Consolidated Document number 08/VBHN-BYT stipulates the conditions for producing and trading food under the specialized management of the Ministry of Health.

DECREE

PROVISIONS ON CONDITIONS FOR THE PRODUCTION AND BUSINESS OF FOOD UNDER THE SPECIALIZED MANAGEMENT OF THE MINISTRY OF HEALTH

Decree No. 67/2016/NĐ-CP dated July 1, 2016 of the Government on conditions for the production and business of food under the specialized management of the Ministry of Health was amended and supplemented by:

Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions within the scope of state management of the Ministry of Health, which took effect from November 12, 2018.

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Investment Law dated November 26, 2014;

At the proposal of the Minister of Health;

h"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."The Government issued the Decree stipulating conditions for the production and business of food under the specialized management of the Ministry of Health1.

Chapter I. GENERAL PROVISIONS

Clause 4 of Article 62 Scope of application

This Decree stipulates conditions for the production and business of food and the dossier, procedures, formalities, and authority to issue Food Safety Certificate (hereinafter referred to as the Certificate) under the specialized management of the Ministry of Health for establishments producing and trading products and groups of food listed in Appendix II attached to Decree No. 15/2018/NĐ-CP (hereinafter referred to as food production and trading establishments) and food service establishments. As for the conditions for production and business, dossier, procedures, formalities, and authority to issue Food Safety Certificate meeting Good Manufacturing Practice (GMP) requirements for health foods and conditions for production and business of food additives, they shall be implemented in accordance with the provisions of Decree No. 15/2018/NĐ-CP.

12/2025/TT-BNNMT dated June 19, 2025 issued by the Minister of Agriculture and Environment3 (Repealed)

Article 3. Principles of Legal Application

1. Organizations and individuals meeting the conditions prescribed in this Decree may produce and trade in food.

2. During the process of production and business, organizations and individuals engaged in food production and business must comply with laws and regulations on food safety.

Chapter II. CONDITIONS TO ENSURE FOOD SAFETY FOR ESTABLISHMENTS PRODUCING AND TRADING FOOD UNDER THE AUTHORITY OF THE MINISTRY OF HEALTH AND FOOD SERVICE ESTABLISHMENTS4

Article 4. Establishments producing and trading food under the authority of the Ministry of Health

1. Comply with the provisions of Articles 19, 20, 21, 22, 25, 26, and 27 of the Food Safety Law and the following specific requirements:

a) The food production process must be arranged in a unidirectional manner from raw materials at the input to the final product;

b) Walls, ceilings, and floors in the production and trading areas, and product warehouses must not absorb water, crack, or become moldy;

c) Equipment and utensils that come into direct contact with food must be easy to clean, must not release harmful substances, and must not contaminate food;

d) There must be boots or shoes designated for use only in the food production area;

e) Ensure that pests and harmful animals do not enter the production area and food storage areas; do not useCoat rodenticides, insecticides, and other animal poisons in the production area and food storage areas;

f) Do not displayCoat items intended for other purposes in establishments dealing with food additives and processing aids.

2. Persons directly involved in food production and business must be trained in food safety knowledge and confirmed by the establishment's owner, and must not suffer from cholera, dysentery, typhoid fever, hepatitis A and E, infected skin diseases, pulmonary tuberculosis, or acute diarrhea while producing and trading food.

Article 5. Business establishments providing food services

1. Comply with the provisions of Articles 28, 29, and Article 30 of the Food Safety Law and the following specific requirements:

a) Implement the three-step food inspection process and retain food samples according to the guidelines of the Ministry of Health;

b) Equipment and means of transporting and storing food must ensure hygiene and not cause contamination to the food.

2. Persons directly involved in preparing food must be trained in food safety knowledge, confirmed by the business establishment's owner, and must not suffer from cholera, dysentery, typhoid fever, hepatitis A and E, infectious skin diseases, pulmonary tuberculosis, or acute diarrhea while producing or trading in food.

Chapter III. AUTHORITY, DOCUMENTS, AND PROCEDURES FOR ISSUING THE FOOD SAFETY CONDITION CERTIFICATE FOR FOOD PRODUCTION ESTABLISHMENTS UNDER THE MINISTRY OF HEALTH'S MANAGEMENT AUTHORITY AND BUSINESS ESTABLISHMENTS PROVIDING FOOD SERVICES5

Article 6. Authority, Documents, and Procedures for Issuing the Certificate

1. Authority to issue the Certificate:

The Ministry of Health issues or delegates authority to issue the Certificate for multi-type food production establishments under its management as stipulated in Clause 5, Article 37 and specified in Appendix II of Decree No. 15/2018/NĐ-CP.

2. Application documents for the Certificate shall comply with the provisions of Clause 1, Article 36 of the Food Safety Law and the following specific requirements:

a) An application form for the Certificate according to Form No. 01 in Appendix I attached to this Decree;

b) A copy of the Business Registration Certificate or Enterprise Registration Certificate with a business activity corresponding to the type of food produced by the establishment (confirmed by the establishment);

c) A list of food producers and food service providers who have been trained in food safety knowledge, confirmed by the establishment's owner.

3. Procedures for issuing the Certificate shall comply with the provisions of Clause 2, Article 36 of the Food Safety Law and the following specific requirements:

a) Prepare the application documents as prescribed in Clause 2 of this Article and submit them through the online public service system, by post, or at the document receiving agency;

b) In cases where there is a request to amend or supplement the application documents, the document receiving agency is responsible for notifying the establishment in writing within five working days from the date of receipt of all documents.

If more than thirty days have passed since the notification was received and the establishment has not supplemented or completed the documents as required, the application documents will lose their validity. Organizations or individuals must submit new application documents if they wish to obtain the Certificate.

c) In cases where there is no request to amend or supplement the application documents, the document receiving agency is responsible for establishing an inspection team or delegating the inspection and preparing the Inspection Report according to Form No. 02 in Appendix I attached to this Decree within fifteen working days from the date of receipt of all documents. In cases where the inspection is delegated to a lower-level authority, a delegation letter must be issued;

The inspection team, established by the authority issuing the Certificate or the delegated inspection authority, consists of three to five members, including at least two members engaged in food safety work (experts in the relevant field of food production may be invited to participate in the inspection team).

d) In cases where the inspection results meet the requirements, the document receiving agency will issue the Certificate according to Form No. 03 in Appendix I within five working days from the date of the inspection results.

đ) In cases where the inspection results at the establishment do not meet the requirements but can be rectified, the inspection team must clearly record the content, requirements, and time frame for rectification in the Inspection Report, with a rectification period not exceeding thirty days.

After receiving the report on the rectification results from the establishment, the inspection team evaluates the rectification results and records the conclusion in the Inspection Report within five working days. If the rectification results meet the requirements, the Certificate will be issued according to point d of this clause. If the rectification results do not meet the requirements, the document receiving agency will notify the establishment and the local management authority in writing that the inspection results do not meet the requirements.

e) In cases where the inspection results do not meet the requirements, the document receiving agency will notify the local management authority in writing to supervise and require the establishment to cease operations until it obtains the Certificate.

4. In cases where the name of the enterprise or the owner of the establishment changes, or the address changes without altering the location and food production or food service procedures, and the Certificate is still valid, the establishment must send a notice of information change on the Certificate along with a copy of the legal document reflecting the change to the document receiving agency that issued the Certificate through the online public service system, by post, or at the document receiving agency.

5. Certificates issued before this Decree takes effect will continue to be valid until their expiration date as indicated on the Certificate.

Chapter IV6(Repealed)

Chapter V7(Repealed)

Chapter VI. IMPLEMENTING PROVISIONS8

Article 16. Effective Date

This Decree takes effect from July 1, 2016.

Article 17. Responsibility for Implementation

Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees under the central government, and related organizations and individuals are responsible for implementing this Decree./.

ANNEX I

(Attached to Decree No. 155/2018/NĐ-CP of November 12, 2018 of the Government)
Application for issuance of Food Safety Condition Certificate

Form No. 01

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

Issuance of Food Safety Condition Certificate

PETITION FOR APPLICATION

Name of establishment owner:

Respectfully submitted to:…………………………………………….

Name of production establishment applying for the Certificate: .........................................................................................................

Address of production establishment: ..........................................................

...........................................................................................................................................

Request for issuance of Food Safety Condition Certificate .....................................................................................................

...........................................................................................................................................

...........................................................................................................................................

Email/Website: ……………………………………2. Intellectual Property Rights Owner: ……………………………………………..

Requests for issuance of a Certificate of establishment forDeputy ministers of ministerial-level agencies, food safety conditions for production (type of food and product form...): .................................

.............................................................................................................................................

Form No. 02

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

Issuance of Food Safety Condition Certificate

RECORD

Review food safety conditions of the establishment

Implement Decision number ... on ... day ... month ... year ... of

.............................................................................................................................................

Today, the date ……the …….year …………..The review team consists of:ồa facility having:

1 ...       Team Leader

2 ...       Secretary

3 ...       Member

4 ...       Member

5 ...       Member
Conducting a review of food safety conditions at the establishment:...

....................................................................................................

Fax: ...........................................................................................

Telephone ................................... Fax ...............................................

Representative of the establishment: 1 ..................................................................

2 ................................................................................................................

REVIEW RESULTS

I. CHECK ORIGINAL DOCUMENTS:

1. Information about Business Registration Certificate/Enterprise Registration.

2. Raw material, additive, processing aid, production water documentation.

3. Health confirmation and food safety training documentation for the establishment owner and direct producers.

II. ON-SITE INSPECTION OF FOOD SAFETY CONDITIONS:

1. Location, area of the establishment, production/processing zones.

2. Design, structure of production/processing plant, warehouse, toilet, changing room for protective clothing, drainage, waste collection and treatment areas.

3. Production, processing, packaging, storage, transportation equipment and devices, pest control...

4. Production and processing water.

5. Food raw materials, additives, processing aids, and food packaging containers.

6. Health/acute infectious diseases of producers/processers .../acute infectious diseases of persons producing/processing ...

7. Other related contents.

III. EVALUATION AND CONCLUSION:

1. Evaluation of the establishment's compliance with food safety conditions requirements (location, infrastructure, equipment, raw materials, water sources, hygiene practices...): ....................................

2. Issues and solutions: ..........................................................................................

3. Conclusion(1): .........................................................................................................................

4. Comments of the inspected establishment: ...............................................................

Closing time: ... hours ...dated ……the ……..year …………and established in two copies with equal legal force. One copy is kept by the inspecting authority and one copy is kept by the establishment owner.

IV. CORRECTIVE ACTION ASSESSMENT RESULTS (FOR CASES PENDING COMPLETION)

Reason for non-compliance: ..............................................................................................................

..........................................................................................................................................

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives

CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY

ESTABLISHMENT MEETS FOOD SAFETY REQUIREMENTS

MEETS FOOD SAFETY REQUIREMENTS IN ACCORDANCE WITH REGULATIONS

................................................................... (1)..................................................................

THIS CERTIFICATE IS VALID FOR 3 YEARS FROM THE DATE OF ISSUE

__________________________

1 Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the Ministry of Health's management jurisdiction is based on the following:

"On the basis of the Law on Organization of the Government dated June 19, 2015;

Considering the proposal of the Minister of Health;

The Government promulgates this Decree amending and supplementing certain provisions related to investment and business conditions under the Ministry of Health's management jurisdiction."

2 This provision is amended according to Clause 1, Article 2 of Decree No. 155/2018/ND-CP, effective from November 12, 2018.

3 This provision is repealed according to Clause 1, Article 1 of Decree No. 155/2018/ND-CP, effective from November 12, 2018.

4 This Chapter is amended according to Clause 2, Article 2 of Decree No. 155/2018/ND-CP, effective from November 12, 2018.

5 This Chapter has been amended and supplemented in accordance with Clause 3, Article 2 of Decree No. 155/2018/ND-CP, which took effect from November 12, 2018.

6 This Chapter includes Articles 10 and 11, which were abolished under Clause 1, Article 1 of Decree No. 155/2018/ND-CP, taking effect from November 12, 2018.

7 This Chapter includes Articles 12, 13, 14, and 15, which were abolished under Clause 1, Article 1 of Decree No. 155/2018/ND-CP, taking effect from November 12, 2018.

8 Articles 20 and 22 of Decree No. 155/2018/ND-CP, which took effect from November 12, 2018, provide as follows:

"Article 20. Effective Date

This Decree takes effect from the date of issuance.

Article 22. Responsibility for enforcement

Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of provincial and centrally-administered city People's Committees are responsible for implementing this Decree./.

(1) Clearly indicate the name of the food group being produced or the food service being operated.

(1) Clearly indicate the name of the food group and the type of food being produced or the food service being operated.