Following a written request by Professor Gilles-Eric Séralini, EFSA has today given the researcher access to all available data relating to the Authority’s evaluation of genetically modified (GM) maize NK603 carried out in 2003 and 2009.
EFSA has provided these data under a routine procedure for the release of information known as a Public Access to Documents request. In order to supply the fullest amount of material possible, access has been granted to the data considered by EFSA in its 2009 opinion, which also includes data sets for the 2003 opinion. For the dossier on NK603 maize, public access has been given on six previous occasions to various parties.
The request for data came after EFSA conducted an initial review of a paper by Séralini et al. that raised concerns about the potential toxicity of GM maize NK603 and of a herbicide containing glyphosate. The assessment by the Authority of the Séralini et al publication was undertaken upon the request of the European Commission. The review found the design, reporting and analysis of the study as described in the paper were inadequate and, in its present form, the publication was of insufficient scientific quality to be considered valid for risk assessment.
As EFSA’s mission is to consider all scientific developments that may be relevant to its risk assessments to safeguard consumer health, it invited Séralini et al. to share further information on their study documentation and procedures. EFSA has made no request for raw data at this point as the identified shortcomings of the paper were related to fundamental issues such as methodology and design.
The Authority repeated its previous request for further information in letters sent to Prof Séralini on 4 October and 18 October 2012. To date EFSA has received no documentation from the authors of the Séralini et al. publication.
EFSA is seeking this documentation in view of the second step of its evaluation process. This will also include an overview of EU Member State assessments and an analysis from the German authorities responsible for the assessment of glyphosate. EFSA’s final review is scheduled to be published in the coming weeks.