EFSA Journal (Jun 2014)
Scientific Opinion on application (EFSA-GMO-BE-2011-101) for the placing on the market of herbicide-tolerant genetically modified oilseed rape MON 88302 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
Abstract
Oilseed rape MON 88302 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 EPSPS protein, which confers tolerance to glyphosate. The molecular characterisation of oilseed rape MON 88302 did not raise safety issues. Agronomic and phenotypic characteristics of oilseed rape MON 88302 tested under field conditions revealed no biologically relevant differences between oilseed rape MON 88302 and its conventional counterpart, except for days-to-first flowering. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein, and no evidence that the genetic modification might significantly change the overall allergenicity of oilseed rape MON 88302. The nutritional value of oilseed rape MON 88302 is not expected to differ from that of non-GM oilseed rape varieties. There are no indications of an increased likelihood of spread and establishment of feral oilseed rape MON 88302 plants or hybridising wild relatives, unless these plants are exposed to glyphosate. It is unlikely that the observed difference in days-to-first flowering would lead to any relevant increase in persistence or invasiveness. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from oilseed rape MON 88302 to bacteria were not identified. The post-market environmental monitoring plan is in line with the intended uses of oilseed rape MON 88302. In conclusion, the EFSA GMO Panel considers that the information available addresses the scientific requirements of the EFSA GMO Panel and the scientific comments raised by the Member States, and that oilseed rape MON 88302, as described in this application, is as safe as its conventional counterpart and non-GM commercial oilseed rape varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.
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