Circular No. 23/2018/TT-BYT provides for the recall and handling of food products that do not meet safety standards under the management authority of the Ministry of Health.

CIRCULAR
Regulations on the Recall and Handling of Unsafe Food within the Management Authority of the Ministry of Health
Issued by the Minister of Health to promulgate the Circular on the recall and handling of unsafe food within the management authority of the Ministry of Health.

Pursuant to the Law on Food Safety No. 55/2010/QH12 dated June 17, 2010;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 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 provide detailed regulations on the form, procedure, responsibility for recalling and post-recall handling of food, food additives, food processing aids, food packaging materials, and containers (hereinafter referred to as products) that do not meet food safety standards within the management authority of the Ministry of Health.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular applies to organizations and individuals in Vietnam, foreign organizations and individuals in Vietnam participating in the production and business of products specified in Article 1 of this Circular, competent authorities on food safety, and other organizations and individuals engaged in activities related to food safety in Vietnam.

Article 2. Applicability

FORMS AND PROCEDURES FOR RECALL

Chapter II
Article 3. Forms of Recall

1. Voluntary recall is the act of recalling products by the product owner (the organization or individual who registers the product announcement or self-announces the product hereinafter referred to as the product owner) when they voluntarily discover or receive information from organizations or individuals about products that do not ensure food safety produced or traded by them and which do not fall under the cases stipulated in Clause 2 of this Article.

2. Mandatory recall is the act of the product owner recalling products that do not ensure food safety according to the recall decision of the competent authority as follows:

a) The agency receiving the self-announcement dossier or issuing the Product Announcement Registration Acceptance Certificate as prescribed in Decree No. 15/2018/NĐ-CP dated February 2, 2018 detailing the implementation of certain provisions of the Law on Food Safety (hereinafter referred to as the competent authority on food safety);

b) The agency with the authority to impose administrative penalties for violations of food safety laws.

Article 4. Procedure for Voluntary Recall

1. Within a maximum period of 24 hours from the time of discovery or receipt of information about unsafe products, if it is determined that the product must be recalled, the product owner shall have the following responsibilities:

a) Notify by telephone, email, or other appropriate means, then notify in writing to the entire production and distribution system (production facilities, distribution channels, agents, stores) to stop production and trading and implement the product recall;

b) Notify in writing to provincial and municipal mass media agencies and other relevant agencies and organizations in accordance with the law on protecting consumer rights; In case the recall is carried out in two provinces or more, a written notification must be made to central mass media agencies to inform consumers about the products to be recalled;

d) When notifying in writing about the product recall, the product owner must clearly state: the name and address of the product owner and manufacturer, the product name, packaging specifications, batch number, production date and expiration date, quantity, reason for recalling the product, list of collection and reception locations for recalled products, and the recall period.

c) Notify in writing to the competent authority on food safety regarding the recall of the product;

2. Within a maximum period of three days from the end of the recall, the product owner shall have the responsibility to report the results of the product recall to the competent authority on food safety according to the model prescribed in Appendix 01 attached to this Circular and propose post-recall handling measures.

Within a maximum period of three days from the completion of the product recall, the product owner shall be responsible for reporting the results of the product recall to the competent authority on food safety in accordance with the form prescribed in Appendix 01 issued together with this Circular and proposing the form of post-recall handling.

Article 5. Compulsory Recall Procedure

1. Within a maximum period of 24 hours from the time when it is determined that the product falls under the compulsory recall circumstances, the competent authority specified in Clause 2, Article 3 of this Circular must issue a compulsory recall decision according to the model prescribed in Appendix 02 attached to this Circular.

2. Upon receiving the recall decision, the product owner must implement the provisions stipulated in Clause 1, Article 4 of this Circular.

3. Within three days from the completion of the recall, the product owner has the responsibility to report the results of the product recall to the authority that issued the recall decision according to the model prescribed in Appendix 01 attached to this Circular and propose the post-recall handling measures.

4. The competent authority responsible for imposing administrative penalties when issuing the product recall decision shall be responsible for supervising the recall process and notifying the food safety authorities and relevant agencies to coordinate.

Article 6. Recall Procedure in Serious and Urgent Cases

1. In cases where the product owner does not comply with or fully comply with the compulsory recall decision issued by the competent authority regarding non-compliant products or other urgent situations as stipulated in Point d, Clause 5, Article 55 of the Food Safety Law, the competent authority shall issue a forced recall decision and organize the product recall. The forced recall decision must clearly state the agency or organization responsible for enforcing the recall, the agency or organization responsible for monitoring or witnessing, the deadline for enforcement, and the post-recall handling measures for the product.

2. After completing the recall and handling of non-compliant products, the agency implementing the recall and post-recall product handling shall issue a notification requesting the product owner to fulfill the obligation to pay the costs incurred for the recall.

3. The product owner is responsible for paying the costs of implementing the recall and handling the product (if applicable) within the latest period of 15 days from the date of receipt of the notification from the agency that carried out the product recall.

Chapter III
POST-RECALL HANDLING

Article 7. Forms of Post-Recall Product Handling

1. Non-compliant products subject to recall shall be handled in one of the following ways:

a) Correcting Labeling Errors: applied in cases where the product violates labeling compared to the self-declaration dossier or the product declaration dossier;

b) Changing Usage Purpose: applied in cases where the product poses a risk to consumer health and cannot be used as food but can be used for other purposes;

c) Re-export: applied in cases where imported products have quality or safety limits that do not match the self-declaration dossier or the product declaration dossier or pose a risk to consumer health;

d) Destruction: applied in cases where the product's quality indicators or safety limits do not match the self-declaration dossier or the product declaration dossier, posing a risk to consumer health, and cannot be changed in usage purpose or re-exported as stipulated in Points b and c, Clause 1 of this Article and other necessary cases as stipulated in Article 6 of this Circular.

2. In cases of product recall as prescribed in Article 4 of this Circular, the product owner may choose to apply one of the post-recall product handling forms prescribed in Clause 1 of this Article.

3. In cases of product recall as prescribed in Article 5 of this Circular, within three working days from the date of receipt of the report on the results of the product recall, the authority issuing the recall decision must issue a document agreeing with the post-recall product handling form proposed by the product owner. If they disagree with the proposed form, the authority issuing the recall decision must issue a document stating the reasons for disagreement and propose a post-recall handling form for the product owner to apply.

Article 8. Report on the Results of Handling Post-Recall Products

1. The handling of post-recall products pursuant to a compulsory recall decision by the competent authority must be completed within a maximum period of three (3) months from the date when the competent authority issues a written agreement with the product owner's proposed handling method.

2. For the form of rectifying labeling errors:

a) In the case of voluntary recall: After completing the rectification of labeling errors, the product owner must submit a written notification specifying the name, quantity, and attaching a sample of the corrected label to the competent authority for food safety. After submitting the notification, the product owner may circulate the product.

b) In the case of compulsory recall: After completing the rectification of labeling errors, the product owner must submit a written notification specifying the name, quantity, and attaching a sample of the corrected label to the authority issuing the recall decision. Within three working days from receiving the report from the product owner, the authority issuing the recall decision must issue a written agreement regarding the circulation of the product; if it disagrees, it must specify the reasons. Upon receiving the notification agreeing to the circulation of the corrected product from the authority issuing the recall decision, the product owner must submit a written notification to the competent authority for food safety about the agreement on circulating the product from the authority issuing the recall decision. The product owner may only circulate the product upon receiving a written agreement from the authority issuing the recall decision.

3. For the form of changing the purpose of use:

Within five working days from the completion of the change in the purpose of use for the product, the product owner must submit a written report on the change in the purpose of use, specifying the name, quantity, time, field of change in the purpose of use, and attaching the purchase and sale contract and invoice between the product owner and the buyer to the competent authority for food safety or the authority issuing the recall decision. A buyer who does not ensure food safety may only use the product according to the purpose of use stated in the contract and reported to the competent authority for food safety.

4. For the form of re-exporting:

Within five working days from the completion of the re-exporting of the product, the product owner must submit a written report on the re-exporting of the product, specifying the name, quantity, country of origin, time of re-export, and attaching the re-export documentation to the competent authority for food safety and the authority issuing the recall decision.

5. For the form of destruction:

Within five working days from the completion of the destruction of the product, the product owner must submit a written report on the destruction of the product, specifying the name, quantity, time of completion of destruction, location of destruction, and attaching the destruction record confirmed by the authority implementing the destruction to the competent authority for food safety or the authority issuing the recall decision.

Chapter IV
IMPLEMENTING PROVISIONS

Article 9. Transitional Provisions

Products that have been issued a Certificate of Acceptance of Conformity Declaration or a Confirmation of Compliance with Food Safety Regulations under Decree No. 38/2012/ND-CP dated April 25, 2012 of the Government shall remain valid until the expiration date indicated on the Certificate of Acceptance of Conformity Declaration or Confirmation of Compliance with Food Safety Regulations or the expiration date of the product.

Article 10. Effective Date

1. This Circular takes effect from November 1, 2018.

2. The following documents are abolished from the date this Circular takes effect:

a) Circular No. 17/2016/TT-BYT dated June 30, 2016 of the Minister of Health on the Recall and Handling of Unsafe Foods under the Management Authority of the Ministry of Health;

b) Decision No. 4930/QD-BYT dated September 15, 2016 of the Minister of Health amending Circular No. 17/2016/TT-BYT dated June 30, 2016 of the Minister of Health on the Recall and Handling of Unsafe Foods under the Management Authority of the Ministry of Health.

Article 11. Cross-Reference Provisions

In cases where the documents cited in this Circular are replaced or amended, they shall be implemented according to the replacement document or the amended document.

Article 12. Implementation Organization

1. The Director of the Food Safety Administration (Ministry of Health) is responsible for organizing the implementation of this Circular nationwide.

2. The Directors of Provincial Health Departments, Heads of Health Services of sectors, Competent Authorities for Food Safety, and related organizations and individuals are responsible for enforcing the provisions of this Circular.

During the implementation process, if there are difficulties or obstacles, relevant authorities, organizations, and individuals must promptly report to the Ministry of Health (Food Safety Administration) for guidance and resolution./.