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MINISTRY OF HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence– Freedom – Happiness
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No.: 11/2006/QD-BYT
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Hanoi, March 09, 2006
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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:
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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./.
FOR MINISTER
DEPUTY MINISTER
Trinh Quan Huan
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:
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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;
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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:
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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
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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
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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
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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
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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.
FILE ATTACHED TO
DOCUMENT
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