Scientific Statement of EFSA: Review of the Séralini et al. (2012) publication

 Here is access to the professional European Food Safety Agency preliminary review of the recent shocking CRIIGEN paper. (There is a free access pdf full journal copy at the EFSA webpage)

@ Statement of EFSA: Review of the Séralini et al. (2012) publication:


CONCLUSIONS
EFSA notes that the study, as described in the Séralini et al. (2012) publication, is inadequately reported with many key details of the design, conduct, analysis and reporting being omitted. Without such details it is impossible to give weight to the subsequent results.
Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on the basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication. In particular, Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per treatment per sex. This falls considerably short of the 50 rats per treatment per sex as recommended in the relevant international guidelines on carcinogenicity testing (i.e. OECD 451 and OECD 453). Given the spontaneous occurrence of tumours in Sprague-Dawley rats, the low number of rats reported in the Séralini et al. (2012) publication is insufficient to distinguish between specific treatment effects and chance occurrences of tumours in rats.
Considering that the study as reported in the Séralini et al. (2012) publication has unclear study objectives and given its inadequate design, analysis and reporting, EFSA finds that it is of insufficient scientific quality for safety assessments. Therefore EFSA, concludes that the Séralini et al. study as reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize NK603 and its related stacks.

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 (GM) maize NK603 with and without Roundup WeatherMAX® and Roundup® GT Plus alone (both are glyphosate-containing plant protection products).  EFSA was requested by the European Commission to review this publication and to identify whether clarifications are needed from the authors. EFSA notes that the Séralini et al. (2012) study has unclear objectives and is inadequately reported in the publication, with many key details of the design, conduct and analysis being omitted. Without such details it is impossible to give weight to the results. Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on the basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication. In particular, Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per treatment per sex which is an insufficient number of animals to distinguish between specific treatment effects and chance occurrences of tumours in rats.  Considering that the study as reported in the Séralini et al. (2012) publication is of inadequate design, analysis and reporting, EFSA finds that it is of insufficient scientific quality for safety assessment. Therefore EFSA, concludes that the Séralini et al. study as reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize NK603 and its related stacks. EFSA will give the authors of the Séralini et al. (2012) publication the opportunity to provide further information on their study to EFSA.

Cites:

 Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG (2010) Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research. PLoS Biol 8(6): e1000412. doi:10.1371/journal.pbio.1000412

ARRIVE Recommendations for Animal research

Update 
Nov 28 2013 Elsevier Announces Seralini 2012 Article Retraction from Journal Food and Chemical Toxicology