Following the submission of application EFSA-GMO-NL-2011-100 under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the safety of herbicide-tolerant, increased oleic acid genetically modified (GM) soybean MON 87705 × MON 89788 (Unique Identifier MON-877Ø5-6 × MON-89788-1). The scope of application EFSA-GMO-NL-2011-100 is for food and feed uses, import and processing, but excludes cultivation within the European Union (EU).
The soybean single events MON 87705 (expressing CP4 EPSPS and having an altered fatty acid profile) and MON 89788 (expressing CP4 EPSPS) were assessed previously and no concerns were identified. No safety issue was identified by updated bioinformatic analyses, nor reported by the applicant concerning the two single soybean events, since the publication of the respective scientific opinions. Consequently, the EFSA GMO Panel considers that its previous conclusions on the safety of the single soybean events remain valid.
The two-event stack soybean MON 87705 × MON 89788 was produced by conventional crossing to produce soybean tolerant to glyphosate-based herbicides and having an altered fatty acid profile. The EFSA GMO Panel evaluated soybean MON 87705 × MON 89788 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of GM plants and derived food and feed, the environmental risk assessment of GM plants and the post-market environmental monitoring of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the CP4 EPSPS protein. An evaluation of the comparative analyses of the compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed protein and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of environmental impacts and the post-market environmental monitoring plan was also undertaken. In accordance with the EFSA GMO Panel guidance document applicable to this application “For GM plants containing a combination of transformation events (stacked events) the primary concern for risk assessment is to establish that the combination of events is stable and that no interactions between the stacked events, that may raise safety concerns compared to the single events, occur. The risk assessment of GM plants containing stacked events focuses on issues related to: a) stability of the inserts, b) expression of the introduced genes and their products and c) potential synergistic or antagonistic effects resulting from the combination of the events”.
The molecular data establish that the transformation events stacked in soybean MON 87705 × MON 89788 have the same molecular properties and characteristics as the single transformation events. The presence or absence of interactions that manifest at protein expression level could not be established by comparing the protein levels in the single events and the two-event stack. From the molecular characterisation, no indications of interactions between the events based on the biological functions of the newly expressed proteins were identified.
The EFSA GMO Panel considered the compositional, phenotypic and agronomic data supplied and the observed statistically significant differences between soybean MON 87705 × MON 89788 and its comparator, in the light of the field trial design, measured biological variation and the level of the studied compounds in commercial non-GM soybean reference varieties. No differences in composition requiring further assessment for food/feed safety were observed between soybean MON 87705 × MON 89788 and its comparator, except for the intended trait i.e. altered fatty acid profile (reduced SFAs palmitic acid (C16:0) and stearic acid (C18:0), reduced PUFA linoleic acid (C18:2), and increased MUFA oleic acid (C18:1)).
Nutritional assessment on soybean MON 87705 × MON 89788 oil and oil-containing food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feedingstuffs derived from defatted soybean meal MON 87705 × MON 89788. The EFSA GMO Panel is of the opinion that soybean MON 87705 × MON 89788 is as safe, and at least as nutritious, as its comparator and commercial soybean varieties, in the context of its scope.
Considering the intended modified soybean MON 87705 × MON 89788 nutritional composition, a proposal for a post market monitoring (PMM) plan needs to be provided by the applicant. EFSA recommends that the post-market monitoring plan should initially focus on the collection of import data for Europe; in the event of significant import, requiring a new exposure assessment, consumption data for the European population and concentration data for fatty acids in the oils would be needed.
Considering the scope of application EFSA-GMO-NL-2011-100, there is no requirement for scientific information on possible environmental effects associated with the cultivation of soybean MON 87705 × MON 89788 in Europe. There are no indications of an increased likelihood of establishment and spread of feral soybean MON 87705 × MON 89788 plants in case of accidental release into the environment of viable GM soybean seeds. Potential interactions of soybean MON 87705 × MON 89788 with the biotic and abiotic environment were not considered to be a relevant issue by the EFSA GMO Panel. The unlikely but theoretically possible transfer of the recombinant genes from soybean MON 87705 × MON 89788 to environmental bacteria does not give rise to safety concerns owing to the lack of a selective advantage in the context of its intended uses. The post-market environmental monitoring plan provided by the applicant and the reporting intervals are in line with the scope of application EFSA-GMO-NL-2011-100.
In delivering its scientific opinion, the EFSA GMO Panel took into account application EFSA-GMO-NL-2011-100, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications.
In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87705 × MON 89788 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 87705 × MON 89788 is as safe as its comparator and is unlikely to have adverse effects on human and animal health and the environment in the context of its intended uses as proposed by the applicant.
Considering the modified composition and nutritional values of soybean MON 87705 × MON 89788, the EFSA GMO Panel considered a specific labelling proposal provided by the applicant in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003. The applicant proposed that food and feed products within the scope of application should be labelled as “genetically modified soybean containing increased oleic acid oil”. The GMO Panel is of the opinion that the compositional data show that the fatty acid composition of seeds of soybean MON 87705 × MON 89788 and derived oil has indeed been changed in relation to the comparator.