Following the submission of an application (EFSA-GMO-NL-2010-78) 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 (Unique Identifier MON-87705-6) for food and feed uses, import and processing.
In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-NL-2010-78, additional information supplied by the applicant, scientific comments submitted by the Member States and relevant scientific publications. The scope of application EFSA-GMO-NL-2010-78 is for food and feed uses, import and processing of soybean MON 87705 within the European Union as any non-GM soybean but excludes cultivation in the EU. The EFSA GMO Panel evaluated soybean MON 87705 with reference to the intended uses defined by the applicant and appropriate principles described in its Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed (EFSA, 2006a, 2011a). The applicant stated that the fatty acid properties of soybean MON 87705 oil would be suitable for replacement of liquid vegetable oils currently used in margarine, salad dressing, mayonnaise and spread, and home-use liquid oil. The applicant did not provide data which would allow a nutritional assessment of soybean MON 87705 oil when used for commercial frying (i.e. high-temperature and repeated frying). Therefore, the nutritional assessment of soybean MON 87705 oil performed by the GMO Panel in this Opinion excludes commercial frying.
The scientific risk assessment included molecular characterisation of the inserted DNA, evaluation of the levels of the CP4 EPSPS protein and the increased oleic acid phenotype. An evaluation of the comparative analyses of composition, agronomic and phenotypic traits was undertaken, and the safety of the new proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of the environmental impacts and the post-market environmental monitoring plan was undertaken.
Soybean MON 87705 was transformed using Agrobacterium tumefaciens (renamed as Rhizobium radiobacter) and expresses the CP4 epsps gene from Agrobacterium sp. CP4 coding for 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS), which renders MON 87705 tolerant to glyphosate-containing herbicides. Soybean MON 87705 also expresses fragments of the endogenous FAD2-1A and FATB1-A genes resulting, through RNA interference, in the decreased levels of fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes, and in turn an increased oleic acid phenotype.
The molecular characterisation data establish that genetically modified soybean MON 87705 contains a single insert, consisting of the intact copies of the FAD2-1A/FATB1-A and CP4 epsps expression cassettes. No other parts of the plasmid used for transformation are present in the transformed plant. Results of the bioinformatic analysis of the 5¢ and 3¢ flanking sequences and ORFs within the insert and spanning the junction sites did not indicate a safety issue. The stability of the inserted DNA was confirmed over several generations and a Mendelian inheritance pattern was demonstrated.
The GMO Panel considered the total compositional, phenotypic and agronomic data supplied and the observed compositional differences between soybean MON 87705 and its conventional counterpart in the light of the field trial design, measured biological variation and the level of the studied compounds in soybean reference varieties, and concludes that soybean MON 87705 differs from the conventional counterpart and other non-GM soybean reference varieties only in the fatty acid profile and the newly expressed protein CP4 EPSPS, as intended.
No toxicity of the CP4 EPSPS protein was observed in an acute oral toxicity study in mice. The protein was rapidly degraded under simulated gastric conditions. In bioinformatics studies the protein showed no homology to known toxic proteins and allergens. A subchronic 90- day feeding study in rats using diets including defatted meal derived from soybean MON 87705 provided no indications of adverse effects. Testing of extracts from soybean MON 87705 and the conventional counterpart A3525 with sera from patients allergic to soybeans showed that the allergenicity of the whole plant had not been changed due to the genetic modification. A 42-day feeding study in broiler chickens demonstrated that diets formulated with defatted meal from soybean MON 87705 are as nutritious as diets with defatted meal from the conventional counterpart and non-GM soybean reference varieties. The GMO Panel is of the opinion that soybean MON 87705 is as safe as its conventional counterpart and non-GM soybean reference varieties in the context of the intended uses as proposed by the applicant. The altered fatty acid profile did not raise concerns regarding toxicity.
The nutritional assessment is focused on the intended increase of oleic acid (C18:1) and the accompanying decreases of linoleic acid (C18:2) and palmitic acid (C16:0), of which the levels were outside the ranges of the natural variation. The EFSA GMO Panel concludes that the estimated changes in fatty acid intake resulting from the replacement of conventional vegetable oils with oil from soybean MON 87705 do not raise nutritional concerns in the context of the intended use, as specified by the applicant. The applicant did not provide data which would allow a nutritional assessment of soybean MON 87705 oil when used for commercial frying (i.e. high-temperature and repeated frying). The EFSA GMO Panel is of the opinion that a specific nutritional assessment is required in case oil derived from soybean MON 87705 is used for food applications which have not been considered in the intake assessment provided to the Panel, e.g. commercial frying.
The scope of application EFSA-GMO-NL-2010-78 is for food and feed uses, import and processing and does not include cultivation. Considering the intended uses of soybean MON 87705, the environmental risk assessment is concerned with the indirect exposure mainly through manure and faeces from animals fed seed produced by soybean MON 87705 and with the accidental release into the environment of viable seeds produced by soybean MON 87705 during transport and processing.
In case of accidental release into the environment of viable seeds of soybean MON 87705 during transportation and processing, there are no indications of an increased likelihood of establishment and spread of feral soybean MON 87705 plants, except in the presence of glyphosate-based herbicides. In addition, the low levels of environmental exposure of these GM soybean plants and the newly expressed protein through other routes indicate that the risk to non-target organisms is extremely low. The EFSA GMO Panel considers that it is unlikely that the recombinant DNA in soybean MON 87705 transfers to bacteria. A risk caused by a rare, but theoretically possible, transfer of the recombinant genes from soybean MON 87705 to bacteria in the environment has not been identified by the GMO Panel because expression of these genes would not provide any selective advantage in the context of its intended use. The scope of the post-market environmental monitoring plan provided by the applicant and the reporting intervals are in line with the intended uses of soybean MON 87705.
The EFSA GMO Panel considers that information available for soybean MON 87705 addresses the scientific comments raised by Member States and considers that the soybean MON 87705 assessed in this application is as safe as its conventional counterpart in the context of its intended uses as proposed by the applicant (i.e. use for food and feed as any conventional soybean except for the oil derived from soybean MON 87705, which is to be used in margarine, salad dressing, mayonnaise and home-use liquid vegetable oil, excluding the use of soybean MON 87705 oil for commercial frying).
The EFSA GMO Panel concludes that soybean MON 87705, as described in this application, is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses as proposed by the applicant.
Considering the altered composition and nutritional values of soybean MON 87705, 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 has proposed that, for example, operators handling products containing or consisting of oil produced from MON 87705 shall be required to label these products with the words “increased oleic acid oil produced from genetically modified soybean”. The GMO Panel notes that the compositional data summarised above (section 4.1.2) show that the fatty acid composition of seeds of soybean MON 87705 and derived oil has indeed been changed in relation to the conventional counterpart, including an increased content of oleic acid in MON 87705 beyond the range of non-GM reference varieties and literature values. The proposed labelling does not specifically mention the intended uses of soybean MON 87705 oil. The GMO Panel recommends adding the specific uses, i.e. “only for use in margarine, salad dressing, mayonnaise and spread, and for home-use”.