Circular No. 05/2007/TT-BYT guiding conditions and procedures for designating organizations to conduct state inspections on the quality and food safety hygiene of imported food products.

CIRCULAR

Guidelines on the conditions and procedures for designating organizations to conduct state inspections of quality and food safety of imported products

State inspection for the quality and food safety hygiene of imported products

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Pursuant to the Food Safety Ordinance No. 12/2003/PL-UBTVQH11 dated July 26, 2003;

Pursuant to the Ordinance on Product Quality No. 18/1999/PL-UBTVQH10 dated December 24, 1999;

Pursuant to the Product Quality Ordinance No. 18/1999/PL-UBTVQH10 dated December 24, 1999;

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

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government detailing the functions, tasks, powers, and organizational structure of the Ministry of Health;

To ensure consistency in designating organizations to carry out state inspections for the quality and food safety hygiene of imported products, the Ministry of Health provides guidance on the conditions and procedures for designation as follows:

Pursuant to Decree No. 163/2004/NĐ-CP dated September 7, 2004 of the Government detailing the implementation of certain provisions of the Food Safety Ordinance;

1. Designating an organization to conduct state inspections for the quality and food safety hygiene of imported products is the act of a competent state agency examining and designating that organization as having the capability to perform state inspections for the quality and food safety hygiene of imported products (hereinafter referred to as the designated organization).

Pursuant to Decree No. 179/2004/NĐ-CP dated October 21, 2004 of the Government on state management of product and commodity quality,

To ensure uniformity in the designation of organizations to conduct state inspections of quality and food safety of imported products, the Ministry of Health provides guidelines on the conditions and procedures for designation as follows:

I. SCOPE OF APPLICATION

1. Designating an organization to conduct state inspections of quality and food safety of imported products is the act of a competent state authority examining and designating that organization as having sufficient capacity to conduct state inspections of quality and food safety of imported products (hereinafter referred to as the designated organization).

2. The designated organization includes:

a) Institutes under the Ministry of Health, Provincial and Central City Health Centers;

b) Non-profit organizations engaged in technical service activities of relevant ministries, and business organizations providing inspection services.

3. Competent state authorities for designation:

a) The Ministry of Health designates organizations specified in point a, Clause 2, Section I;

b) The Ministry of Health takes the lead and coordinates with relevant ministries to designate organizations specified in point b, Clause 2, Section I.

II. CONDITIONS FOR DESIGNATED ORGANIZATIONS

Organizations requesting the Ministry of Health to examine and designate them to conduct state inspections of quality and food safety of imported products must meet the following conditions:

1. Established by a state agency with a decision to operate in the field of quality and food safety inspection and have full legal personality;

2. Have sufficient technical staff with adequate professional qualifications and at least three years of experience in quality and food safety inspection work;

3. Have necessary and appropriate equipment to inspect, test, and evaluate the main indicators of quality and food safety as follows:

- Chemical indicators: Sugar content, protein, fat, ash, moisture, acidity, alkalinity, residues of plant protection chemicals, antibiotic residues, growth hormone residues, food additive content, mycotoxins, and other harmful chemicals;

- Microbiological indicators: Total aerobic bacteria, pathogenic intestinal bacteria, and total yeast and mold spores.

In cases where the necessary equipment for testing all quality and food safety indicators is not available, permission may be granted to use external laboratories (laboratories recognized or with a management system certified to ISO/IEC 17025 standards) to test remaining indicators, and this must be evidenced by a testing service contract.

4. Have sufficient technical regulations, international standards, Vietnamese standards, and other standards, technical documents, and inspection and testing procedures for the inspected food products.

Organizations with laboratories having a management system certified to ISO/IEC 17025 standards will be prioritized for examination and designation.

III. PROCEDURES AND PROCEDURES FOR DESIGNATION

1. Organizations and units meeting the conditions submit application files to the Ministry of Health for examination and issuance of a decision to designate them to conduct state inspections of quality and food safety of imported products. The file (two copies) includes:

a) Application form (as prescribed in Appendix I of this Circular);

b) List of staff conducting inspection and testing work (as prescribed in Appendix II of this Circular);

c) List of measurement and testing equipment (as prescribed in Appendix III of this Circular);

d) List of technical documents, technical regulations, international standards, Vietnamese standards, technical documents, and inspection and testing procedures corresponding to the product and commodity areas being applied for designation (as prescribed in Appendix IV of this Circular);

đ) Contract for using and the capacity of external laboratories (for cases where the necessary equipment for testing all quality and food safety indicators is not available, external laboratories can be used to test remaining indicators);

b) The validity period of the decision appointing the organization to inspect food quality and food safety for imported food is five years. Three months before the decision expires, the appointed organization shall proceed with the necessary procedures to request reappointment if needed;

c) Five years from the date this Circular takes effect, state organizations inspecting the quality and safety of imported food that were designated by the Ministry of Health prior to the effectiveness of this Circular must conduct a review, evaluation, and reappointment according to the provisions of this Circular;

IV. RIGHTS AND RESPONSIBILITIES OF APPOINTED ORGANIZATIONS

1. Rights:

a) Request organizations and individuals importing food to provide relevant files and documents;

b) Conduct inspections of the quality, hygiene, and safety of imported food in accordance with the inspection procedures and technical regulations;

c) Issue certificates confirming that imported food meets quality standards or notify that a batch of food does not meet import quality standards according to the unified forms issued by the Ministry of Health;

d) Collect and manage inspection fees in accordance with the law and guidelines of the Ministry of Finance;

2. Responsibilities:

a) Carry out inspections of the quality and safety of imported food within the scope and fields specified in the appointment;

b) The appointed organization bases its inspections on inspection procedures, Vietnamese standards, international standards, and other regulations concerning food quality, hygiene, and safety issued by competent state agencies;

c) Report and propose measures to the Ministry of Health (Food Safety Administration) regarding batches of imported food that do not meet quality standards;

d) Be responsible under the law for the results of inspections of the quality and safety of imported food conducted by themselves;

e) Concentrate all resources to carry out inspections of the quality and safety of imported food within the designated scope in accordance with the required schedule when there are urgent requests from competent state authorities;

f) Maintain conditions for the appointed organization, perform calibration and verification of testing equipment according to the regulations of the Ministry of Science and Technology and the Ministry of Health;

g) Store inspection records, test records, and related books as required by the state and present them when requested by responsible agencies;

h) Implement reporting requirements as stipulated in Section V of this Circular;

V. REPORTING SYSTEM

1. Appointed organizations have the responsibility to report to the Ministry of Health (Food Safety Administration) when any of the following changes occur:

a) Change in the scope of inspection designated or temporary cessation of operations;

b) Change in office location, change in inspection equipment, change or addition of staff related to the designated inspection field, change in service testing provider;

After reviewing reports on these changes, the Ministry of Health (Food Safety Administration) will issue appropriate notifications or decisions to the appointed organization;

2. Submit periodic six-month and annual reports to the Ministry of Health (Food Safety Administration) on the following contents:

a) List of food import companies that have been inspected;

b) Types and quantities of imported food that have been inspected;

c) Types and quantities of imported food that do not meet quality, hygiene, and safety standards;

d) Complaint situation of enterprises;

e) Recommendations and proposals;

VI. SUPERVISION, INSPECTION, AND VIOLATION HANDLING

1. Periodically or urgently, the Ministry of Health will organize coordination with functional agencies to supervise and inspect the activities of appointed organizations;

2. The Ministry of Health will consider and revoke the appointment decision when an appointed organization violates any of the following provisions:

a) Inspect food quality and safety not in accordance with the law;

b) Conduct inspections outside the designated scope and field;

c) Show dishonest behavior during inspections and confirmation of food quality and safety;

3. Staff members of appointed organizations who abuse their functions, duties, and powers to obstruct businesses or falsify inspection records for personal gain will be dealt with according to the law;

VII. IMPLEMENTATION

1. This Circular takes effect fifteen days after its publication in the Official Gazette;

2. The Ministry of Health assigns the Food Safety Administration to organize the implementation of this Circular;

During the implementation process, if any difficulties arise, agencies and organizations need to promptly reflect them to the Ministry of Health (Food Safety Administration) for consideration and resolution.