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THE
GOVERNMENT
OF VIETNAM
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
46/2026/ND-CP
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Hanoi,
January 26, 2026
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DECREE
ELABORATION OF SOME ARTICLES AND MEASURES FOR ORGANIZATION
OF THE IMPLEMENTATION OF THE LAW ON FOOD SAFETY
Pursuant to the Law on
Government Organization No. 63/2025/QH15;
Pursuant to the Law on Food
Safety No. 55/2010/QH12;
At the request of the Minister
of Health;
The Government promulgates a
Decree on elaboration of some Articles and measures for organization of the
implementation of the Law on Food Safety.
Chapter I
GENERAL PROVISIONS
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This Decree elaborates some
Articles and provides guidance on implementation of some Articles of the Law of
Food Safety, including:
1. Elaboration of regulations on:
a) Registration of declarations of
conformity and duration of declarations of conformity of foods subject to
technical regulations on quality and safety criteria in one of the following
cases: pre-packaged processed foods prescribed in Clause 3 Article 12; food
additives, food processing aids prescribed in Clause 4 Article 17; packages and
instruments having direct contact with foods (hereinafter referred to as
"primary packaging of foods") prescribed in Clause 3 Article 18 of
the Law on Food Safety;
b) Assurance of safety of
genetically modified foods to human health and the environment prescribed in
Clause 2 Article 15 of the Law on Food Safety;
c) Entities not required to obtain
the Certificate of Compliance with Food Safety Regulations prescribed in Clause
3 Article 34 of the Law of Food Safety;
d) Assurance of food safety of
imported foods: Certificate of Free Sale or Health Certificate prescribed in
Clause 2 Article 38 of the Law on Food Safety;
dd) Exemption of state inspection
of food safety of certain imported foods; procedures for state inspection of
food safety in countries from which foods will be exported to Vietnam under
international treaty to which the Socialist Republic of Vietnam is a signatory
prescribed in Clause 1 and Clause 3 Article 39 of the Law on Food Safety;
e) Food labeling, expiration dates
of foods; specific regulations on genetically modified foods subject to
labeling, concentration (%) of genetically modified ingredients in food subject
to labeling a prescribed in Clause 3 Article 44 of the Law on Food Safety.
2. Guidance on implementation of
the following contents:
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b) Revocation of Certificate of
Compliance with Food Safety Regulations prescribed in Article 35 of the Law of
Food safety;
c) Procedures for issuance of
Certificate of Compliance with Food Safety Regulations prescribed in Clause 2
Article 36 of the Law of Food safety;
d) Procedures and methods for state
inspection of imported food safety prescribed in Article 40 of the Law of Food
safety;
dd) Advertising and labeling of
foods prescribed in Chapter VII of the Law on Food Safety;
e) Assurance of food safety during
production, sale, preservation of dietary supplements prescribed in Article 19
and Article 20 of the Law on Food Safety;
g) Assurance of food safety during
sale and use of food additives prescribed in Article 22 of the Law on Food
Safety;
h) Food testing serving state
management prescribed in Section 1 Chapter VIII of the Law on Food Safety;
i) Food origin tracing prescribed
in Section 4 Chapter VIII of the Law on Food Safety.
Article 2.
Regulated entities
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Article 3.
Definitions
For the purpose of this Decree, the
following terms are construed as follows:
1. "functional foods" are
foods used to support the functions of the human body, create a comfortable
state for the body, improve immunity, reduce the risk of contracting diseases.
Functional foods include dietary supplements, medical foods, foods for special
dietary uses, and supplemented foods.
2. " dietary supplements"
(also known as "health supplements" and "food supplements")
are products added to the daily diet in order to maintain, enhance, and improve
the functions of the human body, and reduce the risk of contracting diseases.
Dietary supplements contain one or more of the following substances or mixtures
of substances:
a) Vitamins, minerals, amino acids,
fatty acids, enzymes, probiotics and other bioactive substances;
b) Substances derived from animals,
minerals, plants in the form of extracts, isolates, concentrates or
metabolites;
c) Sources of synthesis of the
substances mentioned in Point a and Point b above.
Dietary supplements may be in the
form of soft gels, pellets, tablets, granules, powder, liquid and other dosage
form divided into smaller unit doses (for use).
3. “medical foods” (also known as
"foods for special medical purposes") are foods that can be consumed
orally or via tube feeding, prescribed to adjust the diet of patients according
to the manufacturer’s instructions.
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5. "supplemented foods"
are foods supplemented with micronutrients and healthy elements such as
vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics,
and other bioactive substances, but not classified as one of the three product
groups specified in Clauses 2, 3, and 4 of this Article.
6. "goods owner" means
the organization or individual having ownership of the goods as prescribed by
law.
7. An "article" or
exports or imports means products of the same type, name, label, manufacturer
and packaging materials.
For the purposes of this Decree,
the word "article" covers: foods, food additives, food processing
aids, primary packaging of foods.
8. “consignment” means an export or
import shipment (having the same bill of lading number) of one or multiple
articles.
9. “small-scale food manufacturer”
means a household or individual that obtains foods by means of farming,
husbandry, gathering, fishing without the Certificate of Enterprise
Registration or other Certificates (certificates of registration of household
business, cooperative, cooperative union, artel, branch, representative office,
business location) under business registration laws.
10. “small-scale food processor”
means a household or individual that preliminarily processes foods without the
Certificate of Enterprise Registration or other Certificates (certificates of
registration of household business, cooperative, cooperative union, artel, branch,
representative office, business location) under business registration laws.
11. “small-scale food seller” means
a household, individual or group of individuals that sells foods without the
Certificate of Business Registration and the Certificate of Enterprise
Registration or other Certificates (certificates of registration of household
business, cooperative, cooperative union, artel, branch, representative office,
business location) under business registration laws.
12. "food owner" means an
organization or individual that owns the formula, manufacture process, standard
or label of a food, or certified by the competent authority of the country of
origin or exporting country.
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14. "quality management
system" of a testing laboratory includes administrative documents,
technical documents, and records related to testing such as: personnel,
equipment, facilities, testing methods ensuring quality, accuracy, and
transparency of test results.
15. "inter-laboratory
comparison" means the organization, implementation, and evaluation of
testing methods on the same or similar subjects by two or more testing
laboratories under predetermined conditions.
16. "proficiency testing"
is the evaluation of the performance of participating parties according to established
criteria through inter-laboratory comparison.
Chapter II
REGISTRATION OF THE CONFORMITY DECLARATION
Article 4.
Cases of registration of the conformity declaration
Organizations and individuals shall
register the declaration of conformity of foods subject to technical
regulations on quality criteria and safety criteria in one of the following
cases:
1. Prepackaged processed foods;
2. Food additives;
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4. Instruments containing, having
direct contact with foods;
5. Packaging containing, having
direct contact with foods.
Article 5.
Documentation and procedures for registration of the product declaration
1. Application for registration of
the conformity declaration:
a) The conformity declaration
prepared in accordance with Form No. 01 in Appendix I hereof;
c) Results of conformity
certification by a certification organization accredited in accordance with
regulations of law on technical regulations, unless the conformity
certification results have been uploaded to the national database in accordance
with information technology laws (a copy bearing the seal of the organization
or individual; or an authenticated electronic copy);
c) In case a third party is
authorized by the manufacturer or owner of the food product to act as the declarant
in the conformity declaration: the authorization letter containing all
information specified in Article 7 of this Decree (a copy bearing the seal of
the organization or individual; or an authenticated electronic copy).
2. Procedures for registration of
the product declaration:
a) The organization or individual
(the applicant) shall submit 01 application for registration of the declaration
of conformity as prescribed in Clause 1 of this Article online (via the
National Public Service Portal or the National Single Window Portal or the
information system for handling administrative procedures at ministerial or
provincial level), by post, or in person to the competent authority designated
by the People’s Committee of the province where the applicant is based
(hereinafter referred to as "receiving authority"). In case the
applicant has multiple business locations, they may choose to submit the
application in any of the registered administrative division having its
business location;
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c) Food manufacturers and sellers
shall disclose their unexpired applications for registration of the declaration
of conformity of the products prescribed in Article 4 of this Decree when
selling foods on e-commerce platforms in Vietnam.
Article 6.
Validity period of the conformity declaration
1. The validity of a declaration of
conformity is the same as that of the conformity certification result and shall
not exceed 03 years.
2. In case of changes to technical
regulations during business operations, organizations and individuals shall
apply for certification of conformity with new technical regulations and
re-apply for registration of the declaration of conformity in accordance with
this Decree.
In case of other changes, the
organization or individual shall send a written notification to the receiving
authority prescribed in Point a Clause 2 Article 5 of this Decree and is
entitled to carry on the production or sale of the product immediately after
the notification is sent.
Article 7.
Regulations on authorization letters
1. The language of presentation
shall be Vietnamese, English, or both Vietnamese and English.
2. The authorization of product
declarant shall comply with relevant regulations of law on authorization and
has the following contents:
a) Name and address of the
manufacturer; in case the authorizing party is the owner of the food product,
both the name and address of the food product owner and the name and address of
the manufacturer must be specified;
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c) Scope of authorization (to act
as the product declarant and jointly bear responsibility for all matters
related to the product);
d) Name of the product covered by
the authorization.
3. In case of changes to the
authorization contents, the authorizing party shall send a written notification
to the competent authority.
4. The authorizing party and the
authorized party shall be jointly responsible for the consequences caused by
violations of the product against regulations on food safety and quality.
Chapter III
ASSURANCE OF FOOD SAFETY IN CERTAIN CASES
Section 1.
ASSURANCE OF SAFETY OF GENETICALLY MODIFIED FOODS
Article 8.
Assurance of safety of foods derived from genetically modified organisms (GMO)
and GMO products
Conditions and procedures for
issuance and revocation of the Certificate of GMO Qualified For Use as Foods
and the list of GMOs granted such Certificate shall comply with the
Government's Decree No. 69/2010/ND-CP, which is amended in 2011, 2018 and 2020.
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1. Manufacturers and sellers of
foods that contain GMOs, GMO products and has at least one genetically modified
(GM) ingredient that exceeds 5% of total ingredients used for manufacture of
such foods, in addition to compliance with regulations of law on goods labeling
prescribed in Chapter VI of this Decree, shall make sure the goods labels
contain information about the GMOs, except for the cases specified in Clause 2
of this Article.
2. Labeling of GM foods is exempted
in the following cases:
a) The prepackaged GM food contains
GM ingredients without discovery of the modified gene or products of the
modified gene in the food;
b) Fresh GM foods, unpackaged
processed GM foods sold directly to consumers;
c) GM foods serving recovery from a
natural disaster or epidemic.
Section 2.
ASSURANCE OF FOOD SAFETY OF IMPORTED TERRESTRIAL ANIMAL PRODUCTS, AQUATIC
ANIMAL PRODUCTS, PLANT PRODUCTS USED AS FOODS, AND EXPORTED FOOD PRODUCTS
REPURPOSED FOR DOMESTIC CONSUMPTION
Article 10.
Conditions applied to imported terrestrial animal products, aquatic animal
products, plant products used as foods, and exported food products repurposed
for domestic consumption
1. Imported terrestrial animal
products, aquatic animal products, plant products used as foods, except
prepackaged and processed foods, foods exported by Vietnamese organizations and
individuals to other countries but returned, and the cases specified in Article
19 of this Decree shall satisfy the following requirements:
a) Their country of origin is a
country or territory (hereinafter referred to as "country") that has
a food safety control system satisfying Vietnam’s regulations and included in
the list of registered countries that export foods derived from animals, plans
and aquatic animals to Vietnam;
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c) Each imported consignment of
animal or aquatic origin must be accompanied by a Certificate of Compliance
with Food Safety Regulations issued by a competent authority of the exporting
country (except fish caught and processed by foreign vessels, or purchased and
transshipped at sea by fishing vessels and directly exported to Vietnam through
designated ports).
2. The registration of the
exporting countries and business establishments prescribed in Article 1 of this
Article shall be carried out in accordance with Article 28 of this Decree.
Article 11.
Customs procedures applied to exported food products repurposed for domestic
consumption
1. When products and raw materials
mentioned in Clauses 3, 4, 6, and 8 Article 19 of this Decree are repurposed
for domestic consumption, procedures for repurposing shall be followed in
accordance with customs laws and food safety regulations as those applicable to
imported products, unless regulations are fully complied with during while
following initial import procedures.
2. Food products manufactured for
export as initially declared but later repurposed for domestic consumption
undergo customs procedures for import of food products and comply with
regulations of law on food safety applicable to food products for domestic
consumption.
3. Provisions of Clauses 1 and 2 of
this Article do not apply to exported products and raw materials that are
returned and repurposed for domestic consumption.
Section 3.
FOOD SAFETY REQUIREMENTS IN PRODUCTION OF DIETARY SUPPLEMENTS
Article 12.
Food safety requirements in production of dietary supplements
1. Manufacturers of dietary
supplements shall satisfy general food safety requirements specified in Clause
1 Article 19, Clause 1 Article 20 of the Law of Food safety, and the following
regulations:
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b) There must be sufficient staff
who have professional qualifications appropriate for their assigned positions
and are trained in basic knowledge of Good Manufacturing Practice (GMP), food
safety, and relevant professional knowledge. The head of the production
department and the head of the quality control department must be official,
full-time employees and work independently of each other. The technical manager
of the establishment must have a bachelor's degree or higher in medicine,
pharmacy, nutrition, food safety, or food technology, and have at least 3
years' experience in a relevant field;
c) The factory, equipment and
auxiliary utilities must be installed in a manner that is suitable for their
purposes, following one-way rules, easy to clean, not confusing, able to prevent
dust, pollution and other elements detrimental to product quality; they must be
cleaned on a daily basis;
d) Documents about the manufacture
process, quality control and distribution are fully retained to make sure the
history of every batch and documents about other activities at the facility can
be extracted;
dd) All production operations must
be carried out according to procedures and instructions. Inspection and
monitoring measures must be implemented during production to prevent risks of
confusion, contamination, and cross-contamination. Results must be recorded
immediately when performing operations or immediately after completing the
production stages;
e) A quality control department
must be established to ensure that the products are manufactured under
conformable conditions and processes; necessary tests have been run; use of raw
materials and sale of products are not approved before the quality is
satisfactory; product stability must be monitored;
g) In case of testing or production
under a contract, the contractor shall have adequate equipment and personnel to
requirements of the hirer and satisfy requirements for testing or production of
dietary supplements established by a competent authority;
h) There must be procedures for
complaint settlement, product recall, self-inspection; documents about these
tasks must be retained in full.
2. The Ministry of Health shall
provide instructions on application of GMP requirements to dietary supplements.
3. Dietary supplement manufacturers
shall apply instructions of the Ministry of Health on GMP for dietary
supplements.
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1. An application for the Certificate
of Compliance with Food Safety Regulations and GMP compliance for dietary
supplements shall include:
a) The application form No. 12 in
Appendix I hereof;
b) Overall diagram and detailed
diagram of production areas, production lines, storage areas, and testing areas
(confirmed by the applicant);
c) A list of primary equipment at
the facility (confirmed by the applicant).
2. Procedures for receiving
applications and issuing the Certificate of Compliance with Food Safety
Regulations and GMP compliance for dietary supplements.
a) An application specified in
Clause 1 of this Article shall be submitted to the Ministry of Health in
person, by post or through the online public service system;
b) If the application has to be
amended or supplemented, the receiving authority shall send a written
notification to the applicant within 05 working days after the application is
received. If the applicant fails to amend or supplement the application as
requested within 30 days, the application will be invalidated and a new
application must be submitted in order to obtain the Certificate;
c) Within 15 working days from the
receipt of the satisfactory application, the receiving authority shall
establish an inspectorate, which will to carry out a site inspection and issue
the inspection record according to form No. 13 in Appendix I hereof.
The inspectorate shall have 05 - 06
persons, at least 02 persons of whom are experienced in GMP, and 01 person is
specialized in testing;
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d) If the inspection results show
that certain remedial actions must be taken, they must be specified by the
inspectorate in the inspection record. After remedial actions are taken, the
applicant shall send a written notification of remedy results to the
inspectorate. Within 07 working days from the receipt of the notification of
remedy results, the inspectorate shall review it and propose issuance of the
Certificate to the Ministry of Health for. If the applicant fails to take
remedial actions and send the notification of remedy results to the
inspectorate within 03 months from the ending date of the inspection, the
application will be invalidated;
e) If the inspection results are
unsatisfactory, within 15 working days, the receiving authority shall send a
written notification to the applicant requesting the applicant to refrain from
initiating operation until the Certificate of Compliance with Food Safety
Regulations and GMP compliance for dietary supplements is issued, and send a
notification to a local authority for supervision.
3.
The Certificate of Compliance with
Food Safety Regulations and GMP compliance for dietary supplements shall be
valid for 03 years from the date of issuance. 06 months before its expiration
date, the Certificate holder shall submit an application for reissuance of the
Certificate. The documentation and procedures for reissuance shall comply with
Clause 1 and Clause 2 of this Article.
4. In cases where the Certificate
of Compliance with Food Safety Regulations and GMP compliance for dietary
supplements is still unexpired but the establishment's name or address on the
Certificate is changed, or the name of the establishment's legal representative
is changed without changes in the establishment's location and the contents
covered by the Certificate, the Certificate holder shall send promptly notify
the issuing authority upon the occurrence of such changes.
5. Applicants for the Certificate
of Compliance with Food Safety Regulations and GMP compliance for dietary
supplements shall pay fees for document processing to the receiving authority.
6. Manufacturers of dietary
supplements shall prepare a periodic report every 12 months from the issuance
date of the Certificate of Compliance with Food Safety Regulations and GMP
compliance for dietary supplements or an equivalent Certificate using Form No.
15 in Appendix I hereof and send it to the Ministry of Health (Vietnam Food
Administration) within 15 days from the last day of the reporting period.
Section 4.
FOOD SAFETY REQUIREMENTS APPLIED TO MANUFACTURE, SALE AND USE OF FOOD ADDITIVES
Article 14.
Food safety requirements applied to food additives
Manufacturers and sellers of food
additives shall satisfy the following food safety requirements:
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2. Only mix food additives on the
list of permitted food additives complied by the Ministry of Health, provided
the mixture does not cause any harm to human health.
3. The subdivision, decanting,
transfer of food additives shall be carried out at a facility that satisfies
food safety requirements. Food additives must be labeled in accordance with
applicable regulations.
Article 15. Use
of food additives
Responsibilities of manufacturers
and sellers:
1. Only use the food additives on
the list of permitted food additives compiled by the Ministry of Health.
2. Use food additives within
permissible limits, for appropriate types of foods; only use food additives
that have clear origins and are unexpired; satisfy administrative and technical
requirements applied to food additives.
Chapter IV
CERTIFICATE OF COMPLIANCE WITH FOOD SAFETY REGULATIONS
Article 16.
Issuance of the Certificate of Compliance with Food Safety Regulations
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2. Requirements for issuance of the
Certificate of Compliance with Food Safety Regulations are specified in Clause
1 Article 34 of the Law of Food safety. Manufacturers of dietary supplements
shall satisfy the requirements specified in Article 12 of this Decree.
3. Procedures for issuance of the
Certificate of Compliance with Food Safety Regulations in the sectors of
Agriculture, Environment, Industry and Trade:
a) If the application has to be
amended or supplemented, the receiving authority shall notify the applicant in
writing within 05 working days from the receipt of the application.
If the applicant fails to amend or
supplement the application as requested within 30 days, the application will be
invalidated and a new application must be submitted in order to obtain the
Certificate;
b) If no amendment or
supplementation is required, the receiving authority shall establish an
inspectorate (if an inferior authority is authorized to carry out the
inspection, there shall be an authorization letter) and prepare the inspection
record according to form No. 15 in Appendix I hereof within 15 working days
from the receipt of the satisfactory application;
The inspectorate established by the
Certificate-issuing authority (or the authorized inspecting authority) shall
have 03 - 05 persons, at least 02 persons are specialized in food safety
(appropriate food manufacture experts of the applicant may be invited to
participate in the inspectorate).
c) If the inspection results are
satisfactory, within 05 working days from the day on which the inspection
results are available, the receiving authority shall the Certificate using form
No. 24 in Appendix I hereof;
d) If the inspection results are
unsatisfactory and remedial actions can be taken, the inspectorate shall
specify the remedial actions and time limit (not more than 30 days) in the
inspection record.
After remedial actions are taken by
the applicant, within 05 working days, the inspectorate shall assess the remedy
results and write the conclusion in the inspection results. If the remedy
results are satisfactory, the Certificate shall be issued in accordance with
Point c of this Clause. If the remedy results are unsatisfactory, the receiving
authority shall notify the applicant and the local authority in writing.
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4. The Minister of Agriculture and
Environment and the Minister of Industry and Trade shall provide set forms for
issuance of the Certificate of Compliance with Food Safety Regulations within
their jurisdiction.
Article 17.
Establishments not required to obtain the Certificate of Compliance with Food Safety
Regulations
1. The following establishments are
not required to obtain the Certificate of Compliance with Food Safety
Regulations:
a) Small-scale food manufacturers;
b) Mobile food manufacturers and
sellers;
c) Small-scale food processors;
d) Small-scale food sellers;
dd) Sellers of prepackaged foods,
food additives, food processing aids, micronutrients;
e) Manufacturers and sellers of
instruments and materials for wrapping and storing foods;
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h) Industrial kitchens not
registered as a food business;
i) Street food vendors;
2. The entities mentioned in Clause
1 of this Article must satisfy corresponding food safety requirements.
Article 18.
Revocation of the Certificate of Compliance with Food Safety Regulations
1. Authority for revocation:
The authorities that issued the
Certificates of Compliance with Food Safety Regulations, Certificates of
Compliance with Food Safety Regulations and GMP compliance for dietary supplements
(hereinafter referred to as "Certificates of Compliance with Food Safety
Regulations") and competent authorities under regulations of law on
administrative penalties have the right to revoke the Certificates of
Compliance with Food Safety Regulations issued.
2. The Certificate of Compliance
with Food Safety Regulations shall be revoked in the following cases:
a) Its holder does not have the
Certificate of Business Registration, Certificate of Enterprise Registration,
or its holder's Certificate of Business Registration or Certificate of
Enterprise Registration does not cover the corresponding food business;
b) Its holder incurs 02 or more
administrative penalties in 12 months for failure to satisfy food safety
requirements specified in Chapter IV of the Law on Food Safety and legislative
documents on food safety requirements.
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d) Its holder manufactures
counterfeit goods that are foods, food additives, or food processing aids;
d) Within 12 months, there are 02
food poisoning incidents or 01 food poisoning incident causing death;
e) A fraudulent document, seal or
signature is used in the application for the Certificates of Compliance with
Food Safety Regulations;
g) A fake certificate of analysis
or false testing result is used in the food safety control dossier of the
Certificate holder;
h) The Certificate holder fails to
notify the competent authority of non-operation in 12 months at the location
covered by the Certificate of Compliance with Food Safety Regulations.
i) The revocation of the
Certificates of Compliance with Food Safety Regulations is requested by its
holder.
Chapter V
STATE INSPECTION OF SAFETY OF IMPORTED AND EXPORTED
FOODS AND INSPECTION DURING THEIR CIRCULATION ON THE MARKET
Article 19.
Cases in which state inspection of food safety is exempted for certain imported
foods (unless there if a food safety warning)
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2. Imports serving personal needs
of persons eligible for diplomatic immunities.
3. Products in transit, merchanting
trade, transshipment, temporarily imported for re-export, or in bonded
warehouses.
4. Test samples whose quantities
are suitable for the testing or research purposes and confirmed by the owners.
5. Products used for displayed at
exhibitions or fairs.
6. Temporarily imported products
for sale at duty-free shops.
7. Imports serving emergency
purposes under orders of the Government or the Prime Minister.
8. Products, raw materials imported
solely for processing or export manufacturing.
9. Goods serving defense and
security under written confirmation of the Minister of National Defense or the
Minister of Public Security.
10. Goods on the List of goods
traded, exchanged by border residents within duty-free allowances under
regulations of law on export and import duties serving production or
consumption by border residents (except wholesale purchases).
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1. Authorities carrying out state
inspection of imported foods prescribed in Clause 1 Article 39 of the Law on
Food Safety are state authorities delegated by the Ministry of Agriculture and
Environment or the People’s Committees of provinces to carry out state
inspection of food safety following the procedures and methods for state
inspection of food safety of imported foods, food additives, food processing aids,
primary packaging of foods in accordance with the Law on Food Safety.
2. Authorities carrying out state
inspection of imported foods (hereinafter referred to as "inspecting
authorities") have the following rights and responsibilities:
a) Carry out state inspection of
imported foods, food additives, food processing aids, primary packaging of
foods following the methods and procedures prescribed in this Decree;
b) Issue the notice of
satisfactory/unsatisfactory inspection result using Form No. 02 in Appendix I
hereof; issue the notice of articles eligible for switching from tightened
inspection to normal inspection, and from normal inspection to reduced
inspection using Form No. 03 in Appendix I hereof;
c) Assign food safety and quality
criteria applicable to imports to corresponding inspection methods;
d) Select food testing laboratories
designated to serve state management of food safety to test the food safety and
quality criteria mentioned in Point c Clause 2 of this Article;
dd) Collect testing and inspection
fees and charges in accordance with regulations of law on fees and charges;
e) Ensure the professional
qualification of testing personnel, the accuracy and objectivity of the
inspection and confirmation of food safety of import consignments and articles;
take full responsibility for state inspection of food safety of import foods;
g) Facilitate the inspection,
follow administrative and professional instructions of the People’s Committees
of provinces, the Ministry of Health, the Ministry of Agriculture and
Environment, the Ministry of Industry and Trade;
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i) Retain inspection documents and
present them at the request of competent authorities;
k) Submit reports every 06 months
to the assigning authority using Form No. 04 in Appendix I hereof, or submit ad
hoc reports to the supervisory Ministry;
l) Select food testing laboratories
designated to serve state management of food safety to test the food safety and
quality criteria of products imported for aid purposes; inspect label contents
of products imported for aid purposes;
m) Take samples for testing and
physical inspection of goods by the inspecting authority or by the food testing
laboratories designated to serve state management of food safety selected by
the inspecting authority. Sampling officials shall have certificates of
training in food sampling.
Article 21.
Methods for state inspection of food safety
Methods for state inspection of
imported foods, food additives, food processing aids, primary packaging of
foods include:
1. Tightened inspection: document inspection,
physical inspection of goods, taking samples for testing food safety and
quality criteria according to the declaration dossier and other criteria that
are unsatisfactory of have warnings against as prescribed in Clause 3 Article
22 of this Decree (if any).
2. Normal inspection: document
inspection, physical inspection of goods, taking samples for testing food
safety and quality criteria selected from groups of food safety and quality
criteria in the dossier.
On the basis of the composition and
history of quality of the article, the process of transport and preservation of
the article, the goods owner's import history, origin of the article, quality
control system being used for the article, the inspecting authority shall
select food safety and quality criteria from the groups of food safety and
quality criteria in the dossier.
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Article 22.
Application of various methods for state inspection of food safety of imported
foods
1. Reduced inspection shall be
carried out in any of the following cases:
a) There is a confirmation of food
safety issued by the competent authority of a country that has entered a mutual
recognition agreement regarding food safety inspection to which Vietnam is also
a signatory; the result of inspection of the consignment or article given by
the competent authority of the exporting country is shown to be conformable
with the law of Vietnam;
b) The inspecting authority issues
the notice of switching from normal inspection to reduced inspection;
The article is eligible for reduced
inspection for up to 12 months from the day on which the notice of switching
from normal inspection to reduced inspection is issued by the inspecting
authority (except for the case specified in Point a Clause 1 of this Article).
2. Normal inspection shall apply
all import articles, except for the cases specified in Clause 1 and Clause 3 of
this Article.
3. Tightened inspection shall be
carried out in any of the following cases:
a) The result of the previous
inspection is unsatisfactory;
b) There are conclusions from the
inspectorates (if any) that the food safety and quality criteria are not fully
satisfied;
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Article 23.
Switching between inspection methods
1. Reduced inspection shall be
applied when an import article is granted 03 consecutive notices of
satisfactory results of normal inspections in 12 months. Reduced inspection
shall be applied for up to 12 months from the day on which the last of the 3
consecutive notices of satisfactory inspection results is signed. Upon
expiration of this 12-month period, normal inspection shall be applied to the
article (except for the cases specified in Clause 3 Article 22 of this Decree).
Normal inspection and reduced
inspection of import articles shall be rotated following the principles stated
above.
2. Normal inspection shall be
applied when an import article is granted 03 consecutive notices of
satisfactory results of tightened inspections in 12 months. Normal inspection
shall be applied from the day on which the notice of switching inspection
method is signed (unless there are other warnings about the tightened
inspection duration issued by competent authorities).
Article 24.
Application for state inspection of food safety of imported foods
1. An application for reduced inspection
shall include the following documents:
a) The imported food inspection
application Form No. 05 in Appendix I hereof;
b) Conformity declaration for
products subject to conformity declaration; declaration of applied standards
for products subject to declaration of applied standards; dossier on
registration of product declaration for products subject to product declaration
registration (confirmation of product declaration registration, product
declaration, label, product standards); product standards for products not
subject to conformity declaration, declaration of applied standards and product
declaration registration. If the application is submitted by post or in person,
it shall include copies bearing the applicant's seal or authenticated electronic
copies;
b) The inspecting authority's
notice of switching from normal inspection to reduced inspection (original copy
or authenticated electronic copy) if it is the case specified in Clause 1
Article 23 of this Decree;
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dd) For the products prescribed in
Article 10 of this Decree, the certificate of fulfillment of food safety
requirements issued by a competent authority of the exporting country (copy
bearing the applicant's seal or authenticated electronic copy), except for fish
caught and processed at sea by foreign vessels and directly sold to Vietnam’s
market.
2. An application for normal
inspection shall include the following documents:
a) The imported food inspection
application Form No. 05 in Appendix I hereof;
b) Conformity declaration for
products subject to conformity declaration; declaration of applied standards
for products subject to declaration of applied standards; dossier on
registration of product declaration for products subject to product declaration
registration (confirmation of product declaration registration, product
declaration, label, product standards); product standards for products not
subject to conformity declaration, declaration of applied standards and product
declaration registration. If the application is submitted by post or in person,
it shall include copies bearing the applicant's seal or authenticated
electronic copies;
c) The inspecting authority's
notice of switching from tightened inspection to normal inspection (original
copy or authenticated electronic copy) if it is the case specified in Clause 2
Article 23 of this Decree;
d) A copy of the packing list;
dd) For the products prescribed in
Article 10 of this Decree, the certificate of fulfillment of food safety
requirements issued by a competent authority of the exporting country (copy
bearing the applicant's seal or authenticated electronic copy), except for fish
caught and processed at sea by foreign vessels and directly sold to Vietnam’s
market.
3. An application for tightened
inspection shall include the following documents:
a) The imported food inspection
application Form No. 05 in Appendix I hereof;
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c) A copy of the packing list;
d) For the products prescribed in
Article 10 of this Decree, the certificate of fulfillment of food safety
requirements issued by a competent authority of the exporting country (copy
bearing the applicant's seal or authenticated electronic copy), except for fish
caught and processed at sea by foreign vessels and directly sold to Vietnam’s
market.
Article 25.
Procedures for state inspection of food safety of imported foods
1. Procedures for reduced
inspection:
a) Before or when the goods arrive
at the border checkpoint, the goods owner shall submit the application for food
safety inspection according to Clause 1 Article 24 of this Decree to the
inspecting authority, whether online (via the National Public Service Portal, National
Single-window Information Portal, ministerial or provincial administrative
procedures information system), by post or in person;
b) Within 03 working days from the
receipt of the complete application, the inspecting authority shall carry out
document inspection and issue a notice of satisfactory/unsatisfactory
inspection results using Form No. 02 in Appendix I hereof. If the application
has to be supplemented, explanation shall be provided. The inspecting authority
may request supplementation of the application once every time the goods owner
submits the supplemented application;
c) The document inspection contents
must specify the suitability of information about the import article presented
in the entire application;
d) The goods owner shall submit the
notice of satisfactory/unsatisfactory inspection results according to Form No.
02 in Appendix I hereof to the customs authority, which serves that the basis
for grating customs clearance, unless such notice is issued via the National
Single-window Information Portal or systems connected thereto, in which case
the customs authority shall look up information on the Portal as the basis for
grating customs clearance.
2. Procedures for normal
inspection:
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b) Within 02 working days from the
receipt of the complete application, the inspecting authority shall carry out
document inspection according to Point c Clause 1 of this Article, determine
the food safety and quality criteria according to the product classification,
risk level and product declaration, and select one of the food testing
laboratories designated to serve state management of food safety to carry out the
testing. If the application has to be supplemented, explanation shall be
provided. The inspecting authority may request supplementation of the
application once every time the goods owner submits the supplemented
application;
c) Within 07 working days from the
day on which the goods arrive at the border checkpoint, the testing laboratory
mentioned in Point b of this Clause shall complete the sampling and physical
inspection of goods, and provide the Test Report to the inspecting authority;
d) Within 01 working day from the
receipt of the Test Report, the testing authority shall sign the notice of
satisfactory/unsatisfactory inspection results according to Form No. 02 in
Appendix I hereof;
dd) The goods owner shall submit
the notice of satisfactory/unsatisfactory inspection results according to Form
No. 02 in Appendix I hereof to the customs authority, which serves that the
basis for grating customs clearance, unless such notice is issued via the
National Single-window Information Portal or systems connected thereto, in
which case the customs authority shall look up information on the Portal as the
basis for grating customs clearance.
3. Procedures for tightened
inspection:
a) Before or when the goods arrive
at the border checkpoint, the goods owner shall submit the application for food
safety inspection according to Clause 3 Article 24 of this Decree to the
inspecting authority, whether online (via the National Public Service Portal,
National Single-window Information Portal, ministerial or provincial administrative
procedures information system), by post or in person;
b) Within 02 working days from the
receipt of the complete application, the inspecting authority shall carry out
document inspection according to Point c Clause 1 of this Article, determine
the food safety and quality criteria according to the product classification,
risk level and product declaration, and select a food testing laboratory
designated to serve state management of food safety to carry out the testing.
If the application has to be supplemented, explanation shall be provided. The
inspecting authority may request supplementation of the application once every
time the goods owner submits the supplemented application;
c) Within 09 working days from the
day on which the goods arrive at the border checkpoint, the testing laboratory
mentioned in Point b of this Clause shall complete the sampling and physical
inspection of goods, and provide the Test Report for the inspecting authority;
d) Within 01 working day from the
receipt of the Test Report, the testing authority shall sign the notice of
satisfactory/unsatisfactory inspection results according to Form No. 02 in
Appendix I hereof;
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4. In cases where the goods owner
authorizes another organization or individual to submit the application for
food safety inspection according to Clause 1, Clause 2 or Clause 3 of this
Article, the authorization shall be carried out as prescribed by law and
the authorization letter (original copy or authenticated electronic copy) must
be included in the application for food safety inspection.
5. If notice of unsatisfactory
inspection results is issued, the inspecting authority shall take appropriate
measures in accordance with Clause 3 Article 55 of the Law of Food Safety and
submit a report on goods unqualified for import and results of disposal thereof
foods to the People’s Committee of the province and the supervisory Ministry.
6. In cases where an import article
is subject to both state inspection of food safety and quarantine according to
regulations of law carried out by competent authorities assigned by the
Ministry of Agriculture and Environment, food safety and quarantine shall be
carried out simultaneously.
Article 26.
Disposal of non-compliant foods unfit for import
1. After disposal of the
non-compliant foods unfit for import is completed under the decision issued by
the inspecting authority, the goods owner shall submit the following documents
to the inspecting authority and the receiving authority:
a) Re-export documents in case of
re-export;
b) The destruction record certified
by a competent authority;
c) The contract for repurposing
between the goods owner and the buyer or recipient of the non-compliant goods.
Buyer or recipient of the non-compliant goods must not use them as foods.
2. If the goods are unfit for
import due to label-related violations or other violations that are not related
to food safety and quality prescribed by law:
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Article 27.
Rights and obligations of goods owners and organizations and individuals
receiving aid
Goods owners have the following
rights and obligations:
1. Request inspecting authorities
to inspect imports following the methods in one of the cases specified in
Article 21 of this Decree.
2. Request inspecting authorities
to change the method for inspecting imports prescribed in Article 22 of this
Decree. The request shall be prepared using Form No. 06 in Appendix I hereof.
3. Request inspecting authorities
to review import inspection results. If the result of the re-inspection matches
the initial result, the goods owner shall pay the re-inspection costs; if the
result of re-inspection is satisfactory, the goods owner will be reimbursed for
the re-inspection costs.
4. Propose the measures specified
in Clause 3 Article 55 of the Law of Food safety if the goods are unfit for
import.
5. Ensure the integrity of the
consignment and the goods for sampling.
6. Take legal responsibility for
the legality and accuracy of the application for inspection.
7. Implement the decision on goods
disposal issued by the inspecting authority if the goods are non-compliant and
unfit for import.
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Organizations and individuals
receiving aid may only receive the consignment after the inspecting authority
issues the conclusion that the food safety criteria are satisfied and the label
contents are compliant, and shall take full responsibility for the preservation
and provision of instructions for use of the products as recommended by the
manufacturer on the product labels. The aid must be used for intended purposes
and users.
Article 28.
Procedures for registration of the exporting countries and exporters; state
inspection of food safety in the exporting country
1. A competent authority of Vietnam
shall develop an inspection plan, inform and cooperate with the competent
authority of the exporting country in inspecting the food safety control system
of the exporting country and the manufacturer or seller of foods that are
exported to Vietnam (exporter) as follows:
a) The competent authority of the
exporting country shall send 01 application to the Ministry of Agriculture and
Environment, including information about its management system (laws,
standards, food safety control system) and its capacity for food safety control
according to Form No. 07 in Appendix I hereof; a list of manufacturers and
sellers of foods derived from animals and aquatic organisms registered for
export to Vietnam (registered exporters) according to Form No. 08 in Appendix I
hereof, and summary about their fulfillment of food safety requirements
according to Form No. 09 in Appendix I hereof.
b) Within 30 working days from the
day on which adequate documents according to Point a of this Clause are
received, the competent authorities of the exporting country and the
supervisory Ministry shall verify them, inform the competent authority of the
exporting country of the verification result and the inspection plan if
inspection of the exporting country is necessary;
c) Contents of inspection in the
exporting country include: regulations of law on food safety management and
control; capacity of food safety authorities of the exporting country;
fulfillment of food safety requirements by the registered exporters.
2. Processing of inspection results
and publishing of the list of countries and establishments permitted to export
to Vietnam:
a) If a site inspection in the
exporting country is not necessary, the Ministry of Agriculture and Environment
shall publish the inspection results, names of countries permitted to export to
Vietnam. The list of terrestrial animal products and aquatic animal products
must be published together with the list of permitted exporters.
b) If a site inspection in the
exporting country is necessary, the Ministry of Agriculture and Environment
shall process and publish the inspection results within 30 working days after
the end of the inspection in the exporting country.
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c) In case of requesting addition
to the list of permitted exporters of terrestrial animal products and aquatic
animal products, the competent authority of the exporting country shall submit
an application for document inspection or site inspection in the exporting
country which contains a list and information about the exporters according to
Form No. 08 and Form No. 09 mentioned in Point a Clause 1 of this Article to
the Ministry of Agriculture and Environment. The inspection results shall be
the basis for addition of exporters to the list.
Article 29.
State inspection of foods for export
The Minister of Health, the
Minister of Agriculture and Environment, the Minister of Industry and Trade shall
specify the authority, documentation and procedures for state inspection of
safety of foods for export under their management in accordance with Articles
41, 42, 62, 63 and 64 of the Law of Food Safety at the request of the importing
country.
Article 30.
Inspection during circulation on the market
1. Planned inspection:
Annually, on the basis of risk
levels, history of compliance with regulations on food safety of food
manufacturers and food sellers, competent authorities shall develop and issue
the plan for contents and frequency of inspection of foods in circulation on
the market, and organize the implementation of such plan.
2. An ad hoc inspection shall be
carried out in any of the following cases:
a) The inspection is necessary or
requested by a competent agency, organization or person responsible for food
safety management;
b) It is suspected that
requirements for manufacture or sale of foods are unfulfilled, and during food
safety inspection campaigns;
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d) Signs of violations against
regulations on food safety are reported by organizations and individuals in
Vietnam and overseas in any shape or form;
dd) There is information or warning
that the product in circulation does not comply with food safety regulations;
e) Survey results or food quality
inspection results show that the food product has non-compliant labels or is
suspected of non-compliance with declared standards or corresponding technical
regulations.
3. Mandatory inspection contents:
a) Inspection of the conformity of
the product with declared standards, technical regulations, goods labels and
enclosed documents;
b) Product origin tracing as per
regulations;
c) Other contents related to
product quality and safety;
d) If there is suspicion of
inferior quality of products, samples shall be taken.
dd) For food products being sold on
e-commerce platforms, in addition to inspection as prescribed at Points a, b,
c, and d of this Clause, the consistency of the actual products and information
published on websites shall be verified in accordance with regulations of law
on e-commerce.
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FOOD LABELING
Article 31.
Mandatory labeling contents
1. Manufacturers and sellers of
foods in Vietnam, in addition to common regulations of law on goods labeling,
shall comply with the following regulations:
a) The label of medical foods shall
contain the phrase " Thực phẩm dinh dưỡng y học” (“medical food”) and “Sử
dụng cho người bệnh với sự giám sát của nhân viên y tế” (“used under
supervision of health workers”);
b) The front label of foods for
special dietary uses shall contain the phrase “Sản phẩm dinh dưỡng [cho đối tượng
cụ thể]” ("nutritional products for [specific users]").
2. The label of imported products
must specify name and address of the manufacturer, name and address of the
organization or individual that submits the product declaration.
Article 32.
Exceptions
1. The secondary label is not
required for goods in hand luggage serving personal use or meant as gifts
within the duty-free allowance; imports of entities eligible for diplomatic
immunity; goods in transit, merchanting trade, transshipment, temporarily
imported goods; goods in bonded warehouses; test samples; goods for display at
an exhibition or fair; raw materials imported for production or processing of
exports or internal use and not sold domestically.
2. In addition to seasoning and
herbs, small packages whose surface area is smaller than 10 cm2 are
not required to include ingredients, expiration date, storage conditions and
instruction for use if there is a secondary label or secondary package which
contains such information.
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Chapter VII
FOOD ADVERTISEMENTS
Article 33.
Foods for which advertisement contents must be pre-registered
1. Dietary supplements, medical
foods, foods for special dietary uses, supplemented foods (except supplemented
foods that only contain vitamins, minerals and do not have health claims).
2. Dietary products for children up
to 36 months (except breast milk substitutes for children under 24 months of
age, dietary supplements for children under 06 months of age prescribed in
Article 7 of the Law on Advertising).
Article 34.
Registration of food advertisement contents
The registration of food
advertisement contents shall comply with advertising laws and the following
regulations:
1. Before advertising, the owner of
the advertised product shall register the advertisement contents with the
authority that issued confirmation of product declaration registration form
according to applicable regulations.
2. The advertisement contents must
be consistent with the uses, intended users, warnings, recommendations of the
product specified in the product declaration.
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a) It is required to have the text
“Thực phẩm này không phải là thuốc và không có tác dụng thay thế thuốc chữa bệnh”
(equivalent to the phrase “this product is not a medicine and not intended to
diagnose, treat, cure or prevent any disease”);
b) The text in Point a of this
Clause must be read aloud in case of audio and video advertisements;
c) The text in Point a of this
Clause is not required if the duration of an audio or video advertisement is
shorter than 15 seconds, but it must be displayed during the advertisement.
4. An application for certification
of advertisement contents shall include the following documents:
a) The application Form No. 10 in
Appendix I hereof;
b) For audio and video
advertisements, an audio or video recording of the proposed advertisement
script and the proposed advertisement contents (certified by the applicant);
For other types of advertisement, a maquette (certified by the applicant).
In cases where the organization or
individual responsible for placing products on the market authorizes another
organization or individual to act as the holder of the advertisement content
certification, an authorization letter (certified by the authorizing party and
the authorized party).
The aforementioned documents must
be written in Vietnamese language. The applicant shall provide Vietnamese
translations of the documents written in English and take responsibility for
the accuracy of such translations.
Documents in foreign languages
other than English must be accompanied by Vietnamese translations bearing the
translators' authenticated signatures. If the Vietnamese translations cannot be
provided, the applicant shall submit the English translations bearing the
translators' signatures authenticated in the country or origin or exporting
country; The applicant shall provide the Vietnamese translations and take
responsibility for the accuracy of such translations;
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5. Procedures for issuance of the
certificate of advertisement contents:
a) The advertised product owner
shall send the application for certification of advertisement contents to the
authority that issued the confirmation of product declaration registration,
whether online (via the National Public Service Portal or the National Single
Window Portal or the ministerial or provincial administrative procedures
information system), by post, or in person;
b) Within 10 working days from the
receipt of the satisfactory application, the receiving authority shall process
it and issue form No. 11 in Appendix I hereof. This 10-day period shall be
reckoned from the arrival date according to the date stamp appended by the
receiving authority if the application is submitted by post or in person, or
the date of receipt of the satisfactory application on the online public
service system.
If advertisement content is not
accepted or the application has to be supplemented, the receiving authority
shall provide explanation in writing and specify the legal basis.
The applicant shall complete
supplementing the application within 60 days from the receipt of the receiving
authority's request for supplementation. The applicant may supplement the
application up to 02 times. If the application is still unsatisfactory after
the 60-day time limit expires, it shall be invalidated. The receiving authority
may only request supplementation 02 times per application.
Within 10 days from the day on
which the supplemented application is received, the receiving authority shall
process it and issue the advertisement content certification or provide a
written response;
c) The receiving authority shall
publish the names and certified advertisement contents of organizations and
individuals to which the advertisement content certification is granted on its
website and the food safety database;
d) The applicant shall pay the fee
for application processing to the receiving authority.
6. The owner of the advertised
product and the advertiser may only advertise the product after having obtained
the advertisement content certification and must adhere to the certified
content. When selling or advertising food products subject to advertisement
content certification on e-commerce platforms, websites, social networks,
online applications, Internet-connected digital platforms in Vietnam, the
advertisement content certification and the advertisement contents certified by
competent authorities must be published.
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a) Confirmation of product declaration
registration is revoked;
b) The product is being suspended
under a decision of a competent authority.
Chapter VIII
FOOD TESTING SERVING STATE MANAGEMENT
Article 35.
Conditions to be satisfied by food testing laboratories serving state
management and verifying laboratories
1. A food testing laboratory
serving state management shall satisfy the following conditions:
a) The laboratory has been granted
the certificate of registration of testing activities in accordance with
regulations on conditions for provision of conformity assessment services which
covers testing activities appropriate for the proposed operations or testing
criteria on the lists promulgated by the Ministry of Health, the Ministry of
Agriculture and Environment, the Ministry of Industry and Trade, the Ministry
of Science and Technology;
b) The quality control system has
been recognized as conformable with ISO/IEC 17025 on food testing and analysis;
c) The facilities and equipment are
appropriate for the testing requirements and proposed operations;
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dd) The testing and analysis
methods are up to date and certified; the capacity of testing the proposed
criteria is conformable with corresponding technical regulations and other
relevant requirements laid down by the supervisory Ministry;
e) The proposed testing and
analysis methods have undergone proficiency testing or inter-laboratory
comparison with satisfactory results;
If there is no Vietnamese entity
capable of proficiency testing or inter-laboratory comparison of the proposed
testing and analysis methods, there shall be adequate documentation about the
testing and analysis methods, confirmation of usability of the testing and
analysis methods, reference materials or reference strains.
2. Verifying laboratories on the
list of verifying laboratories qualified for operation published by the
supervisory Minister (except the Minister of Industry and Trade).
The verifying laboratory shall
satisfy the following conditions:
a) It is a state-owned testing
laboratory;
b) It has been designated as a food
testing laboratory serving state management.
In case of disputes prescribed in
Clause 1 Article 47 of the Law on Food Safety, the settling authority shall
select a verifying laboratory from the list of verifying laboratories qualified
for operation to carry out the verification testing.
Article 36.
Application for designation as food testing laboratory serving state management
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a) The application form No. 16 in
Appendix I hereof;
b) The procedures, reports
confirming the usability of testing methods for the proposed criteria,
procedures for receiving samples and providing results (copies);
c) Capacity profile, including:
Report on the testing laboratory's capacity according to Form No. 17 in
Appendix I hereof; documentary evidence of testing and analysis quality
(copies): results of proficiency testing or inter-laboratory comparison or
documentation about reference materials or reference strains used for quality
control of testing and analysis methods while an entity capable of proficiency
testing or inter-laboratory comparison is unavailable; reports on test results
of the laboratory analysts' proficiency in testing the proposed criteria.
2. An application for change or
expansion of designation scope shall include the following documents:
a) The application form No. 16 in
Appendix I hereof;
b) The procedures, reports
confirming the usability of testing and analysis methods for the proposed
criteria being changed or expanded;
c) Capacity profile, including:
Report on the testing laboratory's capacity according to Form No. 17 in
Appendix I hereof; documentary evidence of testing and analysis quality
regarding the change or expansion (copies): results of proficiency testing or
inter-laboratory comparison or documentation about reference materials or
reference strains used for quality control of testing and analysis methods
while an entity capable of proficiency testing or inter-laboratory comparison
is unavailable; reports on test results of the laboratory analysts' proficiency
in testing the proposed criteria being changed or expanded.
3. An application for extension of
designation shall include the following documents:
The designation scope of the issued
designation decision shall not be affected by extension. An application for
extension of designation shall include:
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b) The report on performance of the
testing laboratory over the designation period according to Form No. 18 in
Appendix I hereof.
Article 37.
Designation procedures
1. The testing laboratory (the
applicant) shall submit 01 application via the online public service system or
by post or in person to the competent authority (hereinafter referred to as
"designating authority) delegated by the People’s Committee of the
province where the testing and analysis are conducted.
In case of extension of
designation, the testing laboratory shall submit the application 90 days before
the expiration date of the designation decision.
2. Time limit for the designating
authority to process the application according to Article 36 of this Decree:
a) Within 10 days if the
application has up to 20 proposed criteria;
b) Within 20 days if the
application has 21 - 50 proposed criteria;
c) Within 30 days if the application
has more than 50 proposed criteria.
If the application is
unsatisfactory, the designating authority shall request the testing laboratory
to supplement the application in writing. Only 01 supplementation request may
be made per application. The testing laboratory shall complete supplementing
the application within 30 days from the receipt of the designating authority's
request for supplementation. The testing laboratory may only supplement the
application 01 time. If the application is still unsatisfactory when the 30-day
time limit expires, it shall be invalidated. Within 10 days from the receipt of
the supplemented application, the designating authority shall process the
application. If the application is unsatisfactory, the designating authority
shall send a notification and provide explanation.
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The decision on assessment team
establishment shall specify the assessment scope and contents, names and duties
of each member who conducts the on-site assessment. Mandatory evaluation
contents include:
a) The testing laboratory's
fulfillment of the conditions specified in Article 35 of this Decree and
relevant regulations of law;
b) The authenticity of the application
for designation.
The testing laboratory assessment
record shall be prepared accordance with Form No. 19 in Appendix I hereof.
4. Within 15 days from the receipt
of the testing laboratory assessment record:
a) If the assessment results are
satisfactory, the designating authority shall issue the decision on designation
of food testing laboratory serving state management;
b) If the assessment results are
unsatisfactory, the designating authority shall issue a notice of rejection;
c) If the testing laboratory
assessment record requires the testing laboratory to take certain remedial
actions, the testing laboratory shall send a report on remediation to the
designating authority according to Form No. 20 in Appendix I hereof within 60
days from the receipt of the request for remediation.
If the testing laboratory's
remediation is satisfactory, the designating authority shall issue the decision
on designation of food testing laboratory serving state management within 30
days from the receipt of the report on remediation. In case of rejection, the
designating authority shall provide written explanation for the testing
laboratory.
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Article 38.
Assignment of testing serving state management and verifying testing
1. Where it is necessary to test
certain criteria to serve state management that were not previously assigned as
testing criteria serving state management, the People’s Committee of the
province, the supervisory Ministry shall select one of the designated testing
laboratory to test these criteria.
2. Where it is necessary to carry
out a verifying testing but none of the verifying laboratories on the list of
verifying laboratories qualified for operation is capable of the testing, the
dispute-settling authority shall request the supervisory Minister (except the
Minister of Industry and Trade) to select and assign a testing laboratory to
run the verifying testing.
Article 39.
Issuance of testing laboratory codes
Designating authorities shall issue
testing laboratory codes to food testing laboratories serving state management.
Composition of a testing laboratory code:
(ordinal number)/(symbol of the
People’s Committee of the province)-KNTP-sector code (if any)
Article 40.
Responsibilities of designating authorities and food testing laboratories
serving state management
1. Responsibilities of designating
authorities:
a) Designating authorities shall
receive applications for initial designation, extension of designation, changes
or expansion of designation scope; organize assessment and designation of
testing laboratories;
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c) Ensure objectivity and fairness
in assessment, designation and inspection;
d) Protect confidentiality of
information and data related to testing laboratories and verifying
laboratories;
dd) Issue, suspend, un-suspend,
revoke, partially or fully invalidate designation decisions. Consider reinstatement
of the designation decision after the food testing laboratory serving state
management completes and reports the remediation as requested;
e) Publish the list of testing
laboratories whose designation decisions are issued, suspended, reinstated,
revoked, invalidated and the scope of designation, suspension, reinstatement,
revocation, invalidation;
g) Organize inspections, handle
complaints and denunciations related to food testing laboratories serving state
management as prescribed by law;
h) Retain dossiers on food testing
laboratories serving state management;
i) Collect, use fees for assessment
and designation of testing laboratories in accordance with regulations of law
on fees.
2. Responsibilities of food testing
laboratories serving state management:
a) Take legal responsibility for
the test results;
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c) Comply with requirements of the
quality control system recognized as compliant with ISO/IEC 17025; ensure and
maintain adherence with procedures related to the designation scope;
d) Notify the designating authority
of any change to the recognized quality control system and reduction in scope
of designation within 05 working days from the day on which the change occurs;
dd) Notify the designating
authority of supervision results provided by the accrediting organization,
results of participation in proficiency testing and inter-laboratory comparison
(within 03 working days from the day on which the testing laboratory receives
the results);
e) Submit periodic reports, ad hoc
reports or thematic reports to the designating authority:
The periodic report on performance
of the testing laboratory shall be prepared according to Form No. 18 in
Appendix I hereof and submitted before December 20 every year.
Ad hoc reports or thematic reports
shall be submitted as requested by the designating authority;
g) In addition to the regulations
above, testing laboratories must also pay assessment fees in accordance with
regulations of law on fees; ensure honesty, objectivity, and accuracy of test
results; Test Reports must contain all information as prescribed in Form No. 22
Appendix I hereof; facilitate inspections of testing activities when required
by state management authorities;
h) Perform other duties of
conformity assessment organizations prescribed by the Law on Technical
regulations and standards.
Article 41. Cases
or partial or full invalidation of designation decisions
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1. The testing laboratory is
dissolved, has its juridical personality revoked by a competent authority, or
is no longer licensed for food testing under decisions of competent
authorities.
2. It is requested by the food
testing laboratory serving state management.
Chapter IX
TRACING FOOD ORIGINS
Article 42.
Tracing origins of unsafe foods
The manufacturer or seller, upon
discovery that a food being manufactured or sold is not safe or at the request
of a competent authority, shall trace its origin in accordance with Clause 1
and Clause 2 Article 54 of the Law of Food Safety.
Article 43.
Carrying out unsafe food origin tracing
1. Food manufacturers and sellers
shall regularly create and fully retain information about the products, working
days, semi-finished products, manufacturing facilities, suppliers of input
materials, suppliers, distributors, sellers of products and customers who
bought such products in the form of contracts, logbooks or other methods
throughout the processes of manufacture, processing, preservation, transport,
export, import sale to serve origin tracing. Such information shall be retained
in the form of database connected to competent authorities' database.
Information serving origin tracing include:
a) Information about operation of
the food manufacturer or food seller;
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c) Information about products
suppliers, distributors, sellers, and customers (if any).
2. The Minister of Health, the
Minister of Agriculture and Environment, the Minister of Industry and Trade
shall promulgate specific regulations on tracing origins of products under
their management and implementation roadmaps.
Chapter X
RESPONSIBILITIES FOR STATE MANAGEMENT OF FOOD
SAFETY
Article 44.
Rules for determination of responsibility for state management of food safety
1. Conformity with the Law of Food
Safety and relevant legislative documents.
2. Uniform state management of food
safety.
3. Maintain management throughout
the processes of manufacture and sale of foods.
4. Close cooperation between
Ministries and central authorities.
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6. Ensure scientific nature,
adequacy and feasibility.
7. Delegation of state management
of food safety between central and local authorities.
8. Regarding a manufacturer whose
products are under the management of more than one authority, the authority
that is responsible for the largest quantity of the products shall be the
supervisory authority.
9. Regarding a seller whose
products are under the management of more than one authority, the industry and
trade authority shall be the supervisory authority, except for wholesale farm
produce markets.
10. A facility that both
manufactures and sells products that are under the management of more than one
authority, is entitled to select its supervise authority to follow
administrative procedures.
Article 45.
Responsibility of the Ministry of Health for state management of food safety
1. Implement regulations on general
responsibility for state management of food safety in Clause 1 Article 62 of
the Law of Food Safety.
2. Submit periodic and ad hoc
reports on management of food safety on the basis of supervision and
consolidation of reports from other Ministries and the People’s Committees of
provinces.
3. Promulgate national technical
regulations on products under its jurisdiction according to Article 62 of the
Law of Food Safety and the products in Appendix II hereof; promulgate national
technical regulations or regulations on food safety limits after receiving the
full drafts of national technical regulations or regulations on food safety
limits from the Ministry of Agriculture and Environment and the Ministry of
Industry and Trade.
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5. Organize receipt and management
of applications, issuance, revocation of Certificates of Compliance with Food
Safety Regulations and GMP compliance for dietary supplements; advertisement
content certifications for dietary supplements.
6. Issue the List of verifying
laboratories under its jurisdiction.
7. Carry out inspection and handle
violations against regulations of law on food safety during the processes of
manufacture, export, import, sale of foods under its jurisdiction.
8. Carry out inspection,
supervision, take actions against violations against regulations on advertising
of products, goods and services under its jurisdiction.
9. Annually develop and implement
periodic inspection plans and ad hoc inspection plans where necessary under its
jurisdiction.
Article 46.
Responsibility of the Ministry of Agriculture and Environment for state
management of food safety
1. Promulgate national technical
regulations on products and groups of products under its jurisdiction according
to Article 63 of the Law of Food Safety and Appendix III hereof (except primary
packages of foods specified by the Ministry of Health).
2. Establish safety limits applied
to the groups of products in Appendix III hereof and send them to the Ministry
of Health for promulgation.
3. Manage and inspect the
delegation of management of food safety throughout the processes of farming,
breeding, harvesting, catching, extraction, collection, slaughtering,
preparation, processing, preservation, transport, export, import, sale of
cereals, meat and meat products, aquatic products, vegetables, tubers, fruits,
eggs and egg products, raw fresh milk, honey and honey products, genetically
modified foods, salt, and other products and groups of products specified in
Appendix III attached to this Decree.
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5. Establish management hierarchy,
documentation and procedures for issuing various certificates related to food
export when required by the importing country in accordance with Article 42 of
the Law on Food Safety and the provisions of this Decree.
Manage and inspect the issuance of
various certificates related to food export when required by the importing
country in accordance with Article 42 of the Law on Food Safety and the
provisions of this Decree.
6. Issue the List of verifying
laboratories under its jurisdiction.
7. Publish the list of countries
and establishments permitted to export to Vietnam under its jurisdictions.
8. Carry out inspections and handle
violations against regulations of law on food safety during the processes of
manufacture, export, import, sale of foods under its jurisdiction.
9. Annually develop and implement
periodic inspection plans and ad hoc inspection plans where necessary under its
jurisdiction.
10. Organize and delegate the
issuance of Certificates of Compliance with Food Safety Regulations to
manufacturers and sellers of the products under its jurisdiction.
Article 47.
Responsibility of the Ministry of Industry and Trade for state management of
food safety
1. Promulgate national technical
regulations on products and groups of products under its jurisdiction according
to Article 64 of the Law of Food Safety and Appendix IV hereof.
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3. Provide instructions on origin
tracing; develop and operate the system for tracing origin of foods under the
jurisdiction of the Ministry of Industry and Trade.
4. Perform and delegate food safety
management tasks throughout the processes of production, collecting,
preparation, processing, storage, transport, export, import, sale of the
products specified in Appendix IV hereof.
5. Perform food safety management
at supermarkets, shopping malls, convenience stores, facilities of the storage
and distribution system, and other types of business. Carry out inspection and
supervision of food sale on e-commerce platforms, promptly detect and handle
violations, remove violating contents as per regulations.
6. Organize and delegate the
issuance of Certificates of Compliance with Food Safety Regulations to
manufacturers and sellers of the products under its jurisdiction.
7. Carry out inspection to prevent
counterfeit foods and trade fraud regarding every type of foods, food
additives, food processing aids, food containers and packages.
8. Carry out inspection and handle
violations against regulations on law on food safety during the processes of
manufacture, export, import, sale of foods under its jurisdiction. Carry out
inspection and handle manufacture and sale of counterfeit, banned, smuggled,
fraudulent goods and foods on e-commerce platforms.
9. Annually develop and implement
periodic inspection plans and ad hoc inspection plans where necessary under its
jurisdiction.
Article 48.
Responsibility of the Ministry of Finance for state management of food safety
Promptly provide the following
information about food manufacturers and food sellers for the Ministry of
Health, the Ministry of Agriculture and Environment, the Ministry of Industry
and Trade, the People’s Committees of provinces:
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2. Changes of enterprises' business
locations.
3. Suspension, closure or
dissolution of enterprises.
4. Information about import
consignments exempted from state inspection of food safety when requested by
supervisory Ministries.
5. Information about quantities and
values of import and export consignments annually or when requested by
supervisory Ministries.
6. Information about export and
import consignments suspected of violations against regulations on food safety
during customs inspection.
Article 49.
Responsibility of the Ministry of Science and Technology for state management
of food safety
1. Promulgate annual plans for
development of National Standards (TCVN) for foods at the request of the
Ministry of Health, the Ministry of Agriculture and Environment, the Ministry
of Industry and Trade.
2. Inspect and supervise the
operation of organizations registered for recognition of testing laboratories
under ISO/IEC 17025.
Article 50.
Responsibility of the Ministry of Culture, Sports and Tourism for state
management of food safety
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2. Prevent and remove violating
food advertisements following the procedures prescribed in legislative
documents on advertising.
Article 51.
Responsibility of the People’s Committees of provinces of state management of
food safety
1. Carry out state management of
food safety in their provinces; take responsibility to the Government of
Vietnam for food safety in their provinces. Presidents of the People’s
Committees of provinces shall directly hold the position of chief of the
provincial food safety committee and carry out inspection and supervision of
food safety in their provinces; inspect implementation of regulations of law on
food safety by inferior authorities; take actions against cadres and civil
servants who fail to fulfill their duties; organize settlement of complaints
and denunciations; handle violations against regulations of law on food safety;
take responsibility to the Government for occurrences of violations against
food safety in their provinces.
2. Organize implementation of
regulations on food safety of the Government, Ministries and central
authorities in their provinces.
3. Operate the provincial food
safety committees.
4. Organize dissemination and
education of food safety laws in their provinces; encourage professional
associations, socio-political organizations, organizations and individuals, the
people to promptly report food safety-related violations committee in their
provinces.
5. Provide resources for
specialized agencies to perform their food safety management tasks.
6. Take responsibility for food
safety management in their provinces; inspect fulfillment of food safety
requirements by micro food manufacturers and sellers, street vendors, food and
drink businesses and markets in their provinces and within their jurisdiction.
7. Manage food safety requirements
applicable to manufacturers and sellers of primary packaging of foods, water
and ice used for production and sale of agriculture, forestry, aquaculture
products. Manage food safety at wholesale farm produce markets.
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9. Organize, delegate and assign
performance of the following tasks:
a) Receive and manage applications;
issue and revoke advertisement content certifications for medical foods, food
for special dietary uses, dietary products for children up to 36 months,
supplemented foods (except supplemented foods that only contain vitamins,
minerals and do not have health claims);
b) Receive conformity declaration
dossiers; Issue and revoke Certificates of Compliance with Food Safety
Regulations and GMP compliance for dietary supplements;
c) Issue, supplement, revise,
reissue, revoke Certificates of Free Sale (CFS), Health Certificates and other
certificates related to exported foods at the request of importing countries
under assignment and delegation;
d) Issue, suspend, un-suspend,
revoke, partially or fully invalidate decisions on designation of food testing
laboratory serving state management of food safety and quality;
dd) Assign tasks, suspend, revoke
decisions to assign tasks to food safety inspection authorities as delegated by
the Minister of Health, the Minister of Industry and Trade, and organize
inspection of the performance of assigned agencies.
10. Carry out inspection,
supervision, handle violations against regulations on advertising products,
goods and services under its jurisdiction.
11. Assign agencies receiving
conformity declaration dossiers to develop and implement plans for document
inspection after conformity declarations are submitted; take actions against
non-compliant conformity declaration dossiers. Within allocated local funding,
the receiving agency shall annually develop inspection plans, allocate funding
for sampling to monitor quality and safety of products declared for circulation
in the market, focusing on product groups used by high-risk groups such as
children, the elderly, pregnant women, and patients. Based on monitoring
results, conduct site inspections at manufacture and trading establishments,
and handle violations if detected.
12. Promptly provide supervisory
Ministries with the list of food testing laboratories whose certificates of
testing registration have been granted, suspended, revoked, and sanctioned food
testing laboratories.
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14. Inspect and supervise the
operation of food testing laboratories serving state management of food safety;
state inspection agencies for imported foods; registered food testing
laboratories; inspect and supervise the operation of conformity assessment organizations
registered for certification of Hazard Analysis and Critical Control Point
(HACCP) systems; ISO/IEC 17025; International Food Standards (IFS); British
Retail Consortium (BRC) standards; Food Safety System Certification (FSSC) or
equivalent standards in Vietnam.
15. Annually develop and implement
periodic inspection plans and ad hoc inspection plans where necessary under its
jurisdiction.
Article 52.
Cooperation in food safety assurance
1. Ministries, within the scope of
their management, shall cooperate with the Ministry of Health in performing
state management tasks to ensure uniform and effective state management of food
safety.
2. The Ministry of Health shall
preside over the development of a food safety education program; the Ministry
of Agriculture and Environment, the Ministry of Industry and Trade, other
Ministries and central authorities shall cooperate with the Ministry of Health
in running the program.
3. The Ministry of Health, the
Ministry of Agriculture and Environment and the Ministry of Industry and Trade
shall plan and carry out inspections of products under their jurisdiction in
cooperation with other Ministries and central authorities.
4. In case of food poisoning, the
Ministry of Health shall be responsible for organizing emergency aid and
treatment for food poisoning victims. Other Ministries shall provide adequate
documents and information about the origin of the food suspected of poisoning;
cooperate with the Ministry of Health in investigating and tracing the origin
and disposal of the poisoning foods.
5. Upon discovery of non-compliant
foods under jurisdiction of other Ministries and central authorities, the
Ministry of Health shall take charge and cooperate with relevant Ministries and
central authorities in carrying out inspection and giving conclusion.
6. Upon discovery of infringement
of the civil rights of vulnerable groups or public interests, agencies,
organizations and individuals shall file civil lawsuits as prescribed by law to
protect the civil rights of vulnerable groups or to protect public interests.
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8. The Ministry of Health, the
Ministry of Agriculture and Environment, the Ministry of Industry and Trade,
the Ministry of Science and Technology, the People’s Committees of provinces
shall, within the scope of their functions and duties, review, promptly update
and amend National Technical Regulations, local technical regulations, National
Standards for food safety.
9. Owners of e-commerce platforms
and e-commerce applications (including food delivery applications) shall:
a) Establish a mechanism for
content moderation, requesting sellers to provide and public legal documents
about their products as per regulations;
b) Cooperate with regulatory
authorities and promptly remove non-compliant products when requested;
c) Take joint responsibility for
failure to implement content moderation causing food safety incidents and
damage to consumers.
10. Food manufacturers and food
sellers shall update warnings about their products and voluntarily recall the
products upon discovery of risks to consumers' health.
Chapter XI
IMPLEMENTATION CLAUSES
Article 53.
Implementation clauses
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2. The Government’s Decree No.
15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the
Law on Food Safety shall cease to be effective from the effective date of this
Decree.
3. The following regulations are
annulled:
a) Clause 1 Article 24b of the
Government’s Decree No. 77/2016/ND-CP dated July 01, 2016 on amendments to
regulations on conditions for international trade in goods, chemicals, industrial
explosives, fertilizers, gases, foods under the jurisdiction of the Ministry of
Industry and Trade, which is amended by Article 13 of the Government’s Decree
No. 17/2020/ND-CP dated February 05, 2023 on amendments to some Decrees on
business conditions under the jurisdiction of the Ministry of Industry and
Trade;
b) Clause 1 Article 3 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations on business conditions under the jurisdiction of the Ministry of Health;
c) Article 29 of the Government’s
Decree No. 136/2025/ND-CP dated June 12, 2025 on devolution and delegation in
the agriculture and environment sector;
d) Clause 3 Article 27; regulations
on procedures for designation of testing laboratories serving state management
in sections I, II, III and procedures for designation of verifying laboratories
in sections IV, V, VI of Appendix XI promulgated together with the Government’s
Decree No. 146/2025/ND-CP dated June 12, 2025 on devolution and
delegation in the industry and trade sector;
dd) Article 25; Clause 1 Article
28; Article 30, parts 1, 2 and 12 of Appendix V promulgated together with
the Government’s Decree No. 148/2025/ND-CP dated June 12, 2025 on devolution
and delegation in the health sector.
4. In cases where any of the
documents referred to in this Decree are amended or replaced, the newest
document shall be applied.
Article 54.
Transition clauses
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2. From December 12, 2026,
manufacturers of medical foods, foods for special dietary uses, supplemented
foods, nutritional products for children up to 36 months of age shall obtain
the Certificate of Hazard Analysis and Critical Control Point (HACCP), ISO
22000 on Food Safety Management System, International Featured Standards (IFS),
British Retail Consortium (BRC) standards, Food Safety System Certification
(FSSC 22000), an equivalent certification, or Certificate of Compliance with Food
Safety Regulations and GMP compliance.
3. Applications for designation,
change or expansion of scope of designation, extension of period of designation
of food testing laboratories serving state management submitted before the
effective date of this Decree shall be processed in accordance with regulations
applicable when they were submitted, unless the applicants wish to apply the
provisions of this Decree.
4. Decisions on designation of food
testing laboratory serving state management, decisions on promulgation of the
List of verifying laboratories qualified for operation that were issued before
the effective date of this Decree shall remain effective until the expiration
dates written on these decisions.
5. Decisions on designation of
authorities carrying out state inspection of imported foods issued by
supervisory Ministries before the effective date of this Decree shall remain
effective until the end of March 31, 2026.
6. Establishments that were granted
any of the following certificates of compliance with: GMP, HACCP, ISO 22000,
IFS, BRC, FSSC 22000 or an equivalent certificate which is still unexpired and
were not required to obtain the Certificates of Compliance with Food Safety
Regulations shall obtain the Certificates of Compliance with Food Safety
Regulations within 12 months from the effective date of this Decree, except
establishments having unexpired Certificates of Compliance with Food Safety
Regulations and GMP compliance for dietary supplements.
Article 55.
Responsibility for implementation
Ministers, Heads of
ministerial-level agencies, Heads of Governmental agencies, President of the
People’s Committees of provinces, relevant organizations and individuals are
responsible for implementation of this Decree.
...
...
...
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APPENDIX I
(Enclosed
with the Government’s Decree No. 46/2026/ND-CP dated January 26, 2026)
Form
No. 01
DECLARATION OF CONFORMITY
Form
No. 02
Notice of satisfactory/unsatisfactory
results of normal inspections
Form
No. 03
Notification of change of
inspection method
...
...
...
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Report on state inspection of
food safety of imported foods
Form
No. 05
Registration of imported foods
inspection
Form
No. 06
Request for change of inspection
method
Form
No. 07
Information about management
system and capacity for food safety control of the competent authority of the
exporting country
Form
No. 08
List of registered exporters of
foods to Vietnam
...
...
...
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Summary of information about food
producer and seller’s fulfillment of food safety requirements
Form
No. 10
Application form for
certification of advertisement contents
Form
No. 11
Advertisement content
certification
Form
No. 12
Application form for issuance of
the certificate of GMP for dietary supplements
Form
No. 13
Inspection record
...
...
...
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Certificate of food safety and
GMP compliance for dietary supplements
Form
No. 15
Report on manufacture of dietary
supplements
Form
No. 16
Application form for
designation/change/addition/extension of designation of food testing
laboratory serving state management
Form
No. 17
Report on capacity of testing
laboratory
Form
No. 18
Testing laboratory performance
report
...
...
...
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Testing laboratory assessment
record
Form
No. 20
Remediation report
Form
No. 21
Decision on designation of food
testing laboratory serving state management
Form
No. 22
Test record
Form
No. 23
Food safety inspection record
...
...
...
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Certificate of Compliance with
Food Safety Regulations
Form
No. 01
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
DECLARATION
OF CONFORMITY
No.
………………./Name of enterprise/Year of declaration
I. Information about the
declarant
Name of the declarant:
.........................................................................................
Address:
....................................................................................................................;
...
...
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E-mail
.....................................................................................................................
Applicant’s enterprise ID number:
.......................................................................
Number of the Certificate of
Compliance with Food Safety Regulations:
....................................... Date of issue/Issuing authority:
……………….. (if the declarant is subject to issuance of the Certificate of
Compliance with Food Safety Regulations in accordance with regulations of law)
II. Information about the
declared product
1. Name of the product:
............................................................................................
2. Ingredients:
....................................................................................................................
3. Quality criteria and safety
criteria of the product1:
............................................
4. Expiration date (if required on
the label):
........................................................................................................................................
5. Packaging specifications and
packaging materials: ................................................
...
...
...
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.......................................................................................................................................
III. Label design sample (attach
the label design or proposed label design)
IV. Food safety and quality
requirements
This declaration of compliance with
food safety regulations is made according to:
......................................................... 2
We hereby undertake to comply with all
regulations of law on food safety and take full responsibility for legality of
the declaration, food safety and quality of the declared product.
[location,
date]
REPRESENTATIVE OF THE DECLARANT
(Signature and seal)
_________________________
...
...
...
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2 Specify the
number/symbol, date of issue, issuer of the conformity certification results
provided by the accredited certification body.
Form
No. 02
INSPECTING
AUTHORITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
NOTIFICATION
OF SATISFACTORY/UNSATISFACTORY INSPECTION RESULTS
No.
……/20…../TBNK
1. Name, address and phone number of
the goods owner:
........................................................................
...
...
...
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3. Name, address and phone number
of the exporter: ...................................................
4. Customs declaration number (if
any):
....................................................................................
5. Border checkpoint of departure:
............................................................................
6. Border checkpoint of arrival:
...............................................................................
7. Date of inspection: ..........................................................................................
8. Place of inspection:
.............................................................................................................
9. Details about the consignment:
No.
Article
...
...
...
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Name
and address of the manufacturer
Method
of inspection
Satisfactory/unsatisfactory
result
Reasons
for unsatisfactory results
Disposal
of unsatisfactory goods
(1)
(2)
(3)
(4)
...
...
...
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(6)
(7)
(8)
...
...
...
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...
...
...
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Recipients:
- Goods owner: ……………..;
- Border checkpoint customs:…………;
- Archive: ……….
[location,
date]
INSPECTING AUTHORITY
(Signature, seal)
Form
No. 03
INSPECTING
AUTHORITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
……/TB-(authority's symbol)
[location,
date]
...
...
...
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To:
(Name, address of the goods owner)
Pursuant to Article ... of the
Government’s Decree No. ... dated ... on elaboration of some Articles and
measures for organization of the implementation of the Law on Food Safety and
at the request of [goods owner's name] at document No. ... dated ... requesting
change of state inspection method.
[Inspecting authority] hereby
notifies the change of the method of state inspection of food safety:
1. Information about the
products proposed for change of inspection method:
No.
Article
Product
group (According to QCVN or Codex or manufacturer’s standard)
Name
and address of the manufacturer
Applied
inspection method
...
...
...
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(2)
(3)
(4)
(5)
...
...
...
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No.
Article
Product
group (According to QCVN or Codex or manufacturer’s standard)
Name
and address of the manufacturer
New
inspection method
Reasons
for change*
Implementation
period**
(1)
(2)
...
...
...
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(4)
(5)
(6)
(7)
...
...
...
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* Specify the reasons for change
e.g. the product is granted 03 consecutive Notifications of satisfactory results
of normal inspections in 12 months.
** Specify the beginning date and
ending date of the implementation period.
3. Information about the
products ineligible for change of inspection method:
No.
Name
of goods
Product
group (According to QCVN or Codex or manufacturer’s standard)
Name
and address of the manufacturer
Reasons
for not changing inspection method
...
...
...
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(2)
(3)
(4)
(5)
...
...
...
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4. Other contents (if any)
For your information and
cooperation.
Sincerely,
Recipients:
- Goods owner: ……………..;
- Border checkpoint customs:…………;
- Archive: ……….
INSPECTING
AUTHORITY
(Signature, seal)
Form No. 04
INSPECTING
AUTHORITY
-------
...
...
...
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REPORT
State
inspection of food safety of imported foods
From
...... to ......
Name of the inspecting authority:
...........................................................................
Address:
....................................................................................................................
Telephone: ……………………………………… Fax:
...........................................................
I. INSPECTED ITEMS:
A. General information:
...
...
...
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Inspected items
Reduced inspection
Normal inspection
Tightened inspection
Satisfactory (a)
Unsatisfactory (b)
Total (a+b)
Satisfactory (a)
Unsatisfactory (b)
...
...
...
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Satisfactory (c)
Unsatisfactory (d)
Total (c+d)
1
Total
number of articles in each product group (e.g. single-substance food
additives)
...
...
...
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2
Average
time for consignment inspection (hour)
...
...
...
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No.
Name
and address of the goods owner
Name
of products
Product
group
Name
and address of the manufacturing facility
Method
of inspection
Reasons
for unsatisfactory results
Disposal
...
...
...
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...
...
...
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II. SUGGESTIONS:
REPRESENTATIVE
OF INSPECTING AUTHORITY
(Signature, seal)
Form
No. 05
...
...
...
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REGISTRATION
OF IMPORTED FOODS INSPECTION
No.
……../20.../ĐKNK
1. Name, address and phone number
of the goods owner: ..........................................
2. Name, address and phone number
of the applicant authorized by the goods owner (if any):
........................................................................
3. Name, address and phone number
of the exporter: .................................................
4. Expected time of arrival at
border checkpoint: .......................................................
5. Border checkpoint of departure:
.........................................................................
6. Border checkpoint of arrival:
.............................................................................
7. Date of inspection:
..........................................................................................
...
...
...
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9. Name of expected inspecting
authority: .................................................................
10. Detailed information about
articles in the consignment:
No.
Name
of articles
Product
group (According to QCVN or Codex or manufacturer’s standard)
Name
and address of the manufacturing facility
Method
of inspection
Notification
of change of inspection method (if any) *
(1)
...
...
...
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(3)
(4)
(5)
(6)
...
...
...
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* Specify the number, date of issue
and issuer of the Notification of change of inspection method if the goods are
eligible for change of inspection method.
11. Customs declaration number (if
any): .......................................................................
[location,
date]
LEGAL REPRESENTATIVE OF GOODS OWNER
(Signature and seal)
[location,
date]
INSPECTING AUTHORITY
(Signature, seal)
Form
No. 06
NAME
OF GOODS OWNER
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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[location,
date]
To:
[Inspecting authority]
regarding change of the food safety inspection method
Pursuant to Article ... of the Government’s
Decree No. ... dated ... on elaboration of some Articles and measures for
organization of the implementation of the Law on Food Safety, we hereby
requests change of state inspection method as follows:
1. Name and address of the goods
owner: ..........................................
2. Detailed information about
the goods:
No.
Name
of goods
Product
group (According to QCVN or Codex or manufacturer’s standard)
...
...
...
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Applied
inspection method
Notification
of satisfactory inspection results *
(1)
(2)
(3)
(4)
(5)
(6)
...
...
...
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* Specify the number, date of
issue, issuer of the Notification; provide the original copy or authenticated
copy of the Notification of satisfactory inspection results if it cannot be accessed
on the National Single-window Information Portal.
3. Request for change of
inspection method for the following goods:
No.
Name
of goods
Product
group (According to QCVN or Codex or manufacturer’s standard)
...
...
...
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New
inspection method
Reasons
for change*
(1)
(2)
(3)
(4)
(5)
(6)
...
...
...
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* Specify the reasons for change
e.g. the product is granted 03 consecutive Notifications of satisfactory
results of normal inspections in 12 months.
4. Other contents (if any):
For your consideration.
Recipients:
- Goods owner: ……………..;
- Border checkpoint customs:…………;
- Archive: ……….
...
...
...
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Form
No. 07
INFORMATION
ABOUT MANAGEMENT SYSTEM AND CAPACITY FOR FOOD SAFETY CONTROL OF THE COMPETENT
AUTHORITY OF THE EXPORTING COUNTRY
1. Management system:
..................................................................................................................................
..................................................................................................................................
2. Persons in charge (number,
qualifications, technical training courses, etc.):
..................................................................................................................................
..................................................................................................................................
...
...
...
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..................................................................................................................................
..................................................................................................................................
4. System for inspecting and
monitoring residues and pathogenic microorganisms, etc. of the
manufacturer/seller:
..................................................................................................................................
..................................................................................................................................
5. Food safety inspection and
supervision program:
[location,
date]
FOOD SAFETY AUTHORITY OF THE EXPORTING COUNTRY
(Signature, seal)
...
...
...
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Form
No. 08
LIST
OF REGISTERED EXPORTERS OF FOODS DERIVED FROM ANIMALS AND AQUATIC ORGANISMS TO
VIETNAM
No.
Name
of exporter
Identification
number
Address
Proposed
foods for export to Vietnam
Notes
...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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[location,
date]
FOOD SAFETY AUTHORITY OF THE EXPORTING COUNTRY
(Signature, seal)
Form
No. 09
SUMMARY
OF INFORMATION ABOUT FOOD MANUFACTURER/SELLER’S FULFILLMENT OF FOOD SAFETY
REQUIREMENTS
1. Name of the food
manufacturer/seller:
.............................................................
2. Address:
.................................................................................................................
3. Product:
..............................................................................................................
...
...
...
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5. Applied the quality control
system:
[location,
date]
CONFIRMATION BY FOOD SAFETY AUTHORITY OF THE EXPORTING COUNTRY
(Signature, seal)
Form
No. 10
NAME
OF THE APPLICANT
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
: /Abbreviated name of
the applicant
...
...
...
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APPLICATION
FORM FOR CERTIFICATION OF ADVERTISEMENT CONTENTS
To: 2
....................................
1. Name of the applicant: .......................................................................................
2. Address:3
..............................................................................................................
.......................................................................................................................................
Telephone: ……………………………………… Fax:
...........................................................
Application form for certification
of advertisement contents for:
No.
...
...
...
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Number
and symbol of the confirmation of receipt of product declaration registration
Date
of receipt
...
...
...
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The application consists of:
...................................................................................
I hereby declare that the
information and documents provided herein is accurate and truthful and am
committed to advertise the product according to the certified contents.
For your consideration.
DIRECTOR
OR LEGAL REPRESENTATIVE
OF THE APPLICANT
(Signature, seal)
_________________________
1 Geographical name.
2 The receiving
authority specified in Articles 45 and 51 of this Decree.
...
...
...
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Form
No. 11
NAME
OF THE SUPERVISORY AUTHORITY
NAME OF THE RECEIVING AUTHORITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
..../XNQC-…1...
[location,
date]
ADVERTISEMENT
CONTENT CERTIFICATION
Name of the applicant: .................................................................................
...
...
...
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Telephone: ……………………………………… Fax:
...........................................................
No.
Name
of product
Number
and symbol of the confirmation of receipt of product declaration registration
...
...
...
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It is certified that the
advertisement content (enclosed) if conformable with applicable regulations.
The advertiser has the
responsibility to adhere to the certified content.
CERTIFIED
BY
(Signature, full name and seal)
_________________________
1 Abbreviated name of
the certifying authority.
Form
No. 12
...
...
...
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APPLICATION
FOR THE CERTIFICATE OF FOOD SAFETY AND GMP COMPLIANCE FOR DIETARY SUPPLEMENTS
To:
....................................
Name of the applicant:
.................................................................................
Address:
.................................................................................................................
Applicant’s enterprise ID number:
.......................................................................
Name and address of the
manufacturing facility:
..........................................................
We hereby apply for the Certificate
of food safety and GMP compliance for the following dietary supplements: ...
...
...
...
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Form
No. 13
NAME
OF THE SUPERVISORY AUTHORITY
NAME OF THE COMPETENT AUTHORITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
………….
[location,
date]
INSPECTION
RECORD
Fulfillment
of food safety requirements by manufacturer applying GMP for dietary
supplements
...
...
...
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Today, on ….., the inspectorate
including:
1. Chief inspector (name, position,
workplace): ..........................................
2. Secretary (name, position,
workplace): ......................................................
3. Members (name, position,
workplace): ................................................
Location of inspection: ………………..
Representative of the inspected
entity: ...................................................................
GENERAL INFORMATION
1. Information about the applicant
for the Certificate (the manufacturer):
- Name and address of the
manufacturer: ...........................................
...
...
...
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- Legal representative:
..........................................................................................
2. Information about the
inspection:
- Date of inspection:
......................................................................................
- Date of the latest inspection:
...........................................................................
- Inspection method: Document
inspection and site inspection to assess the compliance with GMP rules enclosed
with the Decision No. ……/QĐ-BYT dated …./…../20…
- Scope of inspection: according to
the application of (name of the manufacturer) dated ……/…../……
INSPECTION
RESULTS
I. Site inspection
1. Quality management
...
...
...
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3. Manufacturing facility and
equipment
4. Hygiene
5. Documentation
6. Manufacture
7. Quality control
8. Contractual manufacture and
analysis
9. Complaints and product recall
10. Self-inspection
II. Weaknesses
...
...
...
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IV. Opinions of the inspected
manufacturer .............................................
The record is agreed upon by the
parties and is made into 03 copies. 01 copy is kept by inspected manufacturer, 01
by the inspectorate and 01 by the competent authority.
INSPECTORATE
(Signature, seal)
REPRESENTATIVE
OF THE MANUFACTURER
(Signature, seal)
1. Chief inspector:
2. Secretary:
3. Members:
...
...
...
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Form
No. 14
NAME
OF THE SUPERVISORY AUTHORITY
NAME OF THE COMPETENT AUTHORITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
………….
CERTIFICATE
OF COMPLIANCE WITH FOOD SAFETY REGULATIONS
NAME OF THE MANUFACTURER
ADDRESS
HAS
SATISFIED GMP REQUIREMENTS
APPLIED TO THE FOLLOWING DIETARY SUPPLEMENTS
.......................................................................................................
...
...
...
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[location,
date]
REPRESENTATIVE OF THE ISSUING AUTHORITY
(Signature, seal)
Form
No. 15
NAME
OF MANUFACTURER
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
………….
[location,
date]
...
...
...
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REPORT
MANUFACTURE
OF DIETARY SUPPLEMENTS
(From
............ to ..................)
First reporting period (the first
12 months from the issuance date)
□
Second reporting period (the next
12 months)
□
Third reporting period (the next 12
months)
□
1. Name and address of the dietary
supplement manufacturer: .........
Certificate No. ………………… Issuer:
.................. Date of issue: .........
2. Personnel and training
...
...
...
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Issuance
date/Previous reporting period
Current
period
Number of employees in charge of
quality assurance and quality control/direct production/indirect
production/Total number of employees
…./…./…./….
…./…./…./….
Number of employees receiving in
food safety training, basic GMP training, relevant professional
training/Total number of employees
…./…./…./….
…./…./…./….
Full name and qualifications:
...
...
...
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- Head of production
- Head of quality control or
quality assurance
From
… to ……:……/……
From
… to ……:……/……
From
… to ……:……/……
From
… to ……:……/……
From
… to ……:……/……
From
… to ……:……/……
From
… to ……:……/……
...
...
...
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From
… to ……:……/……
From
… to ……:……/……
From
… to ……:……/……
From
… to ……:……/……
3. Facility and equipment
Diagrams and list of primary
equipment
Unchanged
Changed
3
- Overall floor plan
...
...
...
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□
- Floor plans of facilities
manufacturing dietary supplements
□
□
- Floor plan of the testing
laboratory
□
□
- Equipment of facilities
manufacturing dietary supplements
□
...
...
...
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- In-process control (IPC) equipment
of facilities manufacturing dietary supplements and testing equipment
□
□
- Auxiliary equipment (HVAC, RO,
compressed air, etc.) of facilities manufacturing dietary supplements
□
□
4. Number of unexpired declaration and
manufacturing results of the reporting period
No.
Name of product 5
...
...
...
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Number and date of issue of confirmation of receipt
Declared by the manufacturer
Declared by authorized entity (specify name)
Number and date of submission of notification of
production (if any)
Batches manufactured in the reporting period
Quantity 4
Violations and actions 8 (if any)
Manufactured
Sampled 7
...
...
...
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In stock
Tablets
1.
……….
B1: .... mg
B12:...mcg
…/…
□
...
...
...
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…/…
Batch ...
….. tablets
….. tablets
….. tablets
….. tablets
……..
Batch ...
….. tablets
...
...
...
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….. tablets
….. tablets
……..
2.
……….
….:….. mg
….:….. mg
…/…
□
...
...
...
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…/…
Batch ...
….. tablets
….. tablets
….. tablets
….. tablets
……..
Batch ...
….. tablets
...
...
...
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….. tablets
….. tablets
……..
Ampoules
3.
……….
….:….. mg
….:….. mg
…/…
...
...
...
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……….
…/…
Batch ...
… ampoules
… ampoules
… ampoules
… ampoules
……..
Batch ...
...
...
...
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… ampoules
… ampoules
… ampoules
……..
Total
…. products
…. products
…. products
...
...
...
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…. units
…. units
OWNER
(signature, seal)
_________________________
...
...
...
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4 Finished products
(tablets, ampoules (liquid), jar (semi-solid), bottle (liquid), bag/pack
(powder, liquid, semi-liquid), box (powder, liquid, etc.)...
5 Arranged by dosage
form
6 Having nutritional
value or biological effects
7 Samples are taken and/or
sent for testing before release and for stability monitoring
8 Specify the decision
number, inspectorate's name, violations, number of the revoked confirmation,
number of the recalled batch, quantity of recalled products, fine (million
VND).
Form
No. 16
TESTING
LABORATORY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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[location,
date]
APPLICATION
FORM FOR DESIGNATION/CHANGE/ADDITION/EXTENSION OF DESIGNATION OF FOOD TESTING
LABORATORY SERVING STATE MANAGEMENT
To:
(Designating authority)
1. Name of testing laboratory:
Address:
Telephone:
Fax:
E-mail:
2. Full name and position of the person
in charge of the testing laboratory:
Address:
...
...
...
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3. Certificate of registration of
testing laboratory No. ………………… Date of issue: .........
4. Decision/Certification No. …………
Date of issue: …………
5. Applying for:
Designation □
Change/addition □
Extension □
6. Proposed operations
No.
Food
products, goods
Indicator
Test
method
...
...
...
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Name
of accrediting organization (if any) *
* Name of the accrediting
organization for the accredited method
7. Proposed commencement date:
...
...
...
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HEAD
OF APPLYING UNIT
(Signature, seal)
Form
No. 17
TESTING
LABORATORY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
……/…….
[location,
date]
...
...
...
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REPORT
CAPACITY
OF TESTING LABORATORY
1. Name of testing laboratory:
Address:
Telephone:
Fax:
E-mail:
2. Full name and position of the
person in charge of the testing laboratory:
Address:
Telephone:
Fax:
E-mail:
3. Personnel:
...
...
...
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Full
name
Qualifications
Certificate
of training in management system
Current
tasks
Seniority
in testing
Notes
...
...
...
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4. Equipment
4.1. Equipment requiring
inspection/calibration
No.
Equipment
Measurement range and accuracy
Inspection/calibration cycle
...
...
...
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Inspection/calibration unit
Notes
...
...
...
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No.
Equipment
Technical
specifications
Date
of first use
Notes
...
...
...
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5. Area and environment of the testing
laboratory
5.1. Floor plan and area of each
department of the testing laboratory
5.2. Environmental conditions of
departments of the testing laboratory
- Air conditioning;
- Ventilation and emission control;
- Other conditions (prevention of
vibration, dust, noise, light, radiation, etc.)
5.3. Personal protection and labor
safety for personnel of the testing laboratory
6. Proposed testing criteria:
No.
...
...
...
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Indicator
Test
method
Detection
limit/Quantification limit/Measurement range (if any)
Results
of proficiency testing/inter-laboratory comparison *
...
...
...
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* Specify the name of the program,
criteria, method, sample matrix, results.
7. Performance of the testing
laboratory of the last 01 year:
No.
Food
products, goods
Indicator
Test
method
Sample
size
Notes
...
...
...
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8. The testing laboratory hereby
pledges to:
- Comply with the decision on
designation and management of testing laboratory;
- Fulfill requests of the assessing
authority upon testing laboratory assessment.
...
...
...
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Form
No. 18
TESTING
LABORATORY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
……/…….
[location,
date]
REPORT
(ANNUAL/PERIOD-SPECIFIC)
TESTING LABORATORY PERFORMANCE
...
...
...
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Address:
Telephone:
Fax:
E-mail:
2. Full name and position of the
person in charge of the testing laboratory:
Telephone:
Fax:
E-mail:
3. Training: Advanced training for
personnel of the testing laboratory
No.
Full
name
Position
Training
course
...
...
...
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Results
Notes
...
...
...
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4.1. Inspected/calibrated equipment
No.
Equipment
Measurement range and accuracy
Inspection/calibration cycle
Last inspection/calibration date
Inspection/calibration unit
Notes
...
...
...
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4.2. New equipment
No.
Equipment
Technical
specifications
...
...
...
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Notes
5. Designated testing criteria and
methods:
No.
Food
products, goods
...
...
...
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Test
method
Detection
limit/Quantification limit/Measurement range (if any)
Notes
...
...
...
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No.
Criteria
Test
method
Sample
matrix
Organizer
Participation
time
Result
...
...
...
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7. Result of food testing serving
state management
No.
Food
products, goods
Criteria
Test
method
...
...
...
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Unsatisfactory
samples
HEAD
OF LABORATORY
(Signature, seal)
...
...
...
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Form
No. 19
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
[location,
date]
RECORD
TESTING
LABORATORY ASSESSMENT
The assessment team is established
under Decision No. ....... dated ......... of the designating authority and
consists of:
(Full names of the chief, secretary
and members)
1. Name of testing laboratory:
...
...
...
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2. Conclusion
2.1. Strengths:
2.2. Weaknesses (if any):
No.
Weaknesses
Basis/standards
...
...
...
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Option 1: Designate [name of the
testing laboratory], under ............. as a food testing laboratory serving
state management with the following operations:
No.
Food
products, goods
Criteria
Test
method
Detection
limit/Quantification limit/Measurement range (if any)
...
...
...
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Option 2: Designate [name of the
testing laboratory], under ............. as a food testing laboratory serving
state management with the following operations after all the weaknesses specified
in above are remedied:
No.
Food
products, goods
Criteria
Test
method
Detection
limit/Quantification limit/Measurement range (if any)
...
...
...
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Option 3: Do not designate [name of
the testing laboratory], under ............. as a food testing laboratory
serving state management.
3. This record is passed with the
consent of .... members of the assessment team.
Other opinions (if any):
.............................................................................................
4. Opinions of the testing
laboratory:
...........................................................................
5. Enclosures:
.......................................................................
REPRESENTATIVE
OF TESTING LABORATORY
(Signature, seal)
...
...
...
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CHIEF
OF
ASSESSMENT TEAM
(Signature and full name)
Form
No. 20
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
[location,
date]
REPORT
REMEDIATION
RESULTS
To:
(Designating authority)
1. Name of the assessed testing
laboratory:
...
...
...
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3. Weaknesses:
4. Reasons:
5. Remedial measures:
6. Remediation results:
7. Changes to complete the
management system (if any):
HEAD
OF LABORATORY
(Signature, seal)
REPORTED
BY
(Signature, full name)
...
...
...
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...................................................................................................................................
...................................................................................................................................
9. Conclusion of the chief of the
assessment team:
...................................................................................................................................
...................................................................................................................................
[location,
date]
CHIEF OF ASSESSMENT TEAM
(Signature and full name)
...
...
...
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DESIGNATING
AUTHORITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
.../QĐ-...
[location,
date]
DECISION
Designation
of food testing laboratory serving state management
HEAD
OF DESIGNATING AUTHORITY
Pursuant to the Law on Food
safety dated June 17, 2010;
...
...
...
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In consideration of application
form
....................................................................................................
In consideration of the testing
laboratory assessment record
................................................................
In consideration of the report
on remediation results (if any) ..................................................
At the request of
..........................................................................................................
(Head of the designating
authority)
.......................................................................................
DECIDES:
Article 1. Designate .......
[name of the testing laboratory], under ............. at ................
as a food testing laboratory serving state management within the scope enclosed
with this Decision.
Testing laboratory code: ……………………..
Article 2. This Decision is
effective for 03 years from the day on which it is signed.
...
...
...
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HEAD
OF DESIGNATING AUTHORITY
(Signature, seal)
SCOPE
OF DESIGNATION
(Enclosed
with Decision No. …./QĐ- dated …. of the designating authority)
No.
Criteria
Food
products, goods
...
...
...
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Detection
limit/Quantification limit/Measurement range (if any)
1
2
...
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3
4
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5
6
...
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7
8
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9
10
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11
12
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13
14
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15
16
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17
18
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…
……
……..
……
……….
Form
No. 22
TESTING
LABORATORY
-------
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No.
……/…….
TEST
REPORT
(The results presented in this report apply only to the samples tested)
1. Sample name:
2. Sample code:
3. Sample description: (status of
the sample upon receipt, sample size, date of manufacture, expiration date,
sample storage conditions)
4. Sample storage duration:
5. Sampling date:
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7. Testing time:
8. Sample storage location:
9. Enclosures: (specify the
contents, numbers, dates of enclosed documents)
10. Test results (of designated
testing criteria):
No.
Testing
criteria
Test
method
Unit
Result
...
...
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11. Conclusion:
…………………………………………………………………………………….
(specify whether the result is
satisfactory/unsatisfactory)
12. Notes (if any):
HEAD
OF LABORATORY
(Signature, seal)
PERSON
IN CHARGE OF LABORATORY
(Signature and full name)
...
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1 Compared to
QCVN.../TCVN.../QĐ…/Standard declared by the manufacturer / …… Leave blank if
the testing criteria are not covered by any technical regulations, standards or
legislative documents.
Form
No. 23
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
[location,
date]
FOOD
SAFETY INSPECTION RECORD
Implementing Decision No…. . dated
…. of ……………………
.....................................................................................................................................
Today, on ….., the inspectorate,
including:
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2 ……………………………………………………………. Member,
secretary
3 ……………………………………………………………. Member
4 ……………………………………………………………. Member
5 ……………………………………………………………. Member
Has carried out a food safety of
inspection at: ………………..
Address:
……………………………………………………………............................................
Tel: ..................................................................................................................
Represented by: 1.
.......................................................................................................
2.
.....................................................................................................
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I. ADMINISTRATIVE AND LEGAL
DOCUMENTS
1. Certificate of Enterprise
Registration or equivalent legal certificate (yes/no):
No. ………………………………………… Date of issue:
........................................................
2. Provision of training in food
safety and hygiene for the owner and persons directly engaged in production or
sale of foods:
□ Satisfactory
□ Unsatisfactory, reasons:
3. Health certificates of the owner
and persons directly engaged in production or sale of foods issued by health
facilities of district level or higher
□ Satisfactory
□ Unsatisfactory, reasons:
II. SITE INSPECTION
No.
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Group
of Criteria
Result
Weaknesses
and remediation deadlines
Satisfactory
Unsatisfactory
1
The Law on Food Safety:
Article 19, Clause 1, Point a;
Article 20, Clause 1, Point a;
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Business/production location
(the location must be appropriate and maintained at a safe distance for
sources of toxicity, pollutions and other factors harmful to foods; etc.)
2
The Law on Food Safety:
Article 19, Clause 1, Point a; Article
25, Clause 2;
Corresponding technical
regulations (if any);
Structure of the manufacturing
facility and layout of the business location (adequate area, easy to clean,
protected from food contamination, condensation and standing water; food
preparation and processing stages must be organized according to one-way
principle to avoid cross-contamination, etc.)
...
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3
The Law on Food Safety:
Article 19, Clause 1, Point c;
Corresponding technical
regulations (if any);
Manufacturing/business
equipment (appropriate for preparation, processing, packaging,
preservation, transport of products; equipment having direct contact with
products must be waterproof, non-toxic, easy to clean, etc.)
...
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4
The Law on Food Safety:
Article 19, Clause 1, Point c and
Point dd;
Corresponding technical
regulations (if any);
Sanitation of the
manufacturing facility and equipment (Only cleaning agents included in
the list of permitted substances are used. Cleaning, maintenance, and repair tools,
cleaning procedures must be established and properly implemented, etc.)
5
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Article 19, Clause 1, Point e;
Corresponding technical
regulations (if any);
Persons directly engaged in
production, worker sanitation (All persons directly engaged in production
must receive periodic health checkups and have knowledge about food safety;
restrooms must be available at appropriate locations with adequate sanitary
equipment; regulations on worker sanitation must be issued and properly
implemented, etc.)
6
The Law on Food Safety:
Article 10, Clause 1; Clause 2,
Point a; Article 19, Clause 1, Point b;
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Raw materials and other inputs
for food production (water and ice must comply with regulations on
drinking water quality; food additives, preservatives, and processing aids
must be included in the list of permitted substances, be stored and used in
accordance with regulations; raw materials must meet the food production
requirements.
7
The Law on Food Safety:
Article 19, Clause 1, Point c;
Article 20, Clause 1, Point b;
Corresponding technical
regulations (if any);
Pest control and
waste/wastewater management (There must be pest control equipment; wastewater
must be treated in accordance with regulations before being discharged into
the environment; there must be tools/measures for collection and treatment of
solid wastes, etc.)
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8
The Law on Food Safety:
Article 18; Article 10, Clause 2,
Point b, Point c Clause 19, Clause 1, Point c, Point dd Article 20, Clause 1,
Point a, Point c; Article 21
Corresponding technical
regulations (if any);
Packaging, labeling, storage,
and transport (packaging materials must not contaminate the products;
labels must contain adequate information in accordance with regulations;
there must be appropriate storage areas and transport equipment suitable for
each type of products; products must be arranged reasonable and kept clean,
etc.)
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9
The Law on Food Safety: Article
11, Clause 2; Article 19, Clause 1, Point dd;
Corresponding technical
regulations (if any);
Logging and origin tracing (the
receipt and use of raw materials and input supplies in the production
process; implementation of GMP and SOP; remedial measures must be logged to
ensure product traceability).
10
The Law on Food Safety: Article
19, Clause 1, Point dd;
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(If application HACCP is
mandatory)
Food safety and quality
assurance (food safety must be maintained; GMP and SOP requirements are
fully satisfied; application of advanced quality management programs such as
HACCP or ISO 22000 is encouraged)
Total group of criteria
inspected:
/10
groups
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1. Sampling information (sample
type, sample size; packaging conditions, sample preservation, etc.)
2. Analysis criteria: (enclosed
with the sampling record):
IV. ASSESSMENT AND CONCLUSION:
1. The establishment's fulfillment
of food safety requirements in terms of location, facilities, equipment, raw
materials, water sources, sanitation, etc.:
2. Weaknesses and remedial
measures:
................................................................................
3. Conclusion: .................................................................................................................
Satisfactory
□
Unsatisfactory
□
Pending remediation
□
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4. Opinions of the inspected
entity: .............................................
This record is made at .... on ....
into 02 copies with equal legal values. One copy shall be kept by the
inspecting authority and one by the establishment owner.
REPRESENTATIVE
OF THE ESTABLISHMENT
(Signature and full name)
CHIEF
INSPECTOR
(Signature and full name)
V. REMEDIATION RESULTS (if any)
Satisfactory □
Unsatisfactory □
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[location,
date]
CHIEF INSPECTOR
(Signature and full name)
Form No. 24
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
CERTIFICATE
OF
COMPLIANCE WITH FOOD SAFETY REGULATIONS
………………………………
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CERTIFICATION
Establishment:
Registration number: (*)
Address:
Tel:
Email:
Has
been found to be in compliance with food safety regulations for following
products:
1.
2.
3.
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Valid until (date/month/year)
….,
day/month/year
(Signature, seal/digital signature)
Notes:
1,2,3...: Name of product/group of
products according to Appendices III, IV enclosed with this Decree
xxxx: cardinal number of the
Certificate issued in the year by the issuing authority
yy: 2 digits of the year in which
the Certificate is issue (Example: 25 of the year 2025)
zz: code of province in which the
establishment is located
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APPENDIX II
LIST
OF FOOD PRODUCTS AND GROUPS OF FOOD PRODUCTS UNDER THE MANAGEMENT OF HEALTH
AUTHORITIES
(Enclosed with the Government’s Decree No. 46/2026/NĐ-CP dated January
26, 2026)
No.
Name
of product/group of products
Notes
1
Bottled water, mineral water, ice
(Ready-to-use ice and ice used for food processing)
Other than ice for preservation,
processing of products under the management of the Ministry of Agriculture
and Environment
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Functional foods
Other than medical foods, food
for special dietary uses, supplemented foods and dietary products for
children up to 36 months under the management of the People’s Committees of
provinces
3
Micronutrients
4
Food additives (including food
flavorings), food processing aids
5
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Other than primary packaging of foods
under the management of the Ministry of Agriculture and Environment and the
Ministry of Industry and Trade that are manufactured in the same facility and
only used for such facility’s foods
6
Other products not included in
the lists of the Ministry of Industry and Trade and the Ministry of
Agriculture and Environment
APPENDIX III
LIST
OF FOOD PRODUCTS AND GROUPS OF FOOD PRODUCTS UNDER THE MANAGEMENT OF
AGRICULTURE AND ENVIRONMENT AUTHORITIES
(Enclosed with the Government’s Decree No. 46/2026/NĐ-CP dated January 26,
2026)
No.
Name
of product/group of products
...
...
...
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I
Cereals
1
Cereals
2
Cereal grains worked (husked,
chopped, hulled, heated, etc.)
Other than those in powder form
and powder and starch products
...
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Meat and meat products
1
Fresh, chilled and frozen meat
(carcasses, cuts, slices, pellets, etc.)
2
Edible meat offal of livestock
and poultry (Viscera, bones, legs, neck, wings, fat, blood, etc.)
3
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Other than functional products
under the management of the Ministry of Health
4
Homogenised preparations of meat
(Chinese sausage, hot dog, salami, grilled chopped meat, ham, etc.)
Other than products in cake forms
under the management of the Ministry of Industry and Trade
III
Fish and fish products
(including amphibian species)
1
Fisheries, fresh, chilled,
refrigerated (whole-carcasses, primarily worked, fillet, ground, pullets,
cuts, etc.)
...
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2
Fish offal (skins, fins, eggs,
fat, etc.)
3
Fishery product and fish offal
for food ( fermented, salted, smoked, heated, brine, gelatin, etc. including
additives, processing aids)
Other than functional products
under the management of the Ministry of Health
4
Fat and oils from fisheries,
whether or not worked, used for food
Other than functional foods and
pharmaceuticals under the management of the Ministry of Health
...
...
...
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Aquatic products mixed with
flour, starch, powder, processed milk, vegetable oil (including shrimp, fish,
squid, etc.)
Other than products in cake forms
under the management of the Ministry of Industry and Trade
6
Seaweeds and algae and other
products made from seaweed and algae used for food
Other than functional products made
from seaweeds and algae under the management of the Ministry of Health
IV
Edible vegetables , roots and
tubers and their products
1
...
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Other than vegetables, roots and
tubers for seeding
2
Vegetable, roots and tubers,
worked (fermented, dried, heated, canned, extracted, in powder form, etc.)
Other than confectionery, jams,
beverage and salted dry apricot under the management of the Ministry of
Industry and Trade
V
Eggs and egg products
1
Eggs of terrestrial animals and
amphibians
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2
Eggs of terrestrial animals and
amphibians, worked (frozen, salted, milled, moulded, etc.)
3
Products having eggs and egg
powder for consumption
Other than confectionery containing
eggs and egg powder under the management of the Ministry of Industry and
Trade.
VI
Raw milk
...
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Honey and honey products
1
Pure honey, condensed, diluted
2
Beeswax, pollen, royal jelly with
or without honey
3
...
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Other than confectionery, jams
and beverage containing honey under the management of the Ministry of
Industry and Trade; functional foods and pharmaceutical products under the
management of the Ministry of Health.
VIII
Genetically-modified foods
IX
Salt
1
Sea salt, rock salt
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2
Salt, processed, fined and mixed
with other ingredients
X
Condiments
1
Condiments, single or compound, extracted
from animals and plants (bone or meat-derived flavor, mustard, etc.)
Other than accompanying spices
made from starch and powder ( instant noodle, instant porridge, etc.) within
the management of the Ministry of Industry and Trade
...
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Sauces and preparations therefor
3
Sauce
4
Fruits of the genus Capsicum or
of the genus Pimenta, fresh, dried, crushed or ground
XI
...
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1
Cane or beet sugar and chemically
pure sucrose, in solid form
2
Other sugars, including chemically
pure lactose, maltose, glucose and fructose, in solid form; sugar syrups not
containing added flavouring or colouring matter; artificial honey, whether or
not mixed with natural honey; caramel)
3
Molasses resulting from the
extraction or refining of sugar
...
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XII
Tea
1
Fresh tea, worked, whether or not
flavoured
Other than tea in liquid form;
confectionery and jams containing tea under the management of the Ministry of
Industry and Trade
2
Other tea
Other than tea in liquid form
under the management of the Ministry of Industry and Trade
...
...
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Coffee
1
Coffee beans, fresh or dried,
extracts, essences and concentrates of coffee
2
Coffee, whether or not roasted or
decaffeinated; coffee husks and skins; coffee substitutes containing coffee
in any proportion; extracts in powder form with or without sugar, milk and
cream for consumption, and products containing coffee
Other than those in liquid form;
confectionery and jams containing coffee under the management of the Ministry
of Industry and Trade
XIV
...
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1
Cocoa beans, fresh or dried,
whole or broken, raw or roasted; Cocoa shells, husks, skins and other cocoa
waste; Cocoa paste, whether or not defatted; Cocoa butter, fat and oil; Cocoa
powder, not containing added sugar or other sweetening matter
2
Cocoa preparations in powder
form, whether or not roasted and ground, or in solid, liquid and powder form
with or without sugar, milk, cream and other preparations containing cocoa
Other than cocoa in liquid form;
confectionery and jams containing cocoa under the management of the Ministry
of Industry and Trade
XV
Pepper
...
...
...
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1
Pepper of the genus Piper, fresh
or dried, ground or crushed
2
Fruits of the genus Capsicum or
of the genus Pimenta, fresh, dried, crushed or ground
XVI
Cashew nuts
...
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Cashew nuts
2
Products made from cashew nuts
Other than confectionery and jams
containing cashew nuts under the management of the Ministry of Industry and
Trade
XVII
Other agro products
1
...
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2
Other plant-derived products for
food, raw or worked (Mushrooms, wood ears, soya products excluding oil;
edible hull roots, leaves and rubbers, etc.)
Other than those used as herbal
ingredients and functional foods under the management of the Ministry of
Health
3
Birds' nests and products
therefor
Other than those used as herbal
ingredients and functional foods under the management of the Ministry of
Health
4
Products of insects for food
(locusts, crickets, silkworms, etc.)
...
...
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XVIII
Packages and instruments
having direct contact with foods during manufacture, processing, sale of
foods under their management
XIX
Ice for preservation,
processing of products under the management of the Ministry of Agriculture
and Environment.
APPENDIX IV
LIST
OF FOOD PRODUCTS AND GROUPS OF FOOD PRODUCTS UNDER THE MANAGEMENT OF INDUSTRY
AND TRADE AUTHORITIES
(Enclosed with the Government’s Decree No. 46/2026/NĐ-CP dated January 26,
2026)
...
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Name
of product/group of products
Notes
I
Beer
1
Draught beer
2
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3
Canned beer
II
Alcohol and alcoholic drinks
Excluding alcoholic drinks
infused with animals, plants, minerals, and fungi; alcoholic drinks declared
as functional foods
1
Wine
...
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1.1
Non-carbonated wine
1.2
Carbonated wine
2
Fruit wine
...
...
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Liqueur
4
Strong wine
5
White wine, vodka
6
...
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III
Soft drinks
Excluding mineral water and pure
water under the management of the Ministry of Health
1
Canned beverages, including fruit
and vegetable juices.
2
Soft drinks that need diluting
before drinking
...
...
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3
Instant soft drinks
Excluding mineral water and pure
water under the management of the Ministry of Health
IV
Processed milk
Excluding micronutrient-enriched
products and functional foods under the management of the Ministry of Health
1
Liquid milk (including liquid
milk that contains flavorings or other food additives)
...
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Pasteurized products
1.2
Products sterilized by ultra-high-temperature
processing or other high-temperature methods
2
Fermented milk
2.1
...
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2.2
Solid
3
Powdered milk
4
Condensed milk
...
...
...
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4.1
Sweetened
4.2
Not sweetened
5
Cream
...
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Pasteurized
5.2
UHT
6
Soy milk
7
...
...
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7.1
Butter
7.2
Cheese
7.3
Other products from processed
milk
...
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V
Vegetable oil
Excluding micronutrient-enriched
products and functional foods under the management of the Ministry of Health
1
Sesame oil
2
Bran oil
...
...
...
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Soya-bean oil
4
Peanut oil
5
Olive oil
6
...
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...
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7
Sunflower seed oil
8
Rhum oil
9
Cottonseed oil
...
...
...
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10
Coconut oil
11
Palm seed oil or babasu oil
12
Rapeseed oil or mustard oil
...
...
...
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Flax oil
14
Castor oil
15
Other oils
VI
...
...
...
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Excluding micronutrient-enriched
products and functional foods under the management of the Ministry of Health
1
Wheat flour of meslin flour
2
Milled cereal
3
Potato flour
...
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...
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4
Malt: roasted or not roasted
5
Starch: wheat, corn, potato,
others
6
Inulin
...
...
...
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Wheat gluten
8
Products from dough, raw of
cooked: spaghetti, macaroni, noodle, instant noodle, flat noodle, gnochi,
ravioli, cannelloni, instant porridge, vermicelli, etc.
9
Products from tapioca and
substitutes made of starch, in pieces, grains, fine powder, and the likes
VII
...
...
...
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Excluding micronutrient-enriched
products and functional foods under the management of the Ministry of Health
1
Sweet, salted, or tasteless
cookies
2
Biscuits, baked bread, and the
likes
3
Dough bread
...
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4
Toast
5
Birthday cakes
6
Hard and soft candies with sugar
and no cocoa
...
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...
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Chewing gums, coated or not
coated with sugar
8
Chocolate
9
Jam, fruit jelly, powder and paste
from fruits or nuts, during cooking process, containing sugar, other
sweeteners, or wine
10
...
...
...
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11
Other confectionary products
VIII
Packages and instruments
having direct contact with foods during manufacture, processing, sale of
foods under their management
...
...
...
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