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

Soybean MON 87751 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analy...

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Published inEFSA journal Vol. 16; no. 8; pp. e05346 - n/a
Main Authors 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
Format Journal Article
LanguageEnglish
Published United States John Wiley & Sons, Inc 01.08.2018
John Wiley and Sons Inc
Wiley
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Summary:Soybean MON 87751 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON 87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87751. The nutritional impact of soybean MON 87751‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that soybean MON 87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM soybean reference varieties tested, and no post‐market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON 87751 seeds into the environment, soybean MON 87751 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87751. In conclusion, soybean MON 87751, 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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Panel members: Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikolaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean‐Michel Wal.
Acknowledgements: The Panel wishes to thank the members of its standing Working Groups on Molecular Characterisation, Food/Feed Safety and Environmental Risk Assessment for the preparatory work on this scientific opinion and EFSA staff members Yann Devos, Andrea Gennaro, Irene Muñoz Guajardo and Claudia Paoletti for the support provided to this scientific opinion.
Question number: EFSA‐Q‐2014‐00719
Requestor: Competent Authority of the Netherlands
Competing interests: In line with EFSA's policy on declarations of interest, Panel member Philippe Guerche did not participate in the development and adoption of this scientific opinion.
Adopted: 20 June 2018
ISSN:1831-4732
1831-4732
2314-9396
DOI:10.2903/j.efsa.2018.5346