EFSA releases final opinion on French GM study
Wednesday 28 November 2012
The European Union's food safety watchdog has identified "Serious defects in the design and methodology" of a study by researchers from Caen University, working under Professor Gilles-Eric Séralini, which found rats fed on a diet of GM maize developed cancer at a higher rate than control animals.
EFSA requested more background information from the research team in October; in response, Professor Séralini made a request for all available information on NK603, the GM maize used in his study. On Wednesday (28th November), the EFSA released its review of the study, in which it concluded "It does not meet acceptable scientific standards and there is no need to re-examine previous safety evaluations of genetically modified maize NK603."
Professor Séralini's study was first published in the journal Food and Chemical Toxicology on 19th September 2012. It immediately became a source of controversy, with scientists rushing to condemn the study as unscientific, or hail its author as the victim of a corporate smear campaign.
In addition to the EFSA assessment, six member states also reviewed the study's findings. Although an independent review of the study by French food safety watchdog ANSES came to similar conclusions as the EFSA earlier this month, the agency pointed out that Séralini's study is one of only a few to examine the long-term effect of consuming GM organisms and agricultural chemicals; it advised the EU to increase research funding into the effects of GM crops, drawing attention to the lack of transparency in the area.
Earlier this month, after a study revealed European licensing for widely used herbicide glyphosate may be flawed; the latest in a series of papers published this year which reveal shortcomings in the EU's risk assessment and regulatory processes, Soil Association policy director Peter Melchett drew attention to a duality within European regulatory bodies. He claimed Séralini's research used the same methods regulators require when they license pesticides for use and pointed out that the study was nevertheless subject to a sustained industry-led campaign to discredit the researchers.
Researchers from groups including Earth Open Source and the Pesticide Action Network have also expressed misgivings over a lack of transparency and potential conflicts of interest in European agrochemical regulation.
EFSA evaluation deems Séralini study "inadmissible"
Upon delivering its final review, EFSA reaffirmed its initial assessment that the authors' conclusions "cannot be regarded as scientifically sound because of inadequacies in the design, reporting and analysis of the study as outlined in the paper." They said, "Consequently, it is not possible to draw valid conclusions about the occurrence of tumours in the rats tested [and] there is no need to re-examine its previous safety evaluations of NK603 or to consider these findings in the ongoing assessment of glyphosate."
The Authority noted that "Unclear study objectives, the low number of rats used in each treatment group, a lack of detail on the feed and treatment formulation, key information missing on the statistical methods employed and incomplete endpoint reporting" all rendered the study inadmissible as conclusive evidence of adverse health effects caused by consuming GM maize.
Per Bergman, who led EFSA’s work, commented on Wednesday, "EFSA's analysis has shown that deficiencies in the Séralini et al. paper mean it is of insufficient scientific quality for risk assessment. In addition, several national organisations were independently mandated by Member States to assess this study. These reviews have demonstrated a consensus among a significant part of the EU risk assessment community that the conclusions of Séralini et al. are not supported by the data in the published paper. We believe the completion of this evaluation process has brought clarity to the issue."
The other six member states charged with reviewing the study reached a "broad consensus" on the issue, according to EFSA. The food safety authorities of Belgium, Denmark, France, Germany, Italy and the Netherlands all contributed to the assessment.
Although one GM crop is licensed for production in the EU (MON810 maize sold as Yieldgard), the controversial maize is banned in France and Germany. NK603, the maize fed to rats is licensed for use in animal feed, but not for human consumption or planting in the EU.