Assessment of genetically modified cotton COT102 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2017-141)

publishedVersio

Assessment of genetically modified maize 94804 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application GMFF-2022-10651/EFSA-Q-2023- 00106 (182))

The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize MON 94804 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. The assignment is divided into three stages. (link) Maize MON 94804 MON 94804 is a genetically modified maize developed via Agrobacterium tumefaciens -mediated transformation of maize cells. Maize MON 94804 expresses a micro-RNA (miRNA) transcript, that leads to reduced levels of the hormone gibberellin in the plant. Gibberellin is involved in, i.a., plant stem elongation. Thus, maize MON 94804 plants grow shorter than other maize. The scientific documentation provided in the application for maize MON 94804 is adequate for risk assessment, and in accordance with 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 maize MON 94804 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA scientific Opinion is adequate also for Norwegian conditions. Therefore, a full risk assessment of maize MON 94804 was not performed by the VKM GMO Panel.Assessment of genetically modified maize 94804 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application GMFF-2022-10651/EFSA-Q-2023- 00106 (182))publishedVersio

Assessment of genetically modified maize DP915635 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-172)

The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize DP915635 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. The assignment is divided into three stages. (link) Maize DP915635 DP915635 is a genetically modified maize that expresses the insecticidal protein IPD079Ea for control of corn rootworm pests, the enzyme phosphinothricin acetyltransferase (PAT) for tolerance to glufosinate-ammonium herbicides, and the enzyme phosphomannose isomerase (PMI) that was used as a selectable marker during development. The scientific documentation provided in the application for DP915635 maize is adequate for risk assessment, and in accordance with 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 DP915635 maize to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA scientific Opinion is adequate also for Norwegian conditions. Therefore, a full risk assessment of DP915635 maize was not performed by the VKM GMO Panel. 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.Assessment of genetically modified maize DP915635 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-172)publishedVersio

Assessment of genetically modified soybean MON 87701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-021)

Event MON 87701 is a genetically modified soybean developed via Agrobacterium tumefaciens transformation. MON 87701 plants contain the transgene cry1Ac which encodes the protein Cry1Ac. The protein Cry1Ac provides resistance against specific lepidopteran pests. The scientific documentation provided in the renewal application (EFSA-GMO-RX-021) for soybean MON 87701 is adequate for risk assessment, and in accordance with 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 soybean MON 87701 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of event MON 87701 was not performed by the VKM GMO Panel.Assessment of genetically modified soybean MON 87701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-021)publishedVersio

Assessment of genetically modified soybean MON 87701 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSAGMO-RX-022)

publishedVersio

Assessment of genetically modified maize MON 87429 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-161)

Event MON 87429 is a genetically modified maize developed via Agrobacterium tumefaciens transformation. MON 87429 plants contain the transgenes pat, dmo, ft_t and cp4 epsps. Maize MON 87429 encodes the DMO, PAT and FT_T proteins. In addition, maize MON 87429 encodes the CP4 EPSPS protein and utilises an endogenous maize RNAi regulatory element to suppress its expression in pollen. This results in a lack of viable pollen and thus male sterility when MON 87429 plants are exposed to glyphosate-containing herbicides at growth stages ranging from V8 to V13. This is part of a hybridisation system to be used in inbred lines to facilitate the hybrid seeds production. This is not considered an agronomic trait since the application of glyphosate outside the specific growth stages does not lead to male sterile plants but reduces plant yield compared to plants not expressing the same trait. The scientific documentation provided in the application for genetically modified maize MON 87429 is adequate for risk assessment, and in accordance with 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 event MON 87429 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of event MON87429 was not performed by the VKM GMO PanelAssessment of genetically modified maize MON 87429 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-161)publishedVersio

Assessment of genetically modified maize DP41143 x MON890343 x MON 874113 x DAS40278-9 and sub-combinations for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA GMO-NL-2020-171)

Genetically modified maize DP41149 x MON 890349 x MON 874119 x DAS-40278-9 was developed by crossing to combine four single events: DP4114, MON 89034, MON 87411 and DAS-40278-9. DP4114 express the Cry1F protein to confer protection against certain lepidopteran pests, the Cry34Ab1 and Cry35Ab1 proteins to confer protection against certain coleopteran pests and PAT protein to confer tolerance to glufosinate-ammonium-containing herbicides. MON 89034 express the Cry1A.105 and Cry2Ab2 proteins to confer protection against certain lepidopteran pests. MON 87411 express the Cry3Bb1 protein to confer protection against certain coleopteran larvae and the DvSnf7 dsRNA confer protection against western corn rootworm, and the CP4 EPSPS protein for tolerance to glyphosate containing herbicides. DAS-40278-9 express the AAD-1 protein to catalyse the degradation of the general class ofherbicides known as aryloxyphenoxypropionates (AOPP) and to confer tolerance to 2,4- dichlorophenoxyacetic acid (2,4-D) herbicides.Assessment of genetically modified maize DP41143 x MON890343 x MON 874113 x DAS40278-9 and sub-combinations for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA GMO-NL-2020-171)publishedVersionpublishedVersio

Assessment of genetically modified maize MON 95379 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐170)

Event MON 95379 is a genetically modified maize developed by a two-step process. In the first step, immature embryos of maize inbred line LH244 were co-cultured with a disarmed Agrobacterium tumefaciens (also known as Rhizobium radiobacter) strain ABI containing the vector PV-ZMIR522223. In the second step, selected R2 lines were crossed with maize inbred LH244 line expressing Crerecombinase, which had been transformed with vector PVZMOO513642. In the resulting plants, the CP4 EPSPS-cassette (used for selection of transformed plants) was excised by the Cre recombinase, and the Cre gene was subsequently segregated away, through conventional breeding, to obtain maize MON 95379. Maize MON 95379 expresses Cry1B.868, a chimeric protein containing domains from Cry1A, Cry1B and Cry1C naturally expressed in Bacillus thuringiensis, and Cry1Da_7, an optimised version of Cry1Da carrying four amino acids substitutions to increase its activity. The two Cry proteins expressed in maize MON 95379 provide protection against targeted pests within the order of butterflies and moths (Lepidoptera) including fall armyworm (Spodoptera frugiperda), sugarcane borer (Diatraea saccharalis) and corn earworm (Helicoverpa zea). The scientific documentation provided in the application for genetically modified maize MON 95379 is adequate for risk assessment, and in accordance with 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 event MON 95379 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of event MON 95379 was not performed by the VKM GMO Panel.Assessment of genetically modified maize MON 95379 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2020‐170)publishedVersio

Assessment of genetically modified maize MON 87419 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-140)

publishedVersio

Assessment of genetically modified maize GA21 x T25 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2016-137)

publishedVersio