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Dow AgroSciences Herbicide-Tolerant Soybean DAS-44406-6 for Food and Feed Uses in the EU

Dow AgroSciences Herbicide-Tolerant Soybean DAS-44406-6 for Food and Feed Uses in the EU – The Panel on Genetically Modified Organisms of the European Food Safety Authority has issued a Scientific Opinion which concludes that DAS-44406-6 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 …” – The Panel notes that “… 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 …” – DAS-68416-4 has tolerance to glyphosate-based herbicides, as well as to glufosinate ammonium-based herbicides.

Document Title: The title of the March 21, 2017 EFSA document is “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”

Organization: European Food Safety Authority (EFSA)

Source: March 21, 2017 EFSA Scientific Opinion, which was adopted on February 17, 2017 by the EFSA Panel on Genetically Modified Organisms and published in the EFSA Journal 2017;15(3):4738

Web site: The March 21, 2017 EFSA Scientific Opinion is posted at
http://www.efsa.europa.eu/en/efsajournal/pub/4738
* Specifically at
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4738/epdf

Information about the EFSA Panel on Genetically Modified Organisms is posted at
https://www.efsa.europa.eu/en/panels/gmo

Contact: The Head of the EFSA GMO Unit is Elisabeth Waigmann who may be reached at +39 0521 036 566; e-mail: Elisabeth.Waigmann@EFSA.Europa.EU

Summary: The Abstract of the March 21, 2017 EFSA Scientific Opinion follows:

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 post-market 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.

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