Scientific Opinion on application (EFSA-GMO-UK-2007-43) for the placing on the market of herbicide tolerant genetically modified soybean 356043 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer

GMO, soybean, 356043, risk assessment, food and feed safety, environment, import and processing, Regulation (EC) No 1829/2003, GAT, Glycine max-HRA, NAA, NAG
First published in the EFSA Journal
26 July 2011
6 July 2011
Scientific Opinion


This scientific opinion is an evaluation of a risk assessment for the genetically modified herbicide tolerant soybean 356043 for food and feed uses, import and processing. Soybean 356043 contains a single copy of intact gat4601 and Glycine max-hra cassettes at a single insertion locus. The results of the bioinformatic analyses of the insert and the flanking regions, and the levels of newly expressed proteins did not raise a safety concern. The comparative analysis of phenotypic and agronomic characteristics indicated that soybean 356043 is not different from its conventional counterpart. In the composition, differences were identified between 356043 soybean and its conventional counterpart in the newly expressed proteins Glycine max-HRA and GAT4601, and the levels of the fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acid and the acetylated amino acids N-acetylaspartate (NAA) and N-acetylglutamate (NAG). The safety assessment of the newly expressed proteins Glycine max-HRA and GAT4601 identified no concerns regarding potential toxicity and allergenicity. Heptadecanoic, heptadecenoic and heptadecadienoic acid are present in the diet and the intake of small amounts of these fatty acids via food or feed is not expected to produce adverse effects. NAA and NAG are normal constituents in the mammalian metabolism and the estimated increases in their intake are considered low when related to the normal intake of L-aspartic acid and L-glutamic acid. Further toxicological, allergenicity and nutritional analysis provided no indications of adverse effects. There are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate and ALS-inhibiting herbicides neither a risk caused by a possible transfer of the recombinant gene from soybean 356043 to environmental micro-organisms. The EFSA GMO Panel considers that the information available for soybean 356043 addresses the scientific comments raised by the Member States and states that the soybean 356043, as described in this 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 its intended uses.

Panel members at the time of adoption

Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal
Panel on Genetically Modified Organisms
gmo [at]
EFSA Journal 2011;9(7):2310
Question Number
On request from
Competent Authority of the UK on an application (EFSA-GMO-UK-20007-43) submitted by Pioneer