| Commodity: |
Corn / Maize |
| Traits: |
Coleoptera resistance,Glyphosate tolerance,Lepidoptera resistance |
| Name of product applicant: |
Monsanto |
| Summary of application: |
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| Date of authorization: |
19/12/2018 |
| 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.): |
EU Register of authorised GMOs
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| Summary of the safety assessment (food safety): |
Please see the EU relevant links below. |
| 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: |
Event specific real-time quantitative PCR based method for genetically modified maize MON-89Ø34-3 x MON-88Ø17-3. Reference material: AOCS 0906-E (for MON-89Ø34-3) and AOCS 0406-D (for MON-88Ø17-3) are accessible via the American Oil Chemists Society. Please see the EU relevant links below. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Opinion of the European Food Safety Authority
Method for Detection
Reference Material
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| Authorization expiration date (a blank field means there is no expiration date) |
18/12/2028 |
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). 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 Argentina S.A.I.C. |
| Summary of application: |
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| Date of authorization: |
07/10/2010 |
| 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): |
• Inheritance studies conducted indicated that Mendelian segregation exists,
• New expression proteins are found in low levels in grain,
• It is substantially and nutritionally equivalent to its non-transgenic counterpart,
• No evidence of any similarity or homology with toxic proteins was found,
• The studies presented to evaluate the potential allergenicity show that no allergenic substances are expressed,
• According to the presented evidence, it is unlikely to be interaction of the metabolic routes of the transgenes,
It is concluded that the stacked event MON89034 x MON88017 is similar to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial corn hybrids.
http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/6_7_y_8_-mon89034xmon88017_espanol.pdf |
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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: |
Decision Document - Safety Assessment Summary
GMO approvals for food/feed
Food and feed safety asssessment of GMOs - Argentina
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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 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. Useful links
Relevant documents
Stacked events: Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis. 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
| Name of product applicant: |
Monsanto do Brasil Ltda. |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
29/03/2011 |
| 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.): |
Center for Environmental Risk Assessment
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| Summary of the safety assessment (food safety): |
Insect resistant and glyphosate herbicide tolerant, MON 89034 x MON 88017 is the result of crossing MON 89034 and MON 88017 through techniques of classical genetic improvement. Event MON 89034 has proteins Cry1A.105 and Cry2Ab2 derived from Bacillus thuringiensis that are active against lepidopteran pests important in this culture. Event MON 88017, as well as corn MON 88034 x MON 88017 produces protein 5-enolpyruvylshikimate-3-phosphate synthase of Agrobacterium sp. strain CP4 (CP4 EPSPS), which grants tolerance to glyphosate, and modified protein Cry3Bb1 from Bacillus thuringiensis subsp. kumamotoensis that selectively controls target coleopterans, such as coleopteran larvae of the genus Diabrotica. Events MON 89034
and MON 88017 were already passed by CTNBio for commercial release according to Technical Opinions EPT 2052/2009, in October 2009, and EPT 2764/2010, in December 2010, respectively. The combination of the two events has the purpose of granting farmers in Brazil the possibility of reducing yield losses under the pressure of pest plants and occurrence of root pests of the genus Diabrotica and lepidopteran pests. Comparative molecular analyses between the stacked event, individual events (MON 89034 and MON 88017 ) and conventional corn, showed that the molecular structure was preserved during the process of classical genetic improvement. Studies verified that there is no interaction between proteins Cry1A.105/Cry2Ab2 and Cry3Bb1, being their effect deemed to be additive in controlling pests, that is to say, that the event behaved independently in their contribution towards insect control On the other hand, protein CP4 EPSPS biological activity mode and location are different. While proteins Cry act in the cytoplasm, protein CP4 EPSPS is directed to the chloroplast. There is no known mechanism or possible interaction between these proteins that could lead to an adverse effect to human and animal health. Besides, no changes in the expression of the proteins were detected when compared to individual effects. This way, in order to verify that the stacked event MON 88034 x MON 88017 is equivalent to and as safe as the conventional corn, the applicant submitted data of the literature, results of previous experiments with the isolate events and results of essays conducted under contention and in the environment, following scientific methodologies, with the purpose of showing the absence of interaction between the genes introduced in the stacked event. Field data generated in Brazil enable concluding that corn MON 88034 x MON 88017, except for characteristics that are determined by the genetic modification, is not different from the control corn and, therefore, fails to present environmental risks, increased potential as a weed pest or expanded gene flow to conventional corn. Field experiments conducted in Brazil on ecological interactions of corn MON 88034 x MON 88017 compared to the conventional control corn to and other twelve commercial references. Analyses on damages to the leaf, ear, stem and root, as well as data on rot in ear and stem show that four out of six comparisons displayed significant differences; damages to leaves, ears, stems and roots were significantly lower in the corn analyzed. Besides, assessments on impacts of corn MON 88034 x MON 88017 in non-target organisms
were conducted in four Monsanto do Brasil Experimental Stations. Data submitted corroborate the history of secure use of genetically modified cultures containing genes derived from Bacillus thuringiensis. Either in localized individual analyses and in the microbiota combined analyses, no significant differences were found between results of MON 88034 x MON 88017and the control corn. Therefore, the conclusion was that expression of the four heterologous proteins of the corn under examination has no potential to affect the soil microbiota in a significant way. Regarding alimentary safety, MON 88034 x MON 88017 corn had a behavior substantially similar to conventional corn, as well as to other commercial hybrid corns. Centesimal composition data failed to display significant differences between the genetically modified variety and controls and references, suggesting nutritional equivalence between the corns. Data submitted corroborate the results found in samples collected in Brazil for individual
events, which are also equivalent in composition to conventional corn. A field study was
conducted in Brazil with the purpose of generating samples to assess the levels of expression of proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 and CP4 EPSPS on corn MON 88034 x MON 88017 in leaves during harvest, forage, grains and roots in two harvest times, using the ELISA quantification method. The combined analysis of data collected in Brazil, United States and European Union indicates that the expression levels of the four proteins are equivalent, that is to say, the majority of intervals (minimum values and maximum values) are superimposed in corn MON 88034 x MON 88017 cultivated in different places, as well as equivalent to those detected in individual events (corn MON 89034 and corn MON 88017). Regarding allergenicity and toxicity, it must be stressed that proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 and CP4 EPSPS are rapidly absorbed in simulated gastric fluid. This fact makes improbable that the proteins may act as alimentary allergens. Bioinformatic analysis has verified that proteins Cry1A.105,
Cry2Ab2, Crfy3Bb1 and CP4 EPSPS fail to share significant similarity in amino acid sequencing with known allergens, gliadins, glutenins or toxic proteins that may cause adverse effects to health. In studies of acute oral toxicity in mice, it was shown that proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 and CP4 EPSPS failed to display acute toxicity and failed to cause adverse effects even in the highest doses tested. From the above, the conclusion is that consumption of MON 88034 x MON 88017 corn is not a potential cause of significant degradation to the environment and risks to human and animal health. For the above, there are no restrictions to the use of this corn or derivatives therefrom. CTNBio determines that post-commercial release monitoring shall be conducted in commercial cultures and not in experimental ones. Areas selected to be
monitored shall not be isolated from other areas, possess borders or display any condition that may be different from the commercial pattern. Monitoring shall be conducted in a comparative model between the conventional and the GMO cultivation systems, where collection of date shall be conducted by sampling. The monitoring shall additionally be conducted in biomes that are representative of the main GMO cultivation areas and, if possible, include different types of producers. Monitoring shall be conducted for a period not shorter than five years. Monitoring reports submitted shall detail information on all activities of pre-sowing and sowing, execution thereof, reporting activities conducted in monitoring areas during the culture cycle, and activities of harvesting and climatic conditions. Any aggravation to human and animal health shall be notified through official adverse effect notification systems, including, without limitation, SINEPS (Sistema de Notificação de Eventos Adversos relacionados
a Produtos de Saúde – Notification System of Adverse Effects related to Health Product) as regulated by ANVISA. Analytical methods, results achieved and interpretation thereof shall be developed according to principles of independence and transparency, except for commercial secrecy reasons previously justified and defined as such. A total of 21 monitoring actions are proposed: - sowing, management, and harvesting of corn culture; - soil physical and chemical characteristics; - corn nutritional conduction – corn plant sanity; - pest plant communities and field diaspores; resistance to glyphosate herbicide; - gene flow of MON 88034 x MON 88017 to conventional corn; - residues of glyphosate and AMPA in corn grains and soil; - residue of proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 in maze straw and straw; - microbial diversity associated to the soil; - invertebrates in soil and soil surface; - visual inspection of non-target arthropods in the aerial part; - assessment of non-target arthropods in the aerial part by means of traps; - monitoring of Cry proteins in water; - assessment of target-insects and aggravations to human and animal health; and – complementary agricultural activities |
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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: |
molecular traditional methods |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
National Biosafety Commission
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| Authorization expiration date (a blank field means there is no expiration date) |
Not Applicable |
E-mail:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
Physical full address: SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number: 556120335087
Fax number:
Country introduction: Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques. Useful links
Relevant documents
Stacked events: At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)
| Name of product applicant: |
Compañia Agricola S.A.S |
| Summary of application: |
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| Date of authorization: |
18/05/2011 |
| 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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| Upload: |
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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: |
Compañia Agricola S.A.S |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
18/05/2011 |
| 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. |
| 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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| Upload: |
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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: |
Compañia Agrícola S.A.S |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
01/12/2021 |
| 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 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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| Upload: |
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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 Europe S.A. |
| Summary of application: |
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| Date of authorization: |
17/07/2021 |
| Scope of authorization: |
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): |
Competent National Authority: Ministry of Agriculture-Jehad, Agricultural Research, Education and Extension Organization (AREEO). Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-116235/1 |
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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): ABRII
Contact person name: Gholamreza Salehi Jouzani
Website:
Physical full address: Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number: 0098(26)32701132
Fax number: 0098(26)32701132
Country introduction: Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.
The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation. 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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Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
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Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
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| Name of product applicant: |
Monsanto |
| Summary of application: |
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| Date of authorization: |
26/10/2016 |
| Scope of authorization: |
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): |
Competent National Authority: Ministry of Agriculture-Jehad, Agricultural Research, Education and Extension Organization (AREEO). Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-114200/2 |
| 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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| Upload: |
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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): ABRII
Contact person name: Gholamreza Salehi Jouzani
Website:
Physical full address: Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number: 0098(26)32701132
Fax number: 0098(26)32701132
Country introduction: Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.
The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation. 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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Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
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Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
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| Name of product applicant: |
Monsanto Japan Ltd. |
| Summary of application: |
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| Date of authorization: |
12/02/2008 |
| 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.): |
OECD BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Please see the link below (in Japanese). |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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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)
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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.A. de C.V. |
| Summary of application: |
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| Date of authorization: |
20/01/2010 |
| 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): |
UI OECD: MON-89Ø34-3xMON-88Ø17-3
During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart.
For more detail please find attached the risk assessment summary in this page.
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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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| Upload: |
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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 PARAGUAY S. A. |
| Summary of application: |
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| Date of authorization: |
24/10/2012 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
MON-89Ø34-3xMON-88Ø17-3
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| Summary of the safety assessment (food safety): |
The food and feed safety assessment was performed following the CODEX Guidelines. 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 MON89034xMON88017 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO". |
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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. Useful links
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/
| Name of product applicant: |
Monsanto Philippines |
| Summary of application: |
Monsanto has developed a biotechnology derived product corn MON 89034 through Agrobacterium mediated transformation to express the Bacillus thuringiensis insecticidal proteins, Cry1A.105 and Cry2Ab2. The introduction of corn MON 89034 is expected to provide enhanced benefits for the control of lepidopteran insects pests such as Ostrinia furnacalis (Asian corn borer, ACB), Spodoptera litura (CCW) and Helicoverpa zea (corn earworm, CEW) compared to existing products.
Corn 88017 expressed Cry3Bb1 protein encoded by the cry3Bb1 sequence from Bacillus thuringiensis subs kumamotoensis, which confers insecticidal activity against corn rootworm. It also contains cp4 epsps gene from Agrobacterium sp. Strain CP4, which confers tolerance to glyphosate herbicide
The transgenic corn traits from Event MON89034 and Event MON88017 were combined through conventional breeding to produce the Corn MON89034 x MON88017. This stacked hybrid produces the three transgenic proteins present in Corn MON89034 x MON88017 corn plants.
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| Date of authorization: |
19/10/2009 |
| 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): |
Monsanto Philippines has filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Department of Agriculture (DA)- Administrative Order (AO) No. 8 Part 5 for combined trait corn: corn MON89034 x MON88017 which has been genetically modified for insect protection and herbicide tolerance.
A safety assessment of combined trait product corn: MON89034 x MON88017 was conducted as per Administrative Order No. 8 Series of 2002 and Memorandum Circulars Nos. 6 and 8, Series of 2004. The focus of risk assessment is the gene interactions between the transgenes.
Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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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: |
17/07/2009 |
| 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:
| Name of product applicant: |
Monsanto |
| Summary of application: |
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| Date of authorization: |
24/03/2014 |
| 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.): |
Biosafety Clearing House (BCH)
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| Summary of the safety assessment (food safety): |
The GM maize MON89034xMON88017 has been assessed in terms of the Genetically Modified Organisms Act, 1997 by the Advisory Committee, a scientific panel and the Executive Council an intergovernmental decision making body. The assessment considered amongst others the following: The source of the gene, nature of host organism, protein expression, toxicology and allergenicity issues. |
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E-mail:
Organization/agency name (Full name): Department of Agriculture Forestry and Fisheries
Contact person name: Nompumelelo Mkhonza
Website:
Physical full address: 30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number: +2712 319 6382
Fax number: +2712 319 6298
Country introduction:
Useful links
Relevant documents
Stacked events: South Africa does not have a specific review/authorization mechanism for stacked events. Stacked events just like single events are subjected to a safety assessment as per the GMO Act. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Agriculture,Forestry and Fisheries (DAFF) http://www.daff.gov.za
| Name of product applicant: |
Bayer Thai Co., Ltd. |
| Summary of application: |
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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.): |
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| 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 MON89034 × MON88017 maize is expected to be as safe as the single events that has previously been assessed by the food biosafety subcommittee and technical biosafety committee of the National Center for Genetic Engineering and Biotechnology (BIOTEC). |
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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)
| Name of product applicant: |
Special case: please show below |
| Summary of application: |
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| Date of authorization: |
05/11/2015 |
| Scope of authorization: |
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): |
After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee Biosafety Board has approved the use of genetically modified maize MON89034xMON88017 and products thereof for animal feed. |
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E-mail:
Organization/agency name (Full name): DG of Agricultural Research and Policies (TAGEM)
Contact person name: Ramazan BULBUL
Website:
Physical full address: Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km
Çankaya/ANKARA/TURKEY
Phone number: +90 312 307 60 48
Fax number: +90 312 307 61 90
Country introduction: Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010.
Main objectives of the Biosafety Law are;
- to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
- to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
- to inspect, regulate and monitor the activities in the scope of the law.
The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.
Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope.
According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:
- Releasing GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
- Production of genetically modified plants and animals.
- Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements
According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.
However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.
The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.
Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.
For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.
Members of scientific committees are selected from the List of Experts.
11 members are selected for each GMO application.
List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).
To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.
Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.
Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.
There are not any applications for using GMO and products as food.
After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.
Activities of analysis are performed in laboratories designated by the Ministry.
In the case of any non-compliance detected with relation to the GMO Legislation (such as a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.
Application evaluation process is like below:
- Evaluation of application by Ministry of Agriculture and Forestry 90 days
- Feedback to the applicant 15 days
- Ministry of Agriculture and Forestry’s “Decision” 270 days
(Starts from feedback to the applicant)
Establishing of Scientific Committees
Report preparation of Committees
Report’s public release
Evaluation of public opinions by Committees
Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into
account
- Publishing the Positive Decision 30 days
- Reclamation period to Negative Decision 60 days
- Evaluation of reclamation by Ministry of Agriculture and Forestry 60 days
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Ministry of Agriculture and Forestry
General Directorate of Agricultural Research and Policies
Focal Point of the FAO GM Foods Platform
Ramazan BULBUL
Email: [email protected]
| Name of product applicant: |
Monsanto Co. |
| Summary of application: |
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| Date of authorization: |
15/12/2017 |
| 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.): |
BCH
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| Summary of the safety assessment (food safety): |
Please refer to uploaded 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Sistema Nacional de Bioseguridad
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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) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio. The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) is a committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. Useful links
Relevant documents
Stacked events: GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.
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