RESUMO
Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panel previously assessed the two single maize events and did not identify safety concerns. No new data on the single maize events were identified that could lead to modification of the original conclusions on their safety. 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 in maize GA21 × T25 does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that maize GA21 × T25, as described in this application, is as safe as its conventional counterpart and the non-GM reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable maize GA21 × T25 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize GA21 × T25. Post-market monitoring of food and feed is not considered necessary. The GMO Panel concludes that maize GA21 × T25 is as safe as its conventional counterpart and the non-GM reference varieties tested, with respect to potential effects on human and animal health and the environment.
RESUMO
Structural and phase transformations in the microstructure and new metastable baro- and deformation-induced phases of the Ni50Mn28.5Ga21.5 alloy, typical of the unique class of ferromagnetic shape memory Heusler alloys, have been systematically studied for the first time. Phase X-ray diffraction analysis, transmission and scanning electron microscopy, and temperature measurements of electrical resistivity and magnetic characteristics in strong magnetic fields were used. It was found that in the course of increasing the pressure from 3 to 12 GPa, the metastable long-period structure of martensite modulated according to the 10M-type experienced transformation into a final non-modulated 2M structure. It is proved that severe shear deformation by high pressure torsion (HPT) entails grainsize refinement to a nanocrystalline and partially amorphized state in the polycrystalline structure of the martensitic alloy. In this case, an HPT shear of five revolutions under pressure of 3 GPa provided total atomic disordering and a stepwise structural-phase transformation (SPT) according to the scheme 10M â 2M â B2 + A2, whereas under pressure of 5 GPa the SPT took place according to the scheme 10M â 2M â B2 â A1. It is shown that low-temperature annealing at a temperature of 573 K caused the amorphous phase to undergo devitrification, and annealing at 623-773 K entailed recrystallization with the restoration of the L21 superstructure in the final ultrafine-grained state. The size effect of suppression of the martensitic transformation in an austenitic alloy with a critical grain size of less than 100 nm at cooling to 120 K was determined. It was established that after annealing at 773 K, a narrow-hysteresis thermoelastic martensitic transformation was restored in a plastic ultrafine-grained alloy with the formation of 10M and 14M martensite at temperatures close to those characteristic of the cast prototype of the alloy.
RESUMO
Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six-event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead 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 maize events and of the newly expressed proteins in the six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six-event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable grains of the six-event 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 34 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 six-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the six-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six-event stack maize and its subcombinations are as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.
RESUMO
In this opinion, the GMO Panel assessed the four-event stack maize Bt11 × MIR162 × 1507 × GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four-event stack maize did not give rise to food/feed safety issues. Based on the nutritional assessment of the compositional characteristics of maize Bt11 × MIR162 × 1507 × GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non-GM maize varieties. In the case of accidental release of viable grains of maize Bt11 × MIR162 × 1507 × GA21 into the environment, this would not raise environmental safety concerns. The GMO Panel concludes that maize Bt11 × MIR162 × 1507 × GA21 is nutritionally equivalent to and as safe as its non-GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 × MIR162 × 1507 × GA21 and its subcombinations. A minority opinion expressed by a GMO Panel member is appended to this opinion.
RESUMO
Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant genetically modified maize GA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatics 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 GA21 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-005 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize GA21.
RESUMO
The GMO Panel has previously assessed the single events Bt11, 59122, MIR604, 1507 and GA21 as well as different stacked events corresponding to combinations of these events and no safety concerns were identified. In its assessment of the five-event maize stack Bt11 × 59122 × MIR604 × 1507 × GA21 (application EFSA-GMO-DE-2011-99), the GMO Panel also assessed all the subcombinations of these events not previously assessed, including some for which little or no experimental data were provided, including the three-event stack Bt11 × 1507 × GA21. In line with Article 5 of the decision for authorisation of application EFSA-GMO-DE-2011-99, the European Commission received from Syngenta information on the levels of the newly expressed proteins in subcombination Bt11 × 1507 × GA21 and tasked EFSA to analyse these data and to indicate whether they have an impact on the previously issued opinion on the five-event stack Bt11 × 59122 × MIR604 × 1507 × GA21 and its subcombinations. Analyses of the levels of the newly expressed proteins Cry1Ab, PAT, Cry1F and mEPSPS showed that there is no indication of an interaction between the events combined in maize Bt11 × 1507 × GA21 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel is of the opinion that the new information for maize Bt11 × 1507 × GA21 does not alter the conclusions of the scientific opinion on application EFSA-GMO-DE-2011-99.
RESUMO
The EFSA Panel on Genetically Modified Organisms (GMO) has previously assessed the single events Bt11, MIR162, MIR604 and GA21 as well as different stacked events corresponding to combinations of these events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. In its assessment of the four-event maize stack Bt11 × MIR162 × MIR604 × GA21, the GMO Panel also assessed all the subcombinations of these events not previously assessed, including some for which little or no experimental data were provided, including the two-stack maize event Bt11 × MIR162 (application EFSA-GMO-DE-2009-66). On 8 November 2016, the European Commission received from Syngenta information on the subcombination Bt11 × MIR162. On 14 December 2016, the European Commission tasked EFSA to analyse these data and to indicate whether they have an impact on the previously issued opinion on the four-event stack Bt11 × MIR162 × MIR604 × GA21 and its subcombinations. The GMO Panel used the appropriate principles described in its guidelines for the risk assessment of genetically modified (GM) plants to analyse the provided data. The levels of the newly expressed proteins Cry1Ab, PAT, Vip3Aa20 and PMI are similar between the two-event stack Bt11 × MIR162 and the corresponding single events Bt11 and MIR162. Based on this analysis, there is no indication of an interaction between the events combined in maize Bt11 × MIR162 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel considers that the new information for maize Bt11 × MIR162 does not alter the conclusions of the scientific opinion on application EFSA-GMO-DE-2009-66.