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Crop Biotech Update

EFSA Releases Risk Assessment of New Sequencing Information on GM Soybean Events

August 9, 2017

The European Food Safety Authority (EFSA) has announced new sequencing information on twogenetically modified (GM) soybean events 305423 and 40-3-2.

The GMO Panel has previously assessed GM soybean 305423 as a single event and as part of a two-event stack, 305423 × 40-3-2. These soybean events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. In February 2017, European Commission (EC) requested EFSA to analyze new nucleic acid sequencing data and updated bioinformatics data for soybean event 305423 and to indicate whether the previous conclusions of the GMO Panel on the previously assessed GM soybeans remain valid.

Studies performed for the risk assessment of the single event soybean 305423 and the two-event stack soybean 305423 × 40-3-2 remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence including the RNAi off-target search, did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of the single soybean event 305423 and the two-event stack soybean 305423 × 40-3-2 remains valid.

Likewise, the GMO Panel has previously assessed GM soybean 40-3-2 as a single event and as part of a two-event stack, 305423 × 40-3-2. These soybean events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. In April 2017, EFSA analyzed new nucleic acid sequencing and updated bioinformatics data for soybean event 40-3-2 and to indicate whether the conclusions of the GMO Panel on the previously assessed GM soybeans remain valid. Studies performed for the risk assessment of the single event soybean 40-3-2 and the two-event stack soybean 305423 × 40-3-2 remain valid. The updated bioinformatic analyses performed on the corrected sequence did not give rise to safety issues. Therefore, EFSA concludes, based on the information provided, that the original risk assessment of the soybean event 40-3-2 as a single and the stacked soybean 305423 × 40-3-2 remains valid.

For more details, read Statements for GM soybean events 305423 and 40-3-2 in the EFSA Journal.