Final review of the Séraliniet al. (2012a) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology

Abstract

On 19 September 2012, Séralini et al. published online in the scientific journal Food and Chemical Toxicology a publication describing a 2‐year feeding study in rats investigating the health effects of genetically modified maize NK603 with and without Roundup WeatherMAX® and Roundup® GT Plus alone (both are glyphosate‐containing plant protection products). As requested by the European Commission, EFSA reviewed this publication taking into consideration assessments conducted by Member States and any clarification given by the authors. The assessments of Member States and EFSA revealed an overall agreement. The study as reported by Séralini et al. was found to be inadequately designed, analysed and reported. The authors of Séralini et al. provided a limited amount of relevant additional information in their answer to critics published in the journal Food and Chemical Toxicology. Taking into consideration Member States’ assessments and the authors’ answer to critics, EFSA reaches similar conclusions as in its first Statement (EFSA 2012). The study as described by Séralini et al. does not allow giving weight to their results and conclusions as published. Conclusions cannot be drawn on the difference in tumour incidence between treatment groups on the basis of the design, the analysis and the results as reported. Taking into consideration Member States’ assessments and the authors’ answer to critics, EFSA finds that the study as reported by Séralini et al. is of insufficient scientific quality for safety assessments. EFSA concludes that the currently available evidence does not impact on the ongoing re‐evaluation of glyphosate and does not call for the reopening of the safety evaluations of maize NK603 and its related stacks. EFSA's evaluation of the Séralini et al. article is in keeping with its role to review relevant scientific literature for risk assessment on an ongoing basis to ensure that the advice it provides is up‐to‐date.

Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC

“…Two additional published studies on glyphosate formulations, the first one on initiation-promotion in mice (George et al 2010) and the second one, a study of rats (Seralini et al 2014) that was retracted and republished creating some controversies (Fagan et al 2015), were considered inadequate by IARC and EFSA for carcinogenicity assessment (European Food Safety Authority 2012; IARC 2015). Consequently, industry-sponsored studies, required by several jurisdictions worldwide, have constituted the basis for the assessment of animal carcinogenicity by both IARC and EFSA.…”

Science, safety, and trust: the case of transgenic food

“…Scientific community – with few exceptions (21) – replied with a quantity of opinions and response letters from top scientists, where the Seralini study was dismissed and a more solid peer-review system in scientific journals was claimed for (22). As for institutions deputed to safety evaluation, EFSA delivered its final statement (also in agreement with the independent assessments by organizations of Belgium, Denmark, France, Germany, Italy, and the Netherlands) (23), which recommended rejection of this paper as scientifically unsound and stated a no need to re-examine its previous safety evaluations of maize NK603. Weaknesses in the methodology and experimental design, leading to misleading conclusions, were the basic faults assessed in this paper in particular deriving from the use of inappropriate animal line bearing a natural tumor formation rate of more than 50% and the minimal size of animal sample which was in contrast with the internationally recommended standards for a proper nutritional or toxicological assessment of a GM line.…”

The Seralini affair: degeneration of Science to Re-Science?

“…The European Food Safety Authority (EFSA) of the European Commission had sharply criticized Séralini et al [2] and rejected its utility in a regulatory setting [35]. However, even before the paper was republished, the European Commission announced [36] that they would offer funding for research designed to test the observations of Séralini et al The French government also announced they would fund studies to follow-up Séralini et al [2].…”