Genetically modified (GM) crops and food have aroused controversy in Europe. Among the contentious points is the apparently conflicting evidence on health risks from animal feeding studies: the variability in evidence may often be attributed to methodological inadequacies in some small-scale studies. The latest, most comprehensive research, funded by the European Commission, examined in detail the issues for scientific value, design and interpretation of animal feeding trials for periods from 90 days to 2 years for the safety evaluation of GM maize. In aggregate, this provides a significant contribution to clarifying and augmenting the evidence base on testing procedures.
This research tested GM maize MON 810, resistant to European corn borer and grown in Spain, and NK 603 with tolerance to the herbicide glyphosate and grown in Canada, both approved for the European market. Because of the controversial nature of the topic, the studies were planned and interpreted with stakeholder engagement.
No health risks, including no carcinogenicity, were found for the GM maize tested, reaffirming the conclusions of previous risk assessments. As a result of this extensive and lengthy work, it is concluded that:
1. Based on previous steps of the risk assessment it was not possible to propose a science-based hypothesis for tailoring the design of animal feeding studies for GM maize.
2. Without such a targeted hypothesis, the added scientific value of conducting animal feeding studies is very limited.
3. The mandatory requirement to conduct untargeted animal feeding studies for each novel GM plant should be discontinued.
4. Streamlining future testing regimes according to the established evidence base brings important advantages for the EU in expediting innovation and in reducing the unnecessary use of experimental animals according to the agreed principles of Replacement, Reduction and Refinement.
In the eventuality that a particular concern is identified during the risk assessment procedures, animal feeding studies might be undertaken. In such cases evidence-based criteria such as those developed in the course of these research projects should be used to evaluate the scientific quality of any such study.
Notes to editors
(i) GRACE and G-TwYST projects, conducted over the period 2012-2018 received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration. The conclusions and recommendations of each project are published on the GRACE website and the G-TwYST website.
(ii) For press inquiries, please contact
Joachim Schiemann (GRACE): Tel +49 3946 47 503;
or Pablo Steinberg (G-TwYST): Tel +49 721 6625-201;