| Commodity: |
Corn / Maize |
| Traits: |
Glyphosate tolerance,Lepidoptera resistance,Coleoptera resistance,Glufosinate tolerance |
| Name of product applicant: |
Compañia Agricola S.A.S |
| Summary of application: |
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| Date of authorization: |
04/07/2018 |
| 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.): |
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| 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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| 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) |
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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:
| Name of product applicant: |
Monsanto Comercial, S. de R. L. de C.V. |
| Summary of application: |
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| Date of authorization: |
01/12/2016 |
| 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.): |
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| 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 Maize (Zea mays). OECD Identifier: MON-87427-7 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7, is, based on the existing knowledge to date, as innocuous as its counterpart conventional. |
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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 Useful links
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:
| Name of product applicant: |
Monsanto Philippines, Inc. |
| Summary of application: |
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| Date of authorization: |
12/05/2021 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Gene Interaction
The differences in the modes of action of the CP4 EPSPS, Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34/35Ab1 and PAT proteins, and the localizations of these proteins in the
plant cells indicates no likelihood of interaction with one another which could lead to
production of a new allergen or toxin. In addition to these, there is no known
mechanism of interaction among these proteins that could lead to adverse effects in
humans or animals (Monsanto, 2018). The gene products CP4 EPSPS, Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34/35Ab1 and PAT, have different modes of action and sites of biological activity hence accumulation will not be in the same compartment of the plant parts.
Metabolic Pathways
Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34/35Ab1 proteins are insect control proteins and acts through a toxic action in the midgut of target insects. CP4 EPSPS protein belongs to the EPSPS synthase family which is involved in the penultimate step of the biochemical shikimate pathway that leads to production of aromatic amino acids in the chloroplasts of plants. PAT protein acetylates phosphinotricin, inactivating the compound, and confers tolerance to chemically synthesized phosphinotricin compounds such as the herbicide glufosinate ammonium. The inclusion of the PAT gene enables plant selection of the Bt lines and provides tolerance to glufosinate ammonium herbicides. There is no known mechanism of interaction among CP4 EPSPS, Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34/35Ab1 and PAT proteins that could lead to adverse effects in humans or animals (Monsanto, 2018; Alibhai and Stallings, 2001; Betz et al., 2000; English and Slatin, 1992; Höfte and Whiteley, 1989; OECD, 2007; Rupar et al., 1991; U.S. EPA, 2005).
Gene Expression
Results of testing conducted on the product showed that the expression levels of the
individual protein products did not differ as that of the individually approved
transformation events. The proteins CP4 EPSPS, Cry1A.10, Cry2Ab2, Cry1F, PAT, Cry3Bb1, Cry34Ab1, and Cry35Ab1 in stacked MON 87427 × MON 89034 × TC1507 × MON 88017 × DAS-59122-7 are expressed properly (within the literature range) and similarly than those of the corresponding single events (Monsanto, 2018). There is no possible interaction that could affect the stability and expression level of either one of the genes.
Recommendation
STRP, BPI-PPSSD, and BAI found scientific evidence that the regulated article applied for direct use has no evidence of interaction on the resulting gene products. |
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| Authorization expiration date (a blank field means there is no expiration date) |
May 11, 2026 |
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. Useful links
Relevant documents
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
| Name of product applicant: |
Monsanto Korea Ltd. |
| Summary of application: |
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| Date of authorization: |
24/03/2017 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please see the link below(in Korean). |
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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:
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