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 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)

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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)

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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)

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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

The effect of SME internationalization motivators on initial and successive international market entry mode choice

Source at https://vkm.no/In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.I forbindelse med forberedelse til implementering av EU-forordning 1829/2003 i norsk rett har Miljødirektoratet (tidligere Direktoratet for Naturforvalting) bedt Mattilsynet om vurderinger av allegenmodifiserte organismer (GMOer) og avledete produkter som inneholder eller består av GMOer som er godkjent under forordning 1829/2003 eller direktiv 2001/18 som er godkjent for ett eller flere bruksområder som omfattes av genteknologiloven. På den bakgrunnen har Mattilsynet, i brev av 13. februar 2013 (ref. 2012/150202), bedt Vitenskapskomiteen for mattrygghet (VKM) om å utarbeide endelige vitenskapelige risikovurderinger av 39 GMOer og avledete produkter som inneholder eller består av genmodifiserte organismer, innen Mattilsynets sektoransvar. VKM er bedt om endelige risikovurderinger for de EU-godkjente søknader hvor VKM ikke har avgitt endelig risikovurdering. I tillegg er VKM bedt om å vurdere hvorvidt det er nødvendig med oppdatering eller annen endring av de endelige risikovurderingene som VKM tidligere har lever

Risk assessment of Aquaterra® oil for its intended use as ingredient in fish feed. Scientific Opinion of the Norwegian Scientific Committee for Food and Environment

The Norwegian Scientific Committee for food an Environment (VKM) has assessed an application for authorisation of refined oilseed rape oil (Aquaterra®) derived from genetically modified oilseed rape line NS-B50027-4 for exclusive use as an ingredient in fish feed in Norway. NS-B50027-4 is also named DHA-canola. This report uses the term oilseed rape. NS-B50027-4 produces omega-3 long-chain (≥C20) polyunsaturated fatty acids (omega-3 LC-PUFAs) in its seeds, with a high level of docosahexaenoic acid (DHA) and a small amount of eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA). Aquaterra® also contains a significant level of alpha-Linolenic acid (ALA). Whereas ALA can be derived from plants, the primary producers of EPA and DHA are mainly marine microalgae. EPA and DHA are concentrated in the food chain to fish in the oceans and are often referred to as marine omega-3 fatty acids. NS-B50027-4 was developed as an alternative land-based source of marine fatty acids, mainly DHA. NS-B50027-4 was genetically modified to express seven transgenes derived from yeasts and marine microalgae that encode the enzymes necessary for the biosynthesis of omega-3 long chain polyunsaturated fatty acids. In addition, an eighth gene, pat, was inserted as a marker for selection purposes during development. The pat gene encodes the enzyme phosphinothricin N-acetyltransferase (PAT) conferring tolerance to glufosinate-ammonium herbicides. Equally to conventional refined oilseed rape oils any residues levels of proteins, including the introduced enzymes, will be negligible in the Aquaterra® oil. The risk assessment of Aquaterra® was conducted in accordance with the guidance for risk assessment of derived food and feed from genetically modified plants as described by the European Food Safety Authority (EFSA, 2011a). The risk assessment is based primarily on scientific documentation provided in the application EFSA-GMO-NL-2019-160, which seeks approval for NS-B50027-4 for all applicable food and feed uses in the European Union (EU). VKM concludes that the provided scientific documentation fulfills the criteria of the EFSA guidance and is adequate for risk assessment. VKM concludes that the molecular characterisation, comparative, nutritional, toxicological and allergenicity assessments of NS-B50027-4 do not indicate increased risks to animal or human health compared to its conventional counterpart (comparator) or commercial reference varieties. Based on this together with specific analyses of the seed oil fraction and studies, e.g., in fish, VKM therefore concludes that the refined oil Aquaterra®, is equal to conventional oils from oilseed rape except for the altered composition in fatty acids. VKM concludes there is no increased health risk to fish fed Aquaterra® in feed compared to conventional feeds with oils from other sources, nor is there an indication of increased risk to the environment. Since Aquaterra® is equal to conventional oils from oilseed rape except for the marine omega-3 fatty acids already present in fish feeds, VKM concludes there is no greater need for health or environmental monitoring of feeds containing Aquaterra® than conventional feeds.Risk assessment of Aquaterra® oil for its intended use as ingredient in fish feed. Scientific Opinion of the Norwegian Scientific Committee for Food and EnvironmentpublishedVersionpublishedVersio

Food/feed and environmental risk assessment of application (Reference EFSA/GMO/UK/2008/56) for authorization of insect resistant and herbicide tolerant genetically modified maize Bt11 x MIR604 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds

Source at https://vkm.no/In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency has requested the Norwegian Food Safety Authority to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectorial responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.I forbindelse med forberedelse til implementering av EU-forordning 1829/2003 i norsk rett har Miljødirektoratet (tidligere Direktoratet for Naturforvalting) bedt Mattilsynet om vurderinger av allegenmodifiserte organismer (GMOer) og avledete produkter som inneholder eller består av GMOer som er godkjent under forordning 1829/2003 eller direktiv 2001/18, og som er godkjent for ett eller flere bruksområder som omfattes av genteknologiloven. På den bakgrunnen har Mattilsynet, i brev av 13. februar 2013 (ref. 2012/150202), bedt Vitenskapskomiteen for mattrygghet (VKM) om å utarbeide endelige vitenskapelige risikovurderinger av 39 GMOer og avledete produkter som inneholder eller består av genmodifiserte organismer, innen Mattilsynets sektoransvar. VKM er bedt om å ferdigstille endelige risikovurderinger for de EU-godkjente søknader hvor VKM ikke har avgitt endelig risikovurdering. I tillegg er VKM bedt om å vurdere hvorvidt det er nødvendig med oppdatering eller annen endring av de endelige risikovurderingene som VKM tidligere har levert