Scientific hearing of application GMFF-2024-22152/AP194 for authorisation of the genetically modified maize Bt11 x MIR162 x MZIR098 x DP4114 x NK603 under EU Regulation 1829/2003/EC on genetically modified food and feed

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. The assignment is divided into three stages. (link)

Genetically modified maize Bt11 x MIR162 x MZIR098 x DP4114 x NK603

Maize Bt11 x MIR162 x MZIR098 x DP4114 x NK603 was developed by combining five individual transformation events using conventional breeding. The stacked-event provides resistance of certain lepidopteran and coleopteran insect pests, and tolerance to glufosinate-ammonium and glyphosate in herbicide products.

Maize Bt11 contain the transgenes cry1Ab and pat. The transgene cry1Ab encodes the truncated Cry1Ab protein and is active against certain lepidopteran insect pests. The transgene pat encodes the enzyme phosphinothricin acetyltransferase (PAT). PAT protein acetylates glufosinate-ammonium, thus inactivating it and conferring tolerance to glufosinate-ammonium in herbicide products.

Maize MIR162 contain the transgenes vip3Aa20 and pmi. The transgene vip3Aa20 encodes the Vip3Aa20 protein which is active against certain lepidopteran insect pests. The transgene pmi encodes the enzyme phosphomannose isomerase (PMI) enabling transformed plant cells to utilize mannose as a primary carbon source; it was used as a selectable marker in the development of MIR162 maize.

Maize MZIR098 contain the transgene mcry3A, which encodes the mCry3A protein, and the transgene ecry3.1Ab, which encodes the eCry3.1Ab protein; and the transgene pat-08, which encodes the PAT protein. The modified Cry3A (mCry3A) protein contained in MZIR098 has enhanced activity against certain coleopteran insect pests. The engineered protein eCry3.1Ab confers insecticidal activity against certain coleopteran insect pests. PAT protein acetylates glufosinate-ammonium, thus inactivating it and conferring tolerance to glufosinate-ammonium in herbicide products.

Maize DP4114 contain the transgenes cry34Ab1, cry35Ab1, and cry1F that encode the insecticidal proteins Cry34Ab1 and Cry35Ab1, and Cry1F, respectively. The Cry34Ab1 and Cry35Ab1 proteins are active against certain coleopteran insect pests. The Cry1F protein is active against certain lepidopteran insect pests. DP4114 maize provides tolerance to glufosinate-ammonium through the expression of the PAT protein.

Maize NK603 contain the transgene cp4 epsps. The transgene cp4 epsps encodes the protein CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS). CP4 EPSPS protein produced by NK603 maize confers tolerance to glyphosate in herbicide products.

VKM concludes that the applicant's scientific documentation for the genetically modified X is sufficient for risk assessment, and in accordance with 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

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.