Circular No. 48/2013/TT-BNNPTNT on inspection and certification of food safety for exported aquatic products

CIRCULAR

Regulations on inspection and certification of food safety for exported aquatic products

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Pursuant to the Law on Product Quality and Safety No. 05/2007/QH12 dated November 21, 2007;

Pursuant to the Food Safety Law No. 55/2010/QH12 dated June 17, 2010;

Pursuant to the Government Decree No. 132/2008/NĐ-CP dated December 31, 2008 detailing implementation of certain provisions of the Law on Product Quality and Safety;

Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law;

Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/NĐ-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/NĐ-CP;

At the proposal of the Director of the Quality Management Department for Agricultural, Forestry, and Aquatic Products,

amending and supplementing certain provisions of Circular No. 22/2019/TT-BNNPTNT dated November 30, 2019 of the Minister of Agriculture and Rural Development guiding certain provisions of the Livestock Law on the management of breeds and breeding products of livestock. regulations on inspection and certification of food safety for exported aquatic products.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates:

1. Documents, procedures, and authority for inspection, issuance, and revocation of the Certificate of Food Safety Conditions (hereinafter referred to as the Food Safety Certificate) for production and business establishments dealing with aquatic food products that export (hereinafter referred to as the Establishment).

2. Documents, procedures, and authority for inspection and issuance of food safety certificates for exported aquatic products (hereinafter referred to as the Certificate) to markets where the Competent Authority of the importing country requires the export consignment to be inspected and issued a Certificate by the Directorate of Quality Assurance for Forestry, Agriculture, and Aquatic Products.

Article 2. Applicability

Article 1. The subjects to which this Circular applies include:

a) Production and business establishments dealing with aquatic food products that export;

b) Exported aquatic products to markets where the Competent Authority of the importing country requires the export consignment to be inspected and issued a Certificate by the Directorate of Quality Assurance for Forestry, Agriculture, and Aquatic Products.

2. For exported aquatic products requiring quarantine certification according to current regulations, the inspection and certification body specified in Article 5 of this Circular shall simultaneously perform food safety inspection and certification (Food Safety) and quarantine.

3. The following cases are not subject to this Circular:

a) Production and business establishments dealing with aquatic food products for domestic consumption only.

b) Exported aquatic products not intended for human consumption.

c) Exported aquatic products to markets where the Competent Authority of the importing country does not require the export consignment to be inspected and issued a Certificate by the Directorate of Quality Assurance for Forestry, Agriculture, and Aquatic Products.

Article 3. Explanation of Terms

In this Circular, certain terms are understood as follows:

1. Independent aquatic food production establishment: is an establishment equipped with complete facilities and equipment to fully implement its own production process from raw material reception to finished product packaging; has a dedicated quality management team with at least three staff members conducting food safety control during production and at least one staff member completing training on food safety management according to Hazard Analysis and Critical Control Points (HACCP) principles (hereinafter referred to as HACCP principles) conducted by organizations assigned by the Ministry of Agriculture and Rural Development to train food safety management according to HACCP principles.

2. Production batch: is a quantity of products produced from one or more batches of raw materials of the same origin, using the same technological process, under the same production conditions (with the same factors affecting food safety assurance) within 24 hours at an establishment.

3. Export batch: is the quantity of goods registered for inspection and certification for one-time export to one importer on one means of transport.

4. Similar group of aquatic food products: are aquatic food products with the same level of food safety risk, produced through similar basic technological processes (may differ at some stages but do not generate significant additional food safety risks) at an establishment.

5. Aquatic food production: involves performing one, several, or all activities of harvesting, preliminary processing, manufacturing, packaging, and storage to produce aquatic food products.

6. Aquatic food product: is a seafood product consumed by humans in fresh or processed and preserved forms.

7. Ready-to-eat aquatic food product: is a seafood product that can be directly consumed without special treatment before eating.

Article 4. Basis for inspection, evaluation, and certification

The basis for inspecting, evaluating, issuing the Food Safety Certificate and the Certificate for exported aquatic products is stipulated in Articles 41 and 42 of the Food Safety Law; Vietnam's regulations and technical standards, and the importing countries' regulations and technical standards on food safety for aquatic products.

Article 5. Inspection and Certification Authorities

1. Authorities conducting inspections, evaluations, and issuing Food Safety Certificates: The Directorate of Quality Assurance for Forestry, Agriculture, and Aquatic Products, the Central Quality Assurance Authority for Forestry, Agriculture, and Aquatic Products, and the Southern Quality Assurance Authority for Forestry, Agriculture, and Aquatic Products.

2. Authorities inspecting and issuing Certificates for exported aquatic product consignments: Units under the Directorate of Quality Assurance for Forestry, Agriculture, and Aquatic Products that have been assessed by the competent authorities of importing countries to be capable of performing inspection activities and issuing Certificates for exported aquatic product consignments.

Article 6. Requirements for Inspectors and Team Leaders for Inspection and Evaluation

1. For inspectors:

a) Honesty, objectivity, and no economic interest relationship with the exporting organization or individual (hereinafter referred to as the Shipper) or the owner of the inspected facility;

b) Possess relevant expertise and have completed training courses on aquatic food safety inspection and certification, certified by the Directorate of Quality Assurance for Forestry, Agriculture, and Aquatic Products;

c) Be in good health to ensure the completion of assigned tasks.

2. For team leaders for inspection and evaluation: meet all requirements set forth in Clause 1 of this Article and must have at least five years of experience working in the field of inspection, appointed by the Director of the Directorate of Quality Assurance for Forestry, Agriculture, and Aquatic Products as team leader.

Article 7. Requirements for equipment and tools serving on-site inspection and evaluation

1. Specialized, distinguishable from other tools:

2. In operational condition and well-maintained; calibrated and tested according to regulations; clean, ensuring they are not sources of contamination.

Article 8. Requirements for testing laboratories

Testing laboratories participating in analyzing and testing food safety indicators as prescribed in this Circular must be designated by authorized agencies according to the regulations of the Ministry of Agriculture and Rural Development.

Article 9. Fees and Charges

The collection of fees and charges for reviewing applications, evaluating facilities, inspecting, sampling, and testing food safety indicators to serve food safety inspection and certification as prescribed in this Circular shall be carried out in accordance with the provisions of Article 48 of the Food Safety Law and current regulations of the Ministry of Finance and related legal documents.

Chapter II

INSPECTION AND ISSUANCE OF FOOD SAFETY CERTIFICATES

Article 10. Application for Issuance of Food Safety Certificate

1. The application for issuance of the Food Safety Certificate includes:

a) An application form for the Food Safety Certificate according to the model attached as Appendix I to this Circular;

b) Business registration certificate or investment certificate: Notarized copy or copy accompanied by the original for verification;

c) Current status report (physical infrastructure, equipment, food safety assurance system) of the facility according to the model attached as Appendix II to this Circular;

d) List of facility owners and persons directly involved in food production who have been certified as fit for work by a health authority at the district level or higher;

đ) List of facility owners and persons directly involved in food production who have been trained in food safety knowledge and issued certificates by the competent quality assurance authority for forestry, agriculture, and aquatic products within the Ministry of Agriculture and Rural Development;

2. For facilities applying for a Food Safety Certificate after rectifying previous inspection and evaluation errors: the application includes one Report on the Results of Rectifying Errors according to the model attached as Appendix III to this Circular.

3. The facility submits one complete application to the inspection and certification authority through one of the following methods: direct submission, postal service; fax, email, or online registration (followed by submission of the original).

Article 11. Processing of Registration Files for Issuing Food Safety Certificates

1. Within three working days from the date of receiving the registration file of the Facility, the Inspection and Certification Authority must examine the validity of the file, guide the Facility to supplement missing or non-compliant contents.

2. If the registration file is valid, within five working days, the Inspection and Certification Authority shall notify the Facility of the anticipated time for on-site assessment at the Facility but not later than ten working days from the date of receipt of the complete valid file.

Article 12. Forms of Inspection and Assessment

1. On-site Assessment for Issuing a Food Safety Certificate: Applied in the following cases:

a) The Facility has not yet obtained a Food Safety Certificate;

b) The Facility had its Food Safety Certificate revoked;

c) The Facility holds a Food Safety Certificate with less than six months remaining validity;

d) The Facility has been issued a Food Safety Certificate but has changed ownership or upgraded production conditions leading to changes in the potential for food safety hazards compared to the initial state;

đ) The Facility supplements products that do not belong to the group of similar products already certified;

e) The Facility has been issued a Food Safety Certificate but has postponed periodic inspections for more than twelve months;

g) The Facility registers to be added to the list of permitted processing and export facilities for markets requiring such lists.

2. Post-Issuance Certificate Inspections:

a) Periodic Inspections: This is an unannounced inspection form aimed at monitoring the maintenance of food safety assurance conditions for Facilities that have been issued a Food Safety Certificate according to the following frequency: Class 1 and Class 2 Facilities: once every year; Class 3 Facilities: once every six months; Class 4 Facilities: the inspection timing depends on the level of errors of the inspected Facility and is decided by the Inspection and Certification Authority but not exceeding three months from the previous inspection date.

b) Unannounced Inspections: This is an unannounced inspection form applied to Facilities showing signs of violations of food safety as stipulated in point b, Clause 3, Article 17, Clause 3, Article 31, and Clause 2, Article 36 of this Circular or when complaints are made by organizations or individuals.

Article 13. Formation of Inspection and Assessment Teams

1. The Head of the Inspection and Certification Authority issues a decision to establish an inspection and assessment team for the food safety assurance conditions of the Facility.

2. The decision to establish the inspection and assessment team includes the following contents:

a) Basis for inspection and assessment;

b) Names, positions, and units of work of the members of the team;

c) Name, address, and code number (if available) of the Facility to be inspected and assessed;

d) Scope, content, form, and anticipated time for inspection and assessment;

đ) Responsibilities of the Facility to be inspected and assessed and the inspection and assessment team.

3. The decision to establish the inspection and assessment team must be notified at the Facility when the inspection and assessment begins.

Article 14. Content and Methods of Inspection and Assessment

1. The content of inspection and assessment of food safety assurance conditions of the Facility includes:

a) Physical infrastructure, equipment, and human resources involved in production and management of aquatic product food safety (including checking health certificates and training certificates on food safety knowledge of the Facility owner and direct food producers);

b) Food Safety Management Program based on HACCP principles;

c) Traceability procedures and product recall procedures;

d) Sampling analysis to evaluate the effectiveness of hygiene control during production according to Appendix IV issued together with this Circular.

2. The methods of inspection and assessment are carried out according to Appendix V issued together with this Circular.

Article 15. Inspection and Assessment Report

1. Contents of the Inspection and Assessment Report:

a) Fully and accurately reflect the results of the inspection and assessment according to the model specified in Appendix V issued under this Circular and prepared immediately after the completion of the inspection and assessment at the Facility;

b) Clearly record items that do not meet food safety requirements and the deadline for the Facility to complete corrective measures;

c) Clearly record the overall conclusion and classification level of food safety assurance conditions for the Facility;

d) Include comments from the authorized representative of the Facility regarding the inspection and assessment results, commitment to rectify any deficiencies (if applicable);

đ) Include signatures of the head of the inspection and assessment team and the authorized representative of the Facility; affix a cross-stamp on the Inspection and Assessment Report (or sign each page if there is no stamp at the Facility);

e) Prepared in two copies: one copy retained by the Inspection and Certification Authority, one copy retained by the Facility; additional copies may be prepared if necessary.

2. In case the Facility's representative does not agree to sign the Inspection and Assessment Report, the inspection and assessment team must note: "The Facility's representative did not sign the Report" and specify the reasons. The Report still retains legal validity if it bears the signatures of all members of the inspection and assessment team.

Article 16. Classification of Facilities Based on Assurance Conditions

1. Classification levels for Facilities based on assurance conditions are as follows:

a) Class 1: Very Good;

b) Class 2: Good;

c) Class 3: Satisfactory;

d) Class 4: Unsatisfactory.

2. Specific classification methods for each type of Facility as stipulated in Appendix V issued together with this Circular.

Article 17. Handling Inspection and Assessment Results and Issuing Food Safety Certificates

Within seven working days from the end of the inspection and assessment, the Inspection and Certification Authority will review the Inspection and Assessment Report, handle the results, and notify them to the Facility, specifically as follows:

1. Assessment of the Facility for Issuing a Food Safety Certificate:

a) The Facility achieves satisfactory results (Class 1, Class 2, and Class 3): The Inspection and Certification Authority reports the assessment results to the Department of Quality Management of Forestry, Agriculture, and Aquatic Products for consideration and issuance of a Food Safety Certificate valid for three years from the date of issue according to the model in Appendix VI issued together with this Circular and assigns a unique code number to the Facility (in cases where the Facility meets the independent aquatic product food production facility requirements stipulated in Clause 1, Article 3 of this Circular and does not yet have a code number) according to the numbering system specified in Appendix VII issued together with this Circular. Simultaneously, the Inspection and Certification Authority sends a notification letter of the assessment results to relevant agencies and units for coordinated management.

b) The facility has unsatisfactory results (category 4):

Notify the results of the assessment and require the Facility to implement and report on the results of correcting errors. Depending on the severity of the Facility's errors, the Inspection and Certification Authority decides the deadline for correction but not exceeding 03 (three) months from the date of inspection and re-assessment.

In case the re-assessment result does not meet the requirements (Class 4), the Inspection and Certification Authority notifies the re-assessment results and the expected time for the next assessment. Within 07 (seven) working days from the date of notification of the re-assessment results, the Inspection and Certification Authority publicly announces on mass media the name, address of the Facility, and the product that does not meet food safety assurance conditions.

In case the subsequent re-assessment result still does not meet the requirements (Class 4), the Inspection and Certification Authority recommends relevant authorities to handle according to current regulations.

2. Regular and spot checks:

a) Facilities with satisfactory results (Class 1, Class 2, and Class 3): Notify the Facility about the inspection results and the frequency of regular inspections to be applied in the future.

b) Facilities with unsatisfactory results (Class 4): Implement as stipulated in point b, Clause 1, Article of this Decree.

3. In cases where samples are taken for testing to evaluate the effectiveness of hygiene control during production:

a) Within 01 (one) working day from the date of receiving non-compliant test results, the Inspection and Certification Authority sends a notice requiring the Facility to take corrective actions. Depending on the severity of the Facility's errors, the Inspection and Certification Authority decides the deadline for correction and organizes sampling for re-testing.

b) In case the re-test results still do not comply with regulations, the Inspection and Certification Authority decides to conduct a spot check on the food safety assurance conditions of the Facility.

Article 18. Revocation of Food Safety Certificate

1. The Facility shall have its Food Safety Certificate revoked in cases specified in Article 13 of Decree No. 38/2012/NĐ-CP dated April 25, 2012, of the Government detailing certain provisions of the Food Safety Law.

2. Authority to revoke the Food Safety Certificate: The Directorate of Quality Assurance of Agricultural, Forestry Products and Aquatic Products.

Article 19. Issuance and supplement one Food Safety Certificate

1. The Food Safety Certificate shall be renewed in the following cases:

a) The Certificate is lost;

b) The certificate is damaged;

c) The Facility requests changes or additions to information related to the Food Safety Certificate (excluding cases where an on-site assessment must be conducted to issue the Food Safety Certificate as stipulated in points d and đ, Clause 1, Article 12 of this Circular).

2. Procedures for renewing the Food Safety Certificate:

a) The Facility submits a document to the Directorate of Quality Assurance of Agricultural, Forestry Products and Aquatic Products, clearly stating the reasons for requesting a renewal of the Food Safety Certificate according to the model attached as Appendix VIII to this Circular;

b) Number of documents: 01 (one) request for renewal of the Food Safety Certificate;

c) The Facility may submit the document directly, by mail, fax, or email (followed by submission of the original);

d) Within 03 (three) working days from the date of receipt of the Facility's request, the Directorate of Quality Assurance of Agricultural, Forestry Products and Aquatic Products is responsible for renewing the Food Safety Certificate for the Facility.

3. The validity period of the renewed Food Safety Certificate is the same as that of the old Food Safety Certificate.

Chapter III

INSPECTION AND ISSUANCE OF CERTIFICATES FOR EXPORTED AQUATIC FOOD PRODUCTS

Section 1

CHAPTER PROGRAM FOR CERTIFICATION OF EXPORTED AQUATIC PRODUCTS

Article 20. Scope and Participants of the Program

1. The Program includes activities of inspection and issuance of Certificates for exported aquatic food products to markets where the Importing Country's Competent Authority requires the General Department of Quality Inspection for Forestry, Agriculture and Aquatic Products to inspect and issue Certificates for export consignments according to the List of Markets attached as Appendix IX to this Circular.

2. In case of new market requirements, the General Department of Quality Inspection for Forestry, Agriculture and Aquatic Products shall notify enterprises and organizations implementing the Program, and simultaneously report to the Ministry of Agriculture and Rural Development to update the List of Markets mentioned above within three (3) months from the date of receipt of the relevant regulations from the Importing Country's Competent Authority.

3. Participating establishments must meet the following criteria:

a) Obtaining a Food Safety Certificate in accordance with this Circular;

b) Complying with the import country’s regulations and technical standards on food safety assurance.

Article 21. Domestic air passenger transport service on regular basic economy classlist Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết participating in the Program

1. According to the regulations of each importing country or agreements with the Competent Authority of the importing country, the General Department of Quality Inspection for Forestry, Agriculture and Aquatic Products shall establish and update the list of establishments participating in the export aquatic product certification program for each market for those establishments that fully meet the criteria stipulated in Clause 3 of Article 20 of this Circular.

2. An establishment will be removed from the Program in the following cases:

a) The establishment requests its name to be removed from the list of establishments participating in the Program for each export market;

b) The establishment has had its Food Safety Certificate revoked in accordance with Article 18 of this Circular.

Article 22. Priority List

1. The priority list is a list of establishments with good food safety history (meeting the criteria stipulated in Clause 2 of this Article) and applying the export aquatic product certification procedures as specified in Section 2 of this Chapter.

2. The General Department of Quality Inspection for Forestry, Agriculture and Aquatic Products shall establish a priority list for establishments that fully meet the following criteria at the time of review:

"Article 32. Assessment and issuance of certificates"

b) The establishment is classified as level 1 or level 2 in terms of food safety conditions for a period of twelve (12) months;

c) For three consecutive months, the establishment has exported consignments without any being detected as non-compliant with food safety regulations by the Competent Authority of Vietnam and the importing country.

3. A Facility will be removed from the priority list in the following cases:

a) The Facility fails to maintain food safety assurance conditions and is downgraded to Class 3 or Class 4;

b) The establishment does not obtain a Certificate in accordance with point b, c of Article 26 of this Circular.

4. An establishment may be returned to the priority list after meeting the conditions stipulated in Clause 2 of this Article.

5. An establishment ranked first in the priority list may apply for special sampling verification procedures for food safety in accordance with Appendix X attached to this Circular if it meets the following conditions:

a) There have been no consignments detected as non-compliant with food safety regulations by the Competent Authority of Vietnam or the importing country within twelve (12) months from the date of inclusion in the priority list until the review date;

b) There is a contractual agreement for food safety control and traceability between establishments in the supply chain, and these establishments are certified as meeting food safety conditions or certified under Good Aquaculture Practices (VietGAP) or equivalent.

6. To be considered for special sampling verification procedures, an establishment ranked first in the priority list must submit a request to the inspection and certification authority along with a notarized copy or original copy for comparison of contracts and certificates as stipulated in point b of Clause 5 of this Article. Within five (5) working days from the date of receipt of complete documentation, the inspection and certification authority shall notify the result of the verification to the establishment.

Article 23. Forms of Certification for Exported Consignments

1. For exported consignments produced by establishments listed in the priority list:

a) The inspection and certification authority issues a Certificate based on the results of effective hazard control sampling verification procedures as specified in Section 2 of this Chapter.

b) If the establishment requests individual sampling and testing for each exported consignment, the inspection and certification authority shall implement the procedures as specified in Section 3 of this Chapter.

2. For exported consignments produced by establishments outside the priority list: The inspection and certification authority issues a Certificate based on the results of individual sampling and testing for each exported consignment as specified in Section 3 of this Chapter.

Article 24. Requirements for Exported Products

1. Produced by establishments listed in the list of establishments participating in the export certification program for each market.

2. Comply with labeling requirements for mandatory information as prescribed by the importing country, without misleading the nature of the goods and without violating Vietnamese laws.

3. For products processed or manufactured from different establishments:

a) The establishment performing the final production stage (packaging, labeling) must be listed in the list of establishments participating in the export certification program for each market;

b) Establishments performing previous production stages must comply with Vietnamese and importing country’s regulations on food safety conditions;

c) Establishments participating in the processing and manufacturing of the consignment must provide a commitment to jointly bear responsibility for implementing corrective actions by the inspection and certification authority in case the consignment is warned by the Competent Authority of the importing country or found non-compliant with food safety regulations by the inspection and certification authority;

d) Establishments involved in the production of the consignment must retain full production and food safety control records for the production stages they perform, ensuring the traceability of the product.

Article 25. Provisions for Certificates

1. Each exported consignment is issued one (1) Certificate.

2. The Certificate is only valid for the consignment transported and stored under conditions that do not alter the contents certified regarding food safety.

3. The Certificate must contain content and format consistent with the requirements of the corresponding importing market and be numbered in accordance with Appendix XI promulgated together with this Circular.

Article 26. Establishment Not Entitled to Obtain a Certificate for Exported Consignment

1. The inspection and certification authority shall not issue Certificates for exported consignments produced by the following establishments:

a) An establishment requested by the Competent Authority of the importing country to suspend imports.

b) A facility whose Food Safety Certificate has been revoked in accordance with Article 18 of this Circular;

c) A facility that has been temporarily suspended from production in accordance with Article 30, Article 33 of the Product Quality Law or government regulations on administrative penalties for food safety violations.

2. The facilities mentioned in Clause 1 of this Article shall continue to be issued Certificates when they meet the following conditions:

a) The facility has implemented corrective measures as required by the Inspection and Certification Authority and such measures have been reviewed and confirmed to be effective by the Inspection and Certification Authority;

b) Additionally, the facility mentioned in point a, Clause 1 of this Article must be notified by the Directorate of Quality Assurance of Forestry, Agriculture and Fisheries and must have the temporary import suspension lifted by the competent authority of the importing country.

Section 2

ISSUE CERTIFICATE FOR EXPORT LOT PRODUCED BY FACILITIES

LISTED IN THE PRIORITY LIST

Article 27. REVIEW THE EFFECTIVENESS OF FOOD SAFETY HAZARD CONTROL

1. Principles of review:

a) Review criteria shall be carried out according to the list of food safety criteria and permissible limits based on the requirements of the corresponding importing market, which are submitted by the Directorate of Quality Assurance of Forestry, Agriculture and Fisheries for consideration and publication by the Ministry of Agriculture and Rural Development, and updated periodically.

b) Minimum frequency of sampling for review: Special regime: every two months; Class 1: monthly; Class 2: every two months.

c) Sampling rate for review: Determined based on the classification of food safety assurance conditions; historical food safety assurance; product risk level; scale, capacity, or production volume of the facility as stipulated in Appendix X.

Based on the evaluation of implementation results, the Directorate of Quality Assurance of Forestry, Agriculture and Fisheries will regularly submit to the Ministry of Agriculture and Rural Development for consideration and adjustment of the content specified in Appendix X to ensure appropriateness.

d) Sampling location: At the storage warehouse.

2. Review Plan:

a) The Inspection and Certification Authority shall coordinate with the facility on the review plan including: Sampling date, sample type, number of samples per round, and ensuring at least one review per year for each type of product produced and exported by the facility.

b) In case of changes, the facility must send a written notice to the Inspection and Certification Authority not later than three working days before the change date compared to the previously agreed plan.

3. Handling the Results of Sample Testing:

a) Within one working day from the date of receiving the test results of the review samples that do not comply with the importing country's regulations, the Inspection and Certification Authority shall notify the facility to implement corrective measures and handling procedures for the exported lot. The Inspection and Certification Authority shall review the results of the facility's corrective measures and supplement the testing of non-compliant criteria for the next round of review sampling.

b) In the subsequent review round, if the test results of the review samples continue to be non-compliant, the Inspection and Certification Authority shall require the facility to implement corrective measures and handling procedures for the exported lot, while applying the method of sampling and testing non-compliant food safety criteria for each exported lot until five consecutive lots meet the requirements.

Article 28. Registration, Issue Certificate

1. Registration for Issuing Certificate:

a) Not later than two working days from the export date of the lot, the Shipper must register for issuing the certificate according to the form attached in Appendix XII of this Circular.

b) The Shipper shall submit one set of registration documents to the Inspection and Certification Authority through one of the following methods: direct submission; postal service; fax, email (followed by submission of the original); or online registration.

c) If the Shipper is not the production facility of the lot, the Shipper needs to provide a certified copy or a copy accompanied by the original for verification of the purchase/sales authorization document related to the lot, along with the registration documents, including a commitment from both parties (the production facility and the Shipper) to share responsibility when the lot is warned by the competent authority.

2. Issuing Certificate:

Within one working day from receipt of complete information, the Inspection and Certification Authority shall examine the application, review the effectiveness of food safety hazard control as stated in Article 27 of this Circular, and issue the certificate for the export lot according to the corresponding market requirements, or issue a written response clearly stating the reasons for not issuing the certificate for the export lot.

Section 3

ISSUE CERTIFICATE FOR EXPORT LOT PRODUCED

AT FACILITIES OUTSIDE THE PRIORITY LIST

Article 29. REGISTRATION FOR INSPECTION

1. The inspection registration dossier for one export lot includes:

a) The inspection registration form according to the model attached in Appendix XIII of this Circular;

b) Detailed list of the lot according to the model attached in Appendix XIV of this Circular.

2. Deadline for submitting the registration dossier:

a) For fresh and ice-packed aquatic products: At least three working days before the expected export date.

b) For other cases: At least nine working days before the expected export date.

3. The Shipper shall submit one set of inspection registration dossier to the Inspection and Certification Authority through one of the following methods: direct submission, postal service; or fax, email, online registration (followed by the facility sending one inspection registration form to the Inspection and Certification Authority).

4. If the Shipper is not the production facility of the lot, the Shipper needs to provide a certified copy or a copy accompanied by the original for verification of the purchase/sales authorization document related to the lot, along with the registration dossier, including a commitment from both the production facility and the Shipper to share responsibility when the lot is warned by the competent authority.

5. Handling the Registration Dossier: Within one working day from receipt of the complete dossier as stipulated in Clause 1 of this Article, the Inspection and Certification Authority shall examine the validity of the dossier and guide the Shipper to supplement missing or incorrect contents (if any).

Article 30. INSPECTION AND SAMPLE TESTING

1. The Inspection and Certification Authority shall dispatch inspectors to conduct inspections and sample testing of the lot within two working days from the date the Shipper requests or according to the time agreed between the Shipper and the Inspection and Certification Authority.

2. Content and procedures for inspecting the consignment shall be carried out in accordance with the provisions set forth in Appendix XV attached to this Circular.

Article 31. Handling results of inspections and tests that do not meet food safety standards

1. In case the inspection results of the consignment do not comply with the production file requirements, sensory, and external quality criteria: Within 01 (one) working day from the completion of the inspection, the Inspection and Certification Authority shall notify the Owner of the consignment Non-compliance Notification in the format prescribed in Appendix XVI attached to this Circular.

2. In case the test results of the consignment do not meet food safety regulations:

a) The Inspection and Certification Authority shall send the test results to the Owner within 01 (one) working day from the date when all test results are available;

b) Within 03 (three) days from the date the test results are sent to the Owner, if the Owner provides written comments on the test results, the Inspection and Certification Authority shall act in accordance with the provisions at point 2, section 8 of Appendix XV attached to this Circular.

c) Within 03 (three) days from the date the test results are sent to the Owner, if the Owner does not provide written comments on the test results, the Inspection and Certification Authority shall notify the Owner Non-compliance Notification in the format prescribed in Appendix XVI attached to this Circular, clearly stating the reasons for non-compliance, requesting the Owner to investigate the cause, implement corrective measures, handle the consignment, and submit a report to the Inspection and Certification Authority.

3. Within 03 (three) working days from receiving the explanation report from the Facility, the Inspection and Certification Authority shall review the contents of the report and issue a notification of the review results to the Facility. If an urgent inspection is required for verification, the Inspection and Certification Authority shall conduct the inspection and notify the Facility of the results within 07 (seven) working days from receiving the report from the Facility.

Article 32. CIssuing the Certificate

1. Within 02 (two) working days from the export of the consignment, the Owner must provide in writing all necessary information as stipulated in the certificate template according to the requirements of the importing country's competent authority to the Inspection and Certification Authority for issuance of the Certificate. Within 01 (one) working day from receiving complete information, the Inspection and Certification Authority shall issue the Export Certificate for the consignment in the format corresponding to the importing market if the inspection and testing results of the consignment meet the requirements.

2. After 90 (ninety) days from the inspection date, if the Owner fails to provide complete information to the Inspection and Certification Authority for issuance of the Certificate, the Owner must register for inspection as prescribed in Article 29 of this Circular.

Section 4

HANDLING AFTER ISSUING THE CERTIFICATE

Article 33. Reissuing the Certificate

1. When the Certificate is lost or damaged, the Owner must submit a written request for reissuance of the Certificate specifying the reason to the Inspection and Certification Authority through one of the following methods: Direct submission, postal service; or fax, email (followed by submission of the original).

2. The Inspection and Certification Authority shall reissue the Certificate within 01 (one) working day from receiving the Owner's request and ensure the following requirements:

a) The reissued Certificate must contain accurate content matching the content of the originally issued Certificate for the corresponding consignment;

b) The reissued Certificate shall be assigned a new number in accordance with the provisions set forth in Appendix XI attached to this Circular and marked with the note: "This Certificate replaces Certificate number ..., issued on ...”.

Article 34. Transferring the Certificate

In case the Owner requests the transfer of the Certificate for the consignment, the Inspection and Certification Authority shall ensure the following requirements:

1. It shall be carried out immediately upon receipt of the initial Certificate;

2. The transferred Certificate must contain accurate content matching the content of the initial Certificate.

Article 35. Post-certification supervision of the consignment

1. Annually or urgently when requested, the Inspection and Certification Authority shall work with the Customs Authority to verify information, status, and consistency of the post-certified consignment compared to the certified consignment, including coordinating to conduct actual inspections of the consignment at the consolidation location when it awaits customs clearance for export if necessary.

2. In case of violation detection, the Inspection and Certification Authority shall examine, record the working session, and issue a document to revoke the validity of the Certificate (already issued) and send it to the relevant parties; simultaneously requesting the Customs Authority to handle it according to regulations. Depending on the severity of the Owner's violation, the Inspection and Certification Authority may issue a document to request the competent authority to impose administrative penalties according to current laws.

Article 36. Handling cases where the consignment is warned

1. Within 03 (three) working days from receiving formal warning information from the importing country's competent authority, the Inspection and Certification Authority shall issue a document requesting the Facility to perform the following actions:

a) Conduct traceability of the consignment, organize an investigation into the cause leading to the failure to meet food safety standards; establish and implement corrective actions; submit a report to the Inspection and Certification Authority in the format specified in Appendix XVII attached to this Circular;

b) Temporarily suspend exports to corresponding importing countries if required by the importing country's competent authority;

c) Comply with sampling and testing regimes for non-conforming criteria/groups of criteria for each exported consignment of the violating product produced at the Facility until the Inspection and Certification Authority issues a document approving the Facility's investigation result and corrective action report;

2. Within 03 (three) working days from receiving the Facility's report on the investigation results and corrective actions, the Inspection and Certification Authority shall review the report contents and issue a notification of the review results to the Facility. If an urgent inspection is required for verification, the Inspection and Certification Authority shall conduct the inspection and notify the Facility of the results within 07 (seven) working days from receiving the Facility's report.

Chapter IV

RESPONSIBILITIES AND LIMITATIONS OF THE INVOLVED PARTIES

Article 37. Facilities granted Food Safety Certificates

1. Responsibilities:

a) Register with the Inspection and Certification Authority in accordance with this Circular to undergo inspection and obtain a Food Safety Certificate; comply with the assessment and inspection plan of the Inspection and Certification Authority;

b) Arrange for an authorized representative of the Facility to work with the inspection and evaluation team at the Facility;

c) Provide complete information, files, documents, and product samples for testing to evaluate the effectiveness of hygiene control during production as required by the inspection and evaluation team and be responsible for the provided information and documents;

d) Maintain the conditions ensuring food safety that have been certified on a regular basis;

đ) Implement repairs and corrections to the errors noted in the Inspection Report and notifications from the inspection and certification authority within the specified deadlines;

e) Sign the Inspection Report;

g) Pay the inspection, evaluation, and certification fees as stipulated in Article 9 of this Circular;

2. Authorities:

a) Express agreement or disagreement (with clear reasons) regarding the results of the inspection and evaluation in the Inspection Report;

b) Lodge complaints about the conclusions of the inspection and evaluation against the Facility;

c) Promptly report to the head of the inspection and certification authority about any negative actions of the inspection and evaluation team or inspectors;

Article 38. The consignor or the production facility of the export shipment

1. Responsibilities:

a) Register with the inspection and certification authority as prescribed in this Circular to obtain inspection and issuance of the Certificate for the shipment;

b) Comply with the regulations concerning inspection, sampling, and testing for the effectiveness of hazard control, and provide complete files and documents related to the export shipment as required by the inspector;

c) Not alter the characteristics of the product, components of the shipment, or labeling information compared to the registered content and those inspected and certified for the shipment;

d) Proactively report to the inspection and certification authority when a shipment is returned or destroyed in the importing country. Implement appropriate measures for the returned or recalled shipment according to the requirements of the inspection and certification authority;

đ) Ensure the sampling plan for the effectiveness of hazard control has been agreed upon with the inspection and certification authority;

e) Pay the inspection and certification fees as stipulated in Article 9 of this Circular;

2. Authorities:

a) Request the inspection and certification authority to provide relevant regulations concerning the inspection and issuance of the Certificate for the export shipment as prescribed in this Circular;

b) In case the production facility of the shipment is listed in the priority list: The consignor has the right to request the inspection and certification authority to conduct inspections and sample testing for the export shipment to serve as the basis for issuing the Certificate;

c) Reserve a different opinion from the inspection results;

d) Lodge complaints and denunciations against any violations of laws by inspectors, the inspection and certification authority, laboratories, and related individuals or organizations in accordance with the Law on Complaints, the Law on Denunciation, and guiding documents implementing these laws;

Article 39. Examiners

1. When performing assigned tasks, inspectors shall be responsible for:

a) Adhering strictly to the procedures, formalities, contents, methods, and bases for inspecting, evaluating, and certifying the conditions ensuring food safety for the Facility; inspecting and sampling for testing shipments as prescribed in this Circular;

b) Keeping confidential information related to the production and business operations of the Facility and the consignor in accordance with the law; ensuring accuracy, transparency, fairness, honesty, and impartiality without discrimination when performing their duties;

c) Not requesting additional content beyond the regulations that cause harassment or inconvenience to the Facility and the consignor;

d) Following the assignments of the inspection team leader and the head of the inspection and certification authority; being accountable for the inspection and evaluation results before the head of the inspection and certification authority and the law;

2. Within the scope of their assigned tasks, inspectors have the following rights:

a) Request the Facility and the consignor to provide files, documents, and samples (if applicable) for inspection and evaluation purposes;

b) Enter production, storage, and warehouse areas; review files, take samples, photograph, copy, and record necessary information to support their inspection and evaluation tasks;

c) Draft reports, propose, and recommend measures for handling cases where the Facility or the consignor violate regulations related to food safety assurance;

d) Reserve personal opinions and report to the head of the inspection and certification authority in cases where they do not agree with the final conclusion of the inspection team leader as stated in Point b Clause 2 Article 40 of this Circular;

đ) Refuse to conduct inspections and evaluations if the Facility owner does not fully fulfill their responsibilities as stipulated in Points b and c Clause 1 Article 38 of this Circular;

Article 40. Team Leader of Inspection and Evaluation

1. When performing assigned tasks, the team leader of inspection and evaluation shall have the responsibilities of an inspector as stated in Clause 1 Article 39 of this Circular and other responsibilities as follows:

a) Direct and assign tasks to members of the inspection and evaluation team to fully implement the contents of the decision establishing the inspection and evaluation team;

b) Process the opinions and results of inspection and evaluation by team members and issue the final conclusion in the Inspection Report;

c) Review and sign the Inspection Report, report the results of inspection and evaluation, and be accountable to the head of the inspection and certification authority and the law for the results implemented by the inspection and evaluation team;

2. Within the scope of their assigned tasks, the team leader of inspection and evaluation shall have the rights of an inspector as stated in Clause 2 Article 39 of this Circular and other rights as follows:

a) Propose to the head of the inspection and certification authority to issue a decision adjusting the members of the inspection and evaluation team to fully implement the contents of the decision establishing the inspection and evaluation team;

b) Issue the final conclusion of the inspection and evaluation team on the results of inspection and evaluation.

Article 41. The Bureau of Quality Management for Forestry, Agricultural, and Aquatic Products

1. Responsibilities:

a) Organize the examination of files, assessment of Establishments, issuance of Food Safety Certificates, and post-issuance inspection of Food Safety Certificates; inspect and issue Certificates for export aquatic product consignments nationwide;

b) Organize training, instruction, and professional guidance for inspectors regarding file examination, Establishment assessment, issuance of Food Safety Certificates, and post-issuance inspection of Food Safety Certificates; inspect and issue Certificates for export aquatic product consignments;

c) Maintain complete records related to the results of file examination, Establishment assessment, issuance of Food Safety Certificates, and post-issuance inspection of Food Safety Certificates; inspect and issue Certificates for export aquatic product consignments from Establishments in accordance with regulations; provide complete and accurate records and reports on issues related to export aquatic product inspection and certification activities when requested by the Ministry of Agriculture and Rural Development;

d) Be responsible for the results of export aquatic product inspection and certification;

e) Resolve complaints and accusations from Shippers concerning export aquatic product inspection and certification in accordance with regulations;

f) Safeguard information related to production and business secrets of Establishments subject to export aquatic product inspection and certification;

g) Publish and update Lists of Establishments participating in the Export Aquatic Product Certification Program for each market, priority lists as stipulated in this Circular;

h) Report to the Ministry of Agriculture and Rural Development updates on the List of markets where the Importing State's Authority requires the Bureau of Quality Management for Forestry, Agricultural, and Aquatic Products to inspect and issue Certificates for export consignments in accordance with this Circular;

i) Update Vietnamese and importing country technical regulations on food safety conditions and notify Establishments, Shippers; relevant agencies and organizations to ensure uniform application;

2. Authorities:

a) Assess, issue, and revoke Food Safety Certificates for inspected Establishments; handle cases where Establishments violate provisions of this Circular within their authority and in accordance with laws;

b) Inspect and issue Certificates for export consignments in accordance with this Circular; refuse inspection and issuance of Certificates if Shippers fail to fulfill their responsibilities as specified in Clause 1, Article 38 of this Circular;

c) Require inspected and assessed Establishments to rectify deficiencies in food safety conditions noted in inspection reports; investigate causes, establish corrective measures, and report on the implementation of corrective actions for Establishments whose export consignments have been warned about food safety violations by Inspection Authorities and Importing State Authorities according to this Circular;

d) Announce removal from Lists of Establishments participating in the Export Aquatic Product Certification Program for specific export markets or temporarily suspend Certificate issuance for Establishments that do not meet food safety conditions as stipulated in Clause 2, Article 21 and Clause 1, Article 26 of this Circular;

e) Recommend competent authorities to handle organizations and individuals violating this Circular in accordance with laws;

Article 42. the OF AGRICULTURE AND RURAL DEVELOPMENT the provinces and centrally administered cities

Direct Provincial Bureaus of Quality Management for Forestry, Agricultural, and Aquatic Products and related units to cooperate with Inspection Authorities in investigating causes and applying corrective measures for suppliers of raw materials for export processing Establishments that violate food safety regulations and technical standards.

Article 43. Testing Laboratory

1. Responsibilities:

a) Adhere strictly to testing procedures, ensure the capacity of testing equipment, and maintain the confidentiality of the Shipper's information and testing results in accordance with the law;

b) Ensure that testing results are accurate, impartial, and truthful;

c) Only report testing results to the Inspection and Certification Authority and must comply with the prescribed timeframes;

d) Be responsible for test results;

đ) Participate in proficiency testing programs as required by the Ministry of Agriculture and Rural Development;

e) Store testing-related records and documents in compliance with regulations and produce them upon request by authorized authorities.

2. Authorities:

a) Refuse samples that do not meet technical requirements as stipulated. Refuse to test samples and indicators outside the certified scope;

b) Receive information and training opportunities to enhance testing capabilities;

c) Charge testing fees and charges according to current regulations.

Chapter V

IMPLEMENTING PROVISIONS

Article 44. Effective date of implementation

1. This Circular takes effect from December 26, 2013.

2. This Circular replaces Circular No. 55/2011/TT-BNNPTNT dated August 3, 2011, issued by the Minister of Agriculture and Rural Development on quality inspection and certification, food safety, and hygiene for aquatic products.

3. Repeal Clause 3, Article 3 of Circular No. 01/2013/TT-BNNPTNT dated January 4, 2013, issued by the Ministry of Agriculture and Rural Development regarding amendments and supplements to certain provisions of Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011, which stipulates the inspection and evaluation of agricultural input production and business establishments and forestry, agricultural, and aquatic product processing facilities, and replaces some forms attached to Circular No. 53/2011/TT-BNNPTNT dated August 2, 2011, amending and supplementing Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011.

4. Establishments meeting the requirements set out in point a and c, Clause 2, Article 22 of this Circular and maintaining food safety conditions classified as A or B continuously for a period of 12 months prior to the effective date of this Circular shall be considered for inclusion in the Priority List.

Article 45. Amendment and Supplement to the Circular

Any difficulties or obstacles arising during the implementation of this Circular shall be reported to the Minister of Agriculture and Rural Development for consideration and appropriate amendment and supplementation.