THE GOVERNMENT -------- SOCIALIST REPUBLIC OF VIETNAM

THE GOVERNMENT

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SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

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No. 15/2018/ND-CP

Hanoi, February 02, 2018

DECREE

ELABORATION OF SOME ARTICLES OF THE LAW OF FOOD SAFETY

Pursuant to the Law on Government organization dated June 19, 2015;

Pursuant to the Law on Food safety dated June 17, 2010;

At the request of the Minister of Health;

The Government promulgates a Decree to elaborate some Articles of the Law of Food

safety.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Decree elaborates some Articles of the Law of Food safety on:

1. Procedures for product self-declaration.

2. Procedures for registration of the product declaration.

3. Assurance of genetically modified GM foods.

4. Issuance of the certificate of food safety.

5. State inspection of safety of imported and exported foods.

6. Food labeling.

7. Food advertisements.

8. Food safety requirements in production of dietary supplements.

9. Food safety requirements in production, sale and use of food additives.

10. Tracing food origins.

11. Food safety authorities.

Article 2. Regulated entities

This Decree applies to Vietnamese and foreign organizations and individuals that

produce or sell foods in Vietnam; organizations and individuals whose operation involve

food safety in Vietnam.

Article 3. Definitions

For the purpose of this Decree, the following terms are construed as follows:

1. 1) “dietary supplement” means a product used as a supplement to the daily diet to

improve user’s health and immunity. Dietary supplement may contain one or more of the

following substances:

a) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other

biologically active substances;

b) Substances derived from animals, minerals, plants in the form of extracts, isolates,

concentrates or metabolites;

c) Sources 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 doses.

2. “medical food” or “food for special medical purposes” means a food that can be

consumed orally or tube feeding, prescribed to regulate the patient’s diet, the use of

which has to be supervised by a health worker.

3. “food for special dietary uses” means food for people on a diet, elderly people and

other users defined by Codex Alimentarius, processed or formulated to satisfy particular

dietary requirements which exist because of a particular physical or physiological

conditions and/or specific disease and disorder of the user. The composition of this kind

of food differs significantly from that of ordinary foods of comparable nature, if such

ordinary foods exist.

4. “scientific evidence” means scientific documents and information from researches

accepted by competent authorities or published in Vietnamese or foreign academic

journals or articles about traditional medicine in academic prints.

5. “goods owner” means the organization or individual responsible for the goods

specified in the declaration or self declaration of products, or the organization or

individual authorized to import or export food products.

6. “exports and imports” are food products of the same category, names, labels, producers

and packaging materials.

7. “shipment” means the entire food products of an export or import shipment (in the

same bill of lading). A shipment may comprise a single or multiple commodities.

8. “micro food manufacturer” means a household or individual that obtains food

ingredients by means of farming, breeding, fishing or collecting with or without a

certificate of enterprise registration.

9. “micro food processor” means a household or individual that processes food with or

without a certificate of enterprise registration.

10. “micro food business” means an individual, a group of individual or a household that

has registered as a business household and does not have the certificate of business

registration, certificate of enterprise registration and investment registration certificate.

Chapter II

PROCEDURES FOR PRODUCT SELF-DECLARATION

Article 4. Product self-declaration

1. Food manufacturers and food sellers (hereinafter referred to as “suppliers”) shall

prepare self-declaration of pre-packaged processed foods, food additives, food processing

aids, food containers, primary packages of foods (hereinafter referred to as “products”)

other than the commodities specified in Clause 2 of this Article and Article 6 of this

Article.

2. Products, raw materials that are manufactured or imported for production or processing

of exports or internal production and are not sold domestically are exempt from self-

declaration.

Article 5. Self-declaration procedures and documents

1. Self-declaration documents include:

a) The self-declaration form (Form No. 01 in Appendix I hereof);

b) Original copy or certified true copy of the food safety data sheet issued within 12

months before the self-declaration is made by an designated laboratory or a laboratory

complying with ISO 17025; the data sheet must specify safety indicators prescribed by

the Ministry of Health according to risk management principles under international

regulations (or standards applied by the supplier if relevant regulations of the Ministry of

Health are not available).

2. Self-declaration procedures:

a) The self-declaration shall be posted through mass media or the producer’s website or

premises; 01 copy of the self-declaration shall be submitted, directly or by post, to

regulatory authority designated by the People’s Committee of the province (hereinafter

referred to as “receiving authority”);

b) Right after the self-declaration is submitted, the supplier is entitled to manufacture and

sell the product and assume full responsibility for the safety of such product;

c) The receiving authority shall post the self-declaration and the product names therein on

its website.

If the supplier has more than one factory that produces the same product, self-declaration

documents shall be submitted to the regulatory authority of one of the provinces of the

supplier’s choice. Once selected, self-declaration documents shall be submitted to the

same authority.

3. Self-declaration documents must be written in Vietnamese language; documents in

other languages must be translated into Vietnamese language and notarized. The

documents must be unexpired when the self-declaration is submitted.

4. In case of change to the product name, origin or ingredients, the supplier shall submit

another self-declaration. In case of other changes, the supplier shall submit a written

notification to the receiving authority and is entitled to carry on the production or sale of

the product afterwards.

Chapter III

PROCEDURES FOR REGISTRATION OF THE PRODUCT DECLARATION

Article 6. Registration of the product declaration

Food suppliers must register the declarations of the following products:

1. Dietary supplements, medical foods, food for special dietary uses.

2. Dietary products for children up to 36 months.

3. Mixed food additives with new uses, food additives that are not on the list of permitted

food additives or not used for intended foods as prescribed by the Ministry of Health

(hereinafter referred to as “unregistered food additives”).

Article 7. Application for registration of the product declaration

1. An application for regulations of the declaration of imported products consists of:

a) The declaration form (Form No. 02 in Appendix I hereof);

b) The Certificate of Free Sale, Certificate of Exportation or Health Certificate issued by

a competent authority of the country of origin/exporting country, which assures safety of

users or permit free sale of the products in the country of origin/exporting country (the

certificate must be consularly legalized);

c) Original copy or certified true copy of the food safety data sheet issued within 12

months before the self-declaration is made by an designated laboratory or a laboratory

complying with ISO 17025; the data sheet must specify safety indicators prescribed by

the Ministry of Health according to risk management principles under international

regulations (or standards applied by the supplier if relevant regulations of the Ministry of

Health are not available)

d) Documents about scientific evidence of the effects of the product or ingredients

(original or authenticated copy). If scientific evidence of effects of the ingredients is

used, the daily dose must be greater or equal to 15% of the content of such ingredients

mentioned in the document;

dd) The certificate of Good Manufacturing Practice (GMP) or an equivalent certificate if

the imports are dietary supplements, applicable from July 01, 2019 (a copy authenticated

by the supplier).

2. An application for regulations of the declaration of domestic products consists of:

a) The declaration form (Form No. 02 in Appendix I hereof);

b) Original copy or certified true copy of the food safety data sheet issued within 12

months before the self-declaration is made by an designated laboratory or a laboratory

complying with ISO 17025; the data sheet must specify safety indicators prescribed by

the Ministry of Health according to risk management principles under international

regulations (or standards applied by the supplier if relevant regulations of the Ministry of

Health are not available);

c) Scientific evidence of the effects of the product or ingredients (original or

authenticated copy). If scientific evidence of effects of the ingredients is used, the daily

dose must be greater or equal to 15% of the content of such ingredients mentioned in the

document;

d) The certificate of food safety if one is required (a copy authenticated by the supplier);

dd) The certificate of Good Manufacturing Practice (GMP) if the domestic products are

dietary supplements, applicable from July 01, 2019 (a copy authenticated by the

supplier).

3. The documents must be written in Vietnamese language; documents in other languages

must be translated into Vietnamese language and notarized. The documents must be

unexpired when the application is submitted.

Article 8. Procedures for registration of the product declaration

1. The supplier shall submit the application for registration of the product declaration,

whether online, by post or directly, to the following receiving authorities:

a) The Ministry of Health for declarations of dietary supplements, mixed food additives

with new uses and unregistered food additives;

b) A competent authority designated by the People’s Committee of the province for

medical foods, food for special dietary uses and dietary products for children up to 36

months;

c) In the cases where the declaration includes of the products mentioned in both Point a

and Point b of this Clause, the application may be submitted to either receiving authority.

If the supplier has more than one factory that produces the same product, the declaration

may be registered to the regulatory authority of one of the provinces of the supplier’s

choice (except for products that have to be registered to the Ministry of Health). Once

selected, the next applications for registration shall be submitted to the same authority.

2. Within 07 working days (for mixed food additives with new uses, unregistered food

additives, medical foods, food for special dietary uses, dietary products for children up to

36 months) or 21 working days (for dietary supplements) from the day on which adequate

documents are received, the receiving authority specified in Clause 1 of this Article shall

verify the application and issue a certificate of registered product declaration (Form No.

03 in Appendix I hereof).

The time limit for document verification begins on the date of receipt according to the

online public service system (if the application is submitted online) or date stamp of the

receiving authority (if the application is submitted by post or directly).

3. If the application needs to be supplemented, the receiving authority shall provide

explanation in writing and specify the legal basis. The receiving authority may request

the applicant to supplement the application 01 time.

Within 07 working days from the day on which the supplemented application is received,

the receiving authority shall verify it and make a written response. If the applicant fails to

supplement the application within 90 working days from the day on which a written

request is made, the application will be invalidated.

4. In case of change to the product name, origin or ingredients, another application shall

be submitted. In case of other changes, the applicant shall submit a written notification to

the receiving authority mentioned in Clause 1 of this Article and is entitled to carry on the

production or sale of the product afterwards.

5. The receiving authority shall post on its website and update on the food safety database

the names and products of suppliers whose product declarations have been registered.

6. Food suppliers shall pay fees for document verifications in accordance with regulations

of law on fees and charges.

Chapter IV

ASSURANCE OF SAFETY OF GENETICALLY MODIFIED FOODS

Article 9. Assurance of safety of food derived from genetically modified organisms

(GMO) and GMO products

Conditions and procedures for issuance and revocation of the certificate of edible GMO

and the list of GMOs granted such certificate are specified in the Government's Decree

No. 69/2010/ND-CP and Decree No. 108/2011/ND-CP.

Article 10. Labeling of goods containing GMO and GMO products used as foods

1. Manufacturers and sellers of foods the content of GM ingredients in which exceeds 5%

of total ingredients, in addition to compliance with common regulations of law on goods

labeling, the goods label must 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.

Chapter V

ISSUANCE OF THE CERTIFICATE OF FOOD SAFETY

Article 11. Issuance of the certificate of food safety

1. Every food manufacturer and seller must obtain the certificate of food safety, except

for those specified in Clause 1 Article 12 of this Decree.

2. Requirements for issuance of the certificate of food safety are specified in Clause 1

Article 34 of the Law of Food safety. Manufacturers of dietary supplements shall apply

the requirements specified in Article 28 of this Decree.

Article 12. Exemption from the certificate of food safety

1. The following entities are not required to obtain the certificate of food safety:

a) Micro food manufacturers;

b) Mobile food manufacturers and sellers;

c) Micro food processors;

d) Micro food sellers;

dd) Sellers of prepackaged foods;

e) Manufacturers and sellers of instruments and materials for wrapping and storing food;

g) Restaurants within hotels;

h) Industrial kitchens not registered as a food business;

i) Street food vendors;

k) Any food business that has one of the following certificates: GMP, HACCP, ISO

22000, IFS, BRC, FSSC 22000 or an equivalent certificate.

2. The entities mentioned in Clause 1 of this Article must satisfy corresponding food

safety requirements.

Chapter VI

STATE INSPECTION OF SAFETY OF IMPORTED AND EXPORTED FOODS

Article 13. Cases in which state inspection of food safety is exempted unless there if

a food safety warning

1. The product has the certificate of registered product declaration.

2. Foods in hand luggage of inbound passengers that are sent before or after the

passengers arrive to serve the passengers’ personal needs; gifts within duty-free

allowances.

3. Imports serving personal needs of people eligible for diplomatic immunities.

4. Products in transit, temporarily imported or in bonded warehouses.

5. Test samples whose quantities are suitable for the testing purposes and confirmed by

the owners.

6. Products used for displayed at exhibitions or fairs.

7. Products, raw materials that are manufactured or imported for production or processing

of exports or internal production and are not sold domestically.

8. Temporarily imported products for sale at duty-free shops.

9. Imports serving emergency purposes under orders of the Government or the Prime

Minister.

Article 14. Requirements applied to imported products derived from terrestrial

animals, aquatic animals and plants

1. Products derived from terrestrial animals, aquatic animals and plants must satisfy the

following requirements, except for foods that are processed or prepackaged, foods

exported by a Vietnamese organization or individual but then returned, and foods in the

cases specified in Article 13 of this Decree:

a) Their country of origin is a country or territory that has a food safety control system

satisfying Vietnam’s regulations and included in the list of registered countries and

territories that export foods derived from animals, plans and aquatic animals to Vietnam;

b) Terrestrial animals and aquatic animals used as foods must be manufactured by

facilities that satisfy food safety requirements as certified by Vietnamese authorities;

c) Each shipment has a certificate of food safety issued by a competent authority of the

exporting country (except for fish caught and processed by foreign vessels and sold to

Vietnam’s market).

2. Procedures for registration of the exporting countries and territories (hereinafter

referred to as “exporting countries”) mentioned in Clause 1 of this Article are specified in

Article 22 of this Decree.

3. The Ministry of Agriculture and Rural Development shall provide the customs

authorities with the list of exporting countries and exporters allowed to export the

aforementioned products to Vietnam (hereinafter referred to as “list of permitted

exporting countries and exporters”).

Article 15. Inspecting authorities

1. The Ministry of Agriculture and Rural Development, the Ministry of Agriculture and

Rural Development and the Ministry of Industry and Trade shall appoint authorities

responsible for inspection of food safety of imported foods (hereinafter referred to as

“inspecting authorities”).

In the cases where the content of a shipment is under the management of more than one

Ministry, the Ministry of Agriculture and Rural Development shall be the inspecting

authority.

2. Inspecting authorities have the following entitlements and obligations:

a) Decide to switch over from regular inspection to reduced inspection and switch back to

normal inspection after the results of 03 tightened inspections is satisfactory.

b) Carry out food inspection in accordance with the methods and procedures specified in

this Decree;

c) Taking and storing samples in accordance with law;

c) Collect testing and inspection fees in accordance with law;

dd) Ensure accuracy and objectivity of the inspections;

e) Comply with instructions from the Ministry of Health, the Ministry of Agriculture and

Rural Development and the Ministry of Industry and Trade;

g) Settle complaints of goods owners. Pay the inspection and testing fees and

compensation for any damage to the goods owners;

h) Retain inspection documents and present them at the request of competent authorities;

i) Submit biannual reports to the supervisory Ministry (form 06 in Appendix I hereof) and

ad hoc reports to the Ministry of Health, the Ministry of Agriculture and Rural

Development, the Ministry of Industry and Trade or a competent authority of the

manufacturer’s home country, or reports on disposal of disqualified foods.

Article 16. Inspection methods

1. Reduced inspection: document inspection of up to 5% of the shipments within 01 year

randomly chosen by the customs authority.

2. Normal inspection: document inspection only.

3. Tightened inspection: both document inspection and sampling.

Article 17. Application of the inspection methods

1. Reduced inspection will be carried out if:

a) There is a certificate 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 inspection result given by the competent authority of the

exporting country is satisfactory;

b) The results of 03 consecutive normal inspections within 12 months are satisfactory;

c) The manufacturer applies either GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000 or

an equivalent system.

2. Normal inspection applies to all commodities of the shipment, except for the cases

specified in Clause 1 and Clause 3 of this Article.

3. Tightened inspection will be carried out if:

a) The result of the previous inspection is not satisfactory;

b) A shipment or commodity fails to meet requirements during the inspections (if any);

c) A warning is issued by the Ministry of Health, the Ministry of Agriculture and Rural

Development, the Ministry of Industry and Trade, the People’s Committee of the

province or a competent authority of a foreign country or the manufacturer’s home

country.

4. The tightened inspection will be changed into normal inspection in the following cases:

a) The results of 03 consecutive tightened inspection are satisfactory in the cases

specified in Point a and Point b Clause 3 of this Article;

b) The Ministry of Health, the Ministry of Agriculture and Rural Development or the

Ministry of Industry and Trade of Vietnam issues a request for suspension of tightened

inspection in the cases specified in Point c Clause 3 of this Article.

Article 18. Application for inspection

1. An application for reduced inspection consists of the following documents:

a) The product self-declaration;

b) 03 notices of satisfactory results of consecutive normal inspections, or certified true

copies or consularly legalized copies of either GMP, HACCP, ISO 22000, IFS, BRC,

FSSC 22000 certificate of an equivalent certificate that is unexpired when submitted;

c) For products derived from aquatic animals and terrestrial animals, except for processed

or prepackaged products, the original copy of the certificate of fulfillment of food safety

requirements issued by a competent authority of the exporting country.

2. An application for normal inspection and tightened inspection consists of the following

documents:

a) The registration form No. 04 in Appendix I hereof;

b) The product self-declaration;

c) Original copies of 03 notices of satisfactory results of consecutive tightened

inspections (to switch over from tightened inspection to normal inspection).

d) A copy of the packing list;

dd) For the products mentioned in Article 14 of this Decree, the original copy of the

certificate of fulfillment of food safety requirements issued by a competent authority of

the exporting country, except for fish caught and processed by foreign vessels and sold to

Vietnam’s market.

Article 19. Inspection procedures

1. Procedures for reduced inspection:

While following customs procedures, the goods owner shall submit an application

according to Clause 1 Article 18 of this Decree;

b) The customs authority shall carry out document inspection of up to 5% of the

shipments eligible for reduced inspection within 01 year.

Within 03 working days from the receipt of the application, the customs authority shall

process it and consider granting customs clearance. If the application has to be

supplemented, explanation and legal basis must be provided.

2. Procedures for normal inspection:

a) Before the shipment arrives at the border checkpoint, he goods owner shall submit the

application according to Clause 2 Article 18 of this Decree to the inspecting authority or

National Single-window Information Portal of the Ministry of Health, the Ministry of

Agriculture and Rural Development or the Ministry of Industry and Trade (if applied);

b) Within 03 working days from the receipt of the application, the customs authority shall

process it and issue a notice of whether the inspection result is satisfactory (form No. 05

of Appendix I hereof). If the application has to be supplemented, explanation and legal

basis must be provided;

c) The goods owner shall submit the notice of satisfactory inspection result to the

customs authority to be granted customs clearance.

3. Procedures for tightened inspection:

a) The same as Point a Clause 2 of this Article;

b) b) Within 07 working days from the receipt of the application, the customs authority

shall process it and issue a notice of whether the inspection result is satisfactory (form

No. 05 of Appendix I hereof). If the application has to be supplemented, explanation and

legal basis must be provided;

c) The goods owner shall submit the notice of satisfactory inspection result to the

customs authority to be granted customs clearance.

4. If the inspection result is not satisfactory, 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 disposal of unconformable foods to the supervisory Ministry.

Article 20. Disposal of unconformable foods

1. After unconformable foods are disposed of 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 repurposing contract between the goods owner and the buyer or recipient of the

unconformable products. The buyer or recipient of the unconformable products must not

use them as foods.

2. If the goods owner wishes to import the products to Vietnam after rectifying the

violations or label, the goods owner shall follow apply for inspection in accordance with

Article 19 of this Decree.

If the inspection result is still unsatisfactory after rectification, one of the measures

specified in Point c and Point d Clause 3 Article 55 of the Law of Food safety shall be

implemented.

Article 21. rights and obligations of the goods owner

1. Request reduced inspection in the cases specified in Clause 1 Article 17 of this Decree.

2. Request the inspecting authority to reconsider the inspection result or request the

receiving authority to select a designated laboratory to carry out a re-inspection. If the

result of the re-inspection matches the initial result, the goods owner shall pay the re-

inspection cost; if the result of re-inspection is satisfactory, the goods owner will be

reimbursed for the re-inspection cost.

3. Propose the measures specified in Clause 3 Article 55 of the Law of Food safety if the

inspection result is unsatisfactory.

4. Maintain the status quo of the shipment to facilitate sampling by the inspecting

authority.

5. Implement the decision on disposal of unconformable foods issued by a competent

authority.

Article 22. 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 exporter as follows:

a) The competent authority of the exporting country shall send 01 application to the

Ministry of Agriculture and Rural Development, including information about its

management system (laws, standards, food safety control system) and its capacity for

food safety control according to form No. 08 in Appendix I hereof; a list of registered

exports (form No. 07 in Appendix I) and information about their fulfillment of food

safety requirements (form No. 09 in Appendix I).

b) within 30 working days from the day on which adequate documents are received

according to Point a of this Clause, 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) The inspection in the exporting country deals with: 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 result and publishing of the list of eligible exporting countries

and exporters:

a) if a site inspection in the exporting country is not necessary, the Ministry of

Agriculture and Rural Development shall publish the inspection result and list of

countries and territories eligible to export to Vietnam. For products derived from

terrestrial animals and aquatic animals, a list of permissible exporters shall also be

published;

b) If a site inspection in the exporting country is necessary, the Ministry of Agriculture

and Rural Development shall publish the inspection result within 30 working days from

the end of the inspection.

If the inspection result is not satisfactory, the Ministry of Agriculture and Rural

Development shall issue a notice and provide specific explanation.

c) For addition of eligible exporters of products derived from terrestrial animals and

aquatic animals, the competent authority of the exporting country shall submit an

application for document inspection or site inspection which contains a list and

information about the exporters according to form No. 07 and form No. 08 mentioned in

Point a Clause 1 of this Article to the Ministry of Agriculture and Rural Development.

The inspection result is the basis for addition of eligible exporters.

Article 23. State inspection of foods for export

1. The Minister of Health, the Minister of Agriculture and Rural development, the

Minister of Industry and Trade shall specify the power to carry out state inspection of

safety of foods for export under their management in accordance with Article 62 through

64 of the Law of Food safety at the request of the importing country.

2. The Ministry of Agriculture and Rural Development shall specify responsibility to

inspect shipments of foods under the management of more than one Ministry.

Chapter VII

FOOD LABELING

Article 24. Compulsory 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 food 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 food for special dietary uses shall contain the phrase “Sản phẩm dinh

dưỡng (cho đối tượng cụ thể)”.

2. The label of imported products must specify: name and address of the importer, the

organization or individual that submits the declaration or registers the self-declaration of

products.

Article 25. 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, 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 cm

does not have to specify ingredients, expiration date, storage conditions and

instruction for use if there is a secondary label or secondary package which contains such

information.

3. The date of manufacturing is not required on food containers and primary packages.

Chapter VIII

FOOD ADVERTISEMENTS

Article 26. Foods for which advertisement contents must be registered

1. Dietary supplements, medical foods, food for special dietary uses.

2. Dietary products for children up to 36 months not banned from advertising according

to Article 7 of the Law on Advertising.

Article 27. Registration of 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

content to the authority that issued the certificate of product registration.

2. The advertisement content must be consistent with the effects of the product specified

in the product declaration. Do not use images, equipment, uniforms, documents of health

facilities, physicians, pharmacists, health workers, patients’ appreciation letter, articles

written by health facilities, physicians or pharmacists to advertise foods.

3. Regarding dietary supplements:

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 “this product is not intended to diagnose,

treat, cure or prevent any disease”), which must be written clearly and has a contrasting

color with the background;

b) The text in Point a above must be read aloud in case of audio and video

advertisements;

c) The text mentioned in Point a above is not required if the duration of an audio or video

advertisement is shorter than 15 seconds, but must be displayed during the advertisement.

4. An application for certification of advertisement contents consists of the following

documents:

a) The application form (Form No. 10 in Appendix I hereof);

b) The certificate of registered product declaration and the product declaration certified

by a competent authority (a copy certified by the applicant);

c) A sample label (certified by the applicant);

d) For audio or video advertisement, a disc that contains the advertisement script; For

other types of advertisement, a maquette (certified by the applicant);

d) The uses or effects other than those written in the product declaration must be proven

by scientific documents (copies certified by the applicant);

The documents must be written in Vietnamese language; documents in other languages

must be translated into Vietnamese language and notarized.

5. Procedures for issuance of the certificate of advertisement contents:

a) The owner of the advertised product shall submit the application for the certificate of

advertisement content to the authority that issued the certificate of registered product

declaration;

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. The

aforementioned time limit is determined according to the date stamp of the receiving

authority (if the application is sent by post) or the date of receipt on the online public

service system.

If advertisement content is not concurred with or the application has to be supplemented,

the receiving authority shall provide explanation in writing and specify the legal basis.

The receiving authority may request the applicant to supplement the application 01 time.

Within 10 working days from the day on which the supplemented application is received,

the receiving authority shall process it and make a written response. If the application

fails to supplement the application within 90 working days from the day on which a

written request is made, the application will be invalidated;

c) The receiving authority shall post on its website and update on the food safety database

the products that have the certificate of advertisement contents and names of their

suppliers;

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 certificate of advertisement contents and must adhere to the

content of the certificate.

Chapter IX

FOOD SAFETY CONDITIONS IN PRODUCTION OF DIETARY

SUPPLEMENTS

Article 28. Food safety requirements in production of dietary supplements

1. Manufacturers of dietary supplements shall satisfy general food safety conditions

specified in Clause 1 Article 19, Clause 1 Article 20 and Clause 1 Article 21 of the Law

of Food safety and the following regulations:

a) Establish and maintain a quality control system which control the manufacture and

distribution in order to ensure that all products satisfy the applied standards and are safe

until their expiration;

b) Hire employees whose qualifications are suitable for their positions and are trained in

GMP, food safety and relevant knowledge. The head of the production department and

quality control department must be full-time employees and work independently from

one another. The chief supervisor of the facility must have at least a bachelor’s degree in

medicine, pharmacy, nutrition, food safety or food processing technology and 3 years'

working experience in a relevant field;

c) The factory, equipment and auxiliary utilities are installed 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) Retain documents about the manufacture process, quality control and distribution in a

manner that the history of every batch can be accessed, and documents about other

activities at the facility;

dd) All tasks must be performed in accordance with procedures and instructions. Carry

out inspections and supervision during the manufacture process to avoid confusion,

pollution and cross-contamination. Record the result immediately after a process is done;

e) Establish a quality control department to ensure that the products are manufactured

under conformable conditions and processes; necessary tests are 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 satisfy requirements of the hirer, satisfy requirements for

testing or production of dietary supplement established by a competent authority.

h) There are 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. From July 01, 2019, manufacturers of dietary supplements shall satisfy GMP

requirements in accordance with instructions from the Ministry of Health.

Article 29. Procedures for issuance and reissuance of the certificate of GMP for

dietary supplements

1. An application for the certificate of GMP for dietary supplements consists of the

following documents:

a) The application form No. 12 in Appendix I hereof;

b) A floor plan of the production area and production lines (certified by the applicant);

c) A list of primary equipment at the facility.

2. Procedures for issuance of the certificate of GMP for dietary supplements

a) An application specified in Clause 1 of this Article shall be submitted to the Ministry

of Health directly, by post or through the online public service system;

b) 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 consist of at least 5 people, 2 of whom are experienced in GMP,

and 1 person is specialized in testing.

c) If the inspection result is satisfactory, the receiving authority shall issue the certificate

of GMP for dietary supplements (Form No. 14 in Appendix I hereof) within 30 days from

the receipt of the application;

d) If the inspection result is not satisfactory, explanation shall be provided in the

inspection record. After rectification, the applicant shall send a notice to the inspectorate.

Within 07 working days from the receipt of such notice, the inspectorate shall consider

and request the Ministry of Health to issue the certificate of GMP for dietary

supplements. If rectification is not done within 03 months from the end of the inspection

or a notice of rectification is not sent to the inspectorate, the application shall be rejected.

3. A certificate of GMP for dietary supplements is valid for 03 years from its date of

issuance. At least 06 months before expiration of the certificate, the certificate holder

shall submit an application for its reissuance. Documents and procedures for reissuance

are the same as those specified in Clause 1 and Clause 2 of this Article.

4. Applicants for the certificate of GMP for dietary supplements shall pay fees for

document processing to the receiving authority.

Chapter X

FOOD SAFETY REQUIREMENTS APPLIED TO FOOD ADDITIVES

Article 30. Food safety requirements applied to food additives

Manufacturers and sellers of food additives shall satisfy the following food safety

requirements:

1. Satisfy general food safety requirements specified in specified in Clause 1 Article 19,

Clause 1 Article 20 and Clause 1 Article 21 of the Law of Food safety.

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. In the

cases where a new product with new effects is created, such effects, intended users and

dose must be proven.

3. Packaging of food additives shall be carried out at a facility that satisfies food safety

requirements. Food additives must be labeled in accordance with applicable law.

Article 31. Single-ingredient food additives

1. Foods on in the list of permitted food additives compiled by the Ministry of Health

shall be self-declared.

2. Procedures for declaration of single-ingredient food additives are specified in Article 5

of this Decree.

Article 32. Mixed food additives with new uses

1. Product declarations of mixed food additives with new uses shall be registered at the

Ministry of Health.

2. Content of every ingredient in a mixed food additive with new uses must be specified.

3. Procedures for registration of product declaration of mixed food additives with new

uses are specified in Article 7 and Article 8 of this Decree.

Article 33. Use of food additives

1. Only use the food additives on the list of permitted food additives compiled by the

Ministry of Health. Product declarations of unregistered food additives shall be submitted

to the Ministry of Health in accordance with Article 7 and Article 8 of this Decree.

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 XI

TRACING FOOD ORIGINS

Article 34. 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 35. Tracing origins of unsafe foods

1. Food manufacturers and sellers shall retain information about manufacturers or

suppliers of products and buyers (if any) in the form of contracts, logbooks or other

methods to serve origin tracing. Information serving origin tracing includes:

a) Names and categories of the products sold;

d) Dates, quantities, batch numbers of the products sold.

2. The Minister of Health, the Minister of Agriculture and Rural development, the

Minister of Industry and Trade shall promulgate specific regulations on tracing origins of

products under their management.

Chapter XII

STATE MANAGEMENT OF FOOD SAFETY

Article 36. 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. Ensure continuous management of food production and sale.

4. Close cooperation between ministries.

5. Ensure that a product, a manufacturer or a seller is under the management of a single

authority.

6. Ensure scientificness, adequacy and feasibility.

7. Distribution of responsibility for 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 Ministry of Industry and Trade 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 37. Responsibility of the Ministry of Health

1. Implement regulations on 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 be basis of

supervisions and reports from other Ministries and the People’s Committees of provinces.

3. Promulgate technical regulations on products under its management according to

Article 62 of the Law of Food safety and the products in Appendix II hereof; promulgate

technical regulations or impose safety limits on various groups of products at the request

of other Ministries.

4. Perform food safety management throughout the production, processing, storage,

transport, export, import, sale of the products specified in Appendix II hereof.

5. Receive and manage applications, issue the certificate of registered product

declaration, certificate of food safety regarding dietary supplements, mixed food

additives with new uses and unregistered food additives; Certificate of GMP for dietary

supplements; Certificate of advertisement contents for dietary supplements; Certificate of

free sale for products under its management, health certificate.

6. Appoint food testing laboratories and verifying laboratories under its management;

appoint laboratories that run tests serving of arbitration and giving final conclusions in

case of discrepancies in results given by various laboratories.

7. Appoint regulatory authorities responsible for food safety of products under its

management.

Article 38. Responsibility of state capital

1. Promulgate technical regulations on products under its management according to

Article 63 of the Law of Food safety and the products in Appendix III hereof.

2. Establish safety limits applied to the products in Appendix III hereof and send them to

the Ministry of Health for promulgation.

3. Monitor and assign food safety management tasks regarding the processes of farming,

breeding, collecting, fishing, salt production.

4. Perform food safety management and assign food safety management tasks throughout

the processes of production, collecting, preparation, processing, storage, transport, export,

import, sale of the products specified in Appendix III hereof.

5. Organize the issuance of the certificate of free sale for products under its management.

6. Organize the issuance of the certificate of food safety to manufacturers and sellers of

the products mentioned in Clause 3 and Clause 4 of this Article.

7. Perform food safety management at wholesale farm produce markets.

8. Appoint food testing laboratories and verifying laboratories; appoint laboratories

responsible for giving final conclusions in case of discrepancies in results given by

various laboratories under its management.

9. Appoint regulatory authorities responsible for food safety of products under its

management.

10. Publish the list of eligible exporting countries and exporters under its management.

Article 39. Responsibility of the Ministry of Industry and Trade

1. Promulgate technical regulations on products under its management according to

Article 64 of the Law of Food safety and the products in Appendix IV hereof.

2. Establish safety limits applied to the products in Appendix IV hereof and send them to

the Ministry of Health for promulgation.

3. Perform food safety management and assign 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.

4. Perform food safety management at supermarket, shopping malls, convenience stores,

facilities of the storage and distribution system, and other types of business.

5. Organize the issuance of certificate of free sale for products under its management.

6. Organize the issuance of the certificate of food safety to manufacturers and sellers of

the products under its management.

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. Appoint food testing laboratories and verifying laboratories; appoint laboratories

responsible for giving final conclusions in case of discrepancies in results given by

various laboratories under its management.

9. Appoint regulatory authorities responsible for food safety of products under its

management.

Article 40. Responsibility of the People’s Committees of provinces

1. Perform state management of food safety in their provinces and take responsibility to

the GOVERNMENT for food safety in their provinces. Presidents of the People’s

Committees of provinces shall hold the position of chief of the provincial food safety

committee, which carry out inspection and supervision of food safety in their provinces;

inspect implementation of law on food safety by inferior authorities; take actions against

officials who fail to perform their food safety management duties; organize settlement of

complaints and denunciations; take actions against violations against regulations of law

on food safety; take responsibility to the Government for violations against food safety in

their provinces.

2. Organize implementation of regulations on food safety of the Government and

Ministries in their provinces.

3. Operate the provincial food safety committees.

4. Organize dissemination and education of food safety law 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.

7. Develop and promulgate regulations on food safety on local foods.

8. Receive and manage applications; issue the certificate of registered product declaration

and certificate of advertisement contents for medical foods, food for special dietary uses,

dietary products for children up to 36 months.

9. Receive product self-declaration and grant certificate of food safety.

Article 41. 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 develop a food safety education program; the Ministry of

Agriculture and Rural Development, the Ministry of Industry and Trade and other

ministries shall cooperate with the Ministry of Health in running the program.

3. The Ministry of Health, the Ministry of Agriculture and Rural Development and the

Ministry of Industry and Trade shall plan and carry out inspections of products under

their management in cooperation with other ministries.

4. In case of food poisoning, the Ministry of Health is responsible for organizing

emergency treatment. 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 food.

5. Upon discovery of unconformable foods under management of other ministries, the

Ministry of Health shall take charge and cooperate with relevant Ministries in carrying

out inspection and giving conclusion.

Chapter XIII

IMPLEMENTATION

Article 42. Transition clauses

1. The certificates of declaration of conformity and certificates of declaration of

conformity with food safety regulations that are granted before the effective date of this

Decree are still valid until the expiration date of such certificates or the products.

2. Supervisory Ministries shall review and annul the regulations that contravene this

Decree.

Article 43. Effect

1. This Decree comes into force from February 02, 2018.

2. This Decree replaces the Government's Decree No. 38/2012/ND-CP dated April 25,

2012 elaborating some articles of the Law of Food safety; Chapter II of Circular No.

13/2014/TTLT-BYT-BNNPTNT-BCT dated April 09, 2014 of the Ministry of Health,

the Ministry of Agriculture and Rural Development and the Ministry of Industry and

Trade.

Article 44. Responsibility for implementation

Ministries, 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./.

ON BEHALF OF THE GOVERNMENT

THE PRIME MINISTER

Nguyen Xuan Phuc

APPENDIX I

(Enclosed with the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018)

Form No. 01

Self-declaration form

Form No. 02

Product declaration

Form No. 03

Certificate of registered product declaration

Form No. 04

Registration of imported foods inspection

Form No. 05

Notice of satisfactory/unsatisfactory results of normal inspections

Form No. 06

Report on state inspection of food safety of imported foods

Form No. 07

List of registered exporters of foods to Vietnam

Form No. 08

Information about management system and capacity for food safety

control of the competent authority of the exporting country

Form No. 09

Summary of information about food producer’s or seller’s fulfillment of

food safety requirements

Form No. 10

Application form for certification of advertisement contents

Form No. 11

Certificate of advertisement contents

Form No. 12

Application for issuance of the certificate of GMP for dietary

supplements

Form No. 13

Inspection record

Form No. 14

Certificate of GMP for dietary supplements

Form No. 01

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

SELF-DECLARATION FORM

No. ………………./Name of the producer/Year of declaration

I. Information about the producer self-declaring its product

Name of the producer: .....................................................................................................

Address: ..........................................................................................................................

Telephone: …………………………………………….. Fax:

...............................................

E-mail................................................................................................................................

Producer identification number:........................................................................................

Certificate of food safety No. ……………….. Date of issue/Place of issue: …………….

(for the producer that must be issued with a certificate of food safety in accordance with

regulations of law)

II. Information about the product

1. Name of the product: ....................................................................................................

2. Ingredients: ...................................................................................................................

3. Expiration date: ..........................................................................................

4. Packaging specifications and packaging materials: ......................................................

5. Name and address of the producer (in case of rent of the manufacturing

facility):...............................................................................................................................

III. Label design (attach the label design or proposed label design)

IV. Food safety requirements

The food producer or seller satisfies food safety requirements according to:

- National technical regulation No. ....; or

- Circular of ministries; or

- Local technical regulation; or

- National standard (in case national technical regulations, Circulars of ministries and

local technical regulations are not available); or

- Codex Alimentarius, regional standards, international standards (in case national

technical regulations, Circulars of Ministries, local technical regulations and national

standards are not available); or

- Standards attached by the manufacturers (in case national technical regulations,

Circulars of Ministries, local technical regulations, national standards, Codex

Alimentarius, regional standards and international standards are not available).

We are committed to comply with all regulations of the law on food safety and take full

responsibility for legality of the application for registration of the product declaration and

quality and food safety of the declared product./.

……………, date…. month…. year........

REPRESENTATIVE OF THE PRODUCER

(Signature and seal)

Form No. 02

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

PRODUCT DECLARATION

No.……………….

I. Information about the producer declaring its product

Name of the producer: .......................................................................................................

Address: .............................................................................................................................

Telephone: ……………………………………… Fax:

..........................................................

E-mail.................................................................................................................................

Producer identification number:..........................................................................................

Certificate of food safety No. ………………… Date of issue/Place of issue: .........

.............................................................................................................................................

(for the producer that must be issued with a certificate of food safety in accordance with

regulations of law)

II. Information about the product

1. Name of the product: .......................................................................................................

2. Ingredients: ....................................................................................................................

3. Quality indicators contributing effects of the products (applicable to dietary

supplements):

4. Expiration date: ..........................................................................................

5. Packaging specifications and packaging materials: .........................................................

6. Name and address of the producer: ........................................................................

III. Label design (attach the label design or proposed label design)

IV. Food safety requirements

The food producer or seller satisfies food safety requirements according to:

- National technical standard No. ....; or

- Circular of ministries; or

- Local technical standard; or

- National standard (in case national technical regulations, Circulars of ministries and

local technical regulations are not available); or

- Codex Alimentarius, regional standards, international standards (in case national

technical regulations, Circulars of Ministries, local technical regulations and national

standards are not available); or

- Standards attached by the manufacturers (in case national technical regulations,

Circulars of Ministries, local technical regulations, national standards, Codex

Alimentarius, regional standards and international standards are not available).

We are committed to comply with all regulations of the law on food safety and take full

responsibility for legality of the application for registration of the product declaration and

quality and food safety of the declared product, and only produce and sell the product

when issued with the certificate of registered product declaration./.

…………, date…. month…. year………

REPRESENTATIVE OF THE PRODUCER

(Signature and seal)

Form No. 03

NAME OF THE SUPERVISORY

AUTHORITY

NAME OF THE RECEIVING

AUTHORITY

-------

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

……………, date…. month…. year........

CERTIFICATE OF REGISTERED PRODUCT DECLARATION

No. /year/DKSP

……… (name of the receiving authority) ……. confirms receipt of the product

declaration of: ………………………. (name of the producer)

address……………………………….. telephone, …………………….

Fax……………………….. Email …………………………… for the product:

……………………….manufactured by……………………….. (name, address where

manufactured and country of origin) according to the technical

regulation/standard…(number, symbol and name) ……………………….The producer

shall take full responsibility for the conformity of the declared product./.

COMPETENT REPRESENTATIVE OF

THE ISSUING AUTHORITY

(Signature, seal)

Form No. 04

Name of the goods owner

-------

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

REGISTRATION OF IMPORTED FOODS INSPECTION

No. ..../20..../DKNK

1. Name, address and telephone of the goods owner: .......................................................

2. Name, address and telephone of the trader responsible for goods quality: ....

.............................................................................................................................................

3. Name, address and telephone of the exporter: ..............................................................

4. Expected time of import: ..........................................................................................

5. Checkpoint of departure: ................................................................................................

6. Checkpoint of arrival: ......................................................................................................

7. Date of inspection: ..........................................................................................

8. Location of inspection: ..........................................................................................

9. Expected name of the inspecting authority: ....................................................................

10. Details about the shipment:

No.

Name of

goods

Product group (According to

QCVN or Codex or

manufacturer’s standard)

Name and

address of the

manufacturer

Method of

inspection

Inspection

method

confirmation

number*

(1)

(2)

(3)

(4)

(5)

(6)

* Inspection method confirmation means a notice given by a competent authority of the

goods that has been inspected using the said inspection method.

……………, date…. month…. year........

Goods owner

(Signature, seal)

……………, date…. month…. year........

State inspecting authority

(Signature, seal)

Form No. 05

State inspecting authority

-------

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

NOTICE OF SATISFACTORY/UNSATISFACTORY RESULTS OF NORMAL

INSPECTIONS

No. ……/20…../TBNK

1. Name, address and telephone of the goods owner: .......................................................

2. Name, address and telephone of the trader responsible for goods quality: ....

.............................................................................................................................................

3. Name, address and telephone of the exporter: ..............................................................

4. Customs declaration No. .................................................................................................

5. Checkpoint of departure: .................................................................................................

6. Checkpoint of arrival: ......................................................................................................

7. Date of inspection: ..........................................................................................

8. Location of inspection: ....................................................................................................

9. Details about the shipment:

Nam

e of

good

Produc

t group

Name and

address of

the

manufacture

Method

inspectio

Satisfactory/unsatisfacto

Reasons for

unsatisfactor

y results

Note

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

……………, date…. month…. year........

State inspecting authority

(Signature, seal)

Form No. 06

State inspecting authority

-------

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

REPORT ON STATE INSPECTION OF FOOD SAFETY OF IMPORTED FOODS

From ..../…./… to ……../……../……..

Name of the inspecting authority: ......................................................................................

Address: ............................................................................................................................

Telephone: …………………………………………….. Fax: .........................................

Prepared by: ....................................................................................................

I. INSPECTED ITEMS:

A. General information:

Inspecte

d items

Normal inspection

Tightened inspection

Total

(a+b+c+d

)

Satisfactor

y (a)

Unsatisfactor

y (b)

Tota

(a+b

)

Satisfactor

y (c)

Unsatisfactor

y (d)

Tota

(c+d

)

Goods

Shipment

Average

time for

shipment

inspectio

n (hour)

B. List of goods and shipment that fail to satisfy import requirements

No.

Name and

address of

the goods

owner

Name of

shipment/

goods

Product

group

Name and

address of the

manufacturer

Method of

inspection

Reasons for

unsatisfactory

results

Notes

II. SUGGESTIONS:

Representative of State inspecting authority

(Signature, seal)

Form No. 07

LIST OF REGISTERED EXPORTERS OF FOODS TO VIETNAM

No.

Name of exporter

Identification

number

Address

Proposed foods exported

to Vietnam

Notes

……………, date…. month…. year........

FOOD SAFETY AUTHORITY OF THE

EXPORTING COUNTRY

(Signature, seal)

Form No. 08

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.):

.............................................................................................................................................

3. System of documents, standards, food safety inspection and certification processes:

.............................................................................................................................................

4. System for inspecting and monitoring residues and microorganisms, etc. of the

producer/seller:

.............................................................................................................................................

5. Food safety inspection and supervision program:

………, date….. month….. year……..

FOOD SAFETY AUTHORITY OF THE

EXPORTING COUNTRY

(Signature, seal)

Form No. 09

SUMMARY OF INFORMATION ABOUT FOOD PRODUCER’S OR SELLER’S

FULFILLMENT OF FOOD SAFETY REQUIREMENTS

1. Name of the food producer or seller: ...............................................................................

2. Address: ..........................................................................................................................

3. Product: .......................................................................................................................

4. Description of production process: ..................................................................................

5. Applied quality management system: ............................................................................

………., date…. month…. year……

CONFIRMATION BY FOOD SAFETY

AUTHORITY OF THE EXPORTING

COUNTRY

(Signature, seal)

Form No. 10

NAME OF THE

THE SOCIALIST REPUBLIC OF VIETNAM

APPLICANT

-------

Independence - Freedom - Happiness

---------------

No. : /Abbreviated name

of the applicant

……

……., date….. month….. year 20……..

APPLICATION FORM FOR CERTIFICATION OF ADVERTISEMENT

CONTENTS

To:

………………………………………………….

1. Name of the applicant: .......................................................................................

2. Address:

..............................................................................................................

............................................................................................................................................

Telephone: ………………………………….. Fax:

................................................................

Application form for certification of advertisement contents for:

No.

Name of

product

Registered product declaration

certificate number and symbol

Date of receipt

Advertising media: .....................................................................................................

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.

I have the honor to request you to consider issuing the certificate of advertisement

contents./.

Director or legal representative of the

applicant

Signature (full name, title)

Seal

___________________

Place

The receiving authorities: Competent authorities specified in Articles 37 and 40 of this

Decree.

Specified in the business registration certificate

Form No. 11

NAME OF THE SUPERVISORY

AUTHORITY

NAME OF THE RECEIVING

AUTHORITY

-------

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

No. /XNQC-...

…

Name of province/city, date…month…year 20…

CERTIFICATE OF ADVERTISEMENT CONTENTS

Name of the advertiser: ......................................................................................................

Address: .............................................................................................................................

Telephone: ……………………………………………………. Fax:

.......................................

No.

Name of

product

Registered product declaration number and symbol

Advertising media:

.............................................................................................................................................

It is certified that the advertisement content (enclosed) is conformable with applicable

regulations.

The advertiser is requested to adhere to the certified content.

Confirmed by

(Signature, full name and seal)

__________________

Abbreviated name of the certifying authority

Form No. 12

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

APPLICATION FOR ISSUANCE OF THE CERTIFICATE OF GMP FOR

DIETARY SUPPLEMENTS

To:………………….

Name of the applicant: .........................................................................................................

Address: ................................................................................................................................

Applicant identification number:

...........................................................................................

Name and address of the manufacturer: .............................................................................

We have the honor to request you to consider issuing the certificate of GMP for dietary

supplements./.

………., date……. month…… year 20....

OWNER

(signature, seal)

Form No. 13

NAME OF THE SUPERVISORY

AUTHORITY

NAME OF THE COMPETENT

AUTHORITY

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

-------

No. ………….

………., date……. month…… year ………

INSPECTION RECORD

GMP FOR DIETARY SUPPLEMENTS

Implementing the Decision No…. dated….of……………………

Today, on….date…., the inspectorate including:

1. Head (name, title, working location): ............................................................

2. Secretary (name, title, working location): ............................................................

3. Members (name, title, working location): ............................................................

Location of inspection:………………..

Representative of the manufacturer:

.............................................................................................................................................

GENERAL INFORMATION

1. The applicant for issuance of the certificate:

- Name and address of the manufacturer: ...........................................................................

- Applicant’s identification number:

......................................................................................

- Legal representative: ..........................................................................................

2. 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. ……/QD-BYT dated …../……/20……

- Scope of inspection: according to the application of (name of the manufacturer) dated

……/…../……

INSPECTION RESULT

I. Site inspection

1. Infrastructure and equipment: ......................................................................................

2. Hygiene and hygiene supervision: ...........................................................

3. Food ingredients, food additives, food processing aids: ................................................

4. Testing and control of quality of ingredients, semi-finished products, finished products

and necessary tests.

5. Documents: ..................................................................................................................

6. Other contents specified in the GMP manual:............

.............................................................................................................................................

II. Shortcomings and shortcoming categorization

III. Conclusion

IV. Opinions of the inspected manufacturer

.............................................................................................................................................

The record is agreed upon by the parties and is made into 03 (three) copies. The inspected

manufacturer keeps 01 copy and the competent keeps 01 copy.

Inspectorate

(Signature, full name)

Representative of the manufacturer

(Signature, seal and full name)

1. Head:

2. Secretary:

3. Members:

Form No. 14

NAME OF THE SUPERVISORY

AUTHORITY

NAME OF THE COMPETENT

AUTHORITY

-------

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

---------------

No. ………….

CERTIFICATE OF FOOD SAFETY

NAME OF THE MANUFACTURER

HAS SATISFIED GMP REQUIREMENTS APPLIED TO DIETARY

SUPPLEMENTS

WITH RESPECT TO THE FOLLOWING PRODUCTS:

…………………………………………………………………………………….

THE CERTIFICATE IS VALID FOR 03 YEARS FROM ITS SIGNING DATE

………., date……. month…… year ………

Representative of the issuing authority

(Signature, seal)

APPENDIX II

LIST OF PRODUCTS AND COMMODITIES UNDER THE MANAGEMENT OF THE

MINISTRY OF HEALTH

(Enclosed with the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018)

No.

Name of product

Notes

Bottled water, mineral water, ice

(Ready-to-use ice and ice used for food

processing)

Other than ice used for storage and

processing of products under the

management of the Ministry of Agriculture

and Rural Development

Functional foods

Micronutrients

Food additives, food flavorings, food

processing aids

Food packages and containers in direct

contact with foods

Other than food packages and containers in

direct contact with foods under the

management of the Ministry of Agriculture

and Rural Development and the Ministry of

Industry and Trade that are manufactured in

the same facility and only used for such

facility’s foods

Other products not included in the list

of the Ministry of Industry and Trade

and Ministry of Agriculture and Rural

Development

APPENDIX III

LIST OF PRODUCTS AND COMMODITIES UNDER THE MANAGEMENT OF THE

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

(Enclosed with the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018)

No.

Name of product

Notes

Cereals

Cereal grains worked (husked, chopped, hulled,

heated, etc.)

Other than those in powder

form and powder and starch

products

Meat and meat products

Fresh, chilled and frozen meat (carcasses, cuts,

slices, pellets, etc.)

Edible meat offal of livestock and poultry (Viscera,

bones, legs, neck, wings, fat, blood, etc.)

Products made from livestock and poultry meat and

edible offal (dried smoked, canned, heated, salted,

gelatin, etc.)

Other than functional

products under the

management of the Ministry

of Health

Homogenised preparations of meat (Chinese

sausage, hot dog, salami, grilled chopped meat,

Other than products in cake

forms under the management

ham, etc.)

of the Ministry of Industry

and Trade

III

Fish and fish products (including amphibian

species)

Fisheries, fresh, chilled, refrigerated (whole-

carcasses, primarily worked, fillet, ground, pullets,

cuts, etc.)

Fish offal (skins, fins, eggs, fat, etc.)

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

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

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

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

Edible vegetables , roots and tubers and their

products

Vegetables, roots and tubers, fresh and worked (cut,

hulled, threshing, segmented, etc.)

Other than vegetables, roots

and tubers for seeding

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

Eggs and egg products

Eggs of terrestrial animals and amphibians

Eggs of terrestrial animals and amphibians, worked

(frozen, salted, milled, molded, etc.)

Products having eggs and egg powder for

Other than confectionery

consumption

containing eggs and egg

powder under the

management of the Ministry

of Industry and Trade.

Raw milk

VII

Honey and honey products

Pure honey, condensed, diluted

Beeswax, pollen, royal jelly with or without honey

Products containing honey, beeswax, pollen, royal

jelly

Other than confectionery,

jams and beverage containing

honey under the management

of the Ministry of Industry

and Trade Other than

functional foods and

pharmaceuticals under the

management of the Ministry

of Health

VIII

Genetically-modified foods

Salt

Sea salt, rock salt

Salt, processed, fined and mixed with other

ingredients

Condiments

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

Sauces and preparations therefor

Sauce

Fruits of the genus Capsicum or of the genus

Pimenta, fresh, dried, crushed or ground

Sugar

Cane or beet sugar and chemically pure sucrose, in

solid form

Other sugars, including chemically pure lactose,

maltose, glucose and fructose, in solid form; sugar

syrups not containing added flavoring or coloring

matter; artificial honey, whether or not mixed with

natural honey; caramel)

Molasses resulting from the extraction or refining of

sugar

XII

Tea

Fresh tea, worked, whether or not flavored

Other than tea in liquid form;

confectionery and jams

containing tea under the

management of the Ministry

of Industry and Trade

Other tea

Other than tea in liquid form

under the management of the

Ministry of Industry and

Trade

XIII

Coffee

Coffee beans, fresh or dried, extracts, essences and

concentrates of coffee

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

Cocoa

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

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

Pepper

Pepper of the genus Piper, fresh or dried, ground or

crushed

Fruits of the genus Capsicum or of the genus

Pimenta, fresh, dried, crushed or ground

XVI

Cashew nuts

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

Seeds of all types ( sunflower seeds, pumpkin seeds,

etc.), whether or not worked

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

Birds' nests and products therefor

Other than those used as

herbal ingredients and

functional foods under the

management of the Ministry

of Health

Products of insects for food (locusts, crickets,

silkworms, etc.)

XVIII

Instruments and materials for wrapping and

storing food under the management of the

Ministry of Agriculture and Rural Development

XIX

Ice used for storage and processing of food under

the management of the Ministry of Agriculture

and Rural Development.

APPENDIX IV

LIST OF PRODUCTS AND COMMODITIES UNDER THE MANAGEMENT OF THE

MINISTRY OF INDUSTRY AND TRADE

(Enclosed with the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018)

No.

Name of product

Notes

Beer

Draught beer

Bottled beer

Canned beer

Alcohol and alcoholic drinks

Excluding medicinal alcohol

under the management of the

Ministry of Health

Wine

1.1

Non-carbonated wine

1.2

Carbonated wine

Fruit wine

Liqueur

Strong wine

White wine, vodka

Other alcoholic drinks

III

Soft drinks

Excluding mineral water and

pure water under the

management of the Ministry of

Health

Canned beverages, including fruit and vegetable

juices.

Soft drinks that need diluting before drinking

Instant soft drinks

Excluding mineral water and

pure water under the

management of the Ministry of

Health

Processed milk

Excluding micronutrient-

enriched products and functional

foods under the management of

the Ministry of Health

Liquid milk (including liquid milk that contains

flavorings or other food additives)

1.1

Pasteurized products

1.2

Products sterilized by ultra-high-temperature

processing or other high-temperature methods

Fermented milk

2.1

Liquid

2.2

Solid

Powdered milk

Condensed milk

4.1

Sweetened

4.2

Not sweetened

Cream

5.1

Pasteurized

5.2

UHT

Soy milk

Other dairy products

7.1

Butter

7.2

Cheese

7.3

Other products from processed milk

Vegetable oil

Excluding micronutrient-

enriched products and functional

foods under the management of

the Ministry of Health

Sesame oil

Bran oil

Soya-bean oil

Peanut oil

Olive oil

Palm oil

Sunflower seed oil

Rhum oil

Cottonseed oil

Coconut oil

Palm seed oil or babasu oil

Rapeseed oil or mustard oil

Flax oil

Castor oil

Other oils

Flour, starch

Excluding micronutrient-

enriched products and functional

foods under the management of

the Ministry of Health

Wheat flour of meslin flour

Milled cereal

Potato flour

Malt: roasted or not roasted

Starch: wheat, corn, potato, others

Inulin

Wheat gluten

Products from dough, raw of cooked: spaghetti,

macaroni, noodle, instant noodle, flat noodle,

gnochi, ravioli, cannelloni, instant porridge,

vermicelli, etc.

Products from tapioca and substitutes made of

starch, in pieces, grains, fine powder, and the likes

VII

Confectionery

Excluding micronutrient-

enriched products and functional

foods under the management of

the Ministry of Health

Sweet, salted, or tasteless cookies

Biscuits, baked bread, and the likes

Dough bread

Toast

Birthday cakes

Hard and soft candies with sugar and no cocoa

Chewing gums, coated or not coated with sugar

Chocolate

Jam, fruit jelly, powder and paste from fruits or

nuts, during cooking process, containing sugar,

other sweeteners, or wine

Fruits, nuts, and other edible parts of plants, treated

or otherwise preserved, containing with sugar,

other sweeteners, or wine

Other confectionary products

VIII

Instruments and materials for wrapping and

storing food during manufacture, processing,

sale of foods under the management of the

Ministry of Industry and Trade.

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