In the present scientific opinion, the scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (hereafter referred to as the ‘GMO Panel’) reports the outcome of its risk assessment of soybean SYHT0H2 …. The GMO Panel conducted the assessment of soybean SYHT0H2 in line with the principles described in Regulation (EC) No 1829/2003 and its applicable guidelines for the risk assessment of genetically modified (GM) plants.
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The GMO Panel did not identify toxicological and allergenicity concerns regarding the AvHPPD‐03 and PAT proteins expressed in soybean SYHT0H2 and finds no evidence that the genetic modification might significantly change the overall allergenicity of soybean SYHT0H2.
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The GMO Panel concludes that it is unlikely that soybean SYHT0H2 would differ from conventional soybean varieties in its ability to persist under European environmental conditions …. [T]he GMO Panel concludes that soybean SYHT0H2 would not raise safety concerns in the event of accidental release of viable GM soybean seeds into the environment.
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The GMO Panel concludes that soybean SYHT0H2 is as safe as and nutritionally equivalent to the conventional counterpart and the tested non‐GM soybean reference varieties, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean SYHT0H2 grains into the environment, soybean SYHT0H2 would not raise environmental safety concerns.
The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean SYHT0H2. In conclusion, the GMO Panel considers that soybean SYHT0H2, as described in this application, is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.
