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OECD Unique Identifier details

DAS-4Ø278-9xMON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance,2 4-dichlorophenoxyacetic acid (2 4-D) tolerance,Aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitor tolerance
Brazil
Name of product applicant: Dow Agroscience
Summary of application:

Commercial release of maize DAS-40278-9 x NK603. The maize DAS-40278-9 x NK603 expresses the CP4 EPSPS protein, which confers tolerance to the herbicide glyphosate, and the AAD-1 protein, which confers tolerance to herbicides 2,4-D (2,4-Dichlorophenoxyacetic acid), aryloxyphenoxypropionate ( AOPP) and certain herbicides inhibitors of the enzyme acetyl coenzyme A carboxylase (ACCase), termed "fop" herbicides. DAS-40278-9 x NK603 corn was obtained by means of crosses between DAS-40278-9 and NK603, both already approved by CTNBio for commercial planting in Brazil. It is, therefore, a pyramidal event obtained by classic crossing between two GM events already analyzed regarding biosafety by CTNBio and approved.


Field studies, conducted with authorization from CTNBio, demonstrated the effectiveness and agronomic feasibility of the use of DAS-40278-9 x NK603 maize under cultivation conditions in Brazil.
This product does not differ from conventional corn in its chemical and nutritional composition, except for the presence and expression of the cp4 epsps and aad-1 genes, which confer tolerance to the herbicides glyphosate and herbicides of the aryloxyalkanoate family, respectively.

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Date of authorization: 08/10/2015
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.): ISAAA
Summary of the safety assessment (food safety):
1) The inserts had their integrity maintained during the process of classic genetic improvement; 2) The pattern of genetic inheritance has demonstrated that the two events are independent and stably segregate over successive generations; 3) Agronomic evaluations indicated that there was no expression of any new characteristics beyond those expected; 4) The expression profile of the recombinant proteins is not different from the expression obtained in the corns containing the events separately; 5) All tests involving animal and food safety of DAS-40278-9 x NK603 maize demonstrate that there is no toxicological or allergenic evidence; 6) Maize is the species that has reached the highest degree of domestication among cultivated plants, being unable to survive in nature without human intervention; 7) There are no native wild species in Brazil with which maize can interbreed; 8) The studies carried out in Brazil and the United States have shown that DAS-40278-9 X NK603 maize does not differ from conventional maize in agronomic, morphological and reproductive characteristics, survival characteristics and plant dissemination, in response to major Pathogens and pests, as well as chemical and nutritional composition, except for herbicide tolerance characteristics based on 2,4-D, herbicides from the group of aryloxyphenoxypropionates (haloxyfop-R, quizalofope, etc.) and glyphosate, Conferred by the presence and expression of the aad-1 and cp4 epsps gene; 9) The GMO does not present a risk of invasiveness or weed; 10) The biosafety of this event has already been evaluated by the regulatory systems of 05 countries, being approved in all for the intended use: animal feed and / or human nutrition and / or planting; 11) The availability of DAS-40278-9 x NK603 maize will provide corn producers in Brazil with an alternative to increase weed management in the crop, since the integrated management, with rotation of herbicides, is the best way to Reduce the resistance of weeds to herbicides; 12) It is perfectly possible the coexistence in the field between crops of GM maize DAS-40278-9 x NK603 and crops of conventional or Creole maize; 13) The information currently available in the scientific literature;
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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:
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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 DAS-59122-7 x MON-ØØ6Ø3-6 resistant to coleoptera pest attack and tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 04/07/2019
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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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:
Colombia
Name of product applicant: Dow Agrosciences Colombia S.A
Summary of application:

Authorization of the genetically modified maize DAS40278 X NK603 restolerant to herbicides glyphosate and 2,4 D.

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Date of authorization: 19/08/2014
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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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.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Colombia
Name of product applicant: Dow Agroscience de Colombia S.A
Summary of application:

GMO authorization for DAS40278 X NK603 maize as food for direct use or processing.

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Date of authorization: 21/07/2020
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:
Upload:
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.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Japan
Name of product applicant: Dow Chemical JapanLtd.
Summary of application:

Maize tolerant to aryloxyalkanoate and glyphosate herbicides (modified cp4 epsps, modified aad-1, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 26/02/2013
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.): BioTrack Product 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)

Republic of Korea
Name of product applicant: Dow AgroSciences Int'l. Ltd.
Summary of application:

Glyphosate herbicide tolerance , 2,4-D herbicide tolerance

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Date of authorization: 21/06/2018
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):
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: