Circular No. 78/2009/TT-BNNPTNT on inspection and sampling for testing batches of aquatic products

CIRCULAR

Regulations on inspection and sampling for testing batches of aquatic products

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Pursuant to Decree No. 01/2008/ND-CP dated January 8, 2008 of the Government stipulating the tasks, functions, powers, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/ND-CP of the Government amending Article 3 of 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;

Pursuant to the Law on Product Quality and Safety dated November 21, 2007; Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Law on Product Quality and Safety;

Pursuant to the Ordinance on Food Hygiene and Safety dated July 26, 2003; Decree No. 163/2004/ND-CP dated September 7, 2004 of the Government detailing the implementation of certain provisions of the Ordinance on Food Hygiene and Safety;

The Ministry of Agriculture and Rural Development stipulates the activities of inspection and sampling for testing batches of aquatic products as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. Scope of regulation: Detailed procedures, formalities, and methods for inspection and sampling; responsibilities of related parties involved in the inspection and sampling of quality and food hygiene and safety (hereinafter referred to as CL, VSATTP) of batches of aquatic products.

第二条 组织和实施奖励工作的支出水平，如政府第152/2025/NĐ-CP号决定关于分级授权和奖励领域的分权规定

a) Batches of aquatic products before being put on the domestic market;

b) Batches of aquatic products for export to markets requiring inspection and certification of CL, VSATTP by state inspection agencies of Vietnam;

c) Batches of aquatic products for export to markets that require inspection and certification to meet management requirements announced by the Ministry of Agriculture and Rural Development for each period;

d) Batches of aquatic products imported as raw materials for processing facilities;

e) Batches of aquatic products recalled or returned by importing countries.

Article 2. Explanation of terms

In this Circular, the following terms are understood as follows:

1. State inspection agency: refers to the agencies specified in Article 5 of the Inspection and Certification Regulation for Aquatic Product Quality and Food Hygiene and Safety issued together with Decision No. 118/2008/QĐ-BNN dated December 11, 2008 of the Minister of Agriculture and Rural Development (hereinafter referred to as Regulation 118).

2. Batch inspection: is the examination of documents, evaluation of actual batch information, and visual and sensory assessment of batches of aquatic products.

3. Sampling for testing: is the selection of intended samples and their transfer to designated laboratories for analysis of CL, VSATTP indicators.

4. Production batch: is a quantity of aquatic products with the same name, quality, packaging style, processed through the same procedure and stored at the same location, produced from one or more raw material batches with complete origin information at one facility.

5. Inspection lot: is one or more production batches produced from one Facility and registered for inspection once by the Shipper.

6. Initial sample: is the quantity of product or a single package taken at a designated sampling position within the inspected batch.

7. Composite sample: is a sample collected from initial samples.

8. Average sample : is the quantity of product or several packages taken from the composite sample.

9. Analytical sample: is the sample taken from the average sample used for analyzing CL, VSATTP indicators.

10. Retained sample: is the sample taken from the average sample for comparative analysis when necessary.

Article 3. Requirements for inspectors

1. Honesty, objectivity, having no direct or indirect economic interest relationship with the consignor or the production facility that has the batch of aquatic products to be inspected.

2. Professional qualifications appropriate; holding a certificate of participation in training courses on inspection techniques and sampling of aquatic product batches organized by the Directorate of Quality Assurance for Forestry and Aquatic Products.

3. Sufficient health to ensure completion of assigned tasks.

4. Must wear specialized uniforms and identification badges as prescribed when performing duties.

Article 4. Requirements for equipment and tools serving inspection and sampling

1. High specialization, with markings to easily distinguish from other tools.

2. In good operating and maintenance condition; properly calibrated; in good sanitary condition, ensuring they do not become sources of contamination for the batch of goods and samples.

Article 5. Requirements for inspection report forms

The inspection agency must ensure that the inspection report form for the batch of goods meets the following requirements:

1. Fully reflects all information about the batch of goods being inspected and the general conclusions regarding the contents inspected by the inspector at the site.

2. Accompanied by detailed results of sensory and external inspections of the batch of goods. In cases where the batch of goods falls under the category requiring sample testing, the inspection report must include the sample testing form.

3. Possess the ability to link the results of external and sensory inspections and sample testing with the analytical results of sample testing to serve the issuance of quality and food safety certification for the inspected batch of goods.

Chapter II

INSPECTION OF BATCHES OF GOODS

Article 6. Preparation for Inspection

1. After receiving the registration dossier for inspection in accordance with Regulation 118, the inspection agency assigns inspectors who meet the requirements set out in Article 3 of this Circular to conduct the inspection and sampling of the batch of goods.

2. Inspectors shall perform the following tasks:

a) Prepare relevant technical documents, forms, sample labels, uniforms, and inspection and sampling tools and equipment that comply with the requirements set out in Article 4 of this Circular.

b) Review the food safety assurance history of the production facility of the batch of goods including: the results of the most recent inspection of food safety conditions of the production facility; warning information from domestic and foreign authorities and customer feedback (if any) regarding the facility; the results of the latest inspections of CL, VSATTP of batches produced by the facility.

c) Review the supervisory results of competent authorities related to food safety concerning the origin of raw materials for the batch of goods to be inspected, including: the results of monitoring harmful substance residues in farmed aquatic animals and animal products; the results of monitoring hygiene during harvesting of bivalve mollusks; the results of other monitoring programs.

Article 7. On-site Inspection of Dossiers

1. For domestically produced batches of aquatic products before entering the market as specified in Points a, b, and c, Clause 2, Article 1:

a) Review the origin documentation of raw materials used to produce the batch of goods, which must be provided by facilities (wholesalers or farms, fishing vessels...) that have been controlled by the production facility for safety conditions or recognized as meeting food safety standards, specifically:

- Raw materials are wild-caught aquatic products originating from natural fishing areas without food safety warning information.

- Raw materials are farmed aquatic products must originate from farms not banned or suspended from harvesting.

- Raw materials are bivalve mollusks must originate from harvesting areas not banned or suspended from harvesting.

b) Review the suitability of the production dossier of the batch of goods in terms of quantity matching the production capacity of the facility, production quotas; production time matching the registration dossier; results of inspections of quality and food safety indicators according to the quality management program at each stage of production; reliability of the production dossier.

2. For imported batches of goods used as raw materials for processing:

a) Review the consistency of information in the Certificate of Origin of the batch of goods, the Certificate of Quality and Food Safety of the batch of goods issued by the competent authority of the exporting country, and other accompanying documents with the actual information of the batch of goods at the site.

b) In cases where imported batches of goods are intended for processing for export to markets with specific requirements for the origin of raw materials, inspectors shall conduct inspections in accordance with Vietnam's relevant regulations and the requirements of these markets.

3. For batches of aquatic products recalled or returned: Review the reasons for recall or return, analysis results of quality and food safety indicators (if available), and the consistency of information on accompanying documents with the actual inspected batch of goods.

4. If the on-site inspection of dossiers reveals insufficient reliability or discrepancies between the information in the registration dossier and the on-site inspection information, the inspector shall act as follows:

a) Temporarily suspend the inspection, retain evidence of the batch of goods, and record the inspection report for the batch of goods in accordance with Clause 2, Article 11 for imported batches of goods for processing.

b) For domestically produced batches of goods, request the consignor or the production facility owner to provide explanations and take immediate corrective measures. In cases where the consignor or the production facility owner cannot provide sufficient information for explanation and correction of errors in the batch of goods' dossier, the inspector may suspend further inspections of the batch of goods.

Article 8. On-site inspection of consignment at consolidation site or storage warehouse

1. Compare actual information of the consignment at the consolidation site or storage warehouse with the registered inspection location, product type, quantity, weight, and consignment details.

2. Examine the uniformity of the consignment.

3. Inspect the storage conditions of the consignment including: storage warehouse temperature, product arrangement in the warehouse, and warehouse hygiene conditions according to National Technical Regulation No. QCVN 02 - 01: 2009/BNNPTNT - food production and business premises - general conditions for ensuring food safety or National Technical Regulation No. QCVN 02- 09: 2009/BNNPTNT - cold storage for seafood - conditions for ensuring food safety (applicable to consignments stored in independent cold storage).

Article 9. Sampling for sensory and external inspection

1. Based on the results of file inspection and actual consignment information, initial samples are taken from positions that may lead to food safety risks.

2. Samples for external inspection include common samples and average samples.

3. Sensory samples are taken from part of the volume or units of packaging from the average sample for sensory inspection.

4. The method of taking initial, common, and average samples for different types of products shall be carried out according to Vietnamese technical standards and regulations.

Article 10. Sensory and External Inspection

1. External Inspection:

a) Content of external inspection includes: packaging condition, packaging specifications, product label information compared to regulations and registration files.

b) Number of external inspection samples:

- For consignments produced: Take 6 (six) samples per consignment.

- For consignments consisting of multiple produced consignments: At least 2 (two) samples per produced consignment but not less than 6 (six) samples for one inspection consignment.

c) Handling non-compliance with external criteria: Depending on the actual number of samples failing the external criteria and the corrective capability of the facility, the inspector decides whether to continue or stop the inspection, take samples for laboratory testing of the consignment according to Clause 2, Article 11 of this Circular.

2. Sensory Inspection:

a) Content of sensory inspection includes: percentage of mold, net weight, color, smell, freshness, parasites, impurities.

b) Frequency of taking samples for sensory criteria inspection matches the frequency of taking samples for laboratory testing of the consignment as stated in the Appendix of this Circular or the inspector may take samples for inspection if during external inspection of the consignment, sensory criteria are found to be non-compliant with regulations. In cases where it is necessary to confirm sensory criteria results, the inspector will take samples for laboratory analysis.

c) Number of samples used for sensory inspection on-site and the acceptance limit for the consignment meeting sensory requirements are defined as follows:

- For consignments produced: Take 6 (six) samples per consignment, the consignment fails if 1 (one) or more of the 6 samples inspected fail.

- For consignments consisting of multiple produced consignments: At least 2 (two) samples per produced consignment but not less than 6 (six) samples for one inspection consignment, the produced consignment fails sensory criteria if 1 (one) or more samples fail among the inspected samples.

3. Methods of external and sensory inspection for each type and form of product shall be carried out according to Vietnamese technical standards and regulations.

Chapter III

SAMPLING FOR LABORATORY TESTING

Article 11. Sampling for Testing

1. Conditions for a batch to be considered for sampling for testing:

a) When the results of file inspection, actual batch information, storage conditions, and external and sensory indicators meet the requirements.

b) For batches where the actual quantity at the storage location reaches 70% or more of the registered quantity (in cases where the inspected batch includes multiple production batches, the actual quantity is calculated per production batch): the production facility must clearly state the plan to produce the required quantity along with the registration for testing.

2. For batches that fail the file, external appearance, and sensory inspections, the inspector shall proceed as follows:

a) Not perform sampling for testing (for batches that are subject to sampling for testing).

b) The inspector completes the Inspection Report in accordance with Article 14 of this Circular and requests the consignee or production facility representative to sign the Inspection Report (if the consignee/production facility representative does not sign, the batch inspection report remains valid).

c) Report to the Inspection Authority to issue a notification to the consignee or production facility representative requesting an explanation and corrective measures for the non-compliant batch.

Article 12. Frequency of Sampling for Testing

1. For export batches:

a) The frequency of sampling for testing of aquatic product batches is determined based on the level of food safety risk of the product and the classification of production facility hygiene assurance conditions.

b) The frequency of sampling for testing for facilities under routine inspection and those eligible for reduced inspection under Regulation 118 is specified in the Appendix of this Circular.

2. For import batches for processing:

a) Sampling for testing is conducted for each of the first five imported batches.

b) If the consignee has previously had five batches of the same type and origin that passed the inspection and sampling for testing for food safety, the Inspection Authority will conduct sampling for testing at a rate of one out of every five subsequent imported batches.

3. For batches intended for domestic consumption, the provisions of Article 12 of Regulation 118 apply.

4. For recalled or returned batches, the provisions of Article 14 of Regulation 118 apply.

5. Enhanced inspection and removal of enhanced inspection measures for production facilities or consignees whose batches have been detected by the Inspection Authority or notified by the importing country's authority as non-compliant with quality and food safety standards are carried out as follows:

a) The Inspection Authority conducts external and sensory inspections and sampling for testing of five consecutive batches of the same product from the production facility for analysis of non-compliant indicators.

b) The production facility or consignee can have the enhanced inspection measures removed if the enhanced inspection results and the review by the Inspection Authority regarding the corrective measures implemented by the facility meet the requirements.

Article 13. Sampling and Specifying Analytical Indicators

1. When a batch meets the conditions set forth in Clause 1, Article 11, the inspector performs sampling for testing of one batch randomly selected from the registered batches of the facility according to the frequency specified in Article 12 of this Circular.

2. The sample taken by the inspector includes two types of samples (analytical sample and retention sample) with equal weight and number of samples, taken from the average sample.

3. Sample size for analytical and retention samples:

a) Must be sufficient to analyze all designated indicators as per the requirements of the designated laboratory.

b) In cases where samples need to be sent to multiple designated laboratories, additional samples will be taken to meet the analysis requirements.

c) If the unit packaging quantity of the product is larger than the required sample size, a portion of the unit packaging may be separated while ensuring it does not affect the analysis results of the designated indicators.

d) When the consignee has specific requirements for analytical indicators, the inspector will take samples according to the consignee’s requirements but must ensure compliance with the requirements set forth in points a, b, and c of this Clause.

Article 14. Inspection Report for a Lot

After completing the inspection of a lot, the inspector must finalize the inspection report and take samples for testing as follows:

1. The inspection report must be completed at the inspection site where samples are taken; each content of the inspection results of the lot must be accurately and fully reflected.

2. Clearly record non-compliant contents and deadlines for rectification (if any).

3. The inspection report for a lot must be accompanied by sensory and external appearance result sheets, and sample testing result sheets (in cases where the lot falls under the category of samples to be tested according to regulations).

4. The inspection report must bear the signature of the inspector and the signature of the consignor/producer or their authorized representative; it shall be made in two copies, one copy retained by the inspection agency and one copy handed over to the consignor/producer.

Chapter IV

LABELLING, STORAGE, AND TRANSPORTATION OF SAMPLES FOR TESTING

Article 15. Labelling and Storage of Samples

1. Analysis samples and storage samples, after being collected, must be placed in sterile PE bags, sealed tightly, and affixed with sample identification sheets, and stored in specialized containers suitable for each type of product.

2. Samples must be coded to ensure confidentiality and avoid confusion among different types of samples taken from the facility.

Article 16. Transportation and Handover of Samples

1. Analysis samples must be transported to the designated laboratory, while storage samples must be transported to the inspection agency within a maximum of six hours after the completion of the inspection and sampling process, ensuring appropriate storage conditions during transportation to prevent damage to the samples and distortion of test results.

2. At the laboratory and inspection agency, inspectors and sample reception staff shall check the condition of the samples, their characteristics, information on the samples, and pre-analysis requirements before handing them over.

3. Only accept samples for analysis when they meet the provisions set out in Clause 1 of this Article.

Article 17. Storage and Use of Storage Samples

1. Storage samples must be kept at the inspection agency under conditions suitable for each type of product and in their original sealed state after being taken from the lot.

2. The designated laboratory may use storage samples to conduct confirmatory chemical analysis tests upon agreement and supervision of the unsealing of storage samples by the inspection agency.

3. In cases where there are complaints from the consignor or producer regarding the test results, the inspection agency shall use storage samples to send to laboratories for retesting as a basis for resolving complaints.

4. Within three working days after the inspection agency announces the test results of the lot, if there are no complaints from the consignor/producer, the inspection agency shall proceed as follows:

a) Return the storage samples to the consignor/producer.

b) If the consignor or producer does not come to collect the samples or has another agreement, the inspection agency may proactively handle the storage samples appropriately.

Chapter V

IMPLEMENTATION

Article 18. Responsibilities of the Consignor or Producer of the Lot

1. Prepare all necessary conditions for inspection and sample testing before registering for lot inspection.

2. Do not obstruct the inspector when conducting inspections and sample testing, and provide all relevant documents related to the lot when requested.

3. Pay actual costs to the inspection agency in cases where the lot does not meet inspection conditions after the inspector has arrived at the scene or the inspection results show non-compliance with documentation, external appearance, sensory criteria, and insufficient conditions for sample testing, or in cases of re-inspection following corrective actions.

4. Seriously implement timely corrective actions when the inspection results of the lot do not meet requirements.

Article 19. Responsibilities of the Inspection Authority

1. Ensure that sampling and testing activities comply with regulations, are honest, and impartial.

2. Carry out inspections and sampling according to the frequency specified in Article 11 of this Circular for each production facility under its management classification.

3. Promptly conduct re-inspections after the consignor has implemented corrective measures.

4. Organize surprise inspections regarding the compliance with hygiene and food safety standards of production facilities (if necessary) for products produced after the inspection date (if applicable).

5. Store samples under conditions that ensure they do not affect test results until the customer does not lodge a complaint.

Article 20. Responsibilities of the Directorate of Quality Assurance for Agricultural Products, Forestry Products, and Aquatic Products

1. Update and guide the consistent application of external inspection methods, sensory inspection methods, and sampling testing methods for each type of aquatic product for inspection authorities.

2. Organize training on specialized knowledge and inspection procedures for batches of aquatic products for inspectors and supervise their implementation.

3. Regularly update the list of facilities exempted or reduced from inspection according to Regulation 118.

4. Continuously update market regulations to publish a list of designated inspection criteria for batches of aquatic products for relevant units to implement, while reporting to the Ministry of Agriculture and Rural Development.

5. Regularly update the list of markets where the Ministry of Agriculture and Rural Development stipulates mandatory inspections and certifications to meet industry management requirements at different periods.

6. Compile difficulties and obstacles encountered by related organizations and individuals in implementing this Circular to submit to the Minister for consideration and decision to amend and supplement.

Chapter VI

IMPLEMENTING PROVISIONS

Article 21. Effective Date

This Circular takes effect 45 (forty-five) days from the date of issuance./.