Thông tư liên tịch 20/2013/TTLT-BYT-BCT-BNNPTNT của Bộ Y tế, Bộ Công Thương, Bộ Nông nghiệp và Phát triển nông thôn về việc quy định điều kiện, trình tự thủ tục chỉ định cơ sở kiểm nghiệm thực phẩm phục vụ quản lý nhà nước

JOINT CIRCULAR

ON CONDITIONS AND PROCEDURES FOR DESIGNATING FOOD TESTING LABORATORIES FOR STATE GOVERNANCE

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

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

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006, and Decree No. 127/2007/ND-CP dated August 1, 2007, of the Government detailing the implementation of a number of articles of the Law on Standards and Technical Regulations;

Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012, of the Government defining the functions, tasks, powers, and organizational structure of the Ministry of Health;

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

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

At the proposal of the Director General of the Agency of Food Safety Department under the Ministry of Health, the Director of the Science and Technology Department under the Ministry of Industry and Trade, and the Director General of the National Agro-forestry-Fisheries Quality Assurance Department under the Ministry of Agriculture and Rural Development,

The Minister of Health, the Minister of Industry and Trade, and the Minister of Agriculture and Rural Development hereby promulgate the Joint Circular on conditions and procedures for designating food testing laboratories for State governance.

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. Scope of regulation: This Joint Circular regulates the conditions, sequence, and procedures for designating food testing laboratories for State governance (hereinafter referred to as testing laboratories for short).

2. Subjects of application: This Joint Circular applies to testing laboratories and relevant managing authorities involved in the assessment, designation, and management of testing laboratories.

Article 2. Interpretation of terms

In this Joint Circular, the terms below are construed as follows:

1. Testing laboratory means an organization with legal status that conducts testing of food quality and safety.

2. Quality management system includes the system of management and technical documents to ensure the quality, accuracy, and transparency of testing results, as well as all records related to the tests, as well as the quality assurance of results thereof, performed at the laboratories within the registered scope, such as: personnel, equipment, infrastructure, and testing methods.

3. Interlaboratory comparison means the quality assessment of testing results between two or more testing laboratories, which is independently conducted by a third party by comparing the testing results on homogeneous samples with common values of the collection of results obtained from testing laboratories participating in proficiency testing.

4. Proficiency testing means the performance of tests on the same sample by two or more testing laboratories under predetermined conditions to assess the ability to conduct such tests of such testing laboratories.

5. Assessment of testing laboratories means the assessment of the satisfaction of the quality management system and analytical capacity to the testing requirements in terms of specific food quality and safety parameters.

6. Registered scope: Covers criteria/tests applicable to food groups or food products within the management scope assigned to the ministry managing the respective sector.

Article 3. General principles

In an inter-ministerial manner, the Ministry of Health’s Agency of Food Safety, the Ministry of Industry and Trade’s Science and Technology Department, and the Ministry of Agriculture and Rural Development’s National Agro-forestry-Fisheries Quality Assurance Department shall assist the Ministers of Health, Industry and Trade, and Agriculture and Rural Development to conduct the State governance over food testing laboratories (hereinafter referred to as competent State authorities), receive registration dossiers, and assess, designate, inspect, and supervise testing laboratories within the respective scope of State governance over food safety assigned to them.

Chapter 2.

CONDITIONS APPLICABLE TO TESTING LABORATORIES

Article 4. Legal status requirements

They shall be established in accordance with the law; and have the function of food testing or be able to do so under task assignment decisions of competent authorities.

Article 5. Capacity requirements

A testing laboratory, to satisfy the capacity requirements according to the criteria for registration for designation, must:

1. Have a quality management system conforming to TCVN ISO/IEC 17025: 2007 or ISO/IEC 17025:2005;

2. Have adequate equipment and facilities satisfying testing requirements within the registered scope;

3. Employ at least two (02) testers who are technicians holding university degree appropriate to the registered scope, who are well-trained and have at least three (03) years of hands-on experience in testing in the same field;

4. Have its test methods up-to-date and validated for the usefulness and analytical capacity of the registered criteria/tests, satisfying the respective requirements or technical standards and other relevant regulations of the ministry managing the respective sector;

5. Have qualified proficiency testing or interlaboratory comparison of at least one registered criterion/test.

Chapter 3.

DOSSIERS, PROCEDURES FOR REGISTRATION AND DESIGNATION OF TESTING LABORATORIES

Article 6. Registration for designation

1. A testing laboratory satisfying the requirements specified in Articles 4 and 5 of this Joint Circular shall submit (in person or via postal service) a registration dossier for designation to the competent State authority as specified in Article 3 of this Joint Circular.

2. The competent State authorities as specified in Article 3 of this Joint Circular shall receive the registration dossiers, arrange the assessment of the food testing laboratories under their ambit of management, or coordinate with each other in conducting assessments of multidisciplinary food testing laboratories following the procedures specified in this Joint Circular and making appropriate designations in the field that each ministry managing the respective sector is assigned to manage.

3. A registration dossier for designation consists of:

a) An application for designation of the testing laboratory, which is made using the form provided in Appendix 1 to this Joint Circular;

b) The establishment decision or business registration certificate (certified true copy);

c) Technical documents and records, and relevant processes related to the criteria/tests to be designated

d) A capacity profile:

- A list of main equipment and facilities and the records thereof (corresponding to the operational capacity report of the testing laboratory, which is made using the form provided in Appendix 2 to this Joint Circular);

- A list and profiles of testers in the respective field to be designated, along with certified true copies of their professional certificates;

- Supporting documents on testing quality assurance: Proficiency testing plan and results, or inter-laboratory comparison report; Reports on the skill proficiency of testers for the criteria/tests to be designated;

- A operational capacity report of the testing laboratory, which is made using the form provided in Appendix 2 to this Joint Circular;

- A sample of the Test Result Form in accordance with Appendix 3 to this Joint Circular;

- Testing performance results in the field to be designated within the last twelve (12) months, which is made using the form provided in Appendix 4 to this Joint Circular.

dd) Testing laboratories that have been accredited and granted accreditation certificates conforming to TCVN ISO/IEC 17025:2007 or ISO/IEC 17025:2005 by Vietnamese lawfully-established accreditation bodies or foreign accreditation bodies that are members signing mutual recognition agreements of the International Laboratory Accreditation Cooperation (ILAC) and the Asian Pacific Laboratory Accreditation Cooperation (APLAC) and register for designation of the criteria/tests that have been accredited shall submit the documents specified at Points a, b, c, and d Clause 3 of this Article; and certified true copies of the accreditation certificates, the list of accredited criteria/tests and the scope of accreditation.

Article 7. Registration dossier for extension of designation

Within ninety (90) days before the designation decision expires, a testing laboratory shall send a dossier for extension of designation to the competent State authority. Such dossier consists of:

1. An application for extension of designation of the testing laboratory, which is made using the form provided in Appendix 1 to this Joint Circular;

2. Interlaboratory comparison and proficiency testing results for the criteria/tests organized by the competent State authority or from proficiency testing providers relevant to the registered scope;

3. A report on the implementation of testing operations during the designated period, which is made using the form provided in Appendix 4 to this Joint Circular.

Article 8. Registration dossier for change or supplementation of the designated scope

When there is a change or supplementation of the designated scope, the testing laboratory that has been designated must submit a registration dossier for such change or supplementation to the competent State authority. The registration dossier for change or supplementation of the designated scope shall comply with Article 6 of this Joint Circular. In the case where a testing laboratory that has been designated changes its legal status or address, it must send a written notice explicitly stating such change.

Article 9. Designation procedures

1. Within ten (10) working days from the date of receiving the application dossier, the competent State authority shall examine the dossier. If there is a request for amendment or supplementation thereof, a written notice must be given to the applicant to complete the dossier as required. In the case where there is no request for amendment or supplementation, the competent State authority shall proceed with the assessment as specified in Article 10 of this Joint Circular.

2. For any testing laboratory other than those specified at Point dd, Clause 3, Article 6 of this Joint Circular:

a) Within fifteen (15) working days from the date of receiving a complete and valid application dossier, the competent State authority shall sign and issue a decision to establish an assessment team to assess the testing laboratory.

b) The testing laboratory assessment team shall consist of members who have expertise and experience in the field to be assessed and designated.

c) The decision to establish the assessment team must explicitly state the scope of assessment, issues to be assessed, the list of members and responsibilities assigned to each member in charge of the assessment at the testing laboratory. Within five (05) working days from the completion of the assessment at the testing laboratory, the assessment team shall send the conclusions to the competent State authority (made using the testing laboratory assessment report form provided in Appendix 5 to this Joint Circular).

d) Within fifteen (15) working days from the date of receiving the conclusions of the assessment team, the competent State authority shall consider designating the testing laboratory if it satisfies the requirements (made using the designation decision form provided in Appendix 6 to this Joint Circular). If the requirements are not satisfied, the competent State authority shall send a written notice of the reasons for not designating the testing laboratory.

dd) In case of necessity, the competent State authority may establish an advisory council before signing and issuing the designation decision.

3. For any testing laboratory specified at Point dd, Clause 3, Article 6 of this Joint Circular:

a) Within thirty (30) working days from the date of receiving a complete and valid application dossier, the competent State authority shall examine the dossier. If the capacity profile satisfies the requirements specified in Articles 4 and 5 of this Joint Circular and the requirements of the ministry managing the respective sector, the competent State authority shall sign and issue a decision on designation of the testing laboratory, enclosed with a list of the criteria/tests.

In the case where the dossier does not satisfy the requirements, the competent State authority shall send a written notice of the reasons for not designating the testing laboratory.

b) In case of necessity (where the assessment of the dossier cannot serve as a basis to conclude that the analytical capacity of the laboratory satisfies the requirements specified in Article 5), the competent State authority shall establish an assessment team to conduct the assessment at the testing laboratory.

4. The validity period of a designation decision: A designation decision shall be valid for three (03) years from the date of signing.

Article 10. Assessment of testing laboratories

The assessment team established by the competent State authority shall conduct the assessment at the testing laboratory (this is not applicable to testing laboratories specified at Point dd, Clause 3, Article 6, and Point a, Clause 3, Article 9 of this Joint Circular). The assessment process is specified as follows:

1. Assess the compliance and satisfaction of the testing laboratory with the requirements specified in Article 5 of this Joint Circular;

2. Prepare a testing laboratory assessment report, which is made using the form provided in Appendix 7 to this Joint Circular;

3. Make assessment conclusions using the form provided in Appendix 5 to this Joint Circular. Depending on the testing laboratory's report on remedies, if necessary, the competent State authority shall consider re-assessing the testing laboratory.

Article 11. Issuance of testing laboratory identification codes

1. The competent State authorities shall issue and managing identification codes of designated testing laboratories.

2. The identification code of a designated testing laboratory is specified as follows:

(serial number)/(year of issuance)/BYT-KNTP (BCT-KNTP/BNN-KNTP).

3. Format of a testing laboratory identification code:

a) The testing laboratory identification code shall be expressed in size-16 capital letters formatted in non-italic, bold Times New Roman font. The serial number of the testing laboratory identification code consists of three (03) digits.

b) The testing laboratory identification code shall be printed in the upper left corner of the test result form. The test result form should explicitly indicate the designated criteria of the testing laboratory.

Article 12. Verification laboratories

Depending on the management requirements and the criteria specified in Articles 4 and 5 of this Joint Circular, and other relevant regulations of the ministry managing the respective sector, such ministry shall designate verification laboratories in accordance with the law.

Chapter 4.

INSPECTION AND SUPERVISION AFTER DESIGNATION

Article 13. Methods of inspection and supervision

1. Periodic inspection and supervision: Once (01) a year.

2. Ad-hoc inspection and supervision upon request by the managing authorities.

Article 14. Interlaboratory comparison

1. To be able to conduct the interlaboratory comparison, a unit must satisfy the requirements of ISO/IEC 17043:2010 or have equivalent capacity.

2. The competent State authority, depending on the capacity of the units that are able to conduct the interlaboratory comparison, shall designate one to do so.

Article 15. Inspection and supervision of operations

This applies to designated testing laboratories on an annual basis (once a year). The inspection and supervision of operations can be conducted in the following forms:

1. Preliminary assessment of (semi-annual (06-month) and annual) reports submitted by the testing laboratories as required.

2. On-site inspection and supervision at the testing laboratories

Any testing laboratory to be inspected will be notified fifteen (15) days before being supervised. The inspection team established under the decision by the competent State authority shall be tasked to:

a) Evaluate the maintenance of compliance and adequacy of the testing laboratory's management system and capacity as specified in Article 5 of this Joint Circular;

b) Inspect the process of performing designated tests using the registered methods. The methods must satisfy the requirements of the respective technical regulations or the applicable regulations;

c) Inspect the compliance of the testing laboratory with documentation systems, procedures, and regulations in testing;

d) Inspect the records of the testing process;

dd) Report the supervision results using the form in Appendix 8 to this Joint Circular;

e) Appraise the remedies and report them to the competent State authority. Depending on the report on remedies, the competent State authority shall conduct on-site inspections at the testing laboratory if necessary.

Article 16. Exemption from inspection and supervision

1. Testing laboratories specified at Point dd, Clause 3, Article 6, which fully satisfy the requirements specified in Articles 4 and 5 of this Joint Circular, and other relevant regulations of the ministry managing the respective sector shall be exempted from inspection and supervision.

2. Any testing laboratory that satisfies the requirements specified in Clause 1 of this Article shall submit a dossier requesting exemption from inspection and supervision to the competent State authority. Such dossier consists of:

a) An official letter of request for inspection exemption;

b) A supervision report of the accreditation bodies recognizing the conformity to ISO/IEC 17025:2007 or ISO/IEC 17025:2005 (within twelve (12) months from the date of submitting the dossier);

c) An operational report on operations within twelve (12) months from the date of submitting the dossier, which shall indicate the self-assessment of the analytical capacity of the testing laboratory compared to relevant requirements of the ministry managing the respective sector.

3. Within a period of no more than five (05) working days from the date of receiving a complete and valid dossier, the competent State authority will assess the dossier and respond in writing to the testing laboratory.

4. Annually, exempted testing laboratories specified in Clause 1 of this Article shall be subject to ad-hoc inspection and supervision by the managing authorities.

Article 17. Notification of inspection and supervision results

Based on the inspection and supervision results and depending on the degree of violations against this Joint Circular, the inspection and supervision team shall suggest the competent State authority to:

1. Require the testing laboratory to take remedies and submit of a report on such remedies to the competent State authority.

2. Suspend the designation decision. After the testing laboratory completes and reports the remedies it has taken as required by the inspection and supervision team, the competent State authority shall consider reinstating the designation decision.

3. Revoke the designation decision and report to the ministry managing the respective sector if the testing facility is dissolved; no longer operates within the designated scope; or fails to take the remedies with the required period of time; or the violations cannot be remedied.

Chapter 5.

RESPONSIBILITIES OF THE COMPETENT STATE AUTHORITIES AND TESTING LABORATORIES

Article 18. The competent State authorities shall

1. Process the dossiers for registration for designation, extension of designation, and registration of changes; arrange the assessment and designation of testing laboratories.

2. Conduct inspection and supervision after such designation.

3. Ensure objectivity and fairness in the assessment, designation, inspection, and supervision.

4. Secure confidential information and data related to testing laboratories.

5. Issue, suspend, annul, reinstate, and revoke designation decisions.

6. Publicize the list of designated testing laboratories and those that whose designation decisions are suspended, annulled, reinstated, and revoked

7. Arrange the inspection and resolution of complaints related to testing laboratories in accordance with the law.

8. Keep records of testing laboratories.

9. Collect and use fees and charges for the assessment, designation, and supervision of testing laboratory operations in accordance with the law on fees and charges.

Article 19. Testing laboratories shall

1. Submit periodic and ad-hoc reports to the competent State authorities as follows:

a) Periodic reports: Semi-annual (06 months) and annual operational reports (made using the form in Appendix 4 to this Joint Circular) shall be submitted before July 10 and December 30 of each year, respectively.

b) Ad-hoc reports: Upon request of the competent State authorities.

2. Report changes related to the designated scope of testing within a period of no more than thirty (30) days from the date on which such changes are made. The changes to be reported are related to:

a) Legal status;

b) Organizational structure and leadership;

c) Policies and procedures;

d) Address, telephone, fax, email;

dd) Staff, key personnel, equipment, facilities, working environment, or other resources if they affect the management system;

e) Remedial measures upon request, which is made using the form provided in Appendix 9 to this Joint Circular.

3. In addition to complying with Clauses 1 and 2 of this Article, testing laboratories must also:

a) Ensure the reliability and accuracy of testing results if the designated tests;

b) Have their testing operations assessed and supervised by domestic and foreign inspection teams upon request of competent State authorities;

c) Create favorable conditions for the assessment teams while they are conducting the assessment at the testing laboratories;

d) Pay fees for the assessment, designation, and supervision of testing laboratory operations in accordance with the law on fees and charges.

4. Fulfill other obligations as specified in Article 20 of the Law on Product and Goods Quality.

Chapter 6.

IMPLEMENTATION PROVISIONS

Article 20. Effect

This Joint Circular takes effect from October 10, 2013.

Food testing laboratories designated in accordance with the regulations of the respective ministry managing them shall continue to maintain such designation until the expiration of the respective designation decisions.

Article 21. Implementation organization

The Food Safety Department under the Ministry of Health, the Science and Technology Department under the Ministry of Industry and Trade, the National Agro-forestry-Fisheries Quality Assurance Department under the Ministry of Agriculture and Rural Development are responsible for organizing, inspecting, monitoring, and guiding the implementation of this Joint Circular.

During the implementation hereof, organizations and individuals should promptly report any difficulties arising therefrom to the Ministry of Health (via the Food Safety Department), the Ministry of Industry and Trade (via the Science and Technology Department), and the Ministry of Agriculture and Rural Development (via the National Agro-forestry-Fisheries Quality Assurance Department) for consideration and resolution./.