Argentina
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.
Regulatory framework:
My country has a regulatory framework that requires the competent authority to conduct safety assessment of GM food.
Structure for GM food safety assessment:
My country has competent authority, agency, organization, ministry, department, committee, commission or a system/mechanism that is tasked to conduct or review GM food safety assessment.
Supplemental information (regulatory framework):
Relevant contact details:
National Service for Agrifood Health and Quality (Senasa)
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
GM food safety assessment guidelines:
My country follows the relevant Codex Guidelines or national/regional guidelines that are in line with the Codex Guidelines in conducting safety assessment of GM food.
Conduct of GM food safety assessment:
My country regularly conducts food safety assessment of GM food.
Supplemental information (assessment):
The Resolution 412/02 is the specific regulation for food and feed safety assessment derived from GMOs.
Regulation stacked events:
On a case-by-case basis, some stacked events may have reduced/simplified assessment requirements.
Supplemental information (stacked events):
In Argentina, in the case of stacked events in which each individual event (or sub-combinations of events) has been evaluated for food and feed safety, the evaluation is conducted using a "differential process," which is faster and requires significantly less information. The evaluation focuses on determining whether there are any risk hypotheses related to potential interactions between the introduced genes, their expression products, and/or affected metabolic pathways. Additionally, only other risk hypotheses that may arise depending on the specific case under evaluation will be considered. If potential interactions are identified, an assessment will be conducted to determine whether they pose a risk to human or animal health. If no potential interaction hypotheses are identified, it may be concluded that the stacked event—including all possible intermediate combinations and any crosses with conventional varieties—is as safe and no less nutritious than its conventional counterparts and other commercial varieties. In summary, when individual events have already been assessed, the applicant is only required to submit a rationale supporting the absence of interactions and should provide additional information only if other plausible risk hypotheses emerge from the problem formulation.
A regulatory update is currently underway, so a specific form for stacked events will soon be available to be conducted through “differential process” for food and feed assessment.
A regulatory update is currently underway, so a specific form for stacked events will soon be available to be conducted through “differential process” for food and feed assessment.
GM food/feed production:
My country produces GM food or feed for commercial and research purposes.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information (production and trade):
SENASA established a program for control the potential content of unapproved event in the imports, in order to prevent the presence of illegal events in Argentina.
LLP/AP incidents:
My country has faced LLP/AP situations in the last 10 years.
Supplemental information (LLP/AP incidents):
Labelling requirement:
My country does not have any labeling regulations/policies on GM food.
Supplemental information (labelling requirement):
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