EFSA issues opinions on new GM maize:MON 863 maize considered as safe as conventional maize

Given that the Panel was divided in this respect, the European Food Safety Authority will now request the additional study and will then refer the issue back to the GMO Panel.

MON 863 maize was genetically modified to provide protection against certain coleopteran pests, principally corn rootworm. The hybrid maize MON 863xMON 810 was produced by a conventional cross between inbred maize lines in order to combine the rootworm resistant trait with the trait present in MON 810 protecting against lepidopteran pests. (MON 810 maize and derived food and food ingredients have been previously approved for the EU market).

The risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. conducted by the EFSA GMO Panel is based on two questions raised by the Commission related to applications for placing of the maize on the market by Monsanto under Regulation (EC) No 258/97 on novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997. and under Directive 2001/18/EC on the deliberate release of GMOs into the environment. In the first question, the Panel was asked to assess the safety of foods and food ingredients derived from MON 863 and MON 863xMON 810 maize. In the second question, it was requested to determine whether there is any scientific reason to believe that the placing on the market of these GM maize, for import and processing for feed use, is likely to cause any adverse effects on human health or on the environment (in the context of its intended use). These questions followed two separate scientific assessments which were initially carried out by the competent authorities of Germany and subsequently reviewed by all Member States. As questions remained following the evaluation at national level, EFSA was asked by the Commission to carry out a further risk assessment and provide a scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment..

In conclusion, the GMO Panel considers that the information available for MON 863 maize adequately addresses all outstanding questions raised by Member States. It therefore advises that MON 863 will not have an adverse effect on human and animal health or on the environment, in the context of its proposed use. The Panel could not reach a conclusion however on the safety evaluation of the hybrid maize MON 863xMON 810. Dr. Harry Kuiper, Chair of EFSA’s GMO Panel explained further: “While the Panel considered the use of data from the single GM lines MON 863 and MON 810 to support the safety assessment of the GM hybrid maize was scientifically valid, it was divided over the need for specific data confirming the safety assessment of the hybrid maize MON 863xMON 810. In particular, the Panel debated whether an additional 90-day animal study should be conducted in order to provide further reassurance regarding the safety of the hybrid maize.” Therefore, the Panel could not conclude on the safety evaluation of the hybrid.

Given that the Panel was divided with regards to the need for additional data relating to the hybrid maize MON 863xMON 810, EFSA will now request the 90-day study in question and will then refer the issue back to the GMO Panel.