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OECD Unique Identifier details

MON-87427-7 x MON-89Ø34-3 x SYN-IR162-4 x MON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Bayer CropScience LP
Summary of application:

The genetically modified maize MON-87427-7 expresses the CP4 epsps gene, which confers tolerance to glyphosate-based herbicides.

The genetically modified maize MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.

The genetically modified maize SYN-IR162-4 expresses a modified vip3Aa20 gene, which provides protection against certain lepidopteran pests. In addition, the pmi gene coding for the PMI protein was used as a selection marker in the genetic modification process.

The genetically modified maize MON-ØØ6Ø3-6 expresses the CP4 epsps and the CP4 epsps L214P genes, which confer tolerance to glyphosate-based herbicides.

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Date of authorization: 22/01/2022
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:
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-87427-7, MON-89Ø34-3, SYN-IR162-4 and MON-ØØ6Ø3-6 and further verified on maize MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6. Reference Material: AOCS 0512 (for MON-87427-7), AOCS 0906 (for MON-89Ø34-3) and AOCS 1208 (for SYN-IR162-4) are accessible via the American Oil Chemists Society, and ERM®-BF415 (for MON-ØØ6Ø3-6) is accessible via the Joint Research Centre (JRC) of the European Commission.
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) 21/01/2031
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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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:

The stacked event MON87427 × MON89034 × MIR162 × NK603 was obtained by conventional breeding of the parental events MON87427, MON89034, MIR162 and NK603. Each of the parental events was obtained by transformation mediated by Agrobacterium tumesfaciens, except the event NK603 which was obtained by microparticle bombardment.
This maize has the following traits:
- Tolerance to glyphosate-based herbicides.
- Protection against the attack of certain lepidopteran insects

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Date of authorization: 28/06/2019
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):
After having carried out the complete food risk assessment on the information provided by the company Monsanto Argentina S.A.I.C. and taking into account that:  Molecular characterization studies demonstrate that the inserts of each individual event have remained stable in the plant genome after conventional breeding.  Novel proteins in grain are expressed at low levels.  It is substantially and nutritionally equivalent to its conventional counterpart.  No evidence of similarity or homology to known toxic proteins was found.  No evidence of expression of known allergenic substances is found for the proteins expressed in the stacked event.  Studies were evaluated that indicate that there are no interaction effects between the proteins of the events when they are accumulated. It is concluded that the maize stacked event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional corn. According to the above, and based on the scientific knowledge currently available and the internationally accepted requirements and criteria, there are no objections to the approval for human and animal consumption of the MON 87427 × MON 89034 × MIR162 × NK 603 event and all intermediate events resulting from the segregation of the evaluated events.
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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 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:

In Argentina, in the case of stacked events in which each individual event (or sub-combinations of events) has been evaluated for food and feed safety, the evaluation is conducted using a "differential process," which is faster and requires significantly less information. The evaluation focuses on determining whether there are any risk hypotheses related to potential interactions between the introduced genes, their expression products, and/or affected metabolic pathways. Additionally, only other risk hypotheses that may arise depending on the specific case under evaluation will be considered. If potential interactions are identified, an assessment will be conducted to determine whether they pose a risk to human or animal health. If no potential interaction hypotheses are identified, it may be concluded that the stacked event—including all possible intermediate combinations and any crosses with conventional varieties—is as safe and no less nutritious than its conventional counterparts and other commercial varieties. In summary, when individual events have already been assessed, the applicant is only required to submit a rationale supporting the absence of interactions and should provide additional information only if other plausible risk hypotheses emerge from the problem formulation.

A regulatory update is currently underway, so a specific form for stacked events will soon be available to be conducted through “differential process” for food and feed assessment.

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

Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified maize MON87427 x MON89034 x MIR162 x NK603 resistant to lepidoptera  pest attack and tolerant to herbicides glyphosate 

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Date of authorization: 06/02/2017
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:
Mexico
Name of product applicant: Monsanto Comercial, S. de R. L. de C.V.
Summary of application:

Authorization by COFEPRIS: 155


Maize (Zea mays) genetically modified MON 87427 × MON 89034 × MIR162 × NK603 with non-viable pollen production phenotype induced by glyphosate spraying and Lepidoptera resistant and glyphosate tolerant.

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Date of authorization: 12/05/2016
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):
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the Genetically Modified Corn (Zea mays). OCDE identifier: MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6, is, based on the existing knowledge to date, as innocuous as its conventional counterpart.
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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:
Mtra. Andrea Genoveva Solano Rendón
Website:
Physical full address:
Phone number:
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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Relevant documents
Stacked events:

No regulation on stacked events.

 

In Mexico, any GMO intended for human use or consumption, for processing into food for human consumption, public health, or bioremediation, must have an Authorization for commercialization and importation issued by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) of the Ministry of Health (SS). To obtain this, the interested party must submit a request to COFEPRIS for the corresponding authorization through the COFEPRIS procedure 09-013, which must include, in writing, the information and requirements referred to in Articles 23 to 32 of the Regulations of the Biosafety Law of GMOs."

https://www.gob.mx/cofepris/acciones-y-programas/organismos-geneticamente-modificados

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

Secretaría de Salud / Teléfono: +52 55 5080 5200 / Correo electrónico: [email protected]%20

Paraguay
Name of product applicant: MONSANTO PARAGUAY S. A.
Summary of application:

The stacked maize line was obtained through the traditional cross breeding of the parental organisms MON-87427-7, MON-89Ø34-3, MIR162 and MON-ØØ6Ø3-6. The line inherited genes that express cry1A.105, cry2Ab2, vip3Aa19 and cp4epsps. The expression of these genes confer glyphosate herbicide tolerance and resistance to Lepidoptera and Coleoptera.

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Date of authorization: 08/11/2019
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.): MON-87427-7 x MON-89Ø34-3 x SYN-IR162-4 x MON-ØØ6Ø3-6
Summary of the safety assessment (food safety):
Differentiated approval procedure: Through MAG’s Resolutions 1030 and 1071 there was stated a differentiated treatment for the commercial release of novel GE crops and for GE crops that have been approved in third countries, whose scientific, technical and safety characteristics are well-founded. Paraguayan Ministry of Agriculture’s Resolutions authorize taking into consideration the decision documents from third countries with regard to both human and animal food safety in the cases where these evaluations have been based on Codex Alimentarius, such as the Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants and carried out in countries with time-tested regulatory systems and transparent procedures. Concerning environmental safety, assessments are accepted for GE crops that besides having been authorized for commercial planting in countries with sound regulatory systems, include in the decision documents considerations as follows: that the GE crop under review has been studied under different environmental conditions, behaving in the same way as the conventional non-GE counterpart; that it will be managed in an agronomic manner similar to any GE or conventional hybrid/variety of the species; another aspect is that Paraguay is not center of origin of that crop, and finally two relevant characteristics are that there are no related weeds in Paraguay with which the GE crop could cross-breed and that the main target pests and the main non-target arthropod species present in Paraguay have been taken into account in the GE risk assessment carried out in those countries. The Commercial Release Opinion of the National Commission for Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: 1) The commercial release of the event MON-87427-7 x MON-89Ø34-3 x SYN-IR162-4 x MON-ØØ6Ø3-6 2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO".
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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: Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
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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:

The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE.

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Relevant documents
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:

In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/

Philippines
Name of product applicant: Monsanto Philippines Inc.
Summary of application:

On February 22, 2018 Monsanto Philippines Inc.'s filed for application of corn MON87427 x MON89034 x MIR162 x NK603 for direct use as food and feed, or for processing, as original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. After reviewing the Risk Assessment Report and attachments submitted by the applicant, the assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry- Biotech Team (BAI-BT), concurred that corn MON87427 x MON89034 x MIR162 x NK603 is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 29/10/2019
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):
Gene Interaction The protein products (CP4 EPSPS, Cry1A.105, Cry2Ab2, Vip3Aa20, and PMI) have different modes of action and belong to different metabolic reactions. In addition, there is no known mechanism of interaction of the protein products. Therefore they are not expected to interact in the stacked hybrid; hence, no new allergen and toxin could be produced. CP4 EPSPS and Cry2Ab2 are expected to accumulate in the chloroplast while Cry1A.105, Vip3Aa20 and PMI are expected to accumulate in the cytoplasm. Metabolic Pathways The assesors have determined that the mode of action is different for each gene product. They have individual roles, different specificities and do not share same targets or substrates. Genetic and molecular analyses showed that all genes are inherited, expressed and functioning properly in MON 87427 x MON 89034 x MIR 162 x NK 603, as they did similarly in single events. Gene Expression Enzyme-Linked Immunosorbent Assays (ELISA) was used to quantify and determine the level of proteins. The result showed that CP4 EPSPS, Cry1A.105, Cry2Ab2, Vip3Aa20 and PMI proteins are expressed properly in the combined product MON 87427 x MON 89034 x MIR162 x NK603 as in its relevant single events. The expression of the proteins in maize plant tissue from stacked MON 87427 x MON 89034 x MIR162 x NK603, MON 87427, MON 89034, MIR162 and NK603 is similar to the corresponding levels in single events based on ELISA. Results showed that the proteins are expressed properly to the combined trait product as in its relevant single events. Compositional analyses provided by the developer indicated that the stacked MON 87427 x MON89034 x MIR162 x NK603 is substantially equivalent to the control substance MPA640B which has similar background genetics. Conclusion After a thorough and scientific review and evaluation of the documents provided by Monsanto Philippines, Inc. relevant to combined trait corn MON87427 x MON89034 X MIR162 X NK603 the BPI-PPSSD, BAI 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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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 28, 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:
8524-9588 loc 230
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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Stacked events:

As stipulated in Section 20, Article VIII. of the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 01, series of 2021, 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, plants produced through conventional breeding of genetically modified parental lines with approved individual events are not considered novel. The permit holder or an authorized licensee of registered events may request the listing of their stacked events in either the BPI Approval Registry for Commercial Propagation or the BPI Approval Registry for Direct Use, as applicable.

Listing in the BPI Approval Registry for Propagation

If each parental event has a Biosafety Permit for Commercial Propagation, the stacked events may be listed in the BPI Approval Registry for Commercial Propagation. The permit holder or an authorized licensee of registered events may also request the BPI to list any sub-stacks or intermediate stacks.

Listing in the BPI Approval Registry for Direct Use

If each parental event has a Biosafety Permit for Direct Use, the stacked events may be listed in the BPI Approval Registry for Direct Use. The permit holder or an authorized licensee of registered events may also request the BPI to list any sub-stacks or intermediate stacks.

Registration under the Fertilizer and Pesticide Authority

For the commercial propagation of plants with stacked events involving multiple plant-incorporated protectants (PIPs), each individual PIP must first be registered under the Fertilizer and Pesticide Authority (FPA). Additionally, the stacked PIP × PIP must be registered as a new product under the FPA in accordance with its guidelines on the registration of biorational products.

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: Monsanto Korea Ltd.
Summary of application:

Glyphosate herbicide tolerance , Lepidopteran insect resistance

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Date of authorization: 27/04/2016
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:
Thailand
Name of product applicant: Bayer Thai Co., Ltd.
Summary of application:

The stacked event MON87427 × MON89034 × MIR162 × NK603 maize obtained from conventional breeding of genetically modified maize event MON87427, MON89034, MIR162, and NK603 to expresses CP4 EPSPS protein which confers tolerance to glyphosate herbicide, two Bt-toxins (Cry1A.105 and Cry2Ab2 proteins) and Vip3Aa20 protein which provide protection to certain lepidopteran pests.

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Date of authorization: 04/12/2022
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):
The food safety assessment performed by the National Center for Genetic Engineering and Biotechnology (BIOTEC) as advisory and technical arm of Thai FDA. BIOTEC conduct food safety assessment according to codex guideline and based on the safety data and information provided by the applicant (as specified in Annex 2 attached to Notification of the Ministry of Public Health No.431). According to the existing scientific data and information available during the safety assessment, it is concluded that the stacked event MON87427 × MON89034 × MIR162 × NK603 maize is expected to be as safe as the single events that have been previously assessed by food biosafety subcommittee and technical biosafety committee of the National Center for Genetic Engineering and Biotechnology (BIOTEC).
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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):
National Burequ of Agricultural Commodity and Food
Contact person name:
Director of Office of Standard Development
Website:
Physical full address:
50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900
Phone number:
+6625612277 ext.1401
Fax number:
+6625613373
Country introduction:

National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.

The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority. 

Useful links
Relevant documents
Stacked events:

The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account.

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

Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)

Uruguay
Name of product applicant: BAYER S.A
Summary of application:

The stacked maize line was obtained through the traditional cross breeding of the parental organisms MON-87427-7, MON-89Ø34-3, MIR162 and MON-ØØ6Ø3-6. The line inherited genes that express cry1A.105, cry2Ab2, vip3Aa19 and cp4epsps. The expression of these genes confer glyphosate herbicide tolerance and resistance to Lepidoptera and Coleoptera.

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Date of authorization: 05/11/2021
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.): BCH
Summary of the safety assessment (food safety):
Please refer to the upload document.
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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: SNB
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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 Ganadería, Agricultura y Pesca
Contact person name:
Alejandra Ferenczi
Website:
Physical full address:
Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number:
+598 2 4104155 int 3
Fax number:
Country introduction:

The Uruguayan National Biosafety System (SNB for its acronym in Spanish) on GM vegetables applies the Risk Analysis methodology in a case by case basis inluding enviromental and food and feed risk assessment, risk management and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority to define policies on GM vegetables and is responsible to make decisions regarding each aplication. GNBio is integrated by the Ministers of: Agriculture, MGAP (chair); Health (MSP); Economy (MEF); Environment (MVOTMA); Foreign Affairs (MRREE); and Industry (MIEM).

The Risk Management Commission (CGR) is integrated by one delegate of each of the ministries represented within GNBio.  The CGR advises GNBio on biosafety of GM vegetables issues.

The Risk Assessment in Biosafety (ERB) is integrated by experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. ERB is responsible for assuring a case-by-case risk assessment based on science and technical criteria. ERB coordinates the analysis of the risk assesment with The Institutional Articulation Committee (CAI) which is integrated by delegates of nine different national research institutions, From where experts are sourced to form a network of evaluators, which currently consists of between 37 and 40 experts organized in different ad hoc groups. The Ad hoc groups are specialized in different areas of knowledge related to the analysis of the risk assement like molecular characterization and identification, environmental and food safety aspects as well as statistical analysis.  

Useful links
Relevant documents
Stacked events:

In the case of stacked events whose individual events have not been previously analyzed, a full risk assessment is conducted. For stacked events which individual events have already been analyzed, only an assessment of potential interactions between the proteins expressed in the individual events is performed.

In the case of cross-pollinated species, such as maize, if a favorable conclusion is reached, all individual events and possible combinations are authorized. In the case of self-pollinated species, such as soybean, the applicant must indicate whether they wish to be authorized all individual events and their combinations or only the stacked event presented.

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

Nathional Biosafety System (SNB for its acronym in Spanish) office. E-mail: [email protected]; Adress: Constituyente 1476, 2nd floor, 203 and 270 offices, Montevideo 11200, Uruguay.