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 Bt11 in the EEA. The scope of the application includes all uses of maize event Bt11 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-016, on request from the Norwegian Food Safety Authority and the Norwegian Environment Agency.
Commission decision of 2010 authorised the placing of products containing, consisting of, or produced from genetically modified maize event Bt11 on the EU market. The authorisation was granted for a period of ten years.
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.
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 event Bt11 is based on information provided by the applicant in application EFSA-GMO-RX-016, and relevant peer-reviewed scientific literature.
Maize event Bt11 provides tolerance to glufosinate-ammonium herbicides, and protection from feeding damage caused by lepidopteran target pests.
VKM submitted comments on application EFSA-GMO-RX-016 to EFSA before the deadline March 4, 2019.