Genetically Modified Organisms
Report no: Comments to EFSA
The Norwegian Committee for Food and Environment (VKM) has performed a preliminary assessment of a renewal application for authorization of the genetically modified maize event MIR604 in the EEA. The scope of the application includes all uses of maize event MIR604 and sub-combinations independently of their origin equivalent to the uses of any other maize grain and forage. The assessment was performed in connection with EFSA´s (European Food Safety Authorities) public hearing of the renewal application EFSA-GMO-RX-013, on request from the Norwegian Food Safety Authority and the Norwegian Environment Agency.
Commission decision of 2009 authorised the placing of products containing, consisting of, or produced from genetically modified maize event MIR604 on the EU market. The authorisation was granted for a period of ten years.
As a part of the European Economic Area (EEA), Norway is affiliated with the European Union’s (EU) validation system regarding the release of Genetically Modified Organisms (GMOs) to the environment via the EU Directive 2001/18/EF. The Norwegian Biotechnology Act considers this Directive. In the EU, both GMOs and derived products are regulated by the Directive and Regulation 1829/2003. The Regulation concerns genetically modified food and feed and is currently not a part of the EEA or the Norwegian legal system. While preparing to implement the Regulation, Norway follows the EU proceedings for GMO applications.
Applicants wishing to extend the authorization period for genetically modified organisms apply for renewal. EFSA submits the application for a public hearing across all EEA countries. VKM conducts its own review of the application and sends its comments to EFSA. EFSA then completes their scientific opinion based on information from the applicant, comments from EEA countries and independent literature. The scientific opinion is then issued to the European Commission.
The assessment of maize MIR604 is based on information provided by the applicant in application EFSA-GMO-RX-013, and relevant peer-reviewed scientific literature.
After assessing application EFSA-GMO-RX-013, VKM concluded that the application meets the scientific requirements in the EFSA guidance for renewal applications of genetically modified food and feed. Therefore, VKM had no comments to EFSAs public hearing regarding the renewal application for maize MIR604. In 2014, VKM published a risk assessment of maize MIR604 for food and feed uses, import and processing. VKM concluded that maize MIR604 is nutritionally equivalent to conventional maize varieties, and comparable to conventional maize varieties concerning environmental risk.
Maize MIR604 provides protection from feeding damage caused by coleopteran target pests.