Thông tư 23/2018/TT-BYT quy định về thu hồi và xử lý thực phẩm không bảo đảm an toàn thuộc thẩm quyền quản lý của Bộ Y tế

CIRCULAR

ON RECALL AND DISPOSAL OF DISQUALIFIED FOODS UNDER THE MANAGEMENT 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/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of Ministry of Health;

At the request of the Director of Vietnam Food Administration;

The Minister of Health promulgates a Circular on recall and disposal of disqualified foods under management of the Ministry of Health.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides regulations on types, procedures and responsibility for recall and disposal of foods, food additives, food processing aids, food containers and primary packages (hereinafter referred to as “products”) which fail to satisfy corresponding food safety requirements under the management of the Ministry of Health.

Article 2. Regulated entities

This Circular applies to Vietnamese and foreign organizations and individuals that produce or sell the products defined in Article 1 hereof, food safety authority, and other organizations and individuals whose operation involves food safety in Vietnam.

Chapter II

TYPES AND PROCEDURES FOR RECALL OF DISQUALIFIED PRODUCTS

Article 3. Types of recall

1. Voluntary recall is a recall of products voluntarily conducted by organizations or individuals that register the declarations of products or carry out the self-declaration of products (hereinafter referred to as “product owners”) after the discovery or receipt of feedback about safety issues concerning their products other than the case prescribed in Clause 2 of this Article.

2. Mandatory recall is a recall of disqualified products carried out by product owners following the issuance of a mandatory recall decision by:

a) The competent authority that receives their self-declaration documents or issues the certificate of registered product declaration as regulated in the Government's Decree No. 15/2018/ND-CP dated February 02, 2018 (hereinafter referred to as “food safety authority”); or

b) The authority competent to impose penalties for administrative violations against regulations on food safety as regulated by laws.

Article 4. Procedures for voluntary recall

1. Within 24 hours after the discovery or receipt of feedback about safety issues of products and it is concluded that the products have to be recalled, the product owner shall:

a) Notify the recall by telephone, email or in other appropriate forms, and then give written notification to all members of the production and distribution system (including factories, distributors, agencies and stores) in order to request them to suspend the production and distribution of products as well as carry out the recall of products;

b) Give written notification to provincial mass media agencies and other relevant authorities and organizations as regulated by the soft law on protection of consumer rights; If the recall involves two provinces or more, central mass media agencies must be notified in writing in order to publish such recall to consumers;

c) Give written notification of the recall to food safety authorities;

d) When giving written notification of the recall, the product owner must specify name and address of the product owner and of the manufacturer, product’s name, packaging specifications, batch number, date of manufacture, expiration date, quantity, reasons for recall, list of locations receiving recalled products, and recall duration.

2. Within 03 days from the completion of the recall, the product owner must submit a report on the recall of products, which also includes measures for disposal of recalled products, to food safety authorities according to the Form No. 01 enclosed herewith.

Article 5. Procedures for mandatory recall

1. Within 24 hours after it is concluded that the products are subject to the mandatory recall, the authority that has the power to issue a recall decision as regulated in Clause 2 Article 3 hereof shall issue a recall decision made according to the form provided in the Appendix 02 enclosed herewith.

2. Upon the receipt of the recall decision, the product owner must carry out the procedures specified in Clause 1 Article 4 hereof.

3. Within 03 days from the completion of the recall, the product owner must submit a report on the recall of products, which also includes measures for disposal of recalled products, to the authority issuing the recall decision according to the Form No. 01 enclosed herewith.

4. After issuing a recall decision, authorities competent to impose penalties for administrative violations against regulations on food safety must supervise the recall of products and notify food safety authorities and relevant authorities for cooperation.

Article 6. Procedures for recall in serious cases or an emergency

1. In case a product owner fails to carry out the recall or conducts the recall inconsistently with the mandatory recall decision issued by a competent authority or in another case of emergency as regulated in Point d Clause 5 Article 55 of the Law on food safety, the competent authority shall issue a decision to enforce and organize the recall. A decision on enforced recall of products must specify the name of the authority or organization responsible for that enforcement, name of the authority or organization supervising or witnessing the enforced recall of products, time limit for completion of the enforced recall and measures for disposal of recalled products.

2. Upon the completion of the recall and disposal of recalled products, the authority carrying out the recall and disposal of recalled products shall give a written notification requesting the product owner to pay expenses arising during the recall.

3. The product owner shall pay the costs of recall and disposal of recalled products (if any) within 15 days from the receipt of a written notification from the authority in charge of organizing the recall.

Chapter III

DISPOSAL OF RECALLED PRODUCTS

Article 7. Measures for disposing of recalled products

1. Products recalled shall be disposed of as follows:

a) Correction of label error: the product label is yet to be compliant with regulations on labeling or is unconformable with the label description included in the self-declaration documents or the application for registration of the declaration of product;

b) Repurposing: the disqualified product may threaten consumer health, is not conformable with foods purposes but may be used to serve other purposes;

c) Re-exporting: the imported products have quality or safety indicators unconformable with the self-declaration documents of the application for registration of the declaration of products or threaten the consumer health;

d) Destruction: the products have quality or safety indicators unconformable with the self-declaration documents of the application for registration of the declaration of products, threaten the consumer health, and cannot be repurposed or re-exported as regulated in Point b or Point c Clause 1 of this Article and in other necessary cases as prescribed in Article 6 hereof.

2. If products are recalled in accordance with provisions in Article 4 hereof, the product owner shall himself/herself select an appropriate measure for disposing of recalled products in accordance with regulations in Clause 1 hereof.

3. If products are recalled in accordance with provisions in Article 5 hereof, within 03 working days from the receipt of the report on the recall of disqualified products, the competent authority issuing the recall decision must give a written approval for the measure for disposing of recalled products proposed by the product owner. If the competent authority disagrees with the measures for disposing of recalled products proposed by the product owner, it must give a written response indicating reasons thereof and an appropriate measure for disposing of recalled products to the product owner.

Article 8. Reporting on recall of products

1. The product owner must complete the disposal of products recalled according to a mandatory recall decision issued by a competent authority within 03 months from the receipt of the competent authority's written approval for its measure for disposing of recalled products.

2. Correction of label error:

a) Voluntary recall: Upon the completion of the correction of label error, the product owner must give a written notification, which specifies name, quantity and sample of product with correct label, to the food safety authority. After giving a written notification, the product owner may continue selling products;

b) Mandatory recall: Upon the completion of the correction of label error, the product owner must give a written notification, which specifies name, quantity and sample of product with correct label, to the authority issuing the recall decision. Within 03 working days from the receipt of the notification from the product owner, the authority issuing the recall decision shall give a written approval for the sale of products or written reasons for disapproval for the sale of products. Upon the receipt of the written approval for the sale of products after the correction of product label from the authority issuing the recall decision, the product owner must give written notification of such written approval to the food safety authority. Products may be sold only after the product owner obtains a written approval from the authority issuing the recall decision.

3. Repurposing:

Within 05 working days from the completion of the repurposing of products, the product owner must submit a report on the repurposing of products, which indicates name, quantity, time, new purposes, contract and invoice proving transactions between the product owner and the product buyer, to the food safety authority or the authority issuing the recall decision. The buyer may only use disqualified products for the purposes defined in the contract signed with the product owner after submitting a report to the food safety authority.

4. Re-exporting:

Within 05 working days from the completion of the re-exporting of products, the product owner must submit a written report on re-exporting results, which indicates the name, quantity, country of origin, re-exporting time, and is accompanied by re-exporting documents, to the food safety authority and the authority issuing the recall decision.

5. Destruction:

Within 05 working days from the completion of the destruction of recalled products, the product owner must submit a written report on destruction results, which indicates the name, quantity, time and location of destruction, and is accompanied with the written record of the destruction of products certified by the authority in charge of organizing that destruction, to the food safety authority or the authority issuing the recall decision.

Chapter IV

IMPLEMENTATION

Article 9. Transition clauses

The certificates of declaration of conformity or certificates of declaration of conformity with food safety regulations that are granted under regulations of the Government's Decree No. 38/2012/ND-CP dated April 25, 2012 are still valid until the expiration date of such certificates or the products.

Article 10. Effect

1. This Circular comes into force from November 01, 2018.

2. The following documents shall be abrogated from the date of entry into force of this Circular:

a) The Circular No. 17/2016/TT-BYT dated June 30, 2016 by the Minister of Health prescribing the recall and disposal of disqualified foods under the management of the Ministry of Health;

b) The Decision No. 4930/QD-BYT dated September 15, 2016 by the Minister of Health on amendments to the Circular No. 17/2016/TT-BYT dated June 30, 2016 by the Minister of Health.

Article 11. Terms of reference

If legislative documents referred to in this Circular are superseded, supplemented or amended, the new ones shall apply.

Article 12. Implementation

1. The Director of the Vietnam Food Administration (affiliated to the Ministry of Health) shall organize the implementation of this Circular nationwide.

2. Directors of Provincial Departments of Health, heads of ministerial health agencies, food safety authorities, relevant organizations and individuals shall implement this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (via Vietnam Food Administration) for consideration.