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OECD Unique Identifier details

SYN-BTØ11-1xMON-ØØØ21-9
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Glyphosate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Syngenta
Summary of application:

The genetically modified SYN-BTØ11-1xMON-ØØØ21-9 maize, as described in the application, expresses the Cry1Ab protein which confers protection against certain lepidopteran pests, the mEPSPS protein which confers tolerance to glyphosate herbicides and a PAT protein which confers tolerance to glufosinate-ammonium herbicides.

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Date of authorization: 28/07/2010
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Biosafety Clearing House (BCH)
OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the EU relevant links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Event specific real-time quantitative PCR based method for genetically modified maize SYN-BTØ11-1xMON-ØØØ21-9. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below. -- Reference Material: ERM®-BF412 (for SYN-BTØ11-1) accessible via the Joint Research Centre (JRC) of the European Commission, the Institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm and AOCS 0407 (for MON-ØØØ21-9 ) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for Detection
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Authorization expiration date (a blank field means there is no expiration date) 27/7/2020
E-mail:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
3222954092
Fax number:
Country introduction:

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
European Union
Name of product applicant: Syngenta Crop Protection AG
Summary of application:

The genetically modified maize SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 maize, as described in the application, is produced by crosses between maize containing SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5 and MON-ØØØ21-9 events and expresses the Cry1Ab and Vip3Aa20 proteins which confer protection against certain lepidopteran pests; Cry3A protein which confers protection against certain coleopteran pests; mEPSPS protein which confers tolerance to the glyphosate herbicide and PMI protein which was used as a selectable marker.

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Date of authorization: 19/09/2016
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): EU Register of authorised GMOs
Summary of the safety assessment (food safety):
Please see the EU relevant links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Method for detection: Event specific real-time quantitative PCR based methods for SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5 and MON-ØØØ21-9 maizes; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 maize. Reference material: ERM®-BF412 (for SYN-BTØ11-1) and ERM®-BF423 (for SYN-IR6Ø4-5) accessible via the Joint Research Centre (JRC) of the European Commission, and AOCS 1208-A and AOCS 0407-A (for SYN-IR162-4), AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) accessible via the American Oil Chemists Society.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Method for detection
Reference Material
Opinion of the European Food Safety Authority
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Authorization expiration date (a blank field means there is no expiration date) 18/09/2026
E-mail:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
3222954092
Fax number:
Country introduction:

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Argentina
Name of product applicant: Syngenta Agro S.A.
Summary of application:
The stacked event Bt11 x GA21 maize confers tolerance to lepidopteran insects, especially to Diatraea saccharalis, and tolerance to herbicides which active principle is glyphosate and glufosinate ammonium.
Both parental events, Bt11 and GA21, were stacked by conventional crossing (sexual). The stacked event has the mepsps gene from the GA21 event and the genes cry1Ab and pat from the Bt11 event. The transgenes are inherited in independent form, since it presents mendelian segregation. Moreover, the applicant proved the gene stability and the effective levels of the expressed proteins.
The protein Cry1Ab confers resistance to certain lepideroptean insects, and proteins PAT and mEPSPS allows tolerate herbicides ammonium glufosinate and glyphosate respectively.
After comparison of 65 analytes measured in grain and forage, in the compositional analysis study, it is concluded that maize Bt11 x GA21 is equivalent to commercial maize and the parental lines.
The allergenicity and toxicity assessment of the new expression proteins were carried out previously in both single events.
Taking into account the assessment of genetic stability, molecular characterization, products and levels of expression, compositional analyses and morphoagronomic studies, no metabolic interaction is expected that might impact on the food safety when single events are stacked in a conventional way.
The Bt11xGA21 event is substantial and nutritionally equivalent to its non transgenic counterpart.
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Date of authorization: 18/03/2009
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Decision document of food/feed safety assessment of event Bt11xGA21
Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
Fax number:
Country introduction:

In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.

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Stacked events:

Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Service for Agrifood Health and Quality (Senasa)

https://www.argentina.gob.ar/senasa

 

https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia

Brazil
Name of product applicant: Syngenta Seeds Ltda.
Summary of application:
commercial release of genetically modified insect resistant and herbicide tolerant corn Bt11 x GA21
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Date of authorization: 17/09/2009
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for Environmental Risk Assessment
Summary of the safety assessment (food safety):
Bt11 x GA21 corn was generated by classic genetic development, through sexual crossing between genetically modified lineages containing either event BT11 or GA2, previously approved by the National Biosafety Technical Commission – CTNBio to be commercially released. Bt11 x GA21 corn was already approved in the United States, Canada, Japan, Mexico, Korea and the Philippines for human and animal consumption. In the process of developing Bt11 x GA21 corn there were no genetic modifications besides the introgression of both genes in corn lineages. Compared to conventional corn, Bt11 x GA21 corn has no higher ability to survive as a pest. The presence of genes granting resistance to Lepidoptera insects and tolerance to the glyphosate insecticide give Bt11 x GA21 corn selective advantage when exposed to the herbicide and in the presence of target insects. However, these features are not sufficient to turn the product into a pest in corn cultures. The use of corn containing the stacked event, Bt11 x GA21, represents a future trend meeting corn producers’ demand – by combining two important agronomic features into a same hybrid plant. Event Bt11 contains gene cry1A(b) – coming from Bacillus thuringiensis, granting resistance to certain insects, and gene pat, derived from Streptomyces viridochromogenes, a soil bacterium used as a selection marker during the transformation process. Gene cry1A(b) is responsible for producing protein Btk that is proteolytically cleavated in the alkaline intestine of Lepidoptera insects in an active insecticide form. This insecticide protein, when active, interacts with a receptor molecule that is present solely in the epithelial cells of the middle intestine of susceptible insects, generating pores in cell membranes. When the pores are formed, the cell osmotic balance becomes disrupted, cells swell and undergo lysis. The larvae of susceptible insects, when submitted to the Cry protein stop feeding and later die. Several bonding sites featuring high affinity for Bt proteins were already identified in the middle intestine of susceptible insects. Studies showed that the insecticide protein codified by gene cry1A(b) is highly specific for Lepidoptera insects. Event GA21 contains the mutant gene mepsps that is responsible for the expression of protein 5 enolpyruvyl-shikimate-3-phosphate-syntase (mEPSPS). The EPSPS protein is a key enzyme in processing the shikimic acid, which is involved in the biosynthesis of aromatic amino acids and is commonly found in plants, fungi and bacteria. The enzyme does not exist in animals. The EPSPS enzyme is highly sensitive to herbicide products containing the glyphosate active principle. Results from hybridation data show that Bt11 x GA21 corn maintains its hybridation standard in the same way as the respective parental events for each corresponding transgene. The set of evidence obtained based on results of comparative molecular analysis, analysis of genetic heritage standards and comparative analysis of level of expression for proteins Cry1A(b) and mEPSPS in Bt11 x GA21 corn suggest that the levels of exposure to non-target organisms and in human and animal feeding are the same as to either Bt11 or GA21 measured individually. The presence of genes pat and mepsps make the Bt11 x GA21 corn resistant to a pair of chemical products with herbicide properties available in the market: glyphosate and gluphosinate ammonium. Should corn have potential to turn into a pest plant, its control where such products were used could increase its invasive ability. However, the high degree of domestication of corn made the species highly dependent on man. This may be ratified by the absence of pest or even feral populations in agricultural and natural environments, even after millennia of cultivation in Brazil. Therefore, the risk that corn changes into a pest plant, if such risk exists, is negligible. According to Annex I to Ruling Resolution nº 5, of March 12, 2009, the applicant shall have a term of thirty (30) days from the publication of this Technical Opinion to adjust its proposal to the post-commercial release monitoring plan. Under Article 14 of Law no. 11,105/2005, CTNBio found that the request complies with the applicable rules and legislation securing the biosafety of environment, agriculture, human and animal health and reached a conclusion that the stacked corn Bt11 x GA21 is substantially equivalent to conventional corn and its consumption is safe for human and animal health. Regarding the environment, CTNBio’s conclusion is that cultivation of Bt11 x GA21 corn is not a potential cause of significant environmental degradation, keeping with the biota a relation identical to that of conventional corn. TECHNICAL OPINION I. GMO Identification GMO name: Bt11 x GA21 corn. Applicant: Syngenta Seeds Ltda. Species: Zea Mays L. Inserted characteristics: Tolerance to glyphosate herbicide and insect resistance Method of insertion: Bt11 x GA21 corn, ranked as Risk Class I, was developed by classical genetic improvement, through sexual crossing between genetically modified lineages containing event Bt11 and event GA21. Prospective use: Free registration, use, essays, tests, sowing, transport, storage, marketing, consumption, import, release and discarding. II. General Information Corn, Zea Mays L. is a species of the family Gramineae, tribe Maydae, sub-family Panicoidae that is separated within the sub-genus Zea and has chromosome number 2n = 20,21,22,24(1). The wild species closest to corn is the teosinte found in Mexico and some regions of Central America, where it is able to cross with cultivated corn in the production fields. Corn has a history of over eight thousand years in the Americas, and is cultivated since the pre-Columbian era. Among higher plants, corn is the best scientifically characterized and is currently the cultivated species that reached the highest degree of domestication and is unable to survive in nature but when cultivated by man(2). There are currently over 300 identified races of corn and, within each such race, thousands of cultivars. One of the most important sources of food in the world, corn is an input in the production of a wide range of foodstuff, rations and industrial products. Brazil is one of the largest producers of corn over the world, and corn is cultivated nearly all over the national territory(3). Occurrence of insects in Earth is larger in the tropics than in temperate regions, where the damages caused by such animals are more noticeable. Among the most damaging corn pests an important place is taken by the fall armyworm, Spodoptera frugiperda. Cruz et al. (4) estimated that the losses in Brazil caused by infestations of S. frugiperda reach 400 million Dollars each year. Other species of the order Lepidoptera are also important pests in the culture of corn, such as the corn earworm (Helicoverpa zea) and stalk borer (Ditraea sacharalis). The main measure to control insects in the corn cultivation has been the use of insecticides. In some areas of the Brazilian Center-West, for instance, tenths of insecticide sprays are needed in a single culture cycle. Another measure to control pests would be the use of resistant cultivars. Bt11 x GA21 corn was developed through classic genetic improvement, by sexual crossing between genetically modified lineages containing separately event Bt11 and event GA21(5,6). Bt11 x GA21 corn was already approved in the United States, Canada, Japan, Korea and the Philippines for animal and human consumption. In the course of developing Bt11 x GA21 corn, there were no other genetic changes in addition to the introgression of both events contained in corn lineages Bt11 and GA21 separately(7). Compared with conventional corn, Bt11 x GA21 corn fails to display greater ability to survive as a pest. The presence of gens granting resistance to Lepidoptera insects and tolerance to glyphosate herbicide give a selective advantage to Bt11 x GA21 corn when it is exposed to the herbicide and submitted to the presence of target-insects. However, such characteristics are not sufficient to make this corn a pest in corn cultivars(8). The use of corn featuring the stacked event, Bt11 x GA21, represents a future trend – that meets the demand of farmers – by combining two agronomically important features in a single hybrid. Corns with events combined by classic genetic improvement are approved in Japan, Korea, Philippines and are under analysis in a number of other countries(7). III. Description of GMO and Proteins Expressed The corn containing event Bt11 was obtained by direct transfer of DNA in protoplasts of corn lineage H8540 by inserting plasmid pZO1502 containing genes cry1Ab and pat. The expression product of gene cry1Ab is protein Cry1Ab that has insecticide activity on target-pests, protecting the plants from damages caused by such pests. Gene cry1Ab was isolated from bacterium B. thuringiensis subspecies kurstaki strain HD-1(3,8,9). Gene pat is derived from Streptomyces viridochromogenes strain Tu494 and is responsible for codifying enzyme phosphinothricin N-acetyltransferase (PAT). This enzyme is able to chemically inactivate herbicides derived from phosphinotricin, such as glyphosinate ammonium, making resistant cells and plants containing the enzyme. The PAT enzyme activity has its activity described and well known(9). Event GA2 contains gene mepsps that expresses enzyme 5-enolpyruvyl-shikimate-3-phosphate-synthase (mEPSPS). Protein mEPSPS differs from feral EPSPS in two amino acids and is a key enzyme in the shikimic acid process, involved in the biosynthesis of aromatic amino acids. mEPSPS is highly sensitive to herbicide products containing glyphosate. Corn plants transformed with mEPSPS gene, such as those derived from event GA2, synthesize protein mEPSPS that grants tolerance to herbicide products containing glyphosate(10,11). Proteins mEPSPS and Cry1Ab mode of action and biologic activities expressed in Bt11 x GA21 corn are different and do not posses known interaction mechanisms that are able to cause adverse effects to human and animal health, and to the environment. mEPSPS and Cry1Ab proteins present in Bt11 x GA21 corn are accumulated in different cell compartments and display distinct and non-interactive metabolic functions. Therefore, protein mEPSPS is directed to the chloroplast while protein Cry1Ab is accumulated in the cytoplasm(5,6). Expression level of proteins mEPSPS and Cry1Ab is low in individual events (GA21 corn and Br11 corn) and therefore the likelihood that such proteins would interact between them is held improbable, a fact that is macroscopically confirmed through the analysis of agronomic and phenotypical characteristics related to efficacy and selectivity of Bt11 x GA21 corn in the fields(5,6). IV. Aspects Related to Human and Animal Health Safety aspects of proteins Cry1Ab and EPSPS were thoroughly assessed by CTNBio and protein Cry1Ab mode of action is well clarified by scientific literature(5,6). In vitro tests were used to assay increased digestibility of foodstuffs containing pre-heated proteins Cry1Ab and mEPSPS. The study showed that pre-heating increases the protein digestibility in simulated gastric and intestine fluids, suggesting that the likelihood of an eventual allergenic potential of protein Cry1Ab is extremely low, for the easy of its digestion(5,6). Further, in vivo and in vitro studies confirmed that proteins Cry1Ab expressed in B. thuringiensis and Bt11 x GA21 corn are highly selective and do not act on mammals(13,14,15,16,17,18,19). Protein mEPSPS is an enzyme that is present in all plants and in a large number of microorganisms(17), while protein Cry1Ab does not display enzymatic activity in plants and therefore fails to affect plant metabolism. The likelihood that biochemical interaction takes place between proteins mEPSPS and Cry1Ab in the complex matrix of a plant is limited, since such proteins accumulate in different places of the cells and in a low level of expression. With this, a potential exposure to such proteins is extremely low in human and animal feeding. Considering that proteins mEPSPS and Cry1Ab fail to produce toxicity in the maximum doses tested, it is highly unlikely that an interaction able to cause additive or synergic effects occurs between such proteins in the normal doses found in foodstuffs. The literature in the area of toxicology of chemical mixtures provides information showing that such interactions are inexistent when the substances are administered in doses substantially below the levels of unobserved adverse effect(20,2,22,23). Due to the rigorous specificity for substrates, enzymes EPSPS link just S3P, PEP and glyphosate. The only known metabolic product is the 5-enolpyruvyl shikimic-3-phosphate, which corresponds to the penultimate product of the shikimic acid pathway. Shikimic acid is a precursor for biosynthesis of amino acids (phenylalanine, tyrosine and triptophane) and a number of secondary metabolits, such as tetrahydrofolate, ubiquinone and K vitamin(24). Though the shikimic acid (or shikimate) pathway and proteins EPSPS do not occur in mammals, fish, birds and insects, they are important to plants. It is reckoned that aromatic molecules, all of them derived from shikimic acid, represent no less than 35% of a plant’s dry weight(25,26). In vitro assays performed with simulated digestive fluids are widely used tools as a model for animal digestion. This simulated system was used to probe into digestibility of plant proteins(27,28), animal proteins(29), and food additives(30), as well as to assay the protein quality(31) and the allergenicity potential through absorption of the proteins by the digestive system(32). The knowledge on the mode of action, specificity and safe use history of protein EPSPS, potential toxic and allergenic effects of such proteins to humans and other mammals were assayed through in vitro digestion tests. The studies used simulated gastric fluids (pH 1.2) and intestinal fluids (pH 7.5). The degradation rate of protein mEPSPS (mature protein with no transit peptide) was assessed through Western blot analyses. The study showed that protein mEPSPS and peptides degraded in less than 15 seconds after exposed to the gastric fluid. In the simulated intestinal fluid, degradation of protein mEPSPS occurred in a period shorter than 10 minutes(33). Finally, enzyme EPSPS expressed in corn containing event GA21 has no typical characteristics of known allergens, since the behavior of allergenic proteins in the digestive tract is well described(34,35,36). There are no homology regions when the introduced sequence is compared with known allergen sequences. Besides, several alimentary allergens are known to be stable under heat. V. Environmental Aspects Corn is a monoic, allogamic and annual plant, pollinated mostly by the wind. Distances that may be covered by the pollen depend on wind patterns, humidity and temperature. Corn pollen is freely dispersed close to the cultivated area, and may reach styli-stigmas of the same or different genotypes and, under adequate conditions, starts its germination, generating the pollinic tube and promoting the ovule fecundation within an average term of 24 hours. Studies on pollen dispersion have been conducted and some of them show that pollen may travel long distances, though the majority is deposited close to the cultivated area with a very low translocation rate. Over 95% of the pollen may reach distances within 60 m of the pollen source(37). Luna et al. (38) investigated pollen isolation distance and control, where it was shown that crossed pollination occurs within 200 m. However, no crossed pollination, under conditions of non-detasseling, was noticed in distances higher than 300 m from the pollen source. The results indicate that pollen viability is maintained for two hours and that crossed pollination was not observed in distances of 300 m from the pollen source. When compared with concentrations at one meter from the source culture under low-to-moderate winds it was estimated that about 2% of the pollen reaches 60 meters, 1.1% reaches 200 meters, and 0.75% to 0.5% reaches a distance of 500 meters. At a distance of ten meters from the field, the number of pollen grains per unit of area is tenfold lower than the number observed at one meter from the border. Therefore, if established separation distances developed for the production of corn seeds are observed, it may be expected that pollen transfer to surrounding varieties is minimized and that the presence of glyphosate-tolerant genetic materials is unlikely. There are no kindred species of corn naturally distributed within Brazil. However, though the gene flow to local varieties of open pollination is possible, it poses the same risk than the one caused by commercial genotypes available in the marketplace. In the specific case of crossing between GA21 corn and creole varieties, selected pressure from the management by small farmers is not expected; the transgene will not be incorporated to the genome of creole varieties because in practice a small farmer does not use herbicides. From the agronomic viewpoint, coexistence between cultivars of conventional corn (improved or creole) and transgenic corn is possible(39,40). Old communities and modern farmers have learned how to live on without problems with different corn cultivars, while keeping their genetic identities along time. The likelihood of a transgenic plant becoming an invading species, as well as the likelihood that the crossing of GA21 corn with other corn plants generating an invading plant is negligible, in view of the biologic characteristics of the species and the fact that corn cannot survive without human intervention, a result of the selection made during the plant evolution. Corn is held as the species reaching the highest degree of domestication among cultivated plants, and has lost its ability to survive in nature, such as elimination of thrashing. Therefore, corn is a plant that is unable to survive under natural conditions without technical assistance. Therefore, one expects GA21 corn to exhibit an environmental behavior similar to ordinary corn, being hence negligible the possibility of changing into an invading or pest plant. Introduction of gene elements did not change the plant reproductive features, and the odds of crossed fecundation between hybrids and conventional corn lineages will persist between event Bt11 x GA21 and other corn plants. Gene flow in corn may take place through transfer of pollen and dispersion of seeds – which is easily controlled – since corn domestication eliminated the ancient mechanisms of seed dispersion and the movement of pollen is the only effective form for genes to escape from corn plants. The likelihood that a gene mepsps of a transgenic plant passes over to other organisms, such as, for instance, soil microorganisms, is practically zero(41,42). Naturally, gene epsps is common in plants, fungi and microorganisms, occurring abundantly in nature and does not results in significant risk to the soil microbiota. Besides, there is no evidence that plant genes have in some way been transferred to bacteria under natural conditions. Agronomic parameters and efficacy of controlling pest Lepidoptera in Bt11 hybrid corn were compared with isogenic lineages in assays conducted in five locations: City of Uberlândia, State of Minas Gerais; City of Ituiutaba, State of Minas Gerais; City of Iraí de Minas, State of Minas Gerais; City of Campo Mourão, State of Paraná; and City of Pinhalzinho, State of Santa Catarina. Plant height, ear insertion height, date of male and female flowering, percentage of erect plants, type and color of seed-corn, humidity content, yield and ear damage were the parameters observed in agronomic assays. In order to assay the efficacy of event Bt11 in controlling pest Lepidoptera, damages of fall armyworm (S. frugiperda); corn borer (D. saccharalis); and corn earworm (H. zea) (5,6) were examined. Hybrids containing event Bt11 were efficient to control the assayed pest Lepidoptera and exceeded the agronomic parameters related to corn-seed and grain damage. According to available information, the favorable performance difference was mainly related to the efficient protection against attacks from pests studied. As for other agronomic parameters assayed, Bt11 hybrids exhibited a performance statistically similar to the respective isogenic non-genetically modified hybrids. The results confirm the equivalence of agronomic performance between Bt11 hybrids and isogenous corn non-genetically modified under Brazilian cultivation conditions(5,6). Frequent use of chemical insecticides contributes towards environment degradation, environmental pollution and disruption of the whole ecosystem in the corn culture and even of other cultures in rotation. With the adoption of insect resistant genetically modified plants, reduction of insecticides was considerable in countries where the technology has been used for over ten years. In 2001 alone, United States farmers, for instance, obtained a reduction of over 8,000 tons of active insecticide ingredient in (43,44,45). In China, the use of insecticides were reduced by 67% on average, and the reduction in terms of active insecticide ingredient reached 80%(46). In South Africa, the reduction was about 66%(42). These examples suggest that the use of Bt technology in Brazil may contribute for a diminished use of insecticides and, therefore, reduction of the impacts resulting from the use of such pesticides to the environment and human and animal health. Besides, the use of Bt technologies may have positive effects in preserving populations of non-target organisms and beneficial insects, making an integrated management of crop pests easier(47,48,49). Besides, the use of technologies that reduce spraying chemicals on crops may bring secondary benefits with the reduced use of raw-material in the production of pesticides, reduction of fuels used to produce, distribute and apply pesticides and elimination of the need to use and discard pesticide packaging(50). Compared with conventional corn, Bt11 x GA21 corn has no higher ability to survive as a pest. The presence of genes for Lepidoptera insect resistance and glyphosate herbicide tolerance imparts a selective advantage to Bt11 x GA21 corn when exposed to the herbicide and in the presence of target insects. However, such features are not enough for Bt11 x GA21 corn change into a pest to corn cultures(8). Comparison of amino acid sequences of the new proteins expressed by Bt11 x GA21 corn against sequences of toxic or allergenic proteins show that there is no homology likely to indicate similarities. Therefore, toxic or allergenic effects are not expected as a result of contact or consumption of foodstuffs containing event Bt11 x GA21(8). VI. Restrictions to the Use of the GMO and its Derivatives As established by Article 11 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” The studies submitted by applicant showed that there was no significant difference between corn hybrids derived from unmodified lineages and Bt11 x GA21 corn regarding agronomic characteristics; reproduction and dissemination modes; and survival ability. All evidences submitted with the application documents and bibliographic references confirm the risk level of the transgenic variety as being equivalent to the risk level of non transgenic varieties regarding soil microbiota, other plants and human and animal health. Therefore, cultivation and consumption of Bt11 x GA21 corn are not potential causes of significant degradation of the environment, nor of risks to human and animal health. For these reasons, there are no restrictions to the use of such corn and its derivatives, except in locations mentioned by Law nº 11,460, of March 21, 2007. Vertical gene flow to local varieties (the so-called creole corns) of open pollination is possible and poses the same risk as the one caused by commercial genotypes available in the market (80% of conventional corn planted in Brazil comes from commercial seeds that underwent a genetic improvement process). Coexistence of conventional corn (either improved or creole) cultivars and transgenic corn cultivars is possible from the agronomic viewpoint(39,40) and shall comply with the provisions of CTNBio Ruling Resolution nº 4. After being used for ten years in other countries, no problems were detected to human and animal health and the environment that may be ascribed to transgenic corns. It shall be emphasized that the lack of negative effects resulting from farming transgenic corn plants is far from a guarantee that such problems may not occur in the future. Zero risk and absolute safety do not exist in the biologic world, although there is a significant amount of reliable scientific information and a safe history of ten years underlying the fact that Bt11 x GA21 corn is as safe as the traditional corn versions. Therefore, applicant shall conduct the post-commercial release monitoring according to CTNBio Ruling Resolution nº 3. VII. Consideration on the Particulars of Different Regions of the Country (Information to supervisory agencies) As established by Article 11 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” VIII. Conclusion Whereas the corn (Zea mays) variety Bt11 x GA21 belongs to a well characterized species with a solid history of safety for human consumption and that genes cry1A(b), pat, mepsps introduced in this variety codify proteins that are ubiquitous in nature and are present in plants, fungi and microorganisms that are part of human and animal alimentary diet; Whereas insertion of this genotype took place through classic genetic improvement and resulted in insertion of a stable and functional copy of cry1A(b), pat, mepsps genes that granted to the plants tolerance to glyphosate herbicide and resistance to insects; Whereas data on centesimal composition failed to show significant differences between genetically modified and conventional varieties, suggesting a nutritional equivalence between them; Whereas CTNBio conducted a separate assay on the events and issued an opinion favorable to commercial release of the separate events; Whereas: 1. Bt11 x GA21 corn is a genetically modified product, displaying resistance to a number of Lepidoptera pests and tolerance to glyphosate herbicide, developed through classic improvement by sexual crossing between lineages containing event Bt11 and event GA21, previously approved for commercial release; 2. Comparative molecular analysis of Bt11 x GA21 corn evidenced that integrity of inserts was maintained during the classic improvement with the purpose of combining both events; 3. Segregation analysis and genetic heritance standards of Bt11 x GA21 corn showed that genes of events Bt11 and GA21 are independent and segregate on a stable manner along successive generations; 4. Agronomic and efficacy assays of Bt11 x GA21 corn indicate that combination of such events by classic genetic improvement methods (sexual crossings) did not lead to expression of any other characteristics, except those already expected, that is to say, resistance to certain insects and tolerance to glyphosate herbicide; 5. Expressions of proteins Cry1Ab and mEPSPS in Bt11 x GA21 corn are not significantly different from their expression in corns containing the separate events; Therefore, considering internationally accepted criteria in the process of analyzing risks in genetically modified raw-material it is possible to conclude that Bt11 x GA21 corn is as safe as its conventional equivalents. In the context of the competences granted to it under Article 14 of Law nº 11,105/05, CTNBio considered that the request complied with the rules and legislation in effect that intend to guaranty environmental and agricultural biosafety and human and animal health, reaching a conclusion that Bt11 x GA21 corn is substantially equivalent to conventional corn, being its consumption safe for human and animal health. Regarding the environment, CTNBio’s conclusion was that the Bt11 x GA21 corn is not a potential cause of significant degradation to the environment, keeping with the biota a relation identical to that of conventional corn. CTNBio advocates that this activity is not a potential cause of significant degradation to the environment or of harm to human and animal health. Restrictions to the use of the GMO analyzed and its derivatives are conditioned to the provisions of Law nº 11,460, of March 21, 2007, and to CTNBio Ruling Resolution nº 03 and Ruling Resolution nº 04. CTNBio assay took into consideration opinions issued by the Commission members; ad hoc consultants; documents delivered to CTNBio Executive Secretary by applicant; results of planned releases to the environment; and discussions, lectures and papers related to the public hearing held on 03.20.2007. Besides, independent studies and scientific literature of applicant, conducted by third parties were also considered. According to Annex I to Ruling Resolution nº 5, of March 12, 2009, the applicant shall have a term of thirty (30) days from publication of this Technical Opinion to adjust its proposal to the post-commercial release monitoring plan. IX. Bibliography 1. Food and Agriculture Organization of the United Nations / World Health Organization. FAO/WHO – 2000a. Grassland Index. Zea mays L. (Disponível em: http://www.fao.org/WAICENT/faoinfo/agricult/agp/agpc/doc/gbase/data/pf000342.htm). 2. BAHIA FILHO, A. F. C.; GARCIA, J. C. 2000. Análise e avaliação do Mercado brasileiro de sementes de milho. In: UDRY, C. V.; DUARTE, W. F. (Org.) Uma história brasileira do milho: o valor de recursos genéticos. Brasília: Paralelo 15,167-172. 3. Compania Nacional de Abastecimento – CONAB. 2007. Milho total (1ª e 2ª safra) Brasil – Série histórica de área plantada: safra 1976-77 a 2006-07. http:www.conab.gov.br/conabweb/download/safra/Milho TotalSerie Hist.xls. 4. CRUZ, I.; FIGUEIREDO, M. L. C.; OLIVEIRA, A. C.; VASCONCELOS, C. A. 1999. Damage of Spodoptera frugiperda (Smith) in different maize genotypes cultivated in soil under three levels of aluminium saturation. International Journal of Pest Management 45: 293-293. 5. Comissão Técnica Nacional de Biossegurança. CNTBio 2008. Parecer Técnico 1597/2008. Publicado no Diário Oficial da União de 14 /10/2008, Seção 1, pag. 3. 6. Comissão Técnica Nacional de Biossegurança. CNTBio 2008. Parecer Técnico 1255/2008. Publicado no Diário Oficial da União de 16 /01/2008, Seção 1, pag. 2. 7. AGBIOS, 2009. GM DataBase, (http:www.agbios.com/dbase.php?action=Submit&evidcode=NK603+x+MON810), disponível em 07/10/2009. 8. FISCHHOFF, D. A.; BOWDISH, K. S.; PERLK, F. J.; MARRONE, P. G.; MCCORMICK, S. M.; NIEDERMEYER, J. G.; DEAN, D. A.; KUSANO-KRETZMER, K.; MAYER, E. J.; ROCHESTER, D. E.; ROGERS, S. G.; FRALEY, R. T. Insect tolerant transgenic tomato plants. Biotechnology, v. 5, p. 807-813, 1987. 9. FORLANI, G.; OBOJSKA, A. BERLICKI, T.; KAFARSKI, P. 2006. Phosphinothricin analogues as inhibitors of plant glutamine synthetase. J. Agric. Food Chem. 54: 796-802. 10. Haslam, E. 1993. Shikimic acid: metabolism and metabolites. University of Sheffield, UK. 11. Steinrücken, H. C.; Amrhein, N. 1980. The herbicide glyphosate is a potent inhibitor of 5 enilpyruvyul – shikimic acid-3-phosphatase. Biochem Biophys Res Commun 94: 1207-1212. 12. OKUNUKI, H.; TESHIMA, R.; SHIGETA, T.; SAKUSHIMA, J.; AKIYAMA, H.; GODA, Y.; TOYODA, M.; SAWADA, J. Increased digestibility of two products in genetically modified food (CP4-EPSPS and Cry1Ab) after preheating. J. Food Hygienic Soc. Japan. v. 43, p. 68-73, 2002. 13. WOLFERSBERG, M. G. V-ATPASE-ENERGIZED EPITHELIA AND BIOLOGICAL INSECT CONTROL. J. EXP. BIOL. 172, 377-386, 1992. 14. Wieczorek, H.; Brown, D.; Grinstein, S.; Ehrenfeld, J. and Harvey, W. R. (1999). Animal plasma membrane energization by proton-motive V-ATPaes. Bioessays 21, 637-648. 15. Griffitts and Aroian, 2005 J. Griffitts and R. Aroian, Many roads to resistance: how invertebrates adapt to Bt toxins, BioEssays 27 (2005), pp. 614-624. 16. Shimada, N.; Miyamoto, K.; Kanda, K.; Murata, H.; 2006a. Bacillus thuringiensis insecticidal Cry1Ab toxin does not affect the membrane integrity of the mammalian intestinal epithelial cells: an in vitro study. In vitro Cellular and Developmental Biology – Animal, 42: 45-49. 17. Shimada, N.; Miyamoto, K.; Kanda, K.; Murata, H.; 2006a. Binding of Cry1Ab toxin, a Bacillus thuringiensis insecticidal toxin, to proteins of the bovine intestinal epithelial cell: an in vitro study. Applied Entomology and Zoology, 41: 295-301. 18. Stumpff, F.; Bondzio, Einspanier, A.; R. and Martens, H. Effects of the Bacillus thuringiensis toxin Cry1Ab on membrane currents of isolated cells of the ruminal epithelium J, Membr. Biol. 219 (1-3) (2007), pp. 37-47. 19. Bondzio, A,; Stumpff, F.; Scion, J.; Martens, H.; Einspanier, R. 2008. Impact of Bacillus thuringiensis toxin Cry1Ab on rumen epithelial cells (REC) – A new in vitro model for safety assessment of recombinant food compounds. Food and Chemical toxicology, 46: 1976-1984. 20. Groten, J. P.; Schöen,; E. D.; Kuper, C. F.; Van Bladeren, P. J.; Van Zorge, J. A. and Feron, V. J. Subacute of a mixture of nine chemicals in rats: detecting interactive effects with a two level factorial design. Fundamental and Applied Toxicology (1997). 21. Jonker, D.; Woutersen, R. A. and Feron, V. J. Toxicology of mixture of nephrotoxicants with similar or dissimilar mode of action. Food and Chemical Toxicology 31 (1996), pp. 1075-1082. 22. Jonker, D.; Woutersen, R. A.; Van Bladeren, P. J.; Til, H. P. and Feron, V. J. 4-week oral toxicity study of a combination of eight chemicals in rats: comparison with the toxicity of the individual compounds. Food and Chemical Toxicology 28 (1990), pp. 623-631. 23. Jonker, D.; Woutersen, R. A.; Van Bladeren, P. J.; Til, H. P. and Feron, V. J. Subacute (4-wk) oral toxicity of a combination of four nephrotoxins in rats: comparison with the toxicity of the individual compounds. Food and Chemical Toxicology 31 (1993), pp.125-136. 24. TAYLOR, M. L.; HARTNELL, G.; NEMETH, M.; KARUNANANDAA, K.; GEORGE, B. 2005. Comparison of broiler performance when fed diets containing corn grain with insect-protected (corn rootworm and European corn borer) and herbicide-tolerant (glyphosate) traits, control corn, or commercial reference corn-revisited. Poult. Sci. 84: 1893-1899. 25. TAN, S.; EVANS, R.; SINGH, B. 2006. Herbicidal inhibitors of amino acid biosynthesis and herbicide-tolerant crops. Amino Acids 30: 195-204. 26. SILVA-WERNECK, J. O.; SOUZA, M. R. T.; DIAS, J. M. C. S.; RIBEIRO, B. M. 1999. Characterization of Bacillus thuringiensis subsp. Kurstaki strain S93 effective against the fall armyworm (Spodoptera frugiperda). Canadian Journal of Microbiology 45: 464-417. 27. XIA, J. Y.; CUI, J. J.; MA, L. H.; DONG, S. X.; CUI, X. F. 1999. The role of transgenic Bt cotton in integrated insect pest management. Acta Gossypii Sim 11: 57-61. 28. YI, G.; SHIN, Y. M.; CHOE, G.; SHIN, B.; KIM, Y. S.; KIM, K. M. 2007. Production of herbicide-resistant sweet potato plants transformed with the bar gene. Biotechnology. Let. 29: 669-675. 29. YU, J.; XIAN, R.; TAN, L.; XU, W.; ZING, S.; CHEN, J.; TANG, M.; PANG, Y. 2002. Expression of the full-length and 3’-spliced Cry1Ab gene in 135-kDa crystal protein minus derivative of Bacillus thuringiensis subsp. Cur. Microbial. 45: 133-138. 30. AQUILA, J. M.; VILLELLA, F. M. F.; FOSTER, J. E. 2002. Resistencia do milho (Zea mays L.) transgenic (Bt) à lagarta-do-cartucho, Spodoptera frugiperda (Smith) (Lepidoptera: Noctuidae). Revista Brasileira de Milho e Sorgo 1(3): 1-11. 31. WATSON, S. A.; RAMSTAD, P. E. 1987. Corn: chemistry and technology. St. Paul.: American Association of Cereal Chemist, 605p. 32. CARPENTER, J.; FELSOT, ª; GOODE, T.; HAMMING, M.; ONSTAD, D.; SANKULA, S. 2002. Comparative environmental impacts of biotechnology-derived and traditional soybean, corn, and cotton crops (CAST: 1-189). Ames, IA: Council for Agricultural Science and Technology. 33. WATSON, S. A.; RAMSTAD, P. E. 1987. Corn: chemistry and technology. St. Paul.: American Association of Cereal Chemist, 605p. 34. CANTWELL, G. E.; LEHNERT, T.; FOWLER, J. Are biological insecticides harmful to the honey bee. Am. Bee J. v. 112, p. 294-296, 1972. 35. KRIEG, A.; LANGENBRUCH, G. A. Susceptibility of arthropod species to Bacillus thuringiesis. In: Microbiol Control of Pests and Plant Diseases. BURGES, H. D. (Ed). London: Academic Press, 1981. p. 837-896. 36. FLEXNER, J. L.; LIGHTHART, B.; CORFT, B. A. The effects of microbial pesticides on non-target beneficial arthropods. Agric. Ecosys. Environ. v. 16, p. 203-254, 1986. 37. PATERNIANNI, E.; CAMPOS, M. S. 1999. Melhoramento do milho. In BÓREM, A.(Ed) Melhoramento de espécies cultivadas. Viçosa: UFV, p. 429-486. 38. LUNA, S. V.; FIGUEROA, J. M.; BALTAZAR, M. B.; GOMEZ, L. R.; TOWNSEND, R. E.; SCHOPER, J. B. 2001. Maize pollen longevity and distance isolation requirements for effective pollen control. Crop Sci. 41: 1551-1557. 39. BROOKERS, G.; BARFOOT, P.; MELÉ, E.; MESSEGUER, J.; BÉNÉTRIX, F.; BLOC, D.; FOUEILLASSAR, X.; FABIÉ, A.; POEYDOMENGE, C. 2004. Genetically modified maize: pollen movement and crop co-existence. Dorchester, UK: PG Economics, 20 pp. (www.pgeconomics.co.uk/Maizepollennov2004final.pdf); 40. MESSEGUER, J.; PEÑAS, G,; BALLESTER, J.; BAS, M.; SERRA, J.; SALVIA, J.; PALAUDELMAS, M.; MELÉ, E. 2006. Pollen-mediated gene flow in maize in real situations of coexistence. Plant Biotechnology Journal. 4: 633-645. 41. NIELSEN, K. M.; BONES, A. M.; SMALLA, K.; VAN, ELSAS, J. D. 1998 Horizontal gene transfer from transgenic plants to terrestrial bacteria – a rare event? FEMS Microbiology Reviews 22, 79-103. 42. SIQUEIRA, J. O.; TRANNIN, I. C. B.; RAMALHO, M. A. P.; FONTES, E. M. G. 2004. Interferências nos agrossistemas e riscos ambientais de culturas transgênicas tolerantes a herbicidas e protegidas contra insetos. Cadernos de Ciências e Tecnologia 21: 11-81. 43. CARPENTER, J.; FELSOT, ª; GOODE, T.; HAMMING, M.; ONSTAD, D.; SANKUSA, S. 2002. Comparative environmental impacts of biotechnology-derived and traditional soybean, corn, and cotton crops (CAST: 1-189). Ames, IA: Council for Agricultural Science and Technology. 44. EDGE, J. M.; BENEDICT, J. H.; CARROLL, J. P.; REDING, H. K. 2001. Bollgard cotton: an assessment of global economic, environmental and social benefits. J. Cotton Sci 5: 121-136. 45. GIANESSI, L.; SILVERS, C.; SANKUSA, S.; CARPENTER, J. A. 2002. Plant biotechnology: current and potential impact for improving pest management in U.S. agriculture – an analysis of 40 case studies (executive summary). Washington, DC: National Center for food and Agricutural Policy. http:www.ncfap.org/40CaseStudies/NCFAB%20Exec%20Sum.pdf. 46. HUANG, J.; ROZELLE, S.; PRAY, C.; WANG, Q. 2002. Plant biotechnology in China. Science 295: 674-676. 47. XIA, J. Y.; CUI, J. J.; MA, L. H.; DONG, S. X.; CUI, X. F. 1999. The role of transgenic Bt cotton in integrated insect pest management. Acta Gossypii Sim 11: 57-64. 48. HEAD, G.; FREEMAN, B.; MINA, B.; MOAR, W.; RUBERSO, J.; TURNIPSEED, S. 2001. Natural enemy abundance in Commercial Bollgard and conventional cotton fields. Proceedings of the Beltwide Cotton Conference 2: 769-798. Memphis: National Cotton Council. 49. BENEDICT, J.; ALTMAN, D. 2001. Commercialization of transgenic cotton expressing insecticidal crystal protein. In: JENKINS, J.; SAHA, S. (eds). Genetic improvement of cotton: emerging technologies. Enfield: Science Publishers, 137-201. 50. LEONARD, R.; SMITH, R. 2001. IPM and environmental impacts of cotton: a new era of crop protection and consumer benefits. ISN N° 00401074.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date (a blank field means there is no expiration date) Not Applicable
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Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Maria Sueli Felipe Soares
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Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

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Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)

Colombia
Name of product applicant: SYNGENTA
Summary of application:

Authorization of the genetically modified maize Bt11 X GA21 resistant to lepidoptera pest attack and tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 27/09/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
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Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
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Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
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Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

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Japan
Name of product applicant: Syngenta Seeds K.K.
Summary of application:

Bt11 x GA21 has developed by conventionally crossing two genetically modified corn events (Bt11 and GA21) for insect resistance and herbicide tolerance.

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Date of authorization: 06/11/2007
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the link below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Food safety assessment performed by Food Safety Commission of Japan
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Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
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Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
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Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Mexico
Name of product applicant: Syngenta Seeds, Inc.
Summary of application:

Authorization by COFEPRIS: 51


The genetically modified SYN-BTØ11-1xMON-ØØØ21-9 maize, as described in the application, expresses the Cry1Ab protein which confers protection against certain lepidopteran pests, the mEPSPS protein which confers tolerance to glyphosate herbicides and a PAT protein which confers tolerance to glufosinate-ammonium herbicides.

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Date of authorization: 06/12/2007
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
UI OECD: SYN-BTØ11-1xMON-ØØØ21-9 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Biól. Erica L. Hagman Aguilar
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Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 53227700
Fax number:
Country introduction:

México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población. Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano. En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.

Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley. Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

 

Courtesy translation

Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.

The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: [email protected]%20

Philippines
Name of product applicant: Syngenta Philippines
Summary of application:
Backcrossing was used to move the trait into an inbred background to generate a fixed inbred for each trait . The fixed transgenic inbreds (corn Bt 11 and corn GA21) are then crossed to produce a commercial hybrid containing both events, Bt 11 x GA21.
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Date of authorization: 23/01/2012
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Syngenta Philippines, Inc have filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Department of Agriculture (DA)- Administrative Order (AO) No. 8 Part 5 for stacked trait product corn: Bt11 x GA21, which was developed by conventionally crossing two genetically modified corn events (Bt11 and GA21) for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: Bt11 x GA21 was conducted as per Administrative Order No. 8 Series of 2002. The focus of risk assessment is the gene interactions between the two transgenes. Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
Fax number:
Country introduction:

In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

 

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Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

 

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to  food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

Republic of Korea
Name of product applicant: Syngenta Korea
Summary of application:

Glufosinate herbicide tolerance , Glyphosate herbicide tolerance , Lepidopteran insect resistance

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Date of authorization: 02/02/2006
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
South Africa
Name of product applicant: Syngenta
Summary of application:

The GM maize BT11xGA21 is produced through conventional breeding.  The maize expresses Cry1Ab,pat and mepsp proteins which control certain lepidopteran pests and confer tolerance to herbicide products containing glufosinae and glyphosate.

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Date of authorization: 26/09/2011
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Biosafety Clearing House (BCH)
Summary of the safety assessment (food safety):
The GM maize BT11xGA21 has been assessed in terms of the Genetically Modified Organisms Act, 1997 by the Advisory Committee, a scientific panel and the Executive Council an intergovernmental decision making body. The assessment considered amongst others the following: The source of the gene, nature of host organism, protein expression, toxicology and allergenicity issues.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Department of Agriculture Forestry and Fisheries
Contact person name:
Nompumelelo Mkhonza
Website:
Physical full address:
30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number:
+2712 319 6382
Fax number:
+2712 319 6298
Country introduction:
Useful links
Relevant documents
Stacked events:

South Africa does not have a specific review/authorization mechanism for stacked events. Stacked events just like single events are subjected to a safety assessment as per the GMO Act.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Department of Agriculture,Forestry and Fisheries (DAFF) http://www.daff.gov.za

Turkey
Name of product applicant: Special case: please show below
Summary of application:

Application for direct use as feed


Turkish Biosafety Law, entered in force in 2010, diverges from EU legislations in some points
 such as food and feed use require different separate applications, risk assessments and approvals.
  Addition, our Law forsees prision sentences in some circumtances of Law violation and joint
 reponsibilities for the violation. Therefore, GM product owners avoid to make application for approval
and non product developer have made application till now. Instead, some Turkish assosiations
 such as poultry producers assosiations, animal feed assosiations have applied to get approval
for import of GM products for their members. Thus, name of product applicants are not product
developers for our country.


Turkish Feed Manufacturer's Association
Turkish Poultry Meat Producers and Breeders Association
Turkish Egg Producers Association

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Date of authorization: 24/12/2011
Scope of authorization: Feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee and also by considering public opinion, Biosafety Board has approved the use of genetically modified maize Bt11xGA21 and products thereof for animal feed.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
DG of Agricultural Research and Policies (TAGEM)
Contact person name:
Ramazan BULBUL
Website:
Physical full address:
Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km Çankaya/ANKARA/TURKEY
Phone number:
+90 312 307 60 48
Fax number:
+90 312 307 61 90
Country introduction:

Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010.

 Main objectives of the Biosafety Law are;

  • to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
  • to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
  • to inspect, regulate and monitor the activities in the scope of the law.

 The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.

 Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope. 

 According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:

  • Releasing  GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
  • Production of genetically modified plants and animals.
  • Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements

 According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.

 However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.

 The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.

 Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.

 For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.

 Members of scientific committees are selected from the List of Experts.

 11 members are selected for each GMO application.

 List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).

 To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.

Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.

 Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.

There are not any applications for using GMO and products as food.

 After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.

Activities of analysis are performed in laboratories designated by the Ministry.

In the case of any non-compliance detected with relation to the GMO Legislation (such as  a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.

Application evaluation process is like below:

  • Evaluation of application by Ministry of Agriculture and Forestry      90 days
  • Feedback to the applicant                                                            15 days
  • Ministry of Agriculture and Forestry’s “Decision”                             270 days

(Starts from feedback to the applicant)

Establishing of Scientific Committees

Report preparation of Committees

Report’s public release

Evaluation of public opinions by Committees

Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into     

account

  • Publishing the Positive Decision                                                        30 days
  • Reclamation period to Negative Decision                                           60 days
  • Evaluation of reclamation by Ministry of Agriculture and Forestry        60 days
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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Ministry of Agriculture and Forestry

General Directorate of Agricultural Research and Policies

Focal Point of the FAO GM Foods Platform

Ramazan BULBUL

Email: [email protected]

Uruguay
Name of product applicant: Syngenta
Summary of application:

The hybrid maize line Bt11 x GA21 expresses three novel genes: the cry1Ab gene from Bacillus thuringiensis, which produces the delta-endotoxin Cry1Ab and confers resistance to lepidopterans, the pat gene which confers tolerance to the herbicide glufosinate ammonium, and a modified maize epsps gene which confers tolerance to glyphosate-containing herbicides.

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Date of authorization: 21/06/2011
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BCH
Summary of the safety assessment (food safety):
Please refer to uploaded document
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: GNBio
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Ganadería, Agricultura y Pesca
Contact person name:
Alejandra Ferenczi
Website:
Physical full address:
Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number:
+598 2 4104155 int 3
Fax number:
Country introduction:

The Uruguayan National Biosafety System (SNB for its acronym in Spanish) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio.  The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) is a committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. 

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Stacked events:

GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.