Biosafety (GMO) Requirements

BACKGROUND

In 1995, Bhutan became party to the Convention on Biological Diversity (CBD); and in 2002 ratified the Cartagena Protocol on Biosafety (CPB). The Biosafety Act of Bhutan was enacted in 2015, and Biosafety Rules and Regulations in 2018. BAFAR is the national competent authority for the implementation and enforcement of the biosafety legislations.

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 effect of Genetically Modified Organisms (GMOs).

 

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.

 

Risk assessment for approval of GMOS for direct use as food, feed and for processing

While the GMOs/LMOs are prohibited, 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. The applications to import GMO products are subjected to risk assessment by Biosafety Technical Working Group based on the guidelines on environmental safety assessment and food and feed safety assessment. Based on the technical opinion provided by the Biosafety Technical Working Group, the decision to approve 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 regulated according to the labeling threshold level of 5%.

 

Import of GMO products

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.

 

Export of GMO products

BAFRA may issue export certificate for products derived from GMOs in accordance to the regulatory requirements of the importing country which should be fulfilled by the exporter.