Scientific Opinion on an application by Bayer CropScience and Monsanto (EFSA-GMO-NL-2009-75) for placing on the market of genetically modified glufosinate-ammonium- and glyphosate-tolerant oilseed rape MS8 3 RF3 3 GT73 and subcombinations, which have not been authorised previously (i.e. MS8 3 GT73 and RF3 3 GT73) independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food, under Regulation (EC) No 1829/2003
The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed the three single events that are combined to produce the three-event stack oilseed rape (OSR) MS8 3 RF3 3 GT73. In this Scientific Opinion, the GMO Panel assessed the three-event stack OSR and subcombinations that have not been authorised previously (i.e. MS8 3 GT73 and RF3 3 GT73), independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The combination of OSR events, MS8, RF3 and GT73, in the three-event stack OSR does not raise issues relating to molecular, agronomic/phenotypic or compositional characteristics requiring further investigations. In line with previous assessments and considering the scope of this application, the GMO Panel did not find indications of safety concern for food and feed with trace levels of glyphosate oxidoreductase (GOX)v247 protein derived from the three-event stack OSR; whereas, the GMO Panel cannot assess the safety of three-event stack OSR products rich in protein, such as rapeseed protein isolates in feed. As the risk assessment of the three-event stack OSR could not be completed for products rich in protein, such as rapeseed protein isolates, the GMO Panel is not in a position to complete the food and feed safety assessment of subcombinations within the scope of this application (i.e. MS8 3 GT73 and RF3 3 GT73). The two-event stack OSR MS8 3 RF3 is outside the scope of this application. Considering the scope of this application, the mode of action of the introduced traits and the data available for the three-event and two-event stack OSR MS8 3 RF3, the GMO Panel considered that different combinations of the events, MS8, RF3 and GT73, would not raise environmental concerns
Abstract
The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed the three single events that are combined to produce the three-event stack oilseed rape (OSR) MS8 3 RF3 3 GT73. In this Scientific Opinion, the GMO Panel assessed the three-event stack OSR and subcombinations that have not been authorised previously (i.e. MS8 3 GT73 and RF3 3 GT73), independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The combination of OSR events, MS8, RF3 and GT73, in the three-event stack OSR does not raise issues relating to molecular, agronomic/phenotypic or compositional characteristics requiring further investigations. In line with previous assessments and considering the scope of this application, the GMO Panel did not find indications of safety concern for food and feed with trace levels of glyphosate oxidoreductase (GOX)v247 protein derived from the three-event stack OSR; whereas, the GMO Panel cannot assess the safety of three-event stack OSR products rich in protein, such as rapeseed protein isolates in feed. As the risk assessment of the three-event stack OSR could not be completed for products rich in protein, such as rapeseed protein isolates, the GMO Panel is not in a position to complete the food and feed safety assessment of subcombinations within the scope of this application (i.e. MS8 3 GT73 and RF3 3 GT73). The two-event stack OSR MS8 3 RF3 is outside the scope of this application. Considering the scope of this application, the mode of action of the introduced traits and the data available for the three-event and two-event stack OSR MS8 3 RF3, the GMO Panel considered that different combinations of the events, MS8, RF3 and GT73, would not raise environmental concerns
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Birch, Andrew Nicholas