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Food Law in Vietnam PDF
Food Law in Vietnam PDF
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Russin & Vecchi
TABLE OF CONTENTS
INTRODUCTION..................................................................................................................1
WHAT IS FOOD?..................................................................................................................2
QUALITY STANDARDS .....................................................................................................3
Announcement of Standards of Foods ................................................................................4
Announcement Procedures .................................................................................................4
SAFETY AND HYGIENE.....................................................................................................6
LABELING ...........................................................................................................................6
ADVERTISING.....................................................................................................................9
RECALL..............................................................................................................................11
INSPECTIONS ....................................................................................................................12
IMPORT REQUIREMENTS ...............................................................................................13
EXPORT REQUIREMENTS...............................................................................................17
State Inspection and Certification of Aquatic Products Quality.........................................18
Announcement of Quality Standards of Speciality Aquatic Products ................................20
Safety and Quality Requirements for Aquatic Products for Export....................................21
ENFORCEMENT ................................................................................................................21
SCHEDULE: List of cited Laws, Ordinances, Decrees, Circulars and Regulations classified by
subject and by order of appearance.......................................................................................26
ii
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GLOSSARY
In this book, we generally define and abbreviate terms the first time that we use them. Even so,
to make it easier to follow the text, we have prepared this Glossary for easy reference.
iii
FOOD LAW IN VIETNAM
INTRODUCTION
Understanding Vietnamese laws and regulations concerning food can be a challenge. The
confusion results from the lack of a unified food law. Instead, the government relies primarily
on laws which regulate the quality of goods in general. There are also specific regulations that
apply these laws to food products. This means that there are two sets of regulations, one
covering goods in general, and the other covering food products, and they often overlap.
A discussion of Vietnamese food law must begin with a discussion of the management of the
quality of goods. The major law on the subject is the Law on the Quality of Products and
Goods. This Law states that “[t]he State shall implement a uniform system to control the quality
of goods.”1 However, “in cases where international treaties to which the Socialist Republic of
Vietnam is a party contain provisions which differ from the provisions of the Law, the
provisions of such international treaties shall prevail.”2
The Law on the Quality of Products and Goods came into effect on 1 July 2008 and replaces the
Ordinance on the Quality of Goods. The Law provides that manufacturers and traders must take
responsibility for the quality of the goods or products that they manufacture or trade in order to
ensure safety for humans, animals, plants, property and the environment, and to enhance the
productivity, quality and competitiveness of Vietnamese goods and products.3
The Ordinance on the Hygiene and Safety of Foods, which came into force on 1 November
2003, deals specifically with some aspects of food. In particular, this Ordinance details
provisions on “securing food hygiene and safety in the process of food production and sale;
preventing and overcoming food poisoning and diseases which are spread through foods.”4
In language similar to the Law on the Quality of Products and Goods, the Ordinance on the
Hygiene and Safety of Foods states that:
!
This book was originally prepared by Nhan Thien Vu, then with Russin & Vecchi in Vietnam. It was originally
published in 2000 by Prospect Media Pty Ltd. as a chapter on Vietnam in a publication entitled “International
Food Law”. It has been revised and updated many times by Russin & Vecchi. This edition is current through
October 2008.
!
In several places, this book refers to Vietnamese dong. The approximate rate of exchange is US$ 1.00 = VND
16,800.
1
Law on the Quality of Products and Goods, art 68.1
2
Id, art 4.3
3
Id, art 5.2
4
Ordinance on the Hygiene and Safety of Food, art 1
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These two legal documents give the Ministry of Science and Technology (“MOST”) overall
responsibility for the quality of goods, including foods. Specific responsibility for the hygiene
and safety of foods, however, is under the jurisdiction of the Ministry of Health (“MOH”).
Before the enactment of the Law on the Quality of Products and Goods, the Government issued
Decree 179/2004/ND-CP dated 21 October 2004 (“Decree 179”)6 on state management of the
quality of products and goods. Decree 179 details the responsibility of the MOST and of certain
other ministries and branches with respect to the quality of goods.7 The MOH is fully
responsible for the safety and hygiene of foods. However, in case of overlapping
responsibilities between these two ministries, MOST is responsible to report to the Prime
Minister in order to receive a final decision. 8 Decree 179 was promulgated to implement the
now abrogated Ordinance on the Quality of Goods. While a new decree to implement the Law
on the Quality of Products and Goods and to replace Decree 179 is not yet in place, such
provisions of Decree 179 that are not contrary to the Law on the Quality of Products and Goods
remain applicable.
WHAT IS FOOD?
The Ordinance on the Hygiene and Safety of Foods defines “food” as follows: “Foods are
products which human beings eat and drink in their fresh, raw, processed or preserved forms.”9
There are sub-definitions of different types of food, such as functional food, high-risk food,
irradiated food and genetically modified food.
“Functional food” is food used to support the operation of body organs. It has a nutritious
value, creates comfort for the body and reduces pathogenic dangers.10
Circular 08/2004/TT-BYT of the MOH dated 23 August 2004 (“Circular 08”) was issued
specifically to deal with functional food. Functional foods include foodstuffs to which micro-
nutrients have been added, supplemental foodstuffs to protect health and medically nutritious
products.11
“High-risk foods” are foods with a high possibility of contamination by biological, chemical
and/or physical agents and which may affect the health of consumers.12 Decree 163/2004/ND-
CP of the Government dated 7 September 2004 implementing a number of articles of the Law
5
Id, art 2
6
When a Decrees, Decision or Circular appears for the first time or only one time, or if it appears only once, only
the full name will appear. If it appears more than once, we will use a shorthand term.
7
Under Article 23 of Decree 179, the MOH is responsible to manage the quality of assorted raw materials for
production of medicine, assorted medicines for prevention and treatment of human disease, assorted vaccines
and medical biologicals, sanitary supplies and medical equipment, soaps and chemicals for domestic use,
talcum powder, toothpaste, cosmetics, food safety and hygiene, drinking water and water for daily life.
8
Id, art 23.2
9
Ordinance on the Hygiene and Safety of Foods, art 3.1
10
Id, art 3.10
11
Circular 08, art I.2
12
Ordinance on the Hygiene and Safety of Foods, art 3.11
2
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on the Quality of Products and Goods (“Decree 163”) provides a list of high-risk foods that
includes meat and meat products, milk and milk products, egg and egg products, fresh and
processed aquatic products, ice cream, mineral water, functional foods, food additives, and
frozen foods.
“Irradiated foods” or “foods preserved by radiation methods” are foods radiated by sources of
radioactive activity to preserve and prevent food from degeneration.13 Irradiated foods are
specifically regulated by Decision 3616/2004/QD-BYT of the MOH dated 14 October 2004.
“Genetically modified foods” are foods which originate from organisms genetically modified
by genetic technology.14 According to the Ordinance on the Hygiene and Safety of Foods, the
management and use of genetically modified foods is subject to regulations by the Government.
However, to date, no regulation has been issued.
QUALITY STANDARDS
With regard to goods in general, quality standards cover areas such as technical specifications,
experimentation methods, packaging, labeling, transportation, preservation of goods, quality
management systems and other issues relating to the quality of goods.15 The quality of goods
and products is managed on the basis of applicable announcement standards and technical
specifications.16 The system of Vietnamese standards includes national standards (“TCVN”)
and standards applied voluntarily by businesses and individuals (“TCCS”).17 Vietnamese
standards are based on international standards, regional standards, and foreign standards, the
outcome of scientific and technological research, technical progress, factual experience, and the
results of evaluations, tests, experiments, inspections, and appraisals.18
At one time, all goods were subject to quality “registration”. That is, the State required
individuals and organizations that produced and traded goods to follow certain quality
standards. Foods were no exception. Foods had to be registered with the MOH. The registration
included such information as: list of standards with which the food products must comply; a
chart showing stages of processing of the food product from storage of raw materials, through
the processing stage and ultimately to storage and delivery of the finished product; a final or
draft version of the label; instructions and warranties; test results for the food product issued by
an authorized government test centre; and a list of all raw materials used to process a food
product including additives and packing materials. The MOH had the power to reject an
application for registration.
However, since the Ordinance on the Quality of Goods came into effect, individuals and
organizations that produce and trade in goods including food are required only to “announce”,
rather than “register”, their own quality standards. Administrative procedures to announce
quality standards are much simpler than the registration procedures. Producers and traders bear
responsibility to comply with the quality standards which they have announced.19 That is, they
are able, themselves, to decide the quality standards of their goods. Of course, such quality
13
Id, art 3.12
14
Id, art 3.14
15
Decision 42/2005/QD-BYT of the MOH dated 8 December 2005 (“Decision 42”), art 2.2
16
Law on the Quality of Products and Goods, art 5.1
17
Law on Standards and Technical Specifications 68/2006/QH11 dated 29 June 2006, art 10
18
Id, art 13
19
Law on the Quality of Products and Goods, art 10
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standards must satisfy applicable Vietnamese standards or industry standards. Accordingly, the
authoritarian role of the State regarding the quality standards of goods, including food, has been
changed into voluntary commitments by entities to set and to comply with their own quality
standards.
In general, goods related to food, safety, hygiene, human health and the environment must meet
Vietnamese standards. The MOH sets Vietnamese standards for the hygiene and safety of food
products.20 The standards are tailored to each type of food or food group. The standards that
apply to bread, for example, are different from those that apply to fresh milk.
The Regulations on Announcing Standards of Foods21 require all individuals and organizations
that produce and trade food products, including food additives, to announce the quality
standards to the MOH or to the local health authorities. When the health authorities issue a
Certificate of Product Specification, entities must ensure compliance with the announced
standards, and they are subject to periodic inspection.22 Any changes in the standards, except
for those that relate only to the appearance of the label or the product packaging, must also be
announced.23
Announcement Procedures
To announce standards for food products or materials that are in direct contact with food
products (eg, packaging) and that are locally produced,25 the entity that actually produces the
food product (“Company” in this section)26 must submit an announcement application to the
appropriate health authorities. The announcement application must include:27
20
Decree 188/2007/ND-CP of the Government dated 27 December 2007, art 2.10
21
Issued in connection with Decision 42
22
Decision 42, art 9. This Decision refers to the general regulations on goods only when there is no regulation
that deals specifically with food products.
23
Id, art 7
24
Id, art 4.4(a)
25
Announcement procedures that apply to imported foods and food additives are discussed later in the section,
“IMPORT REQUIREMENTS” at page 15
26
The producer of the food product
27
Regulations on Announcing Standards of Foods, art 3
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• Two original copies of the announcement on quality standards issued and stamped by the
Company;
• Certificate on the results of tests which relate to the quality and safety of the food
products;28
• A copy of a Certificate that certifies that the Company has met food hygiene and safety
conditions or a copy of an application to grant such a Certificate;
• A copy of the receipt for payment of fees for examination of the announcement application
and for issuance of the Certificate of Standards of Goods; and
For imported food products, product specifications or a Certificate of the results of tests and a
copy of a Certificate of Good Manufacturing Practices (“GMP”) or Hazard Analysis, Critical
Control Point (“HACCP”) (if any) is also required.
• Establishing new company standards based on scientific and technological research or the
results of tests, evaluation, analysis and experiments; or
28
If it is mineral water, a certificate on the results of tests of the water source is also required.
29
“Food additive”, as defined in art 3.7 of the Ordinance on the Hygiene and Safety of Foods, means a substance
with or without nutritious value that is added to food ingredients in the course of processing, treating,
packaging and transporting food with a view to retaining or improving some characteristic of food.
30
“Food-processing supporting substances”, as defined in art 3.8 of the Ordinance on the Hygiene and Safety of
Foods, means substances used in the course of processing food raw materials or food ingredients in order to
perfect the food-treatment or processing technologies.
31
“Special foods”, as defined in art 2.10 of the Regulations on Announcing Standards of Foods, means nutritious
products for children, genetically modified food, irradiated food and functional food.
32
Circular 21/2007/TT-BKHCN of the MOST dated 28 September 2007 on the Establishment and Use of
Standards, part IV.2.2
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Within 15 days from the date of submission of the announcement application, the health
authorities will grant the Company a Certificate of Standards of Goods. If not, the Company
will be instructed how to revise the announcement application so that it is compliant.
The Company is required to announce standards of a food product to the health authorities only
once before such food product may be sold in Vietnam. That is to say, the announcement is
permanent. However, the Certificate of Standards of Goods must be renewed every three years.
If there is a change in the food product’s standards the Company must announce the change.33
All individuals and entities that want to produce and to trade in foods must satisfy certain
conditions on health and safety in order to be licensed. Entities that deal with high-risk foods
must, in addition, obtain a Certificate on Satisfaction of Conditions on food hygiene and safety.
All conditions on hygiene and safety must be maintained throughout the lifetime of the
business. A food establishment (meaning a workshop or store used by a food producer,
processor, business, importer or canteen service centre, and even equipment and premises used
by a food producer) must satisfy certain health and safety criteria. Any location where food is
processed, manufactured, stored, sold or served must meet “hygienic environmental
requirements.”34 All employees who come into direct contact with food must have a periodic
health check to assure that they meet health conditions mandated by the MOH. In addition, they
must have a training certificate to show that they have studied food safety and hygiene, and
must be adequately supervised so that they follow applicable regulations and possess
sufficiently safe and hygienic tools.35 The tools, equipment, materials and chemicals used in
food establishments must not contaminate food products with toxic substances, chemicals or
bacteria.36
LABELING
The key legislation regarding labeling is Decree 89/2006/ND-CP of the Government dated 30
August 2006 on the Labeling of Goods (“Decree 89”). Decree 89 replaces the Regulations on
the Labeling of Goods issued together with Decision 178/1999/QD-TTg of the Prime Minister
dated 30 August 1999. Decree 89 applies to all goods produced in Vietnam for distribution
within Vietnam or for export. It applies equally to foreign-made goods imported for sale in
Vietnam.37
Labels are defined as “inscriptions, prints, drawings, images or signs that are imprinted or
embossed directly on or affixed, stuck or pinned firmly to goods or their packaging to display
necessary and principal information about such goods.”38 In addition, goods labeling is defined
as the “inscription of necessary and principal information about the goods in order to provide
consumers with basic information to identify goods, and [the labels] serve as a basis for
33
Decision 42/2005/QD-BYT of the MOH dated 8 December 2005, art 7
34
General hygiene conditions applicable to food processing establishments issued in connection with Decision
39/2005/QD-BYT of the Minister of Health dated 28 November 2005, art 1 to art 10
35
Id, arts 17, 18, 19
36
Id, arts 11, 16
37
Decree 89, art 2
38
Id, art 3.1
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purchasers to decide on the selection, consumption and use of goods, and for functional bodies
to conduct inspection and supervision.”39
As provided by Decree 89, domestically circulated foods, imported foods and exported foods
must bear labels, except for unpacked fresh and raw foodstuffs and processed foodstuffs which
are sold directly to consumers. Labels may include both compulsory and non-compulsory
information. The compulsory contents are mandatory and contain the most important
information. Regulations on compulsory contents for all goods labels, whether for goods sold in
Vietnam or for export, are provided in Decree 89 and elaborated in Circular 09/2007/TT-
BKHCN of the MOST dated 6 April 2007 (“Circular 09”):
• Name of the goods: manufacturers or traders of goods may choose a name for their goods,
provided that the name must not mislead as to the nature and use of the goods. They are
liable for the name they choose;40
• Names and addresses of the entities which produced, imported, assembled or finished the
goods;41
• Weight and volume of the goods42 measured in units recognised by Vietnamese law, under
the International System of Measuring Units (“ISMU”);43
• Ingredients, if the product, including seafood, contains food additives.44 Ingredients must be
listed in descending order of volume or content (volume percentage), and must include their
international code (if any);45
• Principal quality criteria, ie factors decisive to safety and consumption by humans and the
environment;46 production date, expiration date and shelf-life of goods.47 An expiration date
is mandatory for food products;48
• Country of origin, applicable only to imported goods and goods for export.50
Decree 89 requires that all letters, numerals, drawings, images, signs and/or marks which
appear on the label must be clear and must accurately reflect the properties of the goods. They
must not be ambiguous, or cause confusion with another product. Labels which are not clearly
visible may result in an administrative violation.
39
Id, art 3.2
40
Id, art 13
41
Id, art 14
42
Id, art 12.2.d
43
Id, art 15.1
44
Id, appendix III
45
Id, art 18.3.a
46
Decree 89, art 19; Circular 09, art II.7
47
Decree 89, art 16
48
Id, art 12.2.c
49
Id, art 12.2.e
50
Id, art 17
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The colour of the text of compulsory contents must contrast with the background colour of the
label.51 Goods distributed in Vietnam must be labelled in the Vietnamese language, except for
contents that are presented in their Latin origin.52 However, depending on the requirements of
each type of goods, a foreign language may be added in smaller print.53 With respect to goods
made only for export, labels may be in the language of the country or territory importing such
goods, if this is agreed in the sale/purchase contracts for the goods.54 With regard to imported
goods, the Vietnamese language must appear either on the original label or on an additional
label which must be attached to the goods before they are put on sale or distributed.55
The size of a label is determined by the individual or organization responsible for labeling the
goods, but it must be large enough for all compulsory contents to be clearly visible.56
According to Circular 09 and Circular 08, in addition to the compulsory contents listed above,
food labels must contain some further information:
• If the name of ingredients is presented on the label of goods in order to attract attention to
the goods, the quantities of such ingredients must be presented. For example, if a phrase
such as “rich calcium content” is used, the calcium content must appear on the label;57
• If perfume, sweetener or colour additives are used in the processing of food, the label must
clearly state whether such additives are natural, synthetic or artificial;58
• If the essence of natural materials is part of the name of goods, the quantities of such
essence or equivalent volumes of materials must be presented;59
• If there are two or more food additives in a product, they must be listed in proportion to
their volumes;60
• The labels of goods and ingredients which are irradiated or genetically modified must be
presented in accordance with international treaties to which Vietnam is a party;62
51
Id, art 8
52
Id, art 9.4
53
Id, art 9.2
54
Id, art 3
55
Id, art 9.3
56
Id, art 7
57
Decree 89, art 18.1; Circular 09, art II.6.b
58
Decree 89, art 18.3.a
59
Circular 09, art II.2.c
60
Decree 89, appendix III
61
Id, appendix IV
62
Id, art 19.4
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• For food that is used to improve nutrition or for treatment of health conditions, information
about nutritional ingredients, specific additional nutrient contents and instructions for use
must be added;64
• Labels for food used for diets must include the phrase “for diets”, and the main “diet”
characteristics of the food must appear next to its name.65
Non-compulsory contents may appear on food labels, but they must not be contrary to the
compulsory labeling requirements referred to above. Non-compulsory contents may be: number
and bar codes granted by national number and bar code organizations; protected trademarks;
medals; certificates of the product's international quality standards; serial number of the
production batch; international markings used for transport, use and storage; foreign language
information and information that promotes the product. However, the law prohibits language
which claims that the food product prevents or treats a particular illness, or that it is equivalent
to a medical alternative.66
Changes made to a registered food label or to the expiration date without the approval of the
competent authority are strictly prohibited.
As previously mentioned, food products manufactured in Vietnam for export may bear a label
in the foreign language of the destination country. Such products may also have their own
labels at the request of the foreign buyers, provided that a phrase such as “made in Vietnam”
appears on the label.67
Cigarettes made in Vietnam under foreign license may be affixed with a label in a foreign
language, but the label must contain the words “made in Vietnam” in Vietnamese or in a
foreign language, and must contain the required information and warnings about hygiene and
safety in Vietnamese, for example “smoking causes lung cancer.”68
ADVERTISING
Current regulations that relate to advertising in general are Decree 24/2003/ND-CP of the
Government dated 13 March 2003 providing Detailed Regulations Implementing the Ordinance
on Advertising (“Decree 24”); Circular 43/2003/TT-BVHTT of the Ministry of Information
and Communications (“MOIC”) dated 16 July 2003 guiding Decree 24 (“Circular 43”);
Circular 79/2005/TT-BVHTT of the MOIC dated 8 December 2005 amending and
supplementing a number of provisions of Circular 43; and Inter-Ministerial Circular
63
Id, art 19.3
64
Circular 08, art II.3.a
65
Id, art II.3.a
66
Circular 08, art II.3.c
67
Decree 89, art 17
68
Decree 119/2007/ND-CP of the Government dated 18 July 2008 on Manufacturing and Trading of Cigarettes,
art 19; Decision 02/2007/QD-BYT of MOH dated 15 January 2007 promulgating Regulations on Hygiene and
Safety of Cigarette Products, Appendix 1.
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01/2004/TTLT-BVHTT-BYT of the MOIC and the MOH dated 12 January 2004 guiding
Advertising Activities in the Domain of Health (“Inter-Ministerial Circular 01”). In general,
the contents of an advertisement of all goods, not just food products, must be accurate, truthful
and must correctly reflect the form, quality, usage, label, design, classification, packing, origin,
use date, preservation period and warranty period of the goods.69 In particular, food
advertisements must be truthful, must accurately describe the quality of the food products, and
must include guidance on use and preservation of those foods for which such guidance is
required.70 The advertisement must be in accordance with food labels and quality standards
which have been announced to or registered with relevant state agencies. 71
Detailed procedures to obtain advertising permits for food products and food additives are
provided in Inter-Ministerial Circular 06/2007/TTLT-BVHTT-BYT-BNN-BXD of the MOIC,
the MOH, the Ministry of Agriculture and Rural Development (“MARD”) and the Ministry of
Construction (“MOC”) dated 28 February 2007 (“Inter-Ministerial Circular 06”). The
application dossier for an advertising permit must be filed with the provincial Department of
Information and Communications (“DOIC”), and must include the following documents:
• Copy of the Business Registration Certificate of the advertiser or the advertising services
firm (as the case may be); and
In order to advertise a food product or food additive that is subject to the examination of
hygiene and safety, the advertiser must provide a copy of the Certificate of Hygiene and Safety
Registration, and a copy of the receipt from filing the application in order to register the
advertisement with the FHSA.73 In respect of a food product or food additive that is subject to
the requirement to announce hygiene and safety quality standards, an application to advertise
must be accompanied by a copy of the company standards and a copy of the receipt from filing
an application to announce quality standards of food hygiene and safety.74
The regulatory timeframe for the DOIC to issue an advertising permit for an advertisement on a
banner, illuminated object, aerial or underwater objects, means of transportation, or other
mobile objects is five working days from the date of receipt of a complete application.75 In
respect of an advertisement on billboards, placards, or panels, the DOIC forwards the complete
application to the DOC within two working days after the date it is received. Within 10 working
69
Decree 24, art 4.2
70
Inter-Ministerial Circular 01, art II.1.e
71
Circular 43, art II.1.a
72
Inter-Ministerial Circular 06, art II.1.7
73
Id, art II.1.5.a
74
Id, art II. 1.5.d;
75
Id, art II.3.1
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days, the DOC makes an assessment, and then responds to the DOIC with its approval or
rejection. The DOIC will then issue an advertising permit within three working days.76
Advertisements of some products, such as sanitary pads and condoms, which do not conform to
Vietnamese culture and way of life, will not be approved.77 Furthermore, advertisements which
incorrectly state the quality of the product and/or address of the producer,78 or which relate to
products either banned by the State or whose consumption is restricted by the State are
prohibited.79 In this regard, tobacco advertising in any form is prohibited.80 Advertising
alcoholic products is permitted, with strict limitations:
• Advertisement of alcoholic products with an alcohol content of more than 15º is allowed
within the premises of the alcohol producers or within product introduction stalls or agents’
shops. However, no one standing outside of the premises or shops should be able to hear,
see or read such advertisements.82
• Various medicated alcohols or tonics may be advertised in accordance with the Regulations
on Information on, and Advertising of, Drugs and Cosmetics for Human Use.83
RECALL
Most laws and regulations that deal with violations of food quality standards do not address the
issue of recall. However, the regulations do allow sanctions that are tantamount to a recall.
These include confiscation of the tools and equipment used to perform the administrative
violation; destruction of items causing damage to human health; suspension of the delivery,
76
Id, art II.3.2
77
Circular 43, art II.6
78
Decree 24, art 3.4
79
Id, art 3.9
80
Circular 43, art II.4
81
Id, art II.3.a
82
Id, art II.3.b
83
Id, art II.3.c
84
Decree 21/2006/ND-CP of the Government dated 27 February 2006 on the Business and Use of Nutritious
Products for Infants, arts 6.1 and 6.2
85
Decree 24, arts 21, 25
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Recalls are discussed in the Ordinance on the Hygiene and Safety of Foods and in Decree 163.
Where an imported or manufactured food product fails to satisfy food hygiene and safety
requirements or where it does not comply with the announced quality standards, the agency
which issued the certificate on food quality may suspend distribution and recall the product.87
The company responsible for the distribution or manufacture of the non-compliant product must
retrieve the food product.88 In the event that the competent authority decides to destroy recalled
food, the company involved must itself do so. Alternatively, it must be responsible for all costs
of destruction incurred by the authorities.89
INSPECTIONS
Responsibility for inspection of the quality of food products is divided among five ministries.
The MOST has primary responsibility to examine and announce the quality of goods in general
and of foods in particular.90 The MOH is authorized to conduct inspections of the hygiene and
safety of foods.91 The Ministry of Industry and Trade (“MOIT”) is responsible for issues
involved in the manufacture, sale and circulation of foods.92 The MARD is responsible for state
management of the hygiene and safety of agricultural products, forestry products, aquatic
products and salt. MARD is also responsible for hygiene and safety in connection with
importation of animals, plants, and materials to grow, cultivate, or process. This includes
temporary import for re-export, temporary export for re-import, and passage through Vietnam.93
The Ministry of Natural Resources and Environment (“MNRE”) exercises state management of
environmental protection in the manufacture and trade of foods94. However, in practice, any one
of these five ministries can initiate an inspection regarding foods, together with any other one.
In general, quality inspections are conducted by inspection teams or individual inspectors. The
team or individual is tasked with: (1) investigating compliance with legislation on quality, (2)
imposing sanctions, and (3) applying or proposing, according to its authority, measures for
preventing or ending a violation. Based on the above, the list of authorized inspections includes:
• Whether the quality of goods distributed in the market conforms to the quality stated
in the announcement;
• Whether the quality of goods distributed in the market conforms with regulations on
safety, hygiene and the environment;
86
Decree 126/2005/ND-CP of the Government dated 10 October 2005 on Administrative Sanctions against
Violations in Measurements and Quality of Products and Goods (“Decree 126”), art 4
87
Ordinance on the Hygiene and Safety of Foods, arts 26, 37; Decree 163, arts 10, 17
88
Decree 163, art 17.2
89
Ordinance on the Hygiene and Safety of Foods, art 26
90
Decree 79/2008/ND-CP of the Government dated 18 July 2008 regulating the System of Organization,
Management, Inspection and Analysis of Food Hygiene and Safety, art 2.4
91
Id, art 2.1
92
Id, art 2.3
93
Id, art 2.2
94
Id, art 2.5
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• Order the entity being inspected to provide all pertinent samples, information,
documents and explanations necessary for the inspection;
• Request that the entity being inspected facilitate the activities of the inspectors;
• Make a record of the inspection and recommend to the head of the relevant quality
control agency measures to be taken in the future;
• Apply measures for the prevention and handling of violations according to law; and
• In the event that any evidence of criminal conduct is discovered, transfer all
information regarding any breaches of the law to criminal investigation authorities.
The contents and conclusions of the inspection and all recommendations are made in an
inspection report. The inspection report is central to resolving problems. The Law on the
Quality of Products and Goods states that organizations and individuals may lodge complaints
with state agencies or competent officers against an administrative decision or an act of an
agency or officer which decision or act they consider to be illegal and which infringes their
rights and interests.95
IMPORT REQUIREMENTS
All imported goods are subject to the regulations described above. Food imported into Vietnam
must meet the following additional conditions:96
• Have a Certificate of Satisfaction of Food Hygiene and Safety Requirements issued by the
MOH. As of the date that food materials and food additives are imported, the expiration
date must be over two-thirds of the total useful life as inscribed on the label;
• Unprocessed food that has any animal or plant origin must receive phyto-sanitary
certificates granted by competent Vietnamese state agencies.
In order to obtain a Certificate of Standards of Goods for imported foods, importers must
announce the standards of the imported foods to the MOH.97 The procedure is very similar to
95
Law on the Quality of Products and Goods, art 64.1
96
Decree 163, art 6
97
Regulations on Announcing Standards of Foods, art 3.2
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the procedure to announce standards of locally made food products, as discussed above in the
subsection entitled Announcement Procedures. However, the requirement to announce
imported foods does not apply to non-traded food products,98 such as foods carried into
Vietnam for personal use or gifts, goods for the diplomatic corps and international
organizations, and samples for fairs and pilot studies. Imported foods that are subject to State
inspection of the Quality of Hygiene and Safety include:99
• processed foods that require no further refinement and are ready for production or
packaging;
• foods that are not normally under State oversight, in case there is risk of injury or epidemic
disease, or as otherwise required by the MOH in writing;
• other products on the list of products which must announce standards, issued periodically by
the MOH.
Imported food can only be distributed and sold in Vietnam after the importer receives one of the
following documents from the appropriate State control authorities:100
In order for an importer to obtain a Certificate of Satisfaction of Food Hygiene and Safety
Requirements, the foods must be examined by the MOH. However, the foods are free from
State oversight102 if they accompany passengers for personal use, and are within the quantity
that is free of import duty, or if they are:
98
Id, art 1.b
99
Decision 23/2007/QD-BYT of the MOH dated 29 March 2007 promulgating Regulations on State Inspection of
the Quality of Hygiene and Safety of Imported foods (‘Decision 23”), art 1.1
100
Id, art 1.2
101
Id, art 5: “File examination only” means a method of inspection of goods under which no physical inspection or
testing of the product is required.
102
Id, art 1.4
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• raw materials to be refined or re-processed (vegetable oil, tobacco, herbal medicines used in
food processing); or
• fresh and semi-processed foods which must be under animal quarantine and vegetable
quarantine.
A dossier to register for examination of imported food hygiene and safety consists of:103
• copy of the original Certificate of Standards of Goods certified by the Food Hygiene and
Safety Administration (“FHSA”) or an FHSA certification that the products may be
released;
• health certificate issued by the appropriate state authorities of the country of origin if the
foods are made from animals or plants and are processed and sterilized at high temperature,
and if there is an epidemic announcement by the MARD or the FHSA; and
• if the food standards have not been announced, a copy of the Certificate of Analysis issued
by an accredited laboratory or manufacturer bearing the stamp and signature of the director
of the enterprise or other authorized person.
Within three days after receiving the dossier for registration of examination, the MOH104 must
issue a receipt so that the importer is permitted to carry out customs clearance procedures.
103
Id, art 6
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Afterwards, the MOH examines the imported foods to determine whether to issue a Certificate
of Satisfaction of Food Hygiene and Safety Requirements.105 A Certificate of Satisfaction of
FHSA must be obtained before the importer can circulate the foods.106
If an imported food fails to comply with regulations on imported food hygiene and safety, its
purpose of use may be changed, or it may be recalled, recycled, destroyed, or re-exported by a
decision of an enforcement authority.107
In addition, where imported goods appear on the “List of goods subject to state quality
examination,”108 the importer must apply to have the goods examined by relevant government
bodies.109 There are a number of aquatic products on this List. After the quality examination,
the examining agency will issue the results in a notice in one of the following forms:110
• Notice that the imported goods are subject to file examination only;
Customs procedures112 are based on the results of the examinations mentioned. That is to say,
Customs import procedures be conducted only if the examination results are favourable. When
Customs procedures are completed, the goods can be imported. If the examination results are
unfavourable, the goods must either be destroyed or returned to the exporting country.
104
According to Decision 2964/2004/QD-BYT of the MOH dated 27 August 2004, the Food Administration, an
agency under the MOH, is responsible to assist the MOH to perform state oversight of quality, hygiene and
safety of food nationwide. As authorized by the MOH, the FHSA is responsible to receive and examine
dossiers, and decide whether to issue Certificates of Standards of Goods and Certificates of Satisfaction of
Food Hygiene and Safety Requirements.
105
Decree 163, arts 10.1 and 10.2
106
Id, art 9.3
107
Id, art 10.3
108
List of goods subject to State Quality Examination promulgated in conjunction with Decision 50/2006/QD-TTg
of the Prime Minister dated 7 March 2006
109
Circular 05/2007/TT-BYT of the MOH dated 7 March 2007 guiding Conditions and Procedures to nominate
Organizations to Implement State Inspection on Quality, Hygiene and Safety of Imported Foods, Part I.2
110
Decision 23, art 11
111
The examining agency will forward this Notice and the results of tests to owner of products/goods and the
customs agency at the port where the products/goods arrive, and send a report to FHSA to propose resolution.
112
Decision 23, art 15.5
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EXPORT REQUIREMENTS
In general, there are no specific export requirements for food products. In principle, it is the
overseas buyer of a food product that sets the quality, safety or hygienic standards with which
the product must comply.
In practice, the overseas buyer usually asks whether the food exporter is in compliance with
International Standardization Organization (“ISO”) provisions. Further, the food product must
follow international standards on hygiene and safety known as HACCP. The principle of
HACCP is to define and isolate the critical points in the process which may pose a food safety
hazard. Processors are responsible for producing safe products. Safe food means marketable
food, and food exporters are responsible to provide safe food in accordance with HACCP.
In addition, an overseas buyer may require a Certificate of Free Sale issued by the MOH for
food products intended for export. If so, the food exporter must apply for the Certificate from
the MOH.113 According to discussions with an MOH official, the food exporter should submit a
letter of request for the Certificate for Free Sale together with the sales contract under which the
Certificate is required by the overseas buyer. Within about two weeks, the food exporter should
receive the Certificate, assuming that it has announced to the MOH the standards on quality,
safety and hygiene of the foods intended for export.
However, if the exported food product falls onto the “List of goods subject to State quality
examination,” the food exporter must proceed with quality examination under the MOH. Export
requirements that relate to foods are the same as those discussed in the previous section,
Import Requirements. A successful examination will help facilitate compliance with customs
procedures which apply to foods for export.
AQUATIC PRODUCTS
Entities involved in processing or producing aquatic products intended for consumption are
subject to inspection by MOAP to assure compliance with standards of food safety and hygiene.
In order to arrange inspections, establishments must register with the bodies which perform
those inspections. There are four types of inspection: first-time inspection, re-inspection,
periodic inspection, and irregular inspection.116 Each type of inspection, except periodic
113
There are no specific provisions on application procedures.
114
The MOAP is responsible for unifying state management of aquatic products as provided by Inter-Ministerial
Circular 24/2005/TTLT-BYT-BTS of the MOH and MOAP dated 8 December 2005 guiding the Assignment
and Co-ordination of State Management of Hygiene and Safety of Aquatic Products, art I.1.a
115
Decree 59, art 17
116
Decision 649/2000/QD-BTS of MOAP dated 4 August 2000 promulgating Regulations on Examination and
Recognition of Satisfaction of Hygiene and Safety of Aquatic Processing and Trading Establishments
(“Decision 649”), art 5
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inspection, is carried out by an inspection team set up by the head of the inspection body.117
Inspection reports must state the inspection team's general assessment of the hygienic standard
of the establishment as it relates to food.
Class A establishments (those that satisfy food hygiene and safety standards)118 or Class B
establishments (those that achieve food hygiene and safety standards, but have some minor
faults which have little impact on the hygiene and safety of the aquatic products)119 will be
granted a code number.120 If the establishment has many serious faults which cannot be
remedied within a short period of time, and if continued production would have a serious
impact on the hygiene and safety of the aquatic products, then at the request of the inspecting
body, the body authorized to rule on such establishments will issue a non-recognition notice.
The exact authorized body is discussed below. A copy of the notice is also sent to the agency
which granted the business registration certificate to that establishment,121 along with a request
that the business registration certificate be suspended.122 The authorized body may, by the same
notice, request the state quality control body to deny quality certificates for goods produced by
the establishment as from the date of the notice.123
A qualified establishment must submit to periodic inspections and maintain hygienic and safe
conditions.124 The frequency of inspections can vary, ranging from once a month to once a year,
depending on the classification of the establishment: eg, Class A establishments are inspected
once every six months, while Class B establishments are inspected once every three months.125
The frequency of inspection also depends on whether the establishment is involved in manual
or industrial processing.126
According to the Regulations on Aquatic Products, the MOAP is responsible for issuing
recognition notices to establishments involved in the production, packaging or preservation of
aquatic products for use as food. The provincial Departments of Aquatic Products deal with all
other establishments involved with aquatic products for use as food.127 The inspecting bodies
may collect inspection fees for first-time inspection, re-inspection and periodic inspection.128
These Regulations do not govern retail establishments that process aquatic products,129 or
catering services that provide aquatic foods.130
All organizations and individuals producing and trading in aquatic products that appear on the
list of goods requiring quality inspection must apply for State inspection, whether the products
117
Id, art 10.1
118
Id, art 11 2.a
119
Id, art 11 2.b
120
Id, art 14.3
121
Id, art 15.2.b
122
Id, art 15.2.c
123
Id, art 15.2.c
124
Id, art 18.3
125
Id, art 12.1.a
126
Id, art 12.1
127
Id, art 6
128
Id, art 24.1
129
Id, art 2.a
130
Id, art 2.b
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are exported, imported or domestically consumed.131 This inspection is made per lot of aquatic
products and a certificate of aquatic products quality will be granted per lot.
Before any lot of aquatic products can be exported, imported or consumed, one of the following
documents is necessary: either a quality certificate or a notice of exemption from quality
inspection.132 A quality certificate is granted if the lot of products meets prescribed standards.133
A particular lot of aquatic products may receive an exemption from inspection if the lot has
already been inspected and approved by the MOAP for export or for domestic consumption134
as the result of a request for inspection by the processing company. If such aquatic products are
returned or rejected by foreign inspection bodies, such products will be subject to inspection in
Vietnam. Enterprises are exempt from inspection only when they have applied all measures to
ensure food safety control, and are certified by the inspecting bodies135 as having done so.
Many imported products are also exempt from inspection. To qualify, such products must have
been granted quality certificates either by an authorized inspection agency from the exporting
country,136 or by a foreign inspection organization approved by the MOAP.137 In addition, the
origin, homogeneity, packaging, labeling and appearance of the imported aquatic products must
be compatible with the importation documentation. If so, the inspecting body will issue a notice
of inspection exemption for the qualified lots.138
If the inspection fails, the owner of the aquatic products will receive a notice of failure. The
owner may request re-inspection,140 and in cases where the original inspection was inaccurate,
resulting in damage or loss to the owner, the aggrieved owner has the right to claim
compensation. The level of compensation can be agreed, but cannot exceed ten times the
inspection charge already collected.141
131
Regulations on State Inspection and Certification of Aquatic Goods Quality (issued together with Decision
650/2000/QD-BTS of the MOAP dated 4 August 2000), arts 1.2, 1.3
132
Regulations on State Inspection and Certification of Aquatic Goods Quality, art 4.1
133
Id, art 12.2.b
134
Id, art 4.1
135
Id, art 4.4
136
If the exporting country is a signatory to a mutual recognition agreement with Vietnam
137
Id, art 11.2
138
Id, art 11.3.a
139
Id, art 13.5
140
Id, art 15.1
141
Id, art 7.6
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There are separate regulations for speciality aquatic products, called Temporary Regulations on
Announcing Quality Standards of Speciality Aquatic Products.142 The Regulations stipulate that
aquatic animals and plants for breeding purposes; industrial processed foods for aquatic
farming; medicines, chemicals, and biological products used in aquatic farming; and nets and
other instruments used in aquatic exploration are subject to announcement procedures of quality
standards. Before the products can be sold in Vietnam, announcement procedures must be
carried out at the Office of Aquatic Resources Protection in the region where the head office of
the establishment is located, whether the products are produced locally or whether they are
imported. If there is no Office of Aquatic Resources Protection in the region, announcement
procedures will be carried out at the Bureau of Aquatic Resources Protection.
To complete these two forms, the applicant144 must provide its standards for the specific
aquatic product. As described above, such standards are set by the applicant and the
applicant’s decision is made in writing, stamped and executed by the applicant. An original
copy of such decision should be included in the announcement application. Further, if the
standards set by the applicant meet either a Vietnamese standard or an international
standard, the applicant should include such additional information.;
• Certificate of the results of tests which relate to the quality of the aquatic products; and
The applicant will know whether its announcement is accepted by the local department of the
MOAP within seven days from the date of submission. If the announcement is accepted, the
applicant is responsible for complying with its announced quality standards and is subject to
periodic inspection by the competent state agency on the quality of its speciality aquatic
products.145 If there is a change in the announced quality standards, the applicant must
announce such change.146
142
These temporary regulations were issued in connection with Decision 425/2001/QD-BTS of the Minister of
Aquatic Products dated 25 May 2001.
143
Id, art 7
144
The applicant is the producer if the speciality aquatic product is locally produced. The importer or the
distributor is the applicant if the speciality aquatic product is imported.
145
Id, art 10.1
146
Id, art 10.2
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The value of aquatic products exported by Vietnam has risen steadily. Vietnam is a prominent
supplier. The Government believes it is important that proper standards be maintained to ensure
confidence in aquatic products that come from Vietnam.
For exports to countries with standards that differ from those of Vietnam, inspection and
certification must be based on the standards and requirements of the importing countries or on
agreements between Vietnam and the importing countries.147 Vietnamese regulations allow
establishments that export their aquatic products to be inspected more frequently than required
by Vietnamese law, if the importing countries require it.148 Accordingly, to export aquatic
products, Vietnamese exporters must comply not only with Vietnamese law, but also with
requirements of the importing country. The Regulations on Aquatic Products state that if an
establishment that has been certified as meeting Vietnamese hygienic and safety standards has
more than two lots of exported goods returned or cancelled by inspectors in either Vietnam or
in the importing country, the certification will be revoked.149
Like any food products, aquatic products should conform to HACCP. In addition, exported
aquatic products must be sanitary. This requirement follows GMP, which is the basic regime
for food manufacturers. The principles are straightforward and aim to prevent contamination of
food through unsanitary practices. There is a close relationship between HACCP and GMP,
inasmuch as GMP is considered to be a prerequisite to HACCP. Without GMP, the risks are
greater.
Vietnamese exporters must also establish their own quality control system to conform to
international criteria and/or the requirements of the importing countries. To this end, the
Regulations on Aquatic Products stipulate that, for exported aquatic products, the standards of
importing countries or market groupings are to be applied to the exporters’ inspection
procedures, provided that such standards meet Vietnamese standards.150 At the moment, aquatic
products for export have been removed from the list of export and import goods which are
subject to state quality inspection.151 The Government has taken that step to encourage aquatic
products exporters to adopt HACCP, GMP and other international criteria voluntarily.
ENFORCEMENT
All organizations and individuals have the right to lodge complaints regarding violations that
relate to the quality of food products.152 They may even make a complaint regarding wrong-
doing by a government official responsible for implementing or enforcing the laws and
147
Decision 649, art 3.3
148
Id, art 12.2
149
Id, art 16.2.c
150
Id, art 3.3
151
Decision 650, art 3
152
Law on the Quality of Products and Goods, art 64; Ordinance on Hygiene and Safety of Foods, art 49.2; Decree
126, art 31.2
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regulations on the quality of food products.153 The authorities must respond to such
complaints.154
All individuals and organizations, including foreign organizations and individuals, that commit
an administrative violation with respect to the quality of goods will be sanctioned.155 This
accords with the Civil Code, which states that: “individuals, legal persons, etc. that are
producers or who do business without ensuring the quality standards of goods and damage any
consumer must compensate” the consumer.156 However, only inspectors of the General
Department of Standards, Measurements and Quality (“GDSMQ”) or one of its branches,
People’s Committees, the police, the Customs Service, market management agencies or
specialist inspection agencies of the ministries have the right to deal with administrative
violations.157 Once a violation has been discovered, the law gives the government much
flexibility in the form and scale of punishment.158 Sanctions include:
1. Warning: applies only to minor or first time violations or violations with extenuating
circumstances;
2. Fine: determined on the basis of the type and seriousness of the violation, the
presence of extenuating or aggravating circumstances, and the personal record of the
offender. The sanctions must be within the prescribed range of fines for each type of
violation. The fines range from VND 100,000 to VND 20 million;
153
Ordinance on Hygiene and Safety of Foods, art 49.1; Decree 126, arts 31.1, 31.2
154
Law on the Quality of Products and Goods, art 46.4; Decree 136/2006/ND-CP of the Government dated 14
November 2006 providing and implementing a number of Articles of the Law on Appeal and Denunciation, art
6
155
Decree 126, arts 2.1, 2.2
156
Civil Code 2005, art 630
157
Decree 126 arts 25, 26 and 27
158
Id, art 4
159
Id, art 4, arts 15 to 24; Decree 95/2007/ND-CP of the Government dated 4 June 2007 amending and
supplementing a number of Articles of Decree 126, arts 1.3, 1.4
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The sanctioning agency will apply either a warning or a fine in almost every instance. Other
sanctions are considered optional.160 Whether an optional sanction is applied depends largely on
the type and seriousness of the violation. However, the enforcement agencies are given
relatively little guidance as to which sanctions to impose or how large a fine should be. The
regulations do list extenuating and aggravating circumstances, as well as situations where
sanctions are not to be applied. As you will see, the regulations refer to violations of many laws,
not just to violations related to food.
• The offender attempts to mitigate the damage caused by the breach or to deal voluntarily
with the consequences and to compensate the injured;
• The violation is committed in a state of nervous excitement caused by the illegal acts of
other persons;
• The violating party is a pregnant woman, an old and sick person, a diseased person, a
disabled person or a person with limited awareness or control over his actions;
• The violation is committed in especially difficult circumstances not brought about by the
offender; or
• Organised violations;
• A violation committed while the offender is under the influence of alcohol or some other
stimulant;
• The offender takes advantage of wartime conditions, natural disasters or other social
difficulties in order to commit the violation;
• An offender persists in the violation despite the request of an authorized person to cease;
160
Decree 126, art 4
161
Ordinance on Dealing with Administrative Violations 44/2002/PL-UBTVQH10 dated 2 July 2002, art 8.1
162
Id, art 9
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• Where the offender had no choice due to urgent circumstances, unforeseen contingent
events, natural disasters, war and similar situations, and every measure to overcome the
difficulties has been taken;
• The offender suffers from a mental or other disease that is confirmed by a medical agency
and which causes him or her to lose awareness or behavioural control;164 and
• Where the statute of limitations (two years for import-export violations and one year for all
other violations) has expired.165
Usually, the more complicated and serious the violation, the higher the level of the inspector
who is sent to deal with it (for example, regular inspector vs. chief inspector of the GDSMQ).
The sanctions which may be imposed on the spot also depend on the level of the inspector.
However, even an inspector of the lowest-level may impose a fine of up to VND 200,000,
confiscate items worth up to VND 2,000,000, require the restoration of the normal state of
affairs, order the implementation of measures to deal with pollution and diseases, and order the
destruction of products damaging to human health.166 Where an inspector believes that it is
necessary to impose a fine beyond his authority, he must submit a file regarding the breach to
the appropriate higher authority.167 Within 10 days (or 30 days for complicated cases) the
relevant government agency will issue a decision on how to handle the administrative
violation.168
If the administrative violation is found to constitute criminal behaviour, and is likely to cause
serious consequences to other people, to hygienic or environmental safety, or to State property,
then the agency handling the administrative violation must send its investigation file to the
appropriate criminal investigation department to handle the violation in accordance with the
Penal Code.169
An injured party may demand compensation by filing suit with the Civil Division of the
People’s Court.
163
Id, art 3.6
164
Ordinance on Dealing with Administrative Violations, art 3.6
165
Decree 126, art 5.1
166
Id, art 25
167
Id, art 29.2
168
Ordinance on Dealing with Administrative Violations, art 56.1
169
Decree 126, art 29.3
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CONCLUSION
In conclusion, regulations on foods have been improved and simplified. A good example is the
replacement of the complex rules regarding registration of food quality, hygiene and safety. A
regime of announced food quality, hygiene and safety now applies. This change provides a
shortened and simplified alternative, which should not impair standards.
The rules on food continue to develop in a way that recognizes the greater sophistication of the
Vietnamese food industry, consumer needs, and import, export and processing standards. The
reality is that the laws must continue to evolve. Rules that were intended to regulate the quality
of goods in general are not completely adequate to regulate the quality of food products. There
is a clear recognition of this, but, as often the case in Vietnam, the process of change and
implementation is measured and deliberate.
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SCHEDULE
List of cited Laws, Ordinances, Decrees, Circulars and Regulations classified by subject and by order of appearance
26
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Recall 13 • Ordinance on the Hygiene and Safety of Standing Committee 26 July 2003
Foods 12/2003/PL-UBTVQH11 of the National
Assembly
Inspection 13 - 15 • Law on the Quality of Products and Goods National Assembly 21 November 2007
05/2007/QH12
• Decree 79/2008/ND-CP regulating the Government 18 July 2008
System of Organization, Management, Inspection
and Analysis of Food Hygiene and Safety
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Examination
• Decision 23/2007/QD-BYT promulgating MOH 29 March 2007
Regulations on State Inspection of the Quality of
Hygiene and Safety of Imported foods
• Circular 05/2007/TT-BYT guiding Conditions MOH 7 March 2007
and Procedures to nominate Organizations to
Implement State Inspection on Quality, Hygiene
and Safety of Imported Foods
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BYT-BTS guiding the Assignment and Co- MOH, MOAP 8 December 2005
ordination of State Management of Hygiene and
Safety of Aquatic Products
30