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OECD Unique Identifier details

DAS-Ø15Ø7-1 x DAS-59122-7 x MON-ØØ81Ø-6 x SYN-IR6Ø4-5 x MON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Lepidoptera resistance,Coleoptera resistance,Glufosinate tolerance
Colombia
Name of product applicant: Dupont Colombia S.A
Summary of application:

Authorization of the genetically modified maize TC1507 x 59122 x MON810 x MIR604 x NK603 resistant to lepidoptera and coleoptera pest attack and tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 28/11/2016
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):
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:
Japan
Name of product applicant: DuPont K.K.
Summary of application:

TC1507 x DAS-59122-7 x NK603 x MON810 x MIR604 has been genetically modified for resistant to Lepidoptera and Coleoptera and tolerant to glufosinate and glyphosate herbicides (modified cry1F, pat, cry34Ab1, cry35Ab1, cry1Ab, modified cp4 epsps, modified cry3Aa2, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 25/04/2012
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.): 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:
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.
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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)

Philippines
Name of product applicant: Pioneer Hi-Bred Philippines
Summary of application:

Five maize lines containing events 1507, DAS59122, MON810, MIR604 and NK603 were crossed by conventional breeding methods to produce the combined trait product 1507xDAS59122xMON810xMIR604xNK603 maize.


1507 maize expresses the Cry1F protein, encoded by the cry1F gene, which renders protection against corn borers. 1507 maize also expresses the PAT protein, encoded by the pat gene, conferring resistance to the herbicidal active ingredient glufosinate-ammonium. DAS59122 maize expresses the Cry34Ab1 and Cry35Ab1 proteins, encoded by the cry34Ab1 and cry35Ab1 genes, respectively, which confers protection against corn rootworm. DAS59122 maize also expresses the PAT protein, encoded by the pat gene, conferring resistance to the herbicidal active ingredient glufosinate-ammonium. MON810 maize expresses the Cry1Ab protein, encoded by the cry1Ab gene, providing protection against corn borers. MIR604 maize provides protection against corn rootworm through the expression of mCry3A protein encoded by the modified cry3A gene. The phosphomannose isomerase enzyme PMI, encoded by the pmi gene, was used as a selectable marker for MIR604 transformation. NK603 maize expresses the CP4 EPSPS enzyme, encoded by the cp4 epsps gene, rendering this maize line tolerant to glyphosate herbicide. 

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Date of authorization: 30/10/2019
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):
Information on the Applied Events Stacked corn TC1507 x DAS59122-7 x MON 810 x MIR604 x NK603 is a product developed through conventional crossing of TC1507, DAS59122-7, MON 810, MIR604 and NK603 corn. It possesses resistance to insects of order Coleoptera and Lepidoptera, and tolerance to glufosinate ammonium and glyphosate herbicides. Corn TC1507 contains the Cry1F gene which produces the Cry1F protein that when ingested by the insect, causes gut paralysis and eventual death. Event TC1507 also produces the PAT protein which provides tolerance to glufosinate herbicide. Corn MIR604 contains the mCry3A gene which encodes the mCry3A protein that provides protection against rootworm and the pmi gene which allows the positive selection for the recovery of the transformed plants. Corn DAS59122-7 contains cry34Ab1 gene which produces the Cry34Ab1 deltaendotoxin and Cry35Ab1 gene which produces Cry35Ab1 delta-endotoxin both of which provide resistance to coleopteran insects particularly corn rootworm by selectively damaging their midgut lining. The pat gene eliminates the herbicidal activity of glufosinate by acetylation. Corn MON810 contains cry1ab gene which produces Cry1Ab delta-endotoxin which confers resistance to lepidopteran insects by selectively damaging their midgut lining. Corn NK603 contains cp4 epsps gene which produces a herbicide tolerant form of 5- enolpyruvulshikimate-3-phosphate synthase (EPSPS) enzyme. The single events of stacked corn TC1507 x DAS59122-7 x MON 810 x MIR604 x NK603 have also been given individual approvals for FFP under the JDC No.1 s2016. The assessment for the safety of the novel proteins focused on the gene interaction, effect on metabolic pathways, and differential gene expression due to stacking. Gene Interaction The inserted eight proteins (Cry1F, Pat, Cry34Ab1, Cry35Ab1, Cry1Ab, Mcry3A, PMI And Cp4 EPSPS) will not interact to produce any new allergen or toxins. This is due to the different mode of action of each protein which is not likely to interact and will accumulate in the cytoplasm (e.g. Cry1F, PAT, Cry34Ab1, Cry35Ab1, Cry1Ab, mCry3A, and PMI) and chloroplast (e.g. CP4 EPSPS) of the regulated stacked event. Despite the co-localization of the major Cry proteins, th would not act on the same metabolic pathways and do not share any intermediate metabolites in the biochemical pathways that the proteins act on or interfere with. Metabolic Pathways Based on the descriptions provided Cry1F, Cry34Ab1, Cry35Ab1, Cry1Ab, mCry3A proteins have similar end-results or desired traits, however their modes of action have similarities to some extent and they differ only on the receptors sites in the insect gut, where they take action. Specificity at the molecular level is very much distinct among the three Cry proteins. With respect to the molecular mechanisms, these novel proteins do not act on the same metabolic pathways and do not share any intermediate metabolites in the biochemical pathways that the proteins act on or interfere with. Hence, there is no expected adverse effect on the target trait that the transgenes confer, more so, no new allergen nor toxin will be produced. Gene Expression Expression levels of the novel proteins were not biologically different between the stacked transgenic plant under evaluation and its parental genotypes. The measurements done by the proponents using ELISA and subsequent statistical analysis. There is a low expression of the novel proteins in the regulated stacked event under evaluation and its parental genotypes. The stability of the genome/partial genome of the parentals in the stacked transgenic corn was demonstrated by the applicant. Conclusion After a thorough and scientific review and evaluation of the documents provided by Pioneer HiBred INC. relevant to Corn TC1507 x 59122 x MON 810 x MIR604 x NK603, The BAI, BPI-PPSSD and STRP find scientific evidence that the regulated article applied for direct use has no evidence of interaction on the resulting gene products.
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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) October 29, 2024
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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Relevant documents
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: DuPont (Korea) Inc.
Summary of application:

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

Upload:
Date of authorization: 05/06/2012
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):
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: