EFSA Panel on Genetically Modified Organisms (GMO)

Soybean 305423 was developed through particle bombardment and contains gm-fad2-1 and gm-hra expression cassettes, conferring a high oleic acid profile and tolerance to acetolactate synthase (ALS)-inhibiting herbicides. Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the GM-HRA protein in soybean 305423 have been sufficiently analysed. Soybean 305423 differs from the conventional counterpart in the seed fatty acid profile and for the presence of the GM-HRA protein. It is agronomically equivalent to nonGM reference soybeans. The safety assessment of GM-HRA identified no concerns regarding potential toxicity and allergenicity. There are no indications that the overall allergenicity of soybean 305423 has changed. Nutritional assessment on soybean 305423 oil and derived food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feeding stuffs derived from soybean 305423. There are no indications of an increased likelihood of establishment and spread of feral GM soybean plants. Environmental risks associated with an unlikely, but theoretically possible, horizontal gene transfer from soybean 305423 to bacteria have not been identified. Potential biotic and abiotic interactions of soybean 305423 were not considered to be an issue owing to the low level of environmental exposure. The post-market environmental monitoring plan is in line with the scope of soybean 305423. The EFSA GMO Panel considers that the information available for soybean 305423 addresses the scientific comments raised by the Member States and states that the soybean 305423, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of the scope. The GMO Panel recommends a post-market monitoring plan, focusing on the collection of consumption data for the European population, for the marketed foods and feed. © European Food Safety Authority, 2013 1 On request from the Competent Authority of the Netherlands for an application EFSA-GMO-NL-2007-45 submitted by Pioneer, Question No EFSA-Q-2007-122, adopted on 4 December 2013. 2 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 Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe. Correspondence: gmo@efsa.europa. eu 3 Acknowledgement: The Panel wishes to thank the members of the Standing Working Groups on Molecular Characterisation, Food and Feed Risk Assessment and Environmental Risk Assessment: Thomas Frenzel, Annette Pöting and Hildegard Przyrembel for the preparatory work on this scientific opinion, and the EFSA staff members: Hermann Broll, Anna Christodoulidou, Zoltán Divéki, Anna Lanzoni, Yi Liu, Karine Lheureux and Sylvie Mestdagh for the support provided to this scientific opinion. Scientific opinion on GM soybean 305423 EFSA Journal 2013;11(12):3499 2