Food safety and quality
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OECD Unique Identifier details

MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7xMON-87427-7
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Lepidoptera resistance,Coleoptera resistance
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:

Monsanto has developed, using modern biotechnology techniques, the maize carriers of the simple events MON 87427 (in order to facilitate the production of hybrid seed), MON 89034 (protected against the attack of certain lepidopteran insects) and MON 88017 (with tolerance to herbicides). based on glyphosate and protected against the attack of certain coleoptera insects). On the other hand, Dow AgroSciences has developed using modern biotechnology techniques the maize carriers of the simple events TC1507 (with tolerance to herbicides based on glufosinate and protected against the attack of certain lepidopteran insects) and DAS-59122-7 (with tolerance to glufosinate-based herbicides and protected against the attack of certain coleopteran insects).
The accumulation of events MON 87427 × MON 89034 × TC1507 × MON 88017 × DAS-59122-7 is the result of the conventional crossing of the single events MON 87427, MON 89034, TC1507, MON 88017 and DAS-59122-7 and expresses the proteins CP4 EPSPS, Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34Ab1, Cry35Ab1 and PAT, respectively.
The event MON 87427 presents tissue-selective tolerance to glyphosate, which facilitates the production of hybrid corn seed. MON 87427 expresses the cp4 epsps gene under a combination of promoter and specific intron that allows the expression of CP4 EPSPS protein in all tissues of the plant and at the same time a very limited or no expression in the male reproductive tissues key to the pollen development. Therefore, in MON 87427 maize, the application of this herbicide in specific stages of the development of the crop, induces male sterility facilitating the production of hybrid seed.
The proteins Cry1A.105 and Cry2Ab2 expressed in the event MON 89034 provide protection against the attack of plague lepidoptera insects such as Spodoptera frugiperda, Helicoverpa zea and against Diatraea saccharalis. Also, the Cry1F protein expressed in the TC1507 event provides protection against lepidopteran insect species, such as Diatraea saccharalis, Helicoverpa zea, Spodoptera frugiperda and Agrotis ipsilon. On the other hand, the Cry3Bb1 protein expressed in the MON 88017 event provides protection against certain insect beetles, such as Diabrotica speciosa. Finally, the proteins Cry34Ab1 and Cry35Ab1 expressed in the event DAS-59122-7 form a binary toxin and act jointly, providing protection against the attack of larvae of certain plague beetles, such as Diabrotica speciosa.
The CP4 EPSPS protein expressed by the MON 88017 event provides tolerance to the glyphosate herbicide in all tissues of the plant and throughout the crop cycle.

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Date of authorization: 14/07/2017
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 are expressed in low levels. • It is compositionally 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. • There is no hypothesis of risk that indicates that there are effects of metabolic interactions and between the proteins of the events when they are accumulated. It is concluded that the stacked event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties.
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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: GMO commercial approvals in Argentina
GMO approvals for food/feed
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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.

Useful links
Relevant documents
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

Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

Glyphosate-induced male-sterile, Lepidoptera and Coleoptera pestresistant, and glufosinate and glyphosate herbicide-tolerant maize (cry1A.105, modified cry2Ab2, cry1F, pat, modified cp4 epsps, modified cry3Bb1, cry34Ab1, cry35Ab1, Zea mays subsp. Mays (L.) Iltis).

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Date of authorization: 05/09/2013
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.): OECD 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:
Kojiro Yokonuma
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: Monsanto Korea Ltd.
Summary of application:

Glufosinate herbicide tolerance , Glyphosate herbicide tolerance ,  Coleopteran insect resistance,  Lepidopteran insect resistance

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Date of authorization: 17/02/2015
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: