CIRCULAR
Inspection and certification of aquatic product quality and food safety
____________________
THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT
Pursuant to Decree No. 01/2008/ND-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/ND-CP;
Pursuant to the Law on Food Safety No. 55/2010/QH12 dated June 17, 2010;
Pursuant to the Law on Product Quality and Goods Quality dated November 21, 2007 and Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Law on Product Quality and Goods Quality;
The Ministry of Agriculture and Rural Development hereby stipulates the inspection and certification procedures for the quality and food safety of aquatic products as follows:
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
1. This Circular prescribes the procedures and formalities for inspecting and certifying aquatic product production and business establishments meeting food safety conditions; inspecting and certifying the quality and food safety (hereinafter referred to as CL, ATTP) of batches of aquatic products and aquatic products used as food (hereinafter referred to as batches); responsibilities and authorities of inspection and certification agencies (hereinafter referred to as inspection agencies) and related organizations and individuals.
2. The inspection and certification of the quality and food safety of imported batches shall be carried out in accordance with Circular No. 25/2010/TT-BNNPTNT dated April 8, 2010 guiding the inspection of food hygiene and safety for animal-origin goods imports, Circular No. 51/2010/TT-BNNPTNT dated September 8, 2010 amending and supplementing some articles of Circular No. 25/2010/TT-BNNPTNT, and Circular No. 06/2010/TT-BNNPTNT.
Article 2. Applicability
1. Aquatic product production and business establishments that have registered food business activities in their Business Registration Certificate according to current regulations of Vietnam and fishing vessels with main engine power of 50 HP or more (hereinafter referred to as Establishments):
a) Establishments producing export products;
b) Establishments producing products for domestic consumption only.
2. Export batches subject to state inspection and certification of CL, ATTP according to the regulations of Vietnam and the importing country.
3. For export batches requiring quarantine certification under current regulations, the inspection agency specified in Clause 1 of Article 5 of this Circular shall simultaneously carry out CL, ATTP inspection and quarantine.
Article 3. Explanation of Terms
In this Circular, the following terms are understood as follows:
1. Fishing port is a dedicated port for fishing vessels, including port land and anchorage area. Port land includes wharf, storage areas, workshops, administrative zones, logistics services, buying and selling, exporting, and importing of aquatic products.
2. Aquatic product production establishment: is an establishment with a fixed location carrying out one, several, or all of the production, processing, packaging, and preservation activities to produce aquatic food products.
3. Aquatic product business establishment: is an establishment providing one, several, or all of the preservation, transportation, or trading services of aquatic food products.
4. Market selling aquatic products: is a fixed location where aquatic food products are bought and sold and may include purchasing, preliminary processing activities.
5. Independent aquatic product production establishment: is an establishment equipped with complete facilities and equipment to independently complete a separate production process from raw material reception to finished product storage at one location; having a quality management team with at least three staff members responsible for quality control and food safety during production and at least one staff member certified by the competent authority to have completed relevant training courses on quality management based on HACCP principles.
6. Independent cold storage for preserving aquatic products: is an insulated building consisting of one or more rooms artificially cooled to provide specialized preservation services for frozen aquatic products.
7. Traceability: is the ability to track and identify a unit of product through each stage of the production, processing, and distribution process.
8. Sampling for testing: is the selection of a predetermined sample and transferring it to designated laboratories for analysis of quality and food safety indicators.
9. Production batch: is a quantity of products produced from one or multiple raw material batches with full origin information following the same technological process, under the same production conditions within a period not exceeding 24 hours at one establishment.
10. Export batch: is the quantity of goods registered for inspection for export once to one importer on one means of transport.
11. Initial sample: is the quantity of product or a single package taken from a production batch at one location.
12. Composite sample: is a sample collected from initial samples.
13. Average sample: is the quantity of product or a number of packages taken from the composite sample.
14. Test sample: is the sample taken from the average sample used for analyzing quality and food safety indicators.
15. Retained sample: is the sample taken from the average sample preserved under conditions that do not alter its original characteristics, used for confirmatory testing when necessary.
16. Aquatic food is all living aquatic animals and plants, amphibians, including eggs and parts thereof used as food or processed food containing aquatic products.
17. Similar groups of aquatic food products are aquatic products with the same level of food safety risk, produced by similar technological processes at one establishment.
18. Ready-to-eat aquatic food products are aquatic products that can be directly consumed by people without any special treatment before eating.
Article 4. Basis for inspection and certification
1. The basis for inspection and certification are the provisions and technical standards of Vietnam regarding food safety conditions in the production and business of aquatic products; the quality and safety of aquatic food products.
2. For establishments producing aquatic products for export, in addition to complying with the contents stipulated in Clause 1 of this Article, they must also meet the requirements under international treaties to which Vietnam is a party and the regulations of the importing country.
Article 5. Inspection Authority
1. The central inspection agency is the Directorate of Quality Assurance for Agricultural Products and Aquatic Products and its subordinate units are responsible for:
a) Inspecting and certifying compliance with food safety conditions for establishments specified in point a, Clause 1 of this Circular, including establishments that produce aquatic products for both domestic consumption and export;
b) Inspecting and certifying quality and food safety for batches of aquatic products and aquatic products intended for export as specified in Clauses 2 and 3 of Article 2 of this Circular.
2. Local inspection agencies:
a) Provincial level: is the District Office of Quality Assurance for Agricultural Products and Aquatic Products (or specialized agencies designated by the Department of Agriculture and Rural Development of provinces/cities directly under the Central Government for provinces/cities that have not established a District Office of Quality Assurance for Agricultural Products and Aquatic Products), responsible for organizing inspections and certifying compliance with food safety conditions for establishments specified in point b, Clause 1 of this Circular, in accordance with the decentralization regulations of the Ministry of Agriculture and Rural Development stipulated in Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011 (hereinafter referred to as Circular 14);
b) District level: is the specialized agency under the People's Committee at the district level, responsible for inspecting and certifying compliance with food safety conditions for production establishments specified in point b, Clause 1 of this Circular (excluding fishing vessels) registered for business by the district level;
c) Commune level: is the People's Committee at the commune level, responsible for inspecting and certifying compliance with food safety conditions for business establishments specified in point b, Clause 1 of this Circular registered for business by the district level located within the commune area;
d) Based on actual conditions, in cases where the inspection agencies at the district and commune levels do not have the capacity to perform the tasks specified in points b and c of Clause 2 of this Article, the provincial inspection agency designated by the Department of Agriculture and Rural Development of the province/city shall be responsible for performing the corresponding tasks assigned to the district and commune inspection agencies and shall transfer the tasks immediately upon the district and commune inspection agencies having the capacity to perform them.
Article 6. Requirements for inspectors and team leaders
1. For inspectors:
a) Honesty, objectivity, and no direct or indirect economic interest relationship with the consignor or the inspected production establishment;
b) Possess relevant expertise and hold a certificate indicating completion of appropriate training courses on inspection and certification of aquatic product quality and food safety;
c) Be in good health to ensure the completion of assigned tasks;
d) Wear specialized uniforms and identification badges as prescribed when performing duties;
2. For team leaders: in addition to the requirements stipulated in Clause 1 of this Article, they must also have experience working in the field of inspection.
Article 7. Requirements for equipment and tools for on-site inspection
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 analysis, testing, and examination of criteria related to quality and safety of food (CL, ATTP) for the purpose of inspecting, evaluating, classifying conditions ensuring food safety (ATTP) for the establishment; inspecting and certifying national quality and safety (CL, ATTP) for batches of goods must be designated by the competent authority according to the regulations of the Ministry of Agriculture and Rural Development.
Chapter II
INSPECTION AND CERTIFICATION OF ESTABLISHMENTS MEETING FOOD SAFETY REQUIREMENTS
FOOD SAFETY
Section 1
PROCEDURES, CONTENTS, AND HANDLING OF INSPECTION RESULTS AND CERTIFICATION
Article 9. Application for inspection and certification
1. Establishments eligible to obtain a Food Safety Certificate (hereinafter referred to as ATTP Certificate) in seafood production and business shall prepare one set of application files for inspection and send them to the Inspection Authority according to the classification specified in Article 5 of this Circular to be inspected and issued the ATTP Certificate.
2. The registration dossier for inspection includes:
a) An inspection application form according to the model attached as Appendix 1 to this Circular;
b) A certified copy of the Business Registration Certificate of the establishment (not applicable to fishing vessels);
c) A report on the current status of food safety conditions of the establishment according to the model at Appendix 2 attached to this Circular (not applicable to fishing vessels);
d) A summary table of the HACCP plan for similar products registered for inspection (applicable to establishments required to develop and implement a CL, ATTP assurance program based on the HACCP principle according to the National Technical Regulation QCVN 02 - 02: 2009/BNNPTNT);
3. For establishments applying for inspection after rectifying errors from the previous inspection, the establishment only prepares a file including one report on the results of rectifying errors according to the model attached as Appendix 3 to this Circular and sends it to the Inspection Authority.
4. The application for inspection is sent to the Inspection Authority through one of the following methods: direct submission, postal service; or fax, email, online registration (after which the establishment submits one inspection application form or error correction report to the Inspection Authority, the remaining files are provided when the inspection team arrives for inspection).
Article 10. Notification of inspection plans
1. The Inspection Authority shall coordinate with the authority issuing the Business Registration Certificate and the authority issuing the fishing vessel registration certificate to conduct statistics and compile a list of establishments under their management according to the division and classification provisions in Clause 1, Article 2 of this Circular and notify the inspection plans to the establishments through one of the following methods: direct submission, fax, email.
2. For establishments that have applied for inspection:
a) Within three working days from the date of receipt of the establishment's inspection application file, the Inspection Authority must review and guide the establishment to supplement missing or non-compliant contents;
b) If the application file is appropriate, within five working days, the Inspection Authority must notify the establishment of the expected inspection time. This time should not be later than fifteen working days from the date of full receipt of the application file.
3. In cases where the establishment does not apply for inspection, the Inspection Authority will still carry out inspections according to the planned schedule.
4. For fishing vessels, the Inspection Authority shall negotiate with the vessel owner to determine a suitable inspection timeframe and location based on the actual operational conditions of the vessel.
Article 11. Forms of inspection
1. Inspection for evaluation and classification: This form of inspection involves prior notification, and a comprehensive check of all criteria regarding food safety assurance conditions of the Facility, applied to:
a) Facilities eligible for issuance of Food Safety Assurance Certificates in seafood production and business but have not yet received them;
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) Facilities that have been issued Food Safety Assurance Certificates but have changed ownership or undergone repairs, upgrades, expansions affecting their ability to produce food safety risks compared to initially;
đ) The Facility supplements products that do not belong to the group of similar products already certified;
e) Facilities that have been issued Food Safety Assurance Certificates according to point a, Clause 1, Article 16 of this Circular but have shifted from domestic consumption to export product sales;
g) Facilities registering to be added to the list of permitted exporters to importing countries requiring such lists;
h) Facilities certified as meeting food safety assurance conditions but have postponed regular inspections for more than 12 (twelve) months.
2. Regular inspection: This form of inspection is unannounced, aimed at monitoring the maintenance of food safety assurance conditions for Facilities that have been issued Food Safety Assurance Certificates.
3. Surprise inspection: This form of inspection is unannounced, applied to facilities showing signs of violations concerning hygiene and food safety assurance or when complaints are made by organizations or individuals.
Article 12. Establishment of Inspection Teams
1. The head of the Inspection Agency issues a decision to establish an Inspection Team for inspecting food safety assurance conditions of the Facility.
2. The decision to establish the Inspection Team includes the following contents:
a) Basis for inspection;
b) Scope, content, form, and expected time of inspection;
c) Name, address, and code number (if any) of the inspected Facility;
d) Names, positions, and units of work of the team leader and members of the team;
đ) Responsibilities of the inspected Facility and the Inspection Team.
3. The decision to establish the Inspection Team must be notified at the Facility when the inspection begins.
Article 13. Content and Methods of Inspection
1. The content of inspecting food safety assurance conditions of the Facility includes:
a) Physical infrastructure, equipment, and personnel directly involved in food safety assurance in seafood production and business;
b) Quality management program;
c) Product traceability procedures;
d) Sampling for assessing the effectiveness of self-monitoring activities related to food safety assurance of the Facility when necessary (not applicable if the Inspection Agency is a People's Committee at the commune level). In cases where sampling is conducted, the Inspection Team must prepare a sample testing record with signatures of the Inspection Team Leader and the authorized representative of the Facility;
2. Inspection methods and guidance for evaluation for Facilities shall be carried out according to the Appendices issued along with Circular 14 and Appendix 4 issued along with this Circular.
Article 14. Inspection Records
1. Inspection records must ensure:
a) A complete and accurate reflection of the inspection results according to the prescribed model and prepared at the Facility immediately after the inspection ends;
b) Clearly stating non-compliant items and deadlines for rectifying deficiencies;
c) Concluding remarks on food safety assurance conditions and classification levels for the Facility as stipulated in Article 15 of this Circular;
d) Opinions of the authorized representative of the Facility regarding the inspection results and commitments to rectify deficiencies;
đ) Signatures of the Inspection Team Leader and the authorized representative of the Facility. Stamp across the Inspection Record or the Inspection Team Leader signs each page of the Inspection Record if the Facility does not have a seal.
e) Prepared in two (two) copies: one (one) copy retained by the Inspection Agency, one (one) copy retained by the Facility, additional copies may be prepared if necessary.
2. If the Facility's representative disagrees to sign the Inspection Record and does not provide comments on the inspection results or commitments to rectify deficiencies, the Inspection Team must clearly note: "The representative of the inspected Facility did not sign the record" and specify the reasons why the representative did not sign. This record remains legally valid if it has the signatures of all members of the Inspection Team.
Article 15. Classification of Food Safety Assurance Conditions for Establishments
The classification levels for Establishments regarding food safety assurance conditions shall be applied as follows:
1. Class A (Excellent): applicable to Establishments that fully meet the requirements for food safety assurance conditions, without serious or very serious violations.
2. Class B (Satisfactory): applicable to Establishments that meet the requirements for food safety assurance conditions, with few serious violations but no very serious violations.
3. Class C (Unsatisfactory): applicable to Establishments that fail to meet the requirements for food safety assurance conditions, with many serious violations or very serious violations, which if not corrected within the time limit set by the inspection authority will continue to produce products that seriously affect quality and cause food safety issues.
4. Specific classification levels for each type of Establishment shall be determined according to the annexes issued along with Circular 14 and Annex 4 issued along with this Circular.
Article 16. Handling Inspection Results
Within no more than seven working days from the end of the inspection, the Inspection Authority shall review the inspection report of the Inspection Team, handle the results, and send the inspection results directly or through postal service to the Establishment, specifically as follows:
1. Inspection and classification evaluation:
a) Establishment meeting the requirements (Class A or B): Issue a Decision recognizing the establishment as meeting food safety assurance conditions, issue a Food Safety Certificate valid for three years from the date of issuance according to the model at Annex 5 issued along with this Circular, and assign a unique code for the Establishment according to the system specified in Annex 6 issued along with this Circular when the establishment owner applies for the Food Safety Certificate.
b) Establishment failing to meet the requirements (Class C): Notify the inspection results and request the establishment to submit a detailed report on corrective actions. Depending on the severity of the violation, the Inspection Authority decides on the deadline for correction and organizes a re-inspection. If at the time of re-inspection, the Establishment still does not meet food safety assurance conditions (classified as C), the Inspection Authority will revoke the Food Safety Certificate (if already issued) and notify the competent authority to impose administrative penalties, while also notifying relevant authorities to consider revoking the business registration certificate previously issued to the Establishment.
2. Regular and spot checks:
a) For Establishments with satisfactory results (Class A or B): Notify the Establishment about the inspection results and the frequency of future inspections;
b) For Establishments downgraded to Class C: Implement the provisions stated in point b, Clause 1 of this Article.
3. In cases where samples are taken for testing during the inspection, if the test results reveal violations of food safety regulations or potential risks to food safety, the Inspection Authority shall require the Establishment to report on the implementation of corrective actions, including tracing and recalling products in accordance with current regulations, and organize unannounced inspections of the implementation of corrective actions when necessary.
Article 17. Updating the List of Establishments Permitted to Export to Markets with Requirements
1. An Establishment may be added to the list of establishments permitted to export to importing countries requiring such lists if it meets the following conditions:
a) Register for inspection with the Inspection Authority according to the procedures stipulated in Article 9 of this Circular;
b) Develop and implement quality management programs in accordance with the requirements of the importing country and retain complete records of implementation for at least thirty days from the date of production up to the inspection date;
c) Be inspected and certified by the Inspection Authority as meeting the requirements of the importing country.
2. An Establishment will be removed from the list of establishments permitted to export to importing countries requiring such lists in the following circumstances: When the Establishment sends a letter to the Inspection Authority requesting removal from the export market list or when the Establishment violates the provisions of Clause 1 of Article 19 of this Circular.
3. The Department of Quality Management of Agricultural, Forestry, and Aquatic Products shall update the list of establishments permitted to export to markets according to the regulations of each importing country or according to the agreed procedures with the competent authorities of the importing countries.
Section 2
SUPERVISION OF FOOD SAFETY ASSURANCE CONDITIONS FOR ESTABLISHMENTS AND REVOCATION OF FOOD SAFETY CERTIFICATES
Article 18. Frequency of Regular Inspections
1. Inspection frequency:
a) Type A establishments: once a year;
b) Type B establishments: every six months;
c) Type C establishments: The time for spot inspections depends on the level of errors found at the inspected establishment and is decided by the inspection authority but shall not exceed three (3) months from the previous inspection date.
2. For fishing vessels that have been inspected and meet requirements (Type A, B), the local inspection authority shall conduct inspections when the vessel docks at the port at least twice within three (3) years, with a minimum interval of one (1) year between inspections.
Article 19. Revocation of Food Safety Certificate
1. An establishment's Food Safety Certificate will be revoked in the following cases:
a) An establishment has been issued a Food Safety Certificate but receives a Type C classification after two consecutive inspections;
b) An establishment requests a postponement of inspection but is discovered by the inspection authority to still be producing and selling products during the requested postponement period;
c) An establishment obstructs the inspection team while they are performing their duties as stipulated in this Circular;
d) An establishment violates regulations concerning contaminant control;
đ) An establishment violates regulations concerning the use of prohibited chemicals and antibiotics;
e) An establishment violates labeling regulations for seafood batches;
g) An establishment purchases or uses raw materials from aquaculture establishments, aquaculture zones, and bivalve mollusk harvesting areas that are banned or suspended from harvesting due to non-compliance with food safety standards;
h) An establishment falsifies or alters the content of the Food Safety Certificate; falsifies or alters the content of the Quality and Safety Certificate for seafood batches or test result certificates used for state inspection and certification activities by the inspection authority;
i) An establishment commits other violations as determined by the Minister of Agriculture and Rural Development;
2. The inspection authority shall issue a document revoking the Food Safety Certificate and remove the establishment from the list of permitted exporters to importing countries requiring such lists (applicable to establishments mentioned in point a, Clause 1, Article 2 of this Circular), and simultaneously submit a file to the competent authority for handling according to food safety laws.
Article 20. Reissue of Food Safety Certificate
1. The Food Safety Certificate will be reissued in the following cases: loss of the certificate; damage to the certificate; changes or additions to the establishment's information in the certificate (excluding cases specified in Clause 1, Article 11 of this Circular); specifically, for fishing vessels that have been certified but subsequently change ownership or move regions;
2. The process of reissuing the Food Safety Certificate is as follows:
a) The establishment submits a document to the inspection authority detailing the reasons for requesting a reissued Food Safety Certificate according to the form attached as Appendix 7 to this Circular;
b) Number of application files: one request for reissuance of the Food Safety Certificate;
c) The establishment may submit the application directly, via fax, email, electronic network (followed by submission of the original file), or through postal service;
d) Within three (3) working days from receiving the establishment's request for reissuance of the certificate, the inspection authority must reissue the Food Safety Certificate to the establishment.
3. The expiration date of the reissued Food Safety Certificate will coincide with the expiration date of the original Food Safety Certificate.
Chapter III
INSPECTION AND CERTIFICATION OF QUALITY AND SAFETY FOR SEAFOOD BATCHES
Section 1
REQUIREMENTS FOR BATCHES ENTERING THE MARKET
Article 21. Conditions for batches to be put on the domestic market
Implement the provisions set out in Circular No. 56/2009/TT-BNNPTNT dated September 7, 2009 of the Ministry of Agriculture and Rural Development guiding the inspection and supervision of aquatic food safety before entering the market, and Circular No. 23/2011/TT-BNNPTNT dated April 6, 2011 amending, supplementing, and abolishing certain administrative procedures in the field of aquatic product quality management pursuant to Resolution No. 57/NQ-CP.
Article 22. Conditions for batches to be allowed for export
1. Produced from establishments recognized as meeting food safety conditions according to this Circular, while also complying with food safety requirements of importing countries.
2. Inspected and issued a certificate of conformity and food safety according to the regulations of the importing country and the Ministry of Agriculture and Rural Development.
3. Exported batches of aquatic products may bear information on labels as required by the importer without distorting the nature of the goods or violating Vietnamese and importing country laws. In addition to mandatory information required by the importing country, exported batches must include the following information:
a) Establishment production code;
b) Batch number.
4. In cases where batches are produced from different establishments for export, they must meet the following conditions:
a) The establishment performing the final production process (packaging, labeling) and the establishment performing previous production processes must meet the food safety condition requirements of Vietnam and the final product consumption market;
b) Establishments participating in batch production must have a written commitment to jointly bear responsibility for implementing corrective measures by the inspection authority if the batch is warned by the importing country's competent authority or if the inspection authority discovers non-compliance with quality and food safety standards;
c) Establishments participating in batch production must retain complete production records and quality control documentation for their respective production stages, ensuring traceability of the product origin;
d) The consignor must report to the inspection authority when registering for batch quality and food safety inspection for export purposes; report to the inspection team during inspections at establishments performing batch production stages.
Section 2
PROCEDURE, PROCEDURAL CONTENTS, AND INSPECTION CERTIFICATION
FOR EXPORT BATCHES
Article 23. Registration for Inspection and Certification of Quality and Food Safety
1. The inspection registration dossier for one export lot includes:
a) An inspection registration form according to Appendix 8 promulgated together with this Circular;
b) A detailed batch list according to Appendix 8a promulgated together with this Circular;
2. The consignor sends one set of inspection registration documents to the inspection authority via one of the following methods: direct submission, postal service; fax, email, online registration (after which the establishment submits one inspection registration form to the inspection authority).
3. Processing of registration documents:
Within one working day from receipt of the registration documents as stipulated in Clause 1 of this Article, the inspection authority reviews and guides the consignor to supplement missing or non-compliant contents;
b) For batches subject to sampling and testing, the inspection date shall not be later than two working days after the inspection authority receives all registration documents or is agreed upon by the inspection authority and the consignor according to the consignor's registration.
Article 24. Forms of inspection
1. File inspection: This form involves only inspecting the registration file of the consignor, comparing it with relevant information about the production facility's food safety conditions for the batch, and reviewing the issuance of certificates without conducting on-site inspections.
2. Inspection and sampling testing: This form includes inspecting the registration file of the consignor and conducting on-site inspections and sampling tests for the batch.
Article 25. Inspection and Sampling Testing Regime
1. Reduced inspection: This applies to facilities that meet all the following requirements during the twelve months prior to the date of consideration for reduced batch inspection:
a) Having food safety assurance conditions classified as "A";
b) No batches have been detected or warned by the inspection authority or the importing country's competent authority for non-compliance with hygiene and safety standards;
c) Not being discovered by the competent authority for violations of hygiene and safety assurance regulations through audits or inspections.
2. Regular inspection: This is the inspection regime applied to facilities with food safety assurance conditions (Class A or B).
3. Strict inspection: This is the inspection regime applied to facilities in any of the following cases:
a) The food safety assurance conditions of the facility are classified as C but have not had their food safety assurance certificate revoked;
b) There is a batch that has been warned by the importing country's competent authority for failing to meet hygiene and safety standards.
4. Frequency of inspection:
a) The frequency of batch inspection and sampling testing for facilities mentioned in Clause 1, Clause 2, and Point a Clause 3 of this Article is regulated in Appendix 9 issued together with this Circular;
b) For facilities under the batch inspection regime mentioned in Point b Clause 3 of this Article, the inspection authority shall conduct inspections and sampling tests for batches produced or exported by the facility for similar products to analyze the notified indicators according to market regulations. The facility will be removed from strict inspection when five consecutive batches pass the inspection requirements and the inspection authority's review of the facility's corrective measures meets the requirements;
c) Facilities will lose the reduced batch export inspection regime when they fail to meet any of the conditions specified in Clause 1 of this Article.
5. Procedures for conducting batch inspections and sampling tests are stipulated in Appendix 10 issued together with this Circular.
Article 26. Issuance of Hygiene and Safety Certificates
1. For batches of facilities subject to the inspection form specified in Clause 1 of Article 24 of this Circular, if the inspection results meet the requirements: The inspection authority shall issue a Hygiene and Safety Certificate (hereinafter referred to as the Certificate) according to the model in Appendix 11 issued together with this Circular to the consignor within one working day from the date of receiving complete files and information for certification.
2. For batches of facilities subject to the inspection form specified in Clause 2 of Article 24 of this Circular: From the end of the on-site inspection, the inspection authority shall issue a Certificate for batches whose inspection results meet the requirements within the following deadlines:
a) Not exceeding one working day for fresh or live batches;
b) Not exceeding seven working days for other product batches;
c) In cases where samples need to be sent for external laboratory testing, the inspection authority shall issue a Certificate to the consignor within one working day from the date of receiving complete test results.
3. For export batches destined for importing countries requiring specific certificate formats (hereinafter referred to as Certificates):
a) The consignor is responsible for providing complete written information no later than one working day from the time the batch is exported to the inspection authority for issuing the Certificate;
b) Within one working day from receiving complete information, the inspection authority shall issue the Certificate for the export batch.
4. If the consignor requests a transfer of the Certificate, the inspection authority shall conduct the batch inspection and the inspection authority responsible for issuing the transferred Certificate shall cooperate to ensure the following requirements are met:
a) It must be carried out immediately upon receipt of the original Certificate;
b) The transferred Certificate must accurately reflect the content of the original Certificate.
5. After sixty days from the date of inspection, if the consignor fails to provide complete information to the inspection authority for issuing the Certificate, the consignor must re-register the batch for inspection according to the provisions of Article 23 of this Circular to obtain certification.
Article 27. Requirements for Certificates and Certifications
1. For each export consignment registered for inspection with satisfactory inspection results, the Inspection Authority shall issue one (1) Certificate or Certification. The Certificate or Certification is only valid for the consignment transported and stored under conditions that do not alter the contents already inspected and certified regarding CL and ATTP.
2. The Certificate or Certification shall be numbered according to the provisions set out in Appendix 12 attached hereto.
3. The Certification shall bear the National Emblem and have appropriate content and format.
4. Upon request of the consignor or the importing country, the Inspection Authority may issue additional certificates (without the National Emblem) to ensure they align with the contents already inspected and certified for the consignment.
Article 28. Post-Certification Monitoring of Consignments
1. Quarterly or at any time upon request, the Inspection Authority shall establish a joint inspection team with Customs to inspect the consignment at the consolidation point while it awaits customs clearance for export, in order to verify information about the consignment post-certification.
2. In case of violation detection, the Inspection Authority shall review the working record of the inspection team and issue a document to revoke the Certificate or Certification (if issued) and send it to the consignor. At the same time, it shall request Customs not to allow the consignment to clear customs. Depending on the severity of the violation of the consignment, the Inspection Authority shall issue a document requesting the competent authority to impose administrative penalties according to current laws.
Article 29. Reissuing Certificates and Certifications
1. When the Certificate or Certification is lost or damaged, the consignor shall submit a written statement detailing the reason to the Inspection Authority to request reissue of the Certificate or Certification.
2. The Inspection Authority shall reissue within one (1) working day after receiving the consignor's request and ensuring:
a) The reissued Certificate or Certification accurately reflects the content of the previously issued certificate for the consignment;
b) The reissued Certificate or Certification is newly numbered for management purposes and includes a note stating: "This Certificate (Certification) replaces Certificate (Certification) number ..., issued on ...".
Article 30. Handling Cases Where Consignments Do Not Meet Standards
1. Consignment failing in production file, sensory, and external quality criteria:
Within one (1) working day from the end of the inspection, the Inspection Authority shall send a Notification of Non-Conforming Consignment according to the model set out in Appendix 13 attached hereto to the consignor.
2. Consignment failing in CL and ATTP criteria following testing results:
a) The Inspection Authority shall send a Notification of Non-Conforming Consignment to the consignor, clearly stating the reasons for non-conformity, and simultaneously requiring the consignor to investigate the cause, implement corrective measures, and prepare a report explaining the situation;
b) After receiving the explanation report from the consignor or the production facility of the consignment, the Inspection Authority shall conduct a review of the report contents during subsequent inspections and sampling tests for the next export consignment of the consignor, or combine this review with periodic inspections of ATTP assurance conditions for the production facility of the non-conforming consignment.
3. Within three (3) working days from the date of sending the Notification of Non-Conforming Consignment, if the consignor submits a complaint regarding the inspection results, the Inspection Authority shall handle it according to the procedures and formalities stipulated in Section 12.2 of Appendix 10 attached hereto.
4. The Inspection Authority shall conduct surprise inspections of ATTP assurance conditions for the production facility in the following cases:
a) The production facility has six (6) or more consignments found to violate ATTP criteria as prescribed by Vietnam and the importing country within three (3) months by the Inspection Authority;
b) The production facility fails to submit an explanation report as required by the Inspection Authority in the Notification of Non-Conforming Consignment mentioned in point a, Clause 2 of this Article.
Article 31. Handling of consignments warned about quality and safety by the Importing State's Authority
1. Within five working days from the date of receiving the formal warning information from the Importing State's Authority, the Inspection Agency shall issue a document requesting the Production Facility of the consignment to perform:
a) Trace the origin of the consignment, organize an investigation into the cause leading to the non-compliance with quality and safety standards; establish and implement corrective actions; submit a report within the required time limit to the Inspection Agency;
b) Temporarily suspend exports to corresponding importing countries if requested by the Importing State's Authority or if the Production Facility has more than three consignments of similar products warned about quality and safety within six months by the Importing State's Authority.
2. After receiving the explanation report from the Production Facility as stipulated in Clause 1 of this Article and the results of the strict inspection as prescribed at point b, Clause 3, Article 25 of this Circular, the Inspection Agency shall review the contents of the Production Facility's report, conduct an unannounced inspection at the Production Facility (if necessary).
3. Within no more than ten working days from the completion of the review, the Inspection Agency shall issue a document notifying the results of the review to the Production Facility.
4. In case the consignor/Production Facility reports incomplete contents or fails to submit the report within the required time limit, the Inspection Agency shall issue a document requesting the consignor to re-perform the corrective activities or report to the competent authority for handling according to the provisions of the law.
Chapter IV
RESPONSIBILITIES AND LIMITATIONS OF THE INVOLVED PARTIES
Article 32. Facilities subject to inspection on food safety assurance conditions
1. Responsibilities:
a) Register for inspection according to the procedures, formalities, and documents prescribed in Article 9 of this Circular. Comply with the inspection plan of the Inspection Agency even when registration procedures have not been completed;
b) Provide a list and arrange authorized representatives of the Facility to work with the Inspection Team and facilitate the Inspection Team's work at the Facility;
c) Provide complete information, documents, and test samples as required by the Inspection Team or independent Inspector and bear responsibility for the provided information and documents;
d) Maintain the conditions ensuring food safety that have been certified on a regular basis;
d) Implement repairs and corrective actions for the errors noted in the Inspection Report and notifications from the Inspection Agency within the required time limit;
e) Sign the Inspection Report.
2. Authorities:
a) Express agreement or disagreement with the inspection results in the Inspection Report;
b) Appeal against the inspection results for the Facility;
c) Promptly inform the head of the Inspection Agency about any negative behaviors of the Inspection Team or Inspectors.
Article 33. Consignor/Producer of the consignment
1. Responsibilities:
a) Register for inspection and certification of quality and safety of the consignment with the Inspection Agency according to the procedures and documents prescribed in Article 23 of this Circular;
b) Facilitate the Inspectors of the Inspection Agency in performing their inspection tasks, taking samples, and providing complete documents related to the consignment (in cases where the consignment must be inspected on-site and sampled for testing);
c) Not alter the characteristics of the product or label information different from the registered and certified quality and safety content;
d) Implement appropriate measures for consignments that do not meet quality and safety standards, returned consignments, or recalled consignments according to the requirements of the Inspection Agency and the competent authority;
đ) Pay inspection and certification fees as prescribed in Chapter V.
2. Authorities:
a) Be eligible for reduced consignment inspections if fully meeting the requirements set out in Clause 1 of Article 25 of this Circular;
b) Request the Inspection Agency to provide relevant information, regulations, and forms related to inspection and certification of aquatic product quality and safety according to this Circular;
c) Reserve a different opinion from the inspection results;
d) Request expert appraisal;
đ) File complaints and denunciations regarding any wrongful acts of Inspectors, the Inspection Agency, or testing laboratories according to the law.
Article 34. Inspector
1. When performing assigned tasks, Inspectors shall be responsible for:
a) Adhering strictly to the procedures, formalities, contents, methods, and bases for inspecting food safety conditions at Facilities as stipulated in this Circular; sampling and testing batches of goods according to the provisions of this Circular;
b) Safeguarding information related to production and business operations of Facilities and consignors in accordance with the law; ensuring accuracy, honesty, and objectivity when carrying out their tasks;
c) Complying with assignments from authorized persons and being accountable for the results of their work before the Head of the Inspection Agency and the law when conducting inspections;
2. Within the scope of their assigned tasks, inspectors have the following rights:
a) Requesting Facilities/consignors to provide files, documents, and samples (if any) necessary for inspection tasks;
b) Entering and exiting production, storage, and warehouse areas; reviewing files, sampling, taking photographs, copying, and recording necessary information to serve inspection tasks;
c) Preparing inspection records and sealing samples (if any) for a necessary period and proposing, recommending measures to address violations related to food safety if evidence is found against Facilities/consignors;
d) Reserving their opinions and reporting to the Head of the Inspection Agency in cases where they do not agree with the conclusions of the person directly assigning the task as stated in point c, Clause 1, Article 34 of this Circular;
đ) Refusing to conduct inspections in cases where consignors fail to fully fulfill their responsibilities as prescribed in point c, Clause 1, Article 32 and point b, Clause 1, Article 33 of this Circular.
Article 35. Team Leader
1. When performing assigned tasks, the Team Leader shall have responsibilities similar to those of an Inspector as stated in Clause 1, Article 34 of this Circular, and additional responsibilities as follows:
a) Directing and assigning tasks to members of the inspection team to fully implement the contents recorded in the inspection decision;
b) Handling opinions and inspection results of team members and presenting the final outcome;
c) Reviewing and signing inspection records, reporting inspection results, and being accountable before the Head of the Inspection Agency and the law for the results implemented by the inspection team.
2. Within the scope of assigned tasks, the Team Leader shall have authorities similar to those of an Inspector as stated in Clause 2, Article 34 of this Circular, and additional authorities as follows:
a) Proposing to the Head of the Inspection Agency to issue a decision adjusting the composition of the inspection team to fully implement the contents specified in the inspection decision;
b) Presenting the final conclusion of the inspection team on the inspection results.
Article 36. Local Inspection Agencies
1. Responsibilities:
a) Formulating inspection plans as prescribed in Clause 1, Article 10 of this Circular; organizing inspections and issuing Certificates of Food Safety Conditions for seafood production and business operations at Facilities as assigned and classified under Clause 2, Article 5 of this Circular;
b) Storing relevant files concerning inspection activities and issuance of Certificates of Food Safety Conditions for Facilities within the assigned inspection and certification scope; providing files and explaining comprehensively and accurately issues related to inspections and certifications conducted by their agency when requested by higher-level Inspection Agencies;
c) Safeguarding information related to production and business operations of Facilities within the assigned inspection and certification scope;
d) Periodically compiling and reporting in writing to higher-level Inspection Agencies every six months or upon request;
đ) Proposing training needs and nominating staff to participate in training courses organized by higher-level Inspection Agencies;
2. Responsibilities of Provincial Inspection Agencies:
In addition to the responsibilities prescribed in Clause 1 of this Article, Provincial Inspection Agencies also have the following responsibilities:
a) Cooperating with Inspection Agencies of other provinces/cities to periodically inspect food safety conditions of fishing vessels as stipulated in Clause 2, Article 18 of this Circular;
b) Compiling and reporting periodically every six months or upon request to the Directorate of Quality Control of Forestry, Agriculture, and Aquatic Products about inspection and certification results; the situation of supervision, handling violations related to food safety conditions of Facilities within the assigned inspection and certification scope in the province/city; proposing and recommending solutions to effectively implement these tasks;
c) Annually coordinating with the Directorate of Quality Control of Forestry, Agriculture, and Aquatic Products, and other local Inspection Agencies to unify lists of Facilities within the inspection scope of each agency under their management;
d) Organizing training, instruction, and professional guidance on aquatic food safety for county/village inspectors within the province;
đ) Regularly updating and publishing lists of Facilities meeting and not meeting food safety conditions on the local electronic information website or media;
3. Authorities:
a) Organizing inspections of the implementation by lower-level Inspection Agencies;
b) Requiring Facilities within the assigned inspection and certification scope to register for inspections to obtain Food Safety Certificates as stipulated in Article 10 of this Circular and to rectify deficiencies in food safety conditions noted in the Inspection Records;
c) Issuing and revoking Food Safety Certificates for Facilities within the assigned inspection and certification scope;
d) Recommending competent authorities to handle violations by Facilities that do not meet food safety conditions.
Article 37. Department of Agriculture and Rural Development of the province/city
1. Designate the agency to carry out inspection and certification of food safety conditions for establishments according to the division and classification provisions set forth in Clause 2, Article 5 of this Circular and notify the Directorate of Quality Assurance of Forestry, Agricultural and Fishery Products.
2. Designate the provincial inspection agency to conduct inspection and certification of food safety conditions for establishments within the scope assigned and classified by the district and commune inspection agencies when such agencies have not yet possessed the capacity to perform their tasks; guide and support the district and commune inspection agencies to enhance their capacity and hand over tasks immediately after these agencies have sufficient capacity to perform them.
3. Uniformly guide the establishment of code systems for the establishments mentioned in point b, Clause 1, Article 2 of this Circular within the province/city according to the regulations stipulated in Appendix 4 attached to this Circular.
4. Direct, guide, inspect, and supervise the implementation of this Circular within the scope assigned and classified in the province/city.
5. Propose to the Ministry of Agriculture and Rural Development to amend and supplement relevant regulations and technical standards to be consistent with practical situations in the work of inspection and certification of establishments meeting food safety conditions.
Article 38. Directorate of Quality Assurance of Forestry, Agricultural and Fishery Products
1. Responsibilities:
a) Unify management, inspection, and certification activities related to food safety conditions for establishments nationwide; inspection and certification of batches; periodically inspect and monitor activities related to inspection and certification of fishery product quality and food safety of inspection agencies;
b) Organize training, instruction, and guidance on professional and vocational matters for fishery product quality and food safety inspectors, as well as inspection and certification procedures for batches;
c) Develop and announce plans for inspection of establishments assigned to be inspected and certified according to the provisions of Clause 1, Article 10 of this Circular;
d) Properly retain all relevant files concerning the results of inspections and certifications of food safety conditions for establishments according to regulations; provide files and explain fully and accurately about issues related to inspection and certification activities when requested by the Ministry of Agriculture and Rural Development;
đ) Conduct inspection and certification of fishery product food safety strictly in accordance with the procedures and formalities prescribed in this Circular;
e) Be responsible for the results of inspections; the contents of the Certificate, certificate, and batch notification of non-compliance;
g) Receive and promptly resolve complaints from consignors regarding inspection and certification of fishery product quality and food safety conducted by their own agency in compliance with regulations; compensate material losses to consignors due to errors in inspection and certification according to current laws;
h) Maintain confidentiality of information related to production and business secrets of establishments assigned to be inspected and certified;
i) Annually take the lead in coordinating with the inspection agencies mentioned in Clause 2, Article 5 of this Circular to unify the list of establishments within the inspection scope of both agencies in the area;
k) Announce the list of establishments that have been certified and those that have not been certified to meet food safety conditions within their assigned and classified scope nationwide every six months and upon request;
l) Announce the list of establishments permitted to export to importing countries requiring such lists according to agreed deadlines with the competent authorities of the importing countries;
m) Collect and compile a list of Vietnamese and importing country regulations and technical standards on food safety conditions for fishery products and notify relevant agencies and organizations to uniformly apply them;
2. Authorities:
a) Inspect and supervise the activities of inspection and certification of food safety conditions of provincial/district/commune inspection agencies nationwide;
b) Take samples and inspect batches according to this Circular; refuse inspection and certification of quality and food safety if the consignor does not fulfill responsibilities as stipulated in Clause 1, Article 33;
c) Require establishments within the scope assigned to be inspected and certified to rectify deficiencies in food safety conditions noted in the Inspection Report; investigate contamination causes, establish remedial measures, and report on the implementation of remedial measures for establishments whose batches were warned of violations by the inspection agency and the competent authority of the importing country according to this Circular;
d) Temporarily suspend exports to importing countries requiring inspection and certification of quality and food safety batches and propose the competent authority of the importing country to remove the establishment from the list of permitted exporters if the establishment fails to meet food safety conditions or violates provisions stipulated in Article 19 and point b, Clause 1, Article 31 of this Circular;
đ) Issue and revoke Food Safety Certificates for establishments within the scope assigned to be inspected and certified; handle cases where establishments violate this Circular's provisions according to their authority and legal regulations;
e) Prepare files to propose the Ministry of Agriculture and Rural Development and competent authorities to handle violations of this Circular's provisions.
Article 39. Laboratory Testing Room
1. Responsibilities:
a) Adhere strictly to testing procedures, ensure the capacity of testing equipment, and protect the information of the Subject in accordance with the provisions of the law;
b) Ensure accurate and objective testing results;
c) Report results within the deadline to the Inspection Authority;
d) Be responsible for test results;
d) Participate in proficiency testing programs as required by the Directorate of Quality Assurance for Aquatic Products;
e) Store records and documents related to testing activities in compliance with regulations and produce them when requested by the competent authority;
g) Compensate the Subject materially for consequences resulting from errors in testing conducted by itself according to current regulations.
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
FEES AND CHARGES
Article 40. Fees and Charges
1. The collection of fees and charges for inspection and certification of aquatic products' hygiene and safety under this Circular shall be implemented in accordance with the current regulations of the Ministry of Finance and relevant legal documents;
2. The Inspection Authority shall develop plans and budget estimates for implementation from the annual state budget, submit them for approval by the competent authority, and organize their implementation after approval for inspection and certification activities stipulated in this Circular that have not yet been subject to fee collection regulations.
Chapter VI
COMPLAINTS, REPORTS, AND VIOLATION HANDLING
Article 41. Complaints, Reports, and Resolution of Complaints and Reports
1. All organizations and individuals have the right to file complaints and reports regarding violations of this Circular in accordance with the Law on Complaints and Reports and guiding documents for its implementation;
2. State authorities with jurisdiction are responsible for promptly resolving complaints and reports related to inspection and certification activities concerning food safety conditions of establishments in accordance with the procedures and formalities prescribed by the Law on Complaints and Reports.
Article 42. Handling Violations
1. Handling of violations of this Circular shall be carried out in accordance with the Government's regulations on administrative penalties for food safety violations; regulations on administrative penalties in the field of aquaculture, and other relevant laws.
2. Acts of obstructing or opposing inspection activities of the Inspection Authority, or acts violating this Circular causing serious consequences may be criminally prosecuted as provided by law.
Chapter VII
IMPLEMENTING PROVISIONS
Article 43. Effective Date
1. This Circular:
a) Replaces Decision No. 117/2008/QD-BNN dated December 11, 2008, issued by the Minister of Agriculture and Rural Development on the Regulations on Inspection and Recognition of Aquatic Product Production and Business Establishments Meeting Hygiene and Safety Food Standards; Decision No. 118/2008/QD-BNN dated December 11, 2008, issued by the Minister of Agriculture and Rural Development on the Regulations on Inspection and Certification of Quality and Safety of Aquatic Product Commodities; Circular No. 78/2009/TT-BNNPTNT dated December 10, 2009, issued by the Minister of Agriculture and Rural Development on Inspection and Sampling Testing of Aquatic Product Lots;
b) Abolishes Article 1 and Article 2 of Circular No. 23/2011/TT-BNNPTNT dated April 6, 2011, amending and supplementing, abolishing certain administrative procedures in the field of aquatic product quality management pursuant to Resolution No. 57/NQ-CP dated October 15, 2010;
c) Abolishes Article 3 and Article 4 of Circular No. 47/2010/TT-BNNPTNT dated August 3, 2010, amending and supplementing certain provisions of administrative procedures of Decision No. 71/2007/QD-BNN dated August 6, 2007; Decision No. 98/2007/QD-BNN dated December 3, 2007; Decision No. 118/2008/QD-BNN dated December 11, 2008, and Circular No. 06/2010/TT-BNNPTNT dated February 2, 2010.
2. This Circular shall take effect 45 days from the date of issuance.
3. For establishments that have been inspected, certified, and assigned unique codes prior to the effective date of this Circular but do not fully meet the requirements of being an independent aquatic product production establishment as stipulated in this Circular or have multiple production types but only received one unique code:
a) Such establishments shall retain their assigned codes until June 30, 2012;
b) The Inspection Authority shall be responsible for reviewing, organizing inspections, revoking, supplementing, and reissuing codes in accordance with this Circular starting July 1, 2012.
Article 44. Amendment and supplementation of the Circular
The Quality Management Department for Agricultural, Forestry, and Fisheries Products shall be responsible for compiling difficulties and obstacles arising from the implementation of this Circular and reporting to the Ministry of Agriculture and Rural Development for consideration to amend and supplement it appropriately./.