Thông tư 17/2016/TT-BYT

CIRCULAR

PRESCRIBING THE RECALL AND DISPOSAL OF UNSAFE FOODS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

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

Pursuant to the Government's Decree No. 38/2012/ND-CP of April 25, 2012, detailing a number of articles of the Law on Food Safety;

Pursuant to the Government’s Decree No. 178/2013/ND-CP of November 14, 2013, on sanctioning of administrative violations in the field of food safety;

Pursuant to the Government's Decree No. 63/2012/ND-CP of August 31, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the director of the Department for Food Safety;

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

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular prescribes the order of, and responsibility for, recall and post-recall disposal of unsafe foods, food additives, food processing aids, food-packaging tools and food packages and containers (below referred to as products) under the management of the Ministry of Health.

2. The recall and disposal of foods that may seriously affect community well-being or in other emergency cases, which are directly carried out by competent state agencies, comply with Section d, Clause 5, Article 55 of the Law on Food Safety.

Article 2. Forms of, and competence for, product recall

1. Forms of product recall:

a/ Voluntary recall means the recall of products willingly carried out by organizations and individuals engaged in food production and trading under Clause 6, Article 3 of the Law on Quality of Products and Goods (below referred to as product owners);

b/ Compulsory recall means the recall of products carried out under decisions of competent state agencies under Clause 2 of this Article.

2. State agencies competent to order compulsory recall are:

a/ Agencies issuing receipts of written announcements of regulation conformity or certificates of announcement of conformity with food safety regulations; and agencies assigned to manage food safety as defined in the Law on Food Safety and the Government’s Decree No. 38/2012/ND-CP of April 25, 2012, detailing a number of articles of the Law on Food Safety (below referred to as state agencies in charge of food safety);

b/ State agencies competent to recall products defined in the Government’s Decree No. 178/2013/ND-CP of November 14, 2013, on sanctioning of administrative violations in the field of food safety and functional agencies issuing decisions on product recall in accordance with law.

Chapter II

ORDER OF PRODUCT RECALL

Article 3. Voluntary recall

1. Within 24 hours after identifying a to-be-recalled product, a product owner shall notify responsible persons in his/her/its production and trading system (including the production establishments, distribution channels, agents and stores) of the suspension of production and trading and recall of the product.

2. After completing the recall of a product, a product owner shall send a report on recall of an unsafe product, made according to the form provided in Appendix 1 to this Circular, to the state agency in charge of food safety.

Article 4. Compulsory recall

1. Right after identifying a to-be-recalled product, the state agency competent to recall products defined in Clause 2, Article 2 of this Circular shall issue a decision on product recall, made according to the form provided in Appendix 2 to this Circular.

The decision on product recall shall be sent to the product owner and the state agency defined in Clause 2, Article 2 of this Circular.

2. Responsibilities of product owners:

a/ Right after receiving a decision on product recall, a product owner shall notify responsible persons in his/her/its production and trading system (including the production establishments, distribution channels, agents and stores) of the suspension of the production and trading and sealing of the product;

b/ Within 3 working days after receiving the decision, the product owner shall submit a plan on recall of an unsafe product, made according to the form provided in Appendix 3 to this Circular, to the agency that has issued the decision on product recall and the state agency in charge of food safety. The contents of the product recall plan must conform to the decision on recall of the unsafe product of the decision-issuing agency.

3. The decision-issuing agency shall take the prime responsibility for, and coordinate with state agencies in charge of food safety and related agencies in, supervising the product recall.

Chapter III

POST-RECALL DISPOSAL OF PRODUCTS

Article 5. Methods of disposing of recalled products

Recalled unsafe products shall be handled by one of the following methods:

1. Correction of product defects or labeling errors: This method is applied to products of inferior quality or have labeling errors compared to their announced dossiers, without causing harms to consumer well-being.

2. Change of use purposes: This method is applied to products of inferior quality that are likely to cause harm to consumer well-being but can be used for other purposes.

3. Re-export: This method is applied to imported products of quality lower than that stated in their announced dossiers which may cause harm to consumer well-being and are proposed by their owners to be re-exported.

4. Destruction: This method is applied to products of quality lower than that stated in their announced dossiers which may cause harm to consumer well-being for which the methods of correction, change of use purposes and re-export cannot be applied under Clauses 1, 2 and 3 of this Article.

Article 6. Procedures for approving methods of disposing of recalled products

1. Within 3 (three) working days after completing the product recall, a product owner shall send a report on recall of an unsafe product and propose a method of disposing of the recalled product, made according to the form provided in Appendix 1 to this Circular, to the agency that has issued the decision on product recall and the state agency in charge of food safety. In case opinions of the decision-issuing agency and the state agency in charge of food safety are diverse on the method of disposing of the recalled product, opinions of the state agency assigned to manage such product prevail.

2. Upon receiving a report on recall of an unsafe product and proposal on method of disposing of the recalled product, the state agency in charge of food safety shall send to the product owner a receipt, made according to the form provided in Appendix 4 to this Circular.

3. Within 3 working days from the date stated in the receipt, if the state agency in charge of food safety makes no written request for change or addition of the method of disposing the recalled product, the product owner may dispose of such product under the plan submitted to the state agency in charge of food safety.

4. In case the state agency in charge of food safety disagrees with the method of disposing of the recalled product proposed by the product owner, it shall send a written request to the product owner for disposal method change or addition within 3 working days from the date stated in the receipt. Such a written request must clearly state contents requested to be changed or added.

5. Within 5 working days after receiving a written request for change or addition of the disposal method of the state agency in charge of food safety, the product owner shall finalize the method of disposing of the recalled product and re-submit it to the state agency in charge of food safety.

The finalization of the method of disposing of the recalled product requested to be changed or added must comply with Clauses 2, 3 and 4 of this Article.

Article 7. Disposal of recalled products

After disposing of an recalled product by the approved method, a product owner shall:

1. For a product of inferior quality:

a/ After improving the product quality, a product owner shall submit a written, request for continued circulation of his/her/its product, enclosed with a testing result (against the criteria stated in the announced dossier) provided by the testing laboratory specified at Point b, Clause 2, Article 5, or Article 6 of the Ministry of Health’s Circular No. 19/2012/TT-BYT of November 9, 2012, guiding the regulation conformity announcement and food safety regulation conformity announcement, to the state agency in charge of food safety. The testing result must be consistent with the announced dossier;

b/ After receiving a written request for continued circulation of the product enclosed with the testing result, the state agency in charge of food safety shall send to the product owner a receipt, made according to the form provided in Appendix 4 to this Circular;

c/ Within 5 working days from the date stated in the receipt, the state agency in charge of food safety shall issue a written approval or disapproval of continued product circulation. In case of disapproval, it shall clearly state the reason;

d/ The product owner may only circulate his/her/its product from the date stated in a written approval of product circulation of the state agency in charge of food safety.

2. For case of correction of labeling errors:

a/ After correcting a labeling error, a product owner shall submit a written request for continued product circulation together with a new label to the state agency in charge of food safety;

b/ Upon receiving a written request for continued product circulation together with a new label, the state agency in charge of food safety shall send to the product owner a receipt, made according to the form provided in Appendix 4 to this Circular;

c/ Within 5 working days from the date stated in the receipt, the state agency in charge of food safety shall issue a written approval or disapproval of continued product circulation. In case of disapproval, it shall clearly state the reason.

d/ The product owner may only circulate its/her/his product from the date stated in a written approval of continued product circulation of the state agency in charge of food safety.

3. For case of change of use purposes:

a/ Within 5 working days after completing the change of the use purpose of his/her/its product, a product owner shall send a written notice and the whole dossier for change of use purpose of his/her/its product to the agency that has issued the decision on product recall and state agency in charge of food safety. The dossier must include a contract between the product owner and an organization or individual in charge of changing the use purpose of the recalled product. In case opinions of the recall decision-issuing agency and the state agency in charge of food safety are diverse on the method of disposing of the recalled product, opinions of the state agency assigned to manage such product prevail.

b/ After receiving a written request for change of the product use purpose prescribed at Point a of this Clause, the recall decision-issuing agency and the state agency in charge of food safety shall send to the product owner a receipt, made according to the form provided in Appendix 4 to this Circular.

4. For case of re-export:

a/ Within 5 working days after completing the re-export of his/her/its product, a product owner shall send a written notice of completion of product re-export enclosed with the product re-export dossier to the agency that has issued the product recall decision and the state agency in charge of food safety. In case opinions of the decision-issuing agency and the state agency in charge of food safety are diverse on the method of disposing the recalled product, opinions of the state agency assigned to manage the product prevail;

b/ After receiving a written notice of product re-export prescribed at Point a of this Clause, the decision-issuing agency and the state agency in charge of food safety shall send to the product owner a receipt, made according to the form provided in Appendix 4 to this Circular.

5. For case of destruction:

a/ Within 5 working days after completing the product destruction, a product owner shall send a written notice of completion of product destruction enclosed with the product destruction record, made according to the form provided in Appendix 5 to this Circular, which is certified by the environmental management agency and related agencies in accordance with law, to the recall decision-issuing agency and the state agency in charge of food safety. In case they have diverse opinions on the method of disposing of the recalled product, opinions of the state agency assigned to manage the product prevail;

b/ After receiving a written notice of product destruction prescribed at Point a of this Clause, the decision-issuing agency and the state agency in charge of food safety shall send to the product owner a receipt, made according to the form provided in Appendix 4 to this Circular.

6. Within 5 days after receiving a written notice from the state agency in charge of food safety on termination of trading of the unsafe product, a product owner shall return the receipt of the written announcement of regulation conformity or certificate of announcement of conformity with food safety regulations of such product to the issuing agency.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 8. Effect

This Circular takes effect on August 15, 2016.

Article 9. Reference

In case legal documents mentioned in this Circular are replaced, amended or supplemented, the amending and supplementing legal documents shall prevail.

Article 10. Organization of implementation

The director of the Department for Food Safety, directors of provincial-level Health Departments, heads of health sections and related units shall implement this Circular.

Any problem arising in the course of implementation should be promptly reported by organizations and individuals to the Ministry of Health (the Department for Food Safety) for guiding the settlement.-