Bhutan

Country introduction:

Bhutan regulates genetically modified organisms (GMOs) and products derived from GMOs under the Biosafety Act of Bhutan 2015 and the Biosafety Rules and Regulations of Bhutan 2018. The Bhutan Food and Drug Authority (BFDA), Ministry of Health, is the National Competent Authority responsible for the regulation of GM food and feed, including safety assessment and import control. The Biosafety Technical Working Group (BTWG) provides technical review and recommendations on GMO risk assessments.
Bhutan has established national Guidelines on Safety Assessment of Food and Feed Derived from Genetically Modified (GM) Plants, based on relevant international and Codex principles. The import of approved GM-derived food and feed in non-reproducible/non-viable form is permitted subject to safety assessment and authorization, while viable GMOs/LMOs are restricted. GM-derived products are subject to mandatory labelling where the GM content exceeds 5% of an individual ingredient. The National Food Testing Laboratory (NFTL), BFDA, has a Biotechnology (GMO/LMOs) Section supporting GMO testing and monitoring.
Bhutan is a Party to the Cartagena Protocol on Biosafety, having ratified the Protocol in 2003, and follows a precautionary approach to protect biodiversity, the environment, human and animal health.

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):

Bhutan has a regulatory framework for the safety assessment of GM food and feed under the Biosafety Act of Bhutan 2015 and Biosafety Rules and Regulations of Bhutan 2018. The framework requires risk assessment and safety review of GM food/feed intended for direct use as food, feed or processing. Applications are technically reviewed by the Biosafety Technical Working Group and approved by the National Biosafety Board.

Relevant contact details:

The Bhutan Food and Drug Authority (BFDA), Ministry of Health, is the current National Competent Authority responsible for implementation and enforcement of biosafety-related activities. The Biosafety Technical Working Group provides scientific and technical review of applications and assesses the safety and acceptability of GMOs and products derived from GMOs for food, feed or processing. The National Biosafety Board is responsible for considering the technical recommendations and making decisions on applications. The product applicant/importer is required to submit the prescribed application and supporting information to BFDA for risk assessment and approval prior to importation.

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 (assessment):

Bhutan has established the regulatory and technical framework for conducting GM food safety assessments. The Guidelines on Safety Assessment of Food and Feed Derived from Genetically Modified (GM) Plants, 2025, provide the procedures and information requirements for applicants and reviewers. GM food safety assessments will be conducted when applications for GM-derived food or feed are received.

Regulation stacked events:

Stacked events require full assessment as a new GM event.

Supplemental information (stacked events):

Bhutan does not produce GM food or feed. The national biosafety framework prohibits activities involving viable GMOs/LMOs, while processed or non-viable products derived from GMOs may be imported subject to risk assessment and authorization.

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 (production and trade):

Import of food and feed derived from GMOs in non-reproducible form is subject to risk assessment by the Biosafety Technical Working Group and final approval by the BFDA Governing Board. Following approval, the applicant is required to obtain an import permit from BFDA in accordance with the Biosafety Rules and Regulations 2018.

LLP/AP incidents:

My country has not faced any LLP/AP situations in the last 10 years.

Supplemental information (LLP/AP incidents):

No LLP/AP incidents involving GM food or feed have been reported in Bhutan in the last 10 years. Bhutan has established measures for managing potential GMO incidents, including low-level presence in food and feed, under its biosafety framework.

Labelling requirement:

My country has a mandatory and positive labeling regulation on GM food (i.e., It contains GMO).

Supplemental information (labelling requirement):

Bhutan has mandatory positive labelling requirements for products derived from GMOs. Under Clause 80 of the Biosafety Rules and Regulations of Bhutan 2018, labelling is required where GMO content exceeds 5% of an individual ingredient. Highly refined foods or food ingredients where processing has removed all novel DNA/protein, and foods from animals fed with GM feed, are exempt from the labelling requirement.

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BCH:

FAO GM Foods Platform

Bhutan