EFSA’s Panel on Genetically Modified Organisms (GMO) delivered its scientific opinion on the application to place the MON 87769 soybean crop – intended to modify the lipid profile of the extracted oil - on the European market for a uses food and feed uses, import and processing.
“The EFSA GMO Panel considers that the information available for soybean MON 87769 addresses the scientific issues indicated by the Guidance document of the EFSA GMO Panel and the scientific comments raised by the Member States, and that soybean MON 87769 is as safe as its conventional counterpart and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of this application,” states the scientific opinion.
The GMO Panel added that a comparative analysis of MON 87769 found no phenotypic or agronomic differences to its counterpart (soybean A3525) or to non-GM soybean reference varieties. However, it confirmed that the composition of MON 87769 differs from that of the conventional counterpart and non-GM soybean reference varieties.
“The newly expressed desaturases in soybean MON 87769 seeds resulted in an alteration of the fatty acid profile, leading to the appearance of four new fatty acids (stearidonic acid (SDA), g-linolenic acid and two trans-fatty acids) and a reduction in linoleic acid (LA),” said EFSA.
“The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced desaturase proteins.”
It added that there are no indications that the genetic modification might change the overall allergenicity of MON 87769 when compared with that of its conventional counterpart.
“The EFSA GMO Panel concludes that the estimated changes in fatty acid intake by consumers using oil from MON 87769 are unlikely to constitute a toxicological risk or to have negative nutritional consequences for humans,” said the Panel. “Based on the results of studies in rats, it is concluded that feeding stuffs derived from defatted soybean MON 87769 are as safe and nutritious as those derived from other non-GM soybean varieties.”
The EFSA opinion added that, based on different exposure scenarios, the proposed use of the GM soybean oil in foods is not expected to result in intakes of SDA with adverse effects - and that the other changes in the dietary fatty acid pattern are unlikely to have negative nutritional consequences for humans.
“The quantitative dietary estimates described here would have to be revisited if the oil produced by soybean MON 87769 were to be extensively used in food products not considered in this assessment, for example as dietary supplements or to modify animal feed products,” added the GMO Panel – adding that it recommends a post-market monitoring plan to confirm the exposure assessment using consumption data for the European populations.
The full scientific opinion can be found here.