Inadequate data prevent EFSA from concluding on safety of GM maize 98140

The European Food Safety Authority (EFSA) could not conclude on the safety of genetically modified (GM) maize 98140 after the applicant failed to supply essential data to allow a full risk assessment to take place. EFSA was prevented from reaching a conclusion overall on the potential risks posed by herbicide tolerant GM maize 98140 to human and animal health as the application did not meet all the minimum standards set out by the Authority’s guidance document.

Experts from the Authority’s Panel on Genetically Modified Organisms (GMO) found it was not possible to carry out the comparative assessment of the GM maize because studies submitted as part of the application contained insufficient data on the plant’s characteristics, such as its composition and appearance.

Comparative assessment is the fundamental requirement for the risk evaluation of GMOs. It compares GM plants, and the food and feed derived from them, with their respective conventional counterparts – known as comparators. The basic assumption of this method, which is required under current European Union legislation for all GMO applications, is that food and feed from conventionally-bred plants have a history of safe use. They can therefore serve as a baseline for the risk assessment of food and feed derived from GM plants.

Following an initial assessment of the field trials by the applicant, EFSA concluded that the plant variety chosen by the applicant as a comparator was not valid. As with nearly all GMO applications submitted to EFSA (98% to date), scientists from the Authority requested additional data from the applicant so GM maize 98140 could be properly assessed. However, the information supplied by the company relating to field trials performed for the comparative assessment again failed to meet the criteria in EFSA guidance documents.

There were, however, aspects of the application where the GMO Panel was able to complete a safety assessment. EFSA concluded there was no indication of allergenicity relating to the newly expressed proteins GAT4621 and ZM-HRA in the GM plant. EFSA also confirmed that the elevated levels of certain constituents of GM maize 98140 (amino acids also found in conventional plants) did not raise safety concerns for humans and animals. The Panel also concluded that the GM maize was unlikely to have any adverse effect on the environment in the context of its intended uses in food and feed and import and processing.

But overall, the Authority could not complete the risk assessment of GM maize 98140 due to inadequacies in the comparative assessment performed by the applicant and was therefore unable to draw conclusions on its safety with respect to potential effects on human and animal health.

EFSA’s risk assessment of GM maize 98140 was delivered in line with its remit to provide independent scientific advice to decision-makers in the European Union. Risk managers in the European Commission and Member States take EFSA’s evaluations into account, along with other factors, when deciding on the authorisation of GMOs.

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