Summary

Following the submission of application EFSA‐GMO‐NL‐2016‐128 under Regulation (EC) No 1829/2003 from Monsanto (hereafter referred to as ‘the applicant’), the Panel on Genetically Modified Organisms of the European Food Safety Authority (hereafter referred to as the ‘GMO Panel’) was asked to deliver a scientific opinion on genetically modified (GM) soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 (hereafter referred to as ‘the four‐event stack soybean’). The scope of application EFSA‐GMO‐NL‐2016‐128 is for the placing on the market of the four‐event stack soybean for food and feed uses, import and processing.

The four‐event stack soybean was produced by conventional crossing to combine four single soybean events: MON 87751 (expressing Cry1A.105 and Cry2Ab2), MON 87701 (expressing Cry1Ac), MON 87708 (expressing DMO) and MON 89788 (CP4 EPSPS), to confer tolerance to dicamba‐ and glyphosate‐containing herbicides and resistance against specific lepidopteran pests.

The GMO Panel evaluated the four‐event stack soybean 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 GMO Panel considered the information available on the single events, the four‐event stack soybean, the scientific comments submitted by the Member States and the relevant scientific literature.

The single events MON 87751, MON 87701, MON 87708 and MON 89788 were previously assessed by the European Food Safety Authority (EFSA) and no concerns on their safety were identified. No new safety issue was identified by updated bioinformatic analyses, nor reported by the applicant concerning the four single soybean events, since the publication of the respective scientific opinions. Consequently, the GMO Panel considers that its previous conclusions on the safety of the single soybean events remain valid.

For the four‐event stack soybean, the risk assessment included the molecular characterisation of the inserted DNA and analysis of protein expression. An evaluation of the comparative analysis of agronomic/phenotypic and compositional characteristics was undertaken, and the safety of the newly expressed proteins and the whole food and feed were evaluated with respect to potential toxicity, allergenicity and nutritional characteristics. An evaluation of environmental impacts and the PMEM plan was also undertaken.

The molecular characterisation data establish that the events stacked in the four‐event stack soybean have retained their integrity. Protein expression analyses show that the levels of the newly expressed proteins are comparable in the four‐event stack and in the single events. No indications of interactions that may affect the integrity of the events and the levels of the newly expressed proteins in this four‐event stack soybean were identified.

The comparative analysis of forage and seed composition and agronomic/phenotypic characteristics identified no differences between the four‐event stack soybean and the non‐GM comparator that required further assessment for food/feed safety or environmental impact, except for the levels of Gly m 4 protein in seeds. Those changes were further assessed and not found to have a safety impact.

The molecular characterisation, the comparative analysis and the outcome of the toxicological and allergenicity assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the four‐event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that soybean MON 87751 × MON 87701 × MON 87708 × MON 89788, as described in this application, is as safe as and nutritionally equivalent to the non‐GM comparator and the commercial non‐GM soybean reference varieties (hereafter ‘non‐GM reference varieties’) tested.

Considering the combined events and their potential interactions, the outcome of the comparative analysis and the routes and levels of exposure, the GMO Panel concludes that soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 would not raise safety concerns in the case of accidental release of viable GM soybean seeds into the environment.

Given the absence of safety concerns for foods and feeds from the four‐event stack soybean, the GMO Panel considers that post‐market monitoring of food/feed is not considered necessary. The PMEM plan and reporting intervals are in line with the intended uses of the four‐event stack soybean. The literature searches did not identify any relevant publications on the four‐event stack soybean. In the context of annual PMEM reports, the applicant could further improve future literature searches according to the GMO Panel recommendations provided in this scientific opinion.

The GMO Panel concludes that soybean MON 87751 × MON 87701 × MON 87708 × MON 89788, as described in this application, is as safe as the non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.