Nepal’s regulatory landscape for food safety has entered a new phase with the enactment of the Food Hygiene and Quality, 2081 (2024) (“Food Hygiene and Quality Act”). Replacing the long-standing Food Act, 2023 (1967), the Food Hygiene and Quality Act reflects Nepal’s efforts to modernize its food safety framework and align domestic practices with international standards.
This article provides the general overview of the key provisions, procedures, and compliance requirements under the Food Hygiene and Quality Act.
A. Definition of Food, and Regulation of Food Hygiene & Quality
Food Hygiene and Quality Act defines food as any unprocessed, semi-processed or processed food or beverage commonly consumed by humans, any nutritional ingredient, food additive or condiment (Marmasala) used therein, and the term also includes dietary supplements, packaged purified drinking water, alcoholic beverages, chewing gum and bubblegum.
The Government of Nepal can, time to time, determine the food quality by publishing a notification in Nepal Gazette. The provincial and local level government also has the power to regulate the food hygiene and quality within its province and local level.
B. Approval for registration of food industry
Any person willing to operate a food industry in Nepal must first obtain a recommendation letter from the Department of Food Technology and Quality Control (“DFTQC”) (or its prescribed office) and then secure an approval letter from the concerned local authority or the DFTQC, depending on the type of business.
A step-by-step procedure for obtaining approval for food business registration is provided below:
Step 1: Obtain a Recommendation Letter from the DFTQC or prescribed office
To start a food industry, such like production, processing, packaging, or storage, a person must obtain a recommendation letter from DFTQC or the relevant office. If the industry is registered under a provincial government, a person must obtain a recommendation from the provincial food hygiene office (if such office exist).
Step 2: Submit Necessary Documents for Recommendation
The following documents must be submitted along with the application for obtaining a recommendation letter, details of which are as follows:
| S.N. | Required Documents
|
| 1. | A letter from the industry registration office requesting a recommendation. |
| 2. | Details about the industry (capital amount, production capacity). |
| 3. | Technical proposal regarding the process to maintain food hygiene and quality of the food items to be produced and processed, and details of the related human resource. |
Step 3: Inspection and Issuance of Recommendation
Upon reviewing the submitted documents and conducting necessary inspections, if the proposed food industry is found capable of maintaining hygiene and quality standards, the DFTQC or prescribed office issues a recommendation letter upon payment of the prescribed fee.
Step 4: Obtain Approval Letter
Prior to commencing operations, the food industry must obtain an approval letter, details of which are as follows:
- For local businesses (such as hotels, restaurants, catering services, retail and wholesale food vendors, and street vendors), the approval must be obtained from the Chief of the local level authority or their prescribed official.
- For businesses involved in food import, export, or other activities not falling under the local authority, the approval must be obtained from the Director General of the DFTQC or the head of the prescribed office.
Step 5: Submit Necessary Documents for Approval Letter
The following documents must be submitted along with the application for obtaining an approval letter, details of which are as follows:
| S.N. | Required Documents
|
| 1. | A copy of the food business registration certificate. |
| 2. | Information regarding the types and estimated annual quantities of food products to be handled. |
| 3. | Detailed descriptions of the technologies and procedures to be used for ensuring hygiene and quality during production, processing, packaging, and storage. |
| 4. | Business address, contact information, and details of key personnel involved in the management. |
Step 6: Inspection and Issuance of Approval Letter
The approving authority conducts site inspections and laboratory testing, as necessary. If satisfied that the applicant can maintain the required standards, the authority will issue the approval letter within thirty (30) days, specifying any conditions that must be followed during the operation of the food business.
C. Validity Period and Renewal of Approval Letter
Validity Period:
The approval letter issued for operating a food business remains valid for a period of two (2) years from the date of issuance.
Application for Renewal:
Food business operators must apply for the renewal of their approval letter at least thirty-five (35) days before its expiration. The renewal application must be submitted to the same authority that issued the original approval letter, along with the required documents.
D. Suspension and Revocation of Approval Letter
The grounds for suspension and revocation of approval letter is described in the table below:
| S.N. | Grounds for Suspension | Grounds for Revocation |
|---|---|---|
| 1 | In case of failure to comply with orders issued during inspections regarding food hygiene and quality within the given deadline, the approval will be suspended until compliance is achieved. | If the food business operator voluntarily submits an application requesting the cancellation of their approval letter. |
| 2 | In case a legally authorized official or institution recommends suspension in writing, the approval may be suspended for a maximum of three (3) months. | If the registration of the food business is no longer valid or has been cancelled according to the prevailing laws. |
| 3 | In case the minimum standards of food hygiene and quality, as required under the law, are not maintained, the approval may be suspended until compliance. | – |
| 4 | In case of failure to renew the approval letter as required by law, suspension will remain in effect until renewal is completed. | – |
Note: If the suspension is due to failure to renew the approval and the permitted time for renewal has already expired, the food business operator must pay five (5) times the standard renewal fee to renew the approval to lift the suspension.
E. Import and Export of Food Products
a. Import Approval
Food business operators intending to import food products must obtain prior approval from the DFTQC (or prescribed office) before proceeding with the import.
b. Quality Certification for Export
Food business operators who wish to export food products can request the DFTQC (or prescribed office) to certify whether the products meet the quality standards of the destination country.
F. Prohibited Activities
Chapter 4 of the Food Hygiene and Quality Act provides for the prohibited activities in relation to food production, packaging, sale, and distribution, details of which are as follows:
- Selling or distributing contaminated food products.
- Selling or distributing food products in a deceptive manner.
- Using more than the permitted amount of food additives and processing aids.
- Producing, selling, or distributing food products without proper labeling.
G. Monitoring and Inspection
Chapter 5 of the Food Hygiene and Quality Act provides the framework for monitoring, inspection, to ensure compliance with food safety standards. The key provisions are:
| S.N. | Monitoring and Inspection | Details |
|---|---|---|
| 1 | Inspection | The DFTQC or Ministry of Agriculture and Livestock Development can conduct or initiate high-level investigations if activities contrary to food hygiene, quality, or management systems cause or may cause significant public harm. The DFTQC, its offices, or food inspection officers may also undertake unannounced inspections of food businesses. |
| 2 | Sample Collection and Testing | Authorized officers can collect food samples from the market when there is suspicion of non-compliance with quality standards. Samples are tested in laboratories, and if found unsafe or substandard, appropriate action and public disclosure shall follow. |
| 3 | Restriction Order | Upon reasonable suspicion of non-compliance, authorized officers may, with prior approval, order the restriction or removal of food products from sale. |
| 4 | Compliance Order | If food businesses fail to meet legal obligations, monitoring officers can issue written orders specifying a time frame for compliance. |
Note: Provincial and local authorities can appoint food inspectors to conduct monitoring and inspections within their jurisdictions.
H. Offence and Punishment
| S.N. | Offence | Punishment |
|---|---|---|
| 1 | a) Operating a food business without obtaining an approval letter; b) Undertaking activities resulting in suspension of the approval letter; c) Importing food without obtaining approval or entry permit prior to importation; d) Failure of producers, processors, packagers, importers, transporters, sellers, or service providers to fulfill obligations or acting contrary to the Food Hygiene and Quality Act; e) Undertaking any other activities prohibited by the Food Hygiene and Quality Act. | Fine up to fifty thousand rupees (NPR 50,000) |
| 2 | Producing, processing, exporting, importing, storing, transporting, selling, distributing or putting up for sale contaminated food that is: • Rotten, contaminated with garbage, or toxic; • Made of diseased or pathogenic animal/plant material; • Containing natural/artificial toxins, hormones, or psychotropic chemicals; • Containing radiation exceeding prescribed limits; • Using prohibited substances or materials under prevailing laws. | • Imprisonment up to five (5) years; or • Fine up to five lakhs (NPR 5,00,000); or • Both. |
| 3 | Producing, processing, exporting, importing, storing, transporting, selling, distributing or putting up for sale contaminated food: • Containing pathogenic microorganisms, harmful substances or chemicals exceeding prescribed limits; • Containing chemical residues (pesticides, veterinary drugs, bacterial toxins) exceeding prescribed limits. | • Imprisonment up to one (1) year; or • Fine up to four lakhs (NPR 4,00,000); or • Both. |
| 4 | a) Producing, processing, exporting, importing, storing, transporting, selling or distributing food of substandard quality; b) Producing, processing, exporting, importing, storing, transporting, selling or distributing food by deception or misrepresentation; c) Using more than the permitted amount of food additives or food processing aids. | • Imprisonment up to six (6) months; or • Fine up to three lakhs (NPR 3,00,000); or • Both. |
| 5 | Selling or distributing food without labeling, or labeling food contrary to prevailing laws. | Fine up to one lakh (NPR 1,00,000) |
| 6 | a) Selling or distributing a food product that has been ordered to be removed from sale; b) Failure to comply with an order from an inspection or monitoring officer; c) Selling or distributing a food product in contravention of a recall order. | Fine up to three lakhs (NPR 3,00,000) |
I. Conclusion
Food Hygiene and Quality Act represents a significant advancement in Nepal’s approach to regulating food safety and quality. By establishing clearer standards, modern procedures, and stronger enforcement mechanisms, the Act aims to protect public health and build greater confidence in the food sector.
Disclaimer: This article is for general informational purposes only and does not constitute legal advice, advertisement, personal communication, solicitation or inducement. No attorney-client relationship is created through this content. Gandhi & Associates assumes no liability for any consequences resulting from actions taken based on information contained herein.
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