Genetically Modified Organisms

Assessment of the genetically modified oilseed rape Ms8, Rf3 and Ms8xRf3 under EU Regulation 1829/2003/EC on genetically modified food and feed (renewal application EFSA-GMO-RX-024)


Report no: 2023: 16

Published: 09.06.2023

Key message:

The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified oilseed rape Ms8, Rf3 and Ms8xRf3 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 oilseed rape Ms8, Rf3 and Ms8xRf3

The oilseed rape Ms8xRf3 is a fertile hybrid tolerant to glufosinate-ammonium containing herbicides. The hybrid is derived through conventional breeding of the male sterile oilseed rape event Ms8 and the oilseed rape event Rf3, called the fertility restorer. Ms8 and Rf3 were produced by Agrobacterium tumefaciens-mediated transformation of cells from a conventional oilseed cultivar. The dominant gene for male sterility in event Ms8 is barnase, and the dominant gene for fertility restoration in event Rf3 is barstar. The bar gene, conferring tolerance to glufosinate-ammonium, is found in both Ms8 and Rf3.

VKM has assessed the documentation in application EFSA-GMO-RX-024 and EFSA's scientific opinion on genetically modified oilseed rape Ms8, Rf3 and Ms8xRf3. VKM concludes that the applicant's scientific documentation for the genetically modified oilseed rape Ms8, Rf3 and Ms8xRf3 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 oilseed rape Ms8, Rf3 and Ms8xRf3 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 oilseed rape, VKM's GMO panel has not performed a complete risk assessment of the oilseed rape.

Ms8, Rf3 and Ms8 x Rf3, were previously assessed by VKM in 2008, 2013 and 2014. Previous health and environmental risk assessments of oilseed rape Ms8, Rf3 and Ms8xRf3 show no harmful or altered nutritional properties of the genetically modified oilseed rape Ms8, Rf3 and Ms8xRf3. VKM concluded that the introduced properties in the oilseed rape 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 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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