Final review of the Séralini et 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

Tabs

Article
EFSA Journal 2012;10(11):2986 [10 pp.].
doi
10.2903/j.efsa.2012.2986
European Food Safety Authority
Acknowledgement

EFSA wishes to thank the following EFSA staff: Saghir Bashir, Per Bergman, Danièle Court Marques, Claudia Paoletti, Manuela Tiramani, Didier Verloo and Elisabeth Waigmann for the support provided to this scientific output. EFSA also thanks the concerned MSs who reviewed how their respective assessments are reflected in this report.

Contact
Type
Statement of EFSA
On Request From
European Commission
Question Number
EFSA-Q-2012-00842
Approved
23 November 2012
Published
28 November 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (228.97 KB)228.97 KB
Annex 1 (8.14 MB)
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. 

Keywords
Maize NK603, Roundup, glyphosate, experimental design, rat/rodent feeding study, toxicity, carcinogenicity
Print on demand
Number of Pages
10