General informationNotification NumberB/ES/09/41Member State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority10/03/2009Title of the ProjectApplication to perform complementary field trials with Syngenta’s MIR162 maize product in Spain (2009)Proposed period of release:01/04/2009 to 30/11/2009Name of the Institute(s) or Company(ies)Syngenta Seeds, S.A., on behalf of Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies, ;
3. Is the same GMPt release planned elsewhere in the Community?Yes: Czech Republic; Slovak Republic; Romania; Has the same GMPt been notified elsewhere by the same notifier?NoGenetically modified plantComplete name of the recipient or parental plant(s)
2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:Event MIR162 maize (hereafter referred to as ‘MIR162 maize’) expresses a Vip3Aa protein (designated Vip3Aa20) for control of certain lepidopteran pests and a phosphomannose isomerase (PMI) protein, that acts as a selectable marker trait enabling transformed plant cells to utilize mannose as the only primary carbon source.Genetic modification3. Type of genetic modification:Insertion; In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:- Promoter sequences: Promoter sequences from Zea mays. Provides root-preferential expression in Zea mays.
|Common Name||Family Name||Genus||Species||Subspecies||Cultivar/breeding line|
- Insect tolerance gene: A modified version of the native vip3Aa1 gene found in the Bacillus thuringiensis. It confers resistance to several lepidopteran insect pests.
- Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of manno se-6-phosphate to fructose-6-phosphate.
- NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the gene expression.6. Brief description of the method used for the genetic modification:Event MIR162 maize (hereafter referred to as ‘MIR162 maize’) which expresses a Vip3Aa protein (designated Vip3Aa20) for control of certain lepidopteran pests and a phosphomannose isomerase (PMI) protein, that acts as a selectable marker trait enabling transformed plant cells to utilize mannose as the only primary carbon source.7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:Not applicable as the recipient or parental plant is not a forest tree species.Experimental Release1. Purpose of the release:The objective of the proposed field trial releases is to gain complementary information relating to the performance of this maize product under European conditions, to produce maize for composition and expression analysis and production of nursery for multiplication and observation. They will also allow the further assessment of the event in the environment.2. Geographical location of the site:See following question.3. Size of the site (m2):- Aragón:
Miralsot 500 m2
Lleida-1 500 m2
Lleida-2 700 m2
Lleida-3 200 m2
Bellpuig-1 500 m2
Bellpuig-3 500 m24. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:Evidence from previous field trials in the USA suggests that the genetically modified lines of MIR162 maize do not differ from the recipient plant in mode or rate of reproduction, dissemination or survivability of the plant.Environmental Impact and Risk ManagementSummary of the potential environmental impact from the release of the GMPts:An Environmental Risk Assessment has been completed and submitted with the application. In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified maize with the environment when compared to non-modified maize have been identified.Brief description of any measures taken for the management of risks:All the fields will be sowed at a distance of at least 200 m from commercial maize fields.
A border of at least 8 rows of conventional maize will be planted surrounding the GM maize field.
The products from the trials may be used for analysis and will not be used for human food or animal feed.
Plant material remaining after harvest will be ground and incorporated into the soil.
The sites will be monitored for one year after the release and any volunteer maize appearing will be eliminated before flowering. During the following planting season, commercial maize will not be grown on the trial sites.Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:The trials have not been designed to specifically gain new data on the environment and human health impact of the release. They will also allow the further assessment of the event in the environment.Final reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Not known