6. Registration Processes
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6. Registration Processes
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Beers, RTDs, Whisky
Mongolia
This section provides information on any product notification or registration and manufacturing site registration processes.
6.1 Product Notification
General Food
No requirement.
Category
Alcohol
No requirement.
Product
1) Beer
Same as "Category" above.
2) Alcoholic ready-to-drink beverages (such as Chuhai)
Same as "Category" above.
3) Whisky
Same as "Category" above.
6.2 Product Registration
General Food
Not all food products are required to be registered. According to the Law on Ensuring the Safety of Food Products and MOFALI Order A/515, some categories of food products must be registered with the relevant authorities before they can be circulated in Mongolia [1, 2, 3]. These include:
- Genetically Modified Organisms (GMOs)
- Fortified food, Additives, or Microorganism Cultures
- Enrichment preparations (vitamins and minerals used for industrial fortification of food), food supplement, novel food
In addition, imported organic foods must be registered with the Ministry of Food, Agriculture, and Light Industry (MOFALI) prior to importation. Businesses intending to import organic food are required to submit their registration applications electronically through the Organic Food Registration Database [4]. Once registered, the importer must display the registration number on the product's packaging label, positioned at the bottom, to indicate the product’s organic certification. For detailed guidance on the registration process for imported organic food, please refer to the following link: https://www.mongoliatradeportal.com/index.php?r=searchProcedure/view1&id=27.
Category
Alcohol
Alcoholic beverages are not subject to product registration but are regulated through a special import license. The specific requirements and licensing procedures are detailed in Section 7.1 of this guidebook - Shipment Declaration/Category – Alcohol.
Product
1) Beer
Same as "Category" above.
2) Alcoholic ready-to-drink beverages (such as Chuhai)
Same as "Category" above.
3) Whisky
Same as "Category" above.
6.3 Other Notes or Requirements
Product Notification
N/A.
Product Registration
N/A.
6.4 Manufacturing Site Registration
General Food
Local food production facilities in Mongolia are required to be assessed by MOFALI before operating. MOFALI assesses or inspects these facilities based on checklists designed specifically for each food industry group. Details on the grouping of food production facilities and specific checklists are listed.
For imported food, manufacturers must provide proof of implemented management systems and quality practices, such as Quality and Standards Compliance Certificates (HACCP, GMP, GHP, ISO). This requirement is in line with Article 11.2.2 of the Food Law [7].
Category
Alcohol [5]
Requirements for local production of alcoholic beverages:
The Ministry of Food, Agriculture, and Light Industry (MOFALI) requires local alcoholic beverage manufacturers to obtain a Production License. MOFALI distinguishes between two types of licenses for manufacturers:
- Production of alcoholic beverages using traditional technology
- Production of alcoholic beverages using methods other than traditional technology
This regulatory measure is implemented under Chapter II of the Law on Control of the Circulation of Alcoholic Beverages and Combating Alcoholism [5]. According to the law, the Government determines the number of Production Licenses for alcoholic beverages based on factors such as population density, location, and factory capacity. Licenses for non-traditional alcohol production are auctioned, with the auction procedure approved by the government. The relevant government authority, with input from tax and inspection bodies, is responsible for issuing, renewing, suspending, restoring, or revoking licenses for non-traditional production. In contrast, licenses for traditional production are issued by provincial governors based on territorial authority decisions.
The special license includes details such as the types of alcoholic beverages, production methods, raw materials, location, and factory capacity. Any changes to these details require modification of the license. The transfer or unauthorized use of the license is prohibited, and additional regulations on licensing are governed by the Law on Permits.
Applicants (local producers) seeking a special license must submit a comprehensive set of documents, including an application, proof of stamp duty payment, plant project documentation, financial statements, details of production equipment, and information on raw materials and production capacity. Additional requirements include the installation of recording and reporting equipment, approval from tax authorities for electronic data connections, and an environmental safety assessment. A central state administrative organization is tasked with specifying additional documentation requirements.
The holder of a special license for the production of alcoholic beverages must periodically inform the state administrative bodies responsible for taxation and food regulation of any changes to the product's name or packaging size.
License Duration, Renewal, Suspension, and Revocation
- License for the production of alcoholic beverages is valid for ten years, with the option to renew it for the same duration. Applications for renewal can be processed electronically, and specific documents are required for both obtaining and renewing the license. Extensions are contingent upon compliance with legal requirements, including tax obligations. If conditions are violated or if there are tax arrears, the license cannot be extended.
- The license may be suspended if legal requirements are not met, if inspections are obstructed, or if discrepancies are found in product quantity reporting. Suspensions may last up to three months, with possible extensions. The license can be restored if the violations are rectified within the stipulated timeframe.
- The license may be revoked in cases such as business dissolution, submission of false documents, illegal sale or transfer of alcohol, or failure to comply with quality standards. Additionally, a revoked license results in a three-year prohibition on issuing a new license at the same factory location. The government must submit a proposal for revocation, and production must cease until the issue is resolved.
Requirement for importing alcoholic beverages [5]
Same as “General Food” above. Importers must provide proof that manufacturers implement management systems and quality practices, such as Quality and Standards Compliance Certificates (HACCP, GMP, GHP, ISO). This requirement is in line with Article 11.2.2 of the Food Law [7].
In contrast to domestic manufacturers, the importation of alcoholic beverages does not require the manufacturer to be registered or licensed. Instead, importers in Mongolia must obtain an import license for alcoholic beverages, which is issued by the Ministry of Food, Agriculture, and Light Industry (MOFALI).
More specific information regarding import licenses is provided in Section 7.1 of this guidebook (Shipment Declaration - Category – Alcohol).
Product
1) Beer
Same as "Category" (Alcohol) above.
2) Alcoholic ready-to-drink beverages (such as Chuhai)
Same as "Category" (Alcohol) above.
3) Whisky
Same as "Category" (Alcohol) above.
6.4.1 Standard/Rules for Manufacturing Site
General Food
Food production facilities in Mongolia are required to be assessed by MOFALI before operating. MOFALI assesses or inspects these facilities based on checklists designed specifically for each food industry group. Relevant checklists are mentioned in Section 6.4 above - Manufacturing Site Registration/General Food.
Category
Alcohol
Requirements for manufacturing sites [5]
Local manufacturers must meet several operational and technical requirements. These include having certified buildings, equipment, and warehouses, and installing recording equipment connected to a unified network. Production must follow certified technological procedures, with internal controls ensuring product quality, hygiene, and safety at each stage of production. The license holder must also maintain a laboratory for quality control, ensure compliance with electronic payment systems, and implement environmental impact assessments.
Alcohol production must adhere to approved technological procedures and sanitary standards. Producers are required to use dedicated equipment with controlled input and output, ensuring compliance with technical regulations. Producers must also maintain records of product withdrawals and ensure proper connection to tax and food safety databases. The use of a single assigned name for alcoholic beverages with the same ingredients and characteristics is mandatory.
To ensure compliance, MOFALI has published checklists for manufacturers to follow, which are used as the basis for MOFALI’s evaluations when issuing licenses. These checklists can be found at:
- Checklist for Alcohol and Spirits Production - https://mofa.gov.mn/files/pdf-files/99qxfs9xbjk/660128c2a53d8535c7a1c93b.pdf
- Checklist for beer and wine production - https://mofa.gov.mn/files/pdf-files/mviz52xvnea/6601294fa53d8535c7a1c94d.pdf
- Vodka and special vodkas production - https://mofa.gov.mn/files/pdf-files/rfjgpe2w2gh/66012959a53d8535c7a1c94f.pdf
Common requirements for all types of alcohol production [5]
1) Quality and Safety Control System:
- The production of alcoholic beverages must adhere to the "General principles of food hygiene" in line with the MNS CAC/RCP 1 standard.
- Departments, units, and employees must be assigned responsibility for product quality.
- A laboratory must be in place to control production processes, raw materials, and finished products, meeting the MNS ISO/IEC 17025 standard.
- The quality department must certify each batch of products based on laboratory test results and issue a quality certificate.
- A comprehensive analysis of raw materials and products must be conducted at least quarterly or when new production starts, or when resuming after a long break, by an accredited external laboratory. Costs for testing and certification are borne by the manufacturer.
2) Metering and Equipment:
- Alcohol production lines must be equipped with metered special equipment, certified under the Law on Uniformity of Measurements, and registered in the state registry.
- Monitoring of these meters must follow procedures approved by the relevant authorities.
3) Record Keeping:
- Detailed records must be kept for production, including dates, shifts, quality status, and batch details, with additional protection measures against counterfeit products as needed.
4) Personnel Qualifications and Training:
- Upper and middle management, as well as relevant personnel, must be trained and certified in standards, technical regulations, and quality control.
- Technologists and laboratory managers must hold at least a bachelor's degree in relevant fields, such as food production technology or fermentation.
- Foremen and laboratory technicians must also have relevant degrees or specialized education and training in food production or chemical technology.
- All main production workers should undergo professional courses and training.
5) Compliance with Standards:
- Manufacturers must ensure that employees are trained when new or updated standards and technical regulations are released.
6) Prohibition on Uncertified Materials:
- It is prohibited to use raw materials or products in production without proper certification or quality guarantees from authorized organizations or suppliers.
Alcohol production is prohibited in the following locations:
- Offices, buildings, and land owned and operated by government organizations.
- Kindergartens, schools of all levels, hospitals, sanatoriums, cultural and artistic centers, and all other types of buildings owned and operated by these institutions.
- All types of buildings and structures are used for sports training, preparation, competitions, and events.
- Schools and student dormitories.
- Residential buildings for public use include entrances, basements, extensions, and basement floors.
- Trains, road transport, maritime transport, and airports.
Requirement for overseas manufacturing sites [5]
To obtain or renew this import license, importers are required to submit the following documents: application forms, proof of stamp duty payment, and financial statements. In addition, they must provide certificates confirming compliance with quality standards and excise tax regulations. Importers must also submit information on warehouse facilities, ensure the installation of safety equipment (such as video surveillance systems), and obtain approval for electronic data connections. Additionally, imported samples must undergo analysis in line with customs regulations to ensure compliance with hygiene and safety standards.
The specific procedures and requirements for obtaining the import license are outlined in Section 7.1 of this guidebook (Shipment Declaration/Category – Alcohol).
Product
1) Beer
Same as "Category" above.
2) Alcoholic ready-to-drink beverages (such as Chuhai)
Same as "Category" above.
3) Whisky
Same as "Category" above.
6.4.2 Other Notes or Requirements for Manufacturing Site Registration
N/A.
6.5 References
1. Law on Ensuring the Safety of Food Products
https://legalinfo.mn/en/edtl/16959947951091
2. Law on fortified food
https://faolex.fao.org/docs/pdf/mon185604.pdf
3. Order A/515 of the Ministry of Food, Agriculture and Light Industry validating the Procedure for registration and release of nutrient enhancers (enriched foodstuffs), food additives, growth additives, and food produced with new technologies
https://faolex.fao.org/docs/pdf/mon215105.pdf
4. Order Of the Minister Of Food Agriculture And Light Industry on Approval of Procedure/Registration of Importing an Organic Food And Publication For Public Use/, 2018 А/180
5. Law on control of the circulation of alcoholic beverages and combating alcoholism
https://legalinfo.mn/mn/detail?lawId=16530861302491
6. Decision of The Government of Mongolia on Technical Regulation for The Production of Alcoholic Beverages MNTR 1:2008
https://legalinfo.mn/mn/detail?lawId=4214
7. Requirements for importing food ingredients and products
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