Scientific Opinion on an application by Pioneer (EFSA-GMO-NL-2007-47) for the placing on the market of the herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 × 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
GMO;soybean 305423 × 40-3-2;herbicide tolerant;high oleic acid;GM-HRA;CP4 EPSPS;RNAi;Regulation (EC) No 1829/2003
First published in the EFSA Journal:
18 August 2016
14 July 2016
28 October 2016. This version replaces the previous one/s.
The Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) previously assessed the two single events combined to produce soybean 305423 × 40-3-2 and did not identify safety concerns. No new data on the single events affecting the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of soybean events 305423 and 40-3-2 in the two-event stack soybean did not raise concerns regarding food and feed safety or nutrition. The combination of the newly expressed proteins in the two-event stack soybean did not raise human or animal health concerns. No compositional differences requiring further assessment were identified between soybean 305423 × 40-3-2, the non-GM comparator, additional comparators and the non-GM commercial soybean reference varieties, except for the altered fatty acid profile (consistent with the intended trait). Nutritional assessment of food products from soybean 305423 × 40-3-2 identified no concerns for human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted toasted soybean 305423 × 40-3-2 meal. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean plants, unless these are exposed to acetolactate-synthase-inhibiting or glufosinate-ammonium-based herbicides. Risks associated with the unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean 305423 × 40-3-2 to bacteria were not identified. Considering the scope of the application, interactions with biotic and abiotic environments are not considered a relevant issue. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean 305423 × 40-3-2. The GMO Panel is of the opinion that soybean 305423 × 40-3-2 is as safe as the non-GM comparator and non-GM commercial soybean varieties with respect to potential effects on human and animal health and environment in the context of its scope. The GMO panel recommends a post-market monitoring plan.
© European Food Safety Authority, 2016
Panel members at the time of adoption:
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikolaj Antoni Grałak, 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 2016;14(8):4566
On request from:
Competent Authority of the Netherlands