Circular No. 40/2013/TT-BCT stipulates the conditions, procedures, and steps for designating testing and certification facilities for food safety under the management responsibility of the Ministry of Industry and Trade.

CIRCULAR

Regulations on conditions and procedures for designating testing and verification facilities

concerning food safety under the responsibility of state management

 of the Ministry of Industry and Trade

________________________ 

Pursuant to the Food Safety Law dated June 17, 2010 and Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain articles of the Food Safety Law;

Pursuant to the Quality Management Law for Products and Commodities dated November 21, 2007 and Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain articles of the Quality Management Law for Products and Commodities;

Pursuant to the Standardization and Technical Regulation Law dated June 29, 2006 and Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing implementation of certain articles of the Standardization and Technical Regulation Law;

Pursuant to Decree No. 95/2012/NĐ-CP dated November 12, 2012, of the Government, detailing the functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;

Based on the proposal of the Director of the Department of Science and Technology;

The Minister of Industry and Trade promulgates this Circular stipulating the conditions and procedures for designating testing and verification facilities concerning food safety under the responsibility of state management of the Ministry of Industry and Trade as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Article 1. Scope of Application: This Circular stipulates the conditions and procedures for designating testing and verification facilities concerning food safety under the responsibility of state management of the Ministry of Industry and Trade.

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) Testing and verification facilities that have registered for testing and verification;

b) Testing and verification facilities designated by the Ministry of Industry and Trade;

c) Relevant administrative agencies involved in evaluation and designation activities.

Article 2. Interpretation of Terms

In this Circular, the following terms shall be understood as follows:

1. Testing and verification is the retesting of test results when there are signs of error, complaints, disputes to confirm the test results regarding food safety for food products under the responsibility of state management of the Ministry of Industry and Trade.

2. Evaluation of testing and verification facilities is the activity of examining the suitability of the quality management system and analytical capacity to meet the requirements of testing and verification for specific quality and food safety criteria.

3. Comparative testing is the assessment of the quality of testing and verification results from a testing and verification facility compared with another designated testing and verification facility for the same test criterion or recognized according to TCVN ISO/IEC 17025:2007 or ISO/IEC 17025:2005 and still within the validity period of designation.

Article 3. Principles of Operation of Testing and Verification Facilities

1. Testing and verification facilities shall conduct testing and verification concerning food safety under the responsibility of the Ministry of Industry and Trade when there are disputes, complaints about food safety from organizations or individuals, or when requested in writing by the Ministry of Industry and Trade.

2. Testing and verification facilities shall be responsible under the law, ensuring the accuracy, truthfulness, and objectivity of testing and verification results.

3. Testing and verification facilities shall not accept testing and verification in any of the following cases:

a) Food products requiring testing and verification have already been tested and verified by a testing facility or other testing facilities within the same quality management system and have received test results;

b) The testing and verification facility is a party involved in the dispute or complaint requiring testing and verification of food safety for disputed or complained food products;

4. Testing and verification facilities must keep confidential the testing and verification results and related information of organizations or individuals who have registered for testing and verification concerning food safety.

 ARTICLE 4. CONDITIONS FOR TESTING AND VERIFICATION FACILITIES

Article 4. Legal entity conditions

The testing facility designated to conduct verification testing must be a state-owned testing facility established in accordance with Vietnamese law, including:

1. A public service unit established in accordance with the law and registered for its field of operation with the competent authority, having the function of food testing or a Decision assigning tasks from authorized state agencies.

2. State-owned enterprises as defined by the law on enterprises.

Article 5. Competence Conditions

The competence of the verification testing facility for the registered criteria must meet the following requirements:

1. The testing facility has been designated to conduct food testing for state management in accordance with Circular Joint No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013, issued by the Minister of Health, the Minister of Industry and Trade, and the Minister of Agriculture and Rural Development, which stipulates the conditions and procedures for designating food testing facilities for state management.

2. Testing methods are updated and confirmed for their usability, analytical/testing capabilities for the registered criteria/measurement methods comply with regulations or corresponding technical standards, and conditions that do not ensure measurement are assessed according to the regulations of the Ministry of Industry and Trade.

3. Verification testing results or inter-laboratory comparison results for the registered criteria/measurement methods meet the requirements. Records retention, result retrieval, and verification testers conducting verification testing comply with ISO/IEC 17025:2005 or TCVN ISO/IEC 17025:2007 procedures.

Chapter III

REGISTRATION DOCUMENTS AND PROCEDURES FOR DESIGNATION OF VERIFICATION TESTING FACILITIES

VERIFICATION TESTING FACILITIES

Article 6. Registration Documents for Designation of Verification Testing Facilities

3. The registration documents include:

a) Application for designation of verification testing facilities in accordance with the form prescribed in Appendix I attached to this Circular;

b) Certified copy of the Decision establishing the public service unit established in accordance with the law or the Decision assigning tasks from authorized state agencies or Business Registration Certificate;

c) Certified copy of the Decision designating the food testing facility for state management still in effect issued by the competent authority;

d) Technical documentation, technical files, and related analysis procedures concerning the registered criteria/measurement methods for verification testing (documents stamped with the seal of the designated verification testing facility);

đ) Competence documents:

- List, technical equipment, infrastructure documents according to the form prescribed in Appendix II attached to this Circular;

- Sample Verification Testing Result Report in accordance with the form prescribed in Appendix III attached to this Circular;

- Testing activity results for the registered fields in the twelve (12) months prior to the application, according to the form prescribed in Appendix IV attached to this Circular.

e) For testing facilities applying for verification testing that have been recognized by international organizations such as the International Laboratory Accreditation Cooperation (ILAC) or the Asia-Pacific Laboratory Accreditation Cooperation (APLAC) based on National Standard TCVN ISO/IEC 17025:2007 or International Standard ISO/IEC 17025:2005, they must submit the documents mentioned in Points a, b, c, and d of Clause 3 of this Article; certified copies (with authentication) of recognition certificates, scope, and range of recognition.

Article 7. Designation Procedure

1. Within ten (10) working days from the date of receiving the dossier, the Ministry of Industry and Trade shall review the dossier. In case of requests for amendments or supplements, a written notice must be issued to the submitting entity to complete the dossier in accordance with the regulations.

2. For registration entities for testing and verification that are not within the scope defined in Point e Clause 3 Article 6 of this Circular:

a) Within fifteen (15) working days from the date of receiving a complete and valid dossier, the Ministry of Industry and Trade shall issue a decision to establish an evaluation team for the conditions and capabilities of the registration entity for testing and verification. The decision to establish the evaluation team must clearly state the scope, content of the evaluation, list, and assignment of responsibilities of each member conducting the evaluation at the testing and verification facility;

b) The evaluation team for the registration entity for testing and verification shall consist of members with specialized knowledge in food safety, analysis, testing, and experience in evaluating testing facilities;

c) If there are no requests for amendments or supplements, the evaluation shall be conducted in accordance with Article 8. Within five (05) working days from the end of the evaluation at the facility, the evaluation team must submit the conclusion to the Ministry of Industry and Trade according to the Model Evaluation Record Form for Testing and Verification Facilities stipulated in Appendix V attached to this Circular;

d) Within fifteen (15) working days from the date of receiving the satisfactory conclusion from the evaluation team, the Ministry of Industry and Trade shall have the responsibility to review and issue the Decision on designation of the testing and verification facility (the Model Decision on Designation is stipulated in Appendix VI attached to this Circular). In case of unsatisfactory conclusions, the Ministry of Industry and Trade must provide a written notification regarding the reasons for non-designation to the registration entity for testing and verification;

đ) In cases where there are recommendations from the registered testing facility regarding the conclusions of the evaluation team, the Ministry of Industry and Trade may establish an advisory board to review the conclusions of the evaluation team before signing the Decision on Designation;

e) In cases of extending the designation period: The testing and verification facility shall submit the dossier in accordance with Article 10 of this Circular for the Ministry of Industry and Trade to review the dossier. Within thirty (30) working days from the date of receiving a complete and valid dossier, the Ministry of Industry and Trade shall issue a decision to extend the designation period for the testing and verification facility. In case of incomplete or invalid dossiers, the Ministry of Industry and Trade must provide a written notification;

g) In cases of changing or supplementing the designated scope: The testing and verification facility shall submit the dossier in accordance with Article 11 of this Circular for the Ministry of Industry and Trade to review the dossier. The Ministry of Industry and Trade shall conduct the designation procedure in accordance with Clause 1, Points a, b, c, d, đ Clause 2 Article 7 of this Circular.

3. For registration entities for testing and verification specified in Point e Clause 3 Article 6 of this Circular:

a) Within thirty (30) working days from the date of receiving a complete and valid dossier, the Ministry of Industry and Trade shall review the dossier. If the capability dossier meets the requirements stipulated in Articles 4 and 5 of this Circular, the Ministry of Industry and Trade shall issue a Decision on designation of the testing and verification facility accompanied by a list of test criteria/methods;

If the dossier does not meet the requirements, the Ministry of Industry and Trade must provide a written notification specifying the reasons for non-designation of the testing and verification facility.

b) In cases where the results of the dossier review do not provide sufficient grounds to conclude that the analytical and testing capabilities of the facility meet the requirements stipulated in Article 5, the Ministry of Industry and Trade shall establish an evaluation team to conduct an evaluation of the testing capabilities at the testing and verification facility in accordance with Article 8 of this Circular;

c) In cases of extending the designation period: The testing and verification facility shall submit the dossier in accordance with Article 10 of this Circular for the Ministry of Industry and Trade to review the dossier. Within thirty (30) working days from the date of receiving a complete and valid dossier, the Ministry of Industry and Trade shall issue a decision to extend the designation period for the testing and verification facility. In case of incomplete or invalid dossiers, the Ministry of Industry and Trade shall provide a written notification to the testing and verification facility applying for an extension of the designation period;

d) In cases of changing or supplementing the designated scope: The testing and verification facility shall submit the dossier in accordance with Article 11 of this Circular for the Ministry of Industry and Trade to review the dossier. The Ministry of Industry and Trade shall conduct the designation procedure in accordance with Clause 1, Points a, b, Clause 3 Article 7 of this Circular.

4. The validity period of the Decision on designation is three (03) years from the date of issuance.

Article 8. Evaluation of Testing and Verification Facilities

The evaluation process shall be carried out as follows:

2. Prepare the Testing and Verification Facility Evaluation Report according to the form prescribed in Appendix VII issued together with this Circular.

Article 9. Issuance of Identification Number for Testing and Verification Facilities

1. The Ministry of Industry and Trade shall be responsible for issuing and managing identification numbers for designated testing and verification facilities to monitor their operations and periodically re-evaluate them.

2. The testing and verification facility will receive its identification number in the initial designation decision, which will remain valid throughout the duration of the facility's designation.

3. The identification number for the testing and verification facility is denoted as follows:

(sequential number)/(year of issuance)/BCT-KNKCTP

Example:

4. Format of the identification number for the testing and verification facility:

a) The identification number for the testing and verification facility shall be presented in uppercase letters, font Times New Roman size 16, upright bold typeface. The sequential number of the identification consists of three (03) digits;

b) The identification number for the testing and verification facility shall be printed in the upper left corner of the test result certificate. On the verification result certificate, the specified criteria of the testing and verification facility must be clearly recorded.

Article 10. Application Documents for Extension of Designation of Testing and Verification Facilities

Sixty (60) days prior to the expiration of the designation decision for the testing and verification facility, the facility shall submit one (01) set of application documents for extension to the Ministry of Industry and Trade. The documents include:

1. An application for extension of designation of the testing and verification facility according to the form prescribed in Appendix I issued together with this Circular.

2. Comparative results between laboratories and proficiency testing results for the criteria/tests registered for designation, conducted by competent state management agencies or from proficient testing providers, which must still be valid for three (03) years (including the extension period).

3. A report on the implementation of testing and verification activities during the designated period according to the form prescribed in Appendix IV issued together with this Circular.

Article 11. Application Documents for Change and Supplement of Scope of Designation for Testing and Verification

1. When there is a change or supplement to the scope of designation, the designated testing and verification facility must register such changes and supplements with the Ministry of Industry and Trade.

2. The application documents for change and supplement of scope of designation include:

a) An application for change and supplement of the testing and verification facility according to the form prescribed in Appendix I issued together with this Circular;

b) A report on the implementation of testing and verification activities during the designated period according to the form prescribed in Appendix IV issued together with this Circular;

c) Certified copy of the Decision designating the food testing facility for state management still in effect issued by the competent authority;

d) Technical documentation and related analytical procedures concerning the criteria/tests registered for designation (documents bearing the stamp of the designated testing and verification facility);

đ) A list and technical documentation of major equipment and infrastructure meeting the requirements for change and supplement (consistent with the operational capacity report of the testing and verification facility according to the form prescribed in Appendix II issued together with this Circular);

POST-DISIGNATION SUPERVISION AND MONITORING OF TESTING AND VERIFICATION FACILITIES

TESTING AND VERIFICATION FACILITIES

Article 12. Methods for inspection and supervision

1. Regular inspection and supervision: Once per year.

2. Unscheduled inspection and supervision when requested by the Ministry of Industry and Trade in cases where the testing and certification facility is subject to complaints, accusations, or disputes regarding its testing and certification activities.

Article 13. Inspection and supervision of activities

Applies to designated testing and certification facilities with a frequency of once per year. Inspection and supervision of activities include the following forms:

1. Preliminary assessment through activity reports submitted by the testing and certification facility according to regulations (six months and annually).

The Ministry of Industry and Trade will notify fifteen (15) days prior to implementing supervision for inspection and verification facilities about the plan to inspect and supervise activities at the facility. The Ministry of Industry and Trade decides to establish an inspection team to perform the following tasks:

a) Evaluation of the maintenance of compliance and suitability of the management system; the capability of the testing and certification facility as stipulated in Article 5 of this Circular;

b) Verification of procedures for performing specified tests according to registered methods. The method must meet the requirements of corresponding Technical Regulations or current regulations;

c) Examination of adherence to documentation, procedures, and regulations in testing and certification;

d) Review of records of the testing and certification process;

đ) Reporting monitoring results according to the model attached as Appendix VIII to this Circular;

e) The supervisory team reviews the results of corrective actions and reports to the Ministry of Industry and Trade. Based on the report of corrective actions, the Ministry of Industry and Trade will conduct on-site inspections at the testing and certification facility if necessary.

Article 14. Exemption from inspection and supervision

2. Testing and certification facilities meeting the requirements stipulated in Clause 1 of this Article shall submit one set of application documents for exemption from inspection and supervision to the Ministry of Industry and Trade. The documents include:

a) A letter requesting exemption from inspection;

b) Supervision record of the accreditation body for conformity to National Standard TCVN ISO/IEC 17025: 2007 or International Standard ISO/IEC 17025:2005 (within twelve months from the date of submission of the application);

c) Report on operational results within twelve months from the date of submission of the application, detailing the self-assessment results of the analytical capability of the testing and certification facility.

3. Within no more than five working days from the date of receipt of complete and valid documents, the Ministry of Industry and Trade will review the documents and respond in writing to the testing and certification facility.

4. Annually, testing and certification facilities exempted from inspection as stipulated in Clause 1 of this Article still have to undergo unscheduled inspections by the Ministry of Industry and Trade.

Article 15. Notification of inspection and supervision results

Based on the results of inspection and supervision and the degree of violation of the provisions of this Circular, within no more than five days, the inspection and supervision team will submit a written proposal to the Ministry of Industry and Trade for the following handling measures:

1. Request for rectification and submission of a rectification report to the Ministry of Industry and Trade.

2. Suspension of the implementation of the designation decision. After the testing and certification facility completes and reports the rectification as required by the inspection and supervision team, the Ministry of Industry and Trade will review and restore the designation decision.

3. Revocation and cancellation of the designation decision when the facility falls under any of the following circumstances: dissolution; no longer operating within the designated scope; exceeding the rectification deadline; violations that cannot be rectified.

Article 16. Inter-laboratory Comparisons

1. Units organizing inter-laboratory comparisons must meet the requirements of the International Standard ISO/IEC 17043:2010.

2. Based on the capabilities of units organizing inter-laboratory comparisons that meet the conditions, the Ministry of Industry and Trade will designate units to organize inter-laboratory comparisons and proficiency testing.

 DUTIES OF THE MANAGEMENT AUTHORITY AND INSPECTION AND VERIFICATION FACILITIES

Article 17. Responsibilities of the State Management Authority

1. Accepting registration files for designation, extension of registration for designation, and changes and additions to registration; organizing evaluation and designation of inspection and verification facilities.

2. Inspecting and supervising designated inspection and verification facilities.

3. Ensuring objectivity and fairness in evaluation, designation, inspection, and supervision activities.

4. Securing information and data related to inspection and verification facilities.

5. Issuing, suspending, revoking, restoring, and recalling the Decision on Designation.

6. Announcing the list of designated inspection and verification facilities, suspended, revoked, restored, and recalled Decisions on Designation on the Ministry of Industry and Trade's electronic portal website.

7. Organizing the handling of complaints and reports related to inspection and verification facilities according to the provisions of the law.

8. Keeping records of inspection and verification facilities.

9. Collecting and using fees and charges for evaluation, designation, and supervision of inspection and verification facilities' activities in accordance with the law on fees and charges.

Article 18. Responsibilities of Inspection and Verification Facilities

1. Implementing regular and ad hoc reporting to the Ministry of Industry and Trade:

a) Regular report: Reporting on six (06) months of operations before July 10 and annual report before December 30 each year (according to the form attached as Appendix IV to this Circular).

b) Ad hoc report: As required by the Ministry of Industry and Trade.

2. In cases where there are changes in the legal status or address of designated inspection and verification facilities, they must provide a written document detailing the changes. Report any changes related to the scope of designated inspection and verification activities within thirty (30) days from the date of change. The contents to be reported include:

a) Legal status;

b) Organizational structure and leadership;

c) Policies and procedures;

d) Address, telephone, Fax, E-mail;

đ) Personnel, key staff, equipment, infrastructure, working environment, or other resources (if any) affecting the management system;

e) Measures for rectification as prescribed in the form set out in Appendix IX issued together with this Circular when requested.

3. In addition to complying with the provisions of Clause 1 and Clause 2 of this Article, inspection and verification facilities must also implement the following:

a) Accepting inspections and supervision of inspection and verification activities by inspection teams upon written request by the Ministry of Industry and Trade;

b) Facilitating the evaluation team during the evaluation process at the inspection and verification facility;

c) Paying fees and charges for evaluation, designation, and supervision of inspection and verification facility activities in accordance with the law on fees and charges.

4. Fulfilling other obligations stipulated in Article 20 of the Product Quality Law.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 19. Effective Date

This Circular takes effect from March 1, 2014.

The Ministry of Industry and Trade assigns the Department of Science and Technology the responsibility to organize implementation, monitor, and guide the implementation of this Circular. 

Any issues encountered during implementation should be promptly reflected to the Ministry of Industry and Trade for research and resolution./.