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

Barbara Rosy Ines Manachini, Barbara Manachini, Yann Devos, Jeremy Sweet, Anna Lanzoni, Elsa Ebbesen Nielsen, Huw Jones, Fabien Nogué, Michele Ardizzone, Fernando Àlvarez, Jose Ángel Gómez Ruiz, Antonio Fernandez Dumont, Philippe Guerche, Nikoletta Papadopoulou, Irina Olaru, Franco Maria Neri, Konstantinos Paraskevopoulos, Christophe Robaglia, Andrew Nicholas Birch, Mikołaj Antoni GralakAdinda De Schrijver, Nils Rostoks, Josep Casacuberta, Antoine Messéan, Christoph Tebbe, Andrew Nicholas Birch, Hermann Broll, Hanspeter Naegeli, Francesco Visioli, Jean-Michel Wal

Risultato della ricerca: Article

Abstract

Maize 4114 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate-ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non-genetically modified (GM) comparator(s) required further assessment. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non-GM maize varieties and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non-GM comparator(s) and non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.
Lingua originaleEnglish
pagine (da-a)1-25
Numero di pagine25
RivistaTHE EFSA JOURNAL
Volume16
Stato di pubblicazionePublished - 2018

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Genetically Modified Organisms
Zea mays
allergenicity
genetically modified organisms
Food
corn
Streptomyces viridochromogenes
markets
glufosinate
animal and human health
Food Safety
environmental monitoring
Environmental Monitoring
Nutritive Value
Streptomyces
active ingredients
genetic engineering
Proteins
proteins
protein synthesis

All Science Journal Classification (ASJC) codes

  • Parasitology
  • Food Science
  • Microbiology
  • Animal Science and Zoology
  • veterinary (miscalleneous)
  • Plant Science

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Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-123). / Manachini, Barbara Rosy Ines; Manachini, Barbara; Devos, Yann; Sweet, Jeremy; Lanzoni, Anna; Nielsen, Elsa Ebbesen; Jones, Huw; Nogué, Fabien; Ardizzone, Michele; Àlvarez, Fernando; Gómez Ruiz, Jose Ángel; Fernandez Dumont, Antonio; Guerche, Philippe; Papadopoulou, Nikoletta; Olaru, Irina; Neri, Franco Maria; Paraskevopoulos, Konstantinos; Robaglia, Christophe; Birch, Andrew Nicholas; Gralak, Mikołaj Antoni; De Schrijver, Adinda; Rostoks, Nils; Casacuberta, Josep; Messéan, Antoine; Tebbe, Christoph; Birch, Andrew Nicholas; Broll, Hermann; Naegeli, Hanspeter; Visioli, Francesco; Wal, Jean-Michel.

In: THE EFSA JOURNAL, Vol. 16, 2018, pag. 1-25.

Risultato della ricerca: Article

Manachini, BRI, Manachini, B, Devos, Y, Sweet, J, Lanzoni, A, Nielsen, EE, Jones, H, Nogué, F, Ardizzone, M, Àlvarez, F, Gómez Ruiz, JÁ, Fernandez Dumont, A, Guerche, P, Papadopoulou, N, Olaru, I, Neri, FM, Paraskevopoulos, K, Robaglia, C, Birch, AN, Gralak, MA, De Schrijver, A, Rostoks, N, Casacuberta, J, Messéan, A, Tebbe, C, Birch, AN, Broll, H, Naegeli, H, Visioli, F & Wal, J-M 2018, 'Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-123)', THE EFSA JOURNAL, vol. 16, pagg. 1-25.
Manachini, Barbara Rosy Ines ; Manachini, Barbara ; Devos, Yann ; Sweet, Jeremy ; Lanzoni, Anna ; Nielsen, Elsa Ebbesen ; Jones, Huw ; Nogué, Fabien ; Ardizzone, Michele ; Àlvarez, Fernando ; Gómez Ruiz, Jose Ángel ; Fernandez Dumont, Antonio ; Guerche, Philippe ; Papadopoulou, Nikoletta ; Olaru, Irina ; Neri, Franco Maria ; Paraskevopoulos, Konstantinos ; Robaglia, Christophe ; Birch, Andrew Nicholas ; Gralak, Mikołaj Antoni ; De Schrijver, Adinda ; Rostoks, Nils ; Casacuberta, Josep ; Messéan, Antoine ; Tebbe, Christoph ; Birch, Andrew Nicholas ; Broll, Hermann ; Naegeli, Hanspeter ; Visioli, Francesco ; Wal, Jean-Michel. / Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-123). In: THE EFSA JOURNAL. 2018 ; Vol. 16. pagg. 1-25.
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title = "Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-123)",
abstract = "Maize 4114 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate-ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non-genetically modified (GM) comparator(s) required further assessment. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non-GM maize varieties and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non-GM comparator(s) and non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.",
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T1 - Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-123)

AU - Manachini, Barbara Rosy Ines

AU - Manachini, Barbara

AU - Devos, Yann

AU - Sweet, Jeremy

AU - Lanzoni, Anna

AU - Nielsen, Elsa Ebbesen

AU - Jones, Huw

AU - Nogué, Fabien

AU - Ardizzone, Michele

AU - Àlvarez, Fernando

AU - Gómez Ruiz, Jose Ángel

AU - Fernandez Dumont, Antonio

AU - Guerche, Philippe

AU - Papadopoulou, Nikoletta

AU - Olaru, Irina

AU - Neri, Franco Maria

AU - Paraskevopoulos, Konstantinos

AU - Robaglia, Christophe

AU - Birch, Andrew Nicholas

AU - Gralak, Mikołaj Antoni

AU - De Schrijver, Adinda

AU - Rostoks, Nils

AU - Casacuberta, Josep

AU - Messéan, Antoine

AU - Tebbe, Christoph

AU - Birch, Andrew Nicholas

AU - Broll, Hermann

AU - Naegeli, Hanspeter

AU - Visioli, Francesco

AU - Wal, Jean-Michel

PY - 2018

Y1 - 2018

N2 - Maize 4114 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate-ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non-genetically modified (GM) comparator(s) required further assessment. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non-GM maize varieties and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non-GM comparator(s) and non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

AB - Maize 4114 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate-ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non-genetically modified (GM) comparator(s) required further assessment. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non-GM maize varieties and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non-GM comparator(s) and non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

UR - http://hdl.handle.net/10447/358400

M3 - Article

VL - 16

SP - 1

EP - 25

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

ER -