Scientific hearing of application EFSA-GMO-NL-2020-167 for authorisation of the genetically modified oilseed rape MS11 x RF3 x MON 88302 under EU Regulation 1829/2003/EC on genetically modified food and feed

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. (link)

Genetically modified oilseed rape MS11 x RF3 x MON 88302

Genetically modified oilseed rape MS11 x RF3 x MON 88302 is generated through conventional breeding of the oilseed rape events MS11, RF3 and MON 88302.

Oilseed rape MS11 express the barnase gene (origin Bacillus amyloliquefaciens) encoding the ribonuclease Barnase. Expression of Barnase in the tapetum cells of MS11 results in lack of viable pollen and male sterility (MS). MS11 also expresses the barstar gene (origin Bacillus amyloliquefaciens) encoding the Barstar protein, which is an inhibitor of the Barnase protein. The expression of Barstar in MS11 is by itself insufficient to prevent male sterility but was included to enhance transformation frequency.

Oilseed rape RF3 also expresses barstar, and when RF3 is conventionally crossed with male-sterile oilseed rape lines, fertility is restored in the resulting plants because Barnase is inhibited by Barstar.

Both MS11 and RF3 also express the bar gene (from Streptomyces hygroscopicus), which encodes phosphinothricin acetyltransferase (PAT/bar) and confers increased tolerance to the herbicide glufosinate-ammonium.

Oilseed rape MON 88302 expresses a 5-enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers increased tolerance to the herbicide glyphosate.

VKM concludes that the applicant's scientific documentation for the genetically modified oilseed rape MS11 x RF3 x MON 88302 is sufficient for risk assessment, and in accordance with EFSA guidance for risk assessment of genetically modified plants for use in food or feed. VKM has not identified specific Norwegian conditions that indicate follow-up. Therefore, VKM had no comments to EFSA regarding the application.

About the assignment:

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.