In yet more fallout from the controversial study from the University of Caen, the new report from the German Federal Institute for Risk Assessment (BfR) identifies ‘shortcomings’ in planning and execution of the research. As a result the German regulator said it believes the data contained in the research cannot support the main statements of the authors.
The French study, led by author Gilles-Eric Séralini (initially reported here ) concluded that rats fed with Monsanto's genetically modified NK603 maize, were at significantly higher risk of developing cancers and experiencing early death than a control group fed non-GM maize.
Now, in the first official response from a national or European regulator, the BfR report said the researchers’ conclusions and statements cannot be justified from the data presented in the publication because of a number of flaws in the design and methodology of the study.
The BfR said the study does not comply with internationally recognised standards for studies on carcinogenicity – noting that the strain of rat used in the study “is characterised by a relatively high spontaneous tumour rate, especially for mammary and pituitary tumours.”
In addition the risk assessor said the number of animals used was ‘insufficient’ for assessing the claimed differences between the test groups and the control group.
"The study shows both shortcomings in study design and in the presentation of the collected data,” said Professor Dr Reiner Wittkowski, vice president of the BfR. “This means that the conclusions drawn by the authors are not supported by the available data."
The safety regulator also criticised that the glyphosate dose administered was not determined in the studies with the glyphosate-containing pesticide Roundup. In addition, the BfR criticised the authors for not presenting its complete set of data in the initial publication.
“Due to these shortcomings, the BfR has asked the authors to provide the complete study report including individual animal data,” said the safety authority.
Calls for a ban?
Following the study, environmental charity Friends of the Earth and the French government called on the European Union to ban the GM product while Russian authorities recently imposed a ‘temporary ban’ on GM crops.
Reacting to the calls for a European ban, European Commission spokesman on health and consumer issues, Frédéric Vincent said the European Food Safety Authority (EFSA) would examine the new study in detail: “If it will be ascertained that the study indeed has scientific groudings, the Commission will draw the consequences.”
The BfR said the research findings do not constitute a reason for a re-evaluation of genetically modified NK603 maize, nor does it affect the renewal of glyphosate approval.
The findings of a preliminary EFSA review into the study are due later this week.