Decision No. 2481/BYT-QĐ on the issuance of the Food Quality Registration Regulation

Pursuant to …;

Regarding the issuance of the "Regulation on Food Quality Registration"

____________________

THE MINISTER OF HEALTH

Pursuant to Article 7, Chapter II of the Law on Protecting People's Health and the Sanitation Regulations issued pursuant to Decree No. 23-HĐBT dated January 24, 1991;

Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government, stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Point 1, Article 4 of Decree No. 86/CP dated December 8, 1995, which assigns responsibilities for state management of product quality, entrusting the Ministry of Health with the function of state management over food safety and hygiene;

Pursuant to Circular No. 07/TTLB dated July 1, 1996 of the Ministry of Health and the Ministry of Science, Technology, and Environment guiding the implementation of Decree No. 86/CP dated December 8, 1995;

With the agreement of the Ministry of Science, Technology, and Environment as stated in Document No. 1052/TĐC-THPC dated December 3, 1996;

At the proposal of the Director of the Department of Preventive Medicine - Ministry of Health.

Pursuant to …;

Article 1: Issued along with this Decision is the "Regulation on Food Quality Registration".

Article 2: This Decision shall take effect from January 1, 1997. All previous regulations that conflict with the provisions of this Decision are hereby abolished.

Article 3: The Director of the Department of Preventive Medicine shall be responsible for guiding and supervising the implementation of this Decision.

Article 4: The Heads of the Office, Inspectorate, Department of Preventive Medicine, Department of Planning and Finance, and related departments of the Ministry, Heads of subordinate units under the Ministry, Directors of Provincial Health Departments, and Heads of health sectors shall be responsible for implementing this Decision.

                                                                                              KT.MINISTER OF HEALTH

                                                                                       DEPUTY MINISTER

                                                                                        (SIGNED)

                                                                                                NGUYEN VAN THUONG

REGULATIONS

Food Quality Registration
(Issued together with Decision No. 2481/QĐ-BYT dated December 18, 1996 of the Minister of Health)

PART I

GENERAL PROVISIONS

Article 1: Objectives and scope of application:

1. All domestic enterprises, foreign-invested enterprises producing, processing food, and food import enterprises (collectively referred to as establishments) listed in the annual food quality registration list published by the Ministry of Health in September each year and in supplementary lists issued by the Ministry of Health must register their food quality according to this regulation.

2. Foods not included in the mandatory food quality registration list may also voluntarily register their food quality.

Article 2: In this document, certain terms are defined as follows:

1. Food: All substances, whether processed or unprocessed, intended for human consumption, including items for eating, drinking, chewing, sucking, and inhaling, and substances used in the production, processing, or handling of food, but excluding cosmetics or substances solely used as pharmaceuticals.

2. Food establishment: Includes establishments of domestic enterprises, foreign-invested enterprises producing, processing food, and food import enterprises.

3. Food Safety and Hygiene Standards (FSHS): These are quality criteria concerning nutrition, microbiological, fungal, mycotoxin, heavy metal, pesticide residue, radiation, food additives, and food packaging and labeling.

4. Food Quality Registration Issuing Authority (issuing authority): This is a state management agency within the health sector system authorized to issue "Food Quality Registration".

Article 3: Provisions on Food Quality Registration:

1. Food quality registration is documented in a unified document called the "Food Quality Registration Certificate." This is a technical regulatory document for establishments to follow and serves as a legal basis for inspections and quality checks during food poisoning incidents or when resolving complaints, accusations about product quality, and economic contract disputes between food establishments and customers.

2. The Food Quality Registration Certificate does not serve as a substitute for a "Test Result Certificate" nor does it confirm the quality of a batch of food products supplied by an establishment to a customer.

3. The registration number has a validity period not exceeding one year. When this period expires, the establishment must apply for renewal if it continues to produce or sell that type of food.

4. The quality registration number recorded in the food quality registration form shall be specified as follows:

* The registration number consists of two parts separated by a hyphen (-)

- The first part is the coding symbol of the issuing authority. The convention for the Ministry of Health is represented by: YT; the convention for provincial health departments is represented by "YT" plus the abbreviation of the province's name; for example, the Department of Health of Quang Ninh Province is designated as YTQN.

- The second part is the product registration sequence number and the year of registration, separated by a forward slash (/); the year of registration is indicated by the last two digits of that year.

* Examples:

a) YT-01/97: is the first product registered with the Ministry of Health in 1997.

b) YT-1234/97: is the 1234th product registered with the Ministry of Health in 1997.

c) YTHCM-01/97: is the first product registered with the Ho Chi Minh City Department of Health in 1997.

d) YTHN-03/01: is the third product registered with the Hanoi Department of Health in 2001.

Article 4. The bases for registering food quality are as follows:

1. Compulsory and voluntary application standards of Vietnam.

2. Food safety and hygiene standards as prescribed by the Ministry of Health.

3. Other standards (including local standards and foreign standards) voluntarily applied by the entity, but not lower than the Vietnamese standards.

4. Quality provisions stated in commercial contracts also serve as a basis for registering food quality in cases where there are no bases stipulated in Clauses 1, 2, and 3 of this Article.

5. Codex standards apply when there are no other Vietnamese regulations.

Article 5: Product labeling is a mandatory component in quality registration and is attached to the food quality registration form.

1. Product labels must be printed, engraved, affixed... onto the packaging of each individual product or large unit packaging (case, bag, box...).

2. Submitting these product labels does not replace the registration for trademark protection as prescribed in Decree 197/HĐBT dated December 14, 1982 and Decree 84/HĐBT dated March 20, 1990 of the Council of Ministers (now the Government). 3. The trade name of a product circulating nationwide and in each locality must not duplicate the trade name of another product already registered.

4. When a certificate of trademark protection, trade name, design... has been issued, the entity must submit a copy of such certificate to the issuing authority for management and monitoring.

Article 6: The authority responsible for issuing food quality registrations:

1. The Ministry of Health uniformly manages and issues registration books for foods from foreign-invested entities and importers, and may delegate to regional institutes or provincial health departments with the necessary conditions to inspect and supervise the quality of products from these entities at the production site and on the market.

State inspection of imported food quality and designation of inspection agencies at border gates are regulated in a separate decision.

2. Provincial health departments under central cities uniformly manage and issue registration numbers for domestic foods produced within their jurisdiction, and simultaneously direct health inspections, central sanitation and epidemic prevention stations to closely cooperate with qualified disease control teams and related sector inspectors within their jurisdiction to inspect and supervise the quality of products from these entities at the production site and on the market.

Chapter II

CONTENT AND PROCEDURES FOR FOOD QUALITY REGISTRATION

Article 7: Conditions for issuing registration numbers:

1. Food production and processing facilities requesting registration must meet food safety standards regarding facility hygiene conditions, production equipment, health management requirements, and organization of training on food safety knowledge for those directly handling food.

2. Products requesting registration must comply with the standards set forth in Clauses of Article 4 of this Regulation.

3. For substances and food additives used in food processing or as part of food products not included in the list of permitted uses in Vietnam, the registration authority will not process the registration or must seek opinions from inter-disciplinary experts on international standards before issuing the registration.

4. For imported foods that are new products requiring consumption in Vietnam, the Ministry of Health requires relevant documents to prove the safety of substances in the product's composition and organizes a council to seek opinions from inter-disciplinary experts before processing the registration.

5. For imported foods that are not or have not been allowed to be freely consumed in the home country, the Ministry of Health will not issue the registration.

Article 8: Procedure for registering food quality:

1. The registration dossier for domestically produced food shall be prepared in three copies, each including:

a) A food quality registration form (model attached as Appendix 1 to this Regulation). The facility must declare the quality standards on the registration form according to the provisions of Article 4 of this Regulation. Each product has its own separate registration form.

b) Certificate of facility meeting food safety standards (copy).

c) Detailed diagram of the production process flowchart from raw material storage through processing stages to finished product, storage, and shipment of finished goods.

d) Product label sample stamped by the facility. If there is no official product label, a draft label must be submitted.

e) User guide and warranty for the product (if applicable).

f) Test result certificate for the product.

g) Product sample.

h) List of ingredients used in processing, including food additives and packaging materials (declared by the facility).

i) Copies of other related documents.

The registration dossier must be typed or printed clearly, without erasures or abbreviations (except for the name of the registered business entity and units of measurement).

2. For imported foods, the dossier shall be prepared in three copies, each including:

a) A food quality registration form (model attached as Appendix 1 to this Regulation). The facility must declare the quality standards on the registration form according to the provisions of Article 4 of this Regulation. Each product has its own separate registration form.

b) User guide and warranty for the product.

c) Test result certificate issued by the authorized agency of the exporting country or by a recognized testing agency in Vietnam.

d) Product sample.

e) Good Manufacturing Practice certificate of the facility (if available).

f) Confirmation letter from the authorized agency of the exporting country stating that "the product is freely circulating in the exporting country."

g) Other related documents.

3. Procedure for extending food quality registration:

a) When there is a change in product quality or labeling compared to the previous registration; the dossier includes the contents specified in Clause 1 of Article 8.

b) When there is no change in product quality or labeling, the dossier includes:

- A letter or application from the facility requesting an extension of the food quality registration, affirming that there has been no change in product quality or labeling compared to the previously registered product.

- Quality test result certificate for the product within the last six months, obtained by the designated quality inspection agency sampling at the facility. The test result certificate must be issued by recognized technical agencies or under the Ministry of Health and the Ministry of Science and Technology Environment.

- Inspection report certifying that the production facility maintains good hygiene requirements within the last six months.

- The current quality registration dossier held by the facility.

Content of the product label:

Article 9: 1. The product label must include the following mandatory information:

- Product name;

- Address of the production facility;

- Name of the production facility;

- Net quantity and permissible error for prepackaged food;

- Registration number issued by the registration authority.

- Main quality indicators;

- Usage instructions;

- Expiry date.

2. For imported foods repackaged for consumption in Vietnam, the label must also include:

- Name of the country and manufacturer;

- Name of the repacking facility.

3. Prepackaged food products labeled according to the temporary regulations promulgated by Decision No. 23/TĐC-QĐ dated February 20, 1995 of the General Bureau of Standards - Measurement - Quality.

4. Additionally, depending on specific goods, other relevant information may be added to the product label. Information such as medals, awards from competitions, statements about industrial property rights, and conformity marks must be accompanied by legal documentation attached to the quality registration dossier.

5. Labels of food products produced and consumed in Vietnam must be in Vietnamese; foreign languages can be used alongside Vietnamese, but the font size of the foreign language cannot exceed that of the corresponding Vietnamese text. For domestically produced tobacco products under foreign licenses, the foreign brand name may be retained, but "Made in Vietnam" must be indicated in Vietnamese or the foreign language, and the warning "Smoking is harmful to health" in Vietnamese must be displayed on the package.

6. For food products produced by foreign-invested enterprises established under the Law on Foreign Investment in Vietnam, it is permissible to use foreign languages for product names provided they are accompanied by the Vietnamese name, subject to having the necessary legal documentation (product trademark registration, design patent protection, license transfer agreement, origin certificate). Other label contents must be in Vietnamese alongside the foreign language.

6. For food products produced at foreign-invested establishments established under the Law on Foreign Investment in Vietnam, it is permissible to use a foreign language for the product name without accompanying it with a Vietnamese name provided that there is sufficient legal documentation allowing such naming (registration of trademark, protection of industrial design, transfer license contract, certificate of origin). Other contents of the label must be in Vietnamese alongside the foreign language.

7. For domestically produced food intended solely for export, it is permitted to label entirely in a foreign language. In cases where such products cannot be exported and are transferred for domestic consumption, they must have an additional label in Vietnamese indicating the name and address of the production facility.

8. For imported food sold exclusively through a sole agency for foreign consumption in Vietnam, the original product label may remain intact for sale, but an additional label in Vietnamese must also be provided indicating the name and address of the agency.

Article 10: The process for reviewing and issuing registration numbers:

1. Registration authority:

a) The Ministry of Health (Department of Sanitation and Epidemic Prevention) shall organize all tasks related to the issuance of registration numbers for products from foreign-invested facilities, importers, and convene advisory councils when necessary. The Central Council shall be established by Decision of the Ministry of Health. The Central Council consists of representatives from the Department of Sanitation and Epidemic Prevention, the Sanitation Inspection Office, Legal Affairs, the Institute of Nutrition, and other relevant experts invited to provide advice.

b) The Provincial Health Departments shall organize all tasks related to the issuance of registration numbers for products from domestic facilities and convene advisory councils when necessary. The Local Councils shall be established by Decision of the Provincial Health Departments. The Local Councils consist of representatives from the Health Services Department, Inspection Office, Testing Room, and Food Safety Room of the Central Sanitation and Epidemic Prevention Station, and other relevant specialists invited to provide advice.

2. Upon receiving the quality registration dossier from the facility, the authority shall compare the contents of the quality registration dossier with the provisions set forth in Clauses 4, 7, 8, and 9 of this Regulation. If the authority finds that:

a) The conditions are met, then proceed with the quality registration procedures:

- Issue a quality registration number and affix the stamp of the issuing authority on the quality registration form and product label.

- Record in the quality registration book and register in the public record.

- Collect the quality registration fee.

- Return to the facility a complete quality registration dossier for food products.

- Two remaining dossiers: one for storage and one for inspection and verification purposes.

For cases where the product label is a draft, within one month of receiving the quality registration, the facility must submit three official product labels to the issuing authority, two of which will be filed in the dossier and the third will be stamped by the issuing authority and returned to the facility.

b) If the conditions for quality registration are not met, the issuing authority must inform the facility of the reasons or issues requiring supplementation.

c) In cases where the conditions for renewal of registration are met, the issuing authority shall specify the renewal period, sign and stamp the three copies of the quality registration form of the old dossier, and return one copy to the facility.

Article 11: Registration and publication: The issuing authority shall establish a registry (Model of Registry attached as Appendix 2) and report quarterly on quality registrations, including the following information:

a) Information related to the facility such as: Facility name, address, telephone number.

b) Information related to registered products: Product name, type, specifications, main quality indicators, registration number.

Chapter III

RESPONSIBILITIES FOR IMPLEMENTING QUALITY REGISTRATION

Article 12: For food facilities:

1. Facilities are only allowed to sell products that meet or exceed the registered quality standards and have product labels consistent with regulations. If a product cannot meet the registered quality standards, the facility must reapply for registration according to the procedures outlined in Article 8 of this Regulation, except for products meeting the criteria specified in Clauses 1 and 2 of Article 4.

2. When there is a change in the product label, the facility must update the registration with the issuing authority before using the new label.

3. When there is a change in product quality or packaging design, the facility must follow the procedures for registering a new product.

4. The facility must submit a quality testing report for the product issued by a technical unit recognized by the issuing authority. The cost of testing shall be borne by the facility according to the agreed contract with the testing unit.

Article 13: For the issuing authority:

1. It is responsible for organizing and implementing quality registration within its jurisdiction in accordance with this regulation.

2. Within its scope of responsibility, it shall direct subordinate technical units to closely cooperate with relevant technical units, regularly conduct inspections, supervision, and promptly handle violations related to quality registration at facilities and in the market in accordance with the law.

3. Quarterly, it shall publish the registry of food products that have been quality registered.

4. It shall comply with the quarterly reporting system on the following matters:

a) Quality registration status (including the registry for the quarter).

b) Inspection, supervision, and handling of violations related to quality registration within its jurisdiction.

c) Other related or emerging issues.

5. Reporting shall be conducted as follows:

a) Provincial health departments directly under the central government shall send reports to the functional institute in their region and the Ministry of Health (Department of Sanitation and Epidemic Prevention).

Chapter IV

HANDLING VIOLATIONS

Article 14:

b) Regional functional institutes shall send reports (including consolidated reports from provincial health departments in the region) to the Ministry of Health (Department of Sanitation and Epidemic Prevention).

1. Products that have been issued a registration number, during the validity period, will be recalled in the following circumstances:

a) Products circulating in the market do not match the registration dossier at the issuing authority (name, label, quality standards, packaging specifications, content...).

b) Products do not meet quality requirements.

2. The issuing authority will revoke registration numbers with or without a time limit for products violating this Regulation.

Article 15: The issuing authority shall notify the decision to suspend circulation and recall products of inferior quality or not produced in accordance with the registration files. Upon issuance of the suspension and recall decision, competent authorities shall inspect, handle, and impose penalties on violative entities in accordance with the law.

Article 16: Upon receipt of the suspension and recall decision, the entity is responsible for strictly complying with the provisions of the law.

Article 17: The entity whose products must be recalled shall bear full responsibility for that batch and shall be subject to all forms of handling as prescribed by law.

Article 18: The entity must take proactive measures to monitor, voluntarily identify, and actively address the recall of inferior quality products that violate current regulations circulating in the market, and promptly report to the higher-level authority.

Article 19: The entity has the right to lodge complaints and reports in accordance with the law.

Article 20: Any agency or individual violating the provisions of this Regulation shall be dealt with according to the law, depending on the severity of the violation.