Risk assessment standards: Pressure growing on EU Commission and EFSA

EU Parliament has again voted against further market approvals of genetically engineered plants

11 March 2021 / The EU Parliament has again voted with a huge majority against further market approvals for genetically engineered plants. Substantial gaps in the European Food Safety Authority (EFSA) risk assessment were identified. In earlier votes, EU member states also voted overwhelmingly against market approvals. Consequently, there is growing pressure on the EU Commission for much closer scrutiny of EFSA findings and applications for market approval.

The applications were for the import of Monsanto/Bayer cotton (for food and feed) and for Syngenta (ChemChina) maize. Maize MZIR098 is resistant to the herbicide, glufosinate, and produces two synthetic insecticides (Bt -toxins). Cotton GHB614 × T304-40 × GHB119 is made resistant to glufosinate and glyphosate and also produces two insecticides.

In their resolutions, members of the EU Parliament identified risks which have long been ignored: for example, Bt toxins produced in the plants can be much more toxic than the toxins in isolation, which are often used for the risk assessment. Further, the Bt toxins are thought to potentially trigger immune responses.

Legally binding provisions in current risk assessment require that field trials are conducted in realistic conditions representative of the conditions in countries where they will be grown. These provisions are routinely ignored. Realistic conditions are, however, necessary to assess the impact of environmental factors on gene expression and plant composition. In most cases, the field trials are only performed in the US at agricultural sites with relatively similar environmental conditions. In addition, the plants are sprayed with much lower amounts of herbicides than would be applied under practical conditions. Ongoing climate change is also not taken into account even though this causes specific stress conditions for the plants.

New questions are emerging on the health impact from consuming these plants, amongst others, from research on gut bacteria showing that bacteria composition is changed if exposed to the herbicides to which the plants are made resistant. Residues from spraying with these herbicides are often found in the food and feed products derived from the plants. These issues and other relevant risks, such as combinatorial effects, are not, or only insufficiently, taken into account during the approval process.

In summary, it is evident that safety of GE plants claimed by EU Commission and industry for many years, is largely based upon on inconclusive risk assessment and incomplete data. Very often risk assessment only examines those aspects which can be carried out within short periods of time and at low cost. The real complexity of risks is largely set aside. Testbiotech also identified these issues in a recent report.

New risks are also emerging regarding the environment: for example, genetically engineered cotton showing unintended effects enabling spread into wild populations. There are concerns this will have detrimental effects in Mexico, which is a centre of origin for cotton.

Against this backdrop, Testbiotech demands a moratorium on EU approvals for genetically engineered plants, higher standards in risk assessment and a re-evaluation of those which are already approved.

Christoph Then, info@testbiotech.org, Tel +49 (0) 151 54638040