Assessment of genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐ 40278‐9 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐151)

Stacked event MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 (EFSA‐GMO‐NL‐2018‐151) is a genetically modified maize developed via conventional breeding. MON 89034× 1507 × MIR162 × NK603 × DAS‐40278‐9 plants contain the transgenes cry1A.105, cry2Ab2, cry1F, Vip3Aa20, cp4 epsps, pat, aad-1 and the phosphomannose isomerase (PMI) used as a selectable marker in the production of MIR162. MON89034 x 1507 x MIR162 x NK603 x DAS-40278-9 maize provides distinct sources for insect resistance combined with three distinct modes of herbicide tolerance: 2,4-D, glufosinate, and glyphosate. The scientific documentation provided in the application for genetically modified 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 event maize 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 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 was not performed by the VKM GMO Panel.Assessment of genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐ 40278‐9 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐151)publishedVersio

Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025)

Event MIR162 is a genetically modified maize developed via Agrobacterium tumefaciens mediated transformation of maize embryos. MIR162 plants contain the transgenes vip3Aa20, a modified version of the native vip3Aa1 from Bacillus thuringiensis, and the pmi gene from Escherichia coli. Vip3Aa20 encodes the insecticidal Vip3Aa20-protein, conferring MIR162 with resistance to several species of lepidopteran (order of butterflies and moths) insect pests. Pmi encodes the enzyme phosphomannose isomerase (PMI) which catalyses the isomerization of mannose-6-phosphate to fructose-6-phosphate. PMI was used as a selectable marker during development of MIR162. The scientific documentation provided in the renewal application (EFSA-GMO-RX-025) for maize MIR162 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 MIR162 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 maize event MIR162 was not performed by the VKM GMO Panel.Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025)publishedVersio

Assessment of genetically modified maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2018-149)

Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 was produced by conventional breeding of the GM maize events Bt11, MIR162, MIR604, MON 89034, 5307 and GA21. Accordingly, Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 maize produces the transgenic proteins in the individual GM maize events (Cry1Ab, PAT, Vip3Aa20, PMI, mCry3A, MIR604 PMI, Cry1A.105, Cry2Ab2, eCry3.1Ab and mEPSPS). Event Bt11 maize expresses the insecticidal protein Cry1Ab that protects against feeding damage caused by certain lepidopteran pests and the phosphinothricin acetyltransferase (PAT) protein for weed control by providing tolerance to herbicide products containing glufosinate ammonium. Event MIR162 maize expresses the insecticidal protein Vip3Aa20 that protects against feeding damage caused by certain lepidopteran pests and the PMI protein which enables transformed plant cells to utilise mannose as a primary carbon source and therefore used as a selectable marker in the development of the MIR162 maize. Event MIR604 maize expresses the insecticidal protein mCry3A that protects against feeding damage caused by certain coleopteran pests and the MIR604 PMI protein which enables transformed plant cells to utilise mannose as a primary carbon source and therefore used as a selectable marker in the development of the MIR604 maize. Event MON 89034 maize expresses the insecticidal proteins Cry1A.105 and Cry2Ab2 that protect against feeding damage caused by certain lepidopteran pests. Event 5307 maize expresses the insecticidal protein eCry3.1Ab that protects against feeding damage caused by certain coleopteran pests and the PMI protein which enables transformed plant cells to utilise mannose as a primary carbon source and therefore used as a selectable marker in the development of the 5307 maize. Event GA21 expresses the double-mutated 5-enolpyruvylshikimate-3-phosphate synthase enzyme (mEPSPS) for weed control by providing tolerance to herbicide products containing glyphosate.The scientific documentation provided in the application for genetically modified maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 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 Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 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 maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 was not performed by the VKM GMO Panel.Assessment of genetically modified maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2018-149)publishedVersio

Assessment of genetically modified maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2018-149)

Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 was produced by conventional breeding of the GM maize events Bt11, MIR162, MIR604, MON 89034, 5307 and GA21. Accordingly, Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 maize produces the transgenic proteins in the individual GM maize events (Cry1Ab, PAT, Vip3Aa20, PMI, mCry3A, MIR604 PMI, Cry1A.105, Cry2Ab2, eCry3.1Ab and mEPSPS). Event Bt11 maize expresses the insecticidal protein Cry1Ab that protects against feeding damage caused by certain lepidopteran pests and the phosphinothricin acetyltransferase (PAT) protein for weed control by providing tolerance to herbicide products containing glufosinate ammonium. Event MIR162 maize expresses the insecticidal protein Vip3Aa20 that protects against feeding damage caused by certain lepidopteran pests and the PMI protein which enables transformed plant cells to utilise mannose as a primary carbon source and therefore used as a selectable marker in the development of the MIR162 maize. Event MIR604 maize expresses the insecticidal protein mCry3A that protects against feeding damage caused by certain coleopteran pests and the MIR604 PMI protein which enables transformed plant cells to utilise mannose as a primary carbon source and therefore used as a selectable marker in the development of the MIR604 maize. Event MON 89034 maize expresses the insecticidal proteins Cry1A.105 and Cry2Ab2 that protect against feeding damage caused by certain lepidopteran pests. Event 5307 maize expresses the insecticidal protein eCry3.1Ab that protects against feeding damage caused by certain coleopteran pests and the PMI protein which enables transformed plant cells to utilise mannose as a primary carbon source and therefore used as a selectable marker in the development of the 5307 maize. Event GA21 expresses the double-mutated 5-enolpyruvylshikimate-3-phosphate synthase enzyme (mEPSPS) for weed control by providing tolerance to herbicide products containing glyphosate.The scientific documentation provided in the application for genetically modified maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 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 Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 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 maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 was not performed by the VKM GMO Panel.Assessment of genetically modified maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2018-149)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

Microarray-based method for detection of unknown genetic modifications

<p>Abstract</p> <p>Background</p> <p>Due to the increased use of genetic modifications in crop improvement, there is a need to develop effective methods for the detection of both known and unknown transgene constructs in plants. We have developed a strategy for detection and characterization of unknown genetic modifications and we present a proof of concept for this method using <it>Arabidopsis thaliana </it>and <it>Oryza sativa </it>(rice). The approach relies on direct hybridization of total genomic DNA to high density microarrays designed to have probes tiled throughout a set of reference sequences.</p> <p>Results</p> <p>We show that by using arrays with 25 basepair probes covering both strands of a set of 235 vectors (2 million basepairs) we can detect transgene sequences in transformed lines of <it>A. thaliana </it>and rice without prior knowledge about the transformation vectors or the T-DNA constructs used to generate the studied plants.</p> <p>Conclusion</p> <p>The approach should allow the user to detect the presence of transgene sequences and get sufficient information for further characterization of unknown genetic constructs in plants. The only requirements are access to a small amount of pure transgene plant material, that the genetic construct in question is above a certain size (here ≥ 140 basepairs) and that parts of the construct shows some degree of sequence similarity with published genetic elements.</p

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

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Scandinavian perspectives on plant gene technology: applications, policies and progress

Plant research and breeding has a long and successful history in the Scandinavian countries, Denmark, Finland, Norway and Sweden. Researchers in the region have been early in adopting plant gene technologies as they developed. This review gives a background, as well as discuss the current and future progress of plant gene technology in these four countries. Country-specific details of the regulation of genetically modified plants are described, as well as similarities and differences in the approach to regulation of novel genome-editing techniques. Also, the development of a sustainable bioeconomy may encompass the application of plant gene technology and we discuss whether or not this is reflected in current associated national strategies. In addition, country-specific information about the opinion of the public and other stakeholders on plant gene technology is presented, together with a country-wise political comparison and a discussion of the potential reciprocal influence between public opinion and the political process of policy development. The Scandinavian region is unique in several aspects, such as climate and certain agriculturally related regulations, and at the same time the region is vulnerable to changes in plant breeding investments due to the relatively small market sizes. It is therefore important to discuss the role and regulation of innovative solutions in Scandinavian plant research and breeding.Peer reviewe

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