Scientific Opinion on application (EFSA-GMO-NL-2010-87) for the placing on the market of genetically modified herbicide tolerant oilseed rape GT73 for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape GT73 (with the exception of refined oil and food additives) under Regulation (EC) No 1829/2003 from Monsanto
This scientific opinion is a risk assessment for the placing on the market of the genetically modified (GM) herbicide-tolerant oilseed rape (OSR) GT73 for food containing or consisting of, and food produced from or containing ingredients produced from, OSR-GT73. OSR-GT73 contains a single insert consisting of the goxv247 and CP4 epsps expression cassettes. Both proteins confer tolerance against glyphosate-based-herbicides. Bioinformatic analyses of inserted DNA and flanking regions did not raise safety concerns. Levels of CP4 EPSPS and GOXv247 proteins in OSR-GT73 were analysed and the stability of the genetic modification was demonstrated. No biologically relevant differences were identified in the compositional/agronomic/phenotypic characteristics of OSR-GT73 compared with its conventional counterpart, except for the newly expressed proteins. No indication of potential concerns over the safety of the newly expressed CP4-EPSPS and GOXv247 proteins or the occurrence of unintended effects were identified in either OSR-GT73 pollen/pollen-containing dietary supplements or the adventitious presence of trace levels of seeds in human foods. An equivalent assessment with isolated seed protein could not be made because of the lack of availability of relevant consumption and safety data. There are no indications of increased establishment and spread of feral OSR-GT73 plants, or of hybridising wild relatives, unless exposed to glyphosate-based-herbicides. Potential interactions of feral plants with the biotic/abiotic environment do not raise concerns. Environmental risks of horizontal gene transfer into bacteria were not identified. The monitoring plan and reporting intervals are in line with the intended uses. The environmental risk assessment of OSR-GT73 did not identify any safety concerns, in the context of its intended uses. While the Panel is not in a position to conclude on the safety of OSR pollen as such, it concludes that the genetic modification in OSR-GT73 does not constitute an additional health risk if OSR-GT73 pollen were to replace non-GM OSR pollen.