Scientific Opinion on application (EFSA‐GMO‐UK‐2009‐76) for the placing on the market of soybean MON 87769 genetically modified to contain stearidonic acid, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Abstract

Soybean MON 87769 was developed using Agrobacterium tumefaciens transformation and was intended to modify the lipid profile of the extracted oil. Soybean MON 87769 contains a single insert consisting of the Pj.D6D gene encoding the Δ6 desaturase protein from Primula juliae and the Nc.Fad3 gene encoding the Δ15 desaturase protein from Neurospora crassa, both involved in the desaturation of endogenous fatty acids into stearidonic acid. The molecular characterisation of soybean MON 87769 does not raise safety issues. Soybean MON 87769 differs from the conventional counterpart in its fatty acid profile. The safety assessment of the newly expressed desaturases identified no concerns regarding potential toxicity and allergenicity. Nutritional assessment of soybean MON 87769 and derived food products did not identify concerns about human health and nutrition. Consumption of MON 87769 soybean oil replacing other oils in food is not expected to result in adverse effects from increased SDA intake as shown in different exposure scenarios. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of the application, potential interactions of soybean MON 87769 with the biotic and abiotic environment were not considered a relevant issue. Environmental risks associated with a theoretically possible horizontal gene transfer from soybean MON 87769 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 87769. Since the use of oil derived from the soybean MON 87769 will result in a higher intake of SDA, a post-market monitoring plan is recommended to confirm the exposure assessment using realistic consumption data for the European population. Since the use of oil derived from the soybean MON 87769 will result in a higher intake of SDA, a post-market monitoring plan is recommended to confirm the exposure assessment using realistic consumption data for the European population. A comparative analysis of soybean MON 87769 identified no phenotypic or agronomic differences with respect to its conventional counterpart (soybean A3525) and to non-GM soybean reference varieties. However, it confirmed that the composition of soybean MON 87769 differs from that of the conventional counterpart and non-GM soybean reference varieties. The newly expressed desaturases in soybean MON 87769 seeds resulted in an alteration of the fatty acid profile, leading to the appearance of four new fatty acids (stearidonic acid (SDA), -linolenic acid and two trans-fatty acids) and a reduction in linoleic acid (LA). The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced desaturase proteins. There are no indications that the genetic modification might change the overall allergenicity of soybean MON 87769 when compared with that of its conventional counterpart. The EFSA GMO Panel concludes that the estimated changes in fat...

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

“…Since the publication of the scientific opinions on the single soybean events by the EFSA Panel on Genetically Modified Organisms (GMO) (EFSA, 2008;EFSA GMO Panel, 2014), no safety issues pertaining to the two single events have been reported by the applicant.…”

“…The similarity to allergens search used a criterion of 35 % identity to the amino acid sequence of known allergens in a window of 80 amino acids. No matches of eight contiguous identical amino acid sequences between these proteins and known allergens were found, with the exception of one match of eight contiguous serine residues (SSSSSSSS) which was already assessed by the EFSA GMO Panel (see Section 5.1.4.1 of EFSA GMO Panel, 2014).…”

“…(EFSA, 2008;EFSA GMO Panel, 2014), and no new genetic modifications were involved. The genetic elements in the expression cassettes of the single events are summarised in Table 2.…”

“…EFSA, 2008EFSA, , 2014. No new information on allergenicity of the newly expressed proteins that might change the previous conclusions of the EFSA GMO Panel has become available.…”

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003

“…nutritionally enhanced crops, P erez- Massot et al, 2013;EFSA GMO Panel, 2014) or in cases of expected unintended compositional changes (e.g. EFSA GMO Panel, 2011b).…”