Genetically Modified Organisms
Preliminary risk assessment of insect resistant and herbicide tolerant genetically modified maize MON 87427 x MON 89034 x MIR162 x NK603 (EFSA-GMO-NL-2016-131)
Report no: Comments to EFSA
The Norwegian Committee for Food Safety (VKM) has performed a preliminary assessment of an application for authorization for the genetically modified maize event MON 87427 x MON 89034 x MIR162 x NK603 in the EAA. The scope of the application includes all uses of maize event MON 87427 x MON 89034 x MIR162 x NK603 and sub-combinations independently of their origin equivalent to the uses of any other maize event MON 87427 x MON 89034 x MIR162 x NK603 grain and forage. The assessment was performed in connection with EFSAs (European Food Safety Authorities) public hearing of application EFSA-GMO-NL-2016-131, on request from the Norwegian Food Safety Authority and the Norwegian Environment Agency.
Through the EEA Agreement, the EU Directive 2001/18/EC on deliberate release into the environment of genetically modified organisms is implemented in Norwegian law. Norway is, therefore, affiliated with the GMO authorisation process in the EU. In the EU, both GMOs and derived products are regulated by the Directive and Regulation 1829/2003/EC. The Regulation concerns genetically modified food and feed and is currently not a part of the EEA Agreement. In preparation for a legal implementation of the Regulation in Norwegian law, Norway follows the EU proceedings for GMO applications.
When a company seeks approval of a genetically modified organism, the application is submitted to the national competent authority of an EU Member State, which forwards the application to EFSA. EFSA then 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 member countries and independent literature. The scientific opinion is then issued to the European Commission.
The assessment of maize event MON 87427 x MON 89034 x MIR162 x NK603 is based on information provided by the applicant in the application EFSA-GMO-NL-2016-131, and relevant peer-reviewed scientific literature.