Circular No. 52/2015/TT-BYT stipulates the state inspection for food safety of imported food and the dossier and procedures for issuing certificates for exported food under the management of the Ministry of Health.

CIRCULAR

Regulations on state inspection for food safety of imported food and documentation,

procedures for issuing certificates for exported food under the management of B||| Re standards

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

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

Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law;

Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating functions, tasks, powers anduorganizational structure of structure Decision No. 10/2010/QĐ-TTg dated February 10, 2010 of the Prime Minister prescribing free circulation certificates for export products and goods; B1. Circular No. 29/2016/TT-BYT dated June 30, 2016 of the Minister of Health stipulating national technical standards for ionizing radiation exposure limits at workplaces.

Pursuant to Decision No. 10/2010Decision No. QĐ-TTg dated February 10, 2010 of the Government Chairman regarding the certificate of preferential free trade for exported and imported products and goods; lưu đãi tự do đối với sản phẩm, hàng hóa xuất khẩu và nhập khẩu;

At the proposal of the Director of the Food Safety Administration,

The Minister of Health issues this Circular regulating state inspection for food safety of imported food and documentation procedures for issuing certificates 3. NATIONAL UNIVERSITIES ARE SUBJECT TO STATE MANAGEMENT BY THE MINISTRY OF EDUCATION AND TRAINING, THE MINISTRY OF SCIENCE AND TECHNOLOGY, OTHER MINISTRIES AND SECTORS, AND PEOPLE'S COMMITTEES AT ALL LEVELS WHERE NATIONAL UNIVERSITIES ARE LOCATED, WITHIN THE SCOPE OF THEIR FUNCTIONS AS PROVIDED BY THE GOVERNMENT AND IN COMPLIANCE WITH LAWS. for exported food under the management of the Ministry of Health.

PART I

GENERAL PROVISIONS

Article 1.perioda) Clause 1 Article 15 regarding accountability;

This Circular stipulates on:

Article 1. Inspection regulations for imported food products under the management of the Ministry of Health are prescribed in:

a) Appendix 01 of Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT dated April 9, 2014 of the Ministries of Health, Agriculture and Rural Development, and Industry and Trade guiding the division of responsibilities and coordination in state management of food safety (hereinafter referred to as Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT);

b) Clause 3, Article 14 of Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law.

Article 2. Documentation and procedures for issuing, revoking certificates for free circulation for exported food products under the management of the Ministry of Health.

Article 3. Documentation and procedures for issuing, revoking health certificates, export certificates for exported food products.

Article 4. This Circular does not regulate inspection for imported food exempted from inspection as provided for in Clause 2, Article 14 of Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law.

Article 2. Interpretation of Terms

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

1. Shipper is a trader responsible for the quality of goods in declaration documents (referred to as a trader) or an organization or individual authorized by such trader to import or export food products.

2. Product (Lot of Products) refers to food products with the same name, brand, production facility, packaging material.

3. Lot refers to the entire quantity of imported or exported food products of one consignment (with the same waybill number). A lot may consist of one product or multiple products.

Chapter II

STATE INSPECTION FOR IMPORTED FOOD

Article 3. State Inspection Authority for Food Safety

The state inspection authority for food safety (hereinafter referred to as the inspection authority) is agencies and units with the necessary conditions and technical capabilities designated by the Ministry of Health to conduct inspections and testing of food products.

Article 4. Basis for comparing inspection results

1. Declaration documents for conformity assessment or compliance with food safety regulations.

2. National technical regulations and international standards on food quality, safety, and labeling.

Article 5. Inspection Methods

1. The general inspection method involves reviewing documentation and taking representative samples for sensory examination, labeling verification, packaging condition, and special storage conditions (if applicable).

During the inspection process, if there are suspicious signs regarding sensory criteria, packaging condition, or special storage conditions (if applicable), the inspection authority will base their decision on the nature of the product's composition, its historical quality record, the shipper's import history, the region or territory of origin, and the quality management system currently applied to select the group and number of indicators to be tested.

2. The strict inspection method applies in the following cases:

a) Reviewing documentation and taking full samples for testing all groups of indicators listed in the declaration documents for products that did not meet requirements in previous inspections;

b) Conducting general inspections and testing indicators flagged by recognized or accredited laboratories by the competent authorities of the exporting country for products flagged by the Ministry of Health or foreign competent authorities or manufacturers.

3. Reduced inspection method involves only reviewing documentation.

The reduced inspection method can be applied for a maximum period of 12 months from the date it was first implemented.

Article 6. Application of inspection methods

1. General inspection shall be applied to 100% of items in a consignment of imported goods, except for cases stipulated in Clauses 2 and 3 of this Article.

2. Reduced inspection shall be applied to items falling under any of the cases prescribed in Points a, b, and c of this Clause as follows:

a) Have been confirmed to meet food safety requirements by the competent authority of the country that has signed an international agreement on mutual recognition in quality and food safety inspection activities, of which Vietnam is a member; the inspection results of the competent authority of the exporting country for the item comply with the mandatory regulations of Vietnam;

b) Meet import requirements after three consecutive inspections at different days within twelve months according to the general inspection method, while also meeting the requirements during inspections and checks (if any);

c) After applying the reduced inspection method for twelve months, have satisfactory results from periodic inspections as prescribed in Clause 1, Article 13 of Circular No. 19/2012/TT-BYT dated November 9, 2012, issued by the Minister of Health guiding the announcement of conformity and compliance with food safety regulations;

d) The application of the reduced inspection method can only be carried out when the Food Safety Administration of the Ministry of Health issues a notification based on reviewing the requirements set forth in Points a, b, and c of Clause 2 of this Article.

To obtain such a notification, the consignee must submit an application for the application of the reduced inspection method for imported food products in accordance with Appendix 1A attached to this Circular. Within five working days from the date of receipt of the consignee's application, the Food Safety Administration of the Ministry of Health will issue a notification allowing or not allowing the application of the reduced inspection method in accordance with Appendix 1B attached to this Circular.

3. Strict inspection shall be applied to imported items falling under any of the following cases:

a) Items that did not meet import requirements in the previous inspection;

b) There is a warning from the Ministry of Health or from a foreign competent authority or from the manufacturer.

4. In case of switching from strict inspection to general inspection:

a) When two consecutive inspections are conducted according to the strict inspection method and the results meet import requirements, the item shall be subject to the general inspection method prescribed in Clause 1 of this Article in the subsequent importation for items that did not meet import requirements in the previous inspection;

b) When there is a notification from the Food Safety Administration of the Ministry of Health to stop strict inspection for cases where there is a warning from the Ministry of Health or from a foreign competent authority or from the manufacturer.

Article 7. Inspection registration Administrative Procedure: Recognition of forest tree planting seed sources application

1. The food import inspection registration form as prescribed in Appendix 02 attached to this Circular.

2. A certified copy or a copy with the stamp of confirmation of the trader, accompanied by the original for comparison, or an online copy with the stamp of the trader for the declaration of conformity or compliance with food safety regulations.

3. Notification from the Food Safety Administration of the Ministry of Health permitting the application of the reduced inspection method (if applicable).

4. Authorization documents of the trader responsible for the quality of goods for organizations or individuals engaged in importing food products (if applicable).

5. A copy of the list of goods attached (Packing List,).

6. A certified copy and confirmed by the consignee: Bill of Lading (Bill of Lading); Invoice (Invoice,).

Article 8. Proceduresitself including computer-based multiple choice tests

1. Prior to or at the time goods arrive at the border gate, the consignee shall submit the application for inspection to the Inspection Authority or the National Single Window Portal upon the decision of the Ministry of Health to apply such procedure.

2. Within 01 (one) working day from the date of receipt of the application for inspection, the inspection authority shall examine the application for inspection:

a) In case the application is complete as prescribed in Article 7 of this Circular, the inspection shall be carried out according to the provisions of Clause 3 or Clause 4 of this Article;

b) In case the application is incomplete as prescribed in Article 7 of this Circular, the inspection authority must issue a document returning the application for inspection, specifying in detail to the consignee about the missing documents or those not meeting the requirements.

3. The inspection of consignment or product subject to reduced inspection shall be conducted as follows: Within a maximum period of 02 (two) working days from the date of receipt of a complete application for inspection, the inspection authority shall be responsible for issuing a Notification of the result confirming whether the food meets or does not meet the import requirements according to the form prescribed in Appendix No. 03 issued together with this Circular.

4. The inspection of consignment or product subject to normal inspection and strict inspection shall be conducted as follows:

a) Within a maximum period of 02 (two) working days from the date of receipt of a complete application for inspection, the inspection authority shall be responsible for taking samples for inspection in cases where the consignment has arrived at the border gate at the time the consignee submits the application for inspection.

In cases where the consignment has not yet arrived at the border gate at the time the consignee submits the application for inspection, the latest sampling time shall be within 02 (two) working days from the date of receipt of the written notification from the consignee regarding the arrival of the consignment at the border gate;

b) Within 06 (six) working days for products subject to normal inspection and 08 (eight) working days for products subject to strict inspection, the inspection authority shall be responsible for:

- Organizing the inspection based on the Declaration of Conformity or declaration of compliance with food safety regulations and national technical standards and international standards on food quality and safety, labeling of goods;

- Issuing a Notification of the result confirming whether the food meets or does not meet the import requirements according to the form prescribed in Appendix No. 03 issued together with this Circular.

5. In case the product does not meet the import requirements, the inspection authority must clearly specify the measures to handle the situation in the Notification of the result confirming that the food does not meet the import requirements according to the forms prescribed in Clause 3, Article 55 of the Food Safety Law, then notify the consignee and immediately transfer the entire file to the Department of Food Safety - Ministry of Health.

6. Within a maximum period of 05 (five) working days from the date of receipt of the Notification of the result confirming that the food does not meet the import requirements, the consignee may request the inspection authority to review the inspection results and handling measures for the consignment or conduct another inspection.

7. Within a maximum period of 05 (five) working days from the date of receipt of the consignee's proposal on the handling measures for the consignment or product and the entire file of the inspection authority, the Department of Food Safety - Ministry of Health will issue a decision document determining the handling measures for products that do not meet the import requirements.

Article 9. Report on the Results of Handling Imported Food Products Not Meeting Safety Standards

1. After completing the handling process for non-compliant items, the consignee shall be responsible for submitting to the inspection agency one of the following documents:

a) Re-export documentation in cases where re-export is applied;

b) A contract with the entity responsible for destruction accompanied by a confirmation record from the environmental management agency or health department inspectorate where the destruction takes place;

c) An agreement changing the purpose of use between the consignee and the buyer or transferee, accompanied by a sales invoice or transfer document. The buyer or transferee of non-compliant imported food products may not use such products as food, except as provided for in Clause 2 of this Article;

d) A report document detailing measures and addresses for correcting product defects and labeling errors.

2. After implementing corrective actions for product defects and labeling errors, if wishing to import into Vietnam again, the consignee shall be responsible for registering for inspection according to the provisions of Article 8 of this Circular.

If the item still does not meet import requirements, it shall not be allowed to undergo corrective actions for product defects and labeling errors again, and must instead apply one of the handling methods prescribed in Points b, c, and d of Clause 3 of Article 55 of the Food Safety Law.

Chapter III

FILE AND PROCEDURES FOR ISSUING AND REVOKING FREE CIRCULATION CERTIFICATE, EXPORT CERTIFICATE

FOR EXPORTED FOOD PRODUCTS

Article 10. Exported food products are issued a Free Circulation Certificate (CFS) or Export Certificate (CE)

1. The Free Circulation Certificate (Certificate of Free Sale - CFS) is issued for food products specified in Appendix 01 of Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT.

2. The Export Certificate (Certificate of Exportation - CE) is issued for food products that have a Notification of Acceptance of Compliance Declaration or Confirmation of Compliance Declaration with Food Safety Regulations upon request of the importing country.

Article 11Documents for application for CFS, CE

Application Documents for Issuing CFS, CE

The application documents for issuing CFS, CE for one food product include:

1. An application form for CFS, CE according to the model prescribed in Appendix 04 attached to this Circular.

2. Notification of Acceptance of Compliance Declaration or Confirmation of Compliance Declaration with Food Safety Regulations (Certified copy).

Article 12. Competent Authority, Procedure, and Process for Issuing CFS, CE

1. Organizations and individuals producing and trading in food products submit the application documents to the National Food Safety Agency - Ministry of Health (submit directly or via postal service).

2. Upon receiving the application documents for CFS, CE, the document reception unit shall check the documents, enter them into the Reception Register, and issue a Document Reception Receipt to the organization or individual according to the model prescribed in Appendix 05 attached to this Circular.

3. Within five working days from the date recorded on the Document Reception Receipt, the competent authority prescribed in Clause 1 of this Article must issue CFS, CE according to the models prescribed in Appendices 06 and 07 attached to this Circular or according to the model requested by the importing country. In case of refusal, a written response stating the reasons for refusal must be provided.

Article 13. Cases for Revoking CFS, CE

1. Organizations or individuals requesting issuance of CFS, CE with forged documents.

2. CFS, CE issued for food products that do not meet applicable technical standards or regulations.

3. The notification of acceptance of conformity declaration or confirmation of compliance with food safety regulations for such food products has been revoked.

4. CFS, CE issued beyond the issuing authority's jurisdiction.

Article 14. Authority and Procedure for Revoking CFS, CEE

1. The competent state agency issuing CFS, CE shall issue a revocation document and send it to the organization or individual who received the CFS, CE.

2. Within five working days from the date of receipt of the revocation document from the competent state agency, the organization or individual receiving the CFS, CE must return the issued CFS, CE to the competent state agency issuing the CFS, CE.

3. In cases where the CFS, CE cannot be recovered, the competent state agency issuing the CFS, CE shall publish information on its website and notify the customs authority about the loss of validity of the CFS, CE mentioned in Clause 1 of this Article.

Chapter IV

HEALTH CERTIFICATE APPLICATION AND REVOCATION PROCEDURES

FOR EXPORTED FOOD PRODUCTS

Article 15. Issuance of Health Certificate insurance

A Health Certificate (HC) is issued for food, food additives, food processing aids; food packaging materials and containers when requested by organizations or individuals.

Article 16. Application Documents for HC

The application documents for HC for one export consignment include:

1. An application form for HC according to the model prescribed in Appendix 08 attached hereto.

2. Testing results for each item in the export consignment, including quality indicators required by corresponding Technical Regulations (for products with Technical Regulations) or main quality indicators and safety indicators as prescribed (for products without Technical Regulations), information on product name, batch number, production date, expiration date by the designated laboratory or independent laboratory recognized or accredited laboratory. (Original or certified copy).

3. Product label sample (Certified copy by the organization or individual).

4. Business registration certificate, Food Safety Condition Certificate (except in cases provided for in Clause 1 of Article 12 of Decree No. 38/2012/ND-CP dated April 25, 2012 of the Government detailing certain provisions of the Law on Food Safety) or Notification of Acceptance of Conformity Declaration or Confirmation of Compliance with Food Safety Regulations (Certified copy by the organization or individual).

Article 17. Authority, Procedure, and Process for Issuing HC

1. Organizations or individuals producing and trading in food products requesting HC shall submit the application to the National Food Safety Agency - Ministry of Health (submit directly or via postal service).

2. Upon receipt of the HC application, the reception department shall check the application, record it in the Register and issue an Application Receipt Form to the organization or individual according to the model prescribed in Appendix 05 attached hereto.

3. Within five working days from the date recorded on the Application Receipt Form, the competent state agency specified in Clause 1 of this Article must review and issue the HC according to the model prescribed in Appendices 09 and 10 attached hereto. If not issued, a written response stating the reasons for non-issuance must be provided.

Article 18. Cases for revoking HC

1. Organizations or individuals requesting issuance of HC with forged documents.

2. HC issued for export consignment where food products in that consignment do not meet published technical standards or regulations (if applicable).

3. Receipt of declaration of conformity or confirmation of compliance with food safety regulations for such food products being revoked (if applicable).

4. HC issued beyond authority.

Article 19. Authority and procedure for revoking HC

1. The competent state agency issuing HC shall issue a document to revoke HC and send it to the organization or individual who has been granted HC.

2. Within five working days from the date of receipt of the revocation document, the organization or individual granted HC must return the issued HC to the competent state agency issuing HC.

3. In cases where HC cannot be revoked, the competent state agency issuing HC shall publish information on its electronic website and notify the customs authority about the HC mentioned in Clause 1 of this Article no longer having effect.

Chapter V

RIGHTS AND RESPONSIBILITIES OF ORGANIZATIONS, GROUPS, AND INDIVIDUALS

Article 20. Rights and obligations of the consignee

The consignee has the following rights and obligations:

1. Request application of reduced inspection methods for imported goods under one of the cases specified at points a, b, and c of Clause 2 of Article 6 of this Circular.

2. Request the inspection agency to review the inspection results or request the Food Safety Department of the Ministry of Health to designate a testing facility to re-inspect within five working days from the date of receiving the notification of non-compliance with import requirements.

a) Require the initial inspection agency to refund the inspection costs if the re-inspection results do not match the initial inspection results;

b) Bear the cost of re-inspection if the re-inspection results match the initial inspection results.

3. Propose in writing one of the measures for handling the non-compliant consignment or product as proposed by the inspection agency in the notification specified in Appendix No. 3 issued pursuant to this Circular.

4. Ensure the original condition of the customs seal at the storage location of the consignment so that the inspection agency can take samples at the correct location registered by the consignee after the consignment has completed customs declaration procedures.

5. Implement the decision on handling by the competent state management agency if the consignment or product does not meet requirements.

Article 21. Rights and responsibilities of the inspection agency

1. Enter and exit places of storage, preservation, and transportation means of food for inspection and sampling. Sampling must comply with the provisions of Circular No. 14/2011/TT-BYT dated April 1, 2011, of the Minister of Health guiding general sampling of food for inspection and quality control, food safety supervision.

2. Conduct inspection of food products according to the method and procedure prescribed in this Circular.

3. Charge fees and inspection fees in accordance with the provisions of the law.

4. Store samples for the period stipulated in the standard test method or similar document for that food item for retesting when requested. After the expiration of this period, the inspection agency shall notify the consignee to collect the sample or prepare a record of disposal for food products that have exceeded the storage period.

5. Ensure professional competence, accuracy, honesty, and objectivity in inspecting and confirming food safety for imported consignments.

6. Be subject to direction, inspection, and guidance on organization and business operations by the Food Safety Department of the Ministry of Health regarding food inspection activities within the scope of management of the Ministry of Health.

7. Receive and resolve complaints from the consignee regarding inspections conducted by itself. Be responsible for any errors during the inspection process. If causing damage to the consignee, the inspection agency must fully refund the testing fee and inspection fee, and compensate for losses to the consignee in accordance with the law.

8. Store inspection records in accordance with the law and present stored records when required by the competent authority.

9. Report monthly, within ten days at the end of each month, to the Food Safety Department of the Ministry of Health in the format specified in Appendix No. 11 issued together with this Circular.

10. If the inspection agency fails to submit regular monthly reports for three consecutive months, the Ministry of Health will suspend its inspection duties and powers within the scope of management of the Ministry of Health for three months.

Article 22. Powers and responsibilities of the Food Safety Agency - Ministry Re standards

1. Announce on the Food Safety Agency's electronic portal and send information to customs authorities and inspection agencies when there is a warning or end of a warning from the Ministry of Health or from competent authorities abroad or from manufacturers in cases where food is suspected of not ensuring safety.

2. Issue notification of permission or non-permission for traders responsible for the quality of goods in declaration files applying reduced inspection methods strictly according to the prescribed time.

3. Decide and guide measures to handle imported consignments that do not meet food safety requirements.

4. Resolve complaints from cargo owners, inspection agencies, and propose competent authorities to handle violations of the law.

5. Annually, the Food Safety Agency has the responsibility to compile and report to the Minister of Health issues related to state inspection of imported food, and at the same time propose appropriate management measures for each period.

Chapter VI

IMPLEMENTING PROVISIONS

Article 23.ệnto effecitselffor implementation

1. This Circular takes effect from February 23, 2016.

2. In case the legal normative documents cited in this Circular are amended, supplemented, or replaced, they shall be applied according to the new legal normative documents.

3. Decision No. 23/2007/QĐ-BYT dated March 29, 2007 of the Minister of Health on the issuance of "Regulations on State Inspection of Quality and Sanitation Safety for Imported Food" ceases to be effective from the date this Circular takes effect.

4. During implementation, if there are difficulties, please reflect them to the Ministry of Health (Food Safety Agency) for consideration and resolution./.