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OECD Unique Identifier details

DAS-Ø15Ø7-1xMON-ØØ81Ø-6
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Pioneer
Summary of application:

DAS-Ø15Ø7-1 maize expresses the Cry1F protein which confers protection against certain lepidopteran pests and the PAT protein, which confers tolerance to glufosinate-ammonium based herbicides. DAS-59122-7 maize expresses Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests and the PAT protein, which confers tolerance to glufosinate-ammonium based herbicides. MON-ØØ81Ø-6 maize expresses the Cry1Ab protein, which confers protection against certain lepidopteran pests. MON-ØØ6Ø3-6 maize expresses the CP4 EPSPS protein, which confers tolerance to glyphosate-containing herbicides.

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Date of authorization: 03/08/2018
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: the quantitative event-specific PCR detection methods for maize 1507 × 59122 × MON 810 × NK603 are those validated for genetically modified maize events DAS-Ø15Ø7-1, DAS-59122-7, MON-ØØ81Ø-6 and MON-ØØ6Ø3-6. Reference material: ERM®-BF418 (for DAS-Ø15Ø7-1), ERM®-BF424 (for DAS-59122-7), ERM®-BF413 (for MON-ØØ81Ø-6) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission. The relevant links are provided below.
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) 05/08/2028
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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Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Argentina
Name of product applicant: Pioneer Argentina S.R.L.
Summary of application:

The corn plants TC1507 x MON810, have been obtained by conventional breeding to express the proteins Cry1F, Cry1Ab, (from Bacillus thuringiensis var. Aizawai and var kurstaki respectively) proteins that confer resistance to certain lepidopteran insects and PAT (phosphinothricin acetyltransferase), a protein that confers tolerance to glufosinate ammonium.

http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/17_y_18_-tc1507xmon810xnk603_espanol.pdf

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Date of authorization: 30/07/2018
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):
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins in grain are expressed in low levels. • It is substantially equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. • The feeding study carried out with broiler chickens showed that there are no adverse dietary effects. • The studies evaluated indicate absence of interaction effects between the proteins of the events when they are accumulated. It is concluded that the event TC1507 x MON810 x NK603 is equivalent to its conventional counterpart, therefore, it is as safe and not less nutritious than conventional commercial soybean. http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/17_y_18_-tc1507xmon810xnk603_espanol.pdf
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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 - Safety Assessment Summary
GMO approvals for food/feed
Food and feed safety asssessment of GMOs - Argentina
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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: Du Pont do Brasil
Summary of application:

Commercial release of maize TC1507 x MON81 

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Date of authorization: 11/08/2011
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.): CERA AGBio
Summary of the safety assessment (food safety):
The maize resistant to insects and tolerant to glufosinate ammonium herbicide TC1507 x MON 810 was produced through conventional breeding technique intersecting corn Herculex I TC1507 event with MON 810 maize. The TC 1507 event includes the cry1F genes conferring protection lepdópteros insects, and Pat conferring tolerance to the herbicide glufosinate ammonium. The Cry1F controls important lepidopteran pests of maize. The PAT protein makes the plant tolerant to herbicides formulated with glufosinate ammonium. MON 810 Maize produces Cry1Ab protein, which also controls lepidopteran insects, pests of maize. The MON 810 and TC 1507 event have already been approved for commercial release by CTNBio, technical advice No. 1,100 / 2007, on 04/09/2007, and No. 1679/2008, on 15/12/2008, respectively. The combination of two events aims to control pests in the same entomological order to add the spectrum of action of the two proteins from Bacillus thuringiensis, as well as serve as an additional tool for resistance management of pests into individual proteins. Field and laboratory tests showed no interaction between the Cry1F and Cry1Ab proteins, and its effect considered additive in pest control, meaning that the events are independent in their contribution for insect control. Changes in the composition or expression of the proteins compared to the individual events were also not detected. Thus, to prove that the stacked event TC1507 x MON810 has the same safety to human / animal health and the environment than conventional commercial strains, or even their genetically modified parental already approved by CTNBio in Brazil and in several other countries , the applicant shall submit test results conducted under restraint and the environment following scientific methodologies, in order to demonstrate the absence of interaction or synergistic effect between genes introduced into the stacked corn or between the expressed proteins, which may cause the emergence of a new feature in the modified plant. Each of parental genetically modified TC1507 and MON810 corn used to obtain the stacked been assessed previously alone or in combinations by CTNBio, having been considered safe for human and animal health and the environment. The levels of Cry1F protein, Cry1Ab and PAT were determined in samples of pollen, leaves, fodder, whole plant and grain grown in planned releases carried out in four regions in Brazil and statistically significant no differences were observed between the mean concentrations of Cry1F protein, Cry1Ab and PAT in samples of leaves, plants, fodder and grains derived from corn TC1507 and TC1507 x MON810. The natural breeding process did not alter the integrity and stability of the inserts in the stacked event; under field conditions of the inserted protein expression levels are similar to individual events. The proximate composition data showed no significant differences between genetically modified and conventional varieties, suggesting nutritional equivalence between them and the agronomic and phenotypic characteristics of the stacked event are kept in field evaluations, and can infer the absence of detectable interactions genes or the proteins expressed in the combined event as well as allowing the expression of any other different characteristics of resistance to lepidopteran insects and tolerance to the herbicide glufosinate ammonium. Given the above it is concluded that the cultivation and consumption of TC1507 x MON810 corn is not potentially cause significant degradation of the environment, or risk to human and animal health. For this reason, there are no restrictions on the use of this corn or its derivatives. CTNBio determines that the post-commercial release monitoring should be conducted on commercial crops rather than experimental. The areas chosen to be monitored should not be isolated from the others, have borders or any situation that is out of commercial standard. Monitoring should be carried out in a comparative model between the conventional system of cultivation and the cultivation of GMOs system, with data collection carried out by sampling. Monitoring should be conducted in representative biomes of the main areas of GMOs culture and, where possible, involve different types of producers. The monitoring should be conducted for a minimum of five years. In our reports should be detailed information on all activities carried out in the pre-planting and planting on their implementation with a report of activities conducted in the areas of monitoring during the crop cycle, on harvesting activities and weather conditions. There should be monitoring of any harm to human and animal health through official systems of reporting of adverse effects, such as the SINEPS (Adverse Event Reporting System related to Health Products) regulated by ANVISA. Analytical methods, results and their interpretations should be developed in accordance with principles of independence and transparency, except aspects of commercial secrecy previously justified and defined as such. With regard to the pat gene, which confer resistance to herbicides should be monitored: the nutritional status and health of GM plants; chemical and physical soil properties related to fertility and other basic soil characteristics; soil microbial diversity; the diaspore bank soil; the community of invasive plants; the development of herbicide resistance in weeds; the herbicide residues in soil, grain and shoot and gene flow of the two inserted genes. With regard to the cry1Ab and cry1F genes which confer insect resistance should be monitored: the impact on target insects and on non-target insects; the impact on soil invertebrates indicators outside the class Insecta; waste of insecticidal proteins in decaying organic matter, soil and waterways near monitoring area; the development of resistance among target insects and gene flow of the two inserted genes.
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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: National Biosafety Commission
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Authorization expiration date (a blank field means there is no expiration date) Not Applicable
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Maria Sueli Felipe Soares
Website:
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: Dupont Colombia S.A
Summary of application:

Authorization of the genetically modified maize RC1507 X MON810 resistant to lepidoptera and coleoptera pest attack and tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 13/06/2012
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)
E-mail:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
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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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Colombia
Name of product applicant: Dupont de Colombia S.A
Summary of application:

GMO authorization for TC1507 X MON 810 maize as food for direct use or processing.

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Date of authorization: 25/08/2020
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 Committee for GMO use exclusively in health and human consumption (CTNSalud) recommends its authorization.
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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):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
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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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Mexico
Name of product applicant: PHI México, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 85


Commercial release of maize TC1507 x MON81

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Date of authorization: 03/08/2010
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: DAS-Ø15Ø7-1xMON-ØØ81Ø-6 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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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):
CIBIOGEM
Contact person name:
Biól. Erica L. Hagman Aguilar
Website:
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

Paraguay
Name of product applicant: Agrotec SA
Summary of application:
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Date of authorization: 15/04/2015
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):
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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):
Ministerio de Agricultura y Ganadería
Contact person name:
Santiago Bertoni
Website:
Physical full address:
Yegros 437 entre 25 de mayo y Cerro Cora
Phone number:
+595 981 256262
Fax number:
Country introduction:

Paraguay is a land locked country that produces and exports agricultural products.The planting area of GMO is 4.5 million hectares, mainly soybeams, corn and cotton .The first regulatory framework entered into force 1997 with the creation of the agricultural biosafety commission. Risk assessments are made according to international guidelines.It is the fourth world exporter of soybeans and first world exporter of organic sugar.GM soybean production is around 10 million tons. Paraguay has a national biotechnology and biosafety policy approved in 2011

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Stacked events:

When a stacked event is approved, all possible combinations are approved.Previously evaluated single events are not reevaluated in stacks.

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

The competent authority is the Biosafety Comission under the Ministry of Agriculture and LivestockAdditional information on the site Wed conbio.mag.gov.py

Republic of Korea
Name of product applicant: DuPont (Korea) Inc.
Summary of application:

Glufosinate herbicide tolerance ,  Lepidopteran insect resistance

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Date of authorization: 28/07/2014
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).
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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):
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
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: