EFSA: Insufficient Data for Concluding Safety of GM Maize Product

21 June 2013 --- The European Food Safety Authority (EFSA) said it cannot reach a conclusion on the safety of genetically modified (GM) maize 3272 after the applicant failed to provide key information to allow a full risk assessment to take place.

The Authority was therefore prevented from concluding on the safety of GM maize 3272 with regard to human and animal health as the application did not meet a number of minimum standards set out in EFSA’s guidance documents.

EFSA’s Panel on Genetically Modified Organisms (GMOs) found that the comparative assessment of GM maize 3272 performed by the applicant was inadequate due to a lack of data.

This is crucial as comparative assessment is the fundamental requirement for the risk evaluation of GMOs in the European Union (EU). This approach 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 EU 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.

After assessing field trials conducted by the applicant, EFSA said the plant variety chosen by the applicant as a comparator was invalid and did not have a history of safe use. As a result of this shortfall, the GMO Panel said it was not possible to draw conclusions on the safety of key characteristics of GM maize 3272, such as its composition, nutritional properties, toxicity and allergenicity of the whole plant. As with nearly all GMO applications submitted to EFSA (98% to date), experts from the Authority requested additional data from the applicant so GM maize 3272 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’s guidance documents for the risk assessment of GMOs.

A lack of data also meant the Panel was unable to fully conclude on the allergenicity of AMY797E - one of two newly expressed proteins in the GM plant. The applicant was asked to supply further information on two occasions.

EFSA was able to complete a safety assessment on some aspects of the application. The GMO Panel said there were no indications of allergenicity or toxicity relating to PMI – the second newly expressed protein present in GM maize 3272. EFSA also concluded that the GM plant was unlikely to have any adverse effect on the environment in the context of its intended uses as food and feed, as well as import, processing and in the production of biofuel.

EFSA’s risk assessment of GM maize 3272 was delivered in line with its remit to provide independent scientific advice to EU decision-makers. 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.