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Udvalget for Fødevarer, Landbrug og Fiskeri 2006-07
KOM (2005) 0163 Bilag 3
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Parma, 28 June 2007

PRESS RELEASE

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.

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:

Member States (MS) were asked to provide any analyses and comments that may contribute to

consideration of this issue.

EFSA set up a Task Force of internal and external statistical experts to help assess the statistical

methodology applied by authors of the publication in their re-analysis of the original data from the

90-day rat feeding study and to consider the contributions received from MS. As part of that work

a meeting was held with the authors of the paper.

EFSA’s GMO Panel has reviewed all the available evidence.

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:

The statistical analysis made by the authors of the paper did not take into account certain

important statistical considerations. The assumptions underlying the statistical methodology

employed by the authors led to misleading results.

EFSA considers that the paper does not present a sound scientific justification in order to question

the safety of MON 863 maize.

Observed statistically significant differences reported by Monsanto, Séralini et al., and EFSA,

were considered not to be biologically relevant. In the absence of any indications that the observed

differences are indicative of adverse effects, the GMO Panel does not consider that this paper

The scientific opinions are available at EFSA website at

http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gmo_opinions/381.Par.0001.File.dat/opinion_gmo_06_en1.pdf

http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gmo_opinions/383.Par.0001.File.dat/opinion_gmo_07_en1.pdf

European Food Safety Authority - Largo N. Palli 5/a, I - 43100 Parma

Tel: (+39) 0521 036 111 • Fax: (+39) 0521 036 110 • [email protected] • www.efsa.europa.eu

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raises new issues with respect to the safety of MON 863 maize. Therefore, the GMO Panel sees no

reason to revise its previous Opinions that the MON 863 maize would not have an adverse effect

in the context of its proposed use.

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:

Letter to the Commission

http://www.efsa.europa.eu/en/about_efsa/structure/who_is_who/home_cgl/correspondence.html

The GMO Panel statement

http://www.efsa.europa.eu/en/science/gmo/statements0/gmo_statement_mon863_ratfeeding.html

EFSA statistical analysis of the Monsanto data

http://www.efsa.europa.eu/en/science/scientific_reports/statistical_analyses_MON863.html

For media enquiries, please contact:

E-mail:

[email protected]

Alun Jones, Press Officer

Tel: + 39 0521 036 487