JOINT CIRCULAR No. 20/2013/TTLT-BYT-BCT-BNNPTNT ON CONDITIONS AND PROCEDURES FOR DESIGNATING FOOD TESTING FACILITIES TO SERVE STATE MANAGEMENT

JOINT CIRCULAR

Regulations on conditions, procedures for designation of food testing facilities to serve state management

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 the implementation of the Food Safety Law CV3: 16º56'21" N, 107º11'06" E; ENVIRONMENTi the Law on Prices.a) The specialized department as stipulated in Clause 2, Article 14 of Decree No. 127/2007/NĐ-CP dated August 1, 2007, issued by the Government detailing a number of articles of the Law on Standards and Technical Regulations; of the Food Safety Law food;

Pursuant to the Quality Management Law on products and goods dated November 21, 2007 and Decree No.Coat 32/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of the Quality Management LawJune 2024;quality management 1of products and goods"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."of Top Secret and CV3: 16º56'21" N, 107º11'06" E; ENVIRONMENTi Pursuant to Decree No. 11/2020/NĐ-CP dated October 15, 2020 of the Government detailing implementation of certain provisions and measures for organizing the implementation of the Law on Petitions;No. INDUSTRIAL EXPLOSIVES - TNP1 EXPLOSIVESono of the Law Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006 and Decree No., 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing the implementation of technical standards and regulations;

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Pursuant to Decree No. 63/2012/NĐ-CP dated October 23, 2012 of the Government stipulating functions, tasks, powers, and organizational structure1 of the Ministry of Industry and Trade;"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Government stipulating functions, tasks, powers, and structure organization WHEREAS Decree No. 215/2013/NĐ-CP dated December 23, 2013 stipulates the functions, tasks, powers, and organizational structure of the Ministry of Finance;

Pursuant to Decree No. 95/2017/NĐ-CP dated August 16, 2017 promulgating the functions, tasks, and powers of the Ministry of Science and Technology;1Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government detailing the functions, tasks, powers, and organizational structure organization of the Ministry of Agriculture and Rural Development and Decree No.

75/2009/NĐ-CP amending Article 3 of Decree No. organization 8/NĐ-CP dated January 3, 2008 of the Government detailing the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;No. At the proposal of the Director of the Food Safety Administration - Ministry of Health 01/200Department of Science and Technology - Ministry of Industry and Trade, the Director of the Quality Control BureauJune 2024;of Forestry Products and Aquatic Products - Ministry of Agriculture and Rural Development,

The Minister of Health - The Minister of Industry and Trade, and the Minister of Agriculture and Rural Development promulgate this CircularThis Decree stipulates the regulations on seniority allowances for teachers.regulating conditions, procedures for designation of food testing facilities to serve state management 1. Scope of Regulation: This joint circular stipulates the conditions, procedures, and formalities for designating food testing facilities to serve state management (hereinafter referred to as testing facilities). Agriculture l2. Applicability: This joint circular applies to testing facilities and relevant administrative agencies involved in the activities of evaluation, designation, and management of testing facilities.ng1. Testing facility is an organization with legal personality that conducts testing of quality and safety indicators of food.

Article 1. Amending and supplementing some articles of Circular No. 21/2023/TT-BTTTT dated December 31, 2023 of the Ministry of Information and Communications on functions and technical features of the Administrative Procedure Handling Information System at the ministerial and provincial levels (hereinafter referred to as Circular No. 21/2023/TT-BTTTT) as follows: 2. Quality management system includes management and technical documentation aimed at ensuring the accuracy, transparency, and completeness of testing results, all related records of testing activities, and ensuring the quality of testing results conducted at the facility within the scope registered such as personnel, equipment, infrastructure, testing methods. - The Minister of Agriculture and Rural Development promulgates this National Technical Regulation on requirements for objects subject to plant quarantine upon import.From 100 million VND to less than 300 million VND3. Inter-laboratory comparison is the assessment of the quality of testing results between two or more testing facilities organized by an independent entity through comparing testing results on identical samples with common values obtained from participating testing facilities proficient in testing.to4. Proficiency testing involves conducting tests on the same sample by two or more testing facilities under predetermined conditions to evaluate the ability of the testing facility to perform that test. hereby jointly issue 5. Evaluation of testing facilities is the activity of reviewing the suitability of the quality management system and analytical capacity to meet the requirements for testing specific quality and safety indicators of food.,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

6. Designated scope: Includes specific testing methods applicable to groups of foods or food products within the scope of management assigned by the sectoral management ministry.

The Joint Ministries assign: The Food Safety Administration - Ministry of Health; Department of Science and Technology - Ministry of Industry and Trade; Quality Control Bureau of Forestry Products and Aquatic Products - Ministry of Agriculture and Rural Development to assist the Ministers of Health, Industry and Trade, and Agriculture and Rural Development in managing state affairs regarding food testing (hereinafter referred to as competent state management agency) to organize the acceptance of registration files, evaluation, designation, inspection, and supervision of testing facilities corresponding to the scope of state management over food safety assigned.

Article 2. Interpretation of Terms

1. Sources of funding for school health work include:

1. A testing facility is an entity with legal personality that conducts tests on quality and safety indicators for food products.

2. The quality management system includes documentation and technical systems to ensure the accuracy, transparency of test results, all relevant records related to testing activities, and the quality of testing results carried out at the facility within the scope of registration, such as personnel, equipment, infrastructure, and testing methods.

3. Inter-laboratory comparison is the evaluation of the quality of testing results between two or more testing facilities conducted by an independent organization through comparing test results on identical samples with the common value derived from the set of results obtained from participating testing facilities proficient in testing.

4. Proficiency testing involves performing tests on the same sample by two or more testing facilities under predetermined conditions to assess the capability of each testing facility to conduct such tests.

5. Evaluation of a testing facility is the activity of reviewing the suitability of the quality management system and analytical capacity to meet the requirements for testing specific quality and safety indicators for food products.

6. Scope of designated registration: Includes the criteria/tests applicable to groups of food products or food items within the regulatory scope assigned by the industry management ministry.

Article 3. General Principles

7. The Joint Ministries assign: The Food Safety Administration under the Ministry of Health; The Science and Technology Department under the Ministry of Industry and Trade; The Quality Management Bureau for Forestry, Agriculture, and Aquatic Products under the Ministry of Agriculture and Rural Development shall assist the Ministers of Health, Industry and Trade, and Agriculture and Rural Development in managing state affairs regarding food testing (hereinafter referred to as the competent authority) to organize the acceptance of registration applications, evaluation, designation, inspection, and supervision of testing facilities corresponding to their respective scopes of responsibility for food safety management.

Chapter II

RULES FOR TESTING FACILITIES

Article 4. Legal entity requirements

Established in accordance with the law; having food testing functions or a Decision assigning tasks by competent authorities.

Article 5. Competence requirements

The competence of the testing facility for registered inspection items must meet the following requirements:

1. A quality management system that meets the National Standard TCVN ISO/IEC 17025: 2007 or the International Standard ISO/IEC 17025:2005;

2. Adequate equipment and facilities suitable for testing requirements and the designated field;

3. At least two (02) testing staff members who are technical officers with a bachelor's degree relevant to the designated field, trained and having at least three (03) years of practical experience in testing within the same field;

4. Testing methods updated and confirmed for their usability, analytical/testing capabilities for registered criteria/tests meeting the regulations or technical standards corresponding to the requirements stipulated by the competent ministry;

5. Proficient testing results or inter-laboratory comparison results meeting the requirements for at least one registered criterion/test.

Chapter III

REGISTRATION AND DESIGNATION PROCEDURES FOR TESTING FACILITIES

Article 6. Registration and designation

1. Testing facilities that meet the requirements set forth in Articles 4 and 5 of this Joint Circular shall submit one (01) registration dossier (either directly or via postal service) to the competent state authority as prescribed in Article 3 of this Joint Circular;

2. The competent state authorities mentioned in Article 3 of this Joint Circular shall be responsible for receiving registration dossiers, organizing evaluations of food testing facilities under their respective fields of management, or coordinating to organize evaluations of multi-field food testing facilities according to the procedures stipulated in this Joint Circular, and considering appropriate designations based on the assigned management fields of each competent ministry.

3. The registration documents include:

a) A registration application form for testing facilities as prescribed in Appendix 1 issued together with this Joint Circular;

b) Establishment decision or business registration certificate (certified copy);

c) Technical documents, technical files, and related procedures concerning the criteria/tests for registration of designation.

d) Competence dossier:

- List, main equipment documentation, infrastructure (consistent with the content of the laboratory activity capability report as prescribed in Appendix 2 issued together with this Joint Circular);

- List, testing officer dossier corresponding to the registered inspection area, accompanied by certified copies of professional certificates;

- Documentation proving quality assurance in testing: plans, proficient testing results or inter-laboratory comparisons; reports on the proficiency testing performance of testing staff for registered criteria/tests;

- Laboratory capability report as prescribed in Appendix 2 issued together with this Joint Circular;

- Testing result certificate format as prescribed in Appendix 3 issued together with this Joint Circular;

- Testing activity results for the designated field in the twelve (12) months prior to the application as prescribed in Appendix 4 issued together with this Joint Circular.

d) For testing facilities that have been evaluated and certified by legally recognized organizations in Vietnam or foreign organizations participating in mutual recognition agreements of the International Laboratory Accreditation Cooperation (ILAC) or the Asia Pacific Laboratory Accreditation Cooperation (APLAC) according to the National Standard TCVN ISO/IEC 17025: 2007 or the International Standard ISO/IEC 17025:2005, registering criteria/tests within the scope of certification: submit the documents specified in Points a, b, c, and d of Clause 3 of this Article; certified copies of the accreditation certificates, scope, and range of certification.

Article 7. Documents for Registration of Extension of Designation

Ninety (90) days before the Decision on designation expires, the testing facility shall submit one (01) set of extension registration documents to the competent state management agency. The documents include:

1. An application for extension of the testing facility's designation according to the form prescribed in Appendix 1 issued together with this Joint Circular;

2. Comparison results between laboratories and proficiency testing outcomes for the criteria/tests from the competent state management agency or from proficient testing providers, related to the scope of the organization’s registration;

3. A report on the implementation of testing work during the designated period according to the form prescribed in Appendix 4 issued together with this Joint Circular.

Article 8. Documents for Registration of Changes and Additions to the Scope of Designation

When there are changes or additions to the scope of designation, the designated testing facility must register such changes or additions with the competent state management agency. The documents for registration of changes and additions to the scope of designation shall be carried out in accordance with Article 6 of this Joint Circular. In cases where the designated testing facility has changed its legal status or address, it must provide a document detailing the changes.

Article 9. Procedures for Designation

1. Within ten (10) working days from the date of receipt of the documents, the competent state management agency shall review the documents. If there is a need for amendments or supplements, a written notice shall be issued to the submitting entity to complete the documents in accordance with the regulations. In cases where there is no need for amendments or supplements, the competent state management agency shall conduct an evaluation in accordance with Article 10 of this Joint Circular.

2. For testing facilities not falling under the provisions of Point đ Clause 3 Article 6 of this Joint Circular:

a) Within fifteen (15) working days from the date of receipt of complete and valid documents, the competent state management agency shall issue a decision to establish an inspection team.

b) The inspection team shall consist of members with expertise and experience in the field of evaluation and designation.

c) The decision to establish the inspection team must clearly specify the scope and content of the inspection, the list of members and their assigned responsibilities for conducting the inspection at the testing facility. Within five (05) working days from the end of the inspection, the inspection team must submit the conclusions to the competent state management agency (the Inspection Report form prescribed in Appendix 5 issued together with this Joint Circular).

d) Within fifteen (15) working days from the date of receipt of the inspection team's conclusions, the competent state management agency shall be responsible for reviewing and designating the testing facility if it meets the requirements (the Designation Decision form prescribed in Appendix 6 issued together with this Joint Circular). If it does not meet the requirements, the competent state management agency must notify the testing facility in writing of the reasons for non-designation.

đ) In necessary cases, the competent state management agency may establish an advisory board prior to issuing the Designation Decision.

3. For testing facilities specified in Point đ Clause 3 Article 6 of this Joint Circular:

a) Within thirty (30) working days from the date of receipt of complete and valid documents, the competent state management agency shall examine the documents. If the capability documents comply with the provisions of Articles 4 and 5 of this Joint Circular and the requirements of the relevant ministry, the competent state management agency shall issue a Designation Decision for the testing facility along with a list of criteria/tests. If the documents do not meet the requirements, the competent state management agency must notify the testing facility in writing of the reasons for non-designation.

b) In necessary cases (if the examination results of the documents are insufficient to conclude that the facility's analytical capabilities meet the requirements of Article 5), the competent state management agency will establish an inspection team to conduct an inspection at the testing facility.

4. Validity Period of the Designation Decision: The Designation Decision shall be effective for three (03) years from the date of issuance.

Article 10. Evaluation of Testing Facilities

The evaluation team established by the competent state management agency shall conduct evaluations at testing facilities (this does not apply to testing facilities specified in Point đ Clause 3 Article 6 and Point a Clause 3 Article 9 of this Joint Circular). The steps for conducting the evaluation are as follows:

1. Assessing the compliance and suitability of the testing facility with the requirements stipulated in Article 5 of this Joint Circular;

2. Preparing a testing facility evaluation report according to the form prescribed in Appendix 7 issued together with this Joint Circular;

3. Concluding the evaluation report according to the form prescribed in Appendix 5 issued together with this Joint Circular. Based on the corrective action report submitted by the testing facility, if necessary, the competent state management agency will conduct a re-evaluation at the testing facility.

Article 11. Issuing Identification Numbers for Testing Facilities

1. The competent state management agency is responsible for issuing and managing identification numbers for designated testing facilities.

2. The identification number for a testing facility is denoted as follows:

 (sequential number)/(year of issuance)/MOH-LAB (MOF-LAB/MARD-LAB).

3. Recording the Identification Number of Testing Facilities:

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

b) The identification number of a testing facility must be printed in the upper left corner of the test result certificate. On the test result certificate, the designated quality indicators of the testing facility must be clearly recorded.

Article 12. Designated Testing Facilities

Based on management needs, the criteria set forth in Articles 4 and 5 of this Joint Circular, and other relevant regulations as provided by the industry management ministry, the industry management ministry designates testing facilities for verification in accordance with the law.

Chapter IV

INSPECTION AND SUPERVISION AFTER DESIGNATION

Article 13. Methods of Inspection and Supervision

1. Regular inspection and supervision: Once per year.

2. Surprise inspections when requested by the management agency.

Article 14. Inter-laboratory Comparisons

1. The organization conducting inter-laboratory comparisons must meet the requirements of the International Standard ISO/IEC 17043:2010 or have equivalent capability.

2. Based on the capabilities of organizations conducting inter-laboratory comparisons that meet the conditions, the competent state management agency will designate the organization to conduct inter-laboratory comparisons.

Article 15. Inspection and Supervision of Operations

Applied to designated testing facilities once every year. Inspection and supervision of operations include the following forms:

1. Preliminary assessment through activity reports submitted by the testing facility as required (six months and annually).

2. On-site inspection and supervision of operations at the testing facility. The testing facility to be inspected will be notified fifteen (15) days prior to the supervision. The inspection team established by the competent state authority according to the decision is responsible for performing the following tasks:

a) Evaluating the maintenance of compliance and suitability of the management system and the capability of the testing facility as stipulated in Article 5 of this Joint 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) Inspecting compliance with documentation systems, procedures, and regulations in testing;

d) Inspecting the records of the testing process;

đ) Reporting the supervision results according to the form in Appendix 8 issued together with this Joint Circular;

e) The supervisory team will review the corrective action results and report to the competent state management agency. Based on the corrective action report, the competent state management agency will conduct an actual inspection at the testing facility if necessary.

Article 16. Exemption from Supervisory Inspection

1. The testing facility specified in Point đ Clause 3 Article 6 shall be exempted from supervisory inspection if it fully complies with the provisions of Article 4 and Article 5 of this Joint Circular and other relevant regulations as prescribed by the competent ministry.

2. A testing facility that meets the requirements stipulated in Clause 1 of this Article shall submit one (01) set of application documents for exemption from supervisory inspection to the competent state management agency. The dossier includes:

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) A report on the results of operations within twelve (12) months from the date of submission of the dossier, clearly stating the self-assessment results of the testing facility's analytical capacity compared to the relevant regulations of the competent ministry.

3. Within no more than five (05) working days from the date of receipt of complete and valid dossiers, the competent state management agency shall review the dossier and respond in writing to the testing facility.

4. Annually, testing facilities exempted from inspection as provided in Clause 1 of this Article must still undergo surprise inspections by the competent authority.

Article 17. Notification of Inspection and Supervision Results

Based on the results of inspection and supervision, depending on the level of violation of the provisions of this Joint Circular, the inspection and supervision team shall propose to the competent state management agency the following forms of handling:

1. Requesting rectification and submitting a rectification report to the competent state management agency.

2. Suspending the implementation of the Decision on designation. After the testing facility completes and reports the rectification according to the requirements of the inspection and supervision team, the competent state management agency will proceed to review and restore the Decision on designation.

3. Revoking and canceling the Decision on designation and reporting to the competent ministry when the facility falls under one of the following circumstances: being dissolved; no longer operating within the designated scope; exceeding the rectification deadline; violations that cannot be rectified.

Chapter V

RESPONSIBILITIES OF THE MANAGEMENT AUTHORITY AND TESTING FACILITIES

Article 18. Responsibilities of the Competent State Management Agency

1. Implementing the acceptance of registration applications, extension of registration, and supplementary change registration; organizing evaluation and designation of testing facilities.

2. Post-designation inspection and supervision.

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

4. Ensuring confidentiality of information and data related to testing facilities.

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

6. Publishing the list of designated testing facilities, those suspended, canceled, restored, and decisions on revocation.

7. Organizing investigations and resolving complaints and reports related to testing facilities in accordance with the law.

8. Keeping records of testing facilities.

9. Collecting and using fees and charges for evaluation, designation, and supervision of testing facility activities in accordance with the law on fees and charges.

Article 19. Responsibilities of Testing Facilities

1. Implementing regular and ad hoc reporting to the competent state management agency:

a) Regular report: Reporting on activities six (06) months before July 10th and annual report before December 30th each year (in accordance with the model at Appendix 4 issued together with this Joint Circular).

b) Ad hoc report: As required by the competent state management agency.

2. Reporting changes related to the designated testing scope 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 they affect the management system;

e) Measures for rectification as required according to the model specified in Appendix 9 issued together with this Joint Circular.

3. In addition to implementing the provisions of Clause 1 and Clause 2 of this Article, testing facilities must also implement the following:

a) Ensuring the reliability and accuracy of test results for designated tests;

b) Accepting inspection and supervision of testing activities by domestic and foreign inspection teams upon request of the competent state management agency;

c) Facilitating the evaluation team during the evaluation process at the testing facility;

d) Paying fees and charges for evaluation, designation, and supervision of testing 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

IMPLEMENTING PROVISIONS

Article 20. Effective Date

This Joint Circular takes effect from October 10, 2013. Food testing facilities already designated in accordance with the regulations of the competent ministries shall continue to maintain their validity until the expiration of the designation decision.

The Food Safety Administration of the Ministry of Health, the Department of Science and Technology of the Ministry of Industry and Trade, and the Quality Management Bureau of Agriculture, Forestry, and Fisheries Products and Aquatic Products of the Ministry of Agriculture and Rural Development are responsible for organizing, inspecting, supervising, and guiding the implementation of this Joint Circular. During the implementation, if there are difficulties, organizations and individuals need to promptly reflect them to the Ministry of Health (Food Safety Administration), the Ministry of Industry and Trade (Department of Science and Technology), and the Ministry of Agriculture and Rural Development (Quality Management Bureau of Agriculture, Forestry, and Fisheries Products and Aquatic Products) for research and resolution.

During the implementation, if there are difficulties, organizations and individuals need to promptly reflect them to the Ministry of Health (Food Safety Administration), the Ministry of Industry and Trade (Department of Science and Technology), and the Ministry of Agriculture and Rural Development (Quality Management Bureau of Agriculture, Forestry, and Fisheries Products and Aquatic Products) for research and resolution./.