Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for 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. 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 Directorate requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.  The genetically modified, glufosinate-tolerant oilseed rape lines MS8, RF3 and MS8 x RF3 (Notification C/BE/96/01) are approved under Directive 2001/18/EC for import and processing for feed and industrial purposes since 26 March 2007 (Commission Decision 2007/232/EC). In addition, processed oil from genetically modified oilseed rape derived from MS8, RF3 and MS8 x RF3 were notified as existing food according to Art. 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients in November 1999. Existing feed and feed products containing, consisting of or produced from MS8, RF3 and MS8 x RF3 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed on the market in January 2000.   An application for renewal of the authorisation for continued marketing of existing food, food ingredients and feed materials produced from MS8, RF3 and MS8 x RF3 was submitted within the framework of Regulation (EC) No 1829/2003 in June 2007 (EFSA/GMO/RX/MS8/RF3). In addition, an application covering food containing or consisting of, and food produced from or containing ingredients produced from oilseed rape MS8, RF3 and MS8 x RF3 (with the exception of processed oil) was delivered by Bayer CropScience in June 2010 (EFSA/GMO/BE/2010/81).  The VKM GMO Panel has previously issued a scientific opinion related to the notification C/BE/96/01 for the placing on the market of the oilseed rape lines for import, processing and feed uses (VKM 2008). The health and environmental risk assessment was commissioned by the Norwegian Directorate for Nature Management in connection with the national finalisation of the procedure of the notification C/BE/96/01 in 2008. Due to the publication of updated guidelines for environmental risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated environmental risk assessment of oilseed rape MS8, RF3 and MS8 x RF3.   A scientific opinion on an application for the placing on the market of MS8/RF3 for food containing or consisting of, and food produced from or containing ingredients produced from MS8/RF3 (with the exception of processed oil) (EFSA/GMO/BE/2010/81) have also been submitted by the VKM GMO Panel (VKM 2012).  The environmental risk assessment of the oilseed rape MS8, RF3 and MS8 x RF3 is based on information provided by the notifier in the applications EFSA/GMO/RX/MS8/RF3, EFSA/GMO/BE/2010/8, the notification C/BE/96/01, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.    The VKM GMO Panel has evaluated MS8, RF3 and MS8 x RF3 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c).   The scientific risk assessment of oilseed rape MS8, RF3 and MS8 x RF3 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms.   The genetically modified oilseed rape lines MS8 and RF3 were developed to provide a pollination control system for production of F1-hybrid seeds (MS8 x RF3).  Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. As a result of hybrid vigor cross-pollinated plants produce higher yield as compared to self-pollinating rape.   The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes derived from the soil bacterium Bacillus amyloliquefaciens into two separate transgenic oilseed rape lines. The barnase gene in the male sterile line MS8 encode a ribonuclease peptide (RNase), expressed in the tapetum cells during anther development. The RNase effect RNA levels, disrupting normal cell function, arresting early anther development, and results in the lack of viable pollen and male sterility.   The fertility restoration line RF3 contains a barstar gene, coding for a ribonuclease inhibitor (Barstar peptide) expressed only in the tapetum cells of the pollen during anther development. The peptide specifically inhibits the Barnase RNase expressed by the MS8 line. The RNase and the ribonuclease inhibitor form a stable one-to-one complex, in which the RNase is inactivated. As a result, when pollen from the receptor line RF3 is crossed to the male sterile line MS8, the MS8 x RF3 progeny expresses the RNase inhibitor in the tapetum cells of the anthers allowing hybrid plants to develop normal anthers and restore fertility.  The barnase and barstar genes in MS8 and RF3 are each linked with the bar gene from Streptomyces hygroscopus. The bar gene is driven by a plant promoter that is active in all green tissues of the plant, and encodes the enzyme phosphinothricin acetyltransferase (PAT). The PAT enzyme inactivates phosphinothricin (PPT), the active constituent of the non-selective herbicide glufosinate-ammonium. The bar gen were transferred to the oilseed rape plants as markers both for use during in vitro selection and as a breeding selection tool in seed production.  Molecular characterization: The oilseed rape hybrid MS8xRF3 is produced by conventional crossing. The parental lines MS8 and RF3 are well described in the documentation provided by the applicant, and a number of publications support their data. It seems likely that MS8 contains a complete copy of the desired T-DNA construct including the bar and barnase genes. Likewise, the event RF3 is likely to contain complete copies of the bar and barstar genes in addition to a second incomplete non-functional copy of the bar-gene. The inserts in the single events are preserved in the hybrid MS8xRF3, and the desired traits are stably inherited over generations.   Oilseed rape MS8, RF3 and MS8xRF3 and the physical, chemical and functional characteristics of the newly expressed proteins have previously been evaluated by the VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2008, 2012). The GMO Panel finds the characterisation of the physical, chemical and functional properties of the recombinant inserts in the oilseed rape transformation events MS8, RF3 and MS8xRF3 to be satisfactory. The GMO Panel has not identified any novel risks associated with the modified plants based on the molecular characterisation of the inserts.  Comparative assessment:  Based on results from comparative analyses of data from field trials located at representative sites and environments in Europe and Canada, it is concluded that oilseed rape MS8, RF3 and MS8 x RF3 is agronomically and phenotypically equivalent to the conventional counterpart, except for the newly expressed barnase, barstar and PAT proteins.  The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape varieties. Environmental risk: Considering the scope of the notification C/BE/96/01, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MS8, RF3 and MS8 x RF3 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported.  Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B. juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. Accidental spillage and loss of viable seeds of MS8, RF3 and MS8 x RF3 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MS8, RF3 and MS8 x RF3 cannot be excluded. Feral oilseed rape MS8, RF3 and MS8 x RF3 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops.  However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway.  There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MS8, RF3 and MS8 x RF3, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties.  Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Overall conclusion: The VKM GMO Panel concludes that oilseed rape MS8, RF3 and MS8xRF3 are unlikely to have any adverse effect on the environment in Norway in the context of its intended usage.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for 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. 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 and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.  The insect-resistant genetically modified maize MIR604 from Syngenta Seeds S.A.S.  (Unique Identifier SYN-IR604-5) is approved under Regulation (EC) No 1829/2003 for food   and feed uses, import and processing since 30 November 2009 (Commission Decision 2009/866/EC).  Genetically modified maize MIR604 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environmental Agency related to the EFSAs public hearing of the applications EFSA/GMO/UK/2005/11 and EFSA/GMO/UK/2010/83 in 2005 (VKM 2005) and 2011 (VKM, unpublished. In addition MIR604 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2008, VKM 2009a,b,c VKM 2012, VKM 2013a,b,c). The food/feed and environmental risk assessment of maize MIR604 is based on information provided by the applicant in the applications EFSA/GMO/UK/2005/11 and EFSA/GMO/UK/2010/83, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.  The VKM GMO Panel has evaluated MIR604 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c).  The scientific risk assessment of maize MIR604 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes.  It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms.  Genetically modified maize MIR604 was developed to provide protection against certain coleopteran target pests belonging to the genus Diabrotica such as the larvae of western   corn rootworm (WCRW; D. virgifera virgifera), the northern corn rootworm (NCRW; D.longicornis barberi) by the introduction of a modified cry3A gene (mcry3A) derived from   Bacillus thuringiensis subsp. tenebrionis. Maize MIR604 also contains the pmi (manA) gene  from Escherichia coli which encodes the phosphomannose isomerise (PMI) protein as a selectable marker. PMI allows transformed maize cells to utilize mannose as a sole carbon     source, while maize cells lacking the pmi gene fail to grow with mannose as single carbon source. Molecular Characterization: The molecular characterisation data indicate that only one copy of the transgenic insert with the mcry3A and pmi genes is integrated in the genome of maize MIR604, and that it is stably inherited over generations. Appropriate analyses of the integration site, inserted DNA sequence, flanking regions, and bioinformatics have been performed. The VKM GMO Panel considers the molecular characterisation of maize MIR604 as adequate.  Comparative Assessment: The applicant has performed comparative analyses of data from field trials located at representative sites and environments in North America during the 2002 and 2003 growing seasons. With the exception of small intermittent variations and the insect resistance conferred by mCry3A, the results showed no biologically significant differences between maize MIR604 and control maize. Based on the assessment of available data, the VKM GMO Panel concludes that maize MIR604 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the newly expressed proteins.  Food and Feed Risk Assessment: Whole food feeding studies on rats, rainbow trout and broilers have not indicated any adverse health effects of maize MIR604. These studies also indicate that maize MIR604 is nutritionally equivalent to conventional maize. The mCry3A and PMI proteins do not show sequence resemblance to other known toxins or IgE allergens, nor have they been reported to cause IgE mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions.  Based on current knowledge, the VKM GMO Panel concludes that maize MIR604 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mCry3A and PMI proteins will introduce a toxic or allergenic potential in food or feed based on maize MIR604 compared to conventional maize.  Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2005/11 includes import and processing of maize MIR604 for food and feed uses. Considering the intended uses of maize MIR604, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MIR604.  Maize MIR604 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MIR604. Maize is the only representative of the genus Zea in Europe and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue.  Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize MIR604 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mCry3A and PMI proteins will introduce a toxic or allergenic potential in food or feed derived from maize MIR604 compared to conventional maize. The VKM GMO Panel likewise concludes that maize MIR604, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Abstract: Genetically modified carnation (Dianthus caryophyllus L.) line IFD-26407-2 with product name Moonvelvet™, expresses three introduced traits. The cytb5 gene and the f3′5′h (Hf1) gene from Petunia x hybrida, coding for cytochrome b5 (CYTB5) and flavonoid 3′,5′hydroxylase (F3′5′H), respectively, lead to the biosynthesis of anthocyanin pigments, which confer the desired violet/blue colour to the flowers. A mutated als gene (SuRB) from Nicotiana tabacum has also been inserted, coding for an acetolactate synthase (ALS) variant protein and thereby conferring tolerance to the active, ALS-inhibiting, herbicidal substances chlorimuron, thifensulfuron and sulfonylureas, used to facilitate the selection of GM shoots during genetic transformation. Bioinformatic analyses of the inserted DNA and flanking sequences in carnation Moonvelvet IFD-26407-2 have not indicated a potential production of putative harmful proteins or polypeptides caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the cytb5 and f3′5′h (Hf1) genes, have been shown over several generations of carnation Moonvelvet IFD-26407-2. Data reported from several field trials show that carnation Moonvelvet IFD-26407-2 petals contain higher levels of the anthocyanins delphinidin and cyanidin, and lower levels of pelargonidin compared to the non-GM (conventional) carnation counterpart Cerise Westpearl (CW). Other morphological traits were reported and along with differing petal colour, carnation Moonvelvet IFD-26407-2 differed significantly in 10 traits compared to conventional carnation counterpart CW. Aqueous extracts from leaves or petals showed no mutagenic activity in vitro. ALS, CYTB5, and F3’5’H proteins do not show sequence resemblance to known toxins or IgE-dependent allergens, nor have they been reported to be toxic to animals or cause IgE-mediated allergic reactions. The anthocyanins delphinidin and cyanidin are present in numerous foods and are also approved food additives. Carnations are cultivated in Norway, but since 1) the intended uses includes import of cut flowers for ornamental use only, 2) the spread and viability of pollen from the cut flowers is low, 3) seed formation in cut flowers is unlikely to occur, and 4) spread of inserted genes to target or non-target organisms is either unlikely to occur or is not of biological relevance, the VKM GMO Panel does not consider that carnation Moonvelvet IFD-26407-2 represents an environmental risk in Norway.    Considering that carnation Moonvelvet IFD-26407-2 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers that comparative analysis of the newly synthesised anthocyanin pigments delphinidin, cyanidin and pelargonidin in its petals is sufficient for the risk assessment. The reported morphological differences between Moonvelvet IFD-26407-2 and its conventional carnation counterpart Cerise Westpearl (CW) do not raise safety concerns. It is unlikely that either the CYTB5, F3’5’H or ALS proteins, or the delphinidin or cyanidin pigments, will introduce a toxic or allergenic potential in Moonvelvet IFD-26407-2.    Based on current knowledge and information supplied by the applicant, and considering the intended uses, which exclude cultivation and use as food and feed, the VKM GMO Panel concludes that Moonvelvet IFD-26407-2 is as safe as its conventional counterpart CW.    Based on the current knowledge and considering its import, distribution and intended use as cut ornamental flowers, the VKM GMO Panel concludes that it is unlikely that carnation Moonvelvet IFD-26407-2 will have any adverse effects on the biotic or abiotic environment in Norway.

Abstract: Genetically modified carnation (Dianthus caryophyllus L.) line IFD-25958-3 with product name Moonberry™, expresses three introduced traits. The dfr gene from Petunia x hybrida and the f3′5′h gene from Viola hortensis, coding for dihydroflavonol 4-reductase (DFR) and flavonoid 3′,5′-hydroxylase (F3′5′H), respectively, lead to the biosynthesis of anthocyanin pigments, which confer the desired violet/blue colour to the flowers. A mutated als gene (SuRB) from Nicotiana tabacum has also been inserted, coding for an acetolactate synthase (ALS) variant protein and thereby conferring tolerance to the active, ALS-inhibiting, herbicidal substances chlorimuron, thifensulfuron and sulfonylureas, used to facilitate the selection of GM shoots during genetic transformation. Of note, carnation Moonberry IFD25958-3 contained a hairpin RNA interference (RNAi) gene, which down-regulates endogenous dfr. Bioinformatics analyses of the inserted DNA and flanking sequences in carnation Moonberry IFD-25958-3 have not indicated a potential production of putative harmful proteins or polypeptides caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the dfr and f3′5′h genes, have been shown over several generations of carnation Moonberry IFD-25958-3. Data reported from several field trials show that carnation Moonberry IFD-25958-3 petals contain higher levels of the anthocyanins delphinidin and cyanidin, and lower levels of pelargonidin compared to the non-GM (conventional) carnation counterpart Cerise Westpearl (CW). Other morphological traits were reported and along with differing petal colour, carnation Moonberry IFD-25958-3 differed significantly in nine traits compared to conventional carnation counterpart CW. Aqueous extracts from leaves or petals showed no mutagenic activity in vitro. ALS, DFR, and F3’5’H proteins do not show sequence resemblance to known toxins or IgE-dependent allergens, nor have they been reported to be toxic to animals or cause IgE-mediated allergic reactions. The anthocyanins delphinidin and cyanidin are present in numerous foods and are also approved food additives. Carnations are cultivated in Norway, but since 1) the intended uses includes import of cut flowers for ornamental use only, 2) the spread and viability of pollen from the cut flowers is low, 3) seed formation in cut flowers is unlikely to occur, and 4) spread of inserted genes to target or non-target organisms is either unlikely to occur or is not of biological relevance, the VKM GMO Panel does not consider that carnation Moonberry IFD-25958-3 represents an environmental risk in Norway.    Considering that carnation Moonberry IFD-25958-3 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers that comparative analysis of the newly synthesised anthocyanin pigments delphinidin, cyanidin and pelargonidin in its petals is sufficient for the risk assessment. The reported morphological differences between Moonberry IFD-25958-3 and its conventional carnation counterpart Cerise Westpearl (CW) do not raise safety concerns. It is unlikely that the DFR, F3’5’H or ALS proteins, or the delphinidin or cyanidin pigments, will introduce a toxic or allergenic potential in Moonberry IFD-25958-3.    Based on current knowledge and information supplied by the applicant, and considering the intended use, which excludes cultivation and use as food and feed, the VKM GMO Panel concludes that Moonberry IFD-25958-3 is as safe as its conventional counterpart CW.    Based on the current knowledge and considering its import, distribution and intended use as cut ornamental flowers, the VKM GMO Panel concludes that it is unlikely that carnation Moonberry IFD-25958-3 will have any adverse effects on the biotic or abiotic environment in Norway.

Abstract: Carnation SHD-27531-4 is a genetically modified variety of Dianthus caryophyllus L. used as a decorative plant species. The red-purple colour of the flowers results from expression of the two newly introduced genes dfr and f 3’5’h, encoding the enzymes dihydroflavonol 4reductase (DFR) and flavonoid 3’,5’-hydroxylase (F3’5’H). The two enzymes enable the production of the pigments delphinidin and cyanidin (anthocyanidins) in the flower petals. Anthocyanidins and their sugar derivatives, anthocyanins, make up a large group of natural colours and are accepted food additives (E 163). The colours of most flowers, berries and fruits consist of a combination of anthocyanidins and anthocyanins.  Carnation line SHD-27531-4 also contains a mutated herbicide tolerance gene from Nicotiana tabacum , coding for an acetolactate synthase (ALS) variant protein, used to facilitate the selection of GM plantlets during the genetic transformation process. Southern blot analysis and sequencing indicate only a single copy of the intended T-DNA insert in the SHD-27531-4 genome. Flanking sequences show no disruption of endogenous genes. In silico analyses show no significant homologies between the DFR, F3’5’H an ALS proteins and known toxins and IgE-bound allergens. No observed changes in the introduced trait, i.e. the particular flower colour, indicative of instability, have been reported during several generations of vegetatively propagated plants.    Considering that carnation SHD-27531-4 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers the comparative analysis of the anthocyanidins delphinidin, cyanidin, petunidin and pelargonidin in the flower petals sufficient for the risk assessment. The reported morphological differences between SHD-27531-4 and the parent cultivar do not raise safety concerns.    Based on current knowledge and the scope of the application, the VKM GMO Panel concludes that the DFR, F3’5’H and ALS proteins and anthocyanidin pigments are unlikely to increase a potential health risk related to an accidental intake or other exposure routes to carnation SHD-27531-4 compared to the conventional counterpart or other non-GM carnations.    Likewise, the VKM GMO Panel concludes that carnation SHD-27531-4, based on current knowledge and the intended use as cut ornamental flowers, does not represent an environmental risk in Norway.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for 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. The assignment includes a scientific environmental risk assessment of oilseed rape T45 (Reference EFSA/GMO/UK/2005/25) from Bayer CropScience for food and feed uses, import and processing. Oilseed rape T45 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority related to the EFSAs public hearing in 2007 (VKM 2007a). Food additives produced from T45 oilseed rape were notified in the EU as existing food additives within the meaning of Article 8 (1)(b) of Regulation 1829/2003, authorized under Directive 89/10/EEC (Community Register 2005). Feed materials produced from T45 were also notified as existing feed products containing, consisting of or produced from T45 according to Articles 8 and 20 of Regulation (EC) No 1829/2003 in 2003.   A notification for placing on the market of T45 according to the Directive 2001/18/EC was submitted in March 2004 (C/GB/04/M5/4), covering import and processing of T45 into food and feed. The application was further transferred into Regulation (EC) No 1829/2003 in November 2005 (EFSA/GMO/UK/2005/25). An application for renewal of authorisation for continued marketing of food additives and feed materials produced from T45 oilseed rape was submitted under Regulation (EC) No 1829/2003 in 2007 (EFSA/GMO/RX/T45). The EFSA GMO Panel performed one single comprehensive risk assessment for all intended uses of genetically modified oilseed rape T45, and issued a comprehensive scientific opinion for both applications submitted under Regulation (EC) No 1829/2003. The scientific opinion was published in January 30 2008 (EFSA 2008), and food and feed products containing or produced from oilseed rape T45 was approved by Commission Decision 26 March 2009 (Commission Decision 2009/184/EC).  The oilseed rape T45 is however currently being phased out (EU-COM 2009). The commercialisation of T45 oilseed rape seeds in third countries was stopped after the 2005 planting season and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed. The applicant commits not to commercialize the event in the future and the import will therefore be restricted to adventitious levels in oilseed rape commodity. Thus the incidence of oilseed rape T45 in the EU is expected to be limited. The environmental risk assessment of the oilseed rape T45 is based on information provided by the notifier in the application EFSA/GMO/UK/2005/25 and EFSA/GMO/RX/T45, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.   The VKM GMO Panel has evaluated T45 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c).  The scientific risk assessment of oilseed rape T45 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms.  The glufosinate ammonium-tolerant oilseed rape transformation event T45 (Unique Identfier ACSBNØØ8-2) was developed by Agrobacterium-mediated transformation of protoplast from the conventional oilseed rape cultivar “AC Excel”. T45 contains a synthetic version of the native pat gene isolated from the bacteria Streptomyces viridochromogenes, strain Tü 494. The inserted gene encodes the enzyme phosphinothricin acetyltransferase (PAT), which confers tolerance to the herbical active substance glufosinate ammonium. The PAT enzyme detoxifies glufosinate-ammonium by acetylation of the L-isomer into N-acetyl-L-glufosinate ammonium (NAG) which does not inhibit glutamine synthetase and therefore confers tolerance to the herbicide. Glufosinate ammonium-tolerant oilseed rape transformation event T45 has been conventionally bred into an array of spring-type oilseed rape varieties. Molecular characterization: The molecular characterisation data established that only one copy of the gene cassette is integrated in the oilseed rape genomic DNA. Appropriate analysis of the integration site including sequence determination of the inserted DNA and flanking regions and bioinformatics analysis have been performed. Bioinformatics analyses of junction regions demonstrated the absence of any potential new ORFs coding for known toxins or allergens. The genetic stability of transformation event T45 was demonstrated at the genomic level over multiple generations by Southern analysis. Segregation analysis shows that event T45 is inherited as dominant, single locus trait. Phenotypic stability has been confirmed by stable tolerance to the herbicide for T45 lines and varieties derived from the event grown in Canada since 1993.  Oilseed rape transformation event T45 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a). Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Canada in 1995-1997, it is concluded that oilseed rape T45 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of maturity and the herbicide tolerance conferred by the PAT protein.  The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event T45 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event T45 compared to conventional oilseed rape. Environmental risk: According to the applicant, the event T45 has been phased out, and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed since 2005. However, since future cultivation and import of oilseed rape T45 into the EU/EEA area cannot be entirely ruled out, the environmental risk assessment consider exposure of viable seeds of T45 through accidental spillage into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported.  Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B. juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape T45, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Accidental spillage and loss of viable seeds of T45 during transport, storage, handling in the environment and processing into derived products is, however, likely to take place over time, and the establishment of small populations of oilseed rape T45 cannot be excluded. Feral oilseed rape T45 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops.  However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. The occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway.  Overall conclusion: Taking into account the expected limited import of oilseed rape T45 (EU COM 2009), the VKM GMO Panel considers that the routes of gene flow from T45 would not introduce significant numbers of transgenic plants into agricultural areas or result in any environmental consequences in Norway.  The VKM GMO Panel concludes that oilseed rape T45 is unlikely to have any adverse effect on the environment in Norway in the context of its intended usage.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for 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. 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 and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.   The insect-resistant and herbicide-tolerant genetically modified maize Bt11 from Syngenta Seeds (Unique Idientifier SYN-BT Ø11-1) is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing (Commission Decision 2010/419/EC).   Genetically modified maize Bt11 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO) as sweet maize in 2005 (Notification xx) and fodder/field maize in  2007 (Notification C/F/96/05.10) (VKM 2005, VKM 2007). Bt11 has also been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2008, VKM 2009a,b,c,d,e VKM 2012a,b, 2013a,b,c).   The food/feed and environmental risk assessment of the maize Bt11 is based on information provided by the applicant in the application EFSA/GMO/RX/Bt11, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.    The VKM GMO Panel has evaluated Bt11 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c).   The scientific risk assessment of maize Bt11 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms and effects on biogeochemical processes.   It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms.   Molecular Characterization: The molecular characterisation data indicate that a single copy of the transgenic insert with the Cry1Ab and pat genes is integrated  in the nuclear genome of maize Bt11, and that it is inherited as a dominant, single locus trait. Appropriate analyses of the integration site, inserted DNA sequence, flanking regions, and bioinformatics have been performed. The VKM GMO Panel considers the molecular characterisation of maize Bt11 as adequate.  Comparative Assessment: Comparative analyses of data from field trials located at representative sites and environments in North America and Europe indicate that maize Bt11 is compositionally equivalent to its conventional counterpart, with the exception of the herbicide tolerance and insect resistance traits, conferred by the expression of the Cry1Ab and PAT proteins. However, data on the amino acid tryptophan, is only given in one out of six studies. Based on current knowledge, the VKM GMO panel concludes that maize Bt11 is compositionally equivalent to conventional maize.  The data provided by the applicant are not sufficient to show that Bt11 maize is phenotypically and agronomically equivalent to conventional near-isogenic maize lines. The agronomic assessment data are provided from one growing season in the North America and one growing season in France. This is not considered to be sufficient for representative testing of agricultural environments.  Food and Feed Risk Assessment: Whole food feeding studies have not indicated any adverse health effects of maize Bt11. These studies also indicate that maize Bt11 is nutritionally equivalent to conventional maize. The Cry1Ab and PAT proteins do not show sequence resemblance to other known toxins or IgE allergens, nor have they been reported to cause IgE mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize Bt11 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab and PAT proteins will introduce a toxic or allergenic potential in food or feed based on maize Bt11 compared to conventional maize.   Environmental Risk Assessment: The scope of the application EFSA/GMO/RX/Bt11 includes import and processing of maize stack Bt11 for food and feed uses. Considering the intended uses of maize Bt11, excluding cultivation, the environmental risk assessment is concerned with accifieldal release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize Bt11.   Maize Bt11 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accifieldal release into the environment of seeds from maize Bt11. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue.  Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize Bt11 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab and PAT proteins will introduce a toxic or allergenic potential in food or feed derived from maize Bt11 compared to conventional maize.   The VKM GMO Panel likewise concludes that maize Bt11, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for 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. 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 and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.   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 authorised 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 authorised 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.  The insect-resistant and herbicide-tolerant genetically modified maize Bt11 x MIR604 (Unique Identifier  SYN-BTØ11-1 x SYN-IR6Ø4-5) from Syngenta Seeds  is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since  21 December 2011 (Commission Decision 2011/893/EC).   The genetically modified maize Bt11 x MIR604 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority  and the Norwegian Environment Agency related to the EFSAs public hearing of the application EFSA/GMO/UK/2007/50  in 2008 (VKM 2009a). In addition, Bt11 and MIR604 have been evaluated by the VKM GMO Panel as single events and as components of several stacked GM maize events (VKM 2005a,b, 2007, 2008, 2009b,c,d,e, 2012a,b, 2013a,b,c).  The food/feed and environmental risk assessment of the maize Bt11 x MIR604 is based on information provided by the applicant in the application EFSA/GMO/UK/2007/50, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.    The VKM GMO Panel has evaluated Bt11 x MIR604 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c).   The scientific risk assessment of maize Bt11 x MIR604 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms and effects on biogeochemical processes.   It is emphasised that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms.   The genetically modified maize stack Bt11 x MIR604 has been produced by conventional crossing between GM inbred lines of maize containing the single events Bt11 and MIR604. The maize hybrid was developed to provide protection against certain lepidopteran and coleopteran target pests, and to confer tolerance to glufosinate-ammonium based herbicides.   Molecular Characterization: Conventional crossing methods were used to produce the stacked maize Bt11 x MIR604. Southern blot analyses have indicated that the recombinant inserts in the parental maize lines Bt11 and MIR604 are retained in the stacked maize Bt11 x MIR604. Genetic stability of the inserts has previously been demonstrated in the parental events. Protein measurements show comparable levels of the Cry1Ab, mCry3A, PAT and PMI proteins between the stacked and single maize lines.   The VKM GMO Panel considers the molecular characterisation of maize Bt11 x MIR604 and the single maize events Bt11 and MIR604 as adequate.   Comparative Assessment: Comparative analyses of agronomic and phenotypic data from field trials located at representative sites and environments in USA in 2005 indicate that maize stack Bt11 x MIR604 is equivalent to its conventional counterpart, with the exception of the insect resistance and the herbicide tolerance, conferred by the Cry1Ab, mCry3A and PAT proteins. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of maize Bt11 x MIR604 compared to conventional maize varieties.  The applicant has performed a compositional analysis on the triple-stack Bt11 x MIR604 x GA21 instead of maize Bt11 x MIR604. The analysis was performed on plant materials from maize Bt11 x MIR604 x GA21 and a near-isogenic control hybrid from field trials in USA in 2006. With the exception of small intermittent variations, no biologically significant compositional differences were found between the triple-stack and the near-isogenic control. The results of the study are considered valid by EFSA also for maize Bt11 x MIR604, since maize Bt11 x MIR604 x GA21 encompasses the transgenic properties of maize Bt11 x MIR604. This is in accordance with the EFSA guidance document for the risk assessment of genetically modified plants containing stacked transformation events (EFSA, 2007b).   The VKM GMO Panel is of the opinion that the applicant should have performed a compositional analysis of maize Bt11 x MIR604 and not only referred to analyses of the triple- stack Bt11 x MIR604 x GA21. However, based on all information available, including agronomic and phenotypic data from  field trials with maize Bt11 x MIR604, a feeding study on broilers showing nutritional equivalence to non-GM maize, and assessments of the single events Bt11 and MIR604, the VKM GMO Panel concludes that forage and grain from maize Bt11 x MIR604 are compositionally equivalent to its conventional counterpart.   Food and Feed Risk Assessment: A whole food feeding study on broilers has not indicated any adverse effects of maize Bt11 x MIR604, and shows that maize Bt11 x MIR604 is nutritionally equivalent to conventional maize. The Cry1Ab, PAT, mCry3A, and PMI proteins do not show sequence resemblance to other known toxins or IgE allergens, nor have they been reported to cause IgE-mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions.  Based on current knowledge, the VKM GMO Panel concludes that maize Bt11 x MIR604 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab, PAT, mCry3A, or PMI proteins will introduce a toxic or allergenic potential in food or feed based on maize Bt11 x MIR604 compared to conventional maize.  Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2007/50 includes import and processing of maize stack Bt11x MIR604 for food and feed uses. Considering the intended uses of maize Bt11 x MIR604, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and  indirect exposure, mainly through manure and faeces from animals fed grains from maize Bt11 x MIR604.   Maize Bt11 x MIR604 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize Bt11 x MIR604. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue.  Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize Bt11 x MIR604 is nutritionally equivalent to its conventional counterpart, except for the presence of the newly expressed proteins. It is unlikely that the Cry1Ab, PAT, mCry3A, or PMI proteins will introduce a toxic or allergenic potential in food or feed derived from maize Bt11 x MIR604 compared to conventional maize.   The VKM GMO Panel likewise concludes that maize Bt11 x MIR604, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Abstract: The environmental risk assessment of the herbicide tolerant genetically modified oilseed rape MON 88302 (Reference EFSA/GMO/BE/2011/101) has been performed by the Panel on Genetically Modified Organisms (GMO) of the Norwegian Scientific Committee for Food Safety (VKM). VKM has been requested by the Norwegian Directorate for Nature Management and the Norwegian Food Safety Authority to issue a preliminary scientific opinion on the safety of the genetically modified oilseed rape MON 88302 (Unique identifier MON-88Ø2-9) for food and feed uses, import and processing, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMOBE/2011/101.  The environmental risk assessment of the MON 88302 is based on information provided by the applicant in the application EFSA/GMO/BE/2011/101, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered peer-reviewed scientific literature as relevant.   The VKM GMO Panel has evaluated MON 88302 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c).  The scientific risk assessment of oilseed rape MON 88302 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasized that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The GMO Panel has therefore not considered possible health and environmental effects of cultivation and processing of oilseed rape MON 88302 outside the EU/EEA area. The genetically modified oilseed rape MON 88302 was developed to provide tolerance to the herbical active substance glyphosate by the introduction of a gene coding for the enzyme 5enolpyruvylshikimate-3-phosphate synthase (EPSPS) from Agrobacterium tumefaciens, strain CP4 (CP4 EPSPS). Glyphosate is a non-selective herbicide and is normally phytotoxic to a broad range of plants. Its mode of action occurs by binding to and inactivating the EPSPS protein, which is a key enzyme in the shikimate pathway that leads to the biosynthesis of the aromatic amino acids tyrosine, tryptophan and phenylalanine. The disruption of this pathway and the resulting inability to produce key amino acids prevents growth and ultimately leads to plant death.  Molecular characterization: The VKM Panel on Genetically Modified Organisms find the conclusion that no major section of the T-DNA plasmid backbone is inserted in MON88302 oilseed rape justified. We also find it justified that there is only one major T-DNA insert in MON88302.  Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in the USA, Canada and Chile, it is concluded that oilseed rape MON 88302 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of the herbicide tolerance conferred by the CP4 EPSPS protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON 88302 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glyphosate herbicide do not alter the phenotypic and agronomic characteristics of MON 88302 compared to conventional oilseed rape. Evaluations of environmental interactions between genetically modified oilseed rape MON 88302 and the biotic and abiotic environment, and studies of seed dormancy, seed germination, pollen morphology and viability indicates no unintended effects of the introduced trait on these characteristics in MON 88302 oilseed rape.  Environmental risk: Considering the scope of the application EFSA/GMO/BE/2011/101, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MON 88302 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30 %, but outcrossing frequencies up to 55 % are reported.  Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B.juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MON 88302, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to glyphosate-containing herbicides. However, accidental spillage and loss of viable seeds of MON 88302 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MON 88302 on locations where glyphosate is frequently applied to control weeds e.g. on railway tracks, cannot be excluded. Feral oilseed rape MON 88302 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario. Apart from the glyphosate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. The VKM GMO Panel concludes that this route of gene flow would not introduce significant numbers of transgenic plants into agricultural areas or result in any environmental consequences in Norway. The environmental risk assessment will be completed and finalized by the VKM Panel on Genetically Modified Organisms when requested additional information from the applicant is available.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for 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. 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 Directorate requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. MON810 notification C/F/95/12-02 is approved under Directive 90/220/EEC for cultivation, seed production, import and processing into feeding stuffs and industrial purposes since 22 April 1998 (Commission Decision 98/294/EC). In December 1997, food and food ingredients derived from the progeny of maize line MON810 were notified under Article 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients. In addition, existing food and feed products containing, consisting of or produced from MON810 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed in the Community Register in 2005.  Three applications for renewal of the authorisation for continued marketing of (1) existing food and food ingredients produced from MON810; (2) feed consisting of and/or containing maize MON810, and MON810 for feed use (including cultivation); and (3) food and feed additives, and feed materials produced from maize MON810 within the framework of Regulation (EC) No 1829/2003 were submitted in 2007.  Maize MON810 has previously been assessed by the VKM GMO Panel commissioned by the Norwegian Directorate for Nature Management in connection with the national finalisation of the procedure of the notification C/F/95/12/02 (VKM 2007a,b). In addition, MON810 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2005a,b,c, VKM 2007c, VKM 2008, VKM 2009, VKM 2012). Due to the publication of updated guidelines for environmental risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated environmental risk assessment of MON810. The environmental risk assessment of the maize MON810 is based on information provided by the applicant in the notification C/F/95/12/02 and application EFSA/GMO/RX/MON810, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.   The VKM GMO Panel has evaluated MON810 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c).  The scientific risk assessment of maize MON810 include molecular characterisation of the inserted DNA and expression of the target protein, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms.  The genetically modified maize MON810 was developed to provide protection against certain lepidopteran target pests, including European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia. Protection is achieved through expression in the plant of the insecticidal Cry protein, Cry1Ab, derived from Bacillus thuringiensis ssp. kurstaki, a common soil bacterium.   Molecular characterisation Appropriate analysis of the integration site including flanking sequences and bioinformatics analyses have been performed to analyse the construct integrated in the GM plant. Updated bioinformatics analyses revealed that one ORF shared sequence similarity to a putative HECT-ubiquitin ligase protein.  The VKM GMO Panel found no safety implications from the interruption of this gene sequence. Analyses of leaf, grains, whole plant tissue and pollen from the maize MON 810 demonstrated that the Cry1Ab protein is expressed at very low levels in all tissues tested and constitutes less than 0.001% of the fresh weight in each tissue. The cry1Ab gene is the only transgene expressed in line MON 810 and was expressed highest in the leaves. The stability of the genetic modification has been demonstrated over several generations. Event MON810 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a,b). Comparative assessment: Comparative analyses of data from field trials located at representative sites and environments in the USA and Europe indicate that maize MON810 is agronomically and phenotypically equivalent to the conventional counterpart and commercially available reference varieties, with the exception of the lepidopteran-protection trait, conferred by the expression of the Cry1Ab protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON810 compared to conventional maize. Evaluations of ecological interactions between maize MON810 and the biotic and abiotic environment indicate no unintended effects of the introduced trait on agronomic and phenotypic characteristics. Environmental risk: There are no reports of the target lepidopteran species attaining pest status on maize in Norway. Since there are no Bt-based insecticides approved for use in Norway, and lepidopteran pests have not been registered in maize, issues related to resistance evolution in target pests are not relevant at present for Norwegian agriculture. Published scientific studies show no or negligible adverse effects of Cry1Ab protein on non-target arthropods that live on or in the vicinity of maize plants. Cultivation of maize MON810 is not considered to represent a threat to the prevalence of red-listed species in Norway. Few studies have been published examining potential effects of Cry1Ab toxin on ecosystems in soil, mineralization, nutrient turnover and soil communities. Some field studies have indicated that root exudates and decaying plant material containing Cry proteins may affect population size and activity of rhizosphere organisms (soil protozoa and microorganisms). Most studies conclude that effects on soil microorganisms and microbial communities are transient and minor compared to effects caused by agronomic and environmental factors. However, data are only available from short term experiments and predictions of potential long term effects are difficult to deduce. Few studies have assessed the impact of Cry proteins on non-target aquatic arthropods and the fate of these proteins in senescent and decaying maize detritus in aquatic environments. However, exposure of non-target organisms to Cry proteins in aquatic ecosystems is likely to be very low, and potential exposure of Bt toxins to non-target organisms in aquatic ecosystems in Norway is considered to be negligible.  Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation with which maize can hybridise and form backcross progeny. Vertical gene transfer in maize therefore depends on cross-pollination with other conventional or organic maize varieties. In addition, unintended admixture of genetically modified material in seeds represents a possible way for gene flow between different crop cultivations. The risk of pollen flow from maize volunteers is negligible under Norwegian growing conditions.  In addition to the data presented by the applicant, the VKM GMO Panel is not aware of any scientific report of increased establishment and spread of maize MON810 and any change in survival (including over-wintering), persistence and invasiveness capacity. Because the general characteristics of maize MON810 are unchanged, insect resistance are not likely to provide a selective advantage outside cultivation in Norway.  Since MON810 has no altered agronomic and phenotypic characteristics, except for the specific target pest resistance, the VKM GMO Panel is of the opinion that the likelihood of unintended environmental effects due to the establishment and survival of maize MON810 will be no different to that of conventional maize varieties in Norway. Overall conclusion: The VKM GMO Panel concludes that cultivation of maize MON810 is unlikely to have any adverse effect on the environment in Norway.