E-mail:
Country:
Bhutan
Organization/agency name (Full name):
Bhutan Food and Drug Authority
Contact person name:
Mr. Jambay Dorji
Website:
Physical full address:
Bhutan Food and Drug Authority, Ministry of Health, Post Box: 1071, Thimphu, Bhutan
Phone number:
+975 2 327031
Fax number:
+975 2 327032
Country introduction
Summary:
The GM food in Bhutan is regulated as per the Biosafety Act of Bhutan 2015 and its Rules and Regulations 2018. The Act was enacted in July 2015 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 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 of the policy issues as well as public inputs.
Framework
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:
The Biosafety Act of Bhutan 2015 Bhutan Agriculture and Food Regulatory Authority (BAFRA) 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.
For imptation 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 Food and Drug Authority, Ministry of Health.
Assessment
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:
The safety assessment would be conducted as per relevant technical guidelines developed 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.
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.
Stacked events
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:
The Biosafety Rules and Regulations 2018 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.
refer chapter IV, clause 34-For GM food/feed containing stacked events, the applicant shall submit new application for approval of GMOs.
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:
GM food and feed in non reproducible form is allowed for import into the country provided risk assessment has been carried out and approved by National Biosafety Board.
LLP/AP incidents
LLP/AP incidents:
My country does not monitor LLP/AP situations.
Supplemental information on the LLP/AP incidents:
Labelling requirement
Labelling requirement:
My country has a mandatory and positive labeling regulation on GM food (i.e., It contains GMO).
Supplemental information on the Labelling requirement:
As per the Biosafety Rules and Regulations 2018 approved GMOs in non reproducible form by the National Biosafety Board requires labelling if the GMO content is above 5%.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment
Other relevant documents:
Country information last modified:
04/03/2024
