38 research outputs found
Assessment of genetically modified maize MON 88017 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSAâGMOâRXâ014)
Following the submission of application EFSAâGMOâRXâ014 under Regulation (EC) No 1829/2003 from Monsanto Company the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insectâresistant and herbicideâtolerant genetically modified maize MON 88017, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained postâmarket environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 88017 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSAâGMOâRXâ014 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 88017
Assessment of genetically modified maize MON 89034 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-015)
Following the submission of application EFSA-GMO-RX-015 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA, the EFSA Panel on Genetically Modified Organisms (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant genetically modified maize MON 89034, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 89034 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-015 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034
Assessment of genetically modified maize MIR604 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSAâGMOâRXâ013)
Following the submission of application EFSAâGMOâRXâ013 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the EFSA Panel on Genetically Modified Organisms (GMO) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insectâresistant genetically modified maize MIR604, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained postâmarket environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MIR604 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSAâGMOâRXâ013 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR604
Assessment of genetically modified maize MON 87427 Ă MON 89034 Ă MIR162 Ă MON 87411 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSAâGMOâNLâ2017â144)
Maize MON 87427 Ă MON 89034 Ă MIR162 Ă MON 87411 (fourâevent stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and MON 87411. The genetically modified organism (GMO) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the fourâevent stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the fourâevent stack maize, as described in this application, is as safe as and nutritionally equivalent to its nonâGM comparator and the nonâGM reference varieties tested. In the case of accidental release of viable grains of the fourâevent stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the fourâevent stack maize. The postâmarket environmental monitoring plan and reporting intervals are in line with the intended uses of the fourâevent stack maize. Postâmarket monitoring of food/feed is not considered necessary. The GMO Panel concludes that the fourâevent stack maize and its subcombinations are as safe as its nonâGM comparator and tested nonâGM reference varieties with respect to potential effects on human and animal health and the environment
Statement complementing the EFSA Scientific Opinion on application (EFSAâGMOâNLâ2009â75) for placing on the market of genetically modified oilseed rape Ms8 Ă Rf3 Ă GT73 and subcombinations, which have not been authorised previously (i.e. Ms8 Ă GT73 and Rf3 Ă GT73) independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food, under Regulation (EC) No 1829/2003), taking into consideration additional information
The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed oilseed rape Ms8 Ă Rf3 Ă GT73 and its subcombinations Ms8 Ă GT73 and Rf3 Ă GT73 according to the scope as defined in the application EFSAâGMOâNLâ2009â75, and was not in the position to complete the safety assessment of products rich in protein, such as rapeseed protein isolates or products of this nature in animal feeding. Following a mandate from the European Commission, the GMO Panel assessed a 28âday toxicity study in mice with the glyphosate oxidoreductase (GOXv247) protein, provided to complement information related to application EFSAâGMOâNLâ2009â75 for the placing on the market of oilseed rape Ms8 Ă Rf3 Ă GT73 and its subcombinations Ms8 Ă GT73 and Rf3 Ă GT73, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The 28âday toxicity study on Escherichia coliâ produced GOXv247 protein did not show adverse effects in mice, at the gavage doses up to 1000 mg/kg body weight (bw) per day. Taking into account its previous assessment on EFSAâGMOâNLâ2009â75 and the outcome of the 28âday toxicity study in mice with the GOXv247 protein provided in this mandate, the GMO Panel, based on a weight of evidence approach, concludes that food and feed containing, consisting and produced from genetically modified oilseed rape Ms8 Ă Rf3 Ă GT73 and its sub combinations Ms8 Ă GT73 and Rf3 Ă GT73, are as safe as its conventional counterpart, according to the scope as defined in the application EFSAâGMOâNLâ2009â75
Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSAâGMOâRXâ002)
Following the submission of application EFSAâGMOâRXâ002 under Regulation (EC) No 1829/2003 from Monsanto Company, the Panel on Genetically Modified Organisms of EFSA (GMO) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicideâtolerant genetically modified oilseed rape GT73. The data received in the context of this renewal application contained postâmarket environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in oilseed rape GT73 considered for renewal of authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSAâGMOâRXâ002 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT73
Statement complementing the EFSA Scientific Opinion on application (EFSAâGMOâUKâ2006â34) for authorisation of food and feed containing, consisting of and produced from genetically modified maize 3272
Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified (GM) maize 3272 (EFSAâGMOâUKâ2006â34). The applicant conducted new agronomic, phenotypic and compositional analysis studies on maize 3272 and assessed the allergenic potential of AMY797E protein, addressing elements that remained inconclusive from previous EFSA opinion issued in 2013. The GMO Panel is of the opinion that the agronomic and phenotypic characteristics as well as forage and grain composition of maize 3272 do not give rise to food and feed safety, and nutritional concerns when compared to nonâGM maize. Considering the scope of this application and the characteristics of the trait introduced in this GM maize, the effect of processing and potential safety implications of specific food or feed products remain to be further investigated. Regarding the allergenic potential of AMY797E protein and considering all possible food and feed uses of maize 3272, the Panel concludes that the information provided does not fully address the concerns previously raised by the Panel in 2013. Owing to the nature and the knowledge available on this protein family, it is still unclear whether under specific circumstances the alphaâamylase AMY797E has the capacity to sensitise certain individuals and to cause adverse effects. To further support the safety of specific products of maize 3272, the applicant provided thorough information relevant for the allergenicity assessment of dried distiller grains with solubles (DDGS), which is the main product of interest for importation into the EU. Having considered the information provided on this product, the Panel is of the opinion that under the specific conditions of use described by the applicant, DDGS produced from maize 3272 does not raise concerns when compared to DDGS from nonâGM maize
Assessment of genetically modified soybean MON 87705 Ă MON 87708 Ă MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSAâGMOâNLâ2015â126)
Soybean MON 87705 Ă MON 87708 Ă MON 89788 (threeâevent stack soybean) was produced by conventional crossing to combine three single soybean events: MON 87705, MON 87708 and MON 89788. This combination is intended to alter the fatty acid profile in the seed (in particular increasing the levels of oleic acid) and tolerance to glyphosateâbased and dicamba herbicides. The Genetically Modified Organisms Panel previously assessed the three single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the threeâevent stack soybean does not give rise to food and feed safety and nutritional concerns. In the case of accidental release of viable threeâevent stack soybean seeds into the environment, this would not raise environmental safety concerns. The postâmarket environmental monitoring plan and the reporting intervals are in line with the intended uses of soybean MON 87705 Ă MON 87708 Ă MON 89788. Considering the altered fatty acid profile of the threeâevent stack soybean, a proposal for postâmarket monitoring needs to be provided by the applicant. The GMO Panel notes that in the context of this application EFSAâGMOâNLâ2015â126 the applicant did not provide a 90âday study on MON 87705 soybean in line with the applicable legal requirements. Therefore, the GMO Panel is not in the position to finalise the risk assessment of soybean MON 87705 Ă MON 87708 Ă MON 89788 under the current regulatory frame
Assessment of genetically modified maize MZIR098 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSAâGMOâDEâ2017â142)
Maize MZIR098 was developed to confer tolerance to glufosinateâammoniumâcontaining herbicides and resistance to certain coleopteran pests. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MZIR098 and its conventional counterpart needs further assessment, except for neutral detergent fibre (NDF) in grains, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the eCry3.1Ab, mCry3A and PAT proteins as expressed in maize MZIR098, and finds no evidence that the genetic modification would change the overall allergenicity of maize MZIR098. In the context of this application, the consumption of food and feed from maize MZIR098 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MZIR098 is as safe as the conventional counterpart and nonâGM maize reference varieties tested, and no postâmarket monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MZIR098 grains into the environment, maize MZIR098 would not raise environmental safety concerns. The postâmarket environmental monitoring plan and reporting intervals are in line with the intended uses of maize MZIR098. In conclusion, the GMO Panel considers that maize MZIR098, as described in this application, is as safe as its conventional counterpart and the nonâGM maize reference varieties tested with respect to potential effects on human and animal health and the environment
Assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSAâGMOâBEâ2016â138)
Oilseed rape MS11 has been developed to confer male sterility and tolerance to glufosinateâammoniumâcontaining herbicides. Based on the information provided in the application and in line with the scope of application EFSAâGMOâBEâ2016â138, the genetically modified organism (GMO) Panel concludes that the molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic characteristics tested between oilseed rape MS11 and its conventional counterpart needs further assessment. No conclusions can be drawn for the compositional analysis due to the lack of an appropriate compositional data set. No toxicological or allergenicity concerns are identified for the Barnase, Barstar and PAT/bar proteins expressed in oilseed rape MS11. Owing to the incompleteness of the compositional analysis, the toxicological, allergenicity and nutritional assessment of oilseed rape MS11 cannot be completed. In the case of accidental release of viable oilseed rape MS11 seeds into the environment, oilseed rape MS11 would not raise environmental safety concerns. The postâmarket environmental monitoring plan and reporting intervals are in line with the scope of the application. Since oilseed rape MS11 is designed to be used only for the production of hybrid seed, it is not expected to be commercialised as a standâalone product for food/feed uses. Thus, seeds harvested from oilseed rape MS11 are not expected to enter the food/feed chain, except accidentally. In this context, the GMO Panel notes that, oilseed rape MS11 would not pose risk to humans and animals, while the scale of environmental exposure will be substantially reduced compared to a standâalone product