Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Application (Reference EFSA/GMO/UK/2008/56) for Authorization of Insect Resistant and Herbicide Tolerant Genetically Modified Maize Bt11 x MIR604 x GA21 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 from Syngenta Seeds

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Anne-Marthe Ganes Jevnaker, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 1-4
DOI: 10.9734/ejnfs/2020/v12i330198

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 and herbicide-tolerant genetically modified maize Bt11 x MIR604 x GA21 (Unique Identifier  SYN-BTØ11-1 x 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 2011/893/EC). 

Genetically modified maize Bt11 x 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/2008/56 in 2008 (VKM 2008a). In addition, Bt11, 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,c, 2007, 2009a,b,c,d, 2010, 2011, 2012a,b,).

The food/feed and environmental risk assessment of the maize Bt11 x MIR604 x GA21 is based on information provided by the applicant in the application EFSA/GMO/UK/2008/56 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 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) and selection of comparators for the risk assessment of GM plants (EFSA 2011b). 

The scientific risk assessment of maize Bt11 x 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. 

The genetically modified maize stack Bt11 x MIR604 x GA21 has been produced by conventional crossing between inbred lines of maize containing the single events Bt11, MIR604 and GA21. The F1 hybrid was developed to provide protection against certain lepidopteran and coleopteran target pests, and to confer tolerance to glufosinate-ammonium glyphosate-based herbicides. 

Molecular Characterisation:Southern blot and PCR analyses have indicated that the recombinant inserts in the parental maize lines Bt11, MIR604 and GA21 are retained in the stacked maize Bt11 x MIR604 x GA21. Genetic stability of the inserts has previously been demonstrated in the parental maize lines. Protein levels measured by ELISA show comparable levels of the Cry1Ab, PAT, mCry3A, PMI and mEPSPS proteins between the stacked and single maize lines. Phenotypic analyses also indicate stability of the insect resistance and herbicide tolerance traits in the stacked maize. The VKM Panel on GMO considers the molecular characterisation of maize Bt11 x MIR604 x GA21 and its parental events Bt11, MIR604 and GA21 as adequate. 

Comparative Assessment: Comparative analyses of data from field trials located at representative sites and environments in North America during the 2006 growing season indicate that maize stack Bt11 x MIR604 x GA21 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, with the exception of the insect resistance and the herbicide tolerance, conferred by the expression of Cry1Ab, mCry3A, PAT, PMI and mEPSPS proteins.

Based on the assessment of available data, the VKM GMO Panel is of the opinion that conventional crossing of maize Bt11, MIR604 and GA21 to produce the hybrid Bt11 x MIR604 x GA21 does not result in interactions between the newly expressed proteins affecting composition and agronomic characteristics.  

Food and Feed Risk Assessment: A whole food feeding study on broilers has not indicated any adverse health effects of maize Bt11 x MIR604 x GA21, and shows that maize Bt11 x MIR604 x GA21 is nutritionally equivalent to conventional maize. The Cry1Ab, PAT, mEPSPS, mCry3A or 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 x GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab, PAT, mEPSPS, mCry3A or PMI proteins will introduce a toxic or allergenic potential in food or feed based on maize Bt11 x MIR604 x GA21 compared to conventional maize.

Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2008/56 includes import and processing of maize stack Bt11 x MIR604 x GA21 for food and feed uses. Considering the intended uses of maize Bt11 x 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 Bt11 x MIR604 x GA21. 

Maize Bt11 x 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 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 Bt11 x MIR604 x GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab, PAT, mEPSPS, mCry3A or PMI proteins will introduce a toxic or allergenic potential in food or feed based on maize Bt11 x MIR604 x GA21 compared to conventional maize.

The VKM GMO Panel likewise concludes that maize Bt11 x MIR604 x GA21, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Genetically Modified Glufosinate-tolerant Oilseed Rape MS8, RF3 and MS8 x RF3 for Import, Processing and Feed Uses under Directive 2001/18/EC (Notification C/BE/96/01)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Anne-Marthe Ganes Jevnaker, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 5-9
DOI: 10.9734/ejnfs/2020/v12i330199

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility.  The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.

 The genetically modified, glufosinate-tolerant oilseed rape lines MS8, RF3 and MS8 x RF3 (Notification C/BE/96/01) are approved under Directive 2001/18/EC for import and processing, for feed and industrial purposes since 26 March 2007 (Commission Decision 2007/232/EC). In addition, processed oil from genetically modified oilseed rape derived from MS8, RF3 and MS8 x RF3 were notified as existing food according to Art. 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients in November 1999. Existing feed and feed products containing, consisting of or produced from MS8, RF3 and MS8 x RF3 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed on the market in January 2000. 

 An application for renewal of the authorisation for continued marketing of existing food, food ingredients and feed materials produced from MS8, RF3 and MS8 x RF3 was submitted within the framework of Regulation (EC) No 1829/2003 in June 2007 (EFSA/GMO/RX/MS8/RF3). In addition, an application covering food containing or consisting of, and food produced from or containing ingredients produced from oilseed rape MS8, RF3 and MS8 x RF3 (with the exception of processed oil) was delivered by Bayer CropScience in June 2010 (EFSA/GMO/BE/2010/81).

 The VKM GMO Panel has previously issued a scientific opinion related to the notification C/BE/96/01 for the placing on the market of the oilseed rape lines for import, processing and feed uses (VKM 2008). The food/feed and environmental risk assessment was commissioned by the Norwegian Environment Agency in connection with the national finalisation of the procedure of the notification C/BE/96/01 in 2008. Due to the publication of updated guidelines for risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated food, feed and environmental risk assessment of oilseed rape MS8, RF3 and MS8 x RF3. A scientific opinion on an application for the placing on the market of MS8 x RF3 for food containing or consisting of, and food produced from or containing ingredients produced from MS8 x RF3 (with the exception of processed oil) (EFSA/GMO/BE/2010/81) have also been submitted by the VKM GMO Panel (VKM 2012, unpublished).

 The risk assessment of the oilseed rape MS8, RF3 and MS8 x RF3 is based on information provided by the notifier in the applications EFSA/GMO/RX/MS8/RF3, EFSA/GMO/BE/2010/81, the notification C/BE/96/01, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. 

 The VKM GMO Panel has evaluated MS8, RF3 and MS8 x RF3 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010a) and the selection of comparators for the risk assessment of GM plants (EFSA 2011b). 

 The scientific risk assessment of oilseed rape MS8, RF3 and MS8 x RF3 include molecular characterisation of the inserted DNA and expression of target proteins, comparative compositional assessment, food/feed safety assessment, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness and potential for horizontal and vertical gene transfer. 

 In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. 

 The genetically modified oilseed rape lines MS8 and RF3 were developed to provide a pollination control system for production of F1-hybrid seeds (MS8 x RF3). Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. As a result of hybrid vigor cross-pollinated plants produce higher yield as compared to self-pollinating rape. 

 The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes derived from the soil bacterium Bacillus amyloliquefaciens into two separate transgenic oilseed rape lines. The barnase gene in the male sterile line MS8 encode a ribonuclease peptide (RNase), expressed in the tapetum cells during anther development. The RNase effect RNA levels, disrupting normal cell function, arresting early anther development, and results in the lack of viable pollen and male sterility. 

 The fertility restoration line RF3 contains a barstar gene, coding for a ribonuclease inhibitor (Barstar peptide) expressed only in the tapetum cells of the pollen during anther development. The peptide specifically inhibits the Barnase RNase expressed by the MS8 line. The RNase and the ribonuclease inhibitor form a stable one-to-one complex, in which the RNase is inactivated. As a result, when pollen from the receptor line RF3 is crossed to the male sterile line MS8, the MS8 x RF3 progeny expresses the RNase inhibitor in the tapetum cells of the anthers allowing hybrid plants to develop normal anthers and restore fertility.

 The barnase and barstar genes in MS8 and RF3 are each linked with the bar gene from Streptomyces hygroscopus. The bar gene is driven by a plant promoter that is active in all green tissues of the plant, and encodes the enzyme phosphinothricin acetyltransferase (PAT). The PAT enzyme inactivates phosphinothricin (PPT), the active constituent of the non-selective herbicide glufosinate-ammonium. The bar gen were transferred to the oilseed rape plants as markers both for use during in vitro selection and as a breeding selection tool in seed production.

 Molecular Characterisation: The oilseed rape hybrid MS8 x RF3 is produced by conventional crossing. The parental lines MS8 and RF3 are well described in the documentation provided by the applicant, and a number of publications support their data. It seems likely that MS8 contains a complete copy of the desired T-DNA construct including the bar and barnase genes. Likewise, the event RF3 is likely to contain complete copies of the bar and barstar genes in addition to a second incomplete non-functional copy of the bar-gene. The inserts in the single events are preserved in the hybrid MS8 x RF3, and the desired traits are stably inherited over generations. 

 The GMO Panel finds the characterisation of the physical, chemical and functional properties of the recombinant inserts in the oilseed rape transformation events MS8, RF3 and MS8 x RF3 to be satisfactory. The GMO Panel has not identified any novel risks associated with the modified plants based on the molecular characterisation of the inserts. 

 Comparative Assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Europe and Canada, it is concluded that oilseed rape MS8, RF3 and MS8 x RF3 is compositionally, agronomically and phenotypically equivalent to the conventional counterpart, except for the newly expressed barnase, barstar and PAT proteins.

In the Canadian field trials, however, compositional and phenotypic characteristics of oilseed rape MS8, RF3 and MS8 x RF3 were compared to null-segregant comparators. As negative segregants are derived from a GM organism, the VKM GMO Panel does not consider them appropriate conventional counterparts with a history of safe use. Data obtained from field trials with negative segregants were considered as supplementary information for the RA.

 Based on the assessment of available data, the VKM GMO Panel is of the opinion that conventional crossing of oilseed rape MS8 and RF3 to produce the hybrid MS8 x RF3 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 studies in broilers have not indicated any adverse health effects of oilseed rape MS8 x RF3. These studies also indicate that oilseed rape MS8 x RF3 is nutritionally equivalent to conventional oilseed rape.  The PAT protein do not show sequence resemblance to other known toxins or IgE allergens, nor has PAT been reported to cause IgE mediated allergic reactions. 

 Based on the current knowledge, the VKM GMO Panel concludes that oilseed rape MS8 x RF3 is nutritionally equivalent to conventional oilseed rape varieties, and that it is unlikely that the newly expressed proteins introduce a toxic or allergenic potential in food and feed derived from oilseed rape MS8 x RF3 compared to conventional oilseed rape.

 Environmental Risk Assessment: Considering the scope of the notification C/BE/96/01, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MS8, RF3 and MS8 x RF3 into the environment during transportation, storage, handling, processing and use of derived products.

 Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30 %, but outcrossing frequencies up to 55 % are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B.juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands.

 Accidental spillage and loss of viable seeds of MS8, RF3 and MS8 x RF3 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MS8, RF3 and MS8 x RF3 cannot be excluded.

 Feral oilseed rape MS8, RF3 and MS8 x RF3 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. 

 However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway. 

There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MS8, RF3 and MS8 x RF3, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. 

 Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity.

 Overall Conclusion: Based on current knowledge, the VKM GMO Panel has not identified toxic, allergenic or altered nutritional properties of oilseed rape MS8, RF3 and MS8 x RF3 or its processed products compared to conventional oilseed rape. 

 The VKM GMO Panel likewise concludes that oilseed rape MS8, RF3 and MS8 x RF3 are unlikely to have any adverse effect on the environment and agriculture in Norway in the context of its intended usage.

Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Insect Resistant Genetically Modified Maize 1507 for Cultivation, Import, Processing, Food and Feed Uses under Directive 2001/18/EC and Regulation (EC) No 1829/2003 (C/ES/01/01, C/NL/00/10, EFSA/GMO/NL/2004/02)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Anne-Marthe Jevnaker, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Hilde-Gunn Opsahl-Sorteberg, Rose Vikse

European Journal of Nutrition & Food Safety, Page 10-14
DOI: 10.9734/ejnfs/2020/v12i330200

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.

Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize Bt11 x MIR604 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/50)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 15-19
DOI: 10.9734/ejnfs/2020/v12i330201

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.

Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize GA21 from Syngenta Seeds for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/19)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Anne-Marthe Ganes Jevnaker, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 20-23
DOI: 10.9734/ejnfs/2020/v12i330202

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.

Open Access Grey Literature

Food/feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize MIR604 x GA21 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/48)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 24-27
DOI: 10.9734/ejnfs/2020/v12i330203

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.

Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Insect-resistant Genetically Modified Maize MIR604 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/11)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Anne-Marthe Ganes Jevnaker, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 28-31
DOI: 10.9734/ejnfs/2020/v12i330204

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.

 The insect-resistant genetically modified maize MIR604 from Syngenta Seeds S.A.S.  (Unique Identifier SYN-IR604-5) is approved under Regulation (EC) No 1829/2003 for food   and feed uses, import and processing since 30 November 2009 (Commission Decision 2009/866/EC).

 Genetically modified maize MIR604 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environmental Agency related to the EFSAs public hearing of the applications EFSA/GMO/UK/2005/11 and EFSA/GMO/UK/2010/83 in 2005 (VKM 2005) and 2011 (VKM, unpublished. In addition MIR604 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2008, VKM 2009a,b,c VKM 2012, VKM 2013a,b,c). The food/feed and environmental risk assessment of maize MIR604 is based on information provided by the applicant in the applications EFSA/GMO/UK/2005/11 and EFSA/GMO/UK/2010/83, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.

 The VKM GMO Panel has evaluated MIR604 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c).

 The scientific risk assessment of maize MIR604 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes.

 It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms.

 Genetically modified maize MIR604 was developed to provide protection against certain coleopteran target pests belonging to the genus Diabrotica such as the larvae of western   corn rootworm (WCRW; D. virgifera virgifera), the northern corn rootworm (NCRW; D.longicornis barberi) by the introduction of a modified cry3A gene (mcry3A) derived from   Bacillus thuringiensis subsp. tenebrionis. Maize MIR604 also contains the pmi (manA) gene  from Escherichia coli which encodes the phosphomannose isomerise (PMI) protein as a selectable marker. PMI allows transformed maize cells to utilize mannose as a sole carbon     source, while maize cells lacking the pmi gene fail to grow with mannose as single carbon source.

Molecular Characterization: The molecular characterisation data indicate that only one copy of the transgenic insert with the mcry3A and pmi genes is integrated in the genome of maize MIR604, and that it is stably inherited over generations. Appropriate analyses of the integration site, inserted DNA sequence, flanking regions, and bioinformatics have been performed. The VKM GMO Panel considers the molecular characterisation of maize MIR604 as adequate.

 Comparative Assessment: The applicant has performed comparative analyses of data from field trials located at representative sites and environments in North America during the 2002 and 2003 growing seasons. With the exception of small intermittent variations and the insect resistance conferred by mCry3A, the results showed no biologically significant differences between maize MIR604 and control maize. Based on the assessment of available data, the VKM GMO Panel concludes that maize MIR604 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the newly expressed proteins.

 Food and Feed Risk Assessment: Whole food feeding studies on rats, rainbow trout and broilers have not indicated any adverse health effects of maize MIR604. These studies also indicate that maize MIR604 is nutritionally equivalent to conventional maize. The mCry3A and PMI proteins do not show sequence resemblance to other known toxins or IgE allergens, nor have they been reported to cause IgE mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions.

 Based on current knowledge, the VKM GMO Panel concludes that maize MIR604 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mCry3A and PMI proteins will introduce a toxic or allergenic potential in food or feed based on maize MIR604 compared to conventional maize.

 Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2005/11 includes import and processing of maize MIR604 for food and feed uses. Considering the intended uses of maize MIR604, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MIR604.

 Maize MIR604 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MIR604. Maize is the only representative of the genus Zea in Europe and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue.

 Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize MIR604 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mCry3A and PMI proteins will introduce a toxic or allergenic potential in food or feed derived from maize MIR604 compared to conventional maize.

The VKM GMO Panel likewise concludes that maize MIR604, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Open Access Grey Literature

Risk Assessment of "Other Substances" – L-phenylalanine and DL-phenylalanine

Livar Frøyland, Margaretha Haugen, Kristin Holvik, Martinus Løvik, Tor A. Strand, Grethe S. Tell, Per Ole Iversen

European Journal of Nutrition & Food Safety, Page 32-34
DOI: 10.9734/ejnfs/2020/v12i330205

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of "other substances" to food supplements.

 "Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 The present report is a risk assessment of L-phenylalanine and DL-phenylalanine and is based on previous risk assessments.

According to information from the Norwegian Food Safety Authority, L- and DL-phenylalanine are ingredients in food supplements sold in Norway. NFSA has requested a risk assessment of the following doses of L-phenylalanine and DL-phenylalanine in food supplements: L-phenylalanine 100, 250, 500, 750 and 1000 mg/day and DL-phenylalanine 50 and 75 mg/day.

 L-phenylalanine is an essential amino acid which means it has to be obtained from the diet. Amino acids are building blocks for proteins and present in protein rich food such as milk, meat, fish, eggs and cheese.

 No data on adverse health effects after chronic ingestion of supplemental phenylalanine in apparently healthy subjects are available, thus no tolerable upper intake level (UL) can be established. Patients with phenylketonuria (PKU), a genetic disorder that impairs phenylalanine hydroxylase (PAH), an enzyme involved in the metabolism of phenylalanine, must keep plasma levels of phenylalanine low in order to maintain normal growth and brain development. In Norway, all newborns are routinely screened for PKU three days after birth.

 The mean dietary intake of phenylalanine in the EU population range from 0.4-4.1 g/day corresponding to 79.0 mg/kg bw per day for adolescents (10-17 years) and 58.7 mg/kg bw per day for adults, respectively (EFSA, 2013). The sweetener aspartame contains phenylalanine. Taking the molecular weight of phenylalanine into account, the proportion of to phenylalanine exposure from aspartame is 56%. The ADI of 40 mg aspartame/day/kg bw (providing 22.4 mg phenylalanine/day/kg bw) JECFA (1981) was re-evaluated and maintained in 2013, based on the notion that elevated plasma levels of phenylalanine in pregnant women leads to developmental toxicity in their children (EFSA, 2013).

 The literature search did not provide novel information on adverse health effects related to intake of L-phenylalanine and no information related to DL-phenylalanine.

 VKM concludes that:

 In adults (≥ 18 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects.

  • In adolescents (14 to < 18 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects.
  • In children (10 to < 14 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects. Although the highest dose provides 23 mg/kg bw per day which slightly exceeds 22.4 mg/kg bw per day, it is considered unlikely to cause adverse health effects in healthy children 10 to < 14 years.
  • None of the above conclusions are applicable for patients with phenylketonuria (PKU).
  • No conclusion can be made regarding DL-phenylalanine.

 Children below 10 years were not included in the terms of reference.

Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Insect-Resistant and Herbicide-Tolerant Genetically Modified Maize Bt11 from Syngenta Seeds for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/RX/Bt11)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Anne-Marthe Ganes Jevnaker, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 35-38
DOI: 10.9734/ejnfs/2020/v12i330206

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.

Open Access Grey Literature

Food/Feed and Environmental Risk Assessment of Insect-Resistant and Herbicide-Tolerant Genetically Modified Maize Bt11 x GA21 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/49)

Åshild Andreassen, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Anne-Marthe Ganes Jevnaker, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Arne Mikalsen, Kåre M. Nielsen, Monica Sanden, Ville Erling Sipinen, Rose Vikse, Hilde-Gunn Opsahl-Sorteberg

European Journal of Nutrition & Food Safety, Page 39-42
DOI: 10.9734/ejnfs/2020/v12i330207

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility.  The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.

 The insect-resistant and herbicide-tolerant genetically modified maize Bt11 x GA21 (Unique Identifier  SYN-BTØ11-1 x MON-ØØØ21-9 ) from Syngenta Seeds  is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since  28 July 2010 (Commission Decision 2010/4263/EC). Genetically modified maize Bt11 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/2007/49  in 2008 (VKM 2009a). In addition, Bt11 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, 2007, 2008, 2009b,c,d, 2010, 2012a,b).

 The food/feed and environmental risk assessment of the maize Bt11x GA21 is based on information provided by the applicant in the application EFSA/GMO/UK/2007/49, 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 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 Bt11x 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. 

 The genetically modified maize stack Bt11 x GA21 has been produced by conventional crossing between inbred lines of maize containing the single events Bt11 and GA21. The F1 hybrid was developed to provide protection against certain lepidopteran target pests, and to confer tolerance to glufosinate-ammonium and glyphosate-based herbicides. 

 Molecular Characterization: Southern blot and PCR analyses have indicated that the recombinant inserts in the parental maize lines Bt11 and GA21 are retained in the stacked maize Bt11 x GA21. Genetic stability of the inserts has previously been demonstrated in the parental maize lines. Protein measurements show comparable levels of the Cry1Ab, PAT and mEPSPS proteins between the stacked and single maize lines. Phenotypic analyses also indicate stability of the insect resistance and herbicide tolerance traits in the stacked maize. The VKM Panel on GMO considers the molecular characterisation of maize Bt11 x GA21 and its parental events Bt11 and GA21 as adequate. 

 Comparative Assessment:mComparative analyses of data from field trials located at representative sites and environments in North America during the 2005 growing season indicate that maize stack Bt11 x GA21 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, with the exception of the insect resistance and the herbicide tolerance, conferred by the expression of Cry1Ab, PAT and mEPSPS proteins.

 Based on the assessment of available data, the VKM GMO Panel is of the opinion that conventional crossing of maize Bt11 and GA21 to produce the hybrid Bt11 x GA21 does not result in interactions between the newly expressed proteins affecting composition and agronomic characteristics.  

 Food and Feed Risk Assessment: A whole food feeding study on broilers has not indicated any adverse health effects of maize Bt11 x GA21, and shows that maize Bt11 x GA21 is nutritionally equivalent to conventional maize. The Cry1Ab, PAT or 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 Bt11 x GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab, PAT or mEPSPS proteins will introduce a toxic or allergenic potential in food or feed based on maize Bt11 x GA21 compared to conventional maize.

 Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2007/49 includes import and processing of maize stack Bt11x GA21 for food and feed uses. Considering the intended uses of maize Bt11 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 Bt11 x GA21. 

 Maize Bt11 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 Bt11 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 Bt11 x GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1Ab, PAT or mEPSPS proteins will introduce a toxic or allergenic potential in food or feed based on maize Bt11 x GA21 compared to conventional maize.

The VKM GMO Panel likewise concludes that maize Bt11 x GA21, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Open Access Original Research Article

The International Code of Marketing of Breastmilk Substitutes: Are Implementers in Southern Nigeria Adequately Informed?

Alice R. Nte, Gracia K. Eke, Ngozi Onuora

European Journal of Nutrition & Food Safety, Page 43-51
DOI: 10.9734/ejnfs/2020/v12i330208

Background: The knowledge about the International Code of Marketing of Breastmilk Substitutes and relevant subsequent World Health Assembly (WHA) Resolutions (the Code), its implementation and enforcement are essential in promoting, protecting and supporting breastfeeding, especially exclusive breastfeeding for the first six months of life and optimal infant and young child feeding. Violations by various stakeholders remain a perennial problem within and outside Nigeria with the main reason being lack of information of the Code and its relevance to child survival, growth and development.

Aims: To share the findings from data collected during the sensitization of stakeholders on the International Code of Marketing of Breastmilk Substitutes in four States in the UNICEF Rivers Field Office, southern Nigeria.

Study Design: Prospective study.

Place and Duration of Study: September-October 2017, Southern, Nigeria.

Methodology: Stakeholders from 4 southern States in Nigeria attended the sensitization meetings. A pre- and post-tests were administered to assess the knowledge they acquired from the workshops. Results were analysed using percentages and test of significance. 

Results: The two-day meeting for each State held in September and October 2017 for a total of 296 participants out of whom data on 237 (80%) participants were analysed for presentation. Over 95% respondents had not read the Code and the Nigerian Regulations 2005, did not know the contents and their responsibility towards its implementation before the meeting. At the post test, the performance of the participants significantly improved (p<0.05) on all test items. All participants now owned the Code, the Nigerian Regulations and other relevant documents to sustain their knowledge and commitment to the implementation of the Code.

Conclusion: Ignorance and lack of ownership of copies of the Code contributed to the level of its violations and poor implementation. Improved compliance with the Code requires creation of awareness about it among stakeholders.

Open Access Original Research Article

Nutritional Quality and Metallic Health Risk Assessment of Industrially Processed Tomato Ketchups Available in the Markets of Bangladesh

Sadia Mehrin, H. M. Zakir, H. P. Seal, Mhafuza Akter

European Journal of Nutrition & Food Safety, Page 67-78
DOI: 10.9734/ejnfs/2020/v12i330210

An experiment was conducted to study the nutritional qualities of industrially processed tomato ketchups compared to homemade one and to assess metallic heath risk due to consumption of those ketchups. Eight different types of industrially processed tomato ketchups available in the markets of Bangladesh from dissimilar producers and one homemade sauce were analysed in this study. Dry matter content in industrially processed tomato ketchups ranged between 32.52-38.41% while it was only 7.90% in case of homemade sauce. The average lycopene content of industrially processed tomato ketchups was 20.02 mg 100g-1 sample while it was 29.10 mg 100g-1 sample for homemade tomato sauce. Among the mineral nutrients- Ca, Mg, P and K contents in homemade tomato sauce were higher compared to industrially processed one. But Na content was higher in different industrially processed ketchups. Concentrations of Cu, Zn, Cr, Pb, Ni, Cd and Mn in industrially processed tomato ketchups ranged between 5.29-6.82, 2.14-34.08, 6.48-9.05, 7.56-11.51, 0.12-0.95, 0.36-0.46 and trace µg g-1 (fresh wt. basis), respectively while in case of homemade tomato sauce the mean concentrations were 2.12, 3.33, 1.66, 2.08, 0.13, 0.09 and 1.73 µg g-1 (fresh wt. basis), respectively. Thus, present study results inferred that higher amount of different heavy metals might be contributed by the addition of spices and other ingredients to industrially processed tomato ketchups. Target hazard quotients (THQ) values for Pb and Cr for industrially processed tomato ketchups approached or surpassed 1 for female. The cumulative target hazard quotients (CTHQ) values for the same tomato ketchups were also greater than one (>1) for both male and female, which indicate that the exposed populations are in a level of concern interval. On the other hand, individual THQ and CTHQ values for homemade sauce were less than 1 for both male and female, which indicate that dietary intake of this sauce is assumed to be safe.

Open Access Original Research Article

Effect of Seed Priming Practices on Dry Matter Production, Yield and Yield Attributes of Aerobic Rice in Coastal Deltaic Region of Karaiakal

S. Pazhanisamy, Al. Narayanan, V. Sridevi, Abhinandan Singh, Amit Kumar Singh

European Journal of Nutrition & Food Safety, Page 79-83
DOI: 10.9734/ejnfs/2020/v12i330211

A field experiment was conducted at Karaikal “the tail end of Cauvery Delta Zone” during Navarai season, 2017 (spring) to identify the optimum dates of sowing and seed priming practices on dry matter production (DMP), yield and yield attributes under aerobic rice condition. The treatment variables were replicated thrice and further evaluated in factorial concept of RBD. The treatments consisted of three dates of sowing by weekly interval (started from Feb. 6, 2017) and five seed priming practices viz., water, 1% KCl, 2% moringa leaf extract, 1% pungam leaf extract and 5% cow dung slurry. Considering the seed priming practices, dry matter production, yield and yield attributes of aerobic rice were higher in seed primed with 2% moringa leaf extract which ultimately produced higher grain yield (2256 kg ha-1) followed by the seeds primed with 5% cow dung slurry (1945.1 kg ha-1) and 1% pungam leaf extract (1912.3 kg ha-1), respectively. From the study, it has proved that seed priming @ 2% moringa leaf extract provides higher productivity of aerobic rice during Navarai season at Karaikal.

Open Access Original Research Article

In-vitro Antioxidant Capacity, Phytochemical Characterisation, Toxic and Functional Properties of African Yam Bean (Sphenostylis stenocarpa) Seed-Enriched Cassava (Manihot esculenta) Product (Pupuru)

Folayemi Janet Isaac-Bamgboye, Victor Ndigwe Enujiugha, Matthew Olusola Oluwamukomi

European Journal of Nutrition & Food Safety, Page 84-98
DOI: 10.9734/ejnfs/2020/v12i330212

Aims: This study aimed at determining the In-vitro antioxidant capacity, characterise phytochemical constituents, assess toxic and functional properties of African yam bean (Sphenostylis stenocarpa) seed-enriched Cassava product (Pupuru) flour blends using standard methods.

Methodology: Pupuru flour blends were produced from spontaneously-fermented cassava tubers substituted with African yam bean (Sphenostylis stenocarpa) seed (AYBS) (5% (EP5), 10% (EP10) and 15% (EP15), before toasting, cooling, milling, sieving and packaging. A commercial sample (CP) with 100% cassava and another produced in this study, were used as controls.

Results: In-vitro 2,2-Azino-bis (3-ethylbenthiazoline-6-sulphonic acid) (ABTS) and 1,1-Diphenyl-2-picrylhydrazyl (DPPH) free radical scavenging abilities, total flavonoid content (TFC), ferric reducing antioxidant power (FRAP) and total phenol content (TPC) increased significantly (P = .05) as AYBS enrichment levels increased. The commercial and laboratory control samples showed no significant difference (P = .05) in all the antioxidants analysed except DPPH: ABTS (7.61- 12.27%); DPPH (26.34-48.26%); TFC (0.10-0.25 mg CAE/g); FRAP (0.81-2.36 (mg/g) and TPC (15.74- 24.15 mg GAE/g). All the phytochemicals except tannins increased significantly (P = .05) as levels of enrichment with AYBS increased. Tannins, phytates, saponins, alkaloids and oxalates were 1.46 -2.87 (mg/g); 0.85-1.40 mg/100 g; 4.18-13.27 mg/g; 24.89-29.05 mg/g and 1.71-3.23 mg/g, respectively. The toxic constituent revealed that all the samples contained significantly different (P = .05) cyanide ranging from 0.87-2.51 mg/kg which reduced as AYBS level of inclusion increased. The functional properties of the samples were significantly (P = .05) enhanced with AYBS enrichment.

Conclusion: Utilisation of AYBS to enrich Pupuru increased its In-vitro antioxidant capacity and phytochemical constituents, reduced the toxic cyanide content enhanced the functional properties, hence, its suitability as a nutraceutical to delay the ageing process and prevent cardiovascular diseases.

Open Access Review Article

Nutritional Potentials and Uses of Pawpaw (Carica papaya): A Review

A. A. Daagema, P. N. Orafa, F. Z. Igbua

European Journal of Nutrition & Food Safety, Page 52-66
DOI: 10.9734/ejnfs/2020/v12i330209

Pawpaw is a fast growing fruit tree with edible fruits which are consumed in many countries of the world. The fruits are edible in its unripe and ripe forms such as in salads, juices, smoothies, soups and for therapeutic purposes. Other uses include in medicine and cosmetic industries were the fruits as well as other parts of the tree are used in the production of drugs and several cosmetic items. Pawpaw fruits are rich in several nutrients especially vitamins and minerals however its consumption is low when considered to other popular fruits. Hence this review looks at the nutritional potential of pawpaw fruit as a good micronutrient source just as other fruits.