Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Abstract

Soybean DAS-44406-6 expresses 5-enolpyruvyl-shikimate-3-phosphate synthase (2mEPSPS), conferring tolerance to glyphosate-based herbicides, aryloxyalkanoate dioxygenase (AAD-12), conferring tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and phosphinothricin acetyl transferase (PAT), conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food/ feed safety. The agronomic and phenotypic characteristics revealed no relevant differences between soybean DAS-44406-6 and its conventional counterpart, except for pod count, seed count and yield. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 31%) in lectin activity in soybean DAS-44406-6. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition of soybean DAS-44406-6 as compared to its conventional counterpart and non-GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the three newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-44406-6. Soybean DAS-44406-6 is as nutritious as its conventional counterpart and the non-GM soybean reference varieties tested. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS-44406-6 plants, unless exposed to the intended herbicides. The likelihood of environmental effects from the accidental release of viable seeds from soybean DAS-44406-6 into the environment is therefore very low. The postmarket environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-44406-6. In conclusion, the GMO Panel considers that the information available for soybean DAS-44406-6 addresses the scientific comments raised by Member States and that soybean DAS-44406-6, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Guidance on allergenicity assessment of genetically modified plants

“…History of endogenous allergenicity assessments Scientific Opinions on soybean including an assessment of endogenous allergenicity were published by the EFSA GMO panel (e.g. EFSA, 2007EFSA, , 2011EFSA, , 2015EFSA, , 2016EFSA, , 2017. Historically, the assessment was carried out using sera from allergic individuals, e.g.…”

Setting an import tolerance for 2,4‐D in soyabeans

“…• Application EFSA-GMO-NL-2011-91 for soybean DAS-68416-4, expressing the AAD-12 and phosphinothricin acetyltransferase (PAT) proteins, which confer tolerance to aryloxyalkanoate herbicides (such as 2,4-D) and glufosinate-ammonium, respectively (EFSA GMO Panel, 2017a) • Application EFSA-GMO-NL-2012-106 for soybean DAS-44406-6, expressing the AAD-12, PAT and 2mEPSPS proteins, which confer tolerance to 2,4-D, glufosinate-ammonium and glyphosate, respectively (EFSA GMO Panel, 2017b) In December 2017, a decision was taken to authorise products containing, consisting of, or produced from genetically modified soybean DAS-68416-4 4 and DAS-44406-6 5 pursuant to Regulation (EC) No 1829/2003 3 .…”

“…In maize grain, the parent compound was the only compound identified (7% TRR; 0.003 mg/kg) and 2,4-DCP could not be detected. Considering that parent was the only compound found in the grain and that grain is the only commodity expected to be imported, EFSA concluded to apply the same residue definitions derived for conventional crops to the GM maize assessed (EFSA, 2017).…”

“…(b): According to the EMS, in DAS-40474-7 more than a single copy of the AAD-1 gene was inserted(EFSA, 2017). (a): Crops which exhibit tolerance to application of 2,4-D herbicide.…”

Human dietary exposure assessment to newly expressed proteins in GM foods

“…proteins expressed in GM crops conferring insect resistance and/or herbicide tolerance. Examples of typical newly expressed proteins, among many others, are 5‐enolpyruvylshikimate‐3‐phosphate‐synthase (CP4‐EPSPS/mEPSPS) enzyme that confers tolerance to glyphosate herbicides, phosphinothricin N ‐acetyltransferase (PAT) enzyme that confers tolerance to glufosinate (phosphinothricin) herbicides or crystal proteins (Cry) that are endotoxins produced by Bacillus thuringiensis conferring resistance to lepidopteran insects (EFSA GMO Panel, , ). In certain occasions, dietary exposure assessment to endogenous food constituents is also performed to characterise potential risks associated, for instance, to significant increases in concentrations of N ‐acetyl amino acids in GM crops expressing glyphosate N ‐acetyltransferase (EFSA GMO Panel, , ,c).…”