Genetically Modified Organisms

Assessment of the genetically modified soybean MON 87701 × MON 89788 under EU Regulation 1829/2003/EC on genetically modified food and feed (renewal application EFSA-GMO-RX-022)

Commissioned:

Report no: 2023: 10

Published: 30.03.2023

Key message:

The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for renewed approval of the genetically modified soybean MON 87701 × MON 89788for 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. The assignment is divided into three stages.

Genetically modified soybean MON 87701 × MON 89788

MON 87701 × MON 89788 was developed via conventional crossing of the two single GM-soybean events MON 87701 and MON 89788. MON 87701 × MON 89788 plants contain the transgenes cry1Ac and cp4 epsps which encode the proteins Cry1Ac and CP4 EPSPS. The protein Cry1Ac provides resistance against specific Lepidopteran (order of butterflies and moths) pests, and the protein CP4 EPSPS provides tolerance against herbicides containing glyphosate.

VKM did not provided comments to EFSA regarding the application EFSA-GMO-RX-022 during the EFSA scientific hearing in accordance with the assignment from the Norwegian Food Safety Authority and the Norwegian Environment Agency, due to other priorities.

However, VKM has assessed the documentation provided in the application and EFSAs scientific opinion on genetically modified MON 87701 × MON 89788. VKM concludes that the applicant's scientific documentation for the genetically modified soybean MON 87701 × MON 89788 is adequate 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 soybean MON 87701 × MON 89788 do not imply increased health or environmental risks in Norway compared to 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 soybean, VKM's GMO panel has not performed a complete risk assessment of the soybean.

In 2010, VKM published a health and environmental risk assessment of soybean MON 87701 × MON 89788. No harmful or altered nutritional properties of the genetically modified soybean were identified. VKM concluded that the introduced properties in soybean 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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