EFSA release two scientific reports to clarify for Dow GM maize/soybeans

Date:12-12-2016

Last week, The European Food Safety Authority (EFSA) released two scientific reports to clearance for two Dow AgroSciences genetically modified crop lines: DAS-40278 herbicide-tolerant maize, sold under the Enlist brand; and DAS-81419 insect-resistant soybeans, sold as Conkesta.

EFSA concluded a positive safety assessment for the import approval of two Dow AgroSciences genetically modified crop lines.

Conclusion for DAS-40278 GM maize:

The EFSA GMO Panel was asked to carry out a scientific assessment of maize DAS-40278-9 for import, processing, and food and feed uses in accordance with Regulation (EC) No 1829/2003.

The molecular characterisation data provided for maize DAS-40278-9 did not raise safety issues.

The GMO Panel concluded that none of the differences identified in the compositional, agronomic and phenotypic characteristics of maize DAS-40278-9 required further assessment regarding food and feed safety.

No concerns regarding the potential toxicity or allergenicity of the newly expressed AAD-1 protein were identified, and no evidence that the genetic modification might significantly change the overall allergenicity of maize DAS-40278-9 was found. The nutritional value of food and feed derived from maize DAS-40278-9 is not expected to differ from that of food and feed derived from non-GM maize varieties. The GMO Panel concludes that maize DAS-40278-9, assessed in this application, is as safe and as nutritious as its non-GM comparator and the non-GM maize reference varieties tested.

Considering the scope of the maize DAS-40278-9 application, which excludes cultivation, there is no requirement for a scientific assessment of possible environmental effects associated with the cultivation of this GM maize. The GMO Panel concluded that there is a very low likelihood of environmental effects resulting from the accidental release of viable seeds from maize DAS-40278-9 into the environment. The unlikely, but theoretically possible, horizontal transfer of the recombinant gene from maize DAS-40278-9 to bacteria does not raise any environmental safety concern. Considering the scope of the application, potential interactions of maize DAS-40278-9 with the biotic and abiotic environment were not considered a relevant issue by the GMO Panel. The scope of the PMEM plan provided by the applicant and the reporting intervals are in line with the intended uses of maize DAS-40278-9 and the GMO Panel guidelines on the PMEM of GM plants (EFSA, 2006b; EFSA GMO Panel, 2011b).

In conclusion, the GMO Panel considers that the information available for maize DAS-40278-9 addresses the scientific comments raised by the Member States and that maize DAS-40278-9, as described in this application, is as safe as the non-GM comparator and other non-GM maize varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Conclusion for DAS-81419 GM soybean:

The EFSA GMO Panel was asked to carry out a scientific assessment of soybean DAS-81419-2 for import, processing, and food/feed uses in accordance with Regulation (EC) No 1829/2003. The molecular characterisation data provided for soybean DAS-81419-2 did not give rise to safety issues. The GMO Panel concluded that none of the differences identified in the compositional, agronomic and phenotypic characteristics of soybean DAS-81419-2 required further assessment regarding food and feed safety. No concerns regarding the potential toxicity or allergenicity of the newly expressed Cry1F, Cry1Ac and the PAT proteins were identified, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-81419-2 was found. The nutritional value of food and feed derived from soybean DAS-81419-2 is not expected to differ from that of food and feed derived from non-GM soybean varieties. The GMO Panel concludes that soybean DAS-81419-2, assessed in this application, is as safe and nutritious as its conventional counterpart and the non-GM soybean reference varieties tested. The GMO Panel concluded that there is a very low likelihood of environmental effects resulting from the accidental release of viable seeds from soybean DAS-81419-2 into the environment. Considering the scope of the application with regard to food and feed use, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely, but theoretically possible, HGT from soybean DAS-81419-2 to bacteria have not been identified. The scope of the PMEM plan provided by the applicant is in line with the intended uses of soybean DAS-81419-2.

In conclusion, the GMO Panel considers that the information available for soybean DAS-81419-2 addresses the scientific comments raised by the Member States and that the soybean DAS-81419-2, as described in this application, is as safe and nutritious as its conventional counterpart and non-GM reference varieties tested with respect to potential effects on human and animal health and the environment in the context of the scope of the application.