Scientific Opinion on an application (EFSA-GMO-NL-2010-85) for the placing on the market of MON 87769 × MON 89788 soybean, genetically modified to contain stearidonic acid and be tolerant to glyphosate for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
GMO, soybean (Glycine max (L.) Merr.), CP4 EPSPS, herbicide tolerant, production of stearidonic acid, stack
First published in the EFSA Journal:
8 October 2015
17 September 2015
The EFSA GMO Panel previously assessed the two single events that are combined to produce soybean MON 87769 × MON 89788 and did not identify safety concerns. No new data on these single events, leading to a modification of the original conclusions on safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean MON 87769 × MON 89788 did not give rise to safety concerns. The Panel considers that there is no reason to expect interactions between the single events to impact on food and feed safety. There were no concerns regarding the potential toxicity or allergenicity of soybean MON 87769 × MON 89788, and no evidence that the genetic modification significantly changes the overall allergenicity. Because of the lack of data on dietary exposure to refined bleached deodorised oil from soybean MON 87769 × MON 89788, the EFSA GMO Panel could not complete the human health and nutrition assessment. There are no concerns regarding the use of feedingstuffs derived from defatted toasted MON 87769 × MON 89788 soybean meal. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Potential interactions of soybean MON 87769 × MON 89788 with biotic and abiotic environments were not considered relevant to this application. The unlikely, but theoretically possible, transfer of recombinant genes from soybean MON 87769 × MON 89788 to environmental bacteria is not of safety concern. The post-market environmental monitoring plan and reporting intervals conform with the scope of this application. In conclusion, the Panel could not complete the food and feed safety assessment of soybean MON 87769 × MON 89788 because of the lack of an appropriate nutritional assessment. The Panel concludes that soybean MON 87769 × MON 89788 is unlikely to have adverse effects on the environment in the context of application EFSA-GMO-NL-2010-85.
© European Food Safety Authority, 2015
Panel members at the time of adoption:
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Achim Gathmann, 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.
Panel on Genetically Modified Organisms
gmo [at] efsa.europa.eu
EFSA Journal 2015;13(10):4256 [25 pp.].
On request from:
Competent Authority of the Netherlands