Food safety and quality
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OECD Unique Identifier details

DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 x SYN-IR162-4
Commodity: Corn / Maize
Traits: Herbicide tolerance,Insect resistance,Lepidoptera resistance,Glufosinate tolerance
Brazil
Name of product applicant: Du Pont do Brasil
Summary of application:

Commercial release of genetically modified corn DAS-Ø15Ø7-1 (TC1507) x MON-ØØ810-6 (MON810) x SYN-IR162-4 (MIR162), also called VYH, containing genes that confer insect resistance and tolerance to the herbicide glufosinate

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Date of authorization: 09/04/2015
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):
Whereas the maize variety (Zea mays) event TC1507 x MON810 x MIR162 belongs to the species well characterized and with a solid safety record for human consumption; Whereas the Cry1F, Cry1Ab, Vip3Aa and PAT proteins which confer insect resistance and tolerance to the herbicides glufosinate ammonium and glyphosate are expressed in several events of different agricultural crops already submitted to risk assessment and approved for commercial use in several countries ; Considering that the parents, event TC1507, event MON810 and event MIR162, have already undergone the analysis of the risk assessment by CTNBio and obtained a favorable opinion for their commercial release; Considering that the genetically modified corn containing four combined events, TC1507 x MON810 x MIR162 x NK603, including the three events of the present application, has already been analyzed by CTNBio Human / Animal and Plant / Environmental Sectors and obtained a favorable decision; Considering that the applicant has submitted a request for compliance with the provisions of Article 4-A of Normative Resolution 5/2008 and that the said article states that "The favorable decision to commercially release a Genetically Modified Organism - GMO containing more than one event, combined Through classical breeding, whose individual events have been previously approved for commercial release by CTNBio, will apply to the possible combinations of individual events as requested by the applicant "; For the planting of genetically modified corn, it is also necessary to observe the Normative Resolution CTNBio No. 4/2007, which deals with the minimum distances between commercial crops of genetically modified and non-genetically modified maize.
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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: http://ctnbio.mcti.gov.br/liberacao-comercial/-/document_library_display/SqhWdohU4BvU/view/614405?_110_INSTANCE_SqhWdohU4BvU_redirect=http%3A%2F%2Fctnbio.mcti.gov.br%2Fliberacao-comercial%3Fp_p_id%3D110_INSTANCE_SqhWdohU4BvU%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3Dcolumn-2%26p_p_col_count%3D3#/liberacao-comercial/consultar-processo
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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 TC1507 x MON 810 X MIR162 resistant to lepidoptera  pest attack and tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 27/01/2016
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):
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):
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:
Japan
Name of product applicant: DuPont K.K.
Summary of application:

A stacked maize line DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 x SYN-IR162-4 obtained through conventional breeding of each of the parental organisms. The modifications in these lines confer tolerance to the glufosinate herbicide and resistance to Lepidoptera and European Corn Borer pests.

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Date of authorization: 28/01/2013
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.): BCH Database
Summary of the safety assessment (food safety):
Please see the link below (in Japanese).
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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 (in Japanese)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
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.
Useful links
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: PHI México, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 140


A stacked maize line DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 x SYN-IR162-4 obtained through conventional breeding of each of the parental organisms. The modifications in these lines confer tolerance to the glufosinate herbicide and resistance to Lepidoptera and European Corn Borer pests.

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Date of authorization: 24/02/2015
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-Ø15Ø7-1 x MON-ØØ81Ø-6 x SYN-IR162-4 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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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):
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

Useful links
Relevant documents
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

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

Glufosinate herbicide tolerance ,  Glyphosate herbicide tolerance ,  Lepidopteran insect resistance

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Date of authorization: 28/01/2015
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):
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:
Upload:
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: