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 x 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

The Panel on Genetically Modi fi ed Organisms of the European Food Safety Authority (GMO Panel) previously assessed the two single events combined to produce soybean 305423 9 40-3-2 and did not identify safety concerns. No new data on the single events affecting the original conclusions were identi fi ed. 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 identi fi ed between soybean 305423 9 40-3-2, the non-GM comparator, additional comparators and the non-GM commercial soybean reference varieties, except for the altered fatty acid pro fi le (consistent with the intended trait). Nutritional assessment of food products from soybean 305423 9 40-3-2 identi fi ed no concerns for human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted toasted soybean 305423 9 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 glyphosate-containing herbicides. Risks associated with the unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean 305423 9 40-3-2 to bacteria were not identi fi ed. 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 9 40-3-2. The GMO Panel is of the opinion that soybean 305423 9 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. 2007; EFSA GMO Panel, 2011a), for the ERA of GM plants (EFSA GMO Panel, 2010a) and for the PMEM of GM plants (EFSA GMO Panel, 2011b). The comments raised by the Member States are addressed in Annex G of EFSA ’ s overall opinion 4 and were taken into consideration during the scienti fi c risk assessment. glycine (CHT, IHT), isoleucine (CHT, IHT), leucine (CHT, IHT), methionine (IHT), phenylalanine (CHT, IHT), proline (CHT), serine (CHT), threonine (CHT, IHT), tryptophan (CHT, IHT), tyrosine (CHT, IHT), valine (CHT, IHT), calcium (CHT, IHT), copper (IHT), iron (CHT, IHT), (CHT, IHT), potassium (CHT), zinc (CHT, IHT), a -tocopherol (CHT, IHT), d -tocopherol (CHT, IHT), c (CHT, IHT), total tocopherols IHT), B1 (thiamine) (CHT, IHT), vitamin B2 (ribo fl avin) (CHT, IHT), vitamin B5 (pantothenic acid) (CHT, IHT), vitamin B6 (pyridoxine) (CHT, IHT), vitamin B9 (folic acid) (CHT, IHT), daidzein (CHT, IHT), daidzin (CHT, IHT), genistin (CHT), glycitin (CHT, IHT), total daidzein (CHT, IHT), total genistein (CHT), total glycitein (CHT, IHT), raf (CHT, IHT), stachyose (CHT, IHT), sucrose (CHT, IHT), lectins (CHT, IHT), trypsin inhibitor (CHT, IHT). tocopherols (CHT, IHT), vitamin B1 (thiamine) (CHT, IHT), vitamin B2 (ribo fl avin) (CHT), vitamin B3 (niacin) (CHT), vitamin B5 (pantothenic acid) (CHT, IHT), vitamin B6 (pyridoxine) (CHT, IHT), daidzein (CHT, IHT), daidzin (CHT, IHT), genistin (CHT, IHT), glycitin (CHT, IHT), total daidzein (CHT, IHT), total genistein (CHT, IHT), total glycitein (CHT, IHT), stachyose (CHT, IHT), sucrose (CHT, IHT), phytic acid (CHT), trypsin inhibitor (CHT, IHT).