Decision No. 2027/2001/QD-BYT on the issuance of the "Provisional Regulations on the Announcement of Quality Standards, Sanitation, and Food Safety"

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of Interim Regulations on the Announcement of Quality Standards, Sanitation, and Food Safety

vệ sinh, an toàn thực phẩm

 

THE MINISTER OF HEALTH

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

Pursuant to the Quality Goods Ordinance dated December 24, 1999;

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 Decree No. 86/CP dated December 8, 1995 on the assignment of responsibilities for state management of product quality and Circular No. 07/TTLT jointly issued by the Ministry of Health, Ministry of Science, Technology, and Environment dated July 1, 1996;

Pursuant to Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on the business and use of breast milk substitutes to protect and promote breastfeeding and Joint Circular No. 04/2001/TTLT/YT-TM-VHTT-UBBVCSTEVN dated March 14, 2001;

At the proposal of the Director of the Department of Quality Control and Food Safety - Ministry of Health,

 

DECISION:

Article 1. The attached Decision promulgates "Interim Regulations on the Announcement of Quality Standards, Sanitation, and Food Safety."

Article 2. The Director of the Department of Quality Control and Food Safety shall be responsible for guiding and supervising the implementation of this Decision.

Article 3. This Decision takes effect fifteen days from the date of issuance and replaces Decision No. 996/2001/QĐ-BYT dated March 30, 2001 of the Minister of Health on the promulgation of Interim Regulations on the Announcement of Food Quality Standards. All previous regulations that conflict with this Decision are hereby abolished.

Article 4. Gentlemen and Ladies: Heads of the Office, Inspector General, Heads of Departments under the Ministry of Health, Directors of the Department of Quality Control and Food Safety, Director of the Department of Drug Management, Heads of units directly under the Ministry, Directors of Provincial Health Services, and Heads of Health Services in sectors are responsible for implementing this Decision. /

 

TEMPORARY PROVISIONS

On the Announcement of Quality Standards, Sanitation, and Food Safety

(Attached to Decision No. 2027/2001/QĐ-BYT

dated May 30, 2001 of the Minister of Health)

 

1. Scope of Regulation and Applicability

1.1 These regulations guide organizations and individuals producing and trading (collectively referred to as enterprises) food products in Vietnam to announce food quality standards in accordance with Articles 10 and 20 of the Ordinance on Product Quality. For food products that are not breast milk substitutes, enterprises only need to announce quality, sanitation, and food safety standards (referred to as announcing standards) once if there is no change in the product's quality standards and must undergo inspection and testing by authorized health authorities regarding quality, sanitation, and food safety.

1.2 Domestic-produced and imported foods intended for consumption in Vietnam must be announced and confirmed to comply with current regulations.

1.3 Breast milk substitute products before being put on the market must register their quality, sanitation, and food safety at the Ministry of Health (Department of Quality Control and Food Safety). The Ministry of Health will issue separate guidance.

1.4 Special food products (including therapeutic nutrition, enteral feeding for critically ill patients, nutritional supplements, functional foods) must be researched and clinically tested before announcing standards.

1.5 Fresh foods, street food, single-packaged processed foods consumed within 24 hours, and imported foods not for commercial purposes (aid, gifts, exhibition samples, research) are exempt from announcing standards under these regulations.

2. Announcement Documents

2.1 For domestically processed foods, the documents include:

a. One announcement form (model in Appendix 1), accompanied by two copies of the enterprise's own standards (stamped by the enterprise), including sensory indicators, physical and chemical indicators, microbiological indicators, heavy metals, food additives, shelf life, usage and storage instructions, production process (model in Appendix 2).

b. Test result sheets for major quality indicators and hygiene and safety indicators of the announced food. For natural mineral water, there must be a test result sheet for the water source.

c. Label or draft label of the product (stamped by the enterprise).

d. Documentation confirming the enterprise's lawful right to use protected industrial property objects (if applicable).

2.2 For imported foods not covered by Points 1.3 and 1.4 of Section 1, the documents include:

a. As specified in Subpoint a, Point 2.1, Section 2.

b. Test result sheets for major quality components and hygiene and safety indicators of the food from the competent authority of the exporting country; if there is no such test result sheet, then a test result sheet from a designated technical authority in Vietnam must be provided.

c. Product label (stamped by the importing enterprise).

d. Free Sale Certificate or Health Certificate from the competent authority of the exporting country.

2.3 For special foods (as stipulated in Point 1.4, Section 1), the announcement documents must include research and clinical trial results and related documents; test results on quality, hygiene, and safety from the authority designated by the Vietnamese Ministry of Health. In cases where Vietnam lacks the capability to conduct tests, the results from the authority of the exporting country or a third country may be used.

3. Announcement Procedures and Authority to Accept Announcement Documents

3.1 Enterprises announce standards using the "Announcement Form" according to the model in Appendix 1, accompanied by the enterprise's own standards according to the model in Appendix 2. For food products already registered with quality standards, one month before the registration expires, enterprises must announce standards in accordance with this regulation.

3.2. Foreign-invested enterprises; domestic enterprises producing bottled naturalwater, cigarettes, and special foods as specified in Point 1.4, Section 1; andenterprises importing food, high-temperature processed raw materials, and foodadditives shall submit standard declaration procedures to the Ministry ofHealth (Food Safety and Quality Control Department).

3.3. Domestic enterprises producing food other than those specified in Point 3.2,Section 3, shall submit standard declaration procedures to the HealthDepartment of the province/city directly under the Central Government (referredto collectively as the province) where their production facilities are located.

3.4. Authority to accept standard declaration procedures:

The Food Safety and Quality Control Department and the Health Departments ofthe provinces shall accept the procedures, check for compliance with nationalregulations. Within fifteen days from the date of receipt of the procedures,these agencies are responsible for reviewing and:

a. If the enterprise's standard declaration has been carried out in accordancewith current regulations, they shall confirm on the Application Form (accordingto the model in Appendix 3) and return one copy of the enterprise's standarddeclaration (stamped by the Food Safety and Quality Control Department or theHealth Department of the province).

b. Notify and guide the enterprise to complete the standard declarationprocedures if the content of the declared standards does not comply withcurrent regulations regarding quality, hygiene, and safety of food.

4. Responsibilities of enterprises:

4.1 Ensure that the declared standards meet the provisions of point 2 and bearresponsibility for the accuracy and truthfulness of the declared food qualitystandards.

4.2 Ensure full compliance with the requirements concerning food productionfacilities stipulated in the Regulations on Quality, Hygiene, and Safety of Foodissued together with Decision No. 4196/1999/QĐ-BYT dated December 29, 1999 ofthe Ministry of Health.

4.3 Ensure strict adherence to the contents already declared for their own foodproducts.

4.4 Implement current regulations of the Ministry of Finance regarding fee andtariff rates for managing food quality, hygiene, and safety.

4.5 Must re-declare if there are any changes to the previously declared contents.

5. Inspection, supervision, and handling of violations:

The Food Safety and Quality Control Department and the Health Departments ofthe provinces are responsible for inspecting hygiene and safety at facilitiesand quality, hygiene, and safety of products.

5.1 Inspections for hygiene and safety at facilities and sampling products forquality, hygiene, and safety testing will be conducted during the sameinspection visit at the facility, specifically as follows:

a. For food products where the Food Safety and Quality Control Departmentcarries out the acceptance of quality standard declarations, the functionalinstitute in the region or the Preventive Health Center entrusted shall berequired to conduct testing in accordance with Circular No. 01/2000/TT-BYTdated January 21, 2000 of the Ministry of Health on "Guidelines forImplementing Inspection and Registration of Food Quality, Hygiene, andSafety."

b. For food products where the provincial Health Department carries out theacceptance of quality standard declarations, the Preventive Health Center shallbe responsible for testing, and if beyond its capacity, samples must besent to the regional functional institute or recognized laboratory for testingin accordance with Circular No. 01/2000/TT-BYT dated January 21, 2000 of theMinistry of Health on "Guidelines for Implementing Inspection andRegistration of Food Quality, Hygiene, and Safety."

5.2 The Ministry of Health's Inspectorate, provincial Health Departments, andrelated agencies shall cooperate to conduct regular or surprise inspections atfacilities when complaints or reports of violations of food quality, hygiene,safety regulations are received, in accordance with the law.

5.3 During inspection and supervision, if enterprises violate food quality,hygiene, and safety regulations, they will be dealt with according to the lawdepending on the nature and extent of the violation.

5.4 The Food Safety and Quality Control Department and the provincial HealthDepartments shall maintain records of food quality standard declarations andquarterly compile and report lists to the Standardization, Measurement, andQuality Management Agency and the Market Supervision Agency at the same levelfor coordinated control of food circulation in the market.

Quarterly, the provincial Health Departments must compile and report to theMinistry of Health (Food Safety and Quality Control Department) on thesituation of food quality and hygiene management in their areas.

During implementation, if there are difficulties, units and localities shallreport to the Ministry of Health (Food Safety and Quality Control Department)for review and resolution.

 

ANNEX 1

FOOD QUALITY STANDARD DECLARATION

No.:...

 

Enterprise: ..................................................................................................................

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

Telephone: ........................................................................................................................

2. Intellectual Property Rights Owner:...................................................................................................................................

Email:..............................................................................................................................

 

DECLARATION

Enterprise standard number:

AApplied to product:

We commit to producing and trading food products in accordance with the above-declared enterprise standards and fully bear responsibility before consumersand state management agencies for any violations of the declared qualitystandards.

                       

..., day ... month ... year ...

Enterprise representative

(Signature, stamp)

 

Appendix 2

(Issued together with Decision No... /... of the Director... (name of theenterprise))

This standard applies to...(product name)

1. Technical requirements:

1.1 Sensory indicators:

            - State:

            - Color:

            - Flavor:

            ......................

1.2 Physical and chemical indicators:.....................

1.3 Microbiological indicators:.....................

1.4 Heavy metal content:.......................

2. Raw materials and food additives used in food processing:

3. Shelf life:

4. Usage and storage instructions:

5. Production process.

ANNEX 3A

MINISTRY OF HEALTH                                            SOCIALIST REPUBLIC OF VIET NAM

Food Safety and Quality Control Department                                         QUALITY CERTIFICATE FOR TYPE APPROVAL

Food Safety and Quality Control

 

Receipt form

Food quality, hygiene, and safety standard declaration procedure

...(serial number)/...(year)/CBTC-YT)

 

The Food Safety and Quality Control Department has accepted:

Food quality standard declaration number: …

For product:…

Of enterprise:…

Address: ...

Confirmation that the above declaration was carried out in accordance withcurrent regulations.

HANOI, day… month… year …

Director

Food Safety and Quality Control Department

Food Safety and Quality Control

(sign, stamp)

 

Appendix 3b

PEOPLE'S COMMITTEE …           socialist republic of vietnam

            Health Department........                                                  Independence - Freedom - Happiness

             

Receipt form

Food quality, hygiene, and safety standard declaration procedure

...(serial number)/...(year)/CBTC-YTHN (of the Health Department of Hanoi)

 

The Health Department of the province …has accepted:

Food quality standard declaration number:…

For product: …

Of enterprise: …

Address: ...

Confirmation that the above declaration was carried out in accordance withcurrent regulations.

..., day... month... year ...

Director

Health Department

(sign, stamp)