Genetically Modified Organisms
Assessment of the genetically modified maize MON 88017 x MON 810 under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-RX-017)
Report no: 2022:12
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize/ MON 88017 x MON 810 for food and feed uses, import and processing in the EU.
In accordance with an assignment specified by the Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA), VKM assesses whether genetically modified organisms (GMOs) intended for the European market can pose risks to human or animal health, or the environment in Norway. VKM assesses the scientific documentation regarding GMO applications seeking approval for use of GMOs as food and feed, processing, or cultivation.
The EU Regulation 1829/2003/EC (Regulation) covers living GMOs that fall under the Norwegian Gene Technology Act, as well as processed food and feed from GMOs (dead material) that fall under the Norwegian Food Act. The regulation is currently not part of the EEA agreement or implemented in Norwegian law.
Norway conducts its own assessments of GMO applications in preparation for the possible implementation of the Regulation.
In accordance with the assignment by NFSA and NEA, VKM assesses GMO applications during public hearings initiated by the European Food Safety Authority (EFSA), as well as after EFSA has published its own risk assessment of a GMO, up until EU member countries vote for or against approval in the EU Commission. The assignment is divided into three stages.
Genetically modified MON 88017 x MON 810
Genetically modified maize MON 88017 x MON 810 (application EFSA‐GMO‐RX-017) was developed by conventional crossing. Maize MON 88017 x MON 810 plants contain the transgenes cp4 epsps, cry3Bb1 and cry1Ab which encode the proteins CP4 EPSPS, Cry3Bb1 and Cry1Ab. CP4 EPSPS provides tolerance to glyphosate. Cry3Bb1 protein provides protection against certain coleopteran insect pests. Cry1Ab protein provides protection from certain lepidopteran insect pests.
VKM has assessed the documentation in application EFSA-GMO-RX-017 and EFSA's scientific opinion on genetically modified maize MON 88017 x MON 810. VKM concludes that the applicant's scientific documentation for the genetically modified maize is satisfactory for risk assessment, and in accordance with EFSA guidelines for risk assessment of genetically modified plants for food or feed uses.
The genetic modifications in maize MON 88017 x MON 810 do not indicate an increased health or environmental risk in Norway compared with EU countries. EFSA's risk assessment is therefore sufficient also for Norwegian conditions. As no specific Norwegian conditions have been identified regarding properties of the genetically modified maize, VKM's GMO panel has not performed a complete risk assessment of the maize.
In 2007 and 2016, VKM published health and environmental risk assessments of maize MON 88017 x MON 810, no harmful or altered nutritional properties of the genetically modified maize were identified. VKM concluded that the introduced properties in maize MON 88017 x MON 810 do not imply an increased risk of spreading and establishment in Norwegian nature, compared with conventional varieties.
About the assignment
The assignment is divided into three stages.
In stage 1, VKM shall assess the health and environmental risks of the genetically modified organism and derived products in connection with the EFSA public hearing of GMO applications. VKM shall review the scientific documentation that the applicant has submitted and possibly provide comments to EFSA. VKM must also consider: i) whether there are specific Norwegian conditions that could give other risks in Norway than those mentioned in the application, ii) whether the Norwegian diet presents a different health risk for the Norwegian population should the GMO be approved, compared to the European population, and iii) risks associated with co-existence with conventional and/or ecologic production of plants for GMOs seeking approval for cultivation. Relevant measures to ensure co-existence must also be considered.
In stage 2, VKM shall assess whether comments from Norway have been satisfactorily answered by EFSA. In addition, VKM shall assess whether comments from other countries imply need for further follow-up. If EFSAs response to Norwegian comments is not satisfactory, or comments by other countries imply the need for further follow-up, VKM shall in stage 3 perform a risk assessment of these conditions, including conditions specific to Norway.