Scientific Opinion on application (EFSA-GMO-BE-2010-81) for the placing on the market of genetically modified herbicide-tolerant oilseed rape Ms8, Rf3 and Ms8 x Rf3 for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape Ms8, Rf3 and Ms8 x Rf3 (with the exception of processed oil) under Regulation (EC) No 1829/2003 from Bayer
This scientific opinion is a risk assessment for the placing on the market of the genetically modified (GM) herbicide-tolerant oilseed rape (OSR) Ms8, Rf3 and Ms8xRf3 for food containing or consisting of, and food produced from or containing ingredients produced from, these GM plants. OSR Ms8 (male sterile) and Rf3 (fertility restorer) are the parents of OSR Ms8xRf3, which is fertile, contains the bar, barstar and barnase genes, and is tolerant to glufosinate-ammonium-containing herbicides. Integrity of the inserts present in the single events was demonstrated in the stack. Molecular characterisation did not reveal any safety issues. No biologically relevant differences were identified in the composition or agronomic and phenotypic characteristics of OSR Ms8xRf3, as compared with its non-GM comparator, except for the newly expressed proteins. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of OSR Ms8, Rf3 and Ms8xRf3. A broiler study confirmed that OSR Ms8xRf3 is as nutritious as its non-GM comparator. There are no indications of an increased likelihood of establishment and spread of feral OSR Ms8, Rf3 and Ms8xRf3 plants, or of hybridising wild relatives, unless exposed to glufosinate-ammonium-containing herbicides. Considering the intended uses, potential interactions of feral OSR Ms8, Rf3 and Ms8xRf3 plants with the biotic and abiotic environment are not considered an issue. Environmental risks associated with a possible horizontal transfer into bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses. In conclusion, the EFSA GMO Panel considers that the information available for OSR Ms8, Rf3 and Ms8xRf3 addresses the scientific comments raised by Member States and that OSR Ms8, Rf3 and Ms8xRf3 are unlikely to have an adverse effect on human and animal health or on the environment, in the context of their intended uses.
Abstract
This scientific opinion is a risk assessment for the placing on the market of the genetically modified (GM) herbicide-tolerant oilseed rape (OSR) Ms8, Rf3 and Ms8xRf3 for food containing or consisting of, and food produced from or containing ingredients produced from, these GM plants. OSR Ms8 (male sterile) and Rf3 (fertility restorer) are the parents of OSR Ms8xRf3, which is fertile, contains the bar, barstar and barnase genes, and is tolerant to glufosinate-ammonium-containing herbicides. Integrity of the inserts present in the single events was demonstrated in the stack. Molecular characterisation did not reveal any safety issues. No biologically relevant differences were identified in the composition or agronomic and phenotypic characteristics of OSR Ms8xRf3, as compared with its non-GM comparator, except for the newly expressed proteins. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of OSR Ms8, Rf3 and Ms8xRf3. A broiler study confirmed that OSR Ms8xRf3 is as nutritious as its non-GM comparator. There are no indications of an increased likelihood of establishment and spread of feral OSR Ms8, Rf3 and Ms8xRf3 plants, or of hybridising wild relatives, unless exposed to glufosinate-ammonium-containing herbicides. Considering the intended uses, potential interactions of feral OSR Ms8, Rf3 and Ms8xRf3 plants with the biotic and abiotic environment are not considered an issue. Environmental risks associated with a possible horizontal transfer into bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses. In conclusion, the EFSA GMO Panel considers that the information available for OSR Ms8, Rf3 and Ms8xRf3 addresses the scientific comments raised by Member States and that OSR Ms8, Rf3 and Ms8xRf3 are unlikely to have an adverse effect on human and animal health or on the environment, in the context of their intended uses.
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Arpaia, Salvatore