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Food Quality and Safety Division

Background

The Food Quality and Safety Division (FQSD) is responsible for ensuring that all food available in the country is safe, hygienic, and of high quality, in compliance with national standards and regulations. The division is responsible for implementing the Food Act of Bhutan 2005 and its Rules and Regulations 2017. The division plays a crucial role in monitoring and enforcing food safety standards through regular inspection, testing and certification of both imported and domestically produced food products. FQSD also oversees risk assessment and management, ensuring that potential threats to food safety are identified and mitigated in a timely manner.
Additionally, FQSD works closely with stakeholders across the food supply chain, from producers to consumers, to promote good hygienic practices, food safety awareness and capacity building. It also facilitates development and revision of food safety guidelines, standards and procedures to align with international best practices such as those of Codex Alimentarius. Through its efforts, the Food Quality and Safety Division contributes to protection of public health and enhancement of consumer confidence in the national food system.

Who is Who

Name Designation Email ID
Dechen Wangmo Chief Regulatory and Quarantine Officer dechenwangmo@bfda.gov.bt
Jambay Dorji Dy. Chief Regulatory and Quarantine Officer jambaydorji@bfda.gov.bt
Sonam Choden Regulatory and Quarantine Officer sonamc@bfda.gov.bt
Dechen Seldon Regulatory and Quarantine Officer dselden@bfda.gov.bt

Mandates

“To ensure quality and safety of food”

  1. Develop and implement national Policy and Regulatory Framework
  2. Inspection and Enforcement
  3. Licensing and Registration
  4. Import and Export Regulation of food and agricultural commodities
  5. Food Safety Assessment and Surveillance
  6. Incident Management and Emergency Response
  7. Promotion of internationally recognized Good Practices including public awareness
  8. Provide food testing services
  9. Collaboration and Coordination with relevant national, regional, and international agencies on matters relating to food safety and quality.
  10. Capacity Building of officials in various areas of food safety to ensure effective implementation of food safety and quality programs.

Services

Section 26 to 39 of the Food Rules and Regulations of Bhutan (2017) aims at enhancement of food safety and the orderly development of the food industries by defining minimum requirements for food businesses and procedures for licensing of the food businesses.
Any person who intends to operate a food business shall obtain a food safety license from BFDA to operate the food business. A food business that complies with BFDA GHP/GMP Criteria for Licensing of food business will be issued a food safety license. The operator shall apply to BFDA for licensing of food business by filling in the application form and with the relevant supporting documents. The issuance of the Food Safety License is done in accordance with BFDA’s Food Safety Licensing Process.

Implementation of ISO/IEC 17020: General

A food business that complies with BFDA GHP/GMP Criteria for Licensing of food business will be issued a food safety license. The operator shall apply to BFDA for licensing of food business by filling in the application form: BFDA-IS-FM-82. The issuance of the Food Safety License is done in accordance with BFDA’s Food Safety Licensing Process. BFDA-IS charges fees for the inspection and licensing activities as follows and also has mentioned it on their website. – Application Registration Fee: Nu. 100 – Food Safety Licensing Fee: Nu. 500.
    1. BFDA’s Licensing Process for Food Business: 
    2. Food Business at project stage at the time of application
    3. Food Business with an established structure at the time of application
    4. BFDA GHP/GMP, Version 3, 2024: 
    5. BFDA-IS Quality Policy: 
    6. BFDA-IS Impartiality statement: 
    7. FSL updated client list: 
    8. Inspection Services of BFDA- Scope and Activities: 
    9. Guideline for use of Food Safety License Mark: 
    10. Procedure for maintaining confidentiality of Data and Information: 
    11. Procedure for handling complaints:   
    12. Procedure for handling appeals: 
    13. Procedure for Publicly Available Information:  
    14. Procedure for Operation of Impartiality Committee: 
    15. Procedure for Management of Impartiality and Conflict of Interest: 

Suspension/ cancellation of Food Safety License

BFDA shall suspend/ cancel the license when the Food Business contravenes the terms and conditions of Food Safety license and provision of Licensing process.
Section 44 to 48 of Food Rules and Regulation defines the need and the importance of licensing of food handlers and the food handlers to at least have the basic knowledge of food safety and hygiene.
BFDA conducts the Food Handlers’ Training, free of charge, for all people who supervise and/or handle food or food contact surfaces. The training is conducted for the food handlers working in food catering units, food processing units, home-based and street food vendors. The training is uniformly provided throughout 20 Dzongkhags based on standard training manuals which are available for download.

Any person can apply for Food Handlers’ Training by registering with BFDA using the application form: BFDA-IS-FM-150   and medical certificate form: BFDA-IS-FM-121. The filled application needs to be duly submitted to the respective BFDA offices. BFDA issues food handlers license after a health screening and interview, training on food safety, and signing an undertaking that the food handler and all those under their supervision avoid themselves from handling food under certain conditions of illness as listed below;

  1. Hepatitis A (Jaundice)
  2. Diarrhoea
  3. Vomiting
  4. Fever
  5. Sore throat with fever
  6. Visibly infected skin lesions (boils, cuts etc.)
  7. Discharge for ear, eye, and nose
The importation of food into Bhutan is strictly governed by the Food Act of Bhutan and its corresponding rules and regulations, which aim to ensure the safety, quality, and compliance of all food products entering the country. Under the current legal framework, any food intended for import must first be certified by a recognized authority in the country of origin. This certification serves as confirmation that the product meets essential safety and quality standards. Furthermore, imported food must comply with the specific standards established by Bhutan for the respective food category. These standards may include microbiological criteria, permissible levels of contaminants, additives, and other food safety parameters, as defined by national authority.
In addition to product compliance, all other aspects such as containers, packaging materials, labelling, and listed ingredients are subject to inspection by a designated food inspector upon arrival in Bhutan. Inspection fees may be levied as established by the BFDA Board. Finally, for effective monitoring and regulatory control, food imports are permitted only through officially designated border entry points.

Currently we regulate imports of a few foods such as seaweed, milk and food ingredients and other fresh and processed meats are regulated by the Animal Biosecurity division. For import of seaweed importers are required to apply using application form Application form-for-the-import-of-Seaweed and applicants are required to submit certificate of analysis from accredited laboratory for indicated heavy metals in the application. For import of milk from India importers are required to apply using Application-Form-for-Import-of-Milk and fullill all the requirements and produce certificate of analysis from accredited laboratory for aflatoxin M1 for specific batch of milk during entry. For import of food ingredients importers are required to use application form APPLICATION FORM FOR IMPORT OF FOOD AND FOOD INGREDIENTS and fulfill prescribed requirement. 

All food imported into Bhutan must have at least 50% of its shelf life at the time of entry into Bhutan.

Food exported from Bhutan is subject to inspection by a food inspector, including its containers, packaging, labelling, and ingredients. Applicable inspection fees may be levied as determined by the BFDA Board. Exporters must notify the BFDA of any inspection, analysis, or documentation required by the importing country. These services may also incur fees set by the Minister after consultation with the Commission. All food exports must occur through officially designated border points.

To export food commodities from Bhutan, exporters must submit an application using the designated form available at: APPLICATION-FORM-FOR-EXPORT-OF-FOOD-COMMODITIES The Bhutan Food and Drug Authority (BFDA) will only certify food products for export that are manufactured by food businesses operating under its official food control system.

The import of GMOs and products derived from GMOs, intended for direct use as food, feed, or for processing in non-reproducible form, must be accompanied by a completed application form for the safety assessment of foods derived from genetically modified plants :Application_Form_for_the_Safety_Assessment_of_GM_Food_and_Feed_11.pdf
Once the safety assessment is completed and approved by the BFDA Board, an import permit will be issued. For GMO products that are being imported into the country for the first time, the approval process takes 125 days, while previously approved GMOs by Bhutan require 10 working days for approval.

The permit shall be valid for a period of sixty (60) days from the date of issue, but may be renewed for 30 days unless there is non-compliance to any of the imposed conditions. 

Food Testing Services

National Food Testing Laboratory

The testing services for regulation and monitoring of food quality and safety is provided by National Food Testing Laboratory (NFTL) established under Food Safety and Quality Division (FSQD), BAFRA. At the district level, the basic testing of food commodities are carried out in the Satellite laboratories. Further, NFTL also provides technical backstopping to the inspection services of BAFRA and facilitates trade by providing the analytical services. National Food Testing Laboratory was established as the National Quality Control Laboratory in 2001 and the change in the nomenclature came into effect from May, 2011. Since then, NFTL has been engaged in testing of food products and water samples. The services are provided to both in-house regulatory inspectors and customers such as other government agencies, private sectors and the general public. Additionally, the lab is also responsible for providing food-testing services for trade facilitation including both import and export. It has testing facilities for Food Microbiology, Food Chemistry and GMO Detection.
To provide food testing services to the regulators, food businesses and the general public, National Food Testing Laboratory was established and it has following testing facilities:
  1. Food Microbiology Section with test parameters (Testing scope)
  2. Food Chemistry (Residues, Contaminants and Nutrition sections) with test parameters (Testing scope)
  3. Biotechnology (GMO/LMOs) section with test parameters (Testing scope)

Submission of  Sample Forms  through LIMS Click here 

Food Sample Submission Form   click here

Implementation of ISO/IEC 17025

Further, in an effort to be at internationally acceptable level of competence, to ensure compliance with the quality system and to gain customer confidence in the Test Reports issued, NFTL is accredited for ISO/IEC 17025: 2017 General Requirements for the Competence of Testing and Calibration Laboratories since 2012 by National Accreditation Board for Testing and Calibration Laboratories (NABL), India and for the scope of accreditation Click here

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