Decree No. 38/2012/ND-CP detailing the implementation of certain provisions of the Food Safety Law

DECREE

Detailed implementation regulations for certain provisions of the Food Safety Law

______________________

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Pursuant to the Food Safety Law dated June 17, 2010;

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

At the proposal of the Minister of Health;

The Government promulgates this Decree to provide detailed implementation regulations for certain provisions of the Food Safety Law,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree provides detailed implementation regulations for certain provisions of the Food Safety Law regarding:

1. Notification of compliance with technical regulations or notification of conformity with food safety regulations.

2. Ensuring the safety of genetically modified foods.

3. Issuance and revocation of Certificates of Food Safety Conditions for establishments.

4. State inspection of food safety for imported and exported foods.

5. Food labeling.

6. Allocation of responsibilities for state management of food safety:

a) Responsibilities of the Ministry of Health for state management of food safety;

b) Responsibilities of the Ministry of Agriculture and Rural Development for state management of food safety;

c) Responsibilities of the Ministry of Industry and Trade for state management of food safety;

d) Responsibilities of People's Committees at all levels for state management of food safety;

đ) Coordination among ministries responsible for sectors in performing their functions in state management of food safety.

7. Specialized inspection of food safety.

Article 2. Applicability

This Decree applies to agencies, organizations, and individuals in Vietnam; foreign organizations and individuals operating in Vietnam involved in food production and business; and organizations and individuals conducting activities related to food safety in Vietnam (hereinafter referred to collectively as organizations and individuals).

Chapter II

NOTIFICATION OF COMPLIANCE WITH TECHNICAL REGULATIONS AND NOTIFICATION OF CONFORMITY WITH FOOD SAFETY REGULATIONS

Article 3. Notification of compliance with technical regulations and notification of conformity with food safety regulations

1. Processed packaged foods; food additives; food processing aids; food packaging materials and containers (hereinafter collectively referred to as products) that have technical standards must be notified of compliance with technical regulations and registered with the competent state agency before being put into circulation on the market.

2. Products without technical standards must be notified of conformity with food safety regulations and registered with the competent state agency before being put into circulation on the market until corresponding technical standards are issued and take effect.

Article 4. Acceptance of notifications of compliance with technical regulations and notifications of conformity with food safety regulations

1. The Ministry of Health shall be responsible for organizing the management of the acceptance of registration forms for notifications of compliance with technical regulations and notifications of conformity with food safety regulations from organizations and individuals producing and trading in products, including: health supplements; food additives; food processing aids; imported processed packaged foods and food packaging materials and containers.

2. Provincial Health Departments shall be responsible for organizing the management of the acceptance of registration forms for notifications of compliance with technical regulations and notifications of conformity with food safety regulations for domestically produced products from organizations and individuals producing and trading in such products within their jurisdiction, except for those specified in Clause 1 of this Article.

3. Within seven working days from the date of receipt of complete and valid files, the competent state agency must issue a Notification Receipt for notifications of compliance with technical regulations according to the form prescribed in Form No. 01a attached to this Decree; if it does not issue a Notification Receipt, the competent state agency must respond in writing with reasons for not issuing it.

4. Within fifteen working days from the date of receipt of complete and valid files, the competent state agency must issue a Confirmation Certificate for notifications of conformity with food safety regulations according to the form prescribed in Form No. 01b attached to this Decree; if it does not issue a Confirmation Certificate, the competent state agency must respond in writing with reasons for not issuing it.

5. Within thirty working days from the date of receipt of complete and valid files, the competent state agency must issue a Confirmation Certificate for notifications of conformity with food safety regulations for health supplements and nutrient-enriched foods according to the form prescribed in Form No. 01b attached to this Decree; if it does not issue a Confirmation Certificate, the competent state agency must respond in writing with reasons for not issuing it.

6. Agencies accepting notifications of compliance with technical regulations or notifications of conformity with food safety regulations are responsible for publicly announcing products that have been issued Notification Receipts or Confirmation Certificates on their websites and through mass media when requested.

Monthly, Provincial Health Departments report to the Ministry of Health on the results of accepting notifications of compliance with technical regulations or notifications of conformity with food safety regulations.

Article 5. Documents for Announcement of Compliance with Technical Regulations for Products Already Having Technical Standards

1. Announcement of compliance based on the results of conformity assessment certification issued by designated conformity assessment bodies (third party), the documents include:

a) The announcement of compliance as specified in Model No. 02 issued together with this Decree;

b) Detailed product information as specified in Model No. 03a or Model No. 03c issued together with this Decree (stamped by the third party);

c) Third-party conformity certificate (certified copy or copy presented with original for verification);

d) Certificate of compliance with HACCP standard or ISO 22000 or equivalent standard in case the organization or individual producing the product has a quality management system certified to comply with HACCP or ISO 22000 or equivalent standard (certified copy or copy presented with original for verification).

2. Announcement of compliance based on self-assessment results of organizations or individuals producing and trading food (first party), the documents include:

a) The announcement of compliance as specified in Model No. 02 issued together with this Decree;

b) Detailed product information as specified in Model No. 03a or Model No. 03c issued together with this Decree;

c) Product testing results within twelve months, including key quality indicators and safety indicators, issued by the following entities: State-authorized inspection laboratories or independent inspection laboratories recognized (original or certified copy); or inspection laboratories of the country of origin recognized by competent authorities in Vietnam (original or certified copy or apostilled copy);

d) Quality control plan established and implemented according to the model specified in Model No. 04 issued together with this Decree (confirmed by the first party);

đ) Periodic monitoring plan (confirmed by the first party);

e) Conformity assessment report (confirmed by the first party);

g) Certificate of compliance with HACCP standard or ISO 22000 or equivalent standard in case the organization or individual producing the product has a quality management system certified to comply with HACCP or ISO 22000 or equivalent standard (certified copy or copy presented with original for verification).

Article 6. Documents for Announcement of Compliance with Food Safety Regulations for Products Without Technical Standards

1. For imported products (excluding dietary supplements and fortified foods), the documents include:

a) The announcement of compliance with food safety regulations as specified in Model No. 02 issued together with this Decree;

b) Detailed product information as specified in Model No. 03a or Model No. 03c issued together with this Decree;

c) Product testing results within twelve months, including key quality indicators and safety indicators, issued by the following entities: State-authorized inspection laboratories or independent inspection laboratories recognized (original or certified copy); or inspection laboratories of the country of origin recognized by competent authorities in Vietnam (original or certified copy or apostilled copy).

d) Periodic monitoring plan (confirmed by the organization or individual);

đ) Product label sample circulating in the country of origin and Vietnamese language label (confirmed by the organization or individual);

e) Complete product sample for the first time imported into Vietnam for submission when filing the application;

g) Business registration certificate with food business activities or legal entity certificate for organizations or individuals importing food (certified copy confirmed by the organization or individual);

h) Certificate of food safety conditions for import establishments required to obtain such certificates under the regulations (certified copy confirmed by the organization or individual);

i) Certificate of compliance with HACCP standard or ISO 22000 or equivalent standard in case the organization or individual producing the product has a quality management system certified to comply with HACCP or ISO 22000 or equivalent standard (certified copy or copy presented with original for verification).

2. For domestically produced products (excluding dietary supplements and fortified foods), the documents include:

a) The announcement of compliance with food safety regulations as specified in Model No. 02 issued together with this Decree;

b) Detailed product information as specified in Model No. 03b or Model No. 03c issued together with this Decree;

c) Product testing results within twelve months, including key quality indicators and safety indicators, issued by State-authorized inspection laboratories or independent inspection laboratories recognized (original or certified copy);

d) Quality control plan established and implemented according to the model specified in Model No. 04 issued together with this Decree (confirmed by the organization or individual);

đ) Periodic monitoring plan (confirmed by the organization or individual);

e) Product label sample (confirmed by the organization or individual);

g) Business registration certificate with food business activities or legal entity certificate for organizations or individuals (certified copy confirmed by the organization or individual);

h) Certificate of food safety conditions for establishments required to obtain such certificates under the regulations (certified copy confirmed by the organization or individual);

i) Certificate of compliance with HACCP standard or ISO 22000 or equivalent standard in case the organization or individual producing the product has a quality management system certified to comply with HACCP or ISO 22000 or equivalent standard (certified copy or copy presented with original for verification).

3. For imported dietary supplements and fortified foods, the documents include:

a) The announcement of compliance with food safety regulations as specified in Model No. 02 issued together with this Decree;

b) Detailed product information as specified in Model No. 03b issued together with this Decree (stamped by the organization or individual);

c) Free circulation certificate or health certificate or equivalent certificate issued by the authorized authority of the country of origin indicating that the product is safe for consumer health and complies with food laws (original or certified copy or apostilled copy);

d) Product testing results within twelve months, including key quality indicators and safety indicators, issued by the following entities: State-authorized inspection laboratories or independent inspection laboratories recognized (original or certified copy); or inspection laboratories of the country of origin recognized by competent authorities in Vietnam (original or certified copy or apostilled copy);

đ) Periodic monitoring plan (confirmed by the organization or individual);

e) Product label circulating in the country of origin and a Vietnamese language label supplement (certified by an organization or individual);

g) A complete product sample for comparison when submitting the application;

h) Business registration certificate with food business activities or legal entity certification for organizations or individuals importing food (certified copy from an organization or individual);

i) Certificate of food safety conditions for establishments required to obtain such certificates under regulations (certified copy from an organization or individual);

k) Certificate of compliance with HACCP standards or ISO 22000 or equivalent standards in cases where organizations or individuals producing products have quality management systems certified as compliant with HACCP or ISO 22000 or equivalent standards (notarized copy or certified copy presented with original for comparison);

l) Scientific information and documentation proving the effect of each component contributing to the declared function (certified copy from an organization or individual).

4. For domestically produced functional foods and nutrient-enriched foods, the application includes:

a) The announcement of compliance with food safety regulations as specified in Model No. 02 issued together with this Decree;

b) Detailed product information as specified in Model No. 03b issued together with this Decree (stamped by the organization or individual);

c) Product testing results within twelve months, including key quality indicators and safety indicators, issued by State-authorized inspection laboratories or independent inspection laboratories recognized (original or certified copy);

d) Product label sample (certified by an organization or individual);

đ) A complete product sample for comparison when submitting the application;

e) Business registration certificate with food business activities or legal entity certification for organizations or individuals (certified copy from an organization or individual);

g) Certificate of food safety conditions for establishments required to obtain such certificates under regulations (certified copy from an organization or individual);

h) Certificate of compliance with HACCP standards or ISO 22000 or equivalent standards in cases where organizations or individuals producing products have quality management systems certified as compliant with HACCP or ISO 22000 or equivalent standards (notarized copy or certified copy presented with original for comparison);

i) Information and scientific documentation proving the effect of each component contributing to the declared function (certified copy from an organization or individual);

k) Report on testing the effectiveness of the product's functions for new products first introduced to the market (notarized copy or certified copy presented with original for comparison);

l) Quality control plan established and implemented according to Model No. 04 issued together with this Decree (certified by an organization or individual);

m) Periodic monitoring plan (certified by an organization or individual).

Article 7. Submission of Application for Declaration of Compliance or Declaration of Conformity with Food Safety Regulations

1. The application for declaration of compliance or declaration of conformity with food safety regulations shall be bound as follows:

a) General legal documents, compiled into one volume, including:

- Business registration certificate with food business activities or legal entity certification for organizations or individuals (certified copy from an organization or individual);

- Certificate of food safety conditions for establishments required to obtain such certificates under regulations (certified copy from an organization or individual);

- Certificate of compliance with HACCP standards or ISO 22000 or equivalent standards in cases where organizations or individuals have quality management systems certified as compliant with HACCP or ISO 22000 or equivalent standards (notarized copy or certified copy presented with original for comparison).

b) Application for declaration of compliance or declaration of conformity with food safety regulations for products, compiled into two volumes, including the documents specified in Articles 5 and 6 of this Decree, except for the documents specified in Point a Clause 1 of this Article.

2. Organizations or individuals producing or trading products shall submit directly the application for declaration of compliance or declaration of conformity with food safety regulations to the competent authority of the Ministry of Health and the Department of Health, or submit the application via postal service.

3. For organizations or individuals producing or trading products that declare compliance or conformity with food safety regulations for the second product or more, they only need to submit one set of general legal documents.

Article 8. Reissuing the Notification of the Declaration of Compliance with Technical Regulations and the Confirmation of Declaration of Compliance with Food Safety Regulations

1. In cases where there is no change in the production or processing procedures that affect quality indicators and exceed food safety limits compared to the initial declaration, food producers and traders must periodically re-register the declaration of compliance with technical regulations or the declaration of compliance with food safety regulations:

a) Every 5 years for products from production and trading establishments holding one of the advanced quality management system certificates: HACCP, ISO 22000 or equivalent;

b) Every 3 years for products from production and trading establishments not holding the above certificates.

2. The re-registration of the declaration of compliance with technical regulations or the declaration of compliance with food safety regulations shall be carried out at the competent state agency that initially issued the Notification of the Declaration of Compliance with Technical Regulations and the Confirmation of Declaration of Compliance with Food Safety Regulations for such product.

3. The application dossier for reissuing the Notification of the Declaration of Compliance with Technical Regulations and the Confirmation of Declaration of Compliance with Food Safety Regulations includes:

a) An application form for reissuing the Notification of the Declaration of Compliance with Technical Regulations or the Confirmation of Declaration of Compliance with Food Safety Regulations according to the model specified in Model No. 05 issued together with this Decree (with confirmation from the organization or individual);

b) The most recent Notification of the Declaration of Compliance with Technical Regulations or Confirmation of Declaration of Compliance with Food Safety Regulations (a copy);

c) Periodic product testing results conducted by a recognized laboratory designated by a competent state authority (a certified copy or a copy presented with the original for verification):

- Once a year for establishments holding one of the advanced quality management system certificates: GMP, HACCP, ISO 22000 or equivalent.

- Twice a year for establishments without the above certificates.

d) A certificate of conformity to the HACCP standard or ISO 22000 or equivalent in cases where the organization or individual has a quality management system certified to conform to the HACCP standard or ISO 22000 or equivalent (a certified copy or a copy presented with the original for verification).

4. Within 7 working days from the date of receipt of the application, the competent state authority must reissue the Notification of the Declaration of Compliance with Technical Regulations or the Confirmation of Declaration of Compliance with Food Safety Regulations; if it does not reissue, the competent state management authority must provide a written explanation for not reissuing.

5. When any changes occur during the production or processing of food that affect quality indicators and exceed food safety limits compared to the initial declaration, food producers and traders must re-declare compliance with technical regulations or declare compliance with food safety regulations to the competent state authority in accordance with Articles 4, 5, and 6 of this Decree.

Article 9. Conformity Mark for Products

Products specified in Clause 1, Article 3 of this Decree may bear a conformity mark in accordance with the laws on standards and technical regulations after being accepted by a competent state authority for the declaration of compliance with technical regulations.

The use of the conformity mark shall be carried out in accordance with Point c, Clause 1, Article 49 of the Law on Standards and Technical Regulations and Article 15 of Decree No. 127/2007/NĐ-CP dated August 1, 2007 detailing certain provisions of the Law on Standards and Technical Regulations.

Chapter III

FOOD SAFETY FOR GENETICALLY MODIFIED PRODUCTS

Article 10. Safeguarding safety for food containing components from genetically modified organisms (GMOs) and products derived from GMOs

1. Regulations on conditions for issuing the Certificate Confirming Genetically Modified Organisms Suitable for Food Use; procedures and formalities for issuing and revoking the Certificate Confirming Genetically Modified Organisms Suitable for Food Use; the list of genetically modified organisms eligible for the Certificate Confirming Genetically Modified Organisms Suitable for Food Use shall be implemented in accordance with the provisions set out in Section 1 of Chapter VI of Decree No. 69/2010/NĐ-CP dated June 21, 2010 on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms.

2. The Minister of Agriculture and Rural Development shall be responsible for issuing and revoking the Certificate Confirming Genetically Modified Organisms Suitable for Food Use; establishing and publishing the List of Genetically Modified Organisms Eligible for the Certificate Confirming Genetically Modified Organisms Suitable for Food Use; establishing, defining functions, tasks, and operational mechanisms of the Biosafety Council for Genetically Modified Organisms and Products Derived from Genetically Modified Organisms Used as Food.

Article 11. Labeling for goods containing genetically modified organisms, products derived from genetically modified organisms used as food

1. Organizations and individuals circulating food containing genetically modified organisms, products derived from genetically modified organisms on the market at a ratio exceeding 5% of each component must, in addition to complying with the regulations of the law on product labeling, also indicate information related to genetically modified organisms on the product label.

2. The Ministry of Agriculture and Rural Development shall take the lead and coordinate with the Ministry of Science and Technology to provide detailed guidance on labeling for food containing genetically modified organisms, products derived from genetically modified organisms.

Chapter IV

ISSUANCE AND REVOCATION OF THE CERTIFICATE OF FOOD SAFETY CONDITIONS

Article 12. Issuance of certificates confirming food safety facilities

1. The issuance of certificates confirming food safety facilities shall be carried out for each production and business establishment; each independent factory located at one site (hereinafter referred to as the facility), except in the following cases:

a) Small-scale primary production;

b) Small-scale food retail;

c) Street vendors;

d) Pre-packaged food sales that do not require special storage conditions as prescribed.

2. The Minister of Health, the Minister of Agriculture and Rural Development, and the Minister of Industry and Trade shall stipulate the authority to issue and revoke certificates confirming food safety facilities within their respective areas of responsibility as provided in Articles 62, 63, and 64 of the Food Safety Law and this Decree, and specify management methods for the types of production and business operations mentioned in Points a, b, c, and d of Clause 1 of this Article.

Article 13. Revocation of certificates confirming food safety facilities

A production and business establishment for food will have its certificate confirming food safety facilities revoked in the following circumstances:

1. Organizations and individuals engaged in food production and business cease to operate the registered food business activities.

2. There is a decision by the competent state agency to change the business activity at the old facility.

3. The food production and business establishment has had its right to use the certificate revoked according to the law on administrative penalties in the field of food safety.

Chapter V

STATE INSPECTION OF IMPORT AND EXPORT FOOD SAFETY

Article 14. Inspection of Imported Food

1. All types of food, food ingredients, food additives, processing aids, equipment, packaging materials, and containers for food must be inspected at state inspection agencies authorized by the relevant ministries when imported into Vietnam, except for cases specified in Clause 2 of this Article.

Article 2. The following cases are exempted from state food safety inspections for imported food:

a) Food items carried by individuals for personal consumption within the tax-free allowance upon entry;

b) Food items in diplomatic and consular bags;

c) Food items in transit or transshipment;

d) Food items stored in bonded warehouses;

đ) Food items for testing or research purposes;

e) Food samples displayed at exhibitions or trade fairs.

3. The Ministry of Health shall be responsible for inspecting and issuing notification of inspection results for consignments of multiple types of food under the jurisdiction of two or more ministries.

The Ministry of Agriculture and Rural Development shall be responsible for inspecting and issuing notification of inspection results for consignments of multiple types of food under the jurisdiction of two or more ministries, including fresh food products.

Article 15. State Inspection on Food Safety in Exporting Countries

1. In cases where mutual recognition assessments are conducted, the competent state management agency of Vietnam shall develop an inspection plan, notify, and coordinate with the competent authority of the exporting country to conduct inspections of the food safety control system of the exporting country and food production and business establishments exporting to Vietnam according to international treaties to which the Socialist Republic of Vietnam is a member:

a) The competent authority of the exporting country shall submit registration files to the relevant ministry.

b) Within thirty working days from the date of receipt of complete registration files of production and business establishments from the competent authority of the exporting country, the competent authority of the relevant ministry shall review the files, notify the competent authority of the exporting country of the review results, and plan for inspections if necessary for the exporting country.

2. The competent authority of the exporting country shall send one set of registration files to the competent authority of Vietnam: the Ministry of Health, the Ministry of Agriculture and Rural Development, or the Ministry of Industry and Trade, including:

a) A list of food production and business establishments registered for export to Vietnam according to Form No. 06 issued together with this Decree;

b) Information about the management system and capacity for food safety control of the competent authority of the exporting country according to Form No. 07 issued together with this Decree;

c) A summary of information about food safety conditions of food production and business establishments according to Form No. 08 issued together with this Decree.

Article 16. State Inspection on Food Safety for Exported Food

1. The Minister of Health, the Minister of Agriculture and Rural Development, and the Minister of Industry and Trade shall stipulate the authority for state inspection on food safety for exported food within their respective areas of responsibility as provided for in Articles 62, 63, and 64 of the Food Safety Law.

2. The Ministry of Agriculture and Rural Development shall be responsible for inspecting consignments of exported food comprising multiple items under the jurisdiction of two or more ministries.

Chapter VI

FOOD LABELING

Article 17. Expiry Date Labeling on Food Products

1. The mandatory labeling of the expiry date as "Best Before" or "Use By" shall apply to health foods, dietary supplements, health foods, medical nutrition foods, fortified foods, and other foods that may deteriorate due to microorganisms. For other foods, the expiry date may be labeled as "Best Before" in accordance with the type of food product.

2. Foods labeled with "Best Before" or "Use By" shall not be sold on the market after the expiration date.

3. For foods labeled with "Best Before," they may still be sold on the market after the date indicated if the manufacturer can prove to the competent state authority that the food remains safe and must clearly label the expiry date as either "Best Before" or "Use By." Only the food manufacturer may extend the expiry date of its products, and the maximum extension period shall not exceed the original expiry date.

Article 18. Mandatory Labeling Content

1. Pre-packaged foods must be labeled in accordance with the provisions of the Food Labeling Law.

2. Depending on the type of pre-packaged food, in addition to the provisions of Clause 1 of this Article, the mandatory labeling content must also comply with the following provisions:

a) Information on the label must reflect the true nature of the product, be honest, accurate, clear, and not mislead consumers.

b) For functional foods, nutrient-enriched foods, the label must clearly indicate the following main contents: declaration of nutritional components; active ingredients; health effects; specify the target group, dosage, usage method, and warnings if necessary.

c) For medical nutrition foods, vitamin supplements, trace element supplements not intended for general community use such as formula food for pregnant women, children under 36 months old, and tube feeding food for patients, the level of nutritional requirements met, dosage for each target group, and doctor's instructions must be declared.

d) Functional foods, nutrient-enriched foods, food additives, certain genetically modified foods (subject to labeling according to the regulations on labeling genetically modified foods) must clearly state the components and their quantities in the food.

đ) When using a component of the product as the name of the product, the quantity of that component must be clearly stated next to the product name.

e) The product name must be the largest and clearest font size on the label, at least three times larger than other fonts on the label.

g) When translating the label, it must ensure that the content does not deviate from the original label.

3. The Ministry of Health shall take the lead and coordinate with the Ministry of Agriculture and Rural Development, the Ministry of Industry and Trade to provide detailed guidance on food labeling.

Chapter VII

ASSIGNMENT OF RESPONSIBILITIES FOR NATIONAL MANAGEMENT OF FOOD SAFETY

Article 19. Principles of Assignment of Responsibilities for National Management of Food Safety

1. Based on the provisions of the Food Safety Law and ensuring consistency with current legal documents.

2. On the basis of unified national management of food safety.

3. Ensuring comprehensive management throughout the entire process of food production and business.

4. Close cooperation among ministries and sectors.

5. Ensuring the principle of one window, one product, one production and business entity only subject to the management of one government agency.

6. Ensuring scientific, completeness, and feasibility.

7. Delegation of central and local government levels' management responsibilities in national management of food safety.

8. During the management process, if there are emerging issues that cannot be clearly defined, the Ministry of Health shall take the lead and coordinate with the Ministry of Agriculture and Rural Development, the Ministry of Industry and Trade to develop Circulars providing specific guidance.

Article 20. Responsibilities of the Ministry of Health in National Management of Food Safety

1. The Ministry of Health is responsible before the Government for implementing unified national management of food safety.

2. Within its scope of duties and powers, the Ministry of Health has the responsibility:

a) To implement the general responsibilities in national management of food safety as stipulated in Clause 1 of Article 62 of the Food Safety Law.

b) To report periodically and urgently to the Government on food safety management work based on supervision and consolidation of reports from sectoral management ministries.

c) To review, build plans and timelines for developing and reviewing national technical standards for all food products, food additives, processing aids, packaging materials, and containers for food in line with management requirements and economic and social development during each period.

d) To lead in building national technical standards for products within the scope of management as stipulated in Article 62 of the Food Safety Law; to issue national technical standards or regulations on criteria and safety limits for all food products, food additives, processing aids, packaging materials, and containers for food.

đ) To designate organizations to certify compliance for food products, food additives, processing aids, packaging materials, and containers for food that have issued technical standards upon consultation with sectoral management ministries when necessary.

e) To manage food safety throughout the production, processing, storage, transportation, export, import, and business processes for food additives, processing aids, bottled water, natural mineral water, functional foods, nutrient-enriched foods, packaging materials, and containers for food.

g) To specify detailed regulations on the management of functional foods, food additives, and nutrient-enriched foods.

h) To organize the issuance of Certificates of Receipt of Declaration of Compliance, Certificates of Confirmation of Compliance with Food Safety Regulations, and Certificates of Confirmation of Food Advertising Content for food products within the assigned management area.

i) To organize and delegate the issuance of certificates of food safety compliance for organizations and individuals producing and trading in products within the scope of management as stipulated in Point e of Clause 2 of this Article.

k) To provide health certification for food, food additives, processing aids, packaging materials, and containers for food upon request from organizations and individuals.

l) To stipulate conditions for testing facilities, designate units to participate in food testing for national management within the scope of management; to designate units to conduct arbitration testing and final conclusions when there are differences in testing results from testing units inside and outside the health sector.

m) To stipulate food safety conditions for collective kitchens, hotels, resorts, restaurants, and food service businesses.

n) To designate state inspection agencies for imported food safety for products within the scope of management as stipulated in Point e of Clause 2 of this Article and Clause 3 of Article 14 of this Decree.

Article 21. State Management Responsibilities for Food Safety of the Ministry of Agriculture and Rural Development

1. Coordinate in developing national technical standards for food products.

2. Manage food safety in the primary production of agricultural, forestry, aquatic products, and salt, including planting, breeding, harvesting, fishing, aquaculture, and salt production.

3. Manage food safety throughout the production, collection, slaughtering, preliminary processing, manufacturing, preservation, transportation, export, import, and trading processes for cereals; meat and meat products; aquatic products and seafood products; vegetables, fruits, and vegetable and fruit products; eggs and egg products; raw milk; honey and honey products; genetically modified foods; salt; spices; sugar; tea; coffee; cocoa; pepper; cashew nuts and other food agricultural products; packaging materials and containers for food within the assigned management scope.

4. Organize the issuance of Food Advertisement Content Confirmation Certificates for food products within the assigned management scope. In cases where the advertisement content confirms health effects, the opinion of the Ministry of Health must be obtained.

5. Organize and classify the issuance of certificates confirming food safety conditions for organizations and individuals producing and trading products within the scope assigned under Clause 2, 3, and 7 of this Article.

6. Develop and promulgate regulations on food safety assurance conditions for production, preliminary processing, manufacturing, and trading establishments for products within the scope assigned under Clause 3 of this Article based on general food safety assurance condition regulations for production and trading establishments issued by the Ministry of Health.

7. Manage food safety for wholesale markets and agricultural product auctions.

8. Specify testing facility conditions; designate testing units and verification testing units; announce testing results for food products within the assigned management scope.

9. Designate state inspection agencies for imported food safety for products within the scope assigned under Clause 3 of this Article and Clause 3 of Article 14 of this Decree.

Article 22. State Management Responsibilities for Food Safety of the Ministry of Industry and Trade

1. Coordinate in developing national technical standards for food products.

2. Manage food safety throughout the production, processing, preservation, transportation, export, import, and trading processes for alcoholic beverages, beer, soft drinks, processed milk, vegetable oil, starch-based products, confectionery, candy, packaging materials within the management scope.

3. Organize the issuance of Food Advertisement Content Confirmation Certificates for food products within the assigned management scope. In cases where the advertisement content confirms health effects, the opinion of the Ministry of Health must be obtained.

4. Organize and classify the issuance of certificates confirming food safety conditions for organizations and individuals producing and trading products within the scope assigned under Clause 2, 5 of this Article.

5. Manage food safety for markets, supermarkets, and food storage and distribution facilities.

6. Implement inspections to prevent counterfeit food, commercial fraud involving all types of food, food additives, food processing aids, packaging materials, and containers on the market.

7. Specify testing facility conditions; designate testing units and verification testing units; announce testing results for food products within the assigned management scope.

8. Designate state inspection agencies for imported food safety for products within the scope assigned under Clause 2 of this Article.

Article 23. State Management Responsibilities for Food Safety of All Levels of People's Committees

1. The People's Committee of provinces and centrally governed cities shall implement state management over food safety within their respective localities and shall be responsible to the Government for food hygiene and safety in their localities.

a) Organize and direct the Inter-sectoral Steering Committee on Food Hygiene and Safety at the provincial and centrally governed city levels;

b) Direct the implementation of regulations of the Government, ministries, and sectors concerning food safety.

2. Issue technical standards for food safety applicable to specific food products of the locality.

3. The Department of Health shall be responsible to the People's Committee of provinces and centrally governed cities for implementing state management over food safety within their jurisdictions; it shall serve as the permanent office of the Inter-sectoral Steering Committee on Food Safety at the local level.

a) Serve as the focal point for compiling and reporting on food safety conditions in the locality to the People's Committee of provinces and centrally governed cities, and the Ministry of Health;

b) Regularly conduct annual inspections of food safety conditions within the jurisdiction; serve as the focal point for monitoring food contamination risks within the jurisdiction;

c) Inspect and supervise food products and establishments producing and trading food additives, food processing aids, bottled water, natural mineral water, functional foods, and micronutrient-enriched foods, as well as food service businesses and street food vendors, according to the classification by the Ministry of Health;

d) Lead and coordinate with specialized departments to organize surprise inspections of the entire production and trading process of food under the management of other sectors when directed by the People's Committee, the Head of the Inter-sectoral Steering Committee on Food Hygiene and Safety at the provincial and centrally governed city levels, and the Ministry of Health; when food, food additives, food processing aids, food packaging materials, and containers circulating in the jurisdiction violate regulations and pose serious health risks to consumers; when there are discrepancies in inspection conclusions among specialized departments; upon request from specialized departments;

đ) Organize the acceptance of conformity declarations or confirmation of compliance with food safety regulations; confirm the content of food advertisements according to the division of responsibilities stipulated in Clause 2, Article 4 of this Decree; issue certificates of food safety compliance for establishments producing and trading various types of food according to the classification by the Ministry of Health;

e) Be responsible for food safety management within the jurisdiction; manage the conditions ensuring food safety for small-scale food production and trading establishments, street food vendors, food service businesses, and food safety at markets within the jurisdiction and other entities according to the classification of management.

4. The Department of Agriculture and Rural Development shall be responsible for:

a) Inspecting and supervising food products and establishments producing and trading food according to the classification by the Ministry of Agriculture and Rural Development;

b) Organizing the issuance of certificates of food safety compliance for establishments producing and trading various types of food according to the classification by the Ministry of Agriculture and Rural Development;

c) Organizing the issuance of certificates confirming the content of food advertisements according to the classification by the Ministry of Agriculture and Rural Development;

d) Regularly and unexpectedly report to the permanent office of the Inter-sectoral Steering Committee (Department of Health) to compile reports for the People's Committee of provinces and centrally governed cities, the Ministry of Health, and the sectoral management ministry;

5. The Department of Industry and Trade shall be responsible for:

a) Inspecting and supervising food products produced and traded by establishments according to the classification by the Ministry of Industry and Trade;

b) Organizing the issuance of certificates of food safety compliance for establishments producing and trading various types of food according to the classification by the Ministry of Industry and Trade;

c) Organizing the issuance of certificates confirming the content of food advertisements according to the classification by the Ministry of Industry and Trade;

d) Implementing inspections to prevent counterfeit food and commercial fraud on the market for all types of food, food additives, food processing aids, food packaging materials, and containers;

đ) Regularly and unexpectedly report to the permanent office of the Inter-sectoral Steering Committee (Department of Health) to compile reports for the People's Committee of provinces and centrally governed cities, the Ministry of Health, and the sectoral management ministry;

6. The People's Committee of districts and counties shall be responsible to the People's Committee of provinces and centrally governed cities for food safety within their jurisdictions.

a) Organize and direct the Inter-sectoral Steering Committee on Food Hygiene and Safety at the district and county levels;

b) Direct and implement regulations of the Government, ministries, sectors, and the People's Committee of provinces and centrally governed cities concerning food safety;

c) Manage the operation of street food vending, restaurants, and hotels within the district and county jurisdiction according to the classification.

7. The People's Committee of communes and wards shall be responsible to the People's Committee of districts and counties for food safety within their jurisdictions.

a) Organize and direct the Inter-sectoral Steering Committee on Food Hygiene and Safety at the commune and ward levels;

b) Implement regulations of the Government, ministries, sectors, and higher-level People's Committees concerning food safety;

c) Be responsible to the People's Committee of districts and counties for managing the operations of street food vending, restaurants, and hotels within the commune and ward jurisdiction according to the classification.

Article 24. Coordination among sectoral ministries in food safety management

Within their respective state management functions, sectoral ministries shall be responsible for coordinating with the Ministry of Health in implementing state management activities to ensure effective and unified state management of food safety.

1. The Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade shall organize the implementation of monitoring, prevention, and control programs for food safety incidents in accordance with Article 52 of the Food Safety Law within their assigned areas.

2. In cases of food poisoning, the Ministry of Health shall be responsible for organizing timely emergency treatment for those affected. Sectoral ministries shall be responsible for providing complete documentation and information related to the suspected source of the food causing the poisoning within their jurisdiction; they shall cooperate with the Ministry of Health to investigate the cause and conduct root cause analysis, trace the origin, and handle the contaminated food.

Chapter VIII

SPECIALIZED INSPECTION FOR FOOD SAFETY

Article 25. Agencies entrusted with the function of food safety inspection

Food safety inspection is specialized inspection carried out by the health sector, the agriculture and rural development sector, and the industry and trade sector. The assignment of agencies to perform specialized food safety inspection functions shall be implemented in accordance with the Government's regulations on agencies entrusted with specialized inspection functions.

Article 26. Coordination among ministries, sectors, and other forces in food safety inspection

1. The Ministries of Health, Agriculture and Rural Development, and Industry and Trade shall be responsible for inspecting food safety throughout the production, processing, storage, transportation, export, import, and sale of food products within their assigned management areas as stipulated in Articles 62, 63, 64, 65, and 67 of the Food Safety Law.

2. The Ministry of Health, as the permanent office of the Central Inter-sectoral Steering Committee for Food Safety, shall take the lead and coordinate with sectoral ministries and other relevant forces to organize and assign inter-sectoral inspections.

3. The Ministry of Health shall conduct surprise inspections of the entire process of production, export, import, and sale of food products under the jurisdiction of other ministries in the following circumstances:

a) Upon the directive of the Prime Minister or the Chairman of the Central Inter-sectoral Steering Committee for Food Safety;

b) When food, food additives, food processing aids, packaging materials, and containers are found to violate regulations and pose serious risks to consumer health;

c) When there are discrepancies in the inspection conclusions of sectoral ministries;

d) Upon the request of a sectoral ministry.

Chapter IX

IMPLEMENTING PROVISIONS

Article 27. Effective Date

This Decree takes effect from June 11, 2012.

Article 28. Responsibility for Implementation

Ministers, Heads of ministerial-level agencies, Heads of central government agencies, Chairpersons of provincial People's Committees, and organizations and individuals concerned shall be responsible for implementing this Decree./.