published
2018
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5. Modifying the infantʼs diet to prevent food allergy

Author

Grimshaw, Kate, Logan, Kirsty, OʼDonovan, Sinead, Kiely, Mairead, Patient, Karine, van Bilsen, Jolanda, Beyer, Kirsten, Campbell, Dianne E, Garcia-Larsen, Vanessa, Grabenhenrich, Linus, Lack, Gideon, Mills, Clare, Wal, Jean-Michel, and Roberts, Graham

Published
2017
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7. Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)

Author

Zeljenková, Dagmar, Ambrušová, Katarína, Bartušová, Mária, Kebis, Anton, Kovrižnych, Jevgenij, Krivošíková, Zora, Kuricová, Miroslava, Líšková, Aurélia, Rollerová, Eva, Spustová, Viera, Szabová, Elena, Tulinská, Jana, Wimmerová, Soňa, Levkut, Mikuláš, Révajová, Viera, Ševčíková, Zuzana, Schmidt, Kerstin, Schmidtke, Jörg, La Paz, Jose Luis, Corujo, Maria, Pla, Maria, Kleter, Gijs A., Kok, Esther J., Sharbati, Jutta, Hanisch, Carlos, Einspanier, Ralf, Adel-Patient, Karine, Wal, Jean-Michel, Spök, Armin, Pöting, Annette, Kohl, Christian, Wilhelm, Ralf, Schiemann, Joachim, and Steinberg, Pablo

Published
2014
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17. Boiling peanut Ara h 1 results in the formation of aggregates with reduced allergenicity

Author

Blanc, Fany, Vissers, Yvonne M., Adel-Patient, Karine, Rigby, Neil M., Mackie, Alan R., Gunning, Patrick A., Wellner, Nikolaus K., Skov, Per S., Przybylski-Nicaise, Laetitia, Ballmer-Weber, Barbara, Zuidmeer-Jongejan, Laurian, Szépfalusi, Zsolt, Ruinemans-Koerts, Janneke, Jansen, Ad P. H., Bernard, Hervé, Wal, Jean-Michel, Savelkoul, Huub F. J., Wichers, Harry J., and Mills, Clare E. N.

Published
2011
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19. Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Ardizzone, Michele, De Sanctis, Giacomo, Fernandez Dumont, Antonio, Ruiz Gómez, José Ángel, Lanzoni, Anna, Papadopoulou, Nikoletta, Paraskevopoulos, Konstantinos, Unité de Recherche Génomique Info (URGI), Institut National de la Recherche Agronomique (INRA), Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, Unité Impacts Ecologiques des Innovations en Production Végétale (ECO-INNOV), Biologie du fruit et pathologie (BFP), Université Bordeaux Segalen - Bordeaux 2-Institut National de la Recherche Agronomique (INRA)-Université Sciences et Technologies - Bordeaux 1 (UB), Service de Pharmacologie et Immunoanalyse (SPI), Médicaments et Technologies pour la Santé (MTS), Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Université Bordeaux Segalen - Bordeaux 2-Institut National de la Recherche Agronomique (INRA)-Université Sciences et Technologies - Bordeaux 1, Service de Pharmacologie et d'Immunoanalyse (SPI), Institut National de la Recherche Agronomique (INRA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay, Naegeli, Hanspeter, Birch, Andrew Nichola, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nil, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean-Michel, Álvarez, Fernando, Ardizzone, Michele, De Sanctis, Giacomo, Fernandez Dumont, Antonio, Ruiz Gómez, José Ángel, Lanzoni, Anna, Papadopoulou, Nikoletta, and Paraskevopoulos, Konstantinos

Subjects
0301 basic medicine, Veterinary (miscellaneous), [SDV]Life Sciences [q-bio], Plant Science, 010501 environmental sciences, 01 natural sciences, Microbiology, [SHS]Humanities and Social Sciences, 03 medical and health sciences, 1507 × NK603, [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, 0105 earth and related environmental sciences, 2. Zero hunger, renewal, Gmo, Regulation (EC) No 1829/2003, Maize, 030104 developmental biology, Scientific Opinion, [SDE]Environmental Sciences, 1507 x NK603, Parasitology, Animal Science and Zoology, Articles 11 and 23, Food Science
Abstract

International audience; Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 x NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 x NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 x NK603 (EFSA, 2006). (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Published
2018
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21. IgE-Mediated food allergy diagnosis: Current status and new perspectives

Author

Asero, Riccardo, Ballmer-Weber, Barbara K., Beyer, Kirsten, Conti, Amedeo, Dubakiene, Ruta, Fernandez-Rivas, Montserrat, Hoffmann-Sommergruber, Karin, Lidholm, Jonas, Mustakov, Tihomir, Elberink, Joanne N. G. Oude, Pumphrey, Richard S. H., Skov, Per Stahl, Ree, Ronald van, Boerstra, Berber J. Vlieg-, Hiller, Reinhard, Hourihane, Jonathan O., Kowalski, Marek, Papadopoulos, Nikos G., Wal, Jean-Michel, Mills, Clare E. N., and Vieths, Stefan

Published
2007
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24. Scientific Opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐michel, Gennaro, Andrea, Neri, Franco Maria, Paraskevopoulos, Konstantinos, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, Université Paris-Saclay, Naegeli, Hanspeter, Birch, Andrew Nichola, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nil, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Gennaro, Andrea, Neri, Franco Maria, and Paraskevopoulos, Konstantinos

Subjects
0106 biological sciences, Cry1A, herbicide tolerance, maïs, Veterinary (miscellaneous), gmo, [SDV]Life Sciences [q-bio], MON87427xMON89034xNK603, ogm, Plant Science, 010501 environmental sciences, maize, CP4EPSPS, 01 natural sciences, Microbiology, zea mays, MON 87427 × MON 89034 × NK603, Cry2Ab2, CP4 EPSPS, 0105 earth and related environmental sciences, 2. Zero hunger, Cry1A.105, indian corn, Regulation (EC) No 1829/2003, GMO, insect resistance, MON 87427 x MON 89034 x NK603, MON 87427 9 MON 89034 9 NK603, Scientific Opinion, Regulation (EC) No1829/2003, Animal Science and Zoology, Parasitology, 010606 plant biology & botany, Food Science
Abstract

Scientific opinionRequestor: Competent Authority of BelgiumQuestion number: EFSA-Q-2013-00765; In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 9 MON 89034 9 NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three-event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three-event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON 87427 9 MON 89034 9 NK603 into the environment, the three-event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the threeevent stack maize is as safe and as nutritious as the non-GM comparator and the tested non-GM reference varieties in the context of its scope. The GMO Panel considered that its previous conclusions on the two-event stack maize MON 89034 9 NK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034 9 NK603 and maize MON 87427 9 MON 89034 9 NK603. Since the post-market environmental monitoring plan for the three-event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

Published
2017
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25. Assessment of genetically modified sugar beet H7‐1 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐006)

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Fernandez‐Dumont, Antonio, Gennaro, Andrea, Ramon, Matthew, University of Zurich, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, Université Paris-Saclay, Naegeli, Hanspeter, Birch, Andrew Nichola, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nil, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Fernandez‐Dumont, Antonio, Gennaro, Andrea, and Ramon, Matthew

Subjects
040301 veterinary sciences, Veterinary (miscellaneous), gmo, [SDV]Life Sciences [q-bio], sugarbeet, ogm, Plant Science, 010501 environmental sciences, sugar beet, H7-1, renewal, articles 11 and 23, regulation (EC) No 1829/2003, CP4 EPSPS, 01 natural sciences, Microbiology, 0403 veterinary science, 0105 earth and related environmental sciences, fungi, 04 agricultural and veterinary sciences, 10079 Institute of Veterinary Pharmacology and Toxicology, betterave sucrière, H7‐1, Scientific Opinion, 570 Life sciences, biology, Animal Science and Zoology, Parasitology, Food Science
Abstract

Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor: European Commission (DG SANTE)Question number: EFSA-Q-2017-00026; Following the submission of application EFSA-GMO-RX-006 under Regulation (EC) No 1829/2003 fromKWS SAAT SE and Monsanto Company, the Panel on Genetically Modified Organisms of the EuropeanFood Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the datasubmitted in the context of the renewal of authorisation application for the herbicide-tolerantgenetically modified sugar beet H7-1. The data received in the context of this renewal applicationcontained a systematic search and evaluation of literature, updated bioinformatics analyses andadditional documents or studies performed by or on behalf of the applicant. The GMO Panel assessedthese data for possible new hazards, modified exposure or new scientific uncertainties identified duringthe authorisation period and not previously assessed in the context of the original application. Underthe assumption that the DNA sequence of the event in sugar beet H7-1 considered for renewal isidentical to the originally assessed event, the GMO Panel concludes that there is no evidence in thecontext of this renewal application for new hazards, modified exposure or scientific uncertainties thatwould change the conclusions of the original risk assessment on sugar beet H7-1.

Published
2017
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26. Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Ardizzone, Michele, Fernandez Dumont, Antonio, Gómez Ruiz, José Ángel, Papadopoulou, Nikoletta, Paraskevopoulos, Konstantinos, and University of Zurich

Subjects
3401 Veterinary (miscellaneous), 2404 Microbiology, 1110 Plant Science, 2405 Parasitology, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology, 1103 Animal Science and Zoology, 1106 Food Science
Published
2018
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27. Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, huw jones, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Cristoph, Visioli, Francesco, Wal, Jean-Michel, Broll, Hermann, Gennaro, Andrea, Neri, Franco Maria, Paraskevopoulos, Konstantinos, and University of Zurich

Subjects
3401 Veterinary (miscellaneous), 2404 Microbiology, 1110 Plant Science, 2405 Parasitology, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology, 1103 Animal Science and Zoology, 1106 Food Science
Published
2018

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

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Devos, Yann, Broll, Hermann, Ramon, Matthew, and University of Zurich

Subjects
3401 Veterinary (miscellaneous), 2404 Microbiology, 1110 Plant Science, 2405 Parasitology, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology, 1103 Animal Science and Zoology, 1106 Food Science
Published
2018

29. Effect of simulated gastro-duodenal digestion on the allergenic reactivity of beta-lactoglobulin

Author

Bossios Apostolos, Theodoropoulou Maria, Mondoulet Lucie, Rigby Neil M, Papadopoulos Nikolaos G, Bernard Hervé, Adel-Patient Karine, Wal Jean-Michel, Mills Clare EN, and Papageorgiou Photini

Subjects
in vitro digestion, cow's milk allergy, β-lactoglobulin, flow cytometry, Basophil activation, skin prick test, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background Cow's milk (CM) allergy affects about 2% of infants. The allergenicity of dietary proteins, including those from CM, has been related to their digestibility although the generality of the link and its causality remains to be demonstrated. In this study we use an in vitro digestion system, to investigate the digestibility of β-lactoglobulin (blg) during gastrointestinal transit and to assess the impact of this process on blg allergenic reactivity in CM allergic children. Methods Blg digesta were prepared using an in vitro digestion protocol simulating either gastric digestion alone or followed by duodenal digestion with or without phosphatidylcholine (PC). Biochemical analysis of blg digesta was performed by SDS-PAGE and their concentration was measured by a sandwich ELISA. Assessment of their allergenic reactivity was done in vitro by EAST inhibition, specific basophil activation (basotest) and lymphocyte proliferation (PCNA-flow cytometry) assays using sera and cells from patients allergic to blg and in vivo by skin prick testing (SPT) of these patients. Results Blg was only broken down to smaller peptides after gastro-duodenal digestion although a sizeable amount of intact protein still remained. Digestion did not modify the IgE binding capacity of blg except for gastro-duodenal digestion performed in the absence of PC. These results are consistent with the quantity of intact blg remaining in the digesta. Overall both gastric and gastroduodenal digestion enhanced activation of sensitized basophils and proliferation of sensitized lymphocytes by blg. However, there was a tendency towards reduction in mean diameter of SPT following digestion, the PC alone during phase 1 digestion causing a significant increase in mean diameter. Conclusions Digestion did not reduce the allergenic reactivity of blg to a clinically insignificant extent, PC inhibiting digestion and thereby protecting blg allergenic reactivity. SPT reactivity was reduced compared to blg immunoreactivity in in vitro tests.

Published
2011
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30. Efficient production and secretion of bovine β-lactoglobulin by Lactobacillus casei

Author

Wal Jean-Michel, Corthier Gérard, Azevedo Vasco, Pothelune Laetitia, Hazebrouck Stéphane, and Langella Philippe

Subjects
Microbiology, QR1-502
Abstract

Abstract Background Lactic acid bacteria (LAB) are attractive tools to deliver therapeutic molecules at the mucosal level. The model LAB Lactococcus lactis has been intensively used to produce and deliver such heterologous proteins. However, compared to recombinant lactococci, lactobacilli offer some advantages such as better survival in the digestive tract and immunomodulatory properties. Here, we compared different strategies to optimize the production of bovine β-lactoglobulin (BLG), a major cow's milk allergen, in the probiotic strain Lactobacillus casei BL23. Results Using a nisin-inducible plasmid system, we first showed that L. casei BL23 strain could efficiently secrete a reporter protein, the staphylococcal nuclease (Nuc), with the lactococcal signal peptide SPUsp45 fused to its N-terminus. The fusion of SPUsp45 failed to drive BLG secretion but led to a 10-fold increase of intracellular BLG production. Secretion was significantly improved when the synthetic propeptide LEISSTCDA (hereafter called LEISS) was added to the N-terminus of the mature moiety of BLG. Secretion rate of LEISS-BLG was 6-fold higher than that of BLG alone while intracellular production reached then about 1 mg/L of culture. The highest yield of secretion was obtained by using Nuc as carrier protein. Insertion of Nuc between LEISS and BLG resulted in a 20-fold increase in BLG secretion, up to 27 μg/L of culture. Furthermore, the lactococcal nisRK regulatory genes were integrated into the BL23 chromosome. The nisRK insertion allowed a decrease of BLG synthesis in uninduced cultures while BLG production increased by 50% after nisin induction. Moreover, modification of the induction protocol led to increase the proportion of soluble BLG to around 74% of the total BLG production. Conclusion BLG production and secretion in L. casei were significantly improved by fusions to a propeptide enhancer and a carrier protein. The resulting recombinant strains will be further tested for their ability to modulate the immune response against BLG via mucosal delivery in a cow's milk allergy model in mice.

Published
2007
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31. Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Ardizzone, Michele, Devos, Yann, Fernández‐Dumont, Antonio, and University of Zurich

Subjects
fungi, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

32. Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Devos, Yann, Lanzoni, Anna, Olaru, Irina, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

33. Scientific opinion on an application by Monsanto (EFSA‐GMO‐NL‐2013‐114) for the placing on the market of a herbicide‐tolerant genetically modified cotton MON 88701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Poeting, Annette, Álvarez, Fernando, Broll, Hermann, Ramon, Matthew, and University of Zurich

Subjects
fungi, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

34. Risk assessment of information on the subcombination Bt11 × MIR162, related to the application of Syngenta (EFSA‐GMO‐DE‐2009‐66) for authorisation of food and feed containing, consisting and produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikolaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Paraskevopoulos, Konstantinos, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

35. Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Ardizzone, Michele, Liu, Yi, Neri, Franco Maria, Ramon, Matthew, EFSA Panel on Genetically Modified Organisms, GMO, and University of Zurich

Subjects
fungi, food and beverages, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

36. Scientific Opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2011‐91) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐68416‐4 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Ardizzone, Michele, Devos, Yann, Gomes, Ana, Liu, Yi, Neri, Franco Maria, Olaru, Irina, and University of Zurich

Subjects
fungi, food and beverages, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

37. Scientific opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Lanzoni, Anna, Paraskevopoulos, Konstantinos, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017
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38. Outcome of the European Member States and Public consultations on the draft guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC)

Author

Birch, Andrew Nicholas, Casacuberta, Josep, Schrijver, Adinda De, Gralak, Mikolaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messean, Antoine, Naegeli, Hanspeter, Ebbesen Nielsen, Elsa, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean-Michel, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, Luminy Génétique et Biophysique des Plantes (LGBP), Institut de Biosciences et Biotechnologies d'Aix-Marseille (ex-IBEB) (BIAM), Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), and Università degli Studi di Milano [Milano] (UNIMI)

Subjects
[SDV.BIO]Life Sciences [q-bio]/Biotechnology, GMO, [SDV]Life Sciences [q-bio], EU Member States, public consultation, low level, guidance
Abstract

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

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2017
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39. Scientific opinion on an application for renewal of authorisation for continued marketing of maize 59122 and derived food and feed submitted under articles 11 and 23 of Regulation (EC) No 1829/2003 by Pioneer Overseas Corporation and Dow AgroSciences LLC

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Ardizzone, Michele, Paraskevopoulos, Kostas, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

40. Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003

Author

EFSA Panel on Genetically Modified Organisms (GMO), ., Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean-Michel, Devos, Yann, Fernández Dumont, Antonio, Lanzoni, Anna, Paoletti, Claudia, Paraskevopoulos, Konstantinos, Waigmann, Elisabeth, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, Université Paris Saclay (COmUE), Service de Pharmacologie et d'Immunoanalyse (SPI), Institut National de la Recherche Agronomique (INRA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay, Institute of Pharmacology and Toxicology [Zurich], University of Zürich [Zürich] (UZH), Université Paris-Saclay, University of Zurich, Naegeli, H., Birch, A., Casacuberta, J., De Schrijver, A., Gralak, M., Guerche, P., Jones, H., Manachini, B., Messéan, A., Nielsen, E., Nogué, F., Robaglia, C., Rostoks, N., Sweet, J., Tebbe, C., Visioli, F., Wal, J., Devos, Y., Fernandez Dumont, A., Lanzoni, A., Paoletti, C., Paraskevopoulos, K., Waigmann, E., Service de Pharmacologie et Immunoanalyse (SPI), Médicaments et Technologies pour la Santé (MTS), Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), and Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)

Subjects
0106 biological sciences, Veterinary (miscellaneous), [SDV]Life Sciences [q-bio], Context (language use), Plant Science, Genetically modified crops, 010501 environmental sciences, 01 natural sciences, Microbiology, Regulation (EU) No 503/2013, Ingredient, presence at low level, [SDV.IDA]Life Sciences [q-bio]/Food engineering, media_common.cataloged_instance, [SDV.BV]Life Sciences [q-bio]/Vegetal Biology, Settore AGR/18 - Nutrizione E Alimentazione Animale, [SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering, European union, food/feed, 0105 earth and related environmental sciences, media_common, guidance, GMO, risk assessment, Regulation (EC) No 1829/2003, business.industry, 10079 Institute of Veterinary Pharmacology and Toxicology, Food safety, Biotechnology, Scientific Opinion, Settore AGR/11 - Entomologia Generale E Applicata, 570 Life sciences, biology, Animal Science and Zoology, Parasitology, Risk assessment, business, 010606 plant biology & botany, Food Science
Abstract

This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1329/full

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2017
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41. Assessment of genetically modified maize 1507 × 59122 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐92)

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Gennaro, Andrea, Lanzoni, Anna, Olaru, Irina, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017
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42. Scientific opinion on an application for renewal of authorisation for continued marketing of maize 1507 and derived food and feed submitted under Articles 11 and 23 of Regulation (EC) No 1829/2003 by Pioneer Overseas Corporation and Dow AgroSciences LLC

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Ardizzone, Michele, Mestdagh, Sylvie, Ramon, Matthew, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2017

43. Risk assessment of new sequencing information on GM maize event DAS‐59122‐7

Author

Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikolaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Paraskevopoulos, Konstantinos, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2016
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44. Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2011-99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Author

Birch, Andrew N E, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikolaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Naegeli, Hanspeter, Ebbesen Nielsen, Elsa, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean-Michel, and University of Zurich

Subjects
3401 Veterinary (miscellaneous), 2404 Microbiology, 1110 Plant Science, 2405 Parasitology, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology, 1103 Animal Science and Zoology, 1106 Food Science
Published
2016

45. Scientific Opinion on an application by Pioneer (EFSA-GMO-NL-2007-47) for the placing on the market of the herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 3 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Author

Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adlinda, Gralak, Mikolaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Naegeli, Hanspeter, Ebbesen Nielsen, Elsa, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean-Michel, and University of Zurich

Subjects
fungi, food and beverages, 570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2016
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46. Scientific Opinion on an application by Bayer CropScience and Monsanto (EFSA-GMO-NL-2009-75) for placing on the market of genetically modified glufosinate-ammonium- and glyphosate-tolerant oilseed rape MS8 3 RF3 3 GT73 and subcombinations, which have not been authorised previously (i.e. MS8 3 GT73 and RF3 3 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

Author

Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gathmann, Achim, Gralak, Mikolaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Naegeli, Hanspeter, Ebbesen Nielsen, Elsa, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Wal, Jean-Michel, and University of Zurich

Subjects
570 Life sciences, biology, 10079 Institute of Veterinary Pharmacology and Toxicology
Published
2016

47. Scientific Opinion on an application by Pioneer (EFSA-GMO-NL-2007-47) for the placing on the market of the herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 × 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Author

Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Naegeli, Hanspeter, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Institut Jean-Pierre Bourgin (IJPB), and Institut National de la Recherche Agronomique (INRA)-AgroParisTech

Subjects
0106 biological sciences, Veterinary (miscellaneous), [SDV]Life Sciences [q-bio], GM‐HRA, Plant Science, TP1-1185, 010501 environmental sciences, Biology, 01 natural sciences, Microbiology, Genetically modified soybean, high oleic acid, TX341-641, Food science, soybean 305423 × 40‐3‐2, 0105 earth and related environmental sciences, High oleic acid, 2. Zero hunger, CP4 EPSPS, GMO, Nutrition. Foods and food supply, Chemical technology, fungi, food and beverages, herbicide tolerant, 13. Climate action, Animal Science and Zoology, Parasitology, 010606 plant biology & botany, Food Science
Abstract

Requestor: Competent Authority of the NetherlandsQuestion number: EFSA-Q-2007-175; The Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) previously assessed the two single events combined to produce soybean 305423 × 40-3-2 and did not identify safety concerns. No new data on the single events affecting the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of soybean events 305423 and 40-3-2 in the two-event stack soybean did not raise concerns regarding food and feed safety or nutrition. The combination of the newly expressed proteins in the two-event stack soybean did not raise human or animal health concerns. No compositional differences requiring further assessment were identified between soybean 305423 × 40-3-2, the non-GM comparator, additional comparators and the non-GM commercial soybean reference varieties, except for the altered fatty acid profile (consistent with the intended trait). Nutritional assessment of food products from soybean 305423 × 40-3-2 identified no concerns for human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted toasted soybean 305423 × 40-3-2 meal. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean plants, unless these are exposed to acetolactate-synthase-inhibiting or glyphosate-containing herbicides. Risks associated with the unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean 305423 × 40-3-2 to bacteria were not identified. Considering the scope of the application, interactions with biotic and abiotic environments are not considered a relevant issue. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean 305423 × 40-3-2. The GMO Panel is of the opinion that soybean 305423 × 40-3-2 is as safe as the non-GM comparator and non-GM commercial soybean varieties with respect to potential effects on human and animal health and environment in the context of its scope. The GMO panel recommends a post-market monitoring plan.

Published
2016
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48. Scientific Opinion on an application by Bayer CropScience and Monsanto (EFSA-GMO-NL-2009-75) for placing on the market of genetically modified glufosinate-ammonium- and glyphosate-tolerant oilseed rape MS8 × RF3 × GT73 and subcombinations, which have not been authorised previously (i.e. MS8 × GT73 and RF3 × GT73) independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food, under Regulation (EC) No 1829/2003

Author

Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gathmann, Achim, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Naegeli, Hanspeter, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Institut Jean-Pierre Bourgin (IJPB), and Institut National de la Recherche Agronomique (INRA)-AgroParisTech

Subjects
0106 biological sciences, 2. Zero hunger, Veterinary (miscellaneous), [SDV]Life Sciences [q-bio], Animal Science and Zoology, Parasitology, Plant Science, 010501 environmental sciences, 01 natural sciences, Microbiology, 010606 plant biology & botany, 0105 earth and related environmental sciences, Food Science
Abstract

Requestor: Competent Authority of the NetherlandsQuestion number: EFSA-Q-2009-00890; The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed the three single events that are combined to produce the three-event stack oilseed rape (OSR) MS8 × RF3 × GT73. In this Scientific Opinion, the GMO Panel assessed the three-event stack OSR and subcombinations that have not been authorised previously (i.e. MS8 × GT73 and RF3 × GT73), independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The combination of OSR events, MS8, RF3 and GT73, in the three-event stack OSR does not raise issues relating to molecular, agronomic/phenotypic or compositional characteristics requiring further investigations. In line with previous assessments and considering the scope of this application, the GMO Panel did not find indications of safety concern for food and feed with trace levels of glyphosate oxidoreductase (GOX)v247 protein derived from the three-event stack OSR; whereas, the GMO Panel cannot assess the safety of three-event stack OSR products rich in protein, such as rapeseed protein isolates in feed. As the risk assessment of the three-event stack OSR could not be completed for products rich in protein, such as rapeseed protein isolates, the GMO Panel is not in a position to complete the food and feed safety assessment of subcombinations within the scope of this application (i.e. MS8 × GT73 and RF3 × GT73). The two-event stack OSR MS8 × RF3 is outside the scope of this application. Considering the scope of this application, the mode of action of the introduced traits and the data available for the three-event and two-event stack OSR MS8 × RF3, the GMO Panel considered that different combinations of the events, MS8, RF3 and GT73, would not raise environmental concerns.

Published
2016
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49. Annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A

Author

Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gathmann, Achim, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Naegeli, Hanspeter, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, Birch A.N., Casacuberta J., De Schrijver A., Gathmann A., Gralak M.A., Guerche P., Jones H., Manachini B., Messéan A., Naegeli H., Nielsen E.E., Nogué F., Robaglia C., Rostoks N., Sweet J., Tebbe C., Visioli F., Wal J.M. (EFSA Panel on Genetically Modified Organisms), and University of Zurich

Subjects
0106 biological sciences, Settore BIO/07 - Ecologia, Veterinary (miscellaneous), [SDV]Life Sciences [q-bio], TP1-1185, Plant Science, 010501 environmental sciences, Zea mays, 01 natural sciences, Microbiology, case‐specific monitoring, Cry1Ab, case-specific monitoring, farmer questionnaires, general surveillance, insect resistance management, Zea mays, TX341-641, Cry1Ab, 0105 earth and related environmental sciences, 2. Zero hunger, Nutrition. Foods and food supply, Chemical technology, fungi, general surveillance, 10079 Institute of Veterinary Pharmacology and Toxicology, farmer questionnaires, insect resistance management, Settore AGR/02 - Agronomia E Coltivazioni Erbacee, Settore AGR/11 - Entomologia Generale E Applicata, 570 Life sciences, biology, Animal Science and Zoology, Parasitology, 010606 plant biology & botany, Food Science
Abstract

Requestor: European CommissionQuestion number: EFSA-Q-2015-00650; Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post-market environmental monitoring (PMEM) report for the 2014 growing season of maize MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein over the 2014 season. However, as the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations for improvement of the insect resistance management plan. The GMO Panel considers that the farmer alert system to report complaints regarding product performance could complement the information obtained from the laboratory bioassays, but encourages the consent holder to provide more information in order to be in a position to appraise its usefulness. The data on general surveillance activities do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 cultivation in 2014. The GMO Panel reiterates its previous recommendations to improve the methodology for the analysis of farmer questionnaires and conduct of the literature review in future annual PMEM reports on maize MON 810. The GMO Panel urges the consent holder to consider how to make best use of the information recorded in national registers to optimise sampling for farmer questionnaires, and requests to continue reviewing and discussing relevant scientific publications on possible adverse effects of maize MON 810 on rove beetles. Also, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring.

Published
2016
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50. Part C notification (reference C/NL/13/02) from Suntory Holdings Limited for the import, distribution and retailing of carnation FLO-40685-2 cut flowers with modified petal colour for ornamental use

Author

Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gathmann, Achim, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Naegeli, Hanspeter, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Institut Jean-Pierre Bourgin (IJPB), Institut National de la Recherche Agronomique (INRA)-AgroParisTech, and University of Zurich

Subjects
0106 biological sciences, Veterinary (miscellaneous), [SDV]Life Sciences [q-bio], Dianthus caryophyllus, TP1-1185, Plant Science, 01 natural sciences, Microbiology, 0404 agricultural biotechnology, import, TX341-641, Directive 2001/18/EC, 2. Zero hunger, delphinidin, Nutrition. Foods and food supply, Chemical technology, 04 agricultural and veterinary sciences, 10079 Institute of Veterinary Pharmacology and Toxicology, 040401 food science, cut flower, carnation, 570 Life sciences, biology, Animal Science and Zoology, Parasitology, 010606 plant biology & botany, Food Science
Abstract

Requestor: European CommissionQuestion number: EFSA-Q-2015-00122; The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation FLO-40685-2 cut flowers to be imported into the EU for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the newly introduced trait (purple flower colour) was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation FLO-40685-2 for humans. The GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring (PMEM) plan. The GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

Published
2016
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