The unsuitable EU authorisation process for GM

While the authorisation of genetically engineered plants for cultivation seems to be in a deadlock, the authorisation of these crops for import and usage in food and feed is still going on - says think-tank

Surprisingly, the European Commission has sent back the dossiers for three genetically engineered maize lines to the European Food Safety Agency . Now, MON810, Bt11 and maize 1507 have all been considered safe by the European Food Safety Authority numerous times. The genetically engineered maize is producing insecticidal toxins - so called Bt toxins. One of them, MON810, is authorised in the European Union already but its authorisation has to be re-evaluated. And EU regulation foresees each authorisation to be reassessed after a period of 10 years. The other two applications, Bt11 and maize 1507 have been pending in the EU for several years. Many observers expected that a vote on these crops would be taken in July or September 2012. Now it looks like the votes are postponed until 2013, after the EFSA requested a deadline to assess new literature until December.

There are continuous scientific debates about the impact of Bt crops on biodiversity. The insecticide is produced in all parts of the plants during the whole period of vegetation. It is also a constituent of the pollen, the grain and is getting into the soil and surface water. The toxins are supposed to be effective only in certain target pest insects, however there are several publications showing effects in other non-target species. There is even some dispute over whether the toxin can have impact in mammals. For example, some immune reactions are shown in several species like mouse, rat, pig and fish. It is agreed by all experts that the toxin can be detrimental to the larvae of protected European butterfly species.

The genetically engineered crops have been an issue that has sparked political controversy over many years. Countries like Germany, France and others have prohibited its cultivation. So it takes us all by surprise that the commission took its decision to temporarily stop the process of authorisation very silently. The letters to the EFSA were sent in June without any public notice. We only just found the communication from the commission in the EFSA´s register of mandates.

The risk assessment for genetically engineered crops has to be improved considerably. During the last 10 years, there have been manifest problems with the independence of EFSA's GM panel. In June 2012, the panel was partly re-established but according to an assessment that we carried out - the majority of experts still can be seen as proponents of genetically engineered plants in agriculture.

The postponing of the decision about the authorisation of these crops was most likely caused by a political deadlock between the commission and member states – over the new EU regulations. The commission proposed that member states should be allowed to take national decisions on the cultivation of genetically engineered plants - even if they were authorised for commercial growing by the EU. This proposal was pushed by Denmark during its EU presidency, but no agreement was reached. Without agreement though, many member states are unwilling to accept any new authorisation of genetically engineered crops for cultivation.

While the authorisation of genetically engineered plants for cultivation seems to be in a deadlock, the authorisation of these crops for import and usage in food and feed is still going on. The last authorisation was a genetically engineered soybean of Monsanto that produces insecticidal proteins and was made tolerant against herbicides as well. Genetically engineered plants with combination of several gene constructs are likely to become more and more important in the future. In America and Canada, some maize varieties are planted derived from an event called SmartStax - which is producing six insecticidal toxins and is made tolerant against two herbicides.

SmartStax maize was assessed by EFSA in the year 2010 as being safe for food and feed and now awaits final authorisation to be imported. SmartStax is derived from crossing genetically engineered plants that have been inserted with the single gene constructs. So far, the EU risk analysis of these plants is mostly based on the assessment of the parental plants with the single gene construct. For example, no feeding trial with the whole plant to assess health effects was requested by EFSA in the case of SmartStax. But European leaders should be aware that combinatorial effects in these plants should have been tested much more thoroughly.

Dr Christoph Then is executive director of the Testbiotech think-tank