Feeding study in rats with genetically modified NK603 maize and with a gly-phosate containing formulation (Roundup) published by Séralini et al. (2012)

In mid-September 2012, a scientific team headed by Gilles-Eric Séralini at the University of Caen in France published the results of a long-term study with rats which had been fed ge-netically modified glyphosate-tolerant NK603 maize…The Federal Institute for Risk Assessment (BfR) has evaluated the study in terms of its relevance for the evaluation of the health risk of genetically modified glyphosate-tolerant maize NK603 and also with regard to the evaluation of the health risk of the glyphosate-containing formulation. On the basis of the publication, the BfR has come to the conclusion that the authors’ main statements are not sufficiently corroborated by experimental evidence, due to deficiencies in the study design and in the presentation and interpretation of the study results. Therefore, the main conclu-sions of the authors are not supported by the presented incomplete data. The study does not comply with internationally recognised standards for long-term carcinogenicity studies. The rat strain used shows a relatively high spontaneous tumour rate, especially for mammary and pituitary tumours, and the number of animals used was too small and insufficient for assess-ing the claimed differences between the test groups and the control group. Also the authors’ hypothesis that the observed effects could result from adverse effects on the endocrine sys-tem is not sufficiently supported by the data presented. Furthermore, the BfR criticises that the glyphosate dose administered was not determined in the studies with the glyphosate-containing plant protection product Roundup. Due to these deficiencies the BfR has asked the authors to provide the complete study report including the individual animal data. More-over, it has asked specific questions in order to allow for a further evaluation of the reported effects.