• Open Access

Scientific opinion on applications EFSA-GMO-RX-T25 and EFSA-GMO-NL-2007-46 for the renewal of authorisation of maize T25, and for the placing on the market of herbicide-tolerant genetically modified maize T25, both for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG

Authors

  • EFSA Panel on Genetically Modified Organisms (GMO)


  • Panel members: Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks, Christoph Tebbe
  • Correspondence: gmo@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Standing Working Groups on Molecular Characterisation, Food and Feed and Environment for the preparatory work on this scientific opinion; Josep Casacuberta, Rosie Hails and Jeremy Sweet as external experts; and the EFSA's staff members Christina Ehlert, Antonio Fernández Dumont, Ana Gomes and Sylvie Mestdagh for the support provided to this scientific opinion.
  • Adoption date: 11 September 2013
  • Published date: 3 October 2013
  • Question number: EFSA-Q-2007-134, EFSA-Q-2007-155
  • On request from: European Commission for an application (EFSA-GMO-RX-T25) submitted by Bayer CropScience AG; Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2007-46) submitted by Bayer CropScience AG

Abstract

This scientific opinion reports on a risk assessment for the authorisation for (continued) marketing of genetically modified maize T25 for food and feed uses, import and processing. Maize T25 contains a single insertion locus containing a pat cassette conferring tolerance to glufosinate-based herbicides. Bioinformatic analyses, protein expression data and genetic stability studies did not raise safety issues. The compositional, agronomic and phenotypic characteristics of maize T25 grain and its conventional counterpart showed no differences that are of relevance for food/feed safety. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced PAT protein. The compositional data indicating the nutritional equivalence of maize T25 were supported by the results of the feeding studies. There was no evidence that the genetic modification might significantly change the overall allergenicity of maize T25. Considering all available information related to the agronomic and phenotypic characterisation of maize T25, the EFSA GMO Panel did not observe any enhanced fitness characteristics of maize T25 that will change its capacity to spread, establish or persist compared with non-genetically modified (GM) maize, except in the presence of glufosinate-based herbicides. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize T25 to bacteria have not been identified. The monitoring plan and reporting intervals were in line with the intended uses. The Panel concluded that maize T25, as described in the applications, is as safe as its conventional counterpart with respect to potential effects on human and animal health or the environment in the context of its intended uses for food and feed, import and processing.

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