“The authors’ conclusions cannot be regarded as scientifically sound because of inadequacies in the design, reporting and analysis of the study as outlined in the paper,” EFSA said in a statement.
EFSA’s final evaluation of the paper – in line with evaluations from six member states – comes two months after a team of researchers led by Professor Gilles-Eric Séralini of the University of Caen sparked a global fracas by linking GM maize and Roundup herbicide consumption with increased incidence of tumours in rats in a paper published in Food and Chemical Toxicology.
Per Bergman, who led EFSA’s assessment of the study, said: “EFSA’s analysis has shown that deficiencies in the Séralini et al. paper mean it is of insufficient scientific quality for risk assessment.”
He added that EFSA and national risk assessment organisations in member states had come to a consensus that the paper’s conclusions were not supported by the data in the published paper.
EFSA had asked Séralini to provide additional information on the study, but the food safety body said Séralini did not respond.
Statistics ‘not powerful enough’
However, on November 9, Séralini et al. published a general response to criticisms of their study, in which the study’s authors said the sample size of their treatment groups was too small to be able to draw conclusions about long-term carcinogenicity and mortality in rats.
“The variability of the mortality can indeed, if interpreted alone, be expected by chance, but in fact the statistics are not powerful enough to conclude that or the contrary,” they wrote.
EFSA pointed out that the authors concluded the opposite in their study – attributing the variability in mortality to consumption of GM maize and Roundup herbicide.
“The results of the study presented here clearly demonstrate that lower levels of complete agricultural glyphosate herbicide formulations, at concentrations well below officially set safety limits, induce severe hormone-dependent mammary, hepatic and kidney disturbances,” Séralini et al. wrote in their study.
EFSA’s final review of the study is available here.