Quyết định 11/2006/QD-BYT

DECISION

ON ISSUING "REGULATION ON ISSUANCE OF QUALIFICATION CERTIFICATES OF HYGIENE AND FOOD SAFETY FOR ESTABLISHMENTS OF PRODUCTION, TRADE OF FOOD OF HIGH-RISK”

MINISTER OF HEALTH

Pursuant to Decree No.49/2003/ND-CP of May 15, 2003 of the Government regulating functions, duties, powers and organizational structure of Ministry of Health;

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

Pursuant to Decree No.163/2004/ND-CP dated September 07, 2004 of the Government detailing the implementation of some Articles of the Ordinance on Hygiene and Food Safety;

At the proposal of the Director of Vietnam Food Administration - Health Ministry

DECIDES:

Article 1. To issue together with this Decision the "Regulation on issuance of qualification certificates of hygiene and food safety for establishments of production, trade of food of high-risk"

Article 2. This Decision takes effect 15 days after its publication in the Official Gazette.

Article 3. Mr.(Ms.): Chief Office, Chief Inspector, Director of Legal Affairs, Director of Vietnam Food Administration and heads of concerned units under the Ministry of Health, Directors of the Health Departments of provinces and cities under central authority shall implement this Decision./.

REGULATION

ON ISSUANCE OF QUALIFICATION CERTIFICATES OF HYGIENE AND FOOD SAFETY FOR ESTABLISHMENTS OF PRODUCTION, TRADE OF FOOD OF HIGH-RISK
(Issued together with Resolution No.: 11/2006/QD-BYT dated March 09, 2006 of Minister of Health)

Chapter 1:

GENERAL PROVISIONS

Article 1. Scope of governing

This Regulation provides for records, procedures and competence for issuance of qualification certificates of hygiene and food safety (hereinafter referred to as certificates) for establishments of production, trade of food of high-risk (hereafter referred to as establishments).

Article 2. Subjects of application

1. This Regulation applies to individuals, organizations, and households producing and trading high-risk foods in Vietnam.

2. High-risk foods include 10 groups as follows:

a) Meat and meat products;

b) Milk and milk products;

c) Eggs and products processed from eggs;

d) Aqua products in fresh and processed;

đ) The ice cream, ice, natural mineral water;

e) Functional foods, food fortifying micronutrients, supplementary food, food additives;

g) Food, beverages prepared for immediately eating;

h) Frozen Foods;

i) Soya milk and products made from soybeans;

k) The vegetables, fresh fruit for immediately eating.

Chapter 2:

PROCEDURES AND COMPETENCE FOR GRANTING CERTIFICATES

Article 3. Dossiers of application for certificate

1. Dossiers of application for the certificate include:

a) An Application for Certificate (Form I attached to this Regulation).

b) A certified copy of certificate of business registration (if any).

c) Written explanation of material facilities, equipment, and tools to ensure hygiene and food safety includes:

- Drawing of ground of establishment of production, business, and the surrounding areas.

- Description of manufacturing process (process of technology) for product group or each specific product.

d) A commitment to ensure hygiene and food safety for food materials and food products produced, traded by the establishment (by form II issued with this Regulation).

đ) Certified copies of "Certificates of eligibility for health" of the owner of the establishment and of the persons who directly produce and trade food.

e) Certified copies of certificate of training knowledge of hygiene and food safety of the owner of the establishment and of the persons who directly produce and trade food.

2. For the establishments applied management system of quality, hygiene, food safety according to HACCP (Hazard Analysis and Control of Critical Points), it must have a certified copy of the certificate of HACCP in the dossiers.

Article 4. Appraisal and inspection of site

1. The appraisal process

a) After receiving the valid dossiers, appraisal agency within 15 working days must evaluate dossiers and examine site. The appraisal results must be clearly stated in the record as "Satisfactory" or "Unsatisfactory". Where "Unsatisfactory", it must be clearly stated the reason (by Form III issued under this Regulation).

b) If the appraisal result is unsatisfactory, it must be clearly stated in the record the re-appraisal period (with a maximum period of 03 months), if the re-appraisal result is still unsatisfactory, the appraisal delegation shall make a record and propose with the competent state agency to suspend the operation of the establishment.

c) In case the establishment applied HACCP, the dossiers and establishment must also be examined.

d) The appraisal record shall be made in 02 copies, the appraisal delegation keeps 01 and owner of establishment keeps 01 copy with the same validity.

2. Establishment of appraisal delegation

a) The appraisal delegation consists of 3-5 members that must have at least 2/3 members as officials working in the profession of hygiene and food safety, specialized inspectors of hygiene and food safety. It may invite experts from outside (suitable expertise) to join in the appraisal delegation.

b) Where the establishments under the competence to issue certificates of the Vietnam Food Administration, the Administration shall establish the appraisal delegation or authorize (in writing) for a unit under the Ministry of Health or provincial Preventive Medical Center to appraise the establishments.

c) When the dossiers are valid, the appraisal agency holds a basis appraisal delegation. The basic appraisal result is recorded in the basis appraisal minute (by Form 3 issued under this Regulation). Then forward all dossiers and minutes to the equivalent competent authority for granting certificate (By Form III issued under this Regulation).

Article 5. Competence to issue certificates

1.The Ministry of Health assigns the Vietnam Food Administration to grant certificates for the establishments of manufacturing, trading functional food, food fortifying micronutrients, supplementary food, food additives, and natural mineral water.

2. The state agencies decentralized in the localities grant certificates for the establishments of manufacturing, trading food of high risk for food not subject to grant of certificate by the Ministry of Health, specifically:

a) Department of Health or Preventive Medicine Center of provinces and cities under central authority (if authorized by the Health Department) (hereinafter referred to as provincial level) grants certificates for the establishments of manufacturing, trading food issued business licenses by central and provincial levels; or for restaurants, collective kitchens with scale from 200 people or more; for the catering services in industrial parks, supermarkets, markets, hospitals; the tourist bases, festivals, conferences organized, managed by the provinces; the one star or higher hotels and in the schools from high school level or more.

b) People's Committees of rural, urban districts, towns and cities under provinces (hereinafter referred to as DPC) or Center for Preventive Medicine of rural, urban districts, towns and cities directly under the provinces authorized by DPC (hereinafter referred to as district level) grants certificates for the establishments of manufacturing, trading food issued business licenses by DPC; the food stores, the canteens, restaurants, collective kitchens, hotels not subject to grant of certificate by provinces; secondary schools; the festivals, conferences, tourist bases, markets and hospitals organized, managed by district level.

c) People's Committees of communes, wards and townships (hereinafter referred to as the commune-level People's Committees) if being authorized by the district-level people's committees grant certificates for the establishments of manufacturing, trading food of high-risk, not subject to business registration; the households and individuals producing simply packaged food and trading fresh food without packaging; the food stores, the stores selling ready-to-eat food for eating immediately in a day and the markets, resorts, festivals, conferences organized, managed by commune level; the primary schools, kindergartens not under the management of their superiors.

Article 6. Issuance of new certificate

When the establishments change their scale of production, business, lines, technology, produced goods or any change affecting the conditions of production, business, they must apply for renewal of certificates. Procedures for renewal of certificates are similar to procedures for the first application.

Chapter 3:

EXAMINATION, INSPECTION AND HANDLING OF VIOLATIONS AND ORGANIZATION OF IMPLEMENTATION

Article 7. Inspection

1. Vietnam Food Administration, Inspectorate of Ministry of Health, Department of Health coordinates with the Market Management agencies (Ministry of Commerce) and other relevant agencies to organize the inspection when receiving complaints, denunciations or signs of violating the regulations on conditions of hygiene and food safety as prescribed by law.

2. Divisions of Health, district medical centers, health stations of communes, wards are responsible for advising the same level People's Committees to establish inter-disciplinary inspection delegations to inspect the observance of general hygienic conditions of the establishments under the management of the local localities in their areas.

3. The superior competent State agencies have the right to examine and inspect the establishments granted certificates by their subordinate competent state agencies.

Article 8. Examination

1. Frequency of periodic examination for each establishment is:

a) Once/year for the establishments with foreign investment, the establishments issued certificates by the Ministry of Health (Vietnam Food Administration) and provincial level, the establishments that have been issued certificates of HACCP.

b) Not more than twice/year for the food establishments issued certificates by the district level.

c) Not more than four times/year for the food establishments issued certificates by the commune-level People's Committees.

2. If during the duration of periodic examination, the establishments have been examined in the peak campaign phases of Month of Action for the quality, hygiene, and food safety; Tet, festival seasons, it shall also be counted as a time of examination.

Article 9. Revocation of certificates

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

a) Serious violations of regulations on conditions to ensure hygiene and food safety or when the establishments let food poisoning and food-borne diseases to consumers occur.

b) In case of the proposals of the market management agencies, Public Security, or competent state agencies when the establishments are stripped business licenses or prosecuted for criminal liability.

2. The certain competent State agencies grant certificates, those agencies may revoke the certificates. The superior competent State agencies may examine, inspect, and revoke certificates issued by subordinate competent state authorities if the violation is detected.

Article 10. Organization of implementation

1. Vietnam Food Administration guides the implementation of this Regulation within the whole country.

2. The Health Departments guide the implementation of this Regulation within their respective provinces and cities.