Bhutan Agriculture and Food Regulatory Authority, Ministry of Agriculture and Forests, Thimphu: Bhutan, Post Box No. 1071
+975 2 327031
+975 2 327032
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 Biosafety Act of Bhutan 2015, passed in July 2015 has been cautiously drafted considering the Kingdom’s current interest and keeping in view the country’s food security needs. The Biosafety Act requires the competent authority, Bhutan Agriculture and Food Regulatory Authority (BAFRA) of the Ministry of Agriculture and Forests (MoAF) to coordinate the conduct of safety assessment of GM Food/Feed. For ease in implementation of the provisions of the Act, the Biosafety Rules and Regulations have been readied; it is yet to be formalized.
Structure for GM Food Safety Assessment
For importation of GMOs for direct use as Food, Feed or for Processing (FFP), GM food safety assessment/review is required. The National Biosafety Board reviews and makes decisions on events based on the scientific/technical risk review provided by the Biosafety Technical Working Group and also taking into consideration policy issues as well as public inputs. The decisions and its related documents would be made publicly available on the websites.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bhutan Agriculture and Food Regulatory Authority (BAFRA) of Ministry of Agriculture and Forests; Thimphu: Bhutan
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 has never conducted food safety assessment of GM food but is planning to conduct such assessment in the near future.
Supplemental information on the implementation:
GM Food Safety Assessment Guidelines
The safety assessment would be conducted as per relevant technical guidelines drafted with financial and technical support from UNEP-GEF through the National Biosafety Framework Project (2012-2014). These safety guidelines have been adapted based on the internationally established scientific guidelines and principles of Codex Guidelines.
Status of GM Food Safety Assessment
Bhutan does not produce any GM food/feed as of now; however, GMOs for FFPs can be imported upon authorization. The GM foods placed in the market has to fulfil mandatory positive labelling requirement. Till date, we have not conducted any safety assessment of GM food.
Regulation of stacked events:
My country is in the process of developing relevant regulations on stacked events.
Supplemental information on the stacked events:
The DRAFT Biosafety Rules and Regulations requires that the GM food/feed containing stacked events be considered as a new product and need a full safety assessment even if the single events have prior approvals.
Production and trade
GM food/feed production:
My country does not produce any GM food or feed.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information on the production and trade:
My country does not monitor LLP/AP situations.
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