Scientific Opinion on an application (EFSA-GMO-NL-2010-85) for the placing on the market of MON 87769 × MON 89788 soybean, genetically modified to contain stearidonic acid and be tolerant to glyphosate for food and feed uses, import and processing under R

Abstract

were assessed previously and no concerns were identified for human and animal health or environmental safety. No safety concern was identified by updated bioinformatic analyses, or reported by the applicant with regard to the two single soybean events, since the publication of the corresponding 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 87769 × MON 89788 was produced by conventional crossing of the soybean lines MON 87769 and MON 89788, combining the production of SDA and the tolerance to glyphosate-based herbicides. The EFSA GMO Panel evaluated soybean MON 87769 × 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 (PMEM) of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. 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. Evaluations of environmental impacts and the PMEM plan were also undertaken. In accordance with the EFSA GMO Panel guidance document applicable to this application (EFSA GMO Panel, 2011a) , "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 87769 × MON 89788 have the same molecular properties and characteristics as the single transformation events. Comparison of the levels of the NcΔ15D, PjΔ6D and CP4 EPSPS proteins between the stack and the corresponding single events did not reveal an interaction that would affect protein or trait expression levels in a way that would give rise to safety concerns. The biological functions of the newly expressed proteins did not suggest the possibility of interactions between the events at a functional level.The EFSA GMO Panel considered the compositional, phenotypic and agronomic data supplied and the observed statistically significant differences between soybean MON 87769 × MON 89788 and its comparator, in the light of the field trial design, measured biological variation an...

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788

“…A post-market monitoring plan is recommended to confirm the predicted consumption and the application of conditions of uses considered during the pre-market risk assessment. GMO Panel, 2015). In this scientific opinion, the GMO Panel could not complete the assessment on the impact of refined bleached deodorised oil (RBD) from MON 87769 3 MON 89788 soybean on human health and nutrition due to the lack of an appropriate nutritional assessment provided by the applicant.…”

“…The GMO Panel was mandated to assess additional information on human nutritional assessment of the genetically modified soybean MON 87769 3 MON 89788 to complement its original scientific opinion adopted in 2015 (EFSA GMO Panel, 2015). The additional information comprises a human nutritional assessment of RBD oil from genetically modified soybean MON 87769 3 MON 89788.…”

“…On 17 September 2015 the GMO Panel adopted a scientific opinion on application EFSA-GMO-NL-2010-85 for the placing on the market of soybean MON 87769 3 MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 1 (EFSA GMO Panel, 2015). In this scientific opinion, the GMO Panel could not complete the assessment on the impact of refined bleached deodorised oil (RBD) from MON 87769 3 MON 89788 soybean on human health and nutrition due to the lack of an appropriate nutritional assessment provided by the applicant.…”

“…In 2015, the GMO Panel delivered the scientific opinion on the two-event stack soybean MON 87769 3 MON 89788 (EFSA GMO Panel, 2015). No safety concerns were identified during the molecular characterisation, the comparative analysis (agronomic, phenotypic and compositional characteristics) and the toxicological and allergenicity assessments.…”

“…The composition data used in this nutritional assessment were already provided as part of the application dossier of soybean MON 87769 3 MON 89788 and as additional information during the risk assessment (EFSA GMO Panel, 2015). Composition data were available for both seeds from soybean MON 87769 3 MON 89788 and its derived RBD oil (Table 1); this oil is the main processed product from soybean for human consumption as well as the most relevant from a nutritional point of view in this application.…”