Circular No. 26/2012/TT-BYT stipulates the issuance of Food Safety Condition Certificate for production and business establishments dealing with health food, nutrient-enriched food, food additives, natural mineral water, bottled drinking water, and food packaging materials and containers under the management of the Ministry of Health.

CIRCULAR

Regulations on issuing Food Safety Condition Certificates for food production facilities, functional foods, nutrient-enriched foods, food additives, food processing aids; natural mineral water, bottled drinking water; food packaging materials and containers under the management of the Ministry of Health.

 production, distribution of functional foods, nutrient-enriched foods, food additives, food processing aids; natural mineral water, bottled drinking water; food packaging materials and containers under the management of the Ministry of Health.

 food processing aids; natural mineral water, bottled drinking water; food packaging materials and containers under the management of the Ministry of Health.

Food packaging materials and containers under the management of the Ministry of Health.

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Pursuant to the Food Safety Law 2010;

Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing some provisions of the Food Safety Law;

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

At the proposal of the Director of the Food Safety and Hygiene Administration;

The Minister of Health issues the Circular stipulating the issuance of Food Safety Condition Certificates for food production and distribution facilities under the management of the Ministry of Health.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the dossier, procedures, and authority for issuing Food Safety Condition Certificates (hereinafter referred to as the Certificate) for food production and distribution facilities including functional foods, nutrient-enriched foods, food additives, food processing aids, bottled natural mineral water, bottled drinking water, and food packaging materials and containers directly contacting with food under the management of the Ministry of Health (hereinafter referred to as the facility).

Article 2. Interpretation of Terms

In this Circular, the terms are understood as follows:

1. Small-scale initial production facility is a facility growing, breeding, harvesting, fishing, or extracting food raw materials at household or individual scale.

2. Small-scale food retail facility is a food retail facility at household or individual scale with or without a business registration certificate for food.

3. Street vendor facility is a mobile food retail facility selling ready-to-eat food or cooked food on the street (without a fixed location).

Chapter II

Dossier, Procedures, and Authority for Issuing Food Safety Condition Certificates

Article 3. Application Dossier

The application dossier for the Certificate shall be compiled into one volume, consisting of the following documents:

1. Application form for the Food Safety Condition Certificate (according to Model 1 issued together with this Circular).

2. Business registration certificate with registered food business activities (certified copy from the facility).

3. Description of physical conditions, equipment, and tools ensuring food safety conditions (certified by the facility), including:

a) Floor plan of the facility and surrounding areas;

b) Flowchart of food production process or storage and distribution process, and description of physical conditions, equipment, and tools of the facility.

4. Confirmation of training on food safety knowledge for the facility owner and direct food producers and distributors:

a) For facilities with less than 30 people: Submit certified copies of confirmation (certified by the facility);

b) For facilities with 30 people or more: Submit a list of those who have been trained (certified by the facility).

5. Confirmation of health status of the facility owner and direct food producers and distributors; negative test result report for intestinal pathogens (shigella, dysentery bacillus, and typhoid) of direct food producers in areas where diarrheal disease outbreaks are currently circulating according to the announcement of the Ministry of Health:

a) For facilities with less than 30 people: Submit certified copies of confirmation (Certified by the facility);

b) For facilities with 30 people or more: Submit a list of health examination and stool testing results for the facility owner and those directly involved in food production and distribution (Certified by the facility).

Article 4. Authority to Issue Certificates

1. The Food Safety Administration shall issue certificates to:

Production and business establishments of functional foods, nutrient-enriched foods, food additives, food processing aids, except for small-scale production and business establishments; other food production and business establishments when there are special needs (importing countries' requirements for products from these establishments).

2. Provincial Food Safety and Hygiene Inspection Branches shall issue certificates to:

a) Production and business establishments of natural mineral water, bottled drinking water, food packaging materials, and food contact utensils under the health sector's jurisdiction within their respective areas;

b) Small-scale production establishments of functional foods, nutrient-enriched foods, food additives, food processing aids;

c) Small-scale business establishments of functional foods, nutrient-enriched foods, food additives, food processing aids that have special product storage requirements.

Article 5. Procedures for Issuing Certificates

The agency receiving applications is responsible for examining the application files, assessing the establishment, and issuing certificates to establishments meeting food safety conditions. The procedures for issuing certificates are as follows:

1. Examination of the application:

a) Within five working days from the date of receipt of complete applications, the agency must examine the validity of the application file and notify the establishment in writing if the application is invalid;

b) If more than sixty days have passed since the notification of an invalid application and the establishment has not responded or supplemented the application as required, the agency will cancel the application;

2. Inspection of the business:

a) After the examination of a valid application, the competent authority is responsible for assessing the establishment within ten working days. In cases where the assessment of the establishment is delegated to a lower-level competent authority, a delegation letter must be issued;

b) Inspection team:

- The inspection team is established by the competent authority issuing the certificate or the delegated authority;

- The inspection team for establishment conditions consists of five to nine members (three to five members for small-scale food production and business establishments), at least two-thirds of whom must be food safety professionals (appropriate experts may be invited to join the inspection team);

- The head of the inspection team is responsible for the results of the establishment assessment;

c) Content of the inspection:

Compare information and assess the legal validity of the certificate application file with the original file kept at the establishment according to regulations; assess food safety conditions at the establishment according to regulations and record them in the inspection report form issued together with this Circular;

3. Issuance of the Certificate:

a) In cases where the establishment meets food safety conditions according to regulations, the agency receiving the application issues the certificate according to the form issued together with this Circular. For seasonal food production and business establishments, the operating period must be clearly stated on the certificate;

d) In cases where the establishment does not meet food safety conditions and requires further improvement, the specific content and completion time (not exceeding sixty days) must be clearly stated. The inspection team will reassess the establishment upon receipt of a confirmation letter stating that all previous food safety condition requirements have been fully met;

c) In cases where the establishment fails to meet food safety conditions, the agency receiving the application notifies the local management authority to supervise and requires the establishment to cease operations until it receives a certificate. The establishment must resubmit its application to be considered for issuance of a certificate according to regulations.

Article 6. Issuance of Replacement Certificates

1. Replacement certificates shall be issued in the following cases:

a) The certificate may only be replaced when it is still valid;

b) When changing the name of the enterprise or/and the owner of the facility, or changing the address but not altering the location and the entire food production and business process;

2. The application for replacement (one set) includes the following documents confirmed by the facility:

a) Application for replacement of the Certificate (according to Model 4 issued together with this Circular);

b) The most recent inspection report (a certified copy);

c) The original Certificate;

d) Legal documents reflecting the changes (certified copies);

đ) Health certificate and training on food safety knowledge of the new facility owner in case of change in the owner's name (a certified copy);

3. Within seven working days from the date of receiving the application for replacement of the Certificate, the authority responsible for receiving applications shall issue the replacement Certificate to the facility; in case of refusal, the authority must notify the facility in writing the reasons for not issuing the replacement Certificate.

Article 7. Revocation of Certificates

1. The Certificate will be revoked in the following cases:

a) Organizations or individuals engaged in food business activities cease to operate the registered food business industry;

b) There is a decision by the competent state agency to change the business activity at the old facility;

c) Food production and business facilities have their Certificate usage rights revoked according to the law on administrative penalties in the field of food safety.

2. Authority to revoke:

b) The superior competent authority has the right to revoke the Certificate issued by the subordinate competent authority.

b) The higher competent authority has the right to revoke the Certificate issued by the lower authority.

Article 8. Post-Issuance Inspection of Certificate

The authority responsible for receiving applications and the competent functional authority shall conduct inspections after issuing the Certificate:

1. Not more than twice a year for facilities that have been issued a Certificate and have GMP, HACCP, ISO 22000 and equivalent certification from the competent authority.

2. Not more than three times a year for facilities that have been issued a Certificate by the competent authority.

Chapter III

REGULATIONS FOR FOOD PRODUCTION AND BUSINESS FACILITIES THAT ARE NOT REQUIRED TO OBTAIN A CERTIFICATE
BELONGING TO THE CATEGORY NOT REQUIRED TO OBTAIN A CERTIFICATE

Article 9. Facilities belonging to the category not required to obtain a Certificate

Food production and business facilities for health foods, nutrient-enriched foods, food additives, processing aids, natural mineral water, bottled water, and food contact materials and articles under the management of the Ministry of Health include:

1. Small initial health food production facilities.

2. Small retail businesses without special product storage requirements.

3. Street vendors.

4. Retail businesses selling pre-packaged products without special storage requirements.

5. Businesses selling food contact materials and articles.

6. Pharmacies that have obtained Good Pharmacy Practice (GPP) certification and sell health foods and nutrient-enriched foods.

Article 10. Inspection of facilities not required to obtain a Certificate

1. Facilities not required to obtain a Certificate must develop internal inspection and monitoring plans regarding food safety conditions at least once a year.

2. Provincial/City Food Safety Authority and the competent authority shall inspect facilities not required to obtain a Certificate within their jurisdiction.

2. The frequency of inspection shall not exceed four times a year for facilities not required to obtain a Certificate.

Chapter IV

IMPLEMENTING PROVISIONS

Article 11. Effective Date

1. This Circular takes effect from January 15, 2013.

2. Decree No. 11/2006/QĐ-BYT dated March 9, 2006 of the Minister of Health on the issuance of "Regulations on Issuing Certificates Meeting Sanitary and Safety Conditions for High-Risk Food Production and Business Facilities" is abolished from the date this Circular takes effect.

Article 12. Implementation Organization

1. The National Food Safety Agency - Ministry of Health is responsible for guiding the implementation of this Circular nationwide.

2. Provincial Departments of Health, Provincial/City Food Safety Authorities are responsible for guiding and implementing this Circular within their jurisdiction./.