Circular No. 48/2013/TT-BNNPTNT: On inspection and certification of the safety of fishery food products for export

Article 1. Scope

This Circular provides regulations on:

1. Applications and procedures for and power of inspection, issuance and revocation of Certificate of eligibility for food safety (hereafter referred to as certificate of food safety) of fishery food business operators for export (hereafter referred to as “business operators”).

2. Applications and procedures for and power of inspection and issuance of certificate of safety of fishery food products for export (hereafter referred to as Certificate) to markets in which the competent authority of import country requests for the inspection of export shipments and issuance of Certificate of the National Argo – Forestry - Fisheries Quality Assurance Department (hereinafter referred to as NAFIQAD).

Article 2. Regulated entities

1. Regulated entities consist of:

a) Fishery food business operators for export;

b) Fishery food products exported to markets in which the competent authority of import country requests for the inspection of the export shipments and issuance of certificate of NAFIQAD;

2. With regard to fishery food products whose quarantine certificates are required as prescribed in applicable regulations, the inspection and certification authority (hereafter referred to as” the inspection authority”) prescribed in Article 5 of this Circular shall carry out the inspection, certification of food safety and quarantine concurrently.

3. The following cases shall not be regulated by this Circular:

a) Fishery food business operators for domestic consume.

b) Fishery food products for export that are not used as food.

b) Fishery food products exported to markets in which the competent authority of import country does not request for the inspection of the export shipments and issuance of certificate of NAFIQAD;

Article 3. Definitions

For the purpose of this Circular, the terms below shall be construed as follows:

1. Independent establishment producing fishery food products means an establishment having adequate facilities to completely carry out the separate process of production from input of materials to full packing of products; having the separate workforce of quality control with at least 3 employees that control the food safety during the production process and at least 01 (one) employee that has completed a training course of food safety according to the principle of Hazard Analysis and Critical Control Points (hereafter referred to as HACCP) organized by authorities and organizations that are assigned to provide training in food safety according to HACCP principle..

2. Batch means a number of products produced from one or more materials having the same origin, in the same technological process and production conditions (conditions for food safety affected by the same elements) within 24 hours in a business operator.

3. Shipment means a number of products that are applied for inspection and certification of eligibility for one-off export to an importer in a vehicle.

4. Group of similar fishery food products means fishery food products that pose the same level of food safety hazards and are produced in a similar technological process (Some stages can be different but they do not arise food safety hazards) in an establishment.

5. Production of fishery food products means the implementation of one, several or all the activities of extraction, preliminary processing, processing, packing and preservation in order to produce fishery food products.

6. Fishery food product means a product that can be eaten or drunk raw or after being preliminarily processed, processed or preserved.

7. Ready-to-eat fishery food product means a product that can be eaten by human without any special processing.

Article 4. Bases for inspection, assessment and certification

The bases for inspection, assessment and issuance of certificate of food safety and certificate of fishery food products for export shall comply with regulations in Articles 41 and 42 of Law on food safety, regulations and standards related to fishery food safety of Vietnam and the import country.

Article 5. Authorities that are in charge of inspection and certification

1. Authorities that are in charge of inspection, assessment and issuance of Certificate of food safety include: NAFIQAD, NAFIQAD CRA (Central Region Authority) and NAFIQAD SRA (South Region Authority).

2. Authorities that are in charge of inspection and issuance of certificate of fishery food products for export include units affiliated to NAFIQAD whose eligibility for inspection and issuance of certificate are evaluated and agreed by the competent authority of the import country.

Article 6. Requirements for inspectors and heads of inspectorates

1. An inspector shall satisfy the following requirements:

a) An inspector is honest, objective and not related to economic benefits of organizations, individuals exporting shipments (hereafter referred to as the owner) or the head of the inspected business operator.

b) The inspector has a suitable professional knowledge and has been issued with a certificate of completion of training course of inspection and certification of fishery food safety by NAFIQAD.

c) The inspector is enough healthy to fulfill his/her assigned tasks.

2. Apart from the requirements prescribed in Clause 1 of this Article, a head of an inspectorate shall have at least 05 years’ experience of inspection and be assigned to work as the head of the inspectorate by Director of NAFIQAD.

Article 7. Requirements for the equipment used for inspection visit

1. The equipment used for inspection visit is specialized and distinguishable from other equipment.

2. The equipment is under good operation and maintenance; inspected and/or calibrated in accordance with regulations and be well-cleaned and not become a source of infection.

Article 8. Requirements for testing laboratories

Laboratories used for analysis and testing of standards in food safety in accordance with regulations of this Circular shall be appointed by the competent authority according to regulations of Ministry of Agriculture and Rural Development.

Article 9. Fees

Collection of fees of processing of application, inspection of the business operator, taking of samples, testing of food safety standards and issuance of certificates of food safety prescribed in this Circular shall comply with Article 48 of Law on Food safety, applicable regulations of Ministry of Finance and relevant legal documents.

Chapter 2.

INSPECTION AND ISSUANCE OF CERTIFICATES OF FOOD SAFETY

Article 10. Applications for Certificate of food safety

1. An application for Certificate of food safety consists of:

a) An application form for Certificate of food safety (using the form prescribed in Appendix I issued together with this Circular)

b) A copy that is notarized or enclosed with the original document of Business Registration Certificate or Investment Certificate;

c) A report on the applicant’s establishment condition (facilities and food safety management systems) (using the specimen prescribed in Appendix II issued together with this Circular;

d) A list of the owner of the applicant and its employees directly producing food that have had their health certified by the health facilities of districts or higher;

dd) A list of the owner of the applicant and the employees directly producing food that have been granted certificates of training in food safety by NAFIQAD.

2. If a business operator submits the application for Certificate of food safety after taking actions to correct non-conformance discovered in the previous inspection, the application shall consist of a corrective action report (using the specimen in Appendix III issued together with this Circular.

3. The application shall be sent to the inspection authority directly or by post; via fax, email or online registration (the original document shall be sent subsequently).

Article 11. Processing of the application for Certificate of food safety

1. Within 03 working days from the day on which the application is received, the inspection authority shall inspect the application’s validity and instruct the applicant to make necessary additions.

2. If the application is valid, within 05 working days, the inspection authority shall inform the applicant of the expected time for an inspection visit which shall not exceed 10 working days from the day on which the valid application is received.

Article 12. Forms of inspection

1. The inspection for issuance of Certificate of food safety shall be applied to following subjects:

a) A business operator that has not been issued with the Certificate of food safety;

b) A business operator whose Certificate of food safety is revoked;

c) A business operator whose certificate only remains for less than 6 months;

d) A business operator that has been issued with the Certificate of food safety but has changed its owner or has its facilities repaired and improved resulting in exposure to a food safety hazard;

Dd) A business operator manufacturing products which are not similar to certified products;

e) A business operator that has been issued with Certificate of food safety but has delayed the periodic inspection for more than 12 months;

g) A business operator that applies for registration of addition to the list of business operators which may process and export products in case of requirement of the import market.

2. Inspection after the certificate of food safety is issued:

a) Periodic inspection is a form of inspection without prior notice aiming to supervise the maintenance of conditions for food safety of business operators that have been issued with Certificate of food safety. The frequency of inspection shall be specified as follows:
+ Class 1 and class 2 business operators: Once a year
+ Class 3 business operators: Twice a year
+ Class 4 business operators: The time for inspection depends on violations of these business operators and is decided by the inspection authority but not exceeding 03 months from the previous inspection.

b) Surprise inspection is a form of inspection without prior notice which applies to business operators that show signs of the violations of food safety prescribed in Point b Clause 3 Article 17, Clause 3 Article 31 and Clause 2 Article 36 of this Circular or is carried out in case of complaints of organizations and individuals.

Article 13. Establishment of inspectorates

1. The head of the inspection authority shall issue a decision on establishment of an inspectorate to inspect the conditions for food safety of a business operator.

2. A decision on establishment of the inspectorate consists of the following contents:

a) Bases for the inspection;

b) Names, titles and workplaces of inspectors;

c) Name, address and code (if any) of the business operator to be inspected;

d) Scope of, contents of, forms of and time for the inspection;

dd) Responsibility of the business operator to be inspected and the inspectorate.

3. Decision on establishment of the inspectorate shall be informed at the business operator’s premises when the inspection begins.

Article 14. Contents of and methods for the inspection

1. Contents of the inspection include:

a) Inspection of facilities and the personnel producing fishery food products and managing the fishery food safety (including health certificates, certificate of training in food safety of the owner of business operator and employees directly producing fishery food products);

b) Inspection of program for management of food safety according to HACCP principle;

c) Inspection of procedures for product traceability and recall;

d) Taking of samples for verification of food hygiene control measures during the production process in accordance with Appendix IV issued together with this Circular.

2. Methods for the inspection shall comply with Appendix V issued together with this Circular.

Article 15. Inspection record

1. An inspection record shall contain:

a) Sufficient and accurate results of the inspection (using the specimen in Appendix 5 of this Circular). The result shall be recorded in the inspected place after the inspection finishes;

b) Items that fail to fulfill requirements of food safety and time limit for completion of corrective actions;

c) General conclusion and classification of conditions for food safety of the business operator;

d) Opinions of legal representative of the business operator about results of the inspection and commitments to take action to correct non-conformance (if any);

dd) Signatures of the head of inspectorate, the legal representative of the business operator and fan stamping (If there is no seal at the business operator, these people will sign on each page of the inspection record) and

e)The inspection record shall be made into 02 copies: a copy shall be kept at the inspection authority’s office and the other copy shall be kept at the business operator’s premises. The quantity of copies may increase if necessary.

2. If the head of the inspected business operator refuses to sign the inspection record, the inspectorate shall write the following sentence "Đại diện Cơ sở được kiểm tra, thẩm định không ký Biên bản" ("the representative of the business operator refuses to sign the record”) and specify the reasons. In this case, the inspection record will be still valid if it contains the signatures of all inspectors of the inspectorate.

Article 16. Classification of business operators based on conditions for food safety

1. Classification of the business operator based on conditions for food safety is specified as follows:

a) Class 1: Excellent;

b) Class 2: Very good;

c) Class 3: Passed;

d) Class 4: Failed.

2. Methods for the classification of each type of business operator shall comply with Appendix V issued together with this Circular.

Article 17. Processing of the inspection results and issuance of certificates of food safety

Within 07 working days from the day on which the inspection finishes, the inspection authority shall verify the inspection record and notify the result to the applicant. In particular:

1. Inspection visit for issuance of Certificate of food safety:

a) With regard to a business operator which obtains the “passed” results (classes 1, 2 and 3), the inspection authority shall submit a report on inspection result to NAFIQAD which shall consider issuing the certificate of food safety (using the specimen in Appendix VI issued together with this Circular) and 01 code to the applicant ( in this case, the applicant has fulfilled requirements prescribed in Clause 1 Article 3 of this Circular but has not been granted a code) according to the code system prescribed in Appendix VII issued together with this Circular . Concurrently, the inspection authority shall send a written notification of the inspection result to relevant authorities and business operators to cooperate in management.

b) With regard to business operators which obtain “failed” result (Class 4):

The inspection authority shall notify the inspection result to the applicant and require the applicant to take action to correct non-conformance and submit a report on corrective action result. The inspection authority shall define the time limit for corrective action of non-conformance based on the extent of non-conformable of the applicant but not exceed 03 months from the day on which the reinspection is carried out.

If the result of the reinspection is still failed (class 4), the inspection authority will notify the result and time for the next reinspection to the applicant. Within 07 working days from the day on which the result of reinspection is notified, the inspection authority shall publish the name, address of the business operators and name of their products that do not ensure the conditions for food safety on media.

If the result of the next inspection is still failed (class 4), the inspection authority will suggest the competent authority to take actions in accordance with applicable regulations.

2. Periodic and surprise inspection:

a) The inspection authority shall notify the “passed” applicant (class 1, 2 or 3) of the inspection result and frequency of periodic inspection in the next time.

b) A failed business operator (class 4) shall be dealt with as prescribed in Point b Clause 1 of this Article.

3. With regard to taking of samples for verification of food hygiene control measures during the production process.

a) Within 01 working day from the day on which it is concluded that the testing result fails to satisfy regulations, the inspection authority shall send the applicant a request for correction to non-conformance. The inspection authority shall define the time limit for corrective action of non-conformance and taking of sample for re-testing based on extent of non-conformance of the applicant.

b) If the result of re-testing fails to satisfy regulations, the inspection authority will decide to inspect surprisely the conditions for food safety of the applicant.

Article 18. Revocation of certificates of food safety

1. A business operator will have its certificate of food safety revoked if it falls into cases prescribed in Article 13 of the Government’s Decree No. 38/2012/ND-CP dated April 25, 2012 on guidelines for certain articles of Law on food safety.

2. NAFIQAD has the power to revoke certificates of food safety.

Article 19. Reissuance of certificates of food safety

1. A certificate of food safety may be reissued in the following cases:

a) Certificate is lost;

b) Certificate is damaged;

c) The business operator applies for adjustments to the certificate of food safety (except for cases in which the inspection visit for issuance of Certificate of food safety prescribed in Points d and dd Clause 1 Article 12 of this Circular shall be carried out).

2. Procedures for reissuance of certificates of food safety:

a) The business operator shall make an application and sent it to NAFIQAD and explain for reissuance of Certificate of food safety (using the specimen in Appendix VII issued together with this Circular);.

b) Quantity of applications: 01 application form for reissuance of Certificate of food safety;

c) The application can be submitted directly or by post, via fax or email (the original document shall be sent subsequently);

d) Within 03 working days from the day on which the application form is received, NAFIQAD shall consider reissuing of the Certificate to the applicant.

3. The validity of certificate of food safety which is reissued shall last for the same period with the original Certificate.

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