This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified maizeNK603 x MON810 (Unique Identifier MON-ØØ6Ø3-6 x MON-ØØ81Ø-6), developed to provide protection against specific lepidopteran pests and tolerance to glyphosate.
In delivering its opinion the GMO Panel considered the application (Reference EFSA/GMO/UK/2004/01) and the specific comments submitted by the Member States as well as the notification C/GB/02/M3/3 for NK603 x MON810 maize as submitted under Directive 2001/18/EC. Further information from placing MON810 and NK603 maize on the market was taken into account where appropriate. Although an overall single risk assessment of all uses, excluding cultivation, has been made, for regulatory reasons, opinions for the application under Regulation (EC) No 1829/2003 and the notification under Directive 2001/18/EC are issued separately.
NK603 x MON810 maize was assessed with reference to its 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 examination of the transgenic DNA present in NK603 x MON810 maize and the nature and safety of the new proteins produced by the transgenic plants with respect to toxicology and allergenicity. Furthermore, a comparative analysis of agronomic traits and composition was undertaken and the safety of the whole food/feed was evaluated. A nutritional and an environmental assessment, including monitoring plan, were both undertaken.
The single events MON810 and NK603 have been the subjects of earlier assessments. MON810 maize has been previously evaluated and approved under Directive 90/220/EEC. NK603 maizehas been previously evaluated and approvedunder Directive 2001/18/EC. The use of food ingredients from MON810 maize and from NK603 maize were both notified under Regulation (EC) No 258/97.
Molecular analysis of the individual inserts in NK603 and MON810 parents included information on the complete sequence of inserts and flanking regions. The GMO Panel is of the opinion that bioinformatic analysis of the DNA insert and flanking regions indicates no cause for concern. As traditional breeding methods were used in the production of NK603 x MON810 maize, no genetic modification was involved and thus the molecular structures of the DNA inserts in NK603 and MON810 were expected to remain unchanged in NK603 X MON810. This was indicated by the preservation of the phenotypes and was further confirmed using Southern blots which demonstrated that insert structures were indeed retained in NK603 x MON810 maize.
The mean levels of Cry1Ab and CP4 EPSPS proteins in forage and grain of NK603 x MON810were not significantly different from MON810 and NK603 maize, which were previously considered safe and approved. There were large but similar ranges in the expression of these proteins in NK603 x MON810and in NK603 and MON810, respectively. The GMO Panel concludes that these data do not raise safety concerns.
The Panel found no evidence of any interactions between the newly expressed proteins Cry1Ab and CP4 EPSPS and there were no indications of altered allergenic potency of NK603 x MON810 as compared to non-modified maize. In addition, a compositional comparison of NK603 x MON810 maize with non-transgenic comparators revealed no relevant differences. The GMO Panel is therefore of the opinion that this hybrid between MON810 and NK603 maize is as safe for human and animal health as conventional maize. The Panel further concludes that experimental studies have shown NK603 x MON810 maize to be nutritionally equivalent to conventional maize.
The application EFSA?GMO?UK?2004?01 concerns food and feed uses. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of the GM maize. The GMO Panel agrees that unintended environmental effects due to the adventitious establishment and spread of NK603 x MON810 maize will not be different from that of traditionally bred maize. The GMO Panel also concludes that the amounts of Cry1Ab protein being distributed onto land in animal and food waste would be very low, minimizing the possibility for exposure of potentially sensitive non-target organisms. The monitoring plan provided by the applicant is in line with the intended uses for the NK603 x MON810 maize.
In conclusion, the GMO Panel considers that the information available for NK603 x MON810 maize addresses the outstanding questions raised by the Member States and considers it unlikely that NK603 x MON810 maize will have any adverse effect on human and animal health or the environment in the context of its proposed uses.
This scientific opinion corresponds to the risk assessment report requested under Article 6(6) of Regulation (EC) No 1829/2003 and will be part of the overall opinion as required by Regulation (EC) No 1829/2003.