Complaint against EU authorisation of genetically engineered soybeans with stacked genes

Several organisations such as the European Network of Scientists for Social and Environmental Responsibility (ENSSER) are filing a complaint against a decision of the EU Commission to authorise a new genetically engineered Monsanto soybean. The soybeans will be mostly sold and grown in Brazil under the brand name Intacta, the harvest will be imported to the EU for use in food and feed. The new genetically engineered soybean expresses an insecticidal protein and is resistant to the herbicide glyphosate, commonly known as Roundup. The EU gave permission for use of the soybeans in food and feed at end of June. However, the European Food Safety Authority EFSA has not carried out the risk assessments for this product in the way as legally required. This is evident from a technical dossier compiled by Testbiotech and from a legal dossier that will be filed to the Commission. The complaint will be been filed under EU regulation 1367/2006, which means there is a chance that the European Court of Justice may become involved on a later stage.

“EFSA is assessing the risks of genetically engineered plants very superficially by just applying a simplified procedure. In addition, the EU Commission is not fulfilling its duty to control market authorisations. The current procedure is in contradiction to existing EU regulations. Our complaint will put pressure on the Commission and the EFSA to give much more weight to the protection of consumers and the environment”, Christoph Then says for Testbiotech. “The data analysis of risk assessment as performed by EFSA shows that crucial points such as allergenic risks and combinatorial effects were not taken into account sufficiently. In result this causes a high level of risks for the consumers.“

Besides the scientists from ENSSER and Testbiotech, several organisations from Germany are involved in filing the complaint such as the Society for Ecological Research, Sambucus, the foundation Manfred-Hermsen-Stiftung for Nature Conservation and Environmental Protection and the Foundation on Future Farming.
Some of the arguments in the complaint are that:

• Residues from spraying and their combinatorial effects with the insecticides as produced in the plants were not investigated.
• Several documents produced by EFSA emphasise the need for specific risk assessment of genetically engineered plants in regard to infants and other groups of consumers more susceptible to allergic reactions. However, in its opinion, EFSA has disregarded this problem completely.
• In several dossiers as presented by Monsanto, it is obvious that the company has not adhered to the standards of Good Laboratory Practice.
• EU Commission did not request post marketing monitoring of health effects as required by EU regulations.

In contrast to the US, in the EU genetically engineered plants are mostly used only in animal feed. Nearly all food producers in the EU decided to avoid genetically engineered plants in their products. However, the EU authorisations allow all usages in food and feed. This means that, for example, producers of baby food could change their standards and use genetically engineered soybeans without needing any further permission. That is why EFSA must assess these risks before any market authorisation can be given.

The requirements in EU regulations such as Directive 2001/18 and Regulation 1829/2003, state that genetically engineered plants should only be authorised for placing on the market after a scientific evaluation of the highest possible standards. The complaint aims to enforce the implementation of these requirements.