Circular No. 17/2024/TT-BNNPTNT dated November 28, 2024 on amendments to Circulars prescribing assessment and certification of compliance with food safety regulations of agro-forestry-fishery food manufacturing and trading businesses under the management of Ministry of Agriculture and Rural Development

CIRCULAR

AMENDMENTS TO CERTAIN CIRCULARS PRESCRIBING ASSESSMENT AND CERTIFICATION OF COMPLIANCE WITH FOOD SAFETY REGULATIONS OF AGRO-FORESTRY-FISHERY FOOD MANUFACTURING AND TRADING BUSINESSES UNDER THE MANAGEMENT OF MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Government’s Decree No. 105/2022/ND-CP dated December 22, 2022 defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

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

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

Pursuant to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 elaborating some Articles of the Law on Food Safety;

Pursuant to the Law on Products and Goods Quality dated November 21, 2007;

Pursuant to the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 elaborating certain Articles of the Law on Product and Goods Quality; Government’s Decree No. 74/2018/ND-CP dated May 15, 2018 amending Decree No. 132/2008/ND-CP ; Government’s Decree No. 13/2022/ND-CP dated January 21, 2022 amending Decree No. 132/2008/ND-CP and Decree No. 86/2012/ND-CP dated October 19, 2012 elaborating and providing guidance on implementation of certain Articles of the Law on Measurement;

At the request of the Director of the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development;

The Minister of Agriculture and Rural Development hereby promulgates a Circular on amendments to certain Circulars prescribing assessment and certification of compliance with food safety regulations of agro-forestry-fishery food manufacturing and trading businesses under the management of Ministry of Agriculture and Rural Development.

Article 1. Amendments to certain Articles of the Circular No. 38/2018/TT-BNNPTNT dated December 25, 2018 of the Minister of Agriculture and Rural Development prescribing assessment and certification of compliance with food safety regulations of agro-forestry-fishery food manufacturing and trading businesses under the management of Ministry of Agriculture and Rural Development (hereinafter referred to as “the Circular No. 38/2018/TT-BNNPTNT):

1. Title of the Circular is amended as follows:

“Circular providing guidelines for certification of compliance with food safety regulations of businesses during production and trading of food under the management of the Ministry of Agriculture and Rural Development”

2. Article 1 is amended as follows:

“Article 1. Scope

This Circular provides guidelines for certification of compliance with food safety regulations and food safety inspection of food manufacturing and trading businesses under the management of Ministry of Agriculture and Rural Development, responsibilities and authority of parties involved”

3. Article 2 is amended as follows:

“Article 2. Regulated entities

1. Entities having their compliance with food safety regulations certified:

Food manufacturing and trading businesses that are put under the control of Ministry of Agriculture and Rural Development (hereinafter referred to as “businesses”), except the following:

a) Small-scale initial production businesses;

b) Food production and trading businesses that do not have fixed locations or fishing vessels with the maximum length of less than 15 meters;

c) Small-scale food processing businesses;

d) Small-scale food trading businesses;

dd) Ready-to-eat food trading businesses;

e) Agro-forestry-fishery production and trading businesses that have already been awarded one of the following certificates: Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Point (HACCP) System, Food Safety Management System ISO 22000, International Food Standard (IFS), Global Standard for Food Safety (BRC), Food Safety System Certificate (FSSC 22000) or equivalent, all of which must remain valid.

2. Entities undergoing food safety inspection:

a) The businesses stipulated in clause 1 of this Article;

b) Agro-forestry-fishery production and trading businesses that have already been awarded one of the following certificates: Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Point (HACCP) System, Food Safety Management System ISO 22000, International Food Standard (IFS), Global Standard for Food Safety (BRC), Food Safety System Certificate (FSSC 22000) or equivalent, all of which must remain valid.

3. Agencies, organizations or individuals whose activities are related to assurance of food safety during food manufacturing and trading by those prescribed in clauses 1 and 2 of this Article.”

4. Article 3 is amended as follows:

“Article 3. Definition

For the purposes of this Circular, terms used herein shall be construed as follows:

1. “agro-forestry-fishery food trading business” means an entity performing a single, certain or all of activities and services, such as preserving, transporting or trading agro-forestry-fishery food or salt.

2. “business carrying out the initial manufacturing of an agro-forestry-fishery food” means an entity performing a single, certain or all of activities and services, such as growing, farming, cultivation, harvest, catching and production of agro-forestry-fishery food and manufacturing of salt.

3. “assessment” means an inspection and verification of legitimacy of documentation and physical inspection of compliance with food safety regulations of an agro-forestry-fishery food production and trading business as prescribed by law.”

5. Article 5 is amended as follows:

“Article 5. Authority to grant and revoke certificates of compliance with food safety regulations (hereinafter referred to as “Certificates”); inspection of food safety

1. Competent bodies at the central level which grant and revoke Certificates; carry out food safety inspections shall be specialized Departments that perform tasks assigned by the Ministry of Agriculture and Rural Development within the scope of management with regard to businesses that:

a) Directly export food or participate in manufacturing, semi-processing, processing or preservation of food for export to countries and territories imposing requirements for health certification or food safety certification granted by Vietnam’s competent bodies;

b) Apply for registration or compilation of or addition to the Export List or other certificates granted by Vietnam’s competent bodies in accordance with regulations of the export market;

2. Assessment bodies at the local level shall be specialized agencies to which the authority to grant and revoke Certificates; conduct food safety inspection of local agro-forestry-fishery production and trading businesses and fishing vessels of other local authorities that so request (except for the businesses specified in clause 1 of this Article) is delegated by People’s Committees of provinces and cities;

In case an importing country’s competent body does not request the central competent body to directly grant or revoke the Certificate, the local competent body shall grant or revoke the Certificate and conduct food safety inspection of the business specified in point a or b clause 1 of this Article.”

6. Article 6 is amended as follows:

“Article 6. Grant of Certificates; inspection of food safety

1. The following businesses shall apply for the Certificate:

a) Businesses that are required to obtain the Certificate for their operation as prescribed in clause 1 Article 2 of this Circular but have yet to undergo assessment and to be granted the Certificate;

b) Businesses that have been granted the Certificate but have had it revoked;

c) Businesses whose Certificate that will expire in less than 6 (six) months or businesses that have suspended their production for more than 12 (twelve) months from the date on which the notification is sent to the body having authority to grant the Certificate;

d) Businesses that change their legal representative or system for management of requirements for compliance with food safety regulations (repair, upgradation, expansion or relocation to a new manufacturing site).

2. Food safety inspection shall be carried out as prescribed in Article 17 of this Circular.”0}

7. Point d clause 1 of Article 7 is amended as follows:

“d) Collection of test samples: The sampling shall be considered and decided by relying on the evaluation of risks in case there is any suspicion that food products fail to meet requirements for compliance with food safety regulations or the food safety control by a business fail to comply with regulations. The collection and analysis of samples shall comply with prevailing regulations.”

8. Clause 2 of Article 7 is amended as follows:

“2. Method of assessment includes reviewing and evaluating documents, materials and current conditions of conformance to requirements for compliance with food safety regulations at a business: factory, equipment, resources for management and program for management of food safety, tracing, recall and handling of products that fail to comply with food safety regulations, implementation results and interviewing related persons and carrying out sampling where necessary.”

9. Article 8 is amended as follows:

“Article 8. Business classification

1. A business shall be classified into:

a) Satisfactory: The business fully complies with requirements for compliance with food safety regulations as prescribed by law;

b) Unsatisfactory: The business has not yet conformed to requirements for compliance with food safety regulations or there is still a non-conformity that cannot be corrected within the required time limit.

2. Guidelines for assessment and classification according to assessment report corresponding to each type of business are provided in the Appendix II and Appendix III enclosed herewith. If the manufacturing and trading business falls into any of the cases specified in clauses 8 and 10 Article 36 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018, the assessment of requirements for compliance with food safety regulations of such business shall be carried out as per regulations applicable to corresponding industries and sectors.”

10. Clauses 1 and 2 of Article 10 are amended as follows:

“1. Eligibility requirements applicable to a member of the assessment team:

a) Be honest and objective, and have no conflict of interest with the assessed business;

b) Have professional qualifications in the assessment sector;

c) Have already completed a professional training or refresher training course on assessment or training or refresher training course on inspection and examination in the assessment sector.

2. Eligibility requirements applicable to the head of the assessment team

a) Meet the requirements set out in clause 1 of this Article;

b) Have at least 02 (two) years of work experience and have already participated in assessing at least 05 businesses in the assessment sector.”

11. Article 11 is amended as follows:

“Article 11. Fees, charges

The collection of fees and charges for the assessment serving the purposes of granting Certificates shall comply with regulations of law on fees and charges”.

12. Title of Chapter II is amended as follows:

“Chapter II

CERTIFICATION COMPLIANCE OF AGRO-FORESTRY-FISHERY FOOD PRODUCTION AND TRADING BUSINESSES WITH FOOD SAFETY REGULATIONS AND FOOD SAFETY INSPECTION THEREOF”

13. Title of Section 1 Chapter II is amended as follows:

“Section 1. GRANT AND REVOCATION OF CERTIFICATES OF COMPLIANCE OF AGRO-FORESTRY-FISHERY FOOD PRODUCTION AND TRADING BUSINESSES WITH FOOD SAFETY REGULATIONS”

14. Article 12 is amended as follows:

“Article 12. Application for Certificates

1. An application for Certificate is composed of the documents specified in clause 1 Article 36 of the Law on Food Safety.

An application form for Certificate of compliance with food safety regulations in the Appendix V to this Circular; Form of description of infrastructure, equipment and tools used for ensuring the conformance to requirements for compliance with food safety regulations in the Appendix VI to this Circular; Certificate of training in food safety knowledge of the business owner and person directly manufacturing and trading food provided and confirmed by the business owner.

2. An organization or individual shall submit the application for Certificate to the competent body specified in Article 5 of this Circular via the online public service system, by post or in person at the competent body.

3. After receiving the application, the competent body shall verify its adequacy and validity and notify the business of the result and estimated date of assessment in case the application is valid; or in case the application is unsatisfactory, give a written notice indicating reasons therefor.

15. Clause 1 of Article 13 is amended as follows:

“1. The competent body specified in Article 5 of this Circular shall issue a decision on establishment of assessment team after receiving the notification that the application is valid. The decision on establishment of an assessment team shall be comprised of the following information:

a) Bases for carrying out the assessment;

b) Scope, contents;

c) Name and address of the assessed business;

d) Full names and title of the Head, deputy head (if any) and members of the assessment team;

dd) Responsibilities of the assessed business and the assessment team.”

16. Article 14 is amended as follows:

“Article 14. On-site assessment

An on-site assessment shall be conducted within 15 (fifteen) days from the date of receiving a sufficient and valid application specified in point b clause 2 Article 36 of the Law on Food Safety. To be specific:

1. The assessment team shall release its establishment decision and clearly state the purposes and contents of the assessment.

2. Carry out physical assessment: review and evaluate documents, materials and current conditions of conformance to requirements for compliance with food safety regulations including factory, equipment, resources for management and programs for management of food safety, tracing, recall and handling of products that fail to comply with food safety regulations, implementation results; interview related persons and carry out sampling where necessary as prescribed in point d clause 1 Article 7 of this Circular.

3. Prepare an assessment report and inform the assessment results to the business’ representative.

4. In case of discovering that the business commits a violation, the assessment team shall issue a notice of administrative violation and submit it to a competent body or competent person for penalty imposition in accordance with laws.”

17. Point d clause 2 of Article 15 is amended as follows:

“d) Draw general conclusions on requirements for compliance with food safety regulations and state the business assessment result;

18. Article 16 is amended as follows:

“Article 16. Processing of assessment results, grant and revocation of Certificates

After checking the assessment report submitted by the assessment team, the competent body shall verify the report (request the assessment team to provide explanation for the assessment contents where necessary) and perform the following tasks:

1. In case the assessment result is “satisfactory”:

a) Grant the Certificate according to the form in the Appendix IV to this Circular in case the business meets the requirements for compliance with food safety regulations. The Certificate shall be valid within 3 (three) years from its date of issue.

b) In case samples are collected for testing in the course of assessment, the Certificate is granted to the business only when the “satisfactory” result is available.

In case testing result shows that the business fails to satisfy food safety regulations, the Certificate is granted to the business only after the business investigates the causes, takes remedial actions, and is assessed by the competent body to meet requirements for compliance with food safety regulations.

2. In case the assessment result is “unsatisfactory” and the business fails to take corrective actions within the required time limit: the competent body shall issue a notification of assessment result and its refusal to grant the Certificate and send it to the local food safety authority in order to make sure the business does not operate during the suspension period.

3. In case the business is given the “unsatisfactory” result but has a corrective action report and is assessed by the assessment team to meet requirements for compliance with food safety regulations by the deadline for obtaining the Certificate as prescribed in point b clause 2 Article 36 of the Law on Food Safety, the competent body shall carry out verification and grant the Certificate as prescribed in point a clause 1 of this Article.

4. On a periodic basis, the competent body shall produce statistics on, update and publish on its web portal the List of Certificate holders, validity period of the Certificate and businesses that have yet to satisfy the requirements for compliance with food safety regulations under its management.

5. Revocation of the Certificate

a) A business will have its Certificate revoked if it fails to fully satisfy the conditions set out under clause 1 Article 34 of the Law on Food Safety;

b) Authority to revoke the Certificate: the body competent to issue the Certificate also has the authority to revoke the issued Certificate;

c) The competent body shall revoke the issued Certificate of the business specified in point a clause 5 of this Article when carrying out food safety inspection, supervision or assessment or at the request of the inspecting body;

The competent body shall issue the decision on Certificate revocation after receiving the written request for Certificate revocation from the inspecting body.

6. In case the issued Certificate is lost or damaged, the competent body shall rely on the archived documents, consider and grant a copy from the master register as prescribed by law on grant of copies from the master register after receiving the business’s request or issue a refusal notice clearly stating the reasons therefor.

7. In case the address or administrative division but the location is changed and the Certificate remains valid, the business shall send a notice of change of information on the Certificate and attach a copy of the legal document showing such change to the body issuing the Certificate.”

19. Title of Section 2 Chapter II is amended as follows:

“Section 2. FOOD SAFETY INSPECTION”

20. Article 17 is amended as follows:

“Article 17. Food safety inspection

1. Inspected authority: The businesses specified in clause 2 Article 2 of this Circular.

2. Inspection principles: According to clause 4 Article 68 of the Law on Food Safety.

3. Inspection activities:

a) Inspection activities shall be conducted by the inspection team which is established by the competent body specified in Article 5 of this Circular and has the responsibilities and powers prescribed in Article 70 of the Law on Food Safety;

b) On-site food safety inspection activities shall be made into a report according to the form in the Appendix IA to this Circular;

c) In case of discovering that the business commits a violation, the inspection team shall issue a working minutes or notice of administrative violation and submit it to a competent body or competent person for penalty imposition in accordance with laws.

4. Planned inspection:

a) On an annual basis, the competent body specified in Article 5 of this Circular shall rely on the managerial requirements, evaluation of the compliance with regulations of law on food safety, developments of food safety incidents, results of food safety monitoring, results of previous inspections, and instructions from superior agencies to develop a plan and estimate of inspection costs as prescribed in point a, Clause 2, Article 69 of the Law on Food Safety and submit them to the competent body for approval;

b) At least 3 (three) days before the inspection, the competent body must notify the inspected business in writing;

c) Inspection frequency: no more than 01 inspection/business/year, except for the surprise inspection specified in clause 5 of this Article.

5. Surprise inspection: The competent body shall conduct a surprise inspection (without prior notice) in the following cases:

a) There is any suspicion that the business violates food safety regulations or is involved in a food safety incident;

b) The business is found to be involved in a food safety-related warning given by a domestic or foreign organization or international organization or food safety-related feedback given by an organization or individual;

c) A thematic inspection is carried out under the direction of the superior food safety authority.

6. Processing of inspection result: Within 5 (five) from the end of the inspection, the competent body shall undertake the following tasks:

a) Notify the result to the business in case the inspection result is satisfactory.

b) In case the inspection result is unsatisfactory: Request the business in writing to correct the non-conformities detected in the inspection report. The business shall submit a corrective action report and attach proofs of the corrective actions within 30 (thirty) days from the date of receiving the written request.

c) In case the business fails to submit the report within the required time limit or the corrective action result is unsatisfactory, the competent body shall revoke the business’s issued Certificate as prescribed in clause 5 Article 16 of this Circular or notify the inspection result to certification body which issued another Certificate in case the business is specified in point k clause 1 Article 12 of the Decree No. 15/2018/ND-CP dated February 02, 2018 in order to revoke or invalidate the issued Certificate. In case the certification body does not revoke or invalidate the Certificate of the business violating food safety regulations, the body issuing the Certificate of registration of conformity assessment is requested to consider taking actions against the certification body (if any violation is detected) as prescribed by law.”

21. Article 19 is amended as follows:

“Article 19. People’s Committees of central-affiliated cities and provinces

1. Designate competent bodies as prescribed in clause 2 Article 5 of this Circular.

2. Provide resources and funding cover by the local government budget so as for the competent authority to perform tasks as prescribed in this Circular.”

22. Article 20 is amended as follows:

“Article 20. Departments of Agriculture and Rural Developments, Food Safety Departments, Food Safety Management Boards of provinces and central-affiliated cities

1. Preside over and cooperate with related agencies in requesting provincial People’s Committees to appoint competent bodies as prescribed in clause 2 Article 5 of this Circular.

2. Direct and provide guidance on implementation of this Circular within their jurisdiction.”

23. Article 21 is amended as follows:

“Article 21. Central competent bodies

1. Provide instructions on assessment and certification of compliance with food safety regulations; food safety inspection in the entire system from the local through central level within their remit.

2. Provide guidance on consistent use of materials, forms and methods of assessment by businesses under their delegated authority. Where necessary, propose, design and appeal to the Ministry of Agriculture and Rural Development to promulgate detailed forms and forms of assessment report relevant to the particular characteristics of each business.

3. Provide professional training and instructions for officials tasked with assessment tasks and of local competent authorities.

4. Annually formulate, approve and organize the implementation of the plan for food safety inspection of businesses under their management as prescribed in Article 17 of this Circular.

5. The National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development shall organize the issuance and revocation of the Certificate; inspect food safety of businesses that semi-process, process and preserve fishery products used as foods, combined foods, and mixtures of multiple ingredients (plants, animals, fishery products) as prescribed in clause 1 Article 5 of this Circular and Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 of the Ministry of Agriculture and Rural Development and the Circular amending this Circular.

6. The Plant Protection Department shall grant and revoke the Certificate; inspect food safety of businesses that semi-process, process and preserve foods of plant origin for export as prescribed in point b clause 1 Article 5 of this Circular.

The Plant Protection Department shall introduce and make a list of businesses that semi-process, process and preserve foods of plant origin for export to countries and territories imposing other requirements for health certification on the basis of the Certificate granted by the local competent body or an unexpired equivalent certificate and in compliance with the food safety criteria laid down by countries and territories of import. The Plant Protection Department shall conduct a physical inspection of these businesses where necessary.

7. The Department of Animal Health shall organize the grant and revocation of the Certificate; inspect food safety of businesses that manufacture, semi-process, process and preserve foods of terrestrial animal origin for export as prescribed in clause 1 Article 5 of this Circular.

The Department of Animal Health shall register, introduce and make a list of businesses that semi-process, process and preserve foods of terrestrial animal origin for export to countries and territories imposing other requirements for health certification on the basis of the Certificate granted by the local competent body or an unexpired equivalent certificate and in compliance with food safety criteria laid down by countries and territories of import. The Plant Protection Department shall conduct a physical inspection of these businesses where necessary.

8. Consolidate, update and publish on web portals of competent bodies and the Ministry of Agriculture and Rural Development the list of businesses conforming or failing to conform to requirements for compliance with food safety regulations under their management.

9. Organize the inspection of implementation by local competent bodies.”

24. Article 22 is amended as follows:

“Article 22. Local competent bodies

1. Organize the issuance and revocation of Certificates and food safety inspection of businesses under their authority decentralized and within their duties assigned by People’s Committees of provinces and cities.

2. Formulate, submit to competent authorities for approval and organize the implementation of the plan for food safety inspection of businesses under their management as prescribed in Article 17 of this Circular.

3. Provide professional training and instructions for officials tasked with carrying out assessments.

4. Periodically consolidate, update and publish on web portals of competent bodies and People’s Committees of provinces and cities the list of businesses conforming or failing to conform to requirements for compliance with food safety regulations under their management.

5. Archive documents related to the grant and revocation of Certificates, and food safety inspection of businesses within their delegated authority or assigned duties.”

25. Clause 5 of Article 24 is amended as follows:

“5. Pay fees for the assessment serving the purposes of granting Certificates according to prevailing regulations.”

26. Several Articles and Appendices of the Circular No. 38/2018/TT-BNNPTNT are amended, repealed and replaced as follows:

a) Article 9 and Article 18 are repealed;

b) The Appendix IA Specimen of the Record on food safety inspection at business is added;

c) The specimen of the Report on assessment of compliance with food safety regulations specified in the Appendix II and Appendix III is replaced with the Appendix II to this Circular; the Appendix V is replaced with the Appendix III to this Circular; the Appendix VI is replaced with the Appendix IV to this Circular; the Appendix IV is replaced with the Appendix V to this Circular.

Article 2. Amendments to certain Articles of the Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 of the Minister of Agriculture and Rural Development prescribing inspection and certification of food safety of fishery products for export (hereinafter referred to as “Circular No. 48/2013/TT-BNNPTNT”):

1. Title of the Circular is amended as follows:

“Circular prescribing inspection and certification of food safety of fishery products for export”

2. Article 1 is amended as follows:

“Article 1. Scope

1. Applications and procedures for assessment of requirements for compliance with food safety regulations to register and add a fishery food business operator (hereinafter referred to as “business operator”) to the Export List to countries and territories which require the registration and compilation of an Export List and export consignments issued with the Food Safety Certificate by a Vietnam's competent body (hereinafter referred to as “Export List”); issuance and revocation of Certificate of compliance with food safety regulations (hereafter referred to as “Food Safety Certificate”) in compliance with regulations of the Law on Food Safety; food safety inspection of business operators on the Export List.

2. Applications, procedures and powers for assessment and issuance of certificates of food safety to consignments of fishery products used as exported foods for (hereinafter referred to as “Health Certificate”) at the request of countries and territories of import.”

3. Article 2 is amended as follows:

“Article 2. Regulated entities

1. Regulated entities consist of:

a) Business operators participating in the chain of business operators manufacturing, semi-processing, processing and preserving fishery food for export to countries and territories requiring registration and compilation of the Export List;

b) Consignments of fishery products used as foods for export to countries and territories that require the Food Safety Certificate granted by a Vietnam's competent body;

c) For consignments of fishery products used as foods for export that require the quarantine certification according to regulations imposed by the import market, the body carrying out assessments and issuing the Health Certificate as specified in clause Article 5 of this Circular shall simultaneously carry out assessment and certification of food safety and quarantine.

2. This Circular does not regulate:

a) Business operators that have their products only produced or traded for domestic consumption and are not specified in point a clause 1 of this Article;

b) Exported fishery products that are not used as foods.”

4. Clauses 8 and 9 are added to Article 3 as follows:

“8. Sample product consignment means any consignment that is exported for the purpose of product introduction, display at fairs or exhibitions or research, not sold for commercial purposes as foods and has a total weight registered and specified in the export certificate not exceeding 50 kg.

9. Assessment means an inspection and verification of adequacy and legitimacy of documentation and physical inspection of compliance with food safety regulations of a business operator and a process for production, processing and preservation of fishery foods for export in accordance with regulations laid down by Vietnam and import market.”

5. Article 4 is amended as follows:

“Article 4. Bases for assessment, certification and inspection of food safety

Bases for assessment and issuance of the Food Safety Certificate and issuance of the Health Certificate to exported fishery food and food safety inspection are the regulations specified in Articles 41, 42, 68, 69 and 70 of the Law on Food Safety; regulations and technical regulations of Vietnam and food safety regulations of the import market.”

6. Article 5 is amended as follows:

“Article 5. Assessment bodies

1. Bodies competent to issue and revoke the Food Safety Certificate and conduct assessments in service of addition of the Export List, and food safety inspection (hereinafter referred to as “competent bodies”) are the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development and its affiliated regional authorities assigned to perform their duties by region (the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development - Central Region Authority and the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development - Southern Region Authority).

2. Bodies conducting assessments in service of issuance of the Health Certificate to consignments of fishery products used as food; supervising the compliance with food safety regulations by business operators and post-certification consignments (hereinafter referred to as “Certification Authority”) are National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development - Center 1, 2, 3, 4, 5, 6 assigned by the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development to perform their duties by locality.”

7. Article 6 is amended as follows:

“Article 6. Eligibility requirements applicable to inspectors and members of assessment teams:

1. Eligibility requirements applicable to an inspector

a) Be honest and objective, and have no conflict of interest with the assessed business operator;

b) Have professional qualifications in the assessment sector;

c) Have already completed a professional training or refresher training course on assessment or training or refresher training course on inspection and examination in the assessment sector.

2. Eligibility requirements applicable to the head of the assessment team

a) Meet the requirements set out in clause 1 of this Article;

b) Have at least 03 (three) years of experience in the assessment sector and have already participated in assessing at least 05 (five) business operators in the assessment sector.

3. Eligibility requirements applicable to a sampling technician

a) Have appropriate professional qualifications;

b) Hold diplomas or certificates in sampling or obtain diplomas or certificates of completion of sampling training courses.”

8. Article 9 is amended as follows:

“Article 9. Fees and charges

The collection of fees and charges for assessment serving issuance of the Food Safety Certificate; fees and charges for assessment serving issuance of the Health Certificate to consignments of exported fishery products shall be subject to regulations of law on fees and charges”

9. Title of Chapter II is amended as follows:

“Chapter II. ASSESSMENT AND ISSUANCE OF CERTIFICATES OF COMPLIANCE WITH FOOD SAFETY REGULATIONS, ADDITION OF EXPORT LIST”

10. Article 10 is amended as follows:

“Article 10. Application for Food Safety Certificate

1. An application for Food Safety Certificate is composed of the documents specified in clause 1 Article 36 of the Law on Food Safety.

An application form for Certificate of compliance with food safety regulations in the Appendix V to this Circular; Form of description of infrastructure, equipment and tools used for ensuring the conformance to requirements for compliance with food safety regulations in the Appendix VI to this Circular; Certificate of training in food safety knowledge of the business owner and person directly manufacturing and trading food provided and confirmed by the business owner.

2. An organization or individual shall submit the application for food safety certificate to the competent authority via the online public service system, by post or in person at the competent body.”

11. Article 11 is amended as follows:

“Article 11. Application processing

1. After receiving the application, the competent body shall verify its adequacy and validity and notify the business operator of the result and estimated date of assessment in case the application is valid; or in case the application is unsatisfactory, give a written notice indicating reasons therefor.

2. An on-site assessment shall be conducted within 15 (fifteen) days from the date of receiving a sufficient and valid application specified in point b clause 2 Article 36 of the Law on Food Safety.”

12. Article 12 is amended as follows:

“Article 12. Issuance of Food Safety Certificate

The following business operators shall be subject to assessment serving issuance of the Food Safety Certificate:

1. Business operators that are required to obtain the Food Safety Certificate as prescribed in points a and b clause 1 Article 2 of this Circular but have yet to undergo assessment and to be issued with the certificate.

2. Business operators whose Food Safety Certificate is revoked or business operators that have suspended their production for more than 12 (twelve) months from the date on which the notification is sent to the competent body.

3. Business operators that have been issued with the Food Safety Certificate but changed their legal representative or safety assurance system as compared to the scope previously assessed and certified.

4. Business operators whose Food Safety Certificate will expire in less than 6 months;

5. Business operators that have another Certificate as specified in point k clause 1 Article 12 of the Decree No. 15/2018/ND-CP dated February 02, 2018 but have not maintained the validity of such Certificate and wish to participate in the Export Certification Program as prescribed in this Circular.”

13. Title of Article 13 is amended as follows:

“Article 13. Establishment of the assessment team”

14. Clause 1 of Article 13 is amended as follows:

“1. The competent body shall issue a decision on establishment of team for assessment of requirements for compliance with food safety regulations which is composed of the head and members in accordance with the regulations set out under Article 6 of this Circular.”

15. Clause 1 of Article 14 is amended as follows:

“1. The assessment of requirements for compliance with food safety regulations by a business operator shall cover:

a) Infrastructure, equipment and human resources for participation in production of fishery products and management of food safety;

b) Food safety management program based on HACCP principles (if mandatory);

c) Procedures for tracing, recall and handling of unsafe products;

d) Specific requirements of the registered market (the importing country) (if any);

dd) Requirements for compliance with food safety regulations by suppliers of raw materials to the business operator (if necessary);

e) Compliance with regulations on combating illegal, unreported and unregulated fishing (IUU) in the production, processing and export of catched fishery products (if any);

g) Collection of samples for analysis and evaluation of the effectiveness of hygiene control during production as outlined in the Appendix IV to this Circular: The assessment team shall consider and make a decision based on the evaluation of food safety risks during the on-site assessment.

The collection and analysis of samples shall comply with prevailing regulations.”

16. Article 15 is amended as follows:

“Article 15. Assessment report

1. The assessment report is provided in the Appendix V to this Circular. If the business operator falls into any of the cases specified in clauses 8 and 10 Article 36 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018, the assessment of requirements for compliance with food safety regulations of such business operator shall be carried out as per regulations applicable to corresponding industries and sectors.”

2. An assessment report must:

a) Be prepared by the assessment team at the assessed business operator immediately after completion of the assessment;

b) Fully and accurately represent the assessment results;

c) Clarify which items fail to conform to food safety requirements, standards and regulations and the deadline for taking remedial actions to correct defects;

d) Draw general conclusions on requirements for compliance with food safety regulations.

dd) Give comments of the assessed business operator’s authorized representative on the assessment results and commitments to correcting non-conformities (if any);

e) Carry the signature of the leader of the assessment team, the signature of the assessed business operator’s authorized representative, show the adjoining stamp of the business operator (if any) in the assessment report or signature on each page of the assessment report in case the assessed business operator does not have its registered stamp;

g) In case where the assessed business operator's authorized representative refuses to sign the assessment report, the assessment team must write: “The assessed business operator’s representative has not signed the report” and clearly explain the reasons for such refusal. The assessment report shall have legal value if it bears signatures of all of members of the assessment team;

h) Be made into 02 copies, including 01 copy deposited with the competent body, 01 copy deposited with the assessed business operator; where necessary, the number of copies may be increased as decided by the team leader.”.

17. Article 17 is amended as follows:

“Article 17. Processing of assessment results, grant of Food Safety Certificate

After receiving the assessment report, the competent body shall inspect the report (request the assessment team to provide explanation for the assessment contents (where necessary)) and perform the following tasks:

1. In case the assessment result is “Satisfactory”:

a) Notify the assessment result, grant a registration code (if the business operator has not granted one) as specified in the Appendix VII to this Circular to the business operator; grant the Food Safety Certificate which shall be valid for 03 (three) years according to the Form in the Appendix VI to this Circular;

b) In case samples are collected for analysis and evaluation of the effectiveness of hygiene control in the course of assessment, the Certificate is granted to the business operator only when the “satisfactory” result is available.

In case testing result shows that the business operator fails to satisfy food safety regulations, the Food Safety Certificate is granted to the business operator only after the business operator reports the result of cause investigation, takes remedial actions, and is assessed by the competent body to meet requirements for compliance with food safety regulations.

2. In case the assessment result is “Unsatisfactory”:

a) In case the business operator fails to take corrective actions within the required time limit: the competent body shall issue a notification of result and reasons for the unsatisfactory result, revoke the effective Food Safety Certificate (if any) as prescribed in Article 18 of this Circular and send it to the local food safety authority in order to make sure the business operator does not operate.

b) In case the business operator has a corrective action report and is assessed by the assessment team to meet requirements for compliance with food safety regulations by the deadline for obtaining the Certificate as prescribed in point b clause 2 Article 36 of the Law on Food Safety, the competent body shall carry out verification and grant the Food Safety Certificate as prescribed in point a clause 1 of this Article.”

18. Article 18 is amended as follows:

“Article 18. Revocation of Food Safety Certificate

1. A business operator will have its Food Safety Certificate revoked if it fails to fully satisfy the conditions set out under clause 1 Article 34 of the Law on Food Safety.

2. Authority to revoke the Food Safety Certificate: the body competent to issue the Food Safety Certificate also has the authority to revoke the issued Certificate.

3. The competent body shall revoke the Food Safety Certificate already issued to the business operator specified in clause 1 of this Article upon conducting inspection, supervision and assessment of compliance with food safety regulations or revoke it at the request of the inspecting body;

The competent body shall issue the decision on Certificate revocation after receiving the written request for Certificate revocation from the inspecting body.”

19. Article 19 is amended as follows:

“Article 19. Modification of Food Safety Certificate

1. A Food Safety Certificate that remains valid may be modified in the following cases: it is lost, misplaced, or damaged; it contains administrative errors during issuance; the business operator has changed information about its name and address due to a change of an administrative boundary without changing its legal representative or food safety management system that has been assessed and certified.

2. After receiving a request for modification, the competent body shall review the archived application and consider issuing a modified Food Safety Certificate whose expiration date is the same as that of the existing Food Safety Certificate or issue a written rejection stating the reasons the business operator.”

20. Article 20 is amended as follows:

“Article 20. Scope and eligible entities for participation in of the Certification Program

1. The Export Fishery Food Certification Program includes the assessment of requirements for compliance with food safety regulations by a business operator for addition to the Export List and the assessment serving the purposes of granting the Health Certificate to fishery food exported to a country or territory as required by the import market. The List of countries and territories is provided in the Appendix IX to this Circular.

2. Participation in the program for certification of exported fishery products is voluntary. Any business operator that wishes to export fishery products to markets that require compliance as per clause 1 of this Article shall register the assessment and addition to the Export List and conduct assessment serving the purposes of granting the Health Certificate with the competent body specified in clause 1 Article 5 of this Circular.

3. In case the import market imposes a new requirement, the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development shall notify it to relevant organizations and individuals and implement necessary measures, and report to the Ministry of Agriculture and Rural Development to update the List of markets within 30 (thirty) days from the date of receiving the regulation from the importing country's competent body.

4. Business operators participating in the Program and registering assessment and addition to the Export List according to Article 10 of this Circular shall be subject to an assessment by the competent body to confirm compliance with::

a) Requirements for compliance with food safety regulations imposed by Vietnam;

b) Regulations, technical regulations on food safety imposed by the corresponding importing country.”

21. Article 21 is amended as follows:

“Article 21. Export List

1. The Export List means a list including business operators which have obtained the “satisfactory” assessment result as prescribed in Chapter II of this Circular and satisfied the criteria set out under points a and b clause 4 Article 20 of this Circular. Such business operators consist of:

a) Business operators required to obtain a Food Safety Certificate;

b) Business operators that have another effective Certificate as specified in point k Article 12 of the Decree No. 15/2018/ND-CP dated February 02, 2018;

c) Business operators that have been included in the Export List but seek addition to new markets requiring such registration, or those adding new product categories that have not yet been assessed and certified.

2. On a monthly basis or as required by the importing country, the competent body defined in clause 1 Article 5 of this Circular shall: register, introduce, verify, and certify requirements for compliance with food safety regulations, and prepare the Export List for each market and submit it to the competent body of the importing country for recognition; update the recognized Export List on the web portal.

3. A business operator shall be removed from the Export List for a specific market in the following cases:

a) The business operator submits a written request for removal from the Export List;

b) The business operator no longer meets the program criteria as specified in clause 4 Article 20 of this Circular or the competent authority of the importing country requests its removal from the Export List;

c) The business operator fails a food safety inspection as specified in point g clause 1 Article 35 of this Circular, and is not assessed by the assessment body to satisfy requirements for compliance with food safety regulations within 30 (thirty) days from the date of inspection result notification;

d) The business operator has ceased its production for at least 12 (twelve) months from the date of notifying the competent body and has not undergone inspection or supervision by the Certification Authority as specified in clause 2 Article 5 of this Circular.”

22. Article 22 is amended as follows:

“Article 22. Priority list

1. The Priority List comprises business operators which have a strong food safety compliance record, meet the criteria specified in clause 3 of this Article and are eligible for an export fishery food certification scheme corresponding to their priority classification as stipulated in Section 2 of this Chapter.

2. Priority classification for a business operator with a strong food safety compliance record:

a) The business operator shall be classified as Priority Level 2 if it has exported at least five (05) consignments and has not been found non-compliant with food safety requirements by the Certification Authority or the import market concerning the following parameters: pathogenic microorganisms; pathogenic parasites; residual contaminants, veterinary drugs, pesticides; additives, food processing aids; biotoxins; allergens for a minimum period of 03 (three) months from the date of notification of the “Satisfactory” assessment result as prescribed in clause 1 Article 17 of this Circular;

b) The business operator classified as Priority Level 2 shall be upgraded to Priority Level 1 if it continues to meet food safety requirements for an additional three (03) months after being included in the Priority List, has exported at least five (05) consignments, and maintained its compliance with the parameters outlined in point a clause 2 of this Article;

During the review period for priority classification, the business operator must not commit any food safety violations or incur administrative penalties under Vietnamese law.

3. Criteria for inclusion in the priority list:

a) The business operator is listed in the Export List;

b) The business operator is classified as Priority Level 1 or Priority Level 2.

4. Removal from the Priority list:

A business operator shall be removed from the Priority List in the following cases:

a) It no longer meets the criteria specified in Clauses 2 and 3 of this Article;

b) It fails to obtain a Health Certificate as per points b, c, and dd clause 1 Article 26 of this Circular;

c) Its export consignment or food safety risk verification sample is found non-compliant by the Certification Authority or the import market based on the parameters specified in point a clause 2 of this Article;

d) It has committed an administrative violation related to food safety and incurred penalties for its administrative violation under Vietnamese law.

5. Reinstatement to the Priority list:

An establishment may be reinstated to the Priority List if it meets the following conditions:

a) It meets the criteria specified in clause 3 of this Article;

b) It has submitted a report on the cause investigation, implemented corrective actions, and received approval from the Certification Authority (applicable to the business operator removed under point c clause 4 of this Article); or successfully complied with an administrative penalty decision for 3 (three) months after the sanction was imposed (applicable to the business operator removed under point d clause 4 of this Article).

6. The Certification Authority specified in clause 2 Article 5 of this Circular shall update the Priority List for business operators in its jurisdiction within a maximum of 3 (three) days from the date the business operator meets the requirements for: upgrading priority classification, inclusion or reinstatement in the Priority List (as per clauses 2, 3 and 5 of this Article), removal from the Priority List (as per clause 4 of this Article).”

23. Clause 3 is added to Article 23 as follows:

“3. For sample product consignments: The Certification Authority shall issue the Health Certificate to the consignments in accordance with clause 3 Article 28 of this Circular.”

24. Article 24 is amended as follows:

“Article 24. Requirements for exported products

1. Products must be produced and stored at a business operator listed in the Export Certification Program for the respective import market.

2. Products must comply with food safety regulations, include mandatory labeling information as required by the import market, ensure no misrepresentation of the product’s nature, and not violate Vietnamese law.

3. For products that have undergone semi-processing, processing, packaging, storage, or handling at multiple establishments:

a) The establishment in charge of final stage of production (responsible for packaging and labeling) or the storage establishment (as required by the importing market) must be listed in the Export List for the respective market;

b) The establishment in charge of previous stages of production must comply with Vietnamese and import market food safety requirements;

c) Establishments involved in transportation, semi-processing, processing, packaging, labeling, storage, and export must sign a written commitment to jointly take responsibility for implementing corrective measures required by the Certification Authority if the consignment is warned by the importing country's competent body or found non-compliant by the Certification Authority;

d) Establishments involved in transportation, semi-processing, processing, packaging, labeling, storage, and export must maintain comprehensive production, food safety control, storage, and export records for their respective stages to ensure traceability in accordance with legal regulations.

4. For live fishery products intended for export as food:

a) Comply with the requirements stated in clauses 1, 2, and 3 of this Article;

b) Be farmed, harvested, packaged, transported, and exported in compliance with Articles 20, 21, and 23 of the Law on Food Safety;

c) The establishment in charge of final stage of production (responsible for packaging and labeling) must establish a production and export supply chain ensuring food safety, traceability, recall, and handling of unsafe products in accordance with Circular No. 17/2021/TT-BNNPTNT .

25. Clauses 1 and 3 of Article 25 are amended as follows:

“1. Each export consignment shall be granted a Health Certificate in accordance with the form required by the respective import market and, if required, a Health Certificate form for transshipment, temporary import, or re-export. The Health Certificate’s contents shall be consistent with the Health Certificate of the import market and/or other relevant certifications related to the export consignment as required by the importing country and in compliance with Vietnamese regulations.

3. The Health Certificate shall conform to the content and format required by the respective importing market and shall be numbered in accordance with Appendix XI enclosed with this Circular. If necessary, an appendix may be attached to the Certificate to ensure full certification of all information related to the consignment as per regulations.”

26. Clause 1 of Article 26 is amended as follows:

“1. The Certification Authority shall not issue a Health Certificate for an export consignment produced at a business operator that:

a) Has been notified by the importing country’s competent body that it has to suspend its import or is subjected to Health Certificate issuance suspension measure or export suspension measure according to regulations of the Ministry of Agriculture and Rural Development on introduction of managerial measures at the import market's request;

b) Fails an inspection or assessment as stipulated in point a clause 2 Article 17 and clause 1 Article 35 of this Circular;

c) Has had its Food Safety Certificate revoked as stipulated in Article 18 of this Circular;

d) Fails to correct non-conformities identified through food safety monitoring or traceability audits as stipulated in clause 2 Article 35 of this Circular;

dd) Is being suspended from production as per Articles 30 and 33 of the Law on Product and Goods Quality or has been subject to sanctions, including suspension or revocation of its Food Safety Certificate, in accordance with the Government’s regulations on administrative penalties for quality and food safety violations;

e) Has received a notification of production suspension.”

27. Article 27 is amended as follows:

“Article 27. Verification of food safety risk control effectiveness

1. Verification principles:

a) Verification parameters shall comply with the list of food safety indicators and permissible limits required by the respective import market and shall be updated and notified by the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development on a periodic or ad hoc basis as any new managerial requirement is imposed;

b) Minimum verification sampling frequency for a business operator: Priority Level 1: Once a month; Priority Level 2: Twice a month. If the business operator’s actual production or export activity does not meet the required sampling frequency, the Certification Authority shall determine an appropriate sampling frequency;

c) Verification sampling rate shall be determined based on: requirements for compliance with food safety regulations; food safety assurance history; product risk level; scale, capacity, or production output of the business operator in accordance with Appendix X to this Circular;

Based on the risk assessment or new regulations imposed by the import market, the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development shall report such to the Ministry of Agriculture and Rural Development for guidance on adjusting and updating contents of the Appendix X to make them conformable;

d) Sampling locations: At any stage of production, including: on the production line; storage warehouse; aquaculture establishment, purchasing establishment, semi-processing and initial packaging establishment for fresh iced, chilled, or live fishery products;

dd) Verification content: Production monitoring records, storage conditions, tracing information, history of food safety assurance conditions of the business operator, and records related to the origin of raw materials.

2. The verification must be carried out for at least once per year for each business operator’s group of products produced and exported:

a) Based on the business operator’s production and export plan, the Certification Authority shall cooperate with the operator to develop a verification plan, including details such as sampling time, sample type, and estimated sample quantity for each round. The plan shall be communicated to the business operator in writing or through an appropriate communication method (email, online software);

b) In case of any change to the production and export plan, the business operator must notify the Certification Authority in writing or via an appropriate communication method no later than 03 (three) working days in advance, or 01 (one) working day for the operator producing live, fresh, or iced seafood, compared to the initially agreed schedule.

3. Handling of verification sample testing results:

a) Within 01 (one) working day from the date of receiving verification sample test results that do not meet the food safety requirements of the import market, the Certification Authority shall issue a non-compliance notification using the form provided in Appendix XVI to this Circular;

The business operator shall carry out tracing and cause investigation, establish and implement corrective actions, including recall and handling of products that fail to satisfy food safety regulations. The business operator must submit an explanatory report using the form in Appendix XVII to this Circular to the Certification Authority within the required limit;

b) Within 05 (five) working days from the receipt of the business operator’s explanatory report, the Certification Authority shall verify the report’s contents and issue a written notification of the verification results to the business operator. If an on-site verification is required, the Certification Authority shall notify the business operator of the results within a maximum of 5 (five) working days from the completion of the on-site verification.”

28. Article 28 is amended as follows:

“1. Application for issuance of a Health Certificate for 01 (one) export consignment includes:

a) An application form for the Health Certificate as per the form in Appendix XII enclosed with this Circular;

b) A detailed list of the consignment as per the form in Appendix XIV enclosed with this Circular;

c) Information in the certificate as required by the importing market in case the certificate is registered through an online system;

d) In case the consignor does not directly conduct the production, processing, or storage of the consignment: a sale/processing/entrustment agreement with the production or processing establishment must be provided, including a commitment from both parties (the production establishment and the consignor) to be jointly responsible if the consignment is subject to a warning from the competent body of the importing country;

dd) The consignor shall provide information related to the export consignment to facilitate verification and certification of the contents in the certificate as required by the respective import market and shall bear responsibility for the accuracy of the provided information.

2. At least 01 (one) working day before the scheduled export date or pursuant to the regulations of the import market regarding the issuance date of the Health Certificate, the consignor shall submit 01 (one) application package to the Certification Authority through one of the following methods: Direct submission; by post; email; or online submission and declaration of certificate-related information based on the import market’s form.

3. Assessment and issuance of the Health Certificate:

Within 01 (one) working day from the receipt of full information, the Certification Authority shall conduct verification and issue the Health Certificate to the export consignment, as well as Health Certificates for transshipment, temporary import, and re-export consignments (if required), ensuring that the contents align with the Health Certificate of the import market on the basis of the result of food safety risk control verification as stated in Article 27 of this Circular or shall provide confirmation and state the reasons for ineligibility in the certificate application.”

29. Article 29 is amended as follows:

“Article 29. Registration of assessment

1. An assessment registration application for 01 (one) export consignment consists of:

a) An application form for assessment as per the form in Appendix XIII enclosed with this Circular;

b) A detailed list of the consignment as per the form in Appendix XIV enclosed with this Circular;

c) If the consignor does not directly produce, process, or store the consignment, they must provide a contract, purchase agreement, or outsourcing agreement with the production/processing establishment. This document must include a commitment from both parties (the production establishment and the consignor) to joint responsibility in case the consignment is warned by the importing country’s competent body.

2. Submission deadline:

a) For live, fresh, or ice-chilled fishery products: The registration application must be submitted at least 01 (one) working day before the expected export date.

b) For other products: The establishment must register and coordinate the inspection schedule with the Certification Authority to ensure that test results are available before the expected export date.

3. The consignor must submit 01 (one) set of the assessment registration application to the Certification Authority through one of the following methods: Direct submission, by post; or email or online submission of the application and declaration of information in the certificate according to the form of the import market during online registration.

4. Processing of the assessment registration application: Within 01 (one) working day of receiving a complete and valid assessment registration application, the Certification Authority shall review the application for completeness and compliance; guide the consignor in supplementing any missing or incorrect information, if applicable.”

30. Point c clause 2 and clause 3 of Article 31 are amended as follows:

“c. Within 03 (three) days from the date on which test results are sent to the consignor, if the consignor does not provide written feedback on the test results, the Certification Authority shall send the consignor a Notification of Non-conformity in accordance with the form provided in Appendix XVI enclosed with this Circular. The consignor is responsible for investigating the cause, implementing corrective measures, handling the consignment within the required time limit, and preparing an Explanatory Report in accordance with the form provided in Appendix XVII enclosed with this Circular for submission to the Certification Authority;

3. Within 05 (five) working days from the date of receiving the consignor’s Explanatory Report, the Certification Authority shall review the contents of the report and issue a written notice of the verification results to the consignor and the production establishment. In cases where an on-site verification is necessary, the Certification Authority shall notify the results to the establishment within a maximum of 05 (five) working days from the completion of the verification process.”

31. Title of Article 32 is amended as follows:

“Article 32. Assessment and issuance of the Health Certificate”

32. Clause 1 of Article 32 is amended as follows:

“1. At least 01 (one) working day before the scheduled export date or pursuant to the regulations of the import market regarding the issuance date of the Health Certificate, the consignor shall provide all information related to the export consignment to facilitate the verification and certification of the contents in the Health Certificate as required by the respective import market and shall bear responsibility for the accuracy of the provided information.

Within 01 (one) working day from the receipt of full information, the Certification Authority shall conduct verification and issue the Health Certificate to the export consignment, as well as Health Certificates for transit, temporary import, or re-export consignments according to the respective form (if required) if the assessment and test results are satisfactory. For live, fresh, or ice-chilled fishery products, the Certification Authority is permitted to issue the Health Certificate while awaiting test results and shall process the test results according to clause 2 Article 31 of this Circular”.

33. Article 33 is amended as follows:

“Article 33. Re-issuance of Health Certificate

1. If the issued Certificate is lost, damaged, contains administrative errors at the time of issuance or has its information changed (excluding changes related to product identification, quantity, product specifications, tracing of the shipment, or previously assessed and certified quality, food safety, or aquatic animal health safety) or at the request of the competent body of the importing country/territory, transit, temporary import, or re-export territory, the consignor must submit a written request for re-issuance to the Certification Authority, clearly stating the reason. The request may be submitted in person, by post or email.

2. The Certification Authority shall reissue the Certificate within 01 (one) working day from the receipt of the consignor's request or issue a written refusal specifying the reason for the refusal, which will be sent to the consignor.

3. The reissued Health Certificate must accurately certify the product identification information, quantity, product specifications, and traceability of the shipment in accordance with the content of the original Health Certificate. It must be assigned a new number as per the provisions of Appendix XI to this Circular and include a note stating: “Chứng thư này thay thế cho Chứng thư số..., cấp ngày...” (“This Health Certificate replaces Certificate No. …, issued on …”) or an annotation complying with the regulations of the importing country, transit, temporary import, or re-export territory.”

34. Article 35 is amended as follows:

“Article 35. Post-assessment and certification inspection and supervision

1. Inspection of maintenance of requirements for compliance with food safety regulations by a business operator on the Export List to markets:

a) The authority responsible for the inspection is defined in clause 1 Article 5 of this Circular;

b) Planned inspection: The competent body shall formulate an annual inspection plan based on managerial requirements; compliance with food safety laws; developments in food safety incidents; results of previous food safety monitoring and inspections; directives from superior regulatory agencies. The inspection plan shall comply with point a clause 2 Article 69 of the Law on Food Safety;

c) The inspection shall be conducted by an inspection team established by the competent body under clause 1 Article 5 of this Circular. The inspection team shall have responsibilities and powers as stipulated in Article 70 of the Law on Food Safety. The competent body must notify the inspected business operator at least 03 (three) working days in advance of the inspection;

d) Frequency of planned inspection: no more than 01 time/business operator/year, except for the surprise inspection specified in point e of this clause;

dd) The inspection contents and report format are provided in the Appendix V to this Circular. If violations are detected, the inspection team must prepare an inspection report or an administrative violation report and submit it to a competent person for handling under regulations;

e) The competent body shall conduct a surprise inspection in the following cases: it is suspected that the business operator violates food safety regulations or is involved in a food safety incident; a thematic inspection is conducted as directed by the superior food safety authority; it is involved in a food safety-related warning given by a domestic or foreign organization or international organization; it is involved in food safety-related feedback given by an organization or individual; it fails 2 (two) assessments according to the results of analysis and evaluation of effectiveness of hygiene control during production.

g) Processing of the inspection result: Within 5 (five) working days after completing the inspection, the competent body shall notify the business operator of the satisfactory or unsatisfactory inspection result, and request it to correct non-conformities and submit a report with evidence of corrective actions within 30 (thirty) days from the date of receiving the request;

If the business operator fails to submit a report or its corrective actions are unsatisfactory, the competent body may remove the business operator from the Export List, revoke its Food Safety Certificate (if any); notify the relevant certification body that issued other certificates if the business operator is specified in point k clause 1 Article 12 of the Government No. 15/2018/ND-CP dated February 02, 2018, and request the authority issuing the certificate of registration of conformity assessment services to consider taking actions against the conformity assessment body as prescribed by law.

2. Supervision of maintenance of requirements for compliance with food safety regulations by a business operator on the Export List to markets:

a) The authority responsible for the supervision is the Certification Authority defined in clause 2 Article 5 of this Circular;

b) The supervision is conducted by inspectors meeting the requirements under clause 1 Article 6 of this Circular (if necessary, the Certification Authority may establish an inspection team to conduct the supervision);

c) Frequency: No more than 1 time/business operator/year (except for the business operators having undergone food safety inspection by the competent body as prescribed in clause 1 of this Article). The supervision should be integrated with activities such as verification, certification of export consignments and/or verification, evaluation of tracing, cause investigation and identification, establishment and implementation of corrective actions with regard to business operators whose products or consignments are found failing to satisfy food safety regulations;

d) The supervision contents are specified in the Inspection Report form provided in the Appendix IB to this Circular. If violations are detected, an inspection report or administrative violation report shall be prepared and submitted to a competent body or competent person for further action;

dd) Processing of supervision result: Within 3 (three) working days after completing the supervision, the Certification Authority shall notify the business operator of the result, request the business operator to take corrective actions and submit a corrective action report (if any);

In case the business operator fails to implement corrective actions within the committed time limit or the corrective actions are inappropriate, the Certification Authority shall suspend the issuance of Health Certificates and propose the revocation of the Food Safety Certificate (if applicable), and remove the business operator from the Export List in accordance with regulations.

3. Post-certification supervision of consignments:

a) The Certification Authority shall conduct post-certification supervision of consignments in conjunction with monitoring the satisfaction of requirements for compliance with food safety regulations by the business operator as prescribed in clause 2 of this Article or assess and certify export consignments, verify and assess the tracing and cause investigation and identification by the business operator whose products or consignments are found failing to satisfy food safety regulations or conduct specialized verification, inspection or supervision as directed by the Ministry of Agriculture and Rural Development or cooperate with customs authorities (if necessary) or a combination of the above activities.

b) Contents of supervision: Considering the consistency of information, documentation, and records regarding the origin of raw materials, the production and processing of the consignment after certification, and comparing them with the information in the application for assessment, on-site supervision or the information recorded at the staging area awaiting export. The contents and results of the supervision are provided in the form prescribed in Appendix IB to this Circular;

In case any violation is detected, the Certification Authority shall issue a working minutes or administrative violation report and transfer the case to the competent body or competent person for handling in accordance with regulations. Simultaneously, it shall issue a document to invalidate issued Health Certificate.

c) For live fishery products intended for food export originating from establishments or production sites located in different provinces/cities, the certification authorities shall cooperate in conducting post-certification supervision to verify the consistency of the tracing information about the consignment exported or awaiting export, satisfaction of requirements for compliance with food safety regulations by the establishments within the production chain under their respective jurisdiction”.

35. Article 36 is amended as follows:

“Article 36. Handling cases of warned consignments and products failing to satisfy food safety regulations before export

1. For a consignment subject to a warning from the competent body of the importing country

Within 03 (three) working days from the date of receiving an official warning from the competent body of the importing country, the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development shall request the business operator in writing to:

a) Trace the consignment, investigate and identify the cause, establish and implement corrective actions; submit a report to the Certification Authority using the form in Appendix XVII to this Circular. Trace, recall and handle products that fail to satisfy safety regulations (in case of recall) as prescribed in the Circular No. 17/2021/TT-BNNPTNT dated December 20, 2021;

b) Suspend export to the corresponding importing countries if required by the competent body of the importing country or in accordance with the regulations of the Ministry of Agriculture and Rural Development;

c) Comply with regulations on sampling and testing of the violating parameters and be subject to supervision by the Certification Authority for each export consignment of the violating product or similar product category manufactured at the business operator until the competent body specified in clause 1 Article 5 of this Circular grants a written approval for the report on cause investigation and corrective actions of the business operator.

2. For products found failing to satisfy food safety regulations before export: The Certification Authority shall act in accordance with the relevant provisions of clause 3 Article 27; point c clause 2, clause 3 Article 31 of this Circular.

3. For an exported consignment or product detected with prohibited chemical residues or antibiotics before export:

a) Within 3 (three) days from the date of receiving information on the violation, the Certification Authority shall directly preside over and cooperate with relevant local regulatory agencies to conduct a cause investigation throughout the entire production, semi-processing, processing, and export chain related to the violation.

b) Implement preventive measures to limit the impact of the violation, issue a working minute or administrative violation report on food safety, and transfer the case to the competent body or competent person for handling in accordance with regulations (if any).

4. After receiving the report on the investigation results and corrective actions from the business operator, the Certification Authority shall verify the contents of the report:

a) Within 05 (five) days, the Certification Authority shall verify the business operator’s explanatory report and send a document stating the verification results to the business operator in case additional information is required or issue a document to the Competent Authority in case the report verification result is satisfactory in the case specified in clause 1 of this Article;

b) In case of an on-site verification, the Certification Authority shall notify the business operator of the on-site verification results and report to the competent body stipulated in clause 1 Article 5 of this Circular within 05 (five) days from the completion of the on-site verification process;

5. Within 01 (one) working day, the Certification Authority shall evaluate the verification report of the Certification Authority and issue a written notification of the verification results to the business operator.”

36. Title of Article 37 is amended as follows:

“Article 37. Business operators participating in the Export Fishery Product Certification Program”

37. Points a and d clause 1 of Article 37 are amended as follows:

“a) Register with the competent body to obtain a Food Safety Certificate, undergo additional assessment for addition to the Export list, and be subject to the assessment according to the competent body's plan;

d) Maintain requirements for compliance with food safety regulations as certified; send a written notice to the competent body in case of suspension of production, change of legal representative or food safety management system compared to the scope assessed and certified;”

38. Point g is added to clause 1 of Article 38 as follows:

“g) If the consignor is an organization or individual who does not directly engage in the manufacturing, processing, or storage of the consignment, they must formulate and apply regulations on tracing, recall, and handling of fishery products failing to satisfy food safety regulations; monitor storage conditions, transport duration, hygiene conditions of the transport means, and the integrity of the products during transportation from the processing or storage establishment in compliance with Articles 54 and 55 of the Law on Food Safety and Circular No. 17/2021/TT-BNNPTNT .

39. Article 39 is amended as follows:

“Article 39. Inspectors in charge of assessment of requirements for compliance with food safety regulations

1. Responsibilities:

a) Comply with regulations on procedures, contents, methods, and bases for the assessment of requirements for compliance with food safety regulations by business operators in accordance with this Circular;

b) Maintain confidentiality of all business-related information, ensure accuracy, transparency, objectivity, and fairness, and avoid discrimination while performing duties;

c) Do not request unnecessary documents or information, and do not cause inconvenience or harassment to the business operator;

d) Accept the assignment by the head of the assessment team and the head of the Certification Authority; take responsibility for the assessment results to the head of the Certification Authority and to the law.

2. Powers:

a) Request the business operator to provide documents, records, and product samples (if any) for the assessment;

b) Access production areas, storage facilities, and warehouses; review records, take samples, photographs, copies and notes necessary for the assessment;

c) Prepare reports and propose handling measures in cases where the business operator violates food safety regulations;

d) Record individual opinions and report to the head of the competent body if there is a disagreement with the conclusions drawn up by the head of the assessment team as stated in point b clause 2 Article 40 of this Circular.”

40. Article 39a is added to after Article 39 as follows:

“Article 39a. Inspectors in charge of quality and food safety assessment and certification

1. Responsibilities:

a) Comply with regulations on procedures, contents, methods of assessment, sampling for verification of effectiveness of food safety risk control and for testing of registered export consignments as prescribed in this Circular;

b) Maintain confidentiality of all business-related information, ensure accuracy, transparency, objectivity, and fairness, and avoid discrimination while performing duties;

c) Do not request unnecessary documents or information, and do not cause inconvenience or harassment to the business operator;

d) Take responsibility for the assessment results to the head of the Certification Authority and to the law.

2. Powers:

a) Request the consignor to provide documents, records, and product samples (if any) for assessment and certification purposes;

b) Access production areas, storage facilities, and warehouses; review records, take samples, photographs, copies and notes necessary for the assessment;

c) Prepare reports and propose handling measures in cases where the consignor or manufacturing establishment violates food quality and safety regulations;

d) Refuse to conduct the assessment if the consignor or manufacturing establishment fails to fully fulfill their responsibilities under points b and c clause 1 Article 38 of this Circular.”

41. Article 40 is amended as follows:

“Article 40. Head of the assessment team

1. When performing assigned duties, the head of the assessment team has responsibilities of an inspector as stipulated in clause 1 Article 39 of this Circular and other responsibilities as follows:

a) Manage and assign tasks to members of the assessment team to fully execute the contents specified in the decision on the establishment of the assessment team;

b) Process opinions and assessment results from members of the assessment team and provide the final conclusion in the assessment report;

c) Review, sign the assessment report, report the assessment results, and be accountable to the head of the competent body and to the law for the results given by the assessment team.

2. Within the ambit of his/her assigned duties, the head of the assessment team has powers of an inspector as stipulated in clause 2 Article 39 of this Circular and other powers as follows:

a) Recommend the head of the competent authority to issue a decision to change the members of the assessment team to fully execute the contents specified in the decision on the establishment of the assessment team;

b) Draw up the final conclusion of the assessment team regarding the assessment results.”

42. Article 41 is amended as follows:

“Article 41. National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development and its affiliated regional authorities

1. Responsibilities:

a) Organize the review of dossiers, conduct food safety inspections, issue, revoke the Food Safety Certificate; conduct assessment and supplement the Export List by areas which they are assigned to manage;

b) Provide inspectors with training in and professional guidance on dossier verification, food safety inspection, assessment, and issuance of the Health Certificate for exported fishery product consignments;

c) Fully archive documentation related to the results of dossier verification, business operator assessment, issuance, revocation of the Food Safety Certificate, and supplementation of the Export List; conduct inspection and post-inspection of business operators in compliance with regulations; provide documents, full and accurate reports on issues related to assessment and certification of compliance with exported fishery product safety regulations at the request of the Ministry of Agriculture and Rural Development;

d) Be responsible for the assessment and certification of food safety of exported fishery products;

dd) Maintain confidentiality of information related to business secrets of the business operators subject to assessment and issuance of the Food Safety Certificate;

e) Publish, register, introduce, and update the list of business operators participating in the Export Fishery Product Certification Program by each market in accordance with this Circular;

g) Report to the Ministry of Agriculture and Rural Development on updates regarding the list of markets where the competent body of the importing country requires the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development to conduct assessment and certification for export consignments as per this Circular;

h) Update regulations and technical regulations of Vietnam and importing countries regarding requirements for compliance with fishery product safety regulations and notify business operators, consignors, relevant authorities, and organizations for consistent application.

2. Powers:

a) Conduct assessment, issue, and revoke the Food Safety Certificate; conduct assessment and add business operators to the Export List; handle cases where business operators violate regulations of this Circular within their competence and under regulations of law;

b) Request business operators subject to assessment to conduct actual production for at least one of the products registered for assessment with a complete process or a high-risk product to serve the assessment activity; request business operators to correct non-conformities related to the requirements for compliance with food safety regulations as stated in the assessment report and food safety inspection report; request business operators to take corrective actions regarding criteria violating food safety regulations as per this Circular.

c) Notify the removal of business operators from the Export List by each market, the list of business operators participating in the Export Fishery Product Certification Program, and apply a temporary suspension of the issuance of the Health Certificate for business operators that do not comply with food safety regulations as stipulated in this Circular;

d) Request relevant competent authority to take actions against organizations and individuals violating the provisions of this Circular in accordance with the law.”

43. Article 41a is added to after Article 41 as follows:

“Article 41a. National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development - Centers

1. Responsibilities:

a) Organize the dossier review, assessment, issuance, revocation, and reissuance of the Health Certificate for exported fishery product consignments in areas which they are assigned to manage;

b) Provide inspectors with training in and professional guidance on dossier review, assessment, and issuance of the Health Certificate for exported fishery product consignments;

c) Supervise the maintenance of requirements for compliance with food safety regulations by business operators on the Export List to markets;

d) Fully archive documentation related to the maintenance of requirements for compliance with food safety regulations, results of dossier review, appraisal, issuance, revocation, and reissuance of Health Certificates to exported fishery product consignments in compliance with regulations; provide documentation and complete and accurate reports on issues related to assessment and certification when requested by the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development its affiliated regional authorities;

dd) Be responsible for the result of supervision of maintenance of requirements for compliance with food safety regulations, assessment and issuance of Health Certificates to exported fishery product consignments;

e) Receive and resolve complaints from consignors regarding the assessment, issuance, revocation, and reissuance of Health Certificates for exported fishery product consignments in accordance with regulations;

g) Maintain confidentiality of information related to business secrets of the business operators subject to assessment and certification of exported fishery product safety;

h) Manage, compile, and update the Priority List in accordance with this Circular;

i) Report to the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development the performance of assigned tasks as stipulated in this Circular;

2. Powers:

a) Conduct assessment, issue, revoke, and reissue Health Certificates to export consignments in accordance with this Circular; refuse assessment and issuance of the Health Certificate if a consignor fails to fulfill their responsibilities as stipulated in clause 1 Article 38 of this Circular;

b) Request any assessed business operator to rectify non-conformities and defects related to requirements for compliance with food safety regulations as stated in the assessment report and supervision report; conduct cause investigation, implement corrective measures, and report the implementation results when the Certification Authority and the competent body of the importing country issues a food safety violation warning as stipulated in this Circular;

c) Request relevant competent authority to take actions against organizations and individuals violating the provisions of this Circular in accordance with the law.”

44. Title of Article 42 is amended as follows:

“Article 42. Departments of Agriculture and Rural Developments, Food Safety Departments, Food Safety Management Boards of provinces and central-affiliated cities

Direct their affiliated units to cooperate with the Certification Authority in tracing, cause investigation, recall, and handling of fishery products failing to comply with food safety regulations regarding establishments under local management that supplied raw materials to processing establishments whose products are found to violate food safety regulations.”

45. Several phrases, Articles and Appendices of the Circular No. 43/2018/TT-BNNPTNT are amended, repealed and replaced as follows:

a) Article 16 and Chapter V are repealed;

b) Appendices III and VIII are repealed;

c) The phrase “kiểm tra” (“inspection”) is removed from the following points and clauses: title of Article 7; clause 2, clause 3 Article 13; title of Article 14; clause 2 Article 14; clause 1, clause 2 Article 37;

d) The phrase “kiểm tra” (“inspection”) is replaced with the phrase “thẩm định” (“assessment”) in the following points, clauses and Articles: clause 3 Article 3; clause 1, clause 2 Article 23; title of Chapter III; Article 30; title of Article 31; clause 1 Article 31; clause 2 Article 32; clause 1, clause 2 Article 38; Appendix XV of Circular No. 48/2013/TT-BNNPTNT ;

d) The phrase “kiểm tra” (“inspection”) is replaced with the phrase “thẩm định” (“assessment”) in the following points, clauses and Articles: clause 3 Article 3; clause 1, clause 2 Article 23; title of Chapter III; Article 30; title of Article 31; clause 1 Article 31; clause 2 Article 32; clause 1, clause 2 Article 38; Appendix XV of Circular No. 48/2013/TT-BNNPTNT ;

e) The phrase “Cơ quan kiểm tra, chứng nhận” (“inspection and certification authority”) is replaced with the phrase “Cơ quan thẩm quyền” (“competent body”) in the following points, clauses, Articles and Appendices: point d clause 1 of Article 37; point c clause 2 of Article 37;

g) The phrase “Cục Quản lý Chất lượng nông lâm sản và thủy sản” (“National Argo – Forestry - Fisheries Quality Assurance Department”) in point b clause 2 of Article 26 is replace with the phrase “Cục Chất lượng, Chế biến và Phát triển thị trường” (“National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development”);

46. Appendix I is replaced with Appendix VI to this Circular; Appendix II is replaced with Appendix VII to this Circular; Appendix IV with Appendix VIII to this Circular; Appendix V is replaced with Appendix IX to this Circular; Appendix VI is replaced with Appendix X to this Circular; Appendix VII is replaced with Appendix XI to this Circular; Appendix IX is replaced with Appendix XII to this Circular; Appendix X is replaced with Appendix XIII to this Circular; Appendix XI is replaced with Appendix XIV to this Circular; Appendix XII is replaced with Appendix XV to this Circular; Appendix XIII is replaced with Appendix XVI to this Circular; Appendix XIV is replaced with Appendix XVII to this Circular.

47. The Appendix IB Supervision form issued together with this Circular is added.

Article 3. Effect

1. This Circular comes into force from January 15, 2025.

2. This Circular supersedes the Circular No. 32/2022/TT-BNNPTNT dated December 30, 2022 of Minister of Agriculture and Rural Development, which shall cease to have effect from the effective date of this Circular.

3. Transitional clauses:

a) Any business operator classified as Priority Level 1 or 2 and included in the Priority List before the effective date of this Circular may continue to apply regulations on sampling for food safety risk verification until there is a change to the priority classification;

b) Any application for registration of food safety assessment or certification; assessment or certification of fishery product consignment submitted before the effective date of this Circular shall comply with the regulations of law in force at the time of submission.

4. In the cases where any of the legislative documents referred to and applied in this Circular is amended, supplemented or replaced, the newest one shall prevail.

5. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Agriculture and Rural Development for consideration and amendments./.