Genetically Modified Organisms - Food and Feed

Scientific consultation of genetically modified oilseed rape MON 94100 under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-NL-2020-169)


Report no: 2022: 26

Published: 04.09.2022

Key message:

Scientific consultation of genetically modified oilseed rape MON 94100 under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-NL-2020-169)

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 consultations 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. es.

Genetically modified oilseed rape MON 94100

MON 94100 was developed via Agrobacterium tumefaciens mediated transformation, to express a dmo-gene from the bacterium S. maltophilia. The gene encodes the enzyme dicamba mono-oxygenase (DMO). DMO confers tolerance of the oilseed rape to the herbicide dicamba (3,6-dichloro-2-methoxybenzoic acid).

The VKM GMO panel has assessed the documentation in application EFSA-GMO-NL-2020-169 and EFSAs scientific opinion on genetically modified oilseed rape MON 94100. 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 oilseed rape MON 94100 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA scientific opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of oilseed rape event MON 94100 was not performed by the VKM GMO Panel.

Previous assessments

Not previously assessed by VKM.

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 consultation 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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