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Scientific Opinion on application (EFSA-GMO-UK-2009-76) for the placing on the market of soybean MON 87769 genetically modified to contain stearidonic acid, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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Soybean MON 87769 was developed using Agrobacterium tumefaciens transformation and was intended to modify the lipid profile of the extracted oil. Soybean MON 87769 contains a single insert consisting of the Pj.D6D gene encoding the Δ6 desaturase protein from Primula juliae and the Nc.Fad3 gene encoding the Δ15 desaturase protein from Neurospora crassa, both involved in the desaturation of endogenous fatty acids into stearidonic acid. The molecular characterisation of soybean MON 87769 does not raise safety issues. Soybean MON 87769 differs from the conventional counterpart in its fatty acid profile. The safety assessment of the newly expressed desaturases identified no concerns regarding potential toxicity and allergenicity. Nutritional assessment of soybean MON 87769 and derived food products did not identify concerns about human health and nutrition. Consumption of MON 87769 soybean oil replacing other oils in food is not expected to result in adverse effects from increased SDA intake as shown in different exposure scenarios. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of the application, potential interactions of soybean MON 87769 with the biotic and abiotic environment were not considered a relevant issue. Environmental risks associated with a theoretically possible horizontal gene transfer from soybean MON 87769 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87769. Since the use of oil derived from the soybean MON 87769 will result in a higher intake of SDA, a post-market monitoring plan is recommended to confirm the exposure assessment using realistic consumption data for the European population.

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