EFSA reaffirms safety of MON 863 maize

On 20 September 2004 the Regulatory Committee under Directive 2001/18/EC discussed a draft Commission decision on the authorization for the placing on the market of genetically modified maize MON 863. Following discussions concerning another evaluation, submitted by German authorities, of one of the studies reviewed by the EFSA Panel, the European Commission decided to postpone the vote on MON 863 maize. The Commission has sought scientific advice from EFSA as to whether this new evaluation might have any impact on the former opinions issued by the GMO Panel related to MON 863 maize.

Following further investigation and careful consideration of the recently published information** made available to EFSA, the GMO Panel concluded that the evidence presented does not affect its previous scientific advice with regards to MON 863. In its opinion, the GMO Panel concluded that “the placing on the market of MON 863 maize is unlikely to have an adverse effect on human and animal health or on the environment, in the context of its intended use.”  

*EFSA, 2004a. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference C/DE/02/9) for the placing on the market of insect-protected genetically modified maize MON 863 and MON 863 x MON 810, for import and processing, under Part C of Directive 2001/18/EC from Monsanto, The EFSA Journal (2004) 49, 1-25  

*EFSA, 2004b. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safety of foods and food ingredients derived from insect-protected genetically modified maize MON 863 and MON 863 x MON 810, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto, The EFSA Journal (2004) 50, 1-25

**Evaluation of and Final Report on the summary report of the "13-Week Dietary Subchronic Comparison Study with MON 863 in Rats Preceded by a 1-Week Baseline Food Consumption Determination with PMI Certified Diet #5002 (Report MSL-18175/Covance Study No. 6103-293)", dated 15 September 2004.