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.
The Brazilian National Biosafety Commission – CTNBio, is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke.
After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
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:
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
Production and trade
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 on the production and trade:
My country has not faced any LLP/AP situations in the last 10 years.
Supplemental information on the LLP/AP incidents:
My country has a mandatory and positive labeling regulation on GM food (i.e., It contains GMO).
Supplemental information on the Labelling requirement:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment