Genetically Modified Organisms - Food and Feed

Scientific hearing of application GMFF-2022-3670/EFSA-Q-2022-00868 (RX-029) for authorisation of the genetically modified maize MON 89034 × 1507 × NK603 under EU Regulation 1829/2003/EC on genetically modified food and feed


Report no: Comments to EFSA

Published: 22.09.2023


Key message:

The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for renewed approval of the genetically modified maize MON 89034 × 1507 × NK603 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.

Genetically modified maize MON 89034 × 1507 × NK603

Maize MON 89034 × 1507 × NK603 was developed through conventional breeding combining the single events MON 89034 (expressing the Cry2Ab2 and Cry1A.105 proteins), 1507 maize (expressing the Cry1F protein and PAT enzyme), and NK603 (expressing CP4 EPSPS enzyme). The Cry2Ab2, Cry1A.105 and Cry1F proteins confer resistance to certain lepidopteran (order of butterflies and moths) insect pests.

The PAT enzyme confers tolerance to glufosinate-ammonium herbicides, and the CP4 EPSPS enzyme confers tolerance to glyphosate herbicides. No new genetic modification was introduced in MON 89034 × 1507 × NK603 maize.

The scientific documentation provided in the application is adequate for risk assessment, and in accordance with the EFSA guidance on risk assessment of genetically modified plants for use in food or feed.

The VKM GMO panel does not consider the introduced modifications in maize MON 89034 × 1507 × NK603 to imply potential specific health or environmental risks in Norway, compared to EU-countries. Therefore, VKM had no comments to EFSA regarding the application.

Previous assessments by VKM

VKM published a health and environmental risk assessment of maize MON 89034 × 1507 × NK603 in 2009.

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.


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