The biosafety requirements are aimed to protect, conserve and safeguard the biodiversity of Bhutan and also to promote the nation’s food and nutrition security by safeguarding plants, animals and human health from unintended effects of Genetically Modified Organisms (GMOs). GMOs are regulated in pursuant to Biosafety Act of Bhutan 2015 (http://www.bafra.gov.bt/BHUTAN_Biosafety_Act_2015.pdf) and Biosafety Rules and Regulations 2018 (http://www.bafra.gov.bt/wp-content/uploads/2015/06/Biosafety-Rules-Regulations-2018.pdf).

Prohibitions on Import, Research and use of GMOs

The following activities are prohibited in the Kingdom:

1. Import of any genetically modified organism capable of reproducing
2. Transit of genetically modified organisms capable of reproducing;
3. Intentional introduction into environment of genetically modified organisms capable of reproducing;
4. Any use, including contained use, of genetically modified organisms capable of reproducing; and
5. Research and development that involves genetically modified organisms capable of reproducing.

Exemptions under Biosafety Act

This Act does not regulate the:

1. Traditional and domestic methods of animal and plant breeding;
2. Traditional and domestic exchange and sale of local seeds, plants, and livestock;
3. Gene sequencing, tissue culture, and other similar methods, which do not involve the use of modern biotechnology; and
4. Products derived from GMOs for pharmaceuticals for human and veterinary use.

Import of GMO products

The products derived from GMOs in non-viable form (not capable of reproducing in the environment) is allowed for import for direct use as food, feed and for processing, subject to safety assessment and approval process. All applicants intending to import GMOs and products derived from GMOs for direct use as food feed or for processing shall obtain a permit from BAFRA which shall be issued upon risk assessment by Biosafety Technical Working Group based on the guidelines on food and feed safety assessment and  environmental safety assessment and the decision to approve GMO is made by the National Biosafety Board, the highest decision-making body for all Biosafety related activities.

As of now, BAFRA has not received any application for import of food products derived from GMOs therefore, we do not have any risk assessment record and no approved GMOs in Bhutan.

Labeling requirement 

The labeling requirements of all approved commercial products derived from GMOs placed in the market shall be subjected to labelling to facilitate informed choices to consumers, if it contains GMOs in proportion more than 5% of the GM ingredient considered individually and additionally be in accordance with the mandatory standards/requirements on labeling for foods derived from GMOs.

Highly refined food or food ingredients, where processing has removed all novel DNA/Protein and foods from animals which were fed with GM feed are exempted from labelling requirements.