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ANSES - French Agency for Food, Environmental and Occupational Health & Safety

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Published on 22/10/2012

ANSES highlights the weaknesses of the study by Séralini et al., but recommends new research on the long-term effects of GMOs

ANSES was requested by the French Government to examine the paper by Séralini et al. published on 19 September 2012. The collective expert assessment carried out by the Agency concluded that the results of this research do not cast doubt on previous regulatory assessments of NK603 maize and Roundup. However, ANSES emphasises the small number of published studies dealing with the potential long-term effects of the consumption of GMOs in association with pesticides and recommends undertaking research into these issues. In addition, the Agency calls for national or European funding to enable large-scale studies and research for consolidating our knowledge of insufficiently documented health risks.

After the publication on 19 September of a study by Séralini et al. on the long-term toxicity of the plant protection product Roundup and the genetically-modified, “glyphosate-ready” NK603 maize, ANSES received requests from the Ministers for Health, Ecology, Agriculture and Consumer Affairs to examine the article.

The expert assessment carried out by the Agency concludes that the results of this research do not cast doubt on the previous assessments of genetically-modified NK603 maize and Roundup.

In addition to the criticism already expressed by other bodies concerning the methodology, and based on the in-depth assessment that it has itself undertaken, ANSES considers that the study’s central weakness lies in the fact that the conclusions advanced by the authors are not sufficiently supported by the data published. These data do not make it possible to scientifically establish any cause and effect relationship between consumption of the GM maize and\or the pesticide and the pathologies mentioned, nor to support the conclusions drawn by the authors or the mechanisms of action they suggest.

ANSES draws attention, however, to the originality of this study, namely its focus on a subject rarely investigated to date: the long-term effects of GMOs in association with plant protection products.

This concern reflects ANSES’s desire to contribute to improving regulatory risk assessment whenever necessary, in order to keep abreast of the constant developments in scientific knowledge and technology.

It was with this in mind that, in 2011, the Agency issued an Opinion recommending more rigorous conditions for carrying out the studies required in the context of applications for authorisation of GMOs, and proposing a very strict methodology for the analysis of data. A draft European Regulation incorporating ANSES’s recommendations is currently being finalised and was submitted to the Member States in the spring of 2012.

Regarding plant protection products, ANSES has made a considerable effort to ensure that the European guidelines more effectively take into account the cumulative effects of active substances. These changes are currently being incorporated into the European assessment criteria with the intention of extending them to include the accumulated effects of combinations of active substances and co-formulants.

In addition to the current efforts to reinforce the regulatory framework, a review of the literature and the expert assessment identified only a few studies on the potential long-term effects of the consumption of GMOs together with pesticides. In fact, the Agency was only able to find two other studies which covered the entire lifetime of the subject animals.

With these points in mind, ANSES recommends initiating studies and research on the long-term effects of GMOs in combination with plant protection products. Public funding should be made available for these studies, which should be carried out using precise investigation protocols. ANSES is willing to work together with other partners, including other European health and safety agencies, in order to draw up the general principles for such study protocols.

The issue of public funding for studies and research is of particular relevance in a context where scientific publications can have a wide range of origins: on the one hand, regulatory studies funded by industry and on the other hand, publicly-funded research, with more limited resources and for which the research priorities do not necessarily include an investigation of potential health effects which have only been rarely studied to date. This situation is by no means restricted to GMOs: there are several other areas marked by an equal lack of scientific knowledge and a particularly strong public desire for independent, publicly-funded research.

To address this situation, ANSES calls for public funding on the national and European level to enable large-scale studies and research for consolidating knowledge of insufficiently documented health risks, similar to the National Toxicology Program implemented in the US.

Find out more

> Opinion of ANSES regarding the study of Séralini et al. (2012) "Long term toxicity of a ROUNDUP herbicide and a ROUNDUP-tolerant genetically modified maize"

> Press kit : ANSES highlights the weaknesses of the study by Séralini et al., but recommends new research on the long-term effects of GMOs

> Hearing with the authors of the publication by Séralini et al. (verbatim report currently being reread by the authors)

> Hearing with the Générations Futures association (in French)

> English version of the publication in Japonese Sakamoto et al., 2008 - Translated by Anses for the need of the expertise

> Contribution from Monsanto