TY - RPRT
T1 - EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion on application (EFSAGMO- NL-2007-39) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 x MON88017 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
AU - EFSA Publication
AU - Sørensen, Ilona Kryspin
PY - 2010
Y1 - 2010
N2 - This opinion reports on an evaluation of a risk assessment for placing on the market the genetically
modified herbicide tolerant and insect resistant maize MON89034 x MON88017 for food and feed
uses, import and processing. Conventional breeding methods were used in the production of maize
MON89034 x MON88017 from inbred lines of the respective parental events. The structural integrity
of the inserts in the single events as well as the phenotypes were retained in the hybrid. The expression
levels of the Cry1A.105, Cry2Ab2, Cry3Bb1 and CP4 EPSPS proteins in maize MON89034 x
MON88017 were demonstrated to be comparable with those of the single events. The comparative
analysis of compositional, phenotypic and agronomic characteristics of this GM maize indicated
equivalence with its conventional counterpart and commercial non-GM maize varieties except for the
expression of the target proteins, providing resistance to certain lepidopteran and coleopteran pests and
tolerance to glyphosate herbicide. The safety assessment identified no concerns regarding potential
toxicity and allergenicity of maize MON89034 x MON88017. A feeding study on broiler chickens
confirmed the nutritional equivalence of this GM maize to its conventional counterpart and
commercial non-GM maize varieties. Considering the intended uses of maize MON89034 x
MON88017, which excludes cultivation within the European Union, no scientific assessment of
potential environmental effects associated with cultivation of maize MON89034 x MON88017 was
required. In case of accidental release of viable maize grain of MON89034 x MON88017 into the environment during transportation and processing, there are no indications of increased likelihood of
establishment or survival of feral maize plants except in the presence of the glyphosate herbicides. In
conclusion, the EFSA GMO Panel considers that the information available for maize MON89034 x
MON88017 addresses the scientific comments raised by the Member States and that the maize
MON89034 x MON88017 as described in this application is as safe as its conventional counterpart
with respect to potential effects on human and animal health and the environment in the context of its
intended uses. The EFSA GMO Panel concludes that maize event MON89034 x MON88017 is
unlikely to have any adverse effect on human and animal health and the environment, in the context of
its intended uses.
AB - This opinion reports on an evaluation of a risk assessment for placing on the market the genetically
modified herbicide tolerant and insect resistant maize MON89034 x MON88017 for food and feed
uses, import and processing. Conventional breeding methods were used in the production of maize
MON89034 x MON88017 from inbred lines of the respective parental events. The structural integrity
of the inserts in the single events as well as the phenotypes were retained in the hybrid. The expression
levels of the Cry1A.105, Cry2Ab2, Cry3Bb1 and CP4 EPSPS proteins in maize MON89034 x
MON88017 were demonstrated to be comparable with those of the single events. The comparative
analysis of compositional, phenotypic and agronomic characteristics of this GM maize indicated
equivalence with its conventional counterpart and commercial non-GM maize varieties except for the
expression of the target proteins, providing resistance to certain lepidopteran and coleopteran pests and
tolerance to glyphosate herbicide. The safety assessment identified no concerns regarding potential
toxicity and allergenicity of maize MON89034 x MON88017. A feeding study on broiler chickens
confirmed the nutritional equivalence of this GM maize to its conventional counterpart and
commercial non-GM maize varieties. Considering the intended uses of maize MON89034 x
MON88017, which excludes cultivation within the European Union, no scientific assessment of
potential environmental effects associated with cultivation of maize MON89034 x MON88017 was
required. In case of accidental release of viable maize grain of MON89034 x MON88017 into the environment during transportation and processing, there are no indications of increased likelihood of
establishment or survival of feral maize plants except in the presence of the glyphosate herbicides. In
conclusion, the EFSA GMO Panel considers that the information available for maize MON89034 x
MON88017 addresses the scientific comments raised by the Member States and that the maize
MON89034 x MON88017 as described in this application is as safe as its conventional counterpart
with respect to potential effects on human and animal health and the environment in the context of its
intended uses. The EFSA GMO Panel concludes that maize event MON89034 x MON88017 is
unlikely to have any adverse effect on human and animal health and the environment, in the context of
its intended uses.
KW - Environment
KW - Risk assessment
KW - Regulation (EC) No 1829/2003
KW - GMO
KW - Insect resistant
KW - Herbicide tolerant
KW - Import and processing
KW - Maize MON89034 x MON88017
KW - Food and feed safety
KW - Maize (Zea mays)
M3 - Report
T3 - the EFSA Journal
BT - EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion on application (EFSAGMO- NL-2007-39) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 x MON88017 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
PB - European Food Safety Authority
ER -