Complaint against EU authorization of GM soybeans

Soy beans cultivation. (Photo:
Leonora Enking/Flickr/CC)

The European Food Safety Authority’s (EFSA) decision to give a green light to cultivation of Monsanto’s herbicide-tolerant soybean have been challenged by the European Network of Scientists for Social and Environmental Responsibility (ENSSER), the research firm Testbiotech, the Society for Ecological Research, Sambucus, the foundation Manfred-Hermsen-Stiftung for Nature Conservation and Environmental Protection and the Foundation on Future Farming. These groups argue that EFSA didn’t carry out risk assessments as legally required.

The soybeans will be mostly sold and grown in Brazil under the brand name Intacta, and the harvest will be imported by 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 EFSA has not carried out the risk assessments for this product in the way as legally required, according to a technical dossier compiled by Testbiotech and a legal dossier 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 authorizations. 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,” said Christoph Then of 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,” he added.

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 emphasize 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 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 authorizations 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 authorized for placing on the market after a scientific evaluation of the highest possible standards. The complaint aims to enforce the implementation of these requirements.

On the other hand, new approvals for the cultivation of genetically engineered crops in Europe in 2012 are unlikely. The Commission returned the dossiers for three maize lines to the European Food Safety Agency (EFSA). MON810, Bt11 and maize 1507 have all been considered safe by EFSA numerous times. In a letter to the EU Commission, EFSA announces a new opinion on maize MON810 till December.

“In our view, this is a first sign that the Commission acknowledges that the present risk assessment for genetically engineered crops must be improved considerably. If EFSA was honest they would admit that there isn’t even any precise knowledge about the content of insecticidal Bt toxin in the plants”, said Christoph Then.

“During the last ten years, there have been manifest problems with the independence of EFSA’s GMO experts. Now, opinions that were already finished with are being put to test again. However, there is a reasonable assumption that EFSA’s safety checks will in fact be more critical than in the past,” he added

In June, the GMO Panel was partly re-established but according to an assessment of Testbiotech, the majority of experts still can be seen as proponents of genetically engineered plants in agriculture.

More information
Testbiotech’s technical dossier:
Professor Ludwig Kraemer’s legal dossier: