Scientific Opinion on application (EFSA‐GMO‐NL‐2012‐108) for the placing on the market of the herbicide‐tolerant genetically modified soybean MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Abstract

Single events MON 87708 and MON 89788 were combined to produce the stack two-event soybean MON 87708 × MON 89788. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single soybean events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of soybean MON 87708 × MON 89788, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of soybean MON 87708 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of application EFSA-GMO-NL-2012-108, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from soybean MON 87708 × MON 89788 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87708 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87708 × MON 89788, as described in this application, is as safe as its non-GM comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of its scope. Soybean containing the single events MON 87708 (expressing DMO) and MON 89788 (expressing CP4 EPSPS) were assessed previously and no concerns were identified for human and animal health or environmental safety. 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 87708 × MON 89788 was produced by conventional crossing to produce soybean tolerant to dicamba and glyphosate-based herbicides. The EFSA GMO Panel evaluated soybean MON 87708 × 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 corresponding proteins. An evaluation of the comparative analyses of the compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expr...

Assessment of genetically modified oilseed rape MON 94100 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐169)

“…The effects of temperature and pH on the DMO protein have been previously evaluated by the GMO Panel (EFSA GMO Panel, 2013 , 2015b , 2019a , b ).…”

“…The resistance to degradation by pepsin of the newly expressed DMO protein has been previously evaluated by the GMO Panel (EFSA GMO Panel, 2013 , 2015b , 2019a , b ).…”

“…The GMO Panel assessed the safety of the DMO protein expressed in oilseed rape MON 94100 considering molecular characterisation, bioinformatic analyses and the previous assessments of the identical DMO protein expressed in soybean MON 87708 (EFSA GMO Panel, 2013 , 2015b , 2019a , b ).…”

“…The studies on protein stability of the DMO protein have been previously assessed (EFSA GMO Panel, 2013 ; Section 3.5.2 ). The allergenic potential of this protein has been previously evaluated (EFSA GMO Panel, 2013 , 2015b , 2019a , b ). In addition, the GMO Panel did not find an indication that the newly expressed protein DMO at the levels expressed in oilseed rape MON 94100 might be adjuvant.…”

Guidance on allergenicity assessment of genetically modified plants

“…History of endogenous allergenicity assessments Scientific Opinions on soybean including an assessment of endogenous allergenicity were published by the EFSA GMO panel (e.g. EFSA, 2007EFSA, , 2011EFSA, , 2015EFSA, , 2016EFSA, , 2017. Historically, the assessment was carried out using sera from allergic individuals, e.g.…”