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Cited by 47Genetically Modified Organisms ResearchAgricultural safety and regulationsCarcinogens and Genotoxicity Assessment

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

Open access
European Food Safety Authority·2012·EFSA Journal
DOI 10.2903/j.efsa.2012.2986
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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.

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Crossref · 10.2903/j.efsa.2012.2986

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  • The Seralini et al. (2012) long-term toxicity study of GM maize NK603 had key limitations including use of a rat strain with spontaneous mammary tumours, small group sizes, lack of reference controls, lack of compositional data, unconventional statistics, and lack of power analysis.

    “The key limitations of the study include (i) the use of a rat strain with a well-known spontaneous occurrence of mammary tumours in female rats, (ii) the small number of animals used in the various test groups, (iii) the lack of reference controls or data on natural variations of test parameters,”

    From New EU legislation for risk assessment of GM food: No scientific justification for mandatory animal feeding trials (2013) · cites this paper as EFSA, 2012

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Authors
Authority, E. F. S.
Corresponding author
European Food Safety Authority
Venue
EFSA Journal
Publisher
Wiley
Published
2012-11
Volume
10
Issue
11
Pages
2986
ISSN
1831-4732 (ISSN-L)
DOI
10.2903/j.efsa.2012.2986
OpenAlex
W4238364435
Cited by
47
References
4
Citations by year
2026: 2 · 2022: 14 · 2021: 1 · 2020: 3 · 2019: 1 · 2018: 1 · 2017: 3 · 2015: 8 · 2014: 6 · 2013: 7 · 2012: 1
FWCI
8.03
Type
journal article
Language
en
Open access
Licence
Locations
  • EFSA Journal (publishedVersion, cc-by-nd)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Genetically Modified Organisms Research
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Carcinogens and Genotoxicity Assessment
Keywords
glyphosate, study design flaws, tumor incidence

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