Circular 08/2025/TT-BYT prescribing dossiers and procedures for issuance of certificates for exported food under the Ministry of Health’s management

CIRCULAR

Prescribing dossiers and procedures for issuance of certificates for exported food under the Ministry of Health’s management

Pursuant to the June 22, 2015 Law on Promulgation of Legal Documents and the June 18, 2020 Law Amending and Supplementing a Number of Articles of the Law on Promulgation of Legal Documents;

Pursuant to the June 17, 2010 Law on Food Safety;

Pursuant to the Government’s Decree No. 15/2018/ND-CP of February 2, 2018, detailing the implementation of a number of articles of the Law on Food Safety;

Pursuant to the Government’s Decree No. 42/2025/ND-CP of February 27, 2025, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Vietnam Food Administration,

The Minister of Health promulgates this Circular prescribing dossiers and procedures for issuance of certificates for exported food under the Ministry of Health’s management,

Article 1. Scope of regulation

1. This Circular prescribes the competence, dossiers and procedures for issuance and revocation of certificates for exported food under the Ministry of Health’s management at the request of importing countries (below referred to as certificates).

2. This Circular does not apply to the issuance of Certificates of Free Sale (CFS) for food under the Ministry of Health’s management.

Article 2. Subjects of application

This Circular applies to export lots (a lot may comprise one or more than one commodity item, or one or more than one product lot) or establishments producing food for export under the Ministry of Health’s management.

Article 3. Certificates for exported food

1. Certificates (health certificates or other relevant certificates at the request of the importing countries) are issued to food products, food additives, food processing aids; food containers and packages at the request of organizations or individuals.

2. Certificates must be expressed in English and at least contain the following information:

a/ Name of certificates (health certificates or other relevant certificates at the request of the importing countries);

b/ Name of issuing agencies;

c/ Certificate number and date of issuance;

d/ Name of commodity items eligible for certificate issuance or name of groups of food products produced by establishments;

dd/ Expiry date/best before date of the lot of products being exported commodities, for health certificates and other certificates related to the exported lot;

Number and validity period of certificates of food safety eligibility or papers of equivalent validity, for certificates related to food production establishments;

e/ Name and address of the exporters; production establishments;

g/ Based on the testing sheet of exported food product lots, the certificates must certify that the product lot complies with Vietnam’s current regulations on food safety and fits for human consumption; or the food production establishment complies with Vietnam’s current regulations on food safety in case the certificates of food safety eligibility or papers of equivalent validity remain valid;

h/ Signature and seal of competent agencies.

3. In case an importing country requires organizations or individuals to submit certificates in the form provided by such country, the issuing agencies shall issue the certificates based on such form as requested.

Article 4. Dossiers of application for issuance of certificates

A dossier of application for issuance of a certificate for 01 (one) exported food lot or an establishment producing food for export must comprise:

1. An application for issuance of the certificate, made according to the form provided in the Appendix to this Circular;

2. A certificate of food safety eligibility or one of the following certificates: Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO 22000 Food Safety Management System, International Food Standards (IFS), Global Standard for Food Safety (BRC), Food Safety System Certification (FSSC 22000) or papers of equivalent validity that remain valid (a copy certified by the exporter), except the cases specified in Clause 1, Article 12 of the Government’s Decree No. 15/2018/ND-CP of February 2, 2015, detailing the implementation of a number of articles of the Law on Food Safety;

3. A food safety testing result sheet for a sample of the exported food product lot (for health certificates and other certificates related to the exported food product lot), containing full information on the product name and the food product lot that is issued by a designated testing laboratory or an ISO 17025 accredited testing laboratory (the original or a certified copy), and the satisfaction of the requirements of the corresponding technical regulations (for products for which technical regulations are applied) or the satisfaction of the criteria in technical regulations/requirements (for products for which technical regulations have not yet been applied) in one of the following documents:

a/ Circulars of ministries and sectors; or

b/ National standards (in case national technical regulations, circulars of ministries and sectors, local technical regulations are not available); or

c/ Standards of the Codex Alimentarius Commission (Codex), regional standards, foreign standards (in case national technical regulations, circulars of ministries and sectors, local technical regulations, national standards are not available); or

d/ The attached producer’s standards (in case national technical regulations, circulars of ministries and sectors, local technical regulations, national standards, Standards of the Codex Alimentarius Commission (Codex), regional standards, foreign standards are not available);

4. A written certification of payment of the appraisal charge for issuance of the certificate for exported food.

In case an imported country requires the certificate using the country’s prescribed form that contains the information other than that specified in Article 3 of this Circular, an organization or individual shall submit relevant papers to prove such information.

Article 5. Competence, order and procedures for issuance of certificates for exported food

1. Organizations and individuals producing or trading in export lots or establishments producing food for export that apply for certificates for exported food shall submit dossiers to the Ministry of Health (the Vietnam Food Administration) via the online public service system or hand-deliver or send by post such dossiers to the Ministry of Health’s single-window division.

2. The time limit for issuance of a certificate must not exceed 5 (five) working days after an applicant submits a complete and valid dossier. In case of refusal to issue a certificate or request for amendment or supplementation of the dossier, the dossier-receiving agency shall notify in writing to the applicant, clearly stating the reason for refusal or legal grounds of the request.

Within 5 (five) working days after receiving the amended or supplemented dossier, the dossier-receiving agency shall appraise the dossier and give a written reply.

In case the applicant fails to amend or supplement the dossier within 90 days after receiving the written request, its/his/her dossier will no longer be valid.

3. The time limit for dossier appraisal shall be counted from the time such dossier is submitted via the online public service system or the date on the arrival stamp of the dossier-receiving agency (in case the dossier is handed deliver or sent by post to Ministry of Health’s single-window division).

4. A certificate or a written notice of refusal shall be issued in the same method as the dossier is submitted.

5. The number of copies of certificates shall be issued as requested by the exporters.

6. Dossier components must be legally valid at the time of dossier submission.

Article 6. Cases subject to revocation of certificates for exported food

1. An organization or individual is detected to have provided dossier components with forged or unspecified papers.

2. A certificate for exported food issued to an export lot of which the food commodities no longer satisfy the announced applicable standards and technical regulations (if any).

3. A certificate for exported food issued to an establishment producing food for export which has a certificate of food safety eligibility or papers of equivalent validity revoked.

4. A certificate for exported food is issued beyond the competence.

Article 7. Competence and order for revocation of a certificate for exported food

1. The Ministry of Health (the Vietnam Food Administration) shall promulgate a written document on revocation of the certificate and send it to the exporter that has been issued the certificate; and concurrently post the information on the invalidation of such certificate on its website and send a written notice thereof to the customs office; the certificate shall cease to be valid after the competent agency issues a written document on the certificate revocation.

2. Within 5 (five) working days after receiving the written document, the exporter shall return the issued certificate to the Ministry of Health (the Vietnam Food Administration).

Article 8. Rights and obligations of organizations and individuals

Organizations and individuals have the following rights and obligations:

1. To be issued by competent state agencies certificates for their export lots or establishments producing food for export as requested by the importing countries.

2. To ensure the authenticity and take full responsibility before law for the declared information and documents in the dossiers of application for issuance of certificates.

3. To pay charges for appraisal of dossiers of application for issuance of certificates under current regulations.

Article 9. Powers and responsibilities of the Ministry of Health (the Vietnam Food Administration)

1. To receive dossiers and issue and revoke certificates under Articles 5, 6 and 7 of this Circular.

2. To manage and collect charges for issuance of certificates in accordance with law.

Article 10. Effect

1. This Circular takes effect on March 7, 2025.

2. The Minister of Health’s Circular No. 52/2015/TT-BYT of December 21, 2015, on the state inspection of food safety for imported food and dossiers and procedures for issuance of certificates for exported food under the management of the Ministry of Health, and ordinal number 1, Part B, Appendix 6 of the Minister of Health’s Circular No. 29/2020/TT-BYT of December 31, 2020, amending, supplementing and annulling a number of legal documents issued or jointly issued by the Minister of Health cease to be effective on the effective date of this Circular.

3. Any problems arising in the course of implementation of this Circular must be reported to the Ministry of Health (the Vietnam Food Administration) for consideration and settlement.-

For the Minister of Health

Deputy Minister

DO XUAN TUYEN