Pandora neoaphidis is a common entomopathogenic fungus on Sitobion avenae , which is an important aphid pest on cereals in Europe. Pandora neoaphidis is known to cause epizootics (i.e. an unusually high prevalence of infected hosts) and the rapid collapse of aphid populations. We developed a weather-driven mechanistic model of the winter wheat- S. avenae - P . neoaphidis system to simulate the dynamics from spring to harvest. Aphid immigration was fixed at a rate that would lead to a pest outbreak, if not controlled by the fungus. We estimated the biocontrol efficacy by running pair-wise simulations, one with and one without the fungus. Uncertainty in model parameters and variation in weather was included, resulting in a range of simulation outcomes, and a global sensitivity analysis was performed. We identified two key understudied parameters that require more extensive experimental data collection to better assess the fungus biocontrol, namely the fungus transmission efficiency and the decay of cadaver, which defines the time window for possible disease transmission. The parameters with the largest influence on the improvement in yield were the weather, the lethal time of exposed aphids, the fungus transmission efficiency, and the humidity threshold for fungus development, while the fungus inoculum in the chosen range (between 10 and 70% of immigrant aphids carrying the fungus) was less influential. The model suggests that epizootics occurring early, around Zadoks growth stage (GS) 61, would lead to successful biocontrol, while later epizootics (GS 73) were a necessary but insufficient condition for success. These model predictions were based on the prevalence of cadavers only, not of exposed (i.e. infected but yet non-symptomatic) aphids, which in practice would be costly to monitor. The model suggests that practical Integrated Pest Management could thus benefit from including the cadavers prevalence in a monitoring program. We argue for further research to experimentally estimate these cadaver thresholds.

Fall armyworm (FAW) Spodoptera frugiperda (J.E. Smith, 1797) (Lepidoptera: Noctuidae) was recorded for the first time in 2016 attacking maize fields in central and west Africa. Soon after, several other regions and countries have reported the pest in almost the entire sub-Saharan Africa. In the present study, we assumed that (i) a variety of alternative plant species host FAW, especially during maize off-season, (ii) a wide range of local parasitoids have adapted to FAW and (iii) parasitoid species composition and abundance vary across seasons. During a two-year survey (from June 2018 to January 2020), parasitoids and alternative host plants were identified from maize and vegetable production sites, along streams and lowlands, on garbage dumps and old maize fields in southern and partly in the central part of Benin during both maize growing- and off-season. A total of eleven new host plant species were reported for the first time, including Cymbopogon citratus (de Candolle) Stapf (cultivated lemon grass), Bulbostylis coleotricha (A. Richard) Clarke and Pennisetum macrourum von Trinius (wild). The survey revealed seven parasitoid species belonging to four families, namely Platygastridae, Braconidae, Ichneumonidae, and Tachinidae associated with FAW on maize and alternative host plants. The most abundant parasitoid species across seasons was the egg parasitoid Telenomus remus (Nixon) (Hymenoptera: Platygastridae). These findings demonstrate FAW capability to be active during the maize off-season in the selected agro-ecologies and provide baseline information for classical and augmentative biocontrol efforts.

Soybean MON 89788 expresses the cp4 epsps gene from the plant pathogenic bacterium Agrobacterium tumefaciens (Rhizobium radiobacter) sp. strain CP4. The encoded enzyme 5enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein confers tolerance to the active herbicidal substance glyphosate. Updated bioinformatics analyses of the inserted DNA and flanking sequences in soybean MON 89788 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 cp4 epsps gene, have been shown over several generations of soybean MON 89788. With the exception of the intended changes caused by the trans-genetically introduced trait, data from several field trials performed in USA and Argentina show that soybean MON 89788 is compositionally, morphologically and agronomically equivalent to its conventional counterpart and other commercial soybean varieties. A sub-chronic feeding study with rats, as well as a nutritional assessment trial with broilers has not revealed adverse effects of soybean MON 89788. These studies indicate that soybean MON 89788 is nutritionally equivalent to, and as safe as conventional soybean varieties. The CP4 EPSPS protein produced in soybean MON 89788 does not show sequence resemblance to known toxins or IgE-dependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. Soybean is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of soybean in Europe. Based on current knowledge, the VKM GMO Panel concludes that with the intended usage, there are no discernible safety concerns associated with soybean MON 89788 regarding human or animal health or to the environment in Norway.

Genetically modified carnation (Dianthus caryophyllus L.) line 123.8.12 with product name Moonaqua™, expresses three introduced traits. The dfr gene from Petunia x hybrida and the f3′5′h (Hf1) gene from Viola sp., 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 mauve 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. Bioinformatics analyses of the inserted DNA and flanking sequences in carnation 123.8.12 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 (Hf1) genes, have been shown over several generations of carnation 123.8.12. Data reported from several field trials show that carnation 123.8.12 petals contain higher levels of the anthocyanins delphinidin and cyanidin compared to the non-GM (conventional) carnation counterpart FE123. Other morphological traits were reported and along with differing petal colour, carnation Moonaqua 123.8.12 differed significantly in one trait compared to conventional carnation counterpart FE123. An acute toxicity study in mice and an in vitro mutagenicity study employing aqueous extracts from leaves or petals showed no adverse effects. DFR, F3’5’H and ALS proteins do not show sequence resemblance to known toxins or IgE-dependent allergens, nor have they been reported to 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 123.8.12 represents an environmental risk in Norway. Considering that carnation Moonaqua 123.8.12 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 petunidin in its petals is sufficient for the risk assessment. The reported morphological differences between Moonaqua 123.8.12 and the conventional carnation counterpart FE123 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 Moonaqua 123.8.12. 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 Moonaqua 123.8.12 is as safe as its conventional counterpart FE123. 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 Moonaqua 123.8.12 will have any adverse effects on the biotic or abiotic environment in Norway.

Soybean MON 87701 expresses the cry1Ac gene from Bacillus thuringiensis. The encoded Cry1Ac protein confers resistance against specific lepidopteran pests. Updated bioinformatics analyses of the inserted DNA and flanking sequences in soybean MON 87701 have not indicated a potential production of harmful toxins and allergens or polypeptides caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the cry1Ac gene, have been shown over several generations of soybean MON 87701. Data from several field trials performed in USA, Canada, Chile and Argentina during 2005-2006 show that soybean MON 87701 is compositionally, morphologically and agronomically equivalent to its conventional counterpart and other commercial soybean cultivars. Subchronic feeding studies with rats as well as nutritional assessment with broilers have not revealed relevant adverse effects of MON 87701. These studies indicate that MON 87701 is nutritionally equivalent to and as safe as conventional soybean cultivars. The Cry1Ac protein produced in soybean MON 87701 do not show sequence resemblance to known toxins or IgE-dependent allergens, nor has the whole GM plant been reported to cause changes in IgE-mediated allergic reactions in patients reactive to soybean or in non-ectopic control individuals. Soybean is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of soybean in Europe. Based on current knowledge and considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that soybean MON 87701 with the Cry1Ac protein: - Is compositionally, morphologically and agronomically equivalent to its conventional counterpart and other commercial soybean cultivars - Is unlikely to introduce a toxic or allergenic potential in food or feed compared to conventional soybean cultivars - Is nutritionally equivalent to and as safe as its conventional counterpart and other conventional soybean cultivars - Does not represent an environmental risk in Norway.

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.

Soybean 356043 expresses both the gat gene from the soil bacterium Bacillus licheniformis and the gm - hra gene, an optimised form of the endogenous acetolactate synthase (als) coding sequence from soybean (Glycine max; gm). The encoded GAT4601 protein, glyphosate acetyltransferase, confers the ability to inactivate the active herbicidal substances glyphosate and glyphosate-ammonium to N-acetyl glyphosate, which does not have herbicidal activity. The encoded GM-HRA protein confers increased tolerance to the active, ALS-inhibiting, herbicidal substances chlorimuron, thifensulfuron and sulfonylureas. Bioinformatics analyses of the inserted DNA and flanking sequences in soybean 356043 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 gat gene, have been shown over several generations of soybean 356043. Data from several field trials performed in USA, Canada, Chile and Argentina during 2005-2006 show that soybean 356043 contains higher levels of especially the acetylated amino acid N-acetyl aspartate, but also N-acetyl glutamate and the odd-chain fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acids, in addition to expression of the newly expressed proteins. Otherwise the soybean 356043 is compositionally, morphologically and agronomically equivalent to its conventional counterpart and other commercial soybean cultivars. The acetylated amino acids and odd-chain fatty acids are normal constituents of plant and animal-derived foods and feeds, and an in-depth toxicity and intake assessment did not reveal safety concerns regarding consumer intake at the levels present in soybean 356043. Sub-chronic feeding studies with rats, repeated-dose toxicity studies with mice, as well as nutritional assessment trials with broilers and laying hens have not revealed adverse effects of soybean 356043. These studies indicate that soybean 356043 is nutritionally equivalent to and as safe as conventional soybean cultivars. The GAT4601 and GM-HRA proteins produced in soybean 356043 do not show sequence resemblance to known toxins or IgE-dependent allergens, nor has the whole GM plant been reported to cause changes in IgE-mediated allergic reactions in patients reactive to soybean or in non-ectopic control individuals. Soybean is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of soybean in Europe. Based on current knowledge and considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that soybean 356043 with the GAT4601 and GM-HRA proteins: - Is – with the exception of the novel traits and resulting increased content of the acetylated amino acids NAA and NAG, and the odd-chain fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acids – compositionally, morphologically and agronomically equivalent to its conventional counterpart and other commercial soybean cultivars - Are unlikely to introduce toxic or allergenic potentials in food or feed compared to conventional soybean cultivars - Is nutritionally equivalent to and as safe as its conventional counterpart and other conventional soybean cultivars - Does not represent an environmental risk in Norway.

Genetically modified carnation (Dianthus caryophyllus L.) line 123.2.38 with product name Moonlite™, expresses three introduced traits. The dfr and f3′5′h (Hf1) genes from Petunia x hybrida 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 colour to the flowers. A mutated als gene 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. Bioinformatics analyses of the inserted DNA and flanking sequences in carnation 123.2.38 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 (Hf1) genes, have been shown over several generations of carnation 123.2.38. Data reported from several field trials show that carnation 123.2.38 petals contain higher levels of the anthocyanins delphinidin and cyanidin compared to the non-GM (conventional) carnation counterpart 123. Other morphological traits were reported and along with differing petal colour, carnation Moonlite 123.2.38 differed significantly in one trait compared to conventional carnation counterpart 123. An acute toxicity study in mice and two in vitro studies, both employing aqueous extracts from leaves or petals, showed no adverse effects. DFR, F3’5’H and ALS proteins do not show sequence resemblance to known toxins or IgE-dependent allergens, nor have they been reported to 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 123.2.38 represents an environmental risk in Norway. Considering that carnation Moonlite 123.2.38 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 petunidin in its petals is sufficient for the risk assessment. The reported morphological differences between Moonlite 123.2.38 and its conventional carnation counterpart 123 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 Moonlite 123.2.38. 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 Moonlite 123.2.38 is as safe as its conventional counterpart 123. 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 Moonlite 123.2.38 will have any adverse effects on the biotic or abiotic environment in Norway.

The natural occurrence of entomopathogenic fungal endophytes in sugarcane (Saccharum officinarum) and in soil samples from sugarcane fields was evaluated in Chikwawa District, southern Malawi. Fungi from soil were isolated by baiting using Galleria mellonella larva. Fungal endophytes were isolated from surface-sterilized plant tissue sections. Forty-seven isolates resembled the genus Beauveria, 9 isolates were Metarhizium, and 20 isolates were Isaria. There was no significant difference in the number and type of fungal isolates collected from soil and from plant tissue. There was, however, a significant difference in the part of the plant where fungal species were isolated, which fungal species were isolated, and the number of fungal species isolated at each location. Phylogenetic analysis of 47 Beauveria isolates based on DNA sequencing of the Bloc intergenic region indicated that these isolates all belonged to B. bassiana and aligned with sequences of B. bassiana isolates of African and Neotropical origin. The Malawian B. bassiana isolates formed a distinct clade. No larvae died from infestation by multiple fungi. To the best of our knowledge, this is the first report of B. bassiana and Isaria spp. occurring naturally as endophytes in sugarcane. Further, it is the first report of B. bassiana, Isaria spp., and Metarhizium spp. in the soil of sugarcane fields in Africa.

Soybean A2704-12 expresses the phosphinothricin-N-acetyltransferase (pat) gene, from the soil bacterium Streptomyces viridochromogenes. The encoded PAT protein confers tolerance to the active herbicidal substance glufosinate-ammonium. Bioinformatics analyses of the inserted DNA and flanking sequences in soybean A2704-12 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 pat gene have been shown over several generations of soybean A2704-12. With the exception of the intended changes caused by the transgenetically introduced trait, data from field trials performed in the USA and Canada show that soybean A2704-12 is compositionally, morphologically and agronomically equivalent to its conventional counterpart and to other commercial soybean varieties. A repeated dose toxicity study in with rats and a nutritional assessment trial with broilers indicate that soybean A2704-12 is nutritionally equivalent to and as safe as conventional soybean varieties. The PAT protein produced in soybean A270412 does not show sequence resemblance to known toxins or IgE-dependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. Soybean is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of soybean in Europe. Based on current knowledge, the VKM GMO Panel concludes that with the intended usage, there are no discernible safety concerns associated with soybean A2704-12 regarding human or animal health or to the environment in Norway.

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.

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 herbicide-tolerant and insect-resistant genetically modified maize NK603 x MON810 (Unique Identifier MON-ØØ6Ø3-6 x MON-ØØ81Ø2-6) from Monsanto Company is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 24 October 2007 (Commission Decision 2007/701/EC). VKM participated in the 90 days public consultation of the application for placing on the market of maize NK603 x MON810 for food and feed uses, import and processing (EFSA/GMO/ UK/2004/01) in 2005, and submitted a preliminary opinion in June 2005 (VKM 2005a). Maize NK603 x MON810 has also been assessed as food and feed by the VKM GMO Panel, commissioned by the Norwegian Environment Agency and the Norwegian Food Safety Authority in connection with the national finalisation of the application in 2008 (VKM 2008a). In addition, NK603 and MON810 has been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2005 a,b,c,d,e, VKM 2007 a,b,c,d,e, 2008b, 2009, 2010 a,b, 2011, 2012 a,b, 2013a,b,c,d,e,f,g,h,i,j). Due to the publication of new scientific literature and updated guidelines for risk assessment of genetically modified plants, the VKM GMO Panel has decided to deliver an updated food/feed and environmental risk assessment of maize NK603 x MON810. The food/feed and environmental risk assessment of the maize NK603 x MON810 is based on information provided by the applicant in the applications EFSA/GMO/UK/2004/01 and EFSA/GMO/2005/26, 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 NK603 x 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 2011a), the environmental risk assessment of GM plants (EFSA 2010a), 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 NK603 x MON810 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 characterisation The stacked maize NK603 x MON810 was produced by conventional crossing of the single maize events NK603 and MON810. Southern blot and PCR analyses have shown that the recombinant inserts from the parental events are retained in the stacked event, and that their structures are intact. Genotypic stability of the inserts has previously been demonstrated for the single events. Protein measurements show comparable levels of CP4 EPSPS and Cry1Ab in forage and grain samples from maize NK603 x MON810 to those measured in maize NK603 and MON810, respectively. The VKM GMO Panel considers the molecular characterisation of maize NK603 x MON810 and its parental events NK603 and MON810 satisfactory. Comparative assessment The applicant has performed comparative analyses of data from field trials located in maize growing regions of Europe and USA in 2000 and 2002. With the exception of small intermittent variations and the insect resistance and herbicide tolerance conferred by the Cry1Ab and CP4 EPSPS proteins, the results showed no biologically significant differences between maize stack NK603 x MON810 and conventional control. Based on the assessment of available data, the VKM GMO Panel concludes that maize NK603 x MON810 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for for the introduced characteristics, and that its composition fell within the normal ranges of variation observed among non-GM varieties. Food and feed risk assessment A whole food feeding study performed on broilers did not indicate any adverse health effects of maize NK603 x MON810, and shows that maize NK603 x MON810 is nutritionally equivalent to conventional maize. The CP4 EPSPS or Cry1Ab 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 NK603 x MON810 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab or CP4-EPSPS proteins will introduce a toxic or allergenic potential in food or feed based on maize NK603 x MON810 compared to conventional maize. Environmental risk assessment Considering the intended uses of maize NK603 x MON810, 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 NK603 x MON810. Maize NK603 x MON810 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 NK603 x MON810. 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 NK603 x MON810 is nutritionally equivalent to conventional maize varieties. It is unlikely that the CP4 EPSPS and Cry1Ab proteins will introduce a toxic or allergenic potential in food or feed based on maize NK603 x MON810 compared to conventional maize. The VKM GMO Panel likewise concludes that maize NK603 x MON810, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

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. Four notifications/applications for placing on the market of insect resistant genetically modified maize 1507 from Pioneer HiBreed & Dow AgroSciences (Unique Identifier DAS-Ø15Ø7-1) have been taken into account: Application EFSA/GMO/NL/2004/02 for placing on the market of insect-tolerant genetically modified maize 1507 for food use under Regulation (EC) 1829/2003 Food and food ingredients containing, consisting of or produced from maize 1507 approved since 3 March 2006 (Commission Decision 2006/197/EC) Notification C/NL/00/10 for import and processing use under Part C of Diretive 2001/18/EC. Approved for importation, processing and feed use since 3 November 2005 (Commission Decision 2005/772/EC) Application EFSA/GMO/RX/1507 for renewal of authorisation of existing products of maize 1507 under Regulation (EC) no 1829/2003 Renewing of the authorisation of existing feed products from maize 1507 granted since 17 June 2011 (Commission Decision 2011/365/EC). Notification C/ES/01/01 for cultivation, import, processing and use as any other maize (excluding food uses) under Directive 2001/18/EC on the deliberate release of GMOs into the environment. The application is still pending for authorisation. Genetically modified maize 1507 has previously been assessed as food and feed by the VKM GMO Panel commissioned by the Norwegian Food Safety Authority in connection with the EFSA official hearing of the application EFSA/GMO/NL/2004/02 in 2004 (VKM 2004). Maize 1507 has also been evaluated by the VKM GMO Panel as a component of several stacked GM maize events under Regulation (EC) 1829/2003 (VKM 2005b, 2007a,b, 2008a,b, 2009a,b, 2012a,b,c, 2013 a,b,c,d,e). The food/feed and environmental risk assessment of the GM maize 1507 is based on information provided by the applicant in the notifications C/ES/01/01 and C/NL/00/10 and the applications EFSA/GMO/NL/2004/02 and EFSA/GMO/RX/1507, previous risk assessments performed by the VKM GMO Panel and scientific opinions and comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment is also based on a risk analysis report of 1507 from the Australia New Zealand Food Authority (FSANZ 2002) and a review and assessment of relevant peer-reviewed scientific literature. The VKM GMO Panel has evaluated maize 1507 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 2010a), 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 1507 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 1507 has been developed to provide protection against certain lepidopteran target pests, such as the European corn borer (ECB, Ostrinia nubilalis), and some species belonging to the genus Sesamia. The insect resistence is achieved through expression of a synthetic version of the truncated cry1F gene derived from Bacillus thuringiensis subsp. aizawai, a common soil bacterium. Maize 1507 also expresses the phosphinothricin-N-acetyltransferase (pat) gene, from the soil bacterium Streptomyces viridochromogenes. The encoded PAT protein confers tolerance to the herbicidal active substance glufosinate-ammonium. The PAT protein produced by maize 1507 has been used as a selectable marker to facilitate the selection process of transformed plant cells and is not intended for weed management purposes. Since the scope of the notification C/ES/01/01 does not cover the use of glufosinate-ammonium-containing herbicides on maize 1507, potential effects due to the use of such herbicides on maize 1507 are not considered by VKM. Molecular Characterisation: Appropriate analyses of the transgenic DNA insert, its integration site, number of inserts and flanking sequences in the maize genome, have been performed. The results show that only one copy of the insert is present in maize 1507. Homology searches with databases of known toxins and allergens have not indicated any potential production of harmful proteins or polypeptides caused by the genetic modification in maize 1507. Southern blot analyses and segregation studies show that the introduced genes cry1F and pat are stably inherited and expressed over several generations along with the phenotypic characteristics of maize 1507. The VKM GMO Panel considers the molecular characterisation of maize 1507 satisfactory. Comparative Assessment: Comparative analyses of maize 1507 to its non-GM conventional counterpart have been performed during multiple field trials located at representative sites and environments in Chile (1998/99), USA (1999) and in Europe (1999, 2000 and 2002). With the exception of small intermittent variations, no biologically significant differences were found between maize 1507 and the conventional maize. Based on the assessment of available data, the VKM GMO Panel concludes that maize 1507 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the introduced characteristics, and that its composition fell within the normal ranges of variation observed among non-GM varieties. Food and Feed Safety Assessment: Whole food feeding studies on rats, broilers, pullets, pigs and cattle have not indicated any adverse health effects of maize 1507. These studies also indicate that maize 1507 is nutritionally equivalent to conventional maize. The PAT and Cry1F 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 1507 is nutritionally equivalent to conventional maize varieties. It is unlikely that the PAT and Cry1F proteins will introduce a toxic or allergenic potential in food or feed based on maize 1507 compared to conventional maize. 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. There are only a limited number of published scientific studies on the environmental effects of Cry1F protein. Published scientific studies showed that the likelihood of negative effects of Cry1F protein on non-target arthropods that live on or in the vicinity of maize plants is low. Cultivation of maize 1507 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 Cry1F 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. The VKM GMO Panel concludes that, although the data on the fate of the Cry1F protein and its potential interactions in soil are limited, the relevant scientific publications analysing the Cry1F protein, together with the relatively broad knowledge about the environmental fate of other Cry1 proteins, do not indicate significant direct effects on the soil environment. 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, and no specific lower-tier studies, assessing the impact of the Cry1F protein on non-target aquatic arthropods have been reported in the scientific literature so far. 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 nontarget 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. Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize 1507 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1 and PAT proteins will introduce a toxic or allergenic potential in food or feed derived from maize 1507 compared to conventional maize. The VKM GMO Panel likewise concludes that cultivation of maize 1507 is unlikely to have any adverse effect on the environment and agriculture in Norway.

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 MIR604 x GA21 (Unique Identifier SYN-IR6Ø4-5 x MON-ØØØ21-9 ) from Syngenta Seeds is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 22 December 2011 (Commission Decision 2011/892/EC). Genetically modified maize MIR604 x GA21 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/2007/48 in 2008 (VKM 2009a). In addition, MIR604 and GA21 has been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2005a,b, 2006, 2008, 2009b,c,d,e, 2010, 2012, 2013a,b,c,d). The food/feed and environmental risk assessment of the maize MI604 x GA21 is based on information provided by the applicant in the application EFSA/GMO/UK/2007/48, 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 x GA21 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 x GA21 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: Southern blot and PCR analyses have indicated that the recombinant inserts in the parental maize lines MIR604 and GA21 are retained in the stacked maize MIR604 x GA21. Genetic stability of the inserts has previously been demonstrated in the parental events. Protein measurements show comparable levels of the mCry3A, PMI and mEPSPS proteins between the stacked and single maize lines. The VKM Panel on GMO considers the molecular characterisation of maize MIR604 x GA21 and its parental events MIR604 and GA21 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 MIR604 x GA21 is equivalent to its conventional counterpart, with the exception of the insect resistance and the herbicide tolerance, conferred by the mCry3A, PMI and mEPSPS proteins. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of maize MIR604 x GA21 compared to conventional maize varieties. The applicant has performed a compositional analysis on the triple-stack Bt11 x MIR604 x GA21 instead of maize MIR604 x GA21. 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 MIR604 x GA21, since maize Bt11 x MIR604 x GA21 encompasses the transgenic properties of maize MIR604 x GA21. 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 MIR604 x GA21 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 MIR604 x GA21, a feeding study on broilers showing nutritional equivalence to non-GM maize, and assessments of the single events MIR604 and GA21, the VKM GMO Panel concludes that forage and grain from maize MIR604 x GA21 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 MIR604 x GA21, and shows that maize MIR604 x GA21 is nutritionally equivalent to conventional maize. The mCry3A, PMI and mEPSPS, 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 x GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mCry3A, PMI or mEPSPS proteins will introduce a toxic or allergenic potential in food or feed based on maize MIR604 x GA21 compared to conventional maize. Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2007/48 includes import and processing of maize stack MIR604 x GA21 for food and feed uses. Considering the intended uses of maize MIR604 x GA21, 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 x GA21. Maize MIR604 x GA21 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 x GA21. 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 x GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mCry3A, PMI or mEPSPS proteins will introduce a toxic or allergenic potential in food or feed based on maize MIR604 x GA21 compared to conventional maize. The VKM GMO Panel likewise concludes that maize MIR604 x GA21, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

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.

Several important vegetable crops grown outdoors in temperate climates in Europe can be damaged by the root-feeding larvae of Diptera (Delia radicum, Delia floralis, Chamaepsila rosae, Delia platura, Delia florilega, Delia antiqua). Knowledge of pest insect phenology is a key component of any Integrated Pest Management (IPM) strategy, and this review considers the methods used to monitor and forecast the occurrence of root-feeding flies as a basis for decision-making by growers and the ways that such information can be applied. It has highlighted some current management approaches where such information is very useful for decision support, for example, the management of C. rosae with insecticidal sprays and the management of all of these pests using crop covers. There are other approaches, particularly those that need to be applied at sowing or transplanting, where knowledge of pest phenology and abundance is less necessary. Going forward, it is likely that the number of insecticidal control options available to European vegetable growers will diminish and they will need to move from a strategy which often involves using a single ‘silver bullet’ to a combination of approaches/tools with partial effects (applied within an IPM framework). For the less-effective, combined methods, accurate information about pest phenology and abundance and reliable decision support are likely to be extremely important.

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 herbicide-tolerant genetically modified maize GA21 from Syngenta Seeds (Unique Identifier MON-ØØØ21-9) is authorised for the import and placing on the market as food or feed in the EU pursuant to Regulation (EC) 1829/2003 by the Commission Decision 2008/280/EC. An application for granting consent to all uses of GA21 maize including the cultivation was submitted by Syngenta in accordance with articles 5 and 17 of the Regulation (EC) No. 1829/2003 on June 30 2008. Maize GA21 has previously been assessed as food and feed by the VKM GMO Panel commissioned by the Norwegian Food Safety Authority in connection with the national finalisation of the procedure of the notification C/ES/98/01 in 2005 (VKM 2005a). VKM also participated in the 90 days public consultation of the application for placing on the market of maize GA21 for food and feed uses, import, processing and cultivation (EFSA/GMO/UK/2008/60) in 2009, and submitted a preliminary opinion in April 2010 (VKM 2010). GA21 has also been evaluated by the VKM GMO Panel as a component of several stacked GM maize events under and Regulation (EC) 1829/2003 (VKM 2008, VKM 2009a,b,c,d, VKM 2012a,b, VKM 2013a,b,c). Due to the publication of new scientific literature and updated guidelines for risk assessment of genetically modified plants, the VKM GMO Panel has decided to deliver an updated food/feed and environmental risk assessment of GA21. The updated food/feed and environmental risk assessment of the maize GA21 is based on information provided by the applicant in the applications EFSA/GMO/UK/2005/19, EFSA/GMO/UK/2008/60 and EFSA/GMO/RX/GA21 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 GA21 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 GA21 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. Maize GA21 expresses a modified version of 5-enolpyruvylshikimate-3-phosphate synthase (mEPSPS), which is derived from maize EPSPS, and renders maize GA21 tolerant to the herbicidal active substance glyphosate. Molecular Characterization: The molecular characterisation data indicate that several copies of the GA21 construct are integrated at a single locus in the DNA, and that they are 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 GA21 as adequate. Comparative Assessment: Comparative analyses of maize event GA21 to its conventional counterpart) have been performed during multiple field trials located at representative sites and environments in North America (1997, 2004, and 2005), Europe (1996, 1997, and 2006) and Brazil (2003). With the exception of small intermittent variations, no biologically significant differences were found between maize GA21 and controls. Based on the assessment of available data, the VKM GMO Panel concludes that maize GA21 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the mEPSPS protein, and that its composition fell within the range observed among nonGM varieties. Food and Feed Risk Assessment: Whole food feeding studies in rats, broilers and cattles have not indicated any adverse health effects of maize GA21. These studies also indicate that maize GA21 is nutritionally equivalent to conventional maize. The mEPSPS protein does not show sequence resemblance to other known toxins or IgE allergens, nor has mEPSPS been reported to cause IgE mediated allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mESPSPS protein will introduce a toxic or allergenic potential in food or feed based on maize GA21 compared to conventional maize. Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2005/19 includes import and processing of maize GA21 for food and feed uses. Considering the intended uses of maize GA21, 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 GA21. Maize GA21 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 GA21. 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 GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mEPSPS protein will introduce a toxic or allergenic potential in food derived from maize GA21 compared to conventional maize. The VKM GMO Panel likewise concludes that maize GA21, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

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. The insect-resistant genetically modified maize MON 89034 (Unique Identifier MON-89Ø34-3) from Monsanto Company is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 30 October 2009 (Application EFSA/GMO/NL/2007/37, Commission Decision 2009/813/EC). Genetically modified maize MON 89034 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 application EFSA/GMO/NL/2007/37 in 2007 (VKM 2008a). VKM has also been requested to issue a preliminary scientific opinion on the safety of the genetically modified maize MON 89034 for cultivation, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMO/BE/2011/90 (VKM 2012a). At the request from the Norwegian Environment Agency the VKM GMO Panel also submitted a final environmental risk assessment of MON 89034 for food and feed uses in 2013 (VKM 2013). Finally, maize MON 89034 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2008b, 2009a,b, 2010a,b). The food/feed and environmental risk assessment of maize MON 89034 is based on information provided by the applicant in the applications EFSA/GMO/NL/2007/37 and EFSA/GMO/BE/2011/90, 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 MON 89034 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 MON 89034 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. The genetically modified maize MON 89034 was developed to provide protection against certain lepidopteran target pest, including European corn borer (Ostrinia nubilalis) and Mediterranean corn borer (Sesamia nonagrioides). Protection is achieved through expression in the plant of two insecticidal Cry proteins, Cry1A.105 and Cry2Ab2, derived from Bacillus thuringiensis, a common soil bacterium. Cry1A.105, encoded by the cry1A.105 gene, is a chimeric protein made up of different functional domains derived from three wild-type Cry proteins from B. thuringiensis subspecies kurstaki and aizawai. The Cry2Ab2 protein is encoded by the cry2Ab2 gene derived from B. thuringiensis subspecies kurstaki. Molecular characterization: Appropriate analyses of the transgenic DNA insert, its integration site, number of inserts and flanking sequences in the maize genome, have been performed. The results show that only one copy of the insert is present in maize MON 89034. Homology searches with databases of known toxins and allergens have not indicated any potential production of harmful proteins or polypeptides caused by the genetic modification in maize MON 89034. Southern blot analyses and segregation studies show that the introduced genes cry1A.105 and cry2Ab2 are stably inherited and expressed over several generations along with the phenotypic characteristics of maize MON 89034. The VKM GMO Panel concludes that the molecular characterisation of maize MON 89034 does not indicate a safety concern. Comparative assessment: Comparative analyses of maize MON 89034 to its non-GM conventional counterpart have been performed during multiple field trials in representative areas for maize cultivation in USA, Argentina and Europe (2004, 2005 and 2007). With the exception of small intermittent variations, no biologically significant differences were found between maize MON 89034 and the conventional non-GM control. Based on the assessment of available data, the VKM GMO Panel concludes that maize MON 89034 is compositionally, agronomical and phenotypically equivalent to its conventional counterpart, except for the introduced characteristics. Food and feed risk assessment: A 90-day subchronic feeding study on rats, as well as whole food feeding studies on broilers and feedlot steers have not indicated any adverse effects of maize MON 89034 and shows that maize MON 89034 is nutritionally equivalent to conventional maize. The Cry1A.105 and Cry2Ab2 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 MON 89034 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1A.105 or Cry2Ab2 proteins will introduce a toxic or allergenic potential in food or feed based on maize MON 89034 compared to conventional maize. Environmental risk assessment: Considering the intended uses of maize MON 89034, 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 MON 89034. Maize MON 89034 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 MON 89034. 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 MON 89034 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1A.105 and Cry2Ab2 proteins will introduce a toxic or allergenic potential in food or feed derived from maize MON 89034 compared to conventional maize. The VKM GMO Panel likewise concludes that maize MON 89034, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

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.