Genetically Modified Organisms - Food and Feed
Scientific hearing of renewal application GMFF-2022-9170 for authorisation of the genetically modified maize MON 89034 x 1507 x MON 88017 x 59122 under EU Regulation 1829/2003/EC on genetically modified food and feed
Report no: Innspill til EFSA
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed a renewal application for approval of the genetically modified maize MON 89034 x 1507 x MON 88017 x 59122 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 scientific 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.
Maize MON 89034 x 1507 x MON 88017 x 59122
MON 89034 × 1507 × MON 88017 × 59122 is a stacked event produced by conventional crossing of the genetically modified single maize events MON 89034, 1507, MON 88017 and 59122. The stacked hybrid inherits the traits for protection towards lepidopteran (order of butterflies and moths) pests from MON 89034 and 1507, protection towards coleopteran (order of beetles and weevils) pests from MON 88017 and 59122, as well as tolerance to glyphosate and glufosinate-ammonium based herbicides from 1507, MON 88017 and 59122. This is due to expression of the insecticidal proteins Cry1A.105 and Cry2Ab2 (MON 89034), Cry1F (1507), Cry3Bb1 (MON 88017), Cry34Ab1 and Cry35Ab1 (59122), and the herbicide tolerance enzymes CP4 EPSPS (glyphosate tolerance, MON 88017) and PAT (glufosinate-ammonium tolerance, 1507 and 59122).
VKM concludes that the applicant's scientific documentation for the genetically modified maize MON 89034 x 1507 x MON 88017 x 59122 is sufficient for risk assessment, and in accordance with the EFSA guidance for risk assessment of genetically modified plants for use in food or feed. VKM has not identified specific Norwegian conditions that indicate follow-up. Therefore, VKM had no comments to EFSA regarding the application.
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 scientific 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.