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 maize MON 863 x MON 810 (Unique Identifier MON-ØØ863-5 x MON-ØØ81Ø-6).
In the past, EFSA was requested to deliver its opinion on two questions raised by the Commission related to applications for the placing on the market of MON 863 x MON 810 maize under the Novel Food Regulation (EC) No 258/97 for food uses and under the Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment for feed uses, import and processing.
In its opinions of 2 April 2004, the Panel concluded that it was acceptable to use data for the single insert lines MON 863 and MON 810 in support of the safety assessment of MON 863 x MON 810 maize, in addition to the data package provided for MON 863 x MON 810 maize. However, the Panel was divided over the need for confirmatory data for the risk assessment of MON 863 x MON 810 maize, in particular the need for an additional 90 day rat study with MON 863 x MON 810 maize. Therefore, the Panel could not reach agreement on the safety evaluation of MON 863 x MON 810 maize. To resolve this issue, EFSA decided to request the study in question from the applicant in order to allow the Panel to finalise its evaluation.
After receipt of the full data package on the 90 days rat study, EFSA referred the issue back to the GMO Panel and asked the Panel to conclude the risk assessment of MON 863 x MON 810 maize.
Due to changes in the EU legislation, the applicant had to introduce an application under Regulation (EC) No 1829/2003 to replace the application under Regulation (EC) No 258/97 and decided to include in the scope both food and feed uses (reference EFSA GMO DE 2004 03). Import and processing are still covered by the scope of the notification under Directive 2001/18 (reference C/DE/02/9).
In delivering the present opinion the Panel considered the different applications regarding MON 863 x MON 810 maize, the information concerning the single insert lines MON 863 and MON 810, the additional information provided by the applicant and the specific questions and concerns, raised by the Member States. Although an overall single risk assessment 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.
MON 863 x MON 810 maize was assessed 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 target proteins. A comparative analysis of agronomic traits and composition was undertaken and the safety of the new proteins and the whole food/feed was evaluated with respect to toxicity and allergenicity. Both a nutritional and an environmental assessment, including monitoring plans, were undertaken.
MON 863 maize was developed to provide protection against certain coleopteran pests, principally corn rootworm (Diabrotica spp.) by the introduction of a variant Bacillus thuringiensis cry3Bb1 gene expressing an insecticidal protein. MON 863 has received an EFSA opinion in favour of its authorisation. MON 810 maize produces the protein Cry1Ab, which confers protection against certain lepidopteran insect pests (Ostrinia nubilalis and Sesamia spp.). MON 810 was approved under Directive 90/220/EEC by Commission Decision 98/294/EC. The use of food and food ingredients from MON 810 maize was notified in 1997 under Regulation (EC) No 258/97.
MON 863 x MON 810 maize was produced by crosses between maize inbred lines containing MON 863 and MON 810 events to combine the rootworm resistance trait in MON 863 with the trait present in MON 810 protecting against lepidopteran pests.
Molecular analysis of the DNA inserts present in MON 863 x MON 810 maize confirmed that the insert structures of the single events were retained.
Cry3Bb1 and Cry1Ab protein levels in kernels of MON 863 x MON 810 maize were higher than in the individual MON 863 and MON 810 lines. However, the ranges were broad and there were overlaps between the levels of Cry proteins expressed in the MON 863 and MON 810 parents and in MON 863 x MON 810 maize. The Panel concludes that these data do not raise safety concerns.
The safety and the allergenic risk of the Cry3Bb1, Cry1Ab and NptII proteins have previously been assessed in the single events for which positive opinions were issued.
Feeding studies conducted on broilers with MON 863 x MON 810 maize showed no adverse effects. The Panel considers that the nutritional properties of this maize would be no different from those of conventional maize.
The results of the 90 day sub chronic rodent study do not indicate adverse effects from consumption of MON 863 x MON 810 maize and the Panel concludes that there are no concerns over its safety.
The application EFSA GMO DE 2004 03 concerns food and feed uses. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of the maize lines. The GMO Panel agrees that unintended environmental effects due to the establishment and spread of GM maize will not be different from that of traditionally bred maize. The Panel concludes that the amounts of Cry toxin being distributed in the environment 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 GMO.
In conclusion, the Panel considers that the information available for MON 863 x MON 810 maize addresses the outstanding questions raised by the Member States and considers that it will not have adverse effects on human and animal health or the environment in the context of its proposed use.