Laws of Vietnam

THE MINISTER OF HEALTH

Article 1.- To promulgate together with this Decision the Regulation on state inspection of quality, hygiene and safety of imported foods.

Article 2.- This Decision takes effect 15 days after its publication in "CONG BAO." To annul the Minister of Health's Decision No. 1370/1997/QD-BYT of July 17, 1997, promulgating the Regulation on state inspection of quality of imported foods.

Article 3.- The director of the Office, the chief inspector, the director of the Legal Department of the Ministry of Health, the director of the Department for Food Safety and Hygiene, directors of provincial/municipal Health Services, heads of concerned units of the Ministry of Health, and heads of health sections of other branches shall implement this Decision.

For the Minister of Health
Vice Minister
TRINH QUAN HUAN

Article 1.- Governing scope

1. This Regulation provides for state inspection method, contents and procedures, and powers and responsibilities of involved parties in assuring quality, hygiene and safety of foods imported for domestic consumption, including the following products (hereinafter collectively referred to as foods):

a/ Food materials that have undergone industrial processing and can be used directly for production or re-packaging without further processing;

b/ Substances used in food processing (processing aids or food additives);

c/ Pre-packaged foods for instant use;

d/ Products specified in Clause 4 of this Article (upon notification on safety or epidemic risks or the Ministry of Health's written request).

e/ Other products on the list of foods subject to standard announcement promulgated by the Ministry of Health in each period.

2. Foods specified in Clause 1 of this Article can be circulated or sold in the Vietnamese market only after being granted by the state inspection agency one of the following papers:

a/ Certificate of compliance with import requirements.

b/ Notice on inspection of dossier of goods lot only.

3. An importing organization or individual that receives a notice on the non-compliance of an imported lot of foods with import requirements may take disposal measures specified in Clause 7, Article 16 of this Regulation.

4. The following foods are exempt from state inspection:

a/ Foods carried along by persons on entry for personal use within import duty-free quantity.

b/ Foods donated for the humanitarian purpose or imported in diplomatic or consular bags under law.

c/ Foods temporarily imported for re-export.

d/ Foods in transit or border gate-to-border gate transfer.

e/ Foods consigned to bonded warehouses.

f/ Foods used as test or research samples.

g/ Foods used as sample goods for display at fairs.

h/ Foods exchanged among border inhabitants.

i/ Foods processed by Vietnamese enterprises for foreign goods consignees for export only.

j/ Raw materials to be refined or reprocessed (vegetable oil, tobacco leaves and shreds, medicinal herbs used in food processing).

k/ Fresh or preliminarily processed foods on the list of foods subject to animal or plant quarantine.

Article 2.- Subjects of application

All organizations and individuals that import foods defined in Clause 1, Article 1 of this Regulation (hereinafter referred to as goods consignees) shall register for inspection and submit to inspection of these foods by the state inspection agency in charge of food quality, hygiene and safety according to the provisions of this Regulation before they can market these foods.

Article 3.- Interpretation of terms

1. Food quality, hygiene and safety (hereinafter referred to as food safety for short) means a guarantee that, at the time of inspection, a food product is safe for consumers and circulated in the market in accordance with law or in conformity with institutional standards announced by a goods consignee responsible for goods quality.

Criteria for identification and control include: Sensory criteria; principal quality criteria; quality indicators; nutritional value; chemical, physical and microbiological hygiene standards; ingredients and food additives; shelf life, usage and preservation instructions; packaging specifications and materials; label contents.

2. State inspection of food quality, hygiene and safety means inspection by state agencies that are technically capable of inspecting, testing and certifying that goods or product lots comply with food safety requirements, and that are designated in writing by the Ministry of Health.

3. Registration for inspection means registration by goods consignees with a state inspection agency in charge of food quality, hygiene and safety (hereinafter referred to as the inspection agency) for food safety inspection of their goods according to the provisions of Clause 1, Article 1 before the goods are allowed for customs clearance.

4. Goods lot means the whole of an import shipment, consisting of either one or several product lots of the same goods item or different types of product.

5. Product lot means products in the same import shipment that bear the same product name and trademark, are made by the same manufacturer and have the same expiry date or manufacture date.

6. Institutional standards means technical requirements on food quality and safety of a product (with the same product name, mark, principal quality criteria and hygienic standards) formulated and announced by goods consignees themselves and for which goods consignees are held responsible before law and consumers.

7. Hygienic standards means limits or regulations on allowable maximum levels of chemical, physical and microbiological agents in a product at which its stable quality and safety is ensured for consumers.

8. Principal quality criteria means levels or quantities of main nutritional ingredients of a product that help identify, classify and distinguish that product from other foods of the same type.

9. Quality indicators means technical specifications by which the stability of quality or the contents of main ingredients of a product can be determined.

10. Certificate of announcement of product standards (referred to as certificate of product standards for short) means a certificate granted by a competent state agency to a goods consignee that has announced food quality, hygiene and safety standards in compliance with the provisions of Vietnamese law on compulsory application of these standards.

Article 4.- Modes of inspection

1. Tightened inspection: To take probability samples or samples at suspected points (in a sufficient minimum quantity) for test and comprehensive assessment of food safety, for all product lots of the same goods lot in one of the following cases:

a/ The product is on the list of high-risk foods (specified in Article 14 of the Government's Decree No. 163/2004/ND-CP of September 7, 2004, detailing the implementation of a number of articles of the Ordinance on Food Hygiene and Safety) and when the inspection agency or customs office detects signs of contamination due to damaged or leaked packages or when the food preservation system on a vehicle of transportation does not work;

b/ When the food is imported from a foreign processing establishment which is reported to or known by the inspection agency to be located in an area where exist contaminated material sources or pathogens harmful to humans;

c/ The last importation fails to comply with import requirements;

d/ The Ministry of Health (the Department for Food Safety and Hygiene) requests in writing the application of the mode of tightened inspection because it is detected that the product currently circulated in the market has health risks.

2. Normal inspection: To take probability samples (random samples) sufficient for sensory inspection and test according to some food quality, hygiene and safety criteria, for goods lots not falling into the cases specified in Clauses 1, 3 and 4 of this Article.

3. Reduced inspection: To take only representative samples for sensory inspection and inspection of the labeling and homogeneity of the goods lot (origin, lot number) without testing of samples for comparison with the dossier in one of the following cases:

a/ The food is at low risk or bears the stamp of conformity with the announced product standards (GMP, HACCP);

b/ Food of the same type and the same origin shows a stable quality through at least two consecutive inspections or has a written certification of the Ministry of Health as eligible for reduced inspection;

c/ Food of the same type and the same origin has passed the test of samples of goods for sale, which comply with the import requirements;

d/ Food of the same type, origin and product lot had been inspected before importation or is accompanied with a notice on results of analysis by a third party in the country of manufacture;

e/ The food is on the list of goods certified as bearing standard conformity stamps of countries of exportation or the regional common market bloc recognized and published by the General Department of Standardization, Measurement and Quality Control in each period;

f/ Certifications of bearing of standard conformity stamps of countries of exportation or the regional common market bloc are confirmed in writing by the Ministry of Health and the General Department of Standardization, Measurement and Quality Control.

4. Inspection of dossier only: This means a mode whereas only dossiers for inspection registration (no product sample is taken) are requested for the issuance of notices on inspection of dossier only after the Department for Food Safety and Hygiene certifies in writing that foods are subject to inspection of dossier only as specified in Article 5 of this Regulation. Products subject to this mode of inspection shall only be inspected by the mode of normal or reduced inspection in one of import shipments within a year, for goods of the same type of the same goods consignee.

Article 5.- Imported foods subject to inspection of dossier only (exempted from sample inspection or testing)

1. Imported foods that are certified as complying with food safety requirements by a competent authority of a country concluding with Vietnam an agreement on mutual recognition in food quality, hygiene and safety inspection.

2. Imported foods that are certified as conforming to standards, foods of production or business organizations and individuals that are certified as having a food safety management system conformable with Vietnam standards or foreign standards or international standards permitted for application in Vietnam.

3. Lots of goods of the same type and the same origin that comply with import requirements in five inspections.

4. The Department for Food Safety and Hygiene shall give written certification of "products subject to inspection of dossier only" upon written request of goods consignees that satisfy one of the three conditions specified in Clauses 1, 2 and 3 of this Article or at the proposal of inspection agencies.

5. Goods lots subject to inspection of dossier only can be unexpectedly inspected upon detection of signs of violation of the provisions of Vietnamese law on food quality, hygiene and safety.

Article 6.- Inspection registration dossiers

A goods consignee shall register for state inspection of food safety with one of the inspection agencies defined in Articles 7 and 8 at least five days before his/her goods arrive at a port (border gate).

1. A dossier of registration for state inspection of food safety comprises:

a/ Written registration for state inspection of food safety, made according to a set form (not printed herein);

b/ Lawful copy of the document on institutional standards (appended with a seal of certification of the Department for Food Safety and Hygiene) or the Department for Food Safety and Hygiene's certification that the product is allowed to be released (when the product standards are not yet announced) as defined in the Regulation on announcement of product standards promulgated together with the Ministry of Health's Decision No. 42/2005/QD-BYT of December 8, 2005;

c/ Dossier set for completion of customs procedures as prescribed;

d/ Medical certificate granted by a competent state authority of the country of origin, for foods of animal or plant origin that have been processed by high-temperature disinfection (required only when there is an epidemic declaration of the Ministry of Agriculture and Rural Development or a written notification of the Department for Food Safety and Hygiene);

e/ Copy of the certificate of analysis granted by an accredited laboratory or the manufacturer with the seal and signature of its director or his/her mandated person, for foods for which standards (if any) have not yet been announced;

f/ Relevant documents necessary for application of the mode of reduced inspection or inspection of dossier only (if any).

2. Registration for state inspection of food safety for exported foods shall be made in accordance with bilateral or multilateral agreements between Vietnam and foreign countries and concerned international organizations or at the proposal of export goods consignees that perform service contracts on certification of food safety for goods lots or product lots at the request of countries of importation.

Article 7.- Designated inspection organizations

1. Inspection agencies are technically specialized agencies or units that have sufficient technical conditions and capability and have been and will be designated by the Ministry of Health to perform the function of state management of food safety.

2. Depending on management requirements, state technical or research organizations or units that have sufficient technical conditions and capability may also be considered and designated by the Ministry of Health to perform the function of state management of food quality, hygiene and safety for imported goods and foods or designated to conduct inspection in the special cases specified in Article 8.

3. Border medical quarantine agencies that have not yet been designated in writing by the Ministry of Health to perform the function of state management of food safety at border gates may only take control samples according to specific procedures and regulations of the Ministry of Health when so requested in writing.

Article 8.- Designation of inspection agencies in special cases

Goods consignees that regularly store their goods at places far from head offices of inspection agencies may request the Department for Food Safety and Hygiene to temporarily designate a technical agency located in the same locality of goods storage places to conduct physical inspection of goods lots in order to make conclusions and issue notices on inspection results before requesting the Ministry of Health to make an official designation in writing.

Article 9.- Cases of independent assessment

If imported goods consignees detect by themselves that foods are lost or deteriorated in the course of unloading, preservation or transportation, for which a written record of loss or deterioration and an independent assessment are required in order to request foreign parties to pay damages according to international practice, those goods consignees may request an independent assessment agency to issue certificates without having to seek for state inspection of food safety.

Article 10.- Inspection procedures

1. The inspection agency shall receive and consider an inspection registration dossier to select a mode of inspection for a goods lot (consisting of one or more product lots), and certify the inspection registration. Particularly for products subject to inspection of dossier only, it shall issue a notice that the goods lot is subject to inspection of dossier only, if an unexpected inspection defined in Clause 5, Article 5 of this Regulation is not required.

2. The inspection agency shall conduct inspection and sampling at the place registered by the goods consignee. If the goods consignee sells or disperses the goods lot from the temporary storage place before samples are taken for inspection, the inspection agency shall notify such in writing to the customs office that has made customs clearance and the Department for Food Safety and Hygiene for recall of the goods or application of appropriate remedies.

3. The inspection agency shall make written records of inspection and sampling. These written records must bear all signatures of the involved parties and be included in the inspection dossier of the goods lot.

4. Grounds for inspection and test: Based on the inspection registration dossier and the compliance history of the goods, the inspection agency shall determine the specific mode of inspection, quantity of samples, number of criteria to be tested, and testing method; and inspect samples according to the following contents:

a/ For food products for which product standards have been announced:

- Based on the announced contents of institutional standards and product samples, to decide whether to apply the mode of normal inspection or reduced inspection;

- Expiry date and label contents;

- Other safety requirements upon receipt of information on risks or written request of the Ministry of Health.

b/ For food products for which product standards have not yet been announced, at least two normal inspections shall be conducted in five consecutive inspections:

- Inspection of food safety indicators;

- Expiry date and label contents;

- Other safety requirements upon receipt of information on risks or written request of the Ministry of Health (the Department for Food Safety and Hygiene or the Inspectorate).

5. Grounds for assessment of inspection results:

a/ Document on institutional standards of products already appended with the seal of certification of the Department for Food Safety and Hygiene (for which a certificate of product standards has been granted).

b/ Vietnam's food quality, hygiene and safety and labeling regulations and standards subject to compulsory application, for products for which product standards have not yet been announced.

c/ In the absence of relevant Vietnamese regulations, international regulations (Codex standards) or regional regulations, for special foods and food additives which are certified in writing by the Department for Food Safety and Hygiene as products permitted for use.

6. Conclusions upon completion of inspection shall be made according to the provisions of Article 11.

7. Notices on inspection results shall be issued under the provisions of Clause 2, Article 14 of this Regulation.

Article 11.- Conclusions upon completion of inspection

1. If the goods lot complies with the prescribed import requirements, the inspection agency shall grant a certificate of compliance with import requirements or issue a notice on inspection of dossier only (made according to a set form, not printed herein).

2. If the goods lot fails to comply with the prescribed import requirements, the inspection agency shall send a notice on the goods lot's non-compliance with import requirements (made according to a set form, not printed herein) enclosed with a test result slip to the goods consignee and the customs office of the port or border gate of arrival of the goods, and concurrently send a written report to the Ministry of Health (the Department for Food Safety and Hygiene), proposing a measure to dispose of the goods lot. Within 15 days (excluding weekends and holidays), the Department for Food Safety and Hygiene shall issue an appropriate handling decision.

Article 12.- Payment of charges and fees

Goods consignees shall pay inspection charges and fees according to the Regulation on rates, payment, management and use of charges and fees for food quality, hygiene and safety management, promulgated together with the Ministry of Finance's Decision No. 80/2005/QD-BTC of November 17, 2005, to the inspection agency before they are issued notices on inspection results.

Article 13.- Management of inspection charges and fees

Inspection charges and fees shall be managed according to current regulations of the State.

Article 14.- Responsibilities of the inspection agency

1. To certify the inspection registration within one working day and conduct the state inspection within the designated scope.

2. To notify inspection results within the following time limits:

a/ For certificates of compliance with import requirements:

- Five working days after samples are taken for inspection plus the testing time required by the applied testing method, for foods subject to tightened inspection specified in Clause 1, Article 4 of this Regulation.

- Two working days after samples are taken for inspection plus the testing time required by the applied testing method, for foods subject to normal inspection or reduced inspection specified in Clause 2 or 3, Article 4 of this Regulation.

b/ For notices on inspection of dossier only: Two working days after the arrival of goods at the port, for foods specified in Article 5 of this Regulation.

c/ A notice on results of tightened inspection or a notice on non-compliance with import requirements delivered to the import goods consignee must be enclosed with a test result slip for each product lot, and a report thereon must be sent to the Ministry of Health (the Department for Food Safety and Hygiene).

3. To keep food samples according to regulations for each type of food for re-testing upon request. Past the set time limit, the inspection agency may request the goods consignee to take back samples or make a written record of the disposal of samples according to regulations.

4. To ensure accurate, honest and objective food safety inspection and certification of imported food lots. To strictly comply with regulations on inspection and testing procedures.

5. To receive and settle goods consignees' complaints about its food safety inspection and certification. To bear responsibility for errors made in the course of inspection and certification. If causing damage to goods consignees, it shall pay compensations therefor according to current regulations.

6. To keep inspection dossiers for three years from the date of issuance of inspection result notices, and produce them upon request of competent agencies.

7. To send quarterly reports (ten days after the end of each quarter), made according to a set form (not printed herein) to the Ministry of Health (the Department for Food Safety and Hygiene), and propose the list of foods that may be considered and granted permits for reduced inspection or inspection of dossier only.

8. To report to the Ministry of Health (the Department for Food Safety and Hygiene) when:

a/ It relocates its head office or has new working offices;

b/ It suspends or terminates operation.

Article 15.- Powers of the inspection agency

1. To request goods consignees to supply relevant documents specified in Article 6 of this Regulation.

2. To enter places where goods are preserved or permit enterprises to present whole product lots at its office for inspection and sampling.

3. To inspect foods by modes and according to procedures specified in this Regulation and may take the initiative in conducting no more than two normal inspections in five inspections.

4. To issue inspection result notices and notify border-gate customs offices of cases where goods consignees register for inspection but fail to present goods for inspection or inspection results show that the goods fail to comply with import requirements.

5. To grant inspection registration certificates with the phrase "goods lot waiting inspection results" and notify border-gate customs offices to allow customs clearance only after inspection results are obtained in the following cases:

a/ There is objective evidence that import goods lots registered for inspection fail to comply with the food safety requirements;

b/ A previously imported lot of goods of the same type of the same consignee fails to comply with the food safety requirements;

c/ Goods are subject to tightened inspection specified in Clause 1, Article 4 of this Regulation.

d/ Imported food additives are not on the list of food additives permitted for use promulgated by the Ministry of Health and for which no standards have been announced yet or which have not yet been certified by the Department for Food Safety and Hygiene as permitted for use for food processing, after referring to Codex standards and free circulation permits granted by the country of origin.

e/ Special types of food (including therapeutic nutritional foods, meal replacements taken through catheters for acute patients, supplements, foods fortified with micro-nutrients, functional foods) that have neither been granted certificates of announcement of product standards nor certified in writing by the Department for Food Safety and Hygiene.

6. To supervise the disposal of goods lots that fail to comply with import requirements and/or request local competent health agencies to join in supervising the disposal of those goods lots in their localities.

Article 16.- Responsibilities of imported goods consignees

1. To register for state inspection of food safety with the inspection agency according to Clause 1, Article 6 of this Regulation and pay the prescribed inspection charges and fees before carrying out customs procedures.

2. After the goods are, upon permission of the customs office, transported to a storehouse with adequate preservation conditions, to take the initiative in producing the goods in the original conditions together with their dossier sets that have gone through customs procedures and inspection registration certificates as prescribed to the inspection agency for state inspection of food safety.

3. To put imported foods into use and circulation only after the inspection agency issues one of inspection result notices specified in Clause 2, Article 1 of this Regulation.

4. To preserve the inspected goods pending the making of inspection conclusions or issuance of competent agencies' decisions in relation to goods lots that have been concluded to be compliant with import requirements according to regulations on food safety or labeling or announced product standards.

5. To pay all expenses borne by the agency supervising the disposal of goods lots failing to comply with import requirements, including expenses borne by staff of the supervising agency.

6. To be allowed to request re-inspection or prove that a goods lot complies with food safety requirements by producing certificates of analysis of the goods lot granted by at least two other accredited test laboratories, attesting to compliance with the grounds for assessment of inspection results specified in Clause 5, Article 10 of this Regulation.

7. To be allowed to propose to the Department for Food Safety and Hygiene one of the following disposal measures:

a/ Reprocessing: Goods consignees shall report the measure of reprocessing and the address of the goods reprocessing place to the inspection agency and may conduct the reprocessing only after obtaining approval of the inspection agency. After the reprocessing, the goods consignee shall request in writing the inspection agency to inspect the reprocessed goods lot and take follow-up actions as follows:

- If the reprocessed goods lot complies with import requirements and/or needs relabeling as the quality of products is lower than that stated in the labels, the inspection agency shall report the case to the Ministry of Health (the Department for Food Safety and Hygiene) for written opinions before granting a certificate of compliance with import requirements for the reprocessed goods, clearly stating "goods lot compliant with import requirements after reprocessing" for the goods to be sold in the domestic market.

- If the reprocessed goods lot still fails to comply with import requirements, the inspection agency shall issue a notice on the reprocessed goods' non-compliance with import requirements and request the Ministry of Health (the Department for Food Safety and Hygiene) to designate an agency to supervise the goods consignee in disposing of the goods lot or redirecting the goods not for use as foods according to Clause 6 of this Article.

b/ Redirection of goods not for use as foods after they are relabeled.

c/ Re-export: The goods consignee shall submit re-export documents to the inspection agency for completion of the dossier.

d/ Destruction: The goods consignee shall enter into a contract with an agency in charge of destruction and obtain a written certification of the destruction time, place, method and content from the environ-mental management agency or the inspectorate of the provincial/municipal Health Service of the locality that has supervised the destruction.

8. To be sanctioned according to current regulations if they violate the provisions of this Regulation.

Article 17.- Powers of imported goods consignees

1. Within 10 days after receiving notices on goods lots' non-compliance with import requirements, goods consignees may furnish written evidence and request the inspection agency that has inspected their goods to reconsider inspection or reinspection results. After their requests are accepted:

a/ If reinspection results are contrary to inspection results, goods consignees are not required to pay the reinspection charge.

b/ If reinspection results are consistent with inspection results, goods consignees shall bear the reinspection expenses.

2. Goods consignees may present to the inspection agency and the Ministry of Health (the Department for Food Safety and Hygiene) the results of analysis of samples certified and tested by standardized laboratories and texts of international law or laws of countries that permit the circulation of goods on allowable contamination contents and minor errors in foods for human consumption.

3. Goods consignees may propose to the Department for Food Safety and Hygiene one of the measures specified in Clause 7, Article 16 of this Regulation to dispose of product lots that fail to comply with import requirements. Proposed measures must be specific and compliant with legal provisions if they are to be accepted.

4. Complaints and denunciations shall be lodged and settled in accordance with the law on complaints and denunciations.

5. Goods consignees may cut expenses and receive inspection result notices earlier for imported foods in the following cases:

a/ They request the Department for Food Safety and Hygiene to approve in writing the reduced inspection of their goods after they are issued notices on compliance with import requirements twice, if the conditions specified in Clauses 3 and 4 of this Regulation are satisfied, and the inspection of dossier only, if the conditions specified in Clause 5 of this Regulation are satisfied.

b/ Imported products satisfy the conditions specified in Clauses 3 and 4 of this Regulation for reduced inspection by the inspection agency.

c/ They request the Department for Food Safety and Hygiene to permit in writing technical agencies located near goods storage places (defined in Article 8 of this Regulation) to perform the state management of food safety.

Article 18.- Responsibilities of the Department for Food Safety and Hygiene

1. To decide on and guide measures for disposal of imported goods lots failing to comply with food safety requirements.

2. To decide on the mode of inspection of imported goods lots: reduced inspection or inspection of dossier only at the proposal of the state inspection agency or the request of goods consignees.

3. To assume the prime responsibility for, and coordinate with concerned units (the Inspectorate and concerned departments of the Ministry of Health) in, evaluating and proposing to the Ministry of Health for designation state technical or research organizations and units to perform the state inspection of food quality, hygiene and safety for imported foods or to conduct inspection in special cases specified in Article 8.

4. To periodically inspect the professional capability of state inspection agencies and propose to the Ministry of Health measures of suspension, expansion or narrowing of the scope of operation of those state inspection agencies.

5. To propose the Ministry of Health to suspend an inspection agency that fails to make quarterly reports twice from conducting the state inspection of food safety.

6. To settle proposals of goods consignees and the state inspection agency, and propose the Inspectorate of the Ministry of Health to administratively handle acts of law violation.

7. To review and report annually to the Department for Food Safety and Hygiene on matters related to the state inspection of imported foods, and concurrently propose management measures appropriate to each period.

Article 19.- Organization of implementation of the Regulation

1. The Department for Food Safety and Hygiene shall organize the implementation of this Regulation.

2. The Inspectorate of the Ministry of Health shall coordinate with the Department for Food Safety and Hygiene in conducting biennial or extraordinary examinations or inspections of the implementation of this Regulation by inspection agencies and report them to the leadership of the Ministry of Health.