Decision No. 42/2005/QĐ-BYT on Issuing the "Regulation on Announcing Product Standards for Food"

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of the "Regulation on the Announcement of Product Standards for Food"

 

THE MINISTER OF HEALTH

 

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government, stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Ordinance No. 12/2003/PL-UBTVQH11 dated July 26, 2003 on Food Safety and Hygiene and Decree No. 163/2004/NĐ-CP dated September 7, 2004 of the Government detailing certain provisions of the Ordinance on Food Safety and Hygiene;

Pursuant to Ordinance No. 18/1999/PL-UBTVQH10 dated December 24, 1999 on Product Quality and Decree No. 179/2004/NĐ-CP dated October 21, 2004 of the Government on State Management of Product Quality;

CONSIDERING THE PROPOSAL OF THE DIRECTOR OF THE FOOD SAFETY AND SANITARY CONTROL COUNCIL - MINISTRY OF HEALTH,

 

DECISION:

 

Article 1. The "Regulation on the Announcement of Product Standards for Food" is hereby promulgated together with this Decision.

Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette and shall replace Decision No. 2027/2001/QĐ-BYT dated May 30, 2001 of the Minister of Health on temporary regulations regarding the announcement of food safety and hygiene standards.

Article 3. Directors of the Office, Heads of the Inspectorate, Heads of the Legal Department - Ministry of Health, Directors of the Food Safety Agency, Directors of Provincial Health Departments under central cities, Heads of units directly subordinate to the Ministry, Heads of health departments of various sectors are responsible for implementing this Decision.

 

REGULATIONS

On the Announcement of Product Standards for Food

(Issued together with Decision No. 42/2005/QĐ-BYT dated December 8, 2005)

of the Minister of Health)

PART I

GENERAL PROVISIONS

Article 1. Scope and Applicability

2. Applicability:

a) This Regulation specifies the dossier, procedures for announcing and extending the announcement of product standards; inspection and supervision; fee collection system and reporting on the announcement of product standards.

b) Products subject to announcement include:

- Food products, food additives, food processing aids, cigarettes, raw materials for food produced domestically and imported for business and consumption in Vietnam.

- Products related to food safety (containers and packaging that come into direct contact with food, main ingredients to produce these products) and products intended solely for export are also encouraged to announce product standards according to the provisions of this document.

- Domestic products intended for export, which must announce their product standards at competent state agencies upon request of the importing country.

c) Products with unstable quality, simple-packaged products for daily use, and seasonal or short-term custom-made products with a shelf life of less than ten days under normal environmental conditions are not required to announce product standards under this regulation.

2. Scope of Application: This Regulation applies to organizations and individuals engaged in food production and business registered in Vietnam and representatives of foreign companies bringing food products into circulation and sale in the Vietnamese market (collectively referred to as traders).

Article 2. Interpretation of Terms

In this Regulation, the following terms are understood as follows:

1. Product quality is the overall attributes (technical indicators, characteristics) of them, determined by measurable and comparable parameters, consistent with current technical conditions, reflecting the ability to meet social and individual needs under specific production and consumption conditions, suitable for the purpose of the product.

2. Product quality standard is a technical document specifying the characteristics, technical requirements for the product, testing methods for these characteristics and requirements, packaging, labeling, transportation, storage requirements for the product, requirements for quality management systems, and other issues related to product quality.

3. Food quality is the overall attributes of a food product that can be determined and are necessary for state control, including: sensory indicators, major quality indicators, quality index standards, chemical, physical, microbiological hygiene standards; ingredient composition and food additives; shelf life; usage and storage instructions; packaging specifications and packaging material; label content.

4. Sanitation standards are limits or maximum allowable levels of chemical, physical, and microbiological factors allowed in the product to ensure stable product quality and safety for users.

5. Basic standards are technical requirements for the quality of a food product (with the same product name, brand, major quality standards, sanitation standards) established, announced, and the responsibility for which lies with the trader before the law and consumers. Basic standards are usually not lower than Vietnamese national standards and industry standards.

6. Major quality indicators are levels or quantities of substances that determine the nutritional value and distinctive characteristics of the product for identification, classification, and differentiation from similar products.

7. Quality index standards are technical indicators through which the stability of product quality or the content of major constituent substances of the product can be determined.

8. Certificate of Product Standard Announcement (referred to as Product Standard Certificate) is a certificate issued by a competent state agency to a trader who has announced product quality, hygiene, and safety standards in compliance with mandatory legal provisions of Vietnam. This certificate is valid for three (03) years from the date signed and stamped by the competent health authority issuing it.

9. The certification number recorded on the Product Standard Announcement Certificate issued by a competent state agency to a trader who has legally announced product quality, hygiene, and safety standards to allow the product to circulate in the market does not certify that each batch meets the announced quality standards, but rather it is the responsibility of the trader to ensure the quality of goods.

10. Special food is a general term for a group of products with special characteristics or intended for specific consumer groups, with special usage methods or special effects on health. Special food may be new technological products and includes the following types in this Regulation:

a) Nutritional products for infants.

b) Tube feeding nutritional foods.

c) Genetically modified foods.

d) Irradiated foods.

đ) Functional foods.

11. Depending on their functions, micronutrient content, and usage instructions, functional foods may also be referred to as follows:

a) Nutritional supplements (dietary supplements) are products processed from high-biological activity raw materials (nutritional supplements) and/or supplemented with micronutrients (micronutrient-enriched foods) at recommended usage levels suitable for age and user groups as specified.

b) Micronutrient-enriched foods are ordinary foods that have been enriched with micronutrients.

c) Medical nutrition foods are special foods that have undergone clinical trials, proven to have the claimed effects, and approved for circulation by authorized agencies, while being prescribed and used under the supervision of medical professionals.

d) Health protection foods is a general term in China, equivalent to functional foods.

Chapter II

REGISTRATION DOCUMENTS AND PROCEDURES

Article 3. Registration Documents

1. For domestically produced food and materials directly contacting finished food products (packaging containers), two sets of documents shall be prepared, each set including:

a) A product standard declaration form (according to Model 1 issued together with this Regulation);

b) The enterprise's self-declared product standard (stamped), including sensory criteria (color, taste, state), key quality indicators, quality index standards, chemical hygiene, microbiological, heavy metal hygiene standards; ingredient composition and food additives; shelf life; usage and storage instructions; packaging material and packaging specifications (according to Model 2 issued together with this Regulation); production process.

c) Business registration certificate of Vietnamese enterprises or Representative Office Establishment Permit of foreign manufacturing companies (certified copy).

d) Test result report including key quality indicators, quality index standards, and hygiene indicators of the declared food, which must be issued by an accredited laboratory or designated by the competent national management agency. Natural mineral water must additionally include a test result report for the source water.

đ) Product samples with labels attached or draft label content complying with labeling laws (stamped by the enterprise).

e) Application for a Certificate of Sanitation and Safety Conditions at the competent authority or a copy of the already issued certificate.

g) Copy of Trademark Registration Certificate (if applicable).

h) Copy of receipt for filing fee and certification number issuance fee submitted to the issuing authority.

i) For irradiated foods, genetically modified foods, new technological products, or those containing ingredients derived from genetically modified or irradiated sources, the registration documents must include a copy of the biosafety, radiation safety certificates, and production process description.

2. For imported foods:

2.1. For imported foods not listed as special foods in Clause 10, Article 2, two sets of documents shall be prepared, each set including:

a) As stipulated in points a and b of Clause 1 of this Article.

b) Business registration certificate of Vietnamese enterprises or Representative Office Establishment Permit of foreign manufacturing companies (certified copy).

c) Product standards (Product Specifications) of the manufacturer or test result reports (for key quality indicators, quality index standards, and related hygiene indicators) of the manufacturer or independent inspection agencies of the exporting country.

d) Product labels or photographs of product labels and draft secondary label content (stamped by the enterprise); labeled product samples (if required for review).

đ) Certified copy of one of the following certificates (if available): Good Manufacturing Practice (GMP) Certification; Hazard Analysis and Critical Control Points (HACCP) Certification; or equivalent certification.

e) Copy of receipt for filing fee and certification number issuance fee submitted to the issuing authority.

g) Copy of Commercial Contract (if applicable).

h) For irradiated foods, genetically modified foods, or those containing ingredients derived from genetically modified or irradiated sources, the registration documents must include a copy of the export country's permit for use for the same purpose within its territory and a production process description.

2.2. For food additives and processing aids, the documents include:

a) As stipulated in Clause 1 of this Article.

b) Free Sale Certificate or Health Certificate issued by the competent authority of the exporting country for food additives and processing aids.

2.3. For special foods listed in Clause 10, Article 2, two sets of documents shall be prepared, each set including:

a) As stipulated in point 2.1, Clause 2 of this Article.

b) Specific requirements for different types of special foods:

- Nutritional products for infants: Free Sale Certificate or Health Certificate issued by the competent authority of the exporting country, including confirmation that the product is suitable for the age or target group.

- Medical nutrition foods: additional clinical research results regarding the function.

- Tube feeding nutritional foods: additional clinical research results regarding safety in tube feeding use and health benefits for the designated group.

- Functional foods: additional clinical research results or documentation proving specific efficacy and food safety.

2.4. For restricted food additives:

a) Food additives not listed in the permitted usage list of Vietnam but allowed for use in the country of production or included in the Codex list shall be considered on a case-by-case basis to permit the announcement of product standards or only be imported in batches as synthetic sweeteners mentioned in paragraph b, point 2.4, clause 2 of this Article.

b) For synthetic sweeteners:

- If in pre-mixed, small-packaged form for single-use: traders announce standards as for food additives permitted for use in Vietnam.

- If in packaged form for multiple uses: traders may only import in lots based on the import agency authorization letter from low-calorie food manufacturers (for patients, obese individuals, or those who do not want to gain weight) or when there is a contract with such low-calorie food manufacturers. For subsequent imports, traders must provide invoices or other documents proving sales exclusively to low-calorie food manufacturers for other purposes.

7. For materials directly contacting finished food products (packaging containers), imported food additives, solely for internal production use within enterprises, and self-imported products for sale at their own hotels and supermarkets, enterprises announce according to the list specified in Model 7 issued together with this Regulation.

8. All documents stipulated in this Article in a foreign language must have a Vietnamese translation, which the trader is responsible for providing or a certified translation if required by the competent health authority.

Article 4. Announcement Procedures

1. Traders announce standards using the "Product Standard Announcement Form" according to Model 1 accompanied by the basic standard according to Model 2 issued together with this Regulation.

2. Traders dealing in bottled natural mineral water, cigarettes, special foods, and traders importing food, raw materials, food additives, and materials directly contacting food shall handle the standard announcement procedures at the Ministry of Health (Food Safety and Hygiene Department). Normally produced domestic products intended for export may be announced at the Ministry of Health (Food Safety and Hygiene Department) if requested by the importing country.

3. Traders producing and trading in food not mentioned in clause 2 of this Article submit the standard announcement application documents to the provincial or municipal Health Department where the production facility is located or to the authorized agency.

4. Competent state agencies prescribed in clauses 2 and 3 of this Article or authorized agencies shall accept applications, check compliance with national regulations within fifteen working days from the date of receiving complete and valid documents, and are responsible for:

a) Issuing a Product Standard Certificate (according to Model 3a, 3b issued together with this Regulation) or issuing an Extension Certificate of Product Standard (according to Model 4a, 4b issued together with this Regulation) if the content of the announcement complies with current regulations on quality, hygiene, and safety of food by the Ministry of Health, and return one set to the trader (stamped by the issuing agency).

b) Notifying and guiding in writing the trader to complete the application documents if the content of the basic standard or product label does not comply with current regulations on quality, hygiene, and safety of food.

Article 5. Regulations on Recording Certification Number for Standard Announcement

1. For products certified by the Ministry of Health, the recording principle shall be as follows: serial number issued + forward slash + year of issuance + forward slash + YT. Example: 234/2003/YT.

2. For products certified by local health authorities: similar to the above but with the abbreviation YT (all capital letters) plus the initials of the province name. Example: 123/2004/YTHN means "Health of Hanoi". In cases where province names overlap: overlapping initials only overlap one initial but differ in the adjacent letter, then add that letter in lowercase form.

Examples: Quang Nam - QNa; Quang Ngai - QNg; Quang Ninh - QNi; Hanoi - HN; Ha Nam - HNa; Abbreviations for the names of provinces and cities according to Model 5 issued together with this Regulation.

Article 6. Responsibilities of Business Entities

1. Announce product standards at state agencies authorized by the Ministry of Health as stipulated in Article 4 of this Regulation; ensure that announced standards comply with mandatory regulations applicable to the product and bear responsibility for the accuracy and truthfulness of the announced content.

2. The name of the announced product must accurately reflect its nature and not mislead about the quality of similar products on the market.

3. Ensure full compliance with production facility conditions as prescribed by law and technological equipment commensurate with the announced quality.

4. Ensure product quality, label content, and advertising information match the announced contents.

5. Ensure fair competition as prescribed by law.

6. Proactively conduct or propose periodic testing in accordance with Article 9 of this Regulation.

7. Must pay inspection fees for production facilities and periodic product testing to directly authorized inspection agencies or those delegated authority, except when unannounced spot checks are conducted without prior notice as prescribed by law or when test results are not provided.

Chapter III

DOCUMENTS AND PROCEDURES FOR EXTENDING THE ANNOUNCEMENT OF PRODUCT STANDARDS

Article 7. Documents

Business entities extend the certification number after three years from the date of issuance of the certification number or extension. The application for extension includes:

a) A request for extension of the Product Standard Certificate (according to Model 6 issued with this Regulation) along with the Product Standard Certificate and previous base standard (original or certified copy).

b) Periodic testing result sheets for domestically produced products and imported special foods (submitted by the business entity or collected by the inspection agency at the production or distribution site and sent to recognized or designated laboratories in Vietnam) or notifications of imported food batches meeting quality requirements from the national food import inspection agency.

c) One sample of the product currently circulating with labels (including supplementary labels for imported foods).

d) A copy of the Food Facility Sanitation Certificate issued by the competent state agency (for domestically produced products).

đ) A copy of the receipt for the fee for reviewing the application and issuing the certification number paid to the competent state agency.

- For food products that have been issued a Receipt for Standard Quality and Food Safety Announcement Application under Decision No. 2027/2001/QĐ-BYT dated May 30, 2001 of the Minister of Health, which is valid for three years from the date of issuance, after this period, business entities must reannounce according to this Regulation.

- In cases where announced contents are changed, business entities must reannounce, except when only the label design or packaging format changes, then submit the modified label along with a request for supplementation or replacement of the current label.

Article 8. Extension Procedure

Where a trader publishes standards, they shall apply for extension at that location.

Chapter IV

INSPECTION, AUDIT, FEES AND REPORTING SYSTEMS

Article 9. Regular Inspection System

The competent state management agency has the responsibility to organize regular testing and urge regular testing on product quality. One of the regular test result certificates must be conducted on products nearing their expiration date or even expired to prove that the published shelf life is correct. The regular inspection system is as follows:

a) Once every three years for products from facilities certified with GMP, GHP, HACCP or equivalent systems.

b) Once a year for products from facilities equipped with laboratories for food quality monitoring.

c) Twice a year for products from facilities without laboratories for food quality monitoring.

d) Four times a year for products from family-run businesses.

đ) Once a year and a Certificate of Confirmation from state inspection agencies regarding the quality of imported batches for ordinary imported products.

e) Once a year and a Certificate of Confirmation from state inspection agencies regarding the quality of imported special food batches.

Article 10. Sampling Method for Regular Testing

Quality inspections for industrially processed foods are carried out on representative samples which are final products or semi-finished products belonging to the same group of products with similar main quality criteria and main raw material components. Handcrafted products are tested on final products.

Article 11. Grading of Regular Inspections

Regular inspections aimed at sampling products for testing can be conducted at the facility or traders may send samples to laboratories themselves but must bear full responsibility for the representativeness of self-collected samples as follows:

1. For domestically produced food products managed by the Ministry of Health (Food Safety and Hygiene Administration) and granted certification numbers, the Provincial Health Centers are responsible for conducting regular inspections at production facilities within their jurisdiction and may collect samples for products requiring special storage or seal samples for traders to send for testing.

2. The Department of Health assigns and grades regular inspections of domestic production facilities within their jurisdiction to provincial and district preventive health centers. The Provincial Health Center is responsible for testing, and if beyond their capacity, samples must be sent to regional functional institutes or recognized laboratories for testing.

Article 12. Spot Checks and Audits

State authorities with competence conduct spot checks and audits of facilities when signs of violations are detected or complaints or reports about violations of regulations concerning food quality, hygiene, and safety are received, following directives from higher authorities.

Article 13. Fee Collection and Reporting System

The state authority specified in Article 4 maintains a record of product standard publication situations and collaborates with the market management agency under its jurisdiction to coordinate the supervision of product quality circulating in the market.

1. Organize fee and charge collection for inspection, testing, and certification of product standard publication according to current regulations of the Ministry of Finance. No fees are collected in cases of re-inspection, spot audit, or testing of products circulating in the market.

2. Issue a document authorizing the competent authority to inspect hygiene for facilities and regularly test quality and hygiene for products, while informing the facility about this delegation. In case of violation, the inspection agency must prepare a report and submit it to the competent authority for handling.

3. Every six months, the Department of Health of provinces and centrally-administered cities is responsible for compiling and reporting the situation of food quality and hygiene management in their jurisdiction to the Ministry of Health (Food Safety and Hygiene Administration) for monitoring and summarization./.