Circular No. 17/2016/TT-BYT on the recovery and handling of food that does not ensure safety under the management authority of the Ministry of Health

CIRCULAR

PROVISIONS ON THE RECALL AND HANDLING OF FOOD THAT DOES NOT MEET SAFETY REQUIREMENTS UNDER THE MANAGEMENT AUTHORITY OF THE MINISTRY OF HEALTH

BASED ON THE FOOD SAFETY LAW NO. 55/2010/QH12 dated June 17, 2010;

Decree No. DECREE NO. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing the implementation of certain Articles of the Food Safety Law;

BASED ON DECREE NO. 178/2013/NĐ-CP dated November 14, 2013 of the Government on administrative penalties for food safety;

BASED ON DECREE NO. 63/2012/NĐ-CP dated August 31,2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

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

The Minister of Health issues this Circular to regulate the recall and handling of food that does not meet safety requirements under the management authority of the Ministry of Health.Article 1. This Circular stipulates the procedures and responsibilities for recalling and post-recall handling of food, food additives, food processing aids, food packaging and storage equipment (hereinafter referred to as products) that do not meet safety requirements under the management authority of the Ministry of Health.Article 2. In cases where there is a risk of serious impact on public health or other emergencies, the recall and handling of food shall be directly organized and implemented by competent state agencies according to the provisions of Section d, Clause 5, Article 55 of the Food Safety Law.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 2. Forms and Competent Authority for Recall

a) Voluntary recall is a recall carried out by organizations or individuals engaged in food production and business (hereinafter referred to as product owners) in accordance with Clause 6, Article 3 of the Product Quality Law;

b) Mandatory recall is a recall based on a decision of a competent state agency as stipulated in Clause 2 of this Article.

4. Business entities must store records and documents in accordance with the Law on Archives, the Decree guiding the Law on Archives, and Circular No. 53/2017/TT-BYT dated December 29, 2017, of the Minister of Health regarding the retention period for professional and technical records in the healthcare sector.

Article 2. Competent State Agencies for Mandatory Recall:

a) Agencies issuing certificates of acceptance of conformity declarations or certificates of compliance with food safety regulations; agencies assigned to manage food safety areas as stipulated in the Food Safety Law and Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing the implementation of certain Articles of the Food Safety Law (hereinafter referred to as competent state agencies for food safety);

b) Competent state agencies for mandatory recall as stipulated in Decree No. 178/2013/NĐ-CP dated November 14, 2013 of the Government on administrative penalties for food safety and other functional agencies issuing recall decisions in accordance with the law.

PROCEDURES FOR RECALL

Article 3. Voluntary Recall

Chapter II

1. Within a maximum period of 24 hours from the time the product is determined to require recall, the product owner must notify responsible persons throughout the production and distribution system (production facilities, distribution channels, agents, stores) to stop production and sales and initiate the recall of the product.

2. After completing the recall process, the product owner must submit a report on the recall of non-compliant products to the competent state agency for food safety as prescribed in Appendix 01 attached to this Circular.

Article 4. Mandatory Recall

1. Immediately upon determining that a product requires recall, the competent state agency for recall as stipulated in Clause 2 of Article 2 of this Circular must issue a Recall Decision in accordance with the model prescribed in Appendix 02 attached to this Circular.

The Recall Decision must be sent to the product owner and the competent state agency as stipulated in Clause 2 of Article 2 of this Circular.specialized agency under the People's Committee of the province/city.

2. Responsibilities of the Product Owner:

a) Upon receiving the Recall Decision, the product owner must notify responsible persons within the production and distribution system (production facilities, distribution channels, agents, stores) to stop production and sales and seal the product;

b) Within a maximum period of three working days from the time of receipt of the Recall Decision, the product owner must submit a Recall Plan for non-compliant products in accordance with the model prescribed in Appendix 03 attached to this Circular to the agency issuing the Recall Decision and the competent state agency for food safety. The content of the Recall Plan must be consistent with the Recall Decision issued by the agency issuing the Recall Decision.

3. The agency issuing the Recall Decision has the responsibility to lead and coordinate with other competent state agencies for food safety and related agencies to supervise the recall process.

Chapter III

3. The agency issuing the Decision to recall the product shall be responsible for taking the lead and coordinating with competent authorities on food safety and relevant agencies to supervise the recall process.

ChươChapter III

POST-RECALL HANDLING

Article 5. Methods for handling products after recallHandling of products after recall

Products that do not ensure safety and are recalled shall be handled in one of the following methods:

1. Rectifying product defects or label errors: applicable in cases where the product violates quality standards or label information compared to the declaration but does not affect consumer health;

2. Changing the purpose of use: applicable in cases where the product violates quality standards with a risk of affecting consumer health but can be used for other purposes;

3. Re-exporting: applicable in cases where imported products have quality issues inconsistent with the declaration, affecting consumer health, and the product owner requests re-exportation;

4. Destruction: applicable in cases where products are inconsistent with the declaration and affect consumer health, cannot rectify defects or change the purpose of use or re-export according to Clause 1, Clause 2, or Clause 3 of this Article.

Article 6. Procedures for approving methods of handling products after recallPost-recall Product Handling Procedures

1. After completing the product recall, within three working days, the product owner must report on the recall of unsafe products and propose a method for handling products after recall according to the form prescribed in Appendix 01 issued together with this Circular to the authority issuing the recall decision and the competent state agency for food safety. In cases where the authority issuing the recall decision and the competent state agency for food safety have different opinions on the method of handling products after recall, the opinion of the competent state agency assigned to manage the product shall prevail.

2. Upon receiving the report on the recall of unsafe products and the proposal for a method of handling products after recall, the competent state agency for food safety shall send the product owner a receipt form according to the form prescribed in Appendix 04 issued together with this Circular.

3. Within three working days from the date recorded on the receipt form, if the competent state agency for food safety does not issue a document requesting modifications or supplements to the method of handling products after recall, the product owner may implement the handling plan submitted to the competent state agency for food safety.

4. If the competent state agency for food safety disagrees with the method of handling products after recall proposed by the product owner, it must issue a document requesting modifications or supplements within three working days from the date recorded on the receipt form. The document requesting modifications or supplements must clearly specify the contents to be modified or supplemented.

5. Within five working days from the date of receiving the document requesting modifications or supplements from the competent state agency for food safety, the product owner is responsible for completing the method of handling products after recall and resubmitting it to the competent state agency for food safety.

The procedures for accepting and handling the modified or supplemented method of handling products after recall shall be carried out according to the provisions of Clause 2, Clause 3, and Clause 4 of this Article.

Article 7. Handling Products After Recall

After processing the products that must be recalled according to the approved method, the product owner shall be responsible for:

1. In cases of quality defects:

a) After rectifying the quality defect, the product owner submits a request for continued circulation of the product along with the testing results (the criteria according to the declaration dossier) from the laboratory as stipulated in Point b Clause 2 Article 5 or Article 6 Circular No. 19/2012/TT-BYT dated November 9, 2012 of the Minister of Health guiding the declaration of conformity and compliance with food safety regulations to the competent state agency for food safety, the test results must be consistent with the previous declaration dossier;

b) Upon receiving the request for continued circulation of the product along with the testing results, the competent state agency for food safety sends the product owner the Receipt Form according to the model prescribed in Appendix 04 issued together with this Circular;

c) Within five working days from the date recorded on the Receipt Form, the competent state agency for food safety shall issue a document agreeing or disagreeing with the circulation of the product. In case of disagreement, the reasons must be clearly stated;

d) The product owner may only circulate the product from the date recorded on the document agreeing with the circulation of the product issued by the competent state agency for food safety.

2. In cases of label correction:

a) After rectifying the quality defect, the product owner submits a request for continued circulation of the product along with the new label to the competent state agency for food safety;

b) Upon receiving the request for continued circulation of the product along with the new label, the competent state agency for food safety sends the product owner the Receipt Form according to the model prescribed in Appendix 04 issued together with this Circular.

c) Within five working days from the date recorded on the Receipt Form, the competent state agency for food safety shall issue a document agreeing or disagreeing with the circulation of the product. In case of disagreement, the reasons must be clearly stated;

d) The product owner may only circulate the product from the date recorded on the document agreeing with the circulation of the product issued by the competent state agency for food safety.

3. In cases of change of purpose:

a) Within five working days from the completion of the purpose change for the product, the product owner must submit a notification letter and all the purpose change documentation for the product to the decision-making authority for recall and the competent state agency for food safety. The documentation must include a contract between the product owner and the organization or individual handling the purpose change of the recalled product. In case the decision-making authority for recall and the competent state agency for food safety have different opinions on the post-recall product handling method, the opinion of the competent state agency assigned to manage the product shall prevail.

b) Upon receiving the documents requesting a change of purpose as stipulated in Point a of this Clause, the decision-making authority for recall and the competent state agency for food safety send the product owner the Receipt Form according to the model prescribed in Appendix 04 issued together with this Circular.

4. In cases of re-export:

a) Within five working days from the completion of the re-export of the product, the product owner must submit a notification letter about the completion of the re-export of the product along with the re-export documentation to the decision-making authority for recall and the competent state agency for food safety. In case the decision-making authority for recall and the competent state agency for food safety have different opinions on the post-recall product handling method, the opinion of the competent state agency assigned to manage the product shall prevail.

b) Upon receiving the documents notifying the re-export of the product as stipulated in Point a of this Clause, the decision-making authority for recall and the competent state agency for food safety send the product owner the Receipt Form according to the model prescribed in Appendix 04 issued together with this Circular.

5. In cases of destruction:

a) Within five working days from the completion of the destruction of the product, the product owner must submit a notification letter about the completion of the destruction of the product along with the Destruction Record according to the model prescribed in Appendix 05 issued together with this Circular, confirmed by the environmental management agency and relevant agencies as prescribed by law to the decision-making authority for recall and the competent state agency for food safety. In case the decision-making authority for recall and the competent state agency for food safety have different opinions on the post-recall product handling method, the opinion of the competent state agency assigned to manage the product shall prevail.

b) Upon receiving the documents notifying the destruction of the product as stipulated in Point a of this Clause, the decision-making authority for recall and the competent state agency for food safety send the product owner the Receipt Form according to the model prescribed in Appendix 04 issued together with this Circular.

6. For products that do not meet safety standards and are recalled, if the competent state agency for food safety has notified the product owner to permanently cease trading such products, the product owner must return the Declaration of Conformity Acceptance Certificate or the Confirmation of Compliance with Food Safety Regulations Certificate of the product to the issuing agency within no more than five days from receipt of the notification.

Chapter IV

IMPLEMENTING PROVISIONS

Article 8. Effective Date

This Circular takes effect from August 15, 2016

Article 9. Reference Clause

In case the referenced documents in this Circular are replaced or amended, they shall be implemented according to the replacing or amended documents.

Article 10. Implementation Organization

The Director of the Food Safety Agency, the Heads of Health Departments of provinces and centrally governed cities, the Heads of health sectors, and related units shall be responsible for implementing the provisions of this Circular.

In case of difficulties or obstacles during implementation, it is recommended that agencies, organizations, and individuals report promptly to the Ministry of Health (Food Safety Agency) for guidance on resolution.