| Commodity: |
Soyabean / Soybeans |
| Traits: |
Herbicide tolerance |
| Name of product applicant: |
BASF SE |
| Summary of application: |
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| Date of authorization: |
21/12/2017 |
| 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.): |
EU Register of authorised GMOs
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| Summary of the safety assessment (food safety): |
Please see the EU relevant links below. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
The method for detection for soybean FG72 x A5547-127 is based on the validated detection methods that are available for genetically modified soybeans FG72 and A5547-127. Certified reference material for genetically modified soybean FG72 and genetically modified soybean A5547-127 is available at the American Oil Chemists’ Society (AOCS): with the respective product code 0610-A3 and 0707-C5. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Method for detection
Reference Material
Opinion of the European Food Safety Authority
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| Authorization expiration date (a blank field means there is no expiration date) |
22/12/2027 |
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: |
Bayer CropScience S. A. |
| Summary of application: |
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| Date of authorization: |
02/03/2018 |
| 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.): |
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| Summary of the safety assessment (food safety): |
• The soybean event FG72 x A5547-127 was obtained by conventional breeding of parental event already approved.
• Molecular and phenotypic studies showed its molecular integrity and its genetic and phenotypic stability as well as a simple dominance Mendelian inheritance pattern.
• The expressed proteins were evaluated (in the submission of the parental events) regarding toxicity and allergenicity and approved without identifying potential risks.
• The expression pattern of 2mEPSPS, HPPDW336 and PAT proteins is equivalent in the parental and in the stack event.
• The compositional analysis shows that it is substantially and nutritionally equivalent to its non-genetically modified counterpart and commercial varieties used as control.
• There are no technical or experimental evidence to indicate that the expressed proteins may have a metabolic interaction resulting in unexpected effects, with no changes in the pattern or expression levels as well as its phenotypic aspects.
It is concluded that soybean event FG72 x A5547-127 is substantially equivalent to its conventional counterpart, therefore, is as safe as and no less nutritional than soybean conventional commercial varieties.
http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/24_.1_decision_document_soybean_fg72_x_a5547-1271.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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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: |
Bayer S.A |
| Summary of application: |
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| Date of authorization: |
10/12/2015 |
| 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): |
A) The safety of the Event FG72 x A5547-127 was evaluated in several studies conducted in Brazil and abroad, in order to demonstrate that the combination of the Events through traditional breeding does not result in strains significantly different from those that originate (Parental events) and Nor of conventional varieties. B) Thus, the safety of soybean FG72 x A5547-127 is demonstrated not only by the information previously presented for the isolated events, but also through analyzes that showed no interaction between the inserts present in this lineage;
C) The safety of the PAT protein, encoded by homologous genes pat or bar (isolated from bacteria Streptomyces viridochromogenes or Streptomyces hygroscopicus), has been extensively demonstrated and presented for the isolated events T25 (corn), LLCotton25 (cotton), A2704-12, A5547-127 (soybean), as well as for the Combined Events GHB614 x T304-40 x GHB119 and GHB614 x LLCotton25, approved for commercial use in Brazil. Safety approvals have already been granted for at least 43 different transformation events, which express PAT protein, of five plant species (soybean, corn, canola, beet, cotton) in different countries, (CERA, 2015);
D) A5547-127 soybean (LibertyLink®) has already been APPROVED in 17 countries (Argentina, Australia, Brazil, Canada, China, Colombia, European Union, Japan, South Korea, Malaysia, Mexico, Philippines, Russia, Singapore, Taiwan, the United States and Uruguay) whether for planting, animal feed or human food (CERA, 2015);
E) The 2mEPSPS protein is present in the Cotton GHB614 Event, and in the Combined Events GHB614 x LLCotton25 and GHB614 x T304-40 x GHB119, whose safety has been evaluated by this Technical Commission, all of which are approved for commercial use in Brazil ;
F) The proteins 2mEPSPS and HPPDW336 are expressed in the genetically modified soybean GT72 Event, whose safety has already been evaluated by this Technical Commission, having been approved for commercial use in Brazil;
(G) FG72 soy has already been APPROVED in 10 countries (Australia, Brazil, Canada, South Korea, Japan, Malaysia, Mexico, New Zealand and Taiwan), whether for planting, animal feed or human ISAAA, 2015);
H) The additional results provided in the documentation forwarded to the event release request FG72 x A5547-127 confirm the safety of a process that combines products already previously determined as safe;
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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) |
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: |
Bayern Crop Science |
| Summary of application: |
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| Date of authorization: |
28/11/2016 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Ministerio de salud y proteccion social
Contact person name: Daniel Rubio
Website:
Physical full address: Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number: 330 5000 ext 1256
Fax number:
Country introduction: The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).
The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer CropScience |
| Summary of application: |
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| Date of authorization: |
28/04/2018 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-114075/2 |
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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: |
Bayer de México, S.A. de C.V. |
| Summary of application: |
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| Date of authorization: |
24/11/2015 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the Genetically Modified Soybean (Glycine max). OCDE identifier: MST-FGØ72-2 x ACS-GMØØ6-4 is, based on the existing knowledge to date, as innocuous as its conventional counterpart. |
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E-mail:
Organization/agency name (Full name): CIBIOGEM
Contact person name: Mtra. Andrea Genoveva Solano Rendón
Website:
Physical full address:
Phone number:
Fax number:
Country introduction: México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.
Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.
En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.
Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.
Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf
Courtesy translation
Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.
The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF PARAGUAYA S.A. |
| Summary of application: |
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| Date of authorization: |
08/11/2019 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
MST-FGØ72-2 X ACS-GMØØ6-4
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| Summary of the safety assessment (food safety): |
The food and feed safety assessment was performed following the CODEX Guidelines. |
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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: |
BASF Paraguaya S.A. |
| Summary of application: |
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| Date of authorization: |
08/11/2019 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
The Commercial Release Opinion of the National Commission of Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of event MST-FGØ72-2 X ACS-GMØØ6-4 (2) In case of detecting an unexpected effect, the company is under the obligation to communicate it to CONBIO". Please see decision document weblinks. For further information, please refer to the decision document link. |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Ministerio de 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: |
Bayer CropScience |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
22/06/2018 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
A. STRP, PPSSD, BAI (Safety Assessment)
After thorough review of the technical documents submitted by the applicant, the assessors’ findings were as follows:
1. Gene Interaction
Any likelihood of interaction among the three proteins (2mEPSPS, HPPD W336 and PAT) is not significant because each protein has distinct mode of action. There is no new genetic modification involved in the development of FG72 x A5547-127 soybean. Likewise, production of a new toxin or allergen is also unlikely.
The molecular analysis of the FG72 x A5547-127 soybean demonstrated the integrity of the inserts in FG72 x A5547-127 soybean when compared to the single parental lines. No new genetic modification was involved in the development of FG72 x A5547-127 soybean.
The HPPD W336, PAT and 2mEPSPS will accumulate in the cytoplasm of the plant cells, however, there is no possible interaction among these proteins because of their specific individual roles in their respective separate metabolic pathways.
2. Metabolic Pathways
The developer provided a complete description of the mode of action for each gene product, HPPD W336, PAT and 2mEPSPS genes. The HPPD enzymes catalyze the second step in the pathway for the catabolism of tyrosine and are responsible for the transformation of p-hydroxyphenylpyruvate into homogentisic acid. The plants expressing the HPPD W336 protein (encoded by the hppd W336 gene) are tolerant to isoxaflutole (IFT) containing herbicides. The pat gene, when expressed, enables the production of the enzyme PAT that metabolizes glufosinate to an inactive, acetylated derivative, thereby conferring tolerance to glufosinate-ammonium herbicide. The 5-enol-pyruvylshikimate-3-phosphate synthase (EPSPS) protein is the 6th enzyme of the shikimate pathway, the metabolic pathway for the biosynthesis of aromatic compounds found in microorganisms and in plants. The plants expressing the 2mEPSPS protein (encoded by the 2mepsps gene) are tolerant to glyphosate herbicides.
Overall, HPPD W336, PAT and 2mEPSPS proteins are structurally and functionally different and have different mode of action; thus, interaction is unlikely. Consequently, there are no possible unexpected effects of the stacked genes on the metabolism of the plant.
3. Gene Expression
The protein expression levels of 2mEPSPS, HPPD W336 and PAT were determined on a fresh weight (FW) and dry weight (DW) by sandwich Enzyme-Linked Immunosorbent Assays (ELISA) in leaf, root, forage, flower and grain matrices, collected at multiple developmental stages of untreated and trait-specific herbicide treated FG72 x A5547-127 soybean. Results showed that the proteins were expressed properly in the combined trait product as in its relevant single events.
Moreover, protein expression level analysis did not show any indication that the marker genes were transferred and expressed in plants containing the combined genes. |
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| Authorization expiration date (a blank field means there is no expiration date) |
June 21, 2023 |
E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 8524-9588 loc 230
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial. Useful links
Relevant documents
Stacked events: As stipulated in Section 20, Article VIII. of the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 01, series of 2021, titled Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically Modified Plant and Plant Products Derived from the Use of Modern Biotechnology, plants produced through conventional breeding of genetically modified parental lines with approved individual events are not considered novel. The permit holder or an authorized licensee of registered events may request the listing of their stacked events in either the BPI Approval Registry for Commercial Propagation or the BPI Approval Registry for Direct Use, as applicable.
Listing in the BPI Approval Registry for Propagation
If each parental event has a Biosafety Permit for Commercial Propagation, the stacked events may be listed in the BPI Approval Registry for Commercial Propagation. The permit holder or an authorized licensee of registered events may also request the BPI to list any sub-stacks or intermediate stacks.
Listing in the BPI Approval Registry for Direct Use
If each parental event has a Biosafety Permit for Direct Use, the stacked events may be listed in the BPI Approval Registry for Direct Use. The permit holder or an authorized licensee of registered events may also request the BPI to list any sub-stacks or intermediate stacks.
Registration under the Fertilizer and Pesticide Authority
For the commercial propagation of plants with stacked events involving multiple plant-incorporated protectants (PIPs), each individual PIP must first be registered under the Fertilizer and Pesticide Authority (FPA). Additionally, the stacked PIP × PIP must be registered as a new product under the FPA in accordance with its guidelines on the registration of biorational products. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
| Name of product applicant: |
Bayer Korea Ltd. |
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| Date of authorization: |
22/12/2016 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Please see the link below(in Korean). |
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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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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: |
BASF |
| Summary of application: |
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| Date of authorization: |
16/04/2021 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
The FG72 X A5547-127 (MST-FGØ72-3 x ACS-GMØØ6-4) stacked soybean event was produced by conventional breeding of FG72 and A5547-127 single events. The stacked soybean event provides tolerance to isoxaflutole and glyphosate herbicides. Both the FG72 and A5547-127 parent events have been previously approved in Singapore for food, feed and processing uses. Molecular analyses showed that the integrity of the transgenic inserts from each single event was preserved during the conventional breeding to produce the stacked soybean event. The stacked soybean event expresses the new proteins 2mEPSPS, HPPD W336 and PAT, which were found to be similarly expressed in their respective parent events. There was absence of interactions and/or potential interactions between these expressed proteins. Compositional analysis of the stacked soybean event showed that it was comparable to that of conventional soybean varieties. Food derived from FG72 X A5547-127 stacked soybean event is considered to be as safe as food derived from conventional soybean varieties. |
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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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E-mail:
Organization/agency name (Full name): Singapore Food Agency (SFA)
Contact person name: Dr Tan Yong Quan
Website:
Physical full address: 52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number: (65)68052750
Fax number:
Country introduction: The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food. SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption. The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork. Useful links
Relevant documents
Stacked events: More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:
https://www.gmac.sg/guidelines/ Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Singapore Food Agency (SFA)
| Name of product applicant: |
BASF (Thai) Limited |
| 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, that the stacked event FG72 × A5547-127 soybean 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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| 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): 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)
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