Food safety and quality
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OECD Unique Identifier details

MON-877Ø8-9 x MON-89788-1 x ACS-GMØØ6-4
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance,Dicamba tolerance,Glufosinate tolerance
Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified soy MON87708 x MON89788 x A5547-127 tolerant to herbicides Dicamba, glufosinate and gliphosate

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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.):
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:
drubio@minsalud.gov.co
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: 164


Soybean (Glycine max) genetically modified (MON 87708 × MON 89788 × A5547-127) Tolerant to the herbicides dicamba, glyphosate and glufosinate ammonium.

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Date of authorization: 14/06/2017
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the MON 87708 × MON 89788 × A5547-127 Genetically Modified Soya (Glycine max). OECD Identifier: MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4 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:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
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:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

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

On August 30, 2017, Monsanto Philippines Inc. applied the stacked trait product soybean MON87708 X MON89788 X A5547-127  for direct use as food and feed, or for processing as an original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1 Series of 2016 (JDC No.1, S2016).


After reviewing the Risk Assessment Report and attachments submitted by the applicant; the Scientific and Technical Review Panel (STRP) member, the Bureau of Animal Industry (BAI), and the BPI-Plant Products Safety Services Division (BPI-PPSSD) found no interaction on the resulting gene product of the regulated article applied for direct use as food and feed, or processing based on scientific evidences provided.


The STRP, BAI, and BPI-PPSSD concurred that the likelihood of interaction among the three (3) proteins (DMO, PAT, and CP4 EPSPS) is unlikely because their modes of action are different.  In addition, allergen and toxicity analyses of the three proteins have shown that these proteins show no homology to any known mammalian allergen or toxin.


The Department of Environment and Natural Resources – Biosafety Committee (DENR-BC), after a thorough scientific review and evaluation of the documents related to Environmental Risk along with the submitted sworn statement and accountability of the proponent, recommended the issuance of a biosafety permit for this regulated event provided that the conditions set by them are complied. 


The Department of Health – Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of documents related to Environmental Health Impact, concluded that soybean MON87708 X MON89788 X A5547-127 will not pose any significant risk to health and environment and that any hazards could be managed by the measures set by the department. DOH-BC also recommended for the issuance of biosafety permit for soybean MON89788.


Lastly, after assessing that there will be no negative socio-economic, ethical and cultural concerns that will arise from the adoption of Genetically Modified Organisms, the Socio-economic, Ethical and Cultural (SEC) expert recommended for the approval and issuance of biosafety permit of soybean MON87708 X MON89788 X A5547-127 for direct use as food and feed, or for processing.

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Date of authorization: 19/11/2018
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.):
Summary of the safety assessment (food safety):
STRP, BAI, BPI-PPSSD ASSESSMENT AND RECOMMENDATION After a thorough review of the documents submitted by the applicant, the STRP made the following assessment and recommendation: A. Gene Interaction The assessors confirmed that Monsanto Philippines, Inc. provided sufficient information and references which support that the presence of three proteins (DMO, CP4 EPSPS and PAT) will not interact to produce new allergen or toxins. This is due to the distinct mode of action of each protein which is not likely to interact. The DMO, CP4 EPSPS and PAT proteins modes and sites of biological activity are different and there is no known or conceivable mechanism of interaction between DMO, CP4 EPSPS and PAT which could lead to adverse health effects in animals or humans. B. Metabolic Pathways The mode of action of each gene product, according to the assessors, was completely described. Dicamba monooxygenase (DMO) is encoded by the dmo gene which was originally derived from the bacterium Stenotrophomonas maltophilia. DMO is the terminal Rieske oxygenase of a three-component system that also includes a ferredoxin and a reductase. In S. maltophilia, the first chemical step in the mineralization of dicamba is catalyzed by the O-demethylating enzyme DMO, which oxidizes the herbicide dicamba to the herbicidally inactive compounds, 3,6-dichlorosalicylic acid (DCSA) and formaldehyde. The presence of the gene and its gene product makes the stacked hybrid resistant to dicamba because of its ability to convert dicamba into DCSA. The gene cp4 epsps which encodes for CP4 EPSPS (5-enoylpyruvyl-shikimate-3-phosphate synthase) was derived from Agrobacterium tumefaciens strain CP4. EPSPS catalyzes the reversible reaction of shikimate-3-phosphate (S3P) and phosphoenolpyruvate (PEP) to produce EPSP and Pi. EPSPS is an enzyme which catalyzes the penultimate step of the shikimate pathway of aromatic amino acid biosynthesis. In plants, EPSPS is localized in the chloroplast. The herbicide glyphosate is an inhibitor of the native plant EPSPS but the CP4 EPSPS is far less sensitive to the inhibitory effects of glyphosate, hence conferring tolerance to glyphosate. The pat gene encodes the enzyme phosphinothricin acetyl transferase. The pat gene from A5547-127 is a synthetic version based on the coding sequence of the pat gene of Streptomyces viridochromogenes, a non-pathogenic bacterium. The PAT protein acetylates phosphinothricin thereby inactivating phosphinothricin compounds such as the herbicide glufosinate ammonium. The presence of the pat gene allows plant selection of transformed plants and provides tolerance to glufosinate ammonium herbicides. The PAT protein in A5547-127 is highly specific for the acetylation of L-phosphinothricin (L-PPT, L-glufosinate) and does not acetylate other L-amino acids. C. Gene Expression The STRP reported that previous assessments have shown the safety of each of the three single events. DMO, CP4 EPSPS and PAT are structurally and functionally different and they are independent from each other. Thus, even if they are bred together in a single hybrid, it is highly likely that they will function independently as in single events. Genetic and molecular analyses showed that all three genes are inherited, expressed and functioning properly in MON 87708 x MON 89788 x A5547-127, as they did similarly in single events. The possibility of occurrence of an unexpected effect of the stacked genes on the metabolism of the hybrid in highly unlikely. It was also reported that DMO, CP4 EPSPS and PAT are all expressed at low levels in MON 87708 x MON 89788 x A5547-127. In addition, protein expression level analysis did not show any indication that the marker genes were transferred and expressed in plants containing the combined genes. The STRP, BAI and BPI-PPSSD found scientific evidence that soybean MON87708 x MON 89788 x A5547-127 applied for direct use has no evidence of interaction on the resulting gene products. DENR-BC ASSESSMENT AND RECOMMENDATION After thorough and scientific reviews and evaluation of the document provided by the Bureau of Plant Industry (BPI) to the DENR Biosafety Committee within the prescribed period pursuant to Joint Department Circular (JDC) No. 1 s2016 on the application of Monsanto Philippines, Inc. for direct use for feed, food or processing of Genetically Modified soybean MON87708 X MON89788 X A5547-127, the following are the observations and recommendations: 1. From the evaluation of the application submitted by the proponent, including the scientific evidence from provided references and literature, as well as other related studies, the Committee finds that the direct use of the regulated article whether for food and/or for processing will not cause any significant adverse effect on the environment (land, air, and water) and non-target organism, to wit: a. Genetic stability in the transgenic crop is ensured such that no unintended horizontal gene transfer shall occur to unrelated species. b) The protein product produced by the transgenic crop will degrade upon exposure to the natural environment and general conditions (i.e. high temperatures (60C and above), varying pH, enzyme digestion, etc); and c) The protein product will not increase the weediness potential of the transgenic crop. The data evaluated support the conclusion that the regulated article is as safe as its conventional counterpart. 2. The project description report (PDR) discusses the specified environmental management plan indicating the possible risk and harm to the environment and non-target organisms as well as the mitigating measures and contingency plan of the proponent. Upon evaluation of the submitted PDR and environmental risk assessment (ERA), the Committee notes that the chances of unintended release or planting of the regulated article is very minimal and will not cause any damaging and lasting effects because the receiving environment is not conducive for plant growth/germination. 3. The importer shall ensure the proper and secure packaging of the regulated article for transport and the safety and durability of the transport vehicle, for prevention of any possible spillage or unintended release during transport/import. The Bureau of Plant Industry (BPI) shall conduct inspection of the shipment at the port of entry. The DENR-BC finds scientific evidence that the regulated article applied for Direct Use as Food and Feed or for Processing is safe as its conventional counterpart and is not expected to pose any significant risk to the environment and to non-target organisms. DOH-BC ASSESSMENT AND RECOMMENDATION After a thorough review and evaluation of the documents provided by the proponent, Monsanto Philippines Inc. through the Bureau of Plant Industry (BPI), in support of their application for approval for Direct Use for Food and Feed or for Processing (FFP) of MON 87708 × MON 89788 × A5547-127. I The DOH-BC concluded that the regulated article applied for Direct Use for Food and Feed or for Processing (FFP) is safe as its conventional counterpart and shall not pose any significant risk to human and animal health, and environment. The following are the observations and recommendations: 1. Scientific pieces of evidence from Toxicity studies and references find that the regulated article will not cause significant adverse health effects to human and animal health. 2. Dietary exposure to the regulated article is unlikely to result allergic reaction. 3. The regulated article is as safe as foo or feed derived from conventional soybean varieties. 4. The regulated article is not materially different in nutritional composition from that of the non-transgenic soybean or the conventional soybean. 5. There shall be a clear instructions that the product is only for the purpose of direct use and is not be used as planting materials to be used as planting materials. SEC EXPERT ASSESSMENT AND RECOMMENDATIONS After thorough review of the documents submitted by the applicant/proponent, the SEC Expert made the following assessment and recommendation: According to the SEC Expert, domestic production of GM soybeans is non-existent since no GM Soybean has been approved for planting or propagation in the Philippine. Thus, approval of this event would not alter the domestic production of soybeans in the Philippines since the application is just for direct use as food and feed ingredients. However, approval of this event may improve our domestic consumption of food products whose main ingredient is soybeans. Allowing this product to be imported for direct use for food would help stabilize prices of soybeans in the Philippines. Domestic soybean production cannot meet the demand of soybean for food and for feeds (The total areas planted to soybean in the Philippines remained at a very insignificant hectarage, maybe a little more than a 1000 hectares). Stable price of raw materials (e.g. soybean) would be beneficial to producers of food products whose main ingredient is soybean and would also stabilize prices of these food products. Stable demand of soybean would increase importation of soybeans. Thus, approval of this event may affect our patterns of agricultural trade (imports). However, since the share of our soybean imports is insignificant to the total agricultural imports, its effect might be minimal. The increasing imports of soybean may reflect the continuous growth of our livestock industry. In addition, importation of soybeans would help stabilize local prices of food products whose main ingredient is soybeans. Likewise, the approval of this event would also stabilize process of feeds as soybeans is also a main ingredient in feed formulation for poultry and livestock sub-sector. The approval of this event may also help develop the feed milling sub-sector in the Philippines, assuring them of continued supply of feed ingredient at a stable price. With the data provided by Monsanto, Philippines, Inc., approval of this event MON 87708 × MON 89788 × A5547-127, will not drastically change the current pattern of production since it will not be grown locally. For consumption, approval of this event may slightly affect (improve) our consumption pattern. However, since the share of soybeans and soybeans products to the total food consumption of Filipinos is very minimal, the change would be negligible. With regards to utilization, approval of this event would improve our current utilization due to availability of raw material (e.g. soybean). With the availability of soybeans for food and feeds formulation, producers and millers will be encouraged to use soybeans as one of the ingredients. In terms of patterns of trade, approval of this event would increase our importation of soybeans. However, since its share to the total agricultural imports, it may have insignificant effect to the overall patterns of agricultural trade. Recommendation Based on the assessment of the above indicators, the SEC expert does not have any socio-economic, social, and ethical issues to raise regarding the approval of the applicant's application for biosafety permit for direct use as food and feed, or for processing of soybean MON 87708 × MON 89788 × A5547-127. The expert recommends for the approval of said application.
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Authorization expiration date (a blank field means there is no expiration date) November 18, 2023
E-mail:
bpibiotechsecretariat@gmail.com
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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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: Monsanto Korea Ltd.
Summary of application:

Glufosinate herbicide tolerance, Glyphosate herbicide tolerance, Dicamba herbicide tolerance

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Date of authorization: 09/03/2018
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.):
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:
mytrue85@korea.kr
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: