Scientific Opinion on application (EFSA-GMO-NL-2009-64) for the placing on the market of herbicide-tolerant genetically modified soybean BPS-CV127-9 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from BASF Plant Science

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Acknowledgements

The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Risk Assessment and Environment Risk Assessment for the preparatory work on this scientific opinion; and EFSA staff: Jaime Aguilera, Yann Devos and Yi Liu for the support provided to this scientific opinion.

Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2014;12(1):3505 [30 pp.].
doi
10.2903/j.efsa.2014.3505
Possible conflict of interest
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
Panel members at the time of adoption
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry and Nils Rostoks.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2009-64) submitted by BASF Plant Science
Question Number
EFSA-Q-2009-00360
Adopted
5 December 2013
Published
17 January 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Soybean BPS-CV127-9 contains a single insertion locus of the csr1-2 gene. Stability of the genetic modification was demonstrated. The expression of the acetohydroxyacid synthase large sub-unit from Arabidopsis thaliana, conferring tolerance to imidazolinone herbicides, was sufficiently analysed. Bioinformatic analyses did not raise safety issues. No differences were identified in the seed composition that would require further assessment with regard to safety. Regarding agronomic and phenotypic characteristics, a difference in seed weight was identified; however, this difference does not affect the overall safety of this soybean. Although the EFSA GMO Panel cannot conclude on its forage composition, soybean forage is not expected to be imported in significant amount for feed uses. Safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins or soybean BPS-CV127-9. Compositional data indicating that soybean BPS-CV127-9 is as nutritious as non-GM soybean varieties were supported by the outcome of a chicken feeding study. There are no indications of an increased likelihood of spread and establishment of feral soybean BPS-CV127-9 plants, unless they are exposed to imidazolinone-containing herbicides. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean BPS-CV127-9 to bacteria have not been identified. Considering the scope of this application, interactions with the biotic and abiotic environment are not considered to be a relevant issue. The post-market environmental monitoring plan and reporting intervals are in line with the scope of this application. In conclusion, the EFSA GMO Panel considers that the information available for soybean BPS‑CV127-9 addresses scientific comments raised by Member States and that the soybean BPS-CV127-9, as described in this application, is as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.

Keywords
GMO, soybean (Glycine max), BPS-CV127-9, herbicide tolerance, AtAHAS, Regulation (EC) No 1829/2003
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Number of Pages
30