| Commodity: |
Soyabean / Soybeans |
| Traits: |
Drought tolerance,Glyphosate tolerance |
| Name of product applicant: |
INDEAR S.A. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
19/06/2017 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
|
| Summary of the safety assessment (food safety): |
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. • There is no hypothesis of risk that indicates that there are effects of metabolic interactions and between the proteins of the events when they are accumulated.
It is concluded that soybean IND-ØØ41Ø-5 x MON-Ø4Ø32-6 is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial soybean varieties.
http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/scan_documento_de_decision_soja_ind410_x_mon40321.pdf |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Decision Document - Safety Assessment Summary
GMO approvals for food/feed
Food and feed safety asssessment of GMOs - Argentina
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
INDEAR |
| Summary of application: |
|
| Upload: |
|
| 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.): |
|
| Summary of the safety assessment (food safety): |
Simplified approval procedure: Through Ministry of Agriculture and Livestock Resolutions 1030 and 1071 there was stated a differentiated treatment for the commercial release of novel GE crops and for GE crops that have been approved in third countries, whose scientific, technical and safety characteristics are well-founded. Paraguayan Ministry of Agriculture’s Resolutions authorize taking into consideration the decision documents from third countries with regard to both human and animal food safety in the cases where these evaluations have been based on Codex Alimentarius, such as the Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants and carried out in countries with time-tested regulatory systems and transparent procedures.
Concerning environmental safety, assessments are accepted for GE crops that besides having been authorized for commercial planting in countries with sound regulatory systems, include in the decision documents considerations as follows: that the GE crop under review has been studied under different environmental conditions, behaving in the same way as the conventional non-GE counterpart; that it will be managed in an agronomic manner similar to any GE or conventional hybrid/variety of the species; another aspect is that Paraguay is not center of origin of that crop, and finally two relevant characteristics are that there are no related weeds in Paraguay with which the GE crop could cross-breed and that the main target pests and the main non-target arthropod species present in Paraguay have been taken into account in the GE risk assessment carried out in those countries.
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 HB4 x GTS-40-3-2 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO". |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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/
|
|
