Scientific Opinion on the application (EFSA-GMO-BE-2012-110) for the placing on the market of tissue-selective herbicide-tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2015;13(6):4130 [25 pp.].
doi
10.2903/j.efsa.2015.4130
Panel members at the time of adoption
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 Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe.
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Safety Assessment and on Environmental Risk Assessment for the preparatory work on this scientific opinion and the EFSA staff Hermann Broll, Zoltán Divéki and Andrea Gennaro for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Member State - Belgium
Question Number
EFSA-Q-2012-00692
Adopted
27 May 2015
Published
19 June 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Maize MON 87427 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) protein, in all tissues except for the male reproductive tissues, conferring tissue-selective tolerance to glyphosate. The molecular characterisation of maize MON 87427 did not give rise to safety issues. Agronomic and phenotypic characteristics as well as compositional data of maize MON 87427 did not raise food/feed and environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein. The nutritional value of maize MON 87427 is not expected to differ from that of non-genetically modified (GM) maize varieties. There are no indications of an increased likelihood of establishment or spread of feral maize plants. Given its intended use in 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 MON 87427 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application for maize MON 87427. In conclusion, the EFSA Panel on Genetically Modified Organisms considers that the information available for maize MON 87427 addresses the scientific comments raised by Member States and that the maize MON 87427, as described in this application, is as safe as its conventional counterpart 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 the application.

Summary

Following the submission of an application (EFSA-GMO-BE-2012-110) under Regulation (EC) No 1829/2003 by Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the safety of tissue-selective herbicide-tolerant genetically modified (GM) maize (Zea mays L.) MON 87427 (Unique Identifier MON-87427-7). The scope of application EFSA-GMO-BE-2012-110 is for import, processing, and food and feed uses of maize MON 87427 within the European Union (EU) in the same way as any non-GM maize, but excludes cultivation in the EU.

The EFSA GMO Panel evaluated maize MON 87427 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of GM plants and derived food and feed, the environmental risk assessment of GM plants and the post-market environmental monitoring of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding protein. An evaluation of the comparative analyses of compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of environmental impacts and the post-market environmental monitoring plan was also undertaken.

Maize MON 87427 was developed by Agrobacterium tumefaciens-mediated transformation of immature maize embryos. The resulting GM maize expresses 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) from Agrobacterium sp. strain CP4, which confers tolerance to the herbicidal active substance glyphosate. However, CP4 EPSPS expression is absent or limited in male reproductive tissues, which eliminates or reduces the need for detasseling when MON 87427 is used as a female parent in hybrid maize seed production. The molecular characterisation data established that maize MON 87427 contains a single insert consisting of the CP4 epsps expression cassette. No other parts of the plasmid used for transformation were detected in maize MON 87427. Bioinformatics analyses and genetic stability studies did not give rise to any safety issues. The levels of the CP4 EPSPS protein in maize MON 87427 were determined and reported adequately.

Based on the agronomic and phenotypic characteristics of maize MON 87427 under the tested conditions (treated and not treated with the intended herbicide), some differences were observed in maize MON 87427 compared with its conventional counterpart. The EFSA GMO Panel concluded that none of the differences identified in the composition, agronomic and phenotypic characteristics of grain and forage obtained from maize MON 87427 is relevant to food and feed safety.

No concerns regarding the potential toxicity or allergenicity of the newly expressed CP4 EPSPS protein were identified, and no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87427 was found. The nutritional value of food and feed derived from maize MON 87427 is not expected to differ from that of food and feed derived from non-GM maize varieties. The EFSA GMO Panel concludes that maize MON 87427 assessed in this application is as safe and nutritious as its conventional counterpart and the commercial non-GM maize varieties tested.

Application EFSA-GMO-BE-2012-110 covers the import, processing, and food and feed uses of maize MON 87427, and excludes cultivation. Therefore, there is no requirement for a scientific assessment of possible environmental effects associated with the cultivation of this GM maize. The EFSA GMO Panel concluded that there are no indications of an increased likelihood of establishment or spread of feral maize MON 87427 plants in the event of the accidental release of viable GM maize grains into the environment. Potential interactions with the biotic and abiotic environment were not considered an issue by the EFSA GMO Panel. Risks associated with an unlikely, but theoretically possible, horizontal gene transfer from maize MON 87427 to bacteria have not been identified. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the scope of the maize MON 87427 application and the guidance document of the EFSA GMO Panel on post-market environmental monitoring of GM plants (EFSA, 2011a). The EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the monitoring plan.

In delivering its scientific opinion, the EFSA GMO Panel took into account application EFSA-GMO-BE-2012-110, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. In conclusion, the EFSA Panel on Genetically Modified Organisms considers that the information available for maize MON 87427 addresses the scientific comments raised by Member States and that the maize MON 87427, as described in this application, is as safe as its conventional counterpart 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 the application.

Keywords
GMO, maize (Zea mays), MON 87427, tissue-selective, herbicide tolerance, CP4 EPSPS, Regulation (EC) No. 1829/2003
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Number of Pages
25