Scientific Opinion of the Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-CZ-2006-33) for the placing on the market of the insect-resistant and glyphosate-tolerant genetically modified maize MON 88017 x MON 810, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
1 Division of Toxicology and Risk Assessment, National Food Institute, Technical University of Denmark2 National Food Institute, Technical University of Denmark
(Question No EFSA-Q-2006-020)
Following a request from Monsanto within the framework of Regulation (EC) No 1829/2003 on genetically modified food and feed, the Panel on Genetically Modified Organisms was asked to deliver a scientific opinion on the authorisation of the insect-resistant, glyphosatetolerant genetically modified maize MON 88017 x MON 810 (Unique Identifier MON88Ø17- 3 x MON-ØØ81Ø-6). In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSAGMO- CZ-2006-33, additional information provided by the applicant (Monsanto) and the scientific comments submitted by the Member States. Further information from applications for placing the single insert lines MON 88017 and MON 810 on the market under EU regulatory procedures was taken into account where appropriate. The scope of application EFSA-GMO-CZ-2006-33 is for food and feed uses, import and processing of genetically modified maize MON 88017 x MON 810 and all derived products, but excluding cultivation in the EU. The EFSA GMO Panel assessed maize MON 88017 x MON 810 with reference to the intended uses and the appropriate principles described in the Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed. The scientific assessment included molecular characterisation of the inserted DNA and expression of the new proteins. A comparative analysis of agronomic traits and composition was undertaken and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional quality. An assessment of environmental impacts and the postmarket environmental monitoring plan were also undertaken. Maize MON 88017 was developed to express a modified Cry3Bb1 protein derived from Bacillus thuringiensis subsp. kumamotoensis rendering maize MON 88017 resistant to certain coleopteran pests and the CP4 EPSPS protein derived from Agrobacterium sp. strain CP4 which provides tolerance to glyphosate. Maize MON 810 expresses the Cry1Ab insecticidal protein, derived from Bacillus thuringiensis subsp. kurstaki, which confers protection against lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia. Maize MON 88017 x MON 810 was produced by crosses between maize inbred lines containing MON 88017 and MON 810 events to combine resistance to certain coleopteran (MON 88017 trait) and lepidopteran (MON 810 trait) pests and to confer tolerance to glyphosate (MON 88017 trait). The molecular characterisation data established that the structure of the individual inserts was retained in the hybrid maize MON 88017 x MON 810. Appropriate analyses of the integration sites in maize MON 88017 x MON 810, including flanking regions, was carried out. The bioinformatic analysis demonstrated the absence of any potential new ORFs coding for known toxins or allergens. Based on results of the comparative analysis the EFSA GMO Panel concludes that maize MON 88017 x MON 810 is compositionally, phenotypically and agronomically equivalent to the non-genetically modified (GM) counterpart and conventional maize varieties, except for the presence of Cry3Bb1, CP4 EPSPS and Cry1Ab proteins in maize MON 88017 x MON 810. Based on the assessment of data available, including the additional information provided by the applicant in response to the EFSA GMO Panel’s requests for maize MON 88017 x MON 810, for the single events and for appropriate non-GM controls, the EFSA GMO Panel has found no indication that crossing of MON 88017 with MON 810 maize results in an interaction between the single events which causes compositional or agronomic changes. The Cry3Bb1 and CP4 EPSPS proteins expressed in the parental maize line MON 88017, and the Cry1Ab protein expressed in the parental maize MON 810 have been assessed previously and no safety concerns were identified. Given all the information provided, the EFSA GMO Panel concludes that interactions between the single events that might impact on food and feed safety are unlikely. The nutritional value of maize MON 88017 x MON 810 has been investigated in a feeding study with broilers which confirmed that the nutritional properties of maize MON 88017 x MON 810 would be no different from those of conventional maize. In conclusion, the EFSA GMO Panel considers that maize MON 88017 x MON 810 is as safe and as nutritious as its non-GM counterpart and that the overall allergenicity of the whole plant is not changed. The application EFSA-GMO-CZ-2006-33 concerns food and feed uses, import and processing. Therefore, there is no requirement for scientific assessment of possible environmental effects associated with the cultivation of maize MON 88017 x MON 810. There are no indications of increased likelihood of establishment or survival of feral maize plants in case of accidental release into the environment of maize MON 88017 x MON 810 viable grains during transportation and processing. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize MON 88017 x MON 810. In conclusion, the EFSA GMO Panel considers that the information available for maize MON 88017 x MON 810 addresses the scientific comments raised by the Member States and that it is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment. Therefore the EFSA GMO Panel concludes that maize MON 88017 x MON 810 is unlikely to have any adverse effect on human or animal health or on the environment in the context of its intended uses.
Cry1Ab; CP4 EPSPS; MON 810; Food safety; MON 88017; Environment, import; Maize (Zea mays); Feed safety; Regulation (EC) No 1829/2003; GMO; Insect-resistant; Processing; Human and animal health; MON 88017 x MON 810; Glyphosate-tolerant; Cry3Bb1