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Soybean GMB151 was developed to confer tolerance to 4-hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides and resistance to nematodes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between soybean GMB151 and its conventional counterpart needs further assessment, except for palmitic acid and heptadecenoic acid in seeds and carbohydrate and crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the HPPD-4 and Cry14Ab-1 proteins as expressed in soybean GMB151, and finds no evidence that the genetic modification would change the overall allergenicity of soybean GMB151. In the context of this application, the consumption of food and feed from soybean GMB151 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean GMB151 is as safe as the conventional counterpart and non-GM soybean reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean GMB151 seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean GMB151. The GMO Panel concludes that soybean GMB151 is as safe as its conventional counterpart and the tested non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment., European Commission: EFSA-Q-2018-00781.

Soybean MON 87751 9 MON 87701 9 MON 87708 9 MON 89788 (four-event stack soybean) was produced by conventional crossing to combine four single events: MON 87751, MON 87701, MON 87708 and MON 89788. The GMO Panel previously assessed the four single events and did not identify safety concerns. No new data on the single events have been identified that would lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) 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 the four-event stack soybean, as described in this application, is as safe as and nutritionally equivalent to the non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable seeds of the four-event stack soybean into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack soybean. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four-event stack soybean 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.

The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous conclusions of the GMO Panel on the risk assessment of GM soybean A2704‐12 remain valid. The new sequencing data indicated seven nucleotide differences as compared to the sequence originally provided in application EFSA‐GMO‐NL‐2005‐18; six nucleotides in the 3′ genomic flanking region and one nucleotide in the soybean chloroplast DNA fragment located 5′ to the insert. Another nucleotide located in a polylinker region of the insert reported as ambiguous in the originally submitted sequence was resolved in the new sequence data. Based on the information provided on the locations affected by the reported nucleotide differences, no open reading frames (ORFs) spanning the junction site between the insert and the 3′ genomic flanking DNA are affected by the differences in the 3′ genomic flanking region and were therefore excluded from the assessment. However, one ORF spanning the junction between the 5′‐chloroplast DNA fragment and the insert and six ORFs overlapping with the resolved nucleotide in the polylinker region were affected and therefore assessed. Based on the analysis of the provided data, EFSA considers that it is highly unlikely that the reported sequence differences (including the single nucleotide difference in the 5′‐chloroplast DNA fragment) are due to spontaneous mutations and can therefore most likely be attributed to sequencing errors in the originally reported soybean A2704‐12 event sequence. With the exception of bioinformatic analyses, the studies performed for the risk assessment of soybean A2704‐12 are not affected. The new sequencing data and the bioinformatic analyses performed on the new sequence did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of soybean A2704‐12 remains valid.

Soybean MON 87751 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON 87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87751. The nutritional impact of soybean MON 87751‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that soybean MON 87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM soybean reference varieties tested, and no post‐market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON 87751 seeds into the environment, soybean MON 87751 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87751. In conclusion, soybean MON 87751, as described in this application, is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

The GMO Panel has previously assessed genetically modified (GM) soybean 305423 as a single event and as part of a two‐event stack, 305423 × 40‐3‐2. These soybean events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. On 23 February 2017, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for soybean event 305423 and to indicate whether the previous conclusions of the GMO Panel on the previously assessed GM soybeans remain valid. The new sequencing data indicated a four base pair (bp) difference compared to the sequencing data originally provided: one bp located in the genomic 3′ flanking region, two bp located in a gene silencing cassette and one bp in a partial promoter. These bp reported as differences in the new nucleic acid sequencing data on soybean event 305423 were already present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, including an off‐target search with the dsRNA expression cassette, the studies performed for the risk assessment of the single event soybean 305423 and the two‐event stack soybean 305423 × 40‐3‐2 remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence including the RNAi off‐target search, did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of the single soybean event 305423 and the two‐event stack soybean 305423 × 40‐3‐2 remains valid., This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4968/full

Requestor: European CommissionQuestion number: EFSA-Q-2013-01032; In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO) assesses the two-event stack soybean FG72 × A5547-127 for food and feed uses, import and processing. The EFSA GMO Panel previously assessed the two single events combined to produce the two-event stack soybean FG72 × A5547-127 and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean FG72 × A5547-127 did not give rise to safety concerns and no reason to expect interactions between the single events impacting on the food and feed safety of the two-event stack soybean was identified. Although the EFSA GMO Panel cannot conclude on forage composition, soybean forage is not expected to be imported in a significant amount for use as feed. Considering the routes of exposure and limited exposure levels, the EFSA GMO Panel concludes that soybean FG72 × A5547-127 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean FG72 × A5547-127. The EFSA GMO Panel concludes that soybean FG72 × A5547-127 is as safe as the non-genetically modified (GM) comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

Soybean MON 87708 contains a single insert consisting of the dmo expression cassette. The DMO (dicamba mono-oxygenase) proteins confer tolerance to dicamba-based herbicides. Bioinformatic analyses of the inserted DNA and flanking regions do not raise safety issues. The levels of DMO proteins in soybean MON 87708 have been sufficiently analysed. The stability of the genetic modification has been demonstrated. No differences were identified in the compositional data of forage and seeds obtained from soybean MON 87708 or in its agronomic and phenotypic characteristics that would require further assessment with regard to safety by the GMO Panel. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the DMO proteins, or of soybean MON 87708. The compositional data indicating that soybean MON 87708 is as nutritious as non-GM soybean varieties were supported by the outcome of a chicken study. There are no indications of an increased likelihood of establishment and spread of feral GM soybean plants. Considering the scope of this application, potential interactions of soybean MON 87708 with the biotic and abiotic environment were not considered to be an issue. Environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean MON 87708 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87708. In conclusion, the GMO Panel considers that the information available for soybean MON 87708 addresses the scientific comments raised by the Member States, and that the soybean MON 87708, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses.

This Scientific Opinion reports on an evaluation of a risk assessment for the placing on the market for cultivation of genetically modified soybean 40-3-2, and updates the previous EFSA GMO Panel Scientific Opinion on the renewal applications for the continued marketing of soybean 40-3-2. The EFSA GMO Panel considered that soybean 40-3-2 is unlikely to raise additional environmental safety concerns compared with conventional soybean, but that the management of its cultivation could result in environmental harm under certain conditions. The Panel therefore recommended managing the use of glyphosate on soybean 40-3-2 in ways that result in similar or reduced environmental impacts compared with conventional soybean cultivation. There is no evidence of adverse effects on non-target organisms (including pollinators) due to the expression of the CP4 EPSPS protein, and there are no indications of the occurrence of adverse effects on non-target predators, herbivores and decomposers due to potential unintended changes in soybean 40-3-2. Owing to the lack of event-specific data on plant-pollinator interactions, scientific uncertainty on the occurrence of adverse effects on pollinators, due to potential unintended changes in soybean 40-3-2, remains, and strategies for resolving this uncertainty are discussed. The Panel recommended the deployment of case-specific monitoring to address: (1) changes in weed community diversity; and (2) the evolution of resistance to glyphosate in weeds due to changes in herbicide and cutivation regimes. The Panel agreed with the general surveillance plan of the applicant, but requested that the Panel‟s proposals to strengthen general surveillance are implemented. The Panel concluded that the information available for soybean 40-3-2 addresses the scientific comments raised by Member States and that soybean 40-3-2, as described in this application, is as safe as its conventional counterpart and commercial non-GM soybean varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation of soybean 40-3-2 is unlikely to have environmental effects any more adverse than those associated with conventional soybean cultivation.

This scientific opinion is an evaluation of a risk assessment of the genetically modified, insect resistant, soybean MON 87701 for food and feed uses, import and processing. Soybean MON 87701 was developed through Agrobacterium‐mediated transformation. It contains a single insert consisting of a cry1Ac expression cassette, encoding the Cry1Ac protein that confers resistance against specific lepidopteran insects. The stability of the insert was confirmed over multiple generations. Bioinformatic analyses of the insert and its flanking regions, and levels of newly expressed protein did not raise safety concerns. Comparative analyses of compositional, phenotypic and agronomic characteristics indicated that soybean MON 87701 is not different from its conventional counterpart (A5547) and equivalent to commercial soybean varieties, except for having an increased vitamin E content (still within normal ranges) and expressing the Cry1Ac protein. The safety assessment of the Cry1Ac protein and soybean MON 87701 identified no concerns regarding potential toxicity and allergenicity. A feeding study on broiler chickens confirmed that defatted soybean MON 87701 meal is as nutritious as conventional defatted soybean meal. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended use as food and feed, environmental risks associated of an unlikely but theoretically possible horizontal gene transfer from soybean MON 87701 to bacteria have not been identified. Potential interactions of soybean MON 87701 with the biotic and abiotic environment were not considered due to the low level of exposure. The monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87701. The EFSA GMO Panel considers that the soybean MON 87701, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses.

This scientific opinion is an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant and herbicide-tolerant soybean MON 87701 × MON 89788 for food and feed uses, import and processing. Soybean MON 87701 × MON 89788 was produced by conventional crossing methods, and the F1 plant is hemizygous for all newly introduced traits. The soybean contains the Cry1Ac and CP4 epsps genes conferring resistance against certain lepidopteran target pests and tolerance to glyphosate-based herbicides. No biologically relevant differences were identified in the composition or agronomic and phenotypic characteristics of soybean MON 87701 × MON 89788, as compared with its comparator, except that it expresses the Cry1Ac and CP4 EPSPS proteins. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of soybean MON 87701 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended use as food and feed, environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean MON 87701 × MON 89788 to bacteria have not been identified. Potential interactions of soybean MON 87701 × MON 89788 with the biotic and abiotic environment were not considered to be an issue owing to the low level of exposure. The monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87701 × MON 89788. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87701 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87701 × MON 89788, as described in this application, is as safe as its comparator with respect to potential effects on human and animal health and the environment, in the context of its intended uses.