THE MINISTRY OF SOCIALIST REPUBLIC OF VIETNAM

HEALTH Independence - Freedom - Happiness

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No. 48/2015/TT-BYT Hanoi, December 01, 2015

CIRCULAR
REGULATIONS ON FOOD SAFETY INSPECTION IN FOOD PRODUCTION AND TRADING
UNDER THE ADMINISTRATION OF THE MINISTRY OF HEALTH
Pursuant to the Clause 5, Article 68 of the Law on Food Safety dated June 17, 2010;
Pursuant to the Decree No. 38/2012/ND-CP on detailing the implementation of a number of Articles of
the Law on Food Safety dated April 25, 2012 by the Government;
Pursuant to the Decree No. 63/2012/ND-CP regulating on functions, powers, and organizational
structure of the Ministry of Health;
Upon the request of the Head of the Department of Food Safety;
The Minister of Health issues regulations on food safety inspection in food production and trading
under the administration of the Ministry of Health.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Circular regulates the responsibilities for food safety inspection; the scope of inspection, modes of
inspection, the inspection process and handling of inspection results in food production and trading
under the administration of the Ministry of Health.
Article 2. Regulated Entities
1. 1. Entities producing and/or trading in sectors of the bottled water, mineral water, functional food,
micronutrient-fortified food, food additives and substances; toolkits and packages under the
administration of the Ministry of Health.
2. Food and beverage businesses and food street vendors.
3. Food manufacturers and businesses whose products are out of the control of the Ministry of
Agriculture and Rural Development, the Ministry of Trade and Industry; food manufacturers and
businesses whose products are under the administration of at least 02 Ministries including the Ministry
of Health as promulgated in the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT- BCT provides
guidance on assignment and cooperation in food safety management dated April 09, 2014 by the
Minister of Health, the Minister of Agriculture and Rural Development, the Minister of Trade and
Industry (hereinafter referred to as the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT- BCT).
4. The competent authority of food safety inspection and the inspectorate established by this competent
authority.
5. Other relevant entities.
6. This Circular shall not apply to:
a) The State inspection of exported and imported food safety conducted by the appointed government
inspectorates.
b) The inspection of conformity certification by the appointed certifying organization.
Article 3. Principles of inspection
1. In conformity with Clause 4, Article 68 of the Law on Food Safety;
2. No repetitions of inspected entities, location and time of inspection. Any repetitions of the inspection
plan of the subordinate food safety authorities and that of the superior authorities shall be solved in
accordance with Clause 3, Article 5 of the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT.
Chapter II
RESPONSIBILITIES, SCOPES AND MODES OF FOOD SAFETY INSPECTION
Article 4. Food inspection agencies; responsibilities and powers of food inspection agencies and
inspectorates.
1. Food inspection agencies:
a) The Department of Food Safety carries out the inspection of food safety nationwide.
b) The Departments of Health, Sub-Departments of Food Safety of provinces and central-affiliated
cities (hereinafter referred to as provinces) conduct the inspection of food safety within their provinces.
c) People’s Committees of districts, the Public Health Office of the People’s Committee of the district
and the Health Center of the district shall responsible for inspecting food safety within their districts.
d) People’s Committees of communes, the Public Health Stations of the wards shall responsible for
inspecting food safety within their wards.
2. The competent authority of food safety inspection shall deliver its responsibilities and powers as
regulated in Article 69 of the Law on Food Safety.
3. The inspectorate, appointed by the competent authority of food safety inspection, has its
responsibility and power as regulated in Article 70 of the Law on Food Safety.
Article 5. Basis of Inspection
1. National technical regulations on food products; Vietnam’s regulations of laws on food safety in
food industry.
2. Standards related to food safety applied by manufacturers to producing and trading food.
3. Regulations on food safety applicable to food manufacturers and food-trading businesses; food and
beverage businesses and street food vendors.
4. Regulations on food advertising and food labeling.
5. Regulations on food testing.
6. Other regulations on food safety.
Article 6. Scope of inspection
1. For food manufacturers and food-trading businesses:
a) Administrative records and legal certificates: Business Registration Certificate, Certificate of Food
Safety, Certificate of Training in Food Safety; a) Health Certificate of the owner or persons who
directly involve in food production and trading; Certificate of ISO/ HACCP (Hazard Analysis Critical
Control Point) and the equivalent;
b) Certificate of Submission of the Declaration of conformity/ and Certificate of the Declaration of
conformity with food safety regulations, Certificate of Approval for Advertisement Contents;
c) Documents about the conformity with regulations on facilities and equipment of the owner or
persons who directly engaging in food production and trading; the process of food production and
processing; the origin and expiry date of food ingredients, substances and additives; other regulations
related to food manufacturers and food-trading businesses and food products.
d) Contents of food labels:
đ) The periodic inspection of food products;
e) The implementation of regulations on food advertising (if any);
g) Relevant papers related to the State inspection of imported foods (for businesses importing food or
trading in imported food).
h) Food samples shall be taken, if necessary. Food sampling shall comply with regulations in the
Circular No. 14/2011/TT-BYT providing guidance on food sampling for inspection and examination of
food safety, quality and hygiene dated April 01,2011 by the Ministry of Health .
2. Food and beverage businesses and street food vendors.
a) Administrative records and legal certificates of food manufacturers: Business Registration
Certificate, Certificate of Food Safety and Certificate of Training in Food Safety . The Health
Certificate of the manufacturer’s owner or persons who directly engage in food production and trading;
c) Records, documents and the conformity of the Owner; or workers who directly engaging in food
production and trading, with the provisions of facility and equipment; the process of food production
and processing; practices of food hygiene and safety; food transportation and preservation; sources of
water used for food processing and production; the origin of food ingredients, substances and additives;
sample storage and other relevant regulations.
c) Collect sample of food or ingredients for testing, if necessary.
Article 7. Planned Inspection
1. Development of an inspection plan:
a)The competent inspection agency shall annually develop the inspection plan as promulgated in point
a, Clause 2, Article 69 of the Law on food safety based on the requirements of food quality
management and its movement, the assessment of the observance of the law on food safety; the last
inspection results; its budget and the direction of its superior management authority.
b) The completion time of development of the inspection plan is as follows: before November 1
applicable to authorities of communes, November 15 for the authorities of districts, December 01 for
the authorities of provinces and December 15 for the Department of Food Safety. The inspection plan
shall be developed as the form indicated in the Annex 01 of this Circular.
2. Prior notice of the inspection: the inspection authority shall inform the inspected facility at least 01
day in advanced before the date of inspection, apart from food businesses or street food vendors that
are not required to apply for business registration.
3. Frequency of inspection:
a) The frequency of inspection applicable to street food businesses is prescribed as the Article 9 of the
Circular No. 30/2012/TT-BYT providing provisions on food safety of street food businesses dated
December 05, 2012 by the Minister of Health.
b) The frequency of inspection applicable to food manufacturers and businesses under the
administration of the Ministry of Health is regulated in the Article 14 of the Circular No. 16/2012/TT-
BYT providing provisions on food safety of food manufacturers and food-trading businesses,
equipment, packages under the administration of the Ministry of Health dated December 22, 2012 by
the Minister of Health.
Article 8. The surprise inspection
1. The food inspection authority shall conduct a surprise inspection in the following cases:
a) Violations against regulations on food safety are suspected or there are food incidents; a surprise
inspection is required during an intensive inspections period or requested by a superior authority;
b) Warnings are issued by domestic, foreign or international organizations related to food safety;
c) Food safety-related issues are reported by organizations or individuals.
2. The inspection authority is not required to notify the inspected food manufacturers, food and
beverage businesses or food street vendors of the surprise inspection in advance.
Chapter III
THE PROCESS OF AN INSPECTION AND HANDLING OF INSPECTION RESULTS
Article 9. Process of an inspection
1. Issuance of an inspection decision:
The Head of food safety authority shall issue the decision of the inspection with the following items:
the location and scope of inspection, modes of inspection (under schedule or surprise inspections), the
term of inspection, time limit of the inspection, members of the inspectorate, and duty of the
inspectorate. The inspection decision shall be made as regulated in the Annex 02 of this Circular.
2. The inspectorate shall conduct the inspection in accordance with the following order:
a) Notify the inspection decision to the inspected entity;
b) Carry out the inspection as regulated in Article 6 of this Circular;
c) Make a Record of Inspection: the Record of Inspection of food manufacturers and food-trading
businesses shall be made using the form regulated in the Annex 03 of this Circular; the Record of
Inspection of entities in food and beverage services shall be made as the form in the Annex 04 of this
Circular; the Record of Inspection of street food vendors shall be made as the form in the Annex 05 of
this Circular.
d) Report the inspection results according to the Article 11 of this Circular;
đ) Issue the decision on handling inspection results as prescribed in the Article 10 of this Circular;
Article 10. Handling of inspection results
The handling of violations of food safety during the inspection shall be conducted under the regulations
in point c, Clause 1, Article 69 of the Law on Food Safety. Some particular cases of handling of food
safety violations are specified as follows:
1. Violations of food labeling or inconsistencies between the sample testing results and the description
of the product or the product ingredients in the specifications or the label enclosed in the Certificate of
Submission of the Declaration of conformity/ and Certificate of the Declaration of conformity with
food safety regulations or the Certificate of Conformity, issued by the competent agency, shall be
solved in compliance with laws on revocation and handling of food safety in the jurisdiction of the
Ministry of Health.
2. Any discovered administrative violations of food safety, depending on the nature and seriousness,
shall be dealt with in accordance with corresponding regulations as follows:
a) Any violations of conditions of food safety and periodic testing shall be punished under the
regulations of the Decree No. 178/2013/ND-CP on administrative penalties on violations of food safety
(hereinafter referred to as the Decree 178/2013/ND-CP).
b) Any violations of the announcement of conformity or the announcement of regulation conformity of
food safety; inconsistencies between the sample testing results and the indicators in the description of
food products or the label or the public applicable criteria, failures to meet the national technical
standards or food safety regulations shall be settled in accordance with regulations of the Decree No.
80/2013/ND-CP on administrative penalties in aspects of the product criteria, measurement and quality
dated July 19, 2013 by the Government (hereinafter referred to as the Decree No. 80/2013/ND-CP) or
the Decree No. 178/2013/ND-CP.
c) Any violations of product labeling shall be settled in accordance with the Decree No. 80/2013/ND-
CP
d) Any violations of food advertising shall be dealt with in accordance with the regulations of the
Decree No. 158/2013/ND-CP on administrative penalties on violations of culture, sport, tourism and
advertising dated Novembers 12, 2013 by the Government.
a) Any violations of commerce, production and trading in counterfeit and banned commodities shall be
punished under the regulations of the Decree No. 185/2013/ND-CP on administrative penalties on
violations of commerce, production and trading in counterfeit or banned commodities and consumer
protection dated November 11, 2013 by the Government.
3. Thee cases beyond the jurisdiction of an authority shall be transferred to its superior authority or to
an investigation agency to verify and handle under Vietnam Laws.
Article 11. Report on inspection results
The Head of the Inspectorate shall submit a written report on the inspection result to the Head of the
authority, which issues the decision on the inspection, within 15 working days from the end of
inspection, according to the content in the Annex 06 of this Circular.
Chapter IV
PROVISIONS OF IMPLEMENTATION
Article 12. Entry into force
This Circular comes into effect from January 15, 2016.
Article 13. Terms of Reference
In cases of any changes, supplementation or replacement of legal normative documents and regulations
presented in this Circular, the new legal normative document shall prevail.
Article 14. The responsibilities of implementation
The Head of the Departments of Food Safety; the Chief of the Ministry Office; the Chief Inspector of
the Ministry; Heads of Divisions, Heads of Departments, the General Department under the Ministry of
Health; Heads of units under Ministries: The Director of The Department of Health of the province;
Heads of the Health authorities of Ministries, Departments, relevant organizations and individuals shall
be responsible for implementing this Circular.
Any concerns or arising issues during the implementation shall be promptly reported to the Ministry of
Health (the Department of Food Safety)./.

KT. ON BEHALF OF THE MINISTER

DEPUTY MINISTER

Nguyen Thanh Long

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