SmartStax has aroused huge concern because it combines several GM characteristics into a single plant: resistance to two herbicides, and six insecticidal Bt toxins.
European Commissioner Borg should withdraw market authorisation for the controversial SmartStax GM maize, according to a formal Complaint filed by Testbiotech.
In November 2013 the European Commission allowed this controversial maize to be imported into the EU and permitted it to be used in both human food and in animal feeds.
Multiple GM characteristics combined
SmartStax has aroused huge concern because it combines several GM characteristics into a single plant: resistance to two herbicides, and six insecticidal Bt toxins.
The herbicides to which SmartStax has resistance are glyphosate and glufosinate. One of the insecticidal proteins is entirely synthetic and does not exist in nature.
According to Testbiotech, the inclusion of so many GM traits into a single plant makes "pyramiding risks and uncertainties inevitable". However combinatorial effects known to multiply toxicity or reactions of the immune system were not taken into account.
"There was hardly any investigation into the combinatorial effects", says Testbiotech. "No feeding study was performed with the stacked maize to investigate potential effects on health and no investigation was carried out to examine the impact of long-term exposure."
Health impacts never assessed, no independent data ...
SmartStax also has a much higher Bt toxin content than any other GM plant ever produced. Health risks associated with Bt toxins include potential human toxicity and impacts on the immune system causing, for example, inflammatory diseases of the intestine, as highlighted by scientific studies. This risk of Bt toxicity was not assessed by EFSA.
A further matter of concern is the quality of the data provided for risk assessment: "These were conducted by and / or commissioned and paid for by industry", complains Testbiotech.
"No independent laboratories were involved, data were not published in peer-reviewed magazines and the wording of some reports indicates manipulation of the data."
For example, a dossier prepared by Monsanto to assess the agronomic performance of SmartStax explicitly states: "oversight ensured that the data were consistent with expectations". However, EFSA accepted the dossier without criticism.
No targetted monitoring
A further failure is that the Commission did not request targeted monitoring of the effects on health from SmartStax GM maize following consumption.
As a result "effects that contribute to complex or chronic diseases will escape notice ... There are not even any adequate methods available to trace and identify SmartStax in food products."
Under EU regulations, the Commission has two months to respond to the Testbiotech complaint. After due process, it may be possible to forward the case to Court of Justice of the European Union (CJEU).
Testbiotech aims to promote independent research and public debate on the impacts of biotechnology. Based in Munich, Germany, it was founded in 2008,
Briefing on risks of SmartStax
E-mail activity for potential supporters of the complaint.