Start of Complaint against SmartStax

Testbiotech filed a complaint against the decision of the EU Commission to allow SmartStax in food and feed. In November 2013, the EU Commission allowed this maize to be imported into the EU. By filing the complaint, Testbiotech wants the EU Commission to withdraw market authorisation. According to EU regulations, the EU Commission has two months to respond. After due process of the complaint, it might be possible to forward the case to Court of Justice of the European Union (CJEU).

The reason for the complaint are:
- SmartStax combines several genetically engineered plants into one plant, making pyramiding risks and uncertainties inevitable. Nevertheless, there was hardly any investigation into the combinatorial effects. 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.

- SmartStax has a much higher Bt content than any other genetically engineered plant to date. Health risks associated with Bt toxins are of concern because of potential toxicity as well as its impact on the immune system. For example, there are studies indicating that consumption of such plants could provoke or enhance the risk of inflammatory diseases of the intestine. This risk was not assessed by EFSA.

- A further matter of concern is the quality of the data, which were provided for risk assessment: The investigations used in the risk assessment were conducted by and/or commissioned and paid for by industry. No independent laboratories were involved, data were not published in peer-reviewed magazines and the wording of some reports even indicates manipulation of the data.

SmartStax is a joint Monsanto and Dow AgroSciences genetically engineered maize that produces six insecticidal proteins (Bt toxins) and is tolerant to two herbicides (glyphosate and glufosinate). One of the insecticidal proteins is derived from synthetic DNA that does not have a natural variant.