This document provides a scientific opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on two applications (References EFSA-GMO-RX-40-3-2[8-1a/20-1a] and EFSA-GMO-RX-40-3-2[8-1b/20-1b]) submitted by Monsanto under Regulation (EC) No 1829/2003 for renewal of the authorisation for continued marketing of (1) food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6); (2) feed containing, consisting of, or produced from soybean 40-3-2; and (3) other products containing or consisting of soybean 40-3-2 with the exception of cultivation.
The scopes of the two renewal applications cover the continued marketing of:
- existing food containing, consisting of, or produced from soybean 40-3-2 (including food additives) (Reference EFSA-GMO-RX-40-3-2[8-1a/20-1a]) that have been placed on the market in accordance with Part C to the Directive 90/220/EC before the entry into force of Regulation (EC) No 258/97 and under Directive 89/107/EEC (Commission Decision 96/281/EC);
- existing feed containing, consisting of, or produced from soybean 40-3-2 (Reference EFSA-GMO-RX-40-3-2[8-1b/20-1b]) that have been placed on the market in accordance with Part C to the Directive 90/220/EEC (Commission Decision 96/281/EC) and as feed materials and feed additives subject to Directive 70/524/EEC;
- other products containing or consisting of soybean 40-3-2 with the exception of cultivation (Commission Decision 96/281/EC).
After the date of entry into force of the Regulation (EC) No 1829/2003, the products mentioned above were notified to the European Commission according to Articles 8 or 20 of this Regulation and subsequently included in the Community Register of GM food and feed.
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 tumefaciens (renamed Rhizobium radiobacter) strain CP4 (CP4 EPSPS). In delivering its scientific opinion, the EFSA GMO Panel considered the renewal applications (EFSA-GMO-RX-40-3-2[8-1a/20-1a], EFSA-GMO-RX-40-3-2[8-1b/20-1b]); a consolidated application on the cultivation of soybean 40-3-2 (application EFSA-GMO-NL-2005-24); additional information submitted by the applicant on request of the EFSA GMO Panel; the scientific comments submitted by Member States; and relevant scientific publications. In accordance with the Guidance Document for renewal of authorisations of existing GMO products, the EFSA GMO Panel has taken into account the new information, experience and data on soybean 40-3-2, which have become available during the authorisation period.
The EFSA GMO Panel assessed soybean 40-3-2 with reference to the intended uses and appropriate principles described in the Guidance Documents of the EFSA GMO Panel for the Risk Assessment of Genetically Modified Organisms and Derived Food and Feed and the Guidance Document of the Scientific Panel on Genetically Modified Organisms for renewal of authorisations of existing GMO products lawfully placed on the market. The scientific assessment included molecular characterisation of the inserted DNA and expression of the target proteins. A comparative analysis of agronomic traits and composition was undertaken and the safety of the new protein and the whole food/feed were evaluated with respect to potential toxicity, allergenicity and nutritional quality. An assessment of environmental impacts and the post-market environmental monitoring plans were undertaken.
The molecular characterisation data establish that the genetically modified soybean 40-3-2 contains one functional insert expressing CP4 EPSPS and a non-functional insert consisting of a 72 bp fragment of the CP4 EPSPS coding sequence. No other parts of the plasmid used for transformation are present in the transformed plant. 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 and a Mendelian inheritance pattern was demonstrated.
The EFSA GMO Panel compared the composition and agronomic characteristics of soybean 40-3-2 and its conventional counterpart, assessed all statistical differences identified, and came to the conclusion that soybean 40-3-2 is compositionally and agronomically equivalent to its conventional counterpart and other commercial soybean varieties, except for the expressing the glyphosate tolerance trait. The risk assessment of the newly expressed protein and the whole crop included an analysis of data from analytical studies, bioinformatics, and in vitro and in vivo studies. The EFSA GMO Panel concluded that the soybean 40-3-2 is as safe as its conventional counterpart and that the overall allergenicity of the whole plant is not changed.
According to the information provided by the applicant, food and feed products produced from soybean 40-3-2 have been consumed without reports of adverse effects since they were approved in the EU in 1996. Scientific publications which have become available since the previous evaluation of soybean 40-3-2 by the Advisory Committee of the Competent Authority of the United Kingdom (UK-ACNFP, 1995) did not raise safety issues. In addition, bioinformatics studies comparing the amino acid sequences of the newly expressed CP4 EPSPS protein in soybean 40-3-2 with amino acid sequences in updated databases of toxic or allergenic proteins confirmed the results of the older studies which identified no relevant similarities to known toxic or allergenic proteins.
The applications EFSA-GMO-RX-40-3-2 concern food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6); feed containing, consisting of, or produced from soybean 40-3-2; and other products containing or consisting of soybean 40-3-2 with the exception of cultivation. Therefore, there is no requirement for scientific assessment of possible environmental effects associated with the cultivation of soybean 40-3-2. There are no indications of an increased likelihood of establishment and spread of feral soybean plants in case of accidental release into the environment of viable grains produced by soybean 40-3-2 during transportation and processing, except in the presence of glyphosate herbicides. Taking into account the scope of the applications, the rare occurrence of feral soybean plants and the low levels of exposure through other routes, the risk to non-target organisms is extremely low. The EFSA GMO Panel considers unlikely that the recombinant DNA in soybean 40-3-2 transfers to bacteria and other microorganisms 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. The EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the general surveillance plan. The EFSA GMO Panel recommends that appropriate management systems should be in place to restrict seeds of soybean 40-3-2 entering cultivation as the latter requires specific approval under Directive 2001/18/EC or Regulation (EC) No 1829/2003.
In conclusion, the EFSA GMO Panel considers that the information available for soybean 40-3-2 addresses the scientific comments raised by the Member States and that the soybean 40-3-2, as described in these applications, 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. The EFSA GMO Panel concludes that soybean event 40-3-2 is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses.