Genetically Modified Organisms - Food and Feed
Public hearing 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: Comments to EFSA
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed a renewal application for approval of genetically modified oilseed rape Ms8, Rf3 and Ms8xRf3 for food and feed uses, import and processing in the European Economic Area (EEA).
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 public 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 oilseed rape events Ms8, Rf3 and Ms8 x Rf3
Oilseed rape event Ms8 x Rf3, is a fertile hybrid tolerant to glufosinate-ammonium containing herbicides. The hybrid is derived through conventional breeding of male sterile oilseed rape event Ms8 and oilseed rape event Rf3, called the fertility restorer. Ms8 and Rf3 were produced by Agrobacterium tumefaciens mediated transformation of cells from a conventional oilseed rape cultivar. The dominant gene for male sterility in Ms8 is barnase, and the dominant gene for fertility restoration in Rf3 is barstar. The bar gene, conferring tolerance to glufosinate-ammonium, is found in both Ms8 and Rf3.
VKM has provided a comment to the application EFSA-GMO-RX-024 during EFSA's public hearing in accordance with the assignment from NSFA and NEA. The comment was regarding choice of scientific databases used in the systematic literature search described in the application.
VKM concludes that the applicant's scientific documentation for the genetically modified oilseed rape events Ms8, Rf3 and Ms8 x Rf3 is sufficient for risk assessment, and in accordance with the EFSA guidance for risk assessment of genetically modified plants for use in food or feed. The VKM GMO Panel does not consider the introduced modifications in the oilseed rape events Ms8, Rf3 and Ms8 x Rf3, to imply potential specific health or environmental risks in Norway, compared to EU-countries.
Previous assessments of oilseed rape events Ms8, Rf3 and Ms8 x Rf3 by VKM
Oilseed rapes Ms8, Rf3 and Ms8 x Rf3, were assessed by VKM in 2008, 2013 and 2014.
The overall conclusion by VKM in 2014 was:
“Based on current knowledge, the VKM GMO Panel has not identified toxic, allergenic or altered nutritional properties of oilseed rape MS8, RF3 and MS8 x RF3 or its processed products compared to conventional oilseed rape.
The VKM GMO Panel likewise concludes that oilseed rape MS8, RF3 and MS8 x RF3, are unlikely to have any adverse effect on the environment and agriculture in Norway in the context of its intended usage.”
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 public 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.