Scientific Opinion on applications (EFSA-GMO-RX-40-3-2[8-1a/20-1a], EFSA-GMO-RX-40-3-2[8-1b/20-1b]) for renewal of authorisation for the continued marketing of (1) food containing, consisting of, or produced from genetically modified soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; (3) other products containing or consisting of soybean 40-3-2 with the exception of cultivation, all under Regulation (EC) No 1829/2003 from Monsanto
This scientific opinion is an evaluation of a risk assessment for the renewal of authorisations for continued marketing of the genetically modified herbicide tolerant soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6) for (1) food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; and (3) of other products containing or consisting of soybean 40-3-2 with the exception of cultivation. Soybean 40-3-2 has been developed for tolerance to glyphosate herbicides by the introduction, via particle gun acceleration technology, of a gene coding for 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS). Molecular analyses indicated that soybean 40-3-2 contains one functional insert expressing CP4 EPSPS and a non-functional insert consisting of a fragment of the CP4 EPSPS coding sequence. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions and the levels of the newly expressed protein in soybean 40-3-2 did not raise any safety concern. The stability of the inserted DNA was confirmed over several generations. Available compositional and agronomic data show that soybean 40-3-2 is compositionally and agronomically equivalent to its conventional counterpart and to other commercial soybean varieties, except for expressing the CP4 EPSPS protein. It is estimated that the European consumers have been exposed to soybean 40-3-2 mainly via soybean oil Processed meal of soybean 40-3-2 has been given to farm animals in the EU at an estimated maximum dietary inclusion levels around 21% for broiler chickens, 18% for pigs, and 12% for dairy cattle. No adverse effects have been linked to these exposures. The safety assessment of the CP4 EPSPS protein expressed in soybean 40-3-2 and the whole soybean plant identified no concerns regarding potential toxicity and allergenicity of soybean 40-3-2. Considering the intended uses of soybean 40-3-2, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of GM soybean 40-3-2 was required. In case of accidental release of viable grains produced by soybean 40-3-2 into the environment during transportation and processing, there are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate herbicides. The EFSA GMO Panel considers unlikely that the recombinant DNA in soybean 40-3-2 transfers to bacteria and other micro-organisms and that the risk caused by a rare but theoretically possible transfer of the recombinant epsps gene from soybean 40-3-2 to environmental microorganisms is regarded to be negligible due to the lack of a selective advantage in the context of its intended use that would be conferred. Taking into account the scope of the application, the rare occurrence of feral soybean plants and the low levels of exposure through other routes, indicate that the risk to non-target organisms is extremely low. The scope of the monitoring plan provided by the applicant and the reporting intervals are in line with the intended uses of soybean 40-3-2 since cultivation is excluded.
In conclusion, on the basis of the information considered in the original application, updated studies in the present applications, and other peer-reviewed scientific data on soybean 40-3-2, the EFSA GMO Panel confirms that soybean 40-3-2 is as safe and nutritious as the conventional counterpart and other commercial soybean varieties.