| Commodity: |
Soyabean / Soybeans |
| Traits: |
Herbicide tolerance,High oleic acid,Low level of fatty acids |
| 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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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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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 Japan Ltd. |
| Summary of application: |
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| Date of authorization: |
10/12/2016 |
| 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): |
Please see the 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: |
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| 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)
Food safety assessment performed by Food Safety Commission of Japan (in English)
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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): 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:
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: |
24/01/2017 |
| 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): |
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the Genetically Modified Soybean (Glycine max). OCDE identifier: MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 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: |
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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): CIBIOGEM
Contact person name: Dra. Consuelo López López
Website:
Physical full address: San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number: +52 (55) 53227700
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:
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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| Upload: |
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| Date of authorization: |
09/07/2018 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
STRP ASSESSMENT AND RECOMMENDATION
Gene Interaction
MON87705 has the cp4epsps gene for glyphosate tolerance and the inverted repeat of
FAD2-1A and FATB1-A which produces ds RNA that suppresses endogenous FATB and FAD
2 RNA levels leading to improve fatty acid profile. MON87708 contains DMO gene that
expresses mono-oxygenase that rapidly demethylates dicamba which renders it inactive
thereby conferring tolerance to dicamba. Lastly, MON89788 contains cp4epsps which
produces CP4EPSPS protein confers tolerance to glyphosate.
The STRP agreed that there is no interaction in the resulting products of the two proteins
dmo and cp4epsps because the mode of action is totally different from each other. The
STRP also stated that DMO and CP4EPSPS would accumulate in the plastids. These proteins
are targeted specifically to the organelle because dmo and cp4epsps genes encodes
chloroplast transit peptides that would direct the proteins to the chloroplast.
Metabolic Pathways
As presented in the request for review of MON87705 x MON87708 x MON89788, page 4
(paragraphs 3 to 6), STRP agreed that the technology developer provides the complete
description of the mode of action of each gene product. Also, as stated earlier, the mode of
action of each gene product is different. The products are not involved in the same
metabolic pathway. Each single event will not alter the metabolism of soybean. RNA based
suppression of FATB and FAD 2 to improve fatty acid composition is totally independent on
the expression of DMO and CP4EPSPS proteins. Since the DMO and CP4EPSPS proteins are
expressed in MON87705 x MON87708 x MON89788, this would indicate that the genes can
also function properly in the stacked trait product.
Gene Expression
The expression levels of the individual protein products are the same as the individual
approved transformation events as presented in table 2 page 9 of the paper request for
review of MON87705 x MON87708 x 89788. It is also shown in the table that the protein
level expression is within the range. In addition, the marker genes are not transferred and
expressed in the stacked plants. The STRP affirmed that the interaction is unlikely to
happen. Stability and expression of the genes will never be affected.
BPI-PPSSD ASSESSMENT AND RECOMMENDATION
Gene Interaction
Based on the documents provided by the developer, the two (2) proteins being expressed
in the combined trait product, DMO and CP4 EPSPS, will not interact to produce any known
allergen or toxins to human and animals. There is no known mechanism of interaction
among the RNA-based suppression and the proteins that could lead to adverse effects in
humans, animals or environment which is not likely to interact.
It is also highly unlikely that the RNA-based FAD2-1A/FATB1-A suppression cassette
present in MON87705 x MON87708 x MON89788 produces a protein. The gene transcript
with an inverted repeat produces double stranded RNA (dsRNA) that, via the RNA
interference (RNAi) pathway, suppresses endogenous FATB and FAD2 RNA levels that
leads to improved fatty acid composition.
In terms of accumulation, the DMO and CP4 EPSPS proteins would accumulate in plastids
because they are targeted specifically to these organelles. The dmo and cp4 epsps genes
contained in MON 87705 × MON 87708 × MON 89788 are designed to encode chloroplast
transit peptides so that the DMO and CP4 EPSPS proteins are directed to the chloroplast.
Metabolic Pathways
The mode of action and metabolic pathways of each protein are significantly different from
each other. DMO belongs to a family of Rieske oxygenase proteins, which is part of a threecomponent system that includes a ferredoxin, a reductase, and an oxygenase. It catalyzes
the NADH-dependent oxidative demethylation of the herbicide dicamba.
The CP4 EPSPS protein belongs to the family of EPSP synthases involved in the penultimate
step of the biochemical shikimate pathway producing aromatic amino acids in the
chloroplasts of plants.
Gene Expression
Enzyme-Linked Immunosorbent Assays (ELISA) was used to quantify and determine the
level of proteins. DMO and CP4 EPSPS proteins were expressed properly in the combined
trait product MON 87705 x MON 87708 x MON 89788 and was comparable to each single
event. The mean DMO protein levels in MON 87705 × MON 87708 × MON 89788 and MON
87708 were 13µg/g dwt and 19µg/g dwt in seed, respectively. The mean CP4 EPSPS
protein levels in MON 87705 × MON 87708 × MON 89788, MON 87705, and MON 89788
are 140µg/g dwt, 130µg/g dwt and 63µg/g dwt in seed, respectively. Molecular analyses
also indicated the absence of any marker gene in MON87705 x MON87708 x MON89788
genome.
BAI ASSESSMENT AND RECOMMENDATION
Gene Interaction
The structural differences of DMO and CP4EPSPS proteins as well as the distinct modes of
action among these proteins are unlikely to produce a significant interaction. BAI affirmed
that this lack of interaction will not lead to production of a new allergen or toxin in the
combined trait product. BAI agreed to the information provided by the developer the gene
products will accumulate the same subcellular compartments. The dmo and cp4epsps are
designed to encode chloroplast transit peptides so that DMO and CP4EPSPS proteins are
directed to chloroplast.
Metabolic pathways
BAI agreed that the mode of action has been completely described in the previous safety
assessment of each individual single event. CP4EPSPS protein confers tolerance to
glyphosate and is involved in an enzymatic pathway producing aromatic amino acids in the
chloroplasts of plants. On the other hand, DMO protein catalyzes the NADH-dependent
oxidative demethylation of the herbicide dicamba rendering inactive, thereby conferring its
tolerance.
The two proteins are structurally and functionally different and not involved in the same
metabolic pathway. The inserted genes, which are not designed to alter the plant
metabolism are inherited and functioning properly when combined into the breeding stack.
It indicates that any mechanisms of interaction between these products are highly unlikely
and that each gene product functions independently as in single event.
Gene Expression
In terms of gene expression, results obtained from ELISA performed on seed tissues of
MON 87705 x MON 87708 x MON 89788, MON 87705, MON 87708 and MON 89788
collected from five field sites during Argentina field trials show that the proteins were
expressed properly in the combined trait product as in its relevant single events. The
proteins were expressed at low level also as demonstrated by ELISA. Also, it did not show
any indication that the marker genes were transferred and expressed in plants containing
the combined genes. Due to the different mode of action, any form of interaction is unlikely.
This means that the stability and expression levels of all the genes will not be significantly
affected. |
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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) |
July 10, 2023 |
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.
Useful links
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
| Name of product applicant: |
Monsanto Korea Ltd. |
| Summary of application: |
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| Date of authorization: |
22/12/2016 |
| 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): |
Please see the link below(in Korean). |
| Upload: |
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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: |
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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): 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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