Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorised 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 NK603 from Monsanto (Unique Identifier MONØØ6Ø3-6) is approved under Directive 2001/18/EC as feed since 19 July 2004 (Commission Decision 2004/643/EC). Foods and food ingredients derived from NK603 was authorised under Novel Foods Regulation (EC) No 258/97 3 March 2005 (Commission Decision 2005/448/EC) (EC 2013).   Genetically modified maize NK603 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMOs), commissioned by the NFSA in connection with the national finalisation of the procedure of the notification in 2005 (VKM 2005a). NK603 has also been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2005b,c,d,e VKM 2007a,b,  VKM 2008a,b, VKM 2009, VKM 2010, VKM 2011, VKM 2012a, VKM 2013a,b). 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 risk assessment of NK603. This updated assessment only covers health and environmental risks with regard to maize NK603 in food products.   The risk assessment of maize NK603 is based on information provided by the applicant in the notification C/EC/00/01, the applications EFSA/GMO/NL/2005/22 and EFSA/GMO/RX/NK603, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considers other relevant peer-reviewed scientific literature.  The VKM GMO Panel has assessed maize NK603 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 NK603 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan.   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 NK603 has been developed to provide tolerance to glyphosate by the introduction, via particle gun acceleration, of a gene coding for 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) from Agrobacterium sp. strain CP4 (CP4 EPSPS).  Molecular Characterization:  NK603 was developed for tolerance to glyphosate by the introduction of the gene cp4 epsps from Agrobacterium sp. strain CP4. via a particle acceleration method. The molecular characterisation data indicate that only one copy of the tandem cp4 epsps cassette is integrated in the DNA of maize NK603, 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. No potential new ORFs with sequence similarities to known toxins or allergens were detected. The Chi square analyses of the segregation results for the glyphosate tolerance trait in the progeny are also consistent with a single active site of insertion. The VKM GMO Panel considers the molecular characterisation of maize NK603 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 NK603 is compositionally, agronomically and phenotypically equivalent to conventional maize, with the exception of the glyphosate tolerance conferred by the CP4 EPSPS protein.   Food and Feed Risk Assessment:  Whole food feeding studies on rats have not indicated any adverse effects of maize NK603. Nutritional feeding studies on broilers, pigs, steers and cows indicate that NK603 is nutritionally equivalent to conventional maize. The CP4 EPSPS protein does not show resemblance to any known toxins or IgE allergens, nor has CP4 EPSPS been reported to cause IgE mediated allergic reactions. An acute oral toxicity test in mice did not indicate toxic effects of purified E. coli produced CP4 EPSPS protein. However, such a test does not provide any additional information about possible adverse effects of maize NK603.  Based on current knowledge, the VKM GMO Panel concludes that maize NK603 is nutritionally equivalent to conventional maize varieties, and that it is unlikely that the CP4 EPSPS protein will introduce a toxic or allergenic potential in food derived from maize NK603 compared to conventional maize.  Environmental Assessment:  The authorisations of maize NK603 under Directive 2001/18/EC and the Novel Foods Regulation (EC) No 258/97 include import and processing of maize NK603 for food and feed uses. Considering the intended uses of maize NK603, excluding cultivation, the environmental risk assessment has been concerned with accidental release into the environment of viable grains during transportation and processing.  The available data indicate that NK603 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. 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, 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 is nutritionally equivalent to conventional maize varieties, and that it is unlikely that the CP4 EPSPS protein will introduce a toxic or allergenic potential in food derived from maize NK603 compared to conventional maize. The VKM GMO Panel likewise concludes that maize NK603, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.   The insect-resistant and herbicide-tolerant genetically modified maize 59122 x NK603 from Pioneer Hi-Bred International, Inc. (Unique Identifier DAS-59122-7 x MONØØ6Ø3-6) is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 30 October 2009 (Commission Decision 2009/815/EC).   Genetically modified maize 59122 x NK603 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority related to the EFSAs public hearing of the application EFSA/GMO/UK/2005/20 in 2007 (VKM 2007a). In addition 59122 x NK603 has been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2005a,b,d, VKM 2007b,c, VKM 2008b,c, VKM 2009a,b, VKM 2012). The food/feed and environmental risk assessment of the maize 59122 x NK603 is based on information provided by the applicant in the application EFSA/GMO/UK/2005/20, 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 59122 x NK603 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 59122 x NK603 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes.    It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms.    The genetically modified maize stack 59122 x NK603 was produced by conventional breeding between inbred lines of maize containing the 59122 and NK603 events. The hybrid was developed to provide protection against certain coleopteran target pests, and to confer tolerance to glufosinateammonium and glyphosate herbicides.   Molecular characterization:   Southern and PCR analyses has been performed and indicate that the recombinant inserts in the single maize events 59122 and NK603 are retained in maize stack 59122xNK603. Genetic stability of the inserts has previously been demonstrated in the parental lines 59122 and NK603. The level of Cry34Ab1/Cry35Ab1, PAT and CP4 EPSPS proteins in seed and forage from the stacked event were measured using ELISA and are comparable to the levels in the single events. Phenotypic analyses also indicate stability of the insect resistance and herbicide tolerance traits of the stacked event.    Comparative Assessment:   Comparative analyses of data from field trials located at representative sites and environments in North America indicate that maize stack 59122 x NK603 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, with the exception of the introduced insect resistance and herbicide tolerance, conferred by the expression of the Cry34Ab1, Cry35Ab1, PAT and CP4 EPSPS proteins. Based on the assessment of available data, the VKM GMO Panel is of the opinion that conventional crossing of maize 59122 and NK603 to produce the hybrid 59122 x NK603 does not result in interactions that cause compositional, agronomic and phenotypic changes that would raise safety concerns.    Food and Feed Risk Assessment:   Whole food feeding study has not been performed using 59122 x NK603 maize. The applicant has, however, provided a nutritional study on broilers using the triple stacked event 59122 x 1507 x NK603 maize as test material. Bioinformatics analyses have not revealed expression of any known ORFs in the parental maize lines, and none of the newly expressed proteins show resemblance to any known toxins or IgE allergens. Nor have the newly expressed proteins been reported to cause IgE mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions.   Acute and repeated toxicity tests in rodents have not indicated toxic effects of the newly expressed proteins. However, these tests do not provide any additional information about possible adverse effects of the stacked event maize 59122 x NK603.   Based on the current knowledge, the VKM GMO Panel concludes that 59122 x NK603 maize is nutritionally equivalent to its conventional maize, and that it is unlikely that newly expressed proteins will introduce a toxic or allergenic potential of food/feed derived from maize 59122 x NK603 compared to conventional maize.   Environmental Risk Assessment:   The scope of the application EFSA/GMO/UK/2005/20 includes import and processing of maize stack 59122 x NK603 for food and feed uses. Considering the intended uses of maize 59122 x NK603, 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 59122 x NK603.   Maize 59122 x NK603 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 59122 x NK603. 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:   The VKM GMO Panel has not identified toxic or altered nutritional properties of maize 59122 x NK603 or its processed products compared to conventional maize. Based on current knowledge, it is also unlikely that the Cry34Ab1 and Cry35Ab1 protein will increase the allergenic potential of food and feed derived from maize 59122 x NK603 compared to conventional maize varieties. The VKM GMO Panel likewise concludes that maize 59122 x NK603, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.  The herbicide-tolerant and insect-resistant genetically modified maize 59122 from Pioneer HiBred/Mycogen Seeds (Unique Identifier DAS-59122-7) is approved under EU Regulation 1829/2003/EC for food and feed uses, import and processing since 24 October 2007 (Application EFSA/GMO/NL/2005/12, Commission Decision 2007/702/EC). An application for granting   consent to all uses of 59122 maize, including cultivation, was submitted by Pioneer in               accordance with articles 5 and 17 of the Regulation (EC) No. 1829/2003 21 October, 2005 (EFSA/GMO/NL/2005/23).   VKM participated in the 90 days public consultation of the application for placing on the market of maize 59122 for food and feed uses, import and processing (EFSA/GMO/NL/2005/12) in 2005, and submitted a preliminary opinion in December 2005 (VKM 2005a). Maize 59122 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). Maize 59122 has also been evaluated by the VKM GMO Panel as a component of several stacked GM maize events under Regulation (EC) 1829/2003 (VKM 2007a,b,c, VKM 2008b, VKM 2009, VKM 2012a,b, VKM 2013a,b,c,d). 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 event 59122.  The updated  food/feed and environmental risk assessment of the maize 59122 is based on information provided by the applicant in the applications EFSA/GMO/NL/2005/12 and EFSA/GMO/NL/2005/23 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 59122 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 59122 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, 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.   Genetically modified maize 59122 expresses the cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis, conferring resistance to certain coleopteran target pests belonging to the genus Diabrotica, such as the larvae of western corn rootworm (D. virgifera virgifera), northern corn rootworm (D. barberi) and the southern corn rootworm (D. undecimpunctata howardi). None of the target pests for maize 59122 are present in the Norwegian agriculture. Maize 59122 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 59122 has been used as a selectable marker to facilitate the selection process of transformed plant cells and is not intended for weed management purposes.  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 59122. 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 59122. Southern blot analyses and segregation studies show that the introduced genes cry34Ab1, cry35Ab1 and pat are stably inherited and expressed over several generations along with the phenotypic characteristics of maize 59122. The VKM GMO Panel considers the molecular characterisation of maize 59122 satisfactory.  Comparative assessment Comparative analyses of maize 59122 to its non-GM conventional counterpart have been performed during multiple field trials in representative areas for maize cultivation in Chile (2002/2003), North America (2003, 2004) and Europe (2003, 2004). With the exception of small intermittent variations, no biologically significant differences were found between maize 59122 and the conventional non-GM control. Based on the assessment of available data, the VKM GMO Panel concludes that maize 59122 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 in rats, as well as whole food feeding studies on broilers, laying hens, lactating dairy cows, feedlot steers, and growing-finishing pigs, have not indicated any adverse effects of maize 59122, and shows that maize 59122 is nutritionally equivalent to conventional maize. The PAT, Cry34Ab1 and Cry35Ab1 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 59122 is nutritionally equivalent to conventional maize varieties. It is unlikely that the PAT, Cry34Ab1 and Cry35Ab1 proteins will introduce a toxic or allergenic potential in food or feed based on maize 59122 compared to conventional maize.  Environmental Risk Assessment:  Considering the intended uses of maize 59122, 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 59122.   Maize 59122 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 59122. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The risk of gene flow from occasional feral GM maize plants to conventional maize varieties is negligible. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered to be an issue.  Overall Conclusion:  Based on current knowledge, the VKM GMO Panel concludes that maize 59122 is nutritionally equivalent to conventional maize varieties. It is unlikely that the PAT, Cry34Ab1 and Cry35Ab1 proteins will introduce a toxic or allergenic potential in food or feed based on maize 59122 compared to conventional maize. The VKM GMO Panel likewise concludes that maize 59122, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian 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.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorised 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 1507 x NK603 from Pioneer Hi-Bred International, Inc. og Mycogen Seeds (Unique Identifier DAS-Ø15Ø7-1 x MONØØ6Ø3-6) is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 24 October 2007 (Commission Decision 2007/703/EC).   Genetically modified maize 1507 x NK603 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMOs), commissioned by the Norwegian Food Safety Authority related to the EFSAs public hearing of the application EFSA/GMO/UK/2004/05 in 2005 (VKM 2005a). In addition,  maize 1507 x NK603 has been assessed by the VKM GMO Panel commissioned by the Norwegian Environment Agency and NFSA in connection with the national finalisation of the procedure of the notification in 2008 (VKM 2008). 1507 x NK603 has also been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2004, VKM 2005b, VKM 2007a, VKM 2009, and VKM 2012a).   The food/feed and environmental risk assessment of the maize 1507 x NK603 is based on information made available on the EFSA website GMO Extranet, and relevant peer-reviewed scientific literature.  The VKM GMO Panel has evaluated 1507 x NK603 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 2006, 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the postmarket environmental monitoring of GM plants (EFSA 2011c).   The scientific risk assessment of maize 1507 x NK603 includes 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 1507 x NK603 was produced by conventional breeding between inbred lines of maize containing the 1507 and NK603 events. The hybrid was developed to provide protection against certain lepidopteran target pests, and to confer tolerance to glufosinate-ammonium and glyphosate herbicides.  Molecular Characterization:  Southern blot and PCR analyses have indicated that the recombinant inserts in the parental maize events1507 and NK603 are retained in the stacked maize 1507 x NK603. Genetic stability of the inserts has previously been demonstrated in the parental events. Protein measurements show comparable levels of Cry1F, PAT and CP4 EPSPS proteins in the stacked maize 1507 x NK603 and the parental lines. Phenotypic analyses also indicated stability of the insect resistance and herbicide tolerance traits.   The VKM Panel on GMO considers the molecular characterisation of maize 1507 x NK603 and its parental events 1507 and NK603 as adequate.   Comparative Assessment:  Comparative analyses of the compositional, agronomic and phenotypic characteristics of maize stack 1507 x NK603 and near-isogenic comparators were performed during multiple field trials in Chile and Europe in 2002/2003. With the exception of small intermittent variations, the results show no indications of unwanted unintentional effects, and that maize stack 1507 x NK603 is compositionally, agronomically and phenotypically equivalent to its comparators, with the exception of the introduced insect resistance and herbicide tolerance traits.  Food and Feed Risk Assessment:  Whole food feeding studies on rats have not indicated any adverse effects of the parental maize lines 1507 and NK603. No rodent whole food feeding study has been performed on the stacked maize 1507 x NK603; the applicant has however provided a nutritional feeding study performed on broilers. No adverse effects were observed in the study. Bioinformatics analyses have not revealed expression of any known ORFs in the parental maize lines, and none of the newly expressed proteins show resemblance to any known toxins or IgE allergens. Nor have the newly expressed proteins been reported to cause IgE mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions.  Acute and repeated dose toxicity tests in rodents have not indicated toxic effects of the Cry1F, PAT or CP4 EPSPS proteins. However, these tests do not provide any additional information about possible adverse effects of maize 1507 x NK603.  Based on current knowledge, the VKM GMO Panel concludes that the stacked maize 1507 x NK603 is nutritionally equivalent to conventional maize varieties, and that it is unlikely that the newly expressed proteins introduce a toxic or allergenic potential in food and feed derived from maize 1507 x NK603 compared to conventional maize.  Environmental Risk:  Considering the intended uses of maize 1507 x NK603, 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 1507 x NK603.   Maize 1507 x NK603 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 1507 x NK603. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The risk of gene flow from occasional feral GM maize plants to conventional maize varieties is negligible. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered to be an issue.  Overall Conclusion:  The VKM GMO Panel has not identified toxic or altered nutritional properties in maize 1507 x NK603 or its processed products compared to conventional maize. Based on current knowledge, it is also unlikely that the Cry1F protein will increase the allergenic potential of food and feed derived from maize 1507 x NK603 compared to conventional maize varieties. The VKM GMO Panel likewise concludes that maize 1507 x NK603, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Abstract: In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the 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 1507 x 59122 from Dow AgroSciences and Pioneer Hi-Bred International, Inc. (Unique Identifier DAS-Ø15Ø7-1 x DAS59122-7) is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 28 July 2010 (Commission Decision 2010/432/EC).   Genetically modified maize 1507 x 59122 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the NFSA and the Norwegian Environment Agency related to the EFSAs public hearing of the applications EFSA/GMO/NL/2005/15 and EFSA/GMO/NL/2005/28 in 2007 (VKM 2007a, 2008a). The stack 1507 x 59122 has also been evaluated by the VKM GMO Panel as single events and as a component of several other stacked GM maize events (VKM 2004, VKM 2005a,b, VKM 2007b,c, VKM 2008b,c, VKM 2009a,b, VKM 2012). The environmental risk assessment of the maize 1507 x 59122 is based on information provided by the applicant in the applications EFSA/GMO/NL/2005/15 and EFSA/GMO/NL/2005/28, 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 1507 x 59122 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), the 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 x 59122 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan.   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 stack 1507 x 59122 was produced by conventional breeding between inbred lines of maize containing the 1507 and 59122 events. The hybrid was developed to provide protection against certain lepidopteran and coleopteran target pests, and to confer tolerance to glufosinate-ammonium herbicides.   Molecular Characterization:   As conventional breeding methods were used in the production of maize 1507 x 59122, no additional genetic modification was involved. Southern and PCR analyses demonstrated that the recombinant insert in the single 1507 and 59122 events were retained in maize stack 1507 x 59122. Genetic stability of the inserts has been demonstrated in the parental lines 1507 and 59122. Phenotypic analyses demonstrated stability of the insect resistance and herbicide tolerance traits in the hybrid. The expression levels of Cry1F, Cry34Ab1/Cry35Ab1 and PAT proteins in seeds and forage were considered comparable with those in the single events.   The characterisation of the recombinant insert and the physical, chemical and functional characteristics of the single events maize 1507 (VKM 2004) and maize 59122 (VKM 2005a, 2008b), have previously been evaluated by the VKM GMO Panel and considered adequate.   Comparative Assessment:   Comparative analyses of data from field trials located at representative sites and environments in the USA, Canada and Europe indicate that maize 1507 x 59122 is agronomically and phenotypically equivalent to the conventional counterpart, with the exception of the lepidopteran and coleopteranprotection traits and herbicide tolerance, conferred by the expression of the Cry1F, Cry34Ab1/Cry35Ab1 and PAT proteins. The field evaluations support the applicant’s conclusion of no other phenotypic changes indicative of increased plant weed/pest potential of 1507 x 59122 compared to conventional maize.   The VKM GMO Panel has previously assessed these data and concluded that maize 1507 x 59122 is agronomically and phenotypically equivalent to the conventional comparators, except for the newly introduced traits (VKM 2007a, 2008a).   Environmental assessment:   The scope of the application EFSA/GMO/NL/2005/15 includes import and processing of maize 1507 x 59122 for food and feed uses. Considering the intended uses of maize 1507 x 59122, excluding cultivation, the environmental risk assessment has been 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 1507 x 59122.   The available data indicate that 1507 x 59122 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 1507 x 59122. 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:   The VKM GMO Panel concludes that maize 1507 x 59122, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.