The Ministry of Health (MINSAL) is responsible for formulating, establishing and control health policies. The Presidential Decree No. 977 of 1996, the Ministry of Health and its amended establishes the sanitary conditions for protect the health and nutrition of the population and ensure the provision of healthy and safe products, which include biotech events that modify food and / or raw materials food for human consumption. The process of risk assessment is performed by the the Public Health Institute of Chile (ISP) that is a public service, which has management autonomy and has legal personality and its own assets, depending on the Ministry of Health. In this process the ISP will review the history of the event presented, according to the following four technical criteria: • Molecular analysis of stability; • allergenicity; • toxicity; and • nutritional assessment. The Director of the ISP will forward a consolidated report of the risk assessment to the Under Secretariat of Public Health for its decision. In case to be accepted, the GMO event may be incorporated into the “List of Biotechnology Events Approved human use" by Official Resolution of the Minister of Health. It´s important to indicate that actually no GMO crop have been authorize for cultivation in Chile. The only activity authorized by The Ministry of Agriculture and the Agricultural and Livestock Service (SAG) is the production of GMO´s for seed production or research.
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.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
- Public Health Institute (ISP) - www.ispch.cl
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 on the implementation:
Regulation of stacked events:
In my country, GM food/feed that contains stacked event(s) is considered as a new product even if all single events that are stacked have already approved.
Supplemental information on the stacked events:
Production and trade
GM food/feed production:
My country produces GM food or feed only for research purposes.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information on the production and trade:
My country has faced LLP/AP situations in the last 10 years.
Supplemental information on the LLP/AP incidents:
My country is in the process of developing regulations/policies on GM food labeling.
Supplemental information on the Labelling requirement:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment