Food Law News - EU - 2007

EFSA Press release, 28 June 2007

GMOs - EFSA reaffirms its risk assessment of genetically modified maize MON 863

At the request of the European Commission (EC), EFSA has examined a paper by Séralini et al. on the statistical evaluation of a 90-day feeding study in animals with genetically modified maize MON 863, to identify any consequences for EFSA's risk assessment of the safety of MON 863.[1] The paper presents an alternative statistical analysis of the 90-day rat study that was considered in the original risk assessment. Following a detailed statistical review and analysis by an EFSA Task Force, EFSA's GMO Panel has concluded that this re-analysis of the data does not raise any new safety concerns.

EFSA undertook a series of actions to give a considered response to the European Commission on this issue:

Following this work, EFSA has responded to the Commission, published a statistical report and issued a scientific statement from its GMO Panel. The main conclusions are:

Prior to this most recent work, MON 863 maize has been subject to a comprehensive risk assessment by EFSA and by other authorities which did not identify any adverse effects on human and animal health or the environment. The 90-day rat study analysed by this paper is one element of the comprehensive risk assessment of MON863 maize. In addition to the original Opinion in April 2004, this study has been reviewed again twice since then, prior to this recent work.

The letter to the Commission, the GMO Panel statement, EFSA statistical analysis of the Monsanto data are available on the EFSA website at the following links:

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