PHỤ LỤC II Thông tư số    /2021/TT-BNNPTNT: MẪU QUYẾT ĐỊNH THU HỒI THỰC PHẨM KHÔNG BẢO ĐẢM AN TOÀN

CIRCULAR

ON ORIGIN TRACING, RECALL, AND HANDLING OF UNSAFE FOOD UNDER THE MANAGEMENT OF THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

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

Pursuant to Decree No. 15/2017/ND-CP dated February 17, 2017 of the Government on functions, duties, entitlements, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to Decree No. 15/2018/ND-CP dated February 2, 2018 of the Government on elaboration of some articles of the Law on Food Safety;

At the request of the Director of the National Agro-Forestry-Fisheries Quality Assurance Department;

The Minister of the Ministry of Agriculture and Rural Development promulgates the Circular on origin tracing, recall, and handling of unsafe food under the management of the Ministry of Agriculture and Rural Development.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for the origin tracing, recall, and handling of unsafe food; responsibilities of organizations or individuals that participate in the process of food production and trading under the management of the Ministry of Agriculture and Rural Development.

Article 2. Regulated entities

1. 1. This Circular applies to organizations or individuals that produce and/or trade in food (hereinafter referred to as "facilities"); other agencies, organizations, or individuals related to Article 1 of this Circular.

2. This Circular does not apply to households or individuals who produce food on a small scale for domestic needs without market sale.

Article 3. Interpretation of terms

For the purpose of this Circular, the following terms shall be construed as follows:

1. Product recall means taking measures to remove a product which fails to meet food safety requirements from the chain of food production and trading.

2. A batch means a specific quantity of goods produced according to the same technological process, under the same production conditions within an uninterrupted period of time.

3. Incoming consignment means a quantity of materials, semi-finished products, or finished products bought or received at a time by a facility for production and trading.

4. Outgoing consignment means a quantity of finished products or semi-finished products of a facility, delivered at a time to another facility for further production or trading.

5. The “one step back, one step forward” principle means a facility must store information in order to ensure the identification of the previous production, trading facility, production stage and the following production, trading facility, production stage during production or trading of a traced product.

Chapter II

FOOD ORIGIN TRACING

Article 4. General requirements for origin tracing

1. A facility shall establish a food origin tracing system according to the “one step back, one step forward” principle to ensure the identification and tracking of a product unit at specified stages of the process to produce and trade food.

2. Upon receiving a food origin tracing request, a facility shall provide the stored information about the consignor and consignee during its production and trading process.

3. After each stage, the food shall be encrypted and identified by an appropriate method in order to serve origin tracing.

4. Facilities subject to the issuance of a certificate of food safety; facilities that have already been issued one of the following certificates: Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Point System (HACCP), ISO 22000 food safety management system, International Food Standard (IFS), British Retailer Consortium (BRC), food safety system certification (FSSC 22000), or equivalences which are all unexpired. Such facilities shall establish and maintain the origin tracing system according to regulations prescribed in Article 5; and store information for origin tracing according to regulations prescribed in Article 6 of this Circular.

5. The establishment of an origin tracing system is optional for facilities that are not prescribed in Clause 4 of this Article. However, such facilities shall store mandatory information for origin tracing purposes prescribed in Clauses 1, 3, 4 Article 6 of this Circular.

Article 5. Origin tracing system establishment

The establishment of an origin tracing system includes:

1. Application scope of the system

2. Procedures for encryption and identification of materials, semi-finished products, and finished products during the entire production and trading process. Encryption procedures shall be ensured to accurately support the origin tracing of necessary information from the previous production stage.

3. Procedures for recording, entering data and storing documents during the production process. 

4. Procedures for annual inspection and system update, amendment, and supplement.

5. Procedures for origin tracing (performer, content, method, time of implementation).

6. Assignment of tasks.

Article 6. Origin tracing information storage

1. The mandatory information that must be stored for origin tracing purposes at each facility for each batch produced and traded domestically:

a) Incoming consignment: Name, address, and code (if any) of the consignor; time, place of receipt; consignment information (name/type, weight, identification code);

b) Batch: information of the batch at each stage (production time, name/type, weight, batch identification code);

c) Outgoing consignment: Name, address, and code (if any) of the consignee; time, place of receipt; consignment information (name/type, weight, identification code).

2. The mandatory information that must be stored for origin tracing purposes at each food import facility about each consignment of imported food includes the information prescribed in Clause 1 of this Article and the information about the production facility and the exporting country.

3. The data management, origin tracing information encryption system shall be stored by appropriate devices in order to be conveniently searched. The minimum storage time from the date of production for food products for which display of shelf life is not mandatory:

a) 6 (six) months for fresh agro-forestry-fishery food products;

a) 2 (two) years for processed or frozen agro-forestry-fishery food products.

4. If information about an agro-forestry-fishery food product of a goods lot includes a shelf life, the facility shall store its origin tracing information for at least 12 months from the date of expiration.

5. Customer information storage is optional for retailers.

Article 7. Origin tracing order

A facility shall conduct origin tracing for unsafe food products prescribed in Clause 1 Article 54 of the Law on Food Safety in the following orders:

1. Determine the batch or the outgoing consignment that needs to be traced through stored documents.

2. Make an information statistic of the type of food, quantity of foods produced, imported, sold, or in inventory; a list of names, addresses of customers, and food distribution agents (if any).

3. Identify stages of production related to the batch or the outgoing consignment that needs to be traced.

4. Make a report on origin tracing results of the batch or outgoing consignment, or results of recall and handling of unsafe food in accordance with Chapter III of this Circular; make an investigation report on the cause of unsafe food and results of remedies application in accordance with Clause 2 Article 18 of this Circular.

Chapter III

RECALL AND HANDLING OF UNSAFE FOOD

Article 8. General requirements for recalling unsafe food

1. Any facility prescribed in Clause 1 Article 2 of this Circular shall establishment its unsafe food (outgoing consignment) recall procedures including the following contents:

a) Develop food recall plans (schemes) according to its actual activities of product production, trading, and distribution;

b) Test the plans; evaluate their effectiveness; revise, supplement, and approve food recall plans for them to take effect;

c) Annually or irregularly inspect, evaluate the effectiveness of the approved food recall plan.

2. Procedures for recall and handling of food:

a) Receive the recall and/or handling request;

b) Evaluate the necessity of the recall and handling;

c) Make a recall plan (according to the approved and effective sample plan) and present it to the head of the facility for consideration for approval;

d) Implement the recall according to the approved plan;

dd) Apply measures for handling unsafe food according to Article 13 of this Circular;

e) Make a report on the recall result and how to handle the recalled consignment, and store documents. If the recall affects facilities in the chain of food production and trading, make and send a report to the competent authority;

g) If the recalled consignment has already been distributed and consumed on a large scale, recall it as quickly as possible in order to minimize risks to consumers’ health and lives. If the recalling facility does not have the ability to handle or recall all of the unsafe food, make and send a report to the competent authority for support.

Article 9. Manners of unsafe food recall

A facility shall recall unsafe food prescribed in Clause 1 Article 55 of the Law on Food Safety in one of the following manners:

1. A voluntary recall means a food recall self-executed by a facility when any abnormal thing is discovered or when it receives complaints from other organizations or individuals about unsafe food and it is not any of the cases prescribed in Clause 2 of this Article.

2. A compulsory recall means an unsafe food recall conducted according to a recall decision by a competent authority prescribed in Articles 15, 16, 17 of this Circular or a recall in accordance with the law on administrative penalties for violations regulations on food safety.

Article 10. Procedures for voluntary recall

1. Within 24 hours from the moment of discovery or receipt of unsafe food complaints and it is determined that a recall is necessary, the facility shall:

a) Notify by phone, email or other appropriate methods, then officially notify the entire production and trading system in writing (production facilities, distribution facilities, agents, stores) to stop the production and trading of food subject to recall and carry out the food recall;

b) Send written notifications to the mass communication agencies of the province or city and related agencies, organizations according to regulations of the law on consumer protection. If the recall is conducted in at least two provinces and/or cities, notify central mass communication agencies in writing in order to inform consumers about the recalled food;

c) Notify the food recall in writing to the food safety authority;

d) Provide the following information in the written notification of the owner of the facility: name, production facility address; food name; packaging specifications, batch number, production date, and expiry date; quantity, food recall cause; a list of gathering, receiving places of recalled food; recall time.

2. Within 3 days from the date of recall completion, the owner of the facility shall make and send a report on the food recall result to the food safety authority according to the form prescribed in Appendix I promulgated with this Circular and the method for handling of recalled food.

Article 11. Procedures for compulsory recall

1. Within a maximum time of 24 hours from the moment of determination of food subject to recall, the competent authority prescribed in Clause 2 Article 9 of this Circular shall issue a recall decision according to the form prescribed in Appendix II promulgated with this Circular.

2. Right after receiving a recall decision, the owner of the facility shall comply with regulations prescribed in Clause 1 Article 10 of this Circular.

3. Within 3 working days from the date of compulsory recall completion, the owner of the facility shall make and report the food recall result to the competent authority that issued the recall decision according to the form prescribed in Appendix I promulgated with this Circular and propose methods for handling of recalled food.

4. The competent authority that issues the food recall decision shall supervise its implementation and inform the food safety authority, related agencies for cooperation.

Article 12. Recall procedures for serious or emergency food safety incidents

1. A competent authority shall issue a coercive recall decision in case the owner of the facility still does not comply with the recall decision of the competent authority by the deadline in accordance with regulations prescribed in Clause 4 Article 55 of the Law on Food Safety.

2. A coercive recall decision issued by a competent authority shall specify the agency or organization that conducts the coercion, the agency or organization that supervises or witnesses the coercion, the time of coercion, and handling of the recalled food.

3. If the food has the potential to seriously affect the health of the community or other emergency cases, the competent authority shall directly organize the recall, food handling in accordance with regulations prescribed in Point d Clause 5 Article 55 of the Law on Food Safety.

4. After the completion of the recall and handling of unsafe food, the competent authority that recalls and handles food after recalls shall notify writing to request the owner of the facility to pay the cost for food recalls.

5. An owner of a facility shall pay the cost for food recall and handling (if any) after receiving a notification in writing from a competent authority.

Article 13. Methods for handling of recalled food

1. Product reconditioning, label correction:

a) Reconditioning: apply to cases where food products can be reconditioned with technical measures for food safety assurance;

b) Label correction: apply to cases where food products are not labeled as per regulation.

2. Repurposing: apply to cases where the food is unsafe, harmful to health, and unusable but can be used for other purposes after appropriate treatments.

3. Re-export: apply to cases where the imported goods are unsafe and subject to re-export in accordance with regulations of the law.

4. Destruction: apply to cases where food products have inappropriate safety limits compared to what stated in the self-declared document, technical standards, food safety regulations, which cause harmful effects to consumers’ health; are unable to be repurposed or re-exported according to regulations prescribed in Clause 2, Clause 3 of this Article and other emergency cases prescribed in Article 12 of this Circular.

5. When products are recalled according to Article 10 of this Circular, the owner of the facility shall select one of the methods specified in Clauses 1, 2, 3, and 4 of this Article.

6. When products are recalled according to Article 11 of this Circular, within 3 working days from the date of receipt of the report of product recall results, the authority that issued the recall decision shall consider issuing a written approval for the methods for handling of recalled products proposed by the owner of the facility. If the proposed handling methods are rejected, respond and provide explanations in writing and impose other handling methods for the owner to apply.

Article 14. Report on results of handling of unsafe food after recalls

1. The handling of food after recalls according to a compulsory recall decision issued by a competent authority shall be completed within 3 months from the date the competent authority issues the written approval for the handling methods of the owner of the facility.

2. With regard to product reconditioning, label correction:

a) In case of a voluntary recall: After the product reconditioning and label correction are done, the owner of a facility shall notify in writing in which specifies the name, quantity, and evidence indicating that the errors have been fixed to the food safety authority. After sending the notification, the owner shall be allowed to circulate the food;

b) In case of a compulsory recall: After the product reconditioning and label correction are done, the owner of a facility shall notify in writing in which specifies the name, quantity, evidence indicating that the errors have been fixed to the competent authority that issued the recall decision. Within 3 working days from the date of receipt of the owner’s report, the competent authority that issued the recall decision shall decide whether to issue a written approval for the circulation of the products or reject it and provide explanations in writing. The owner of a facility may only circulate the food when he/she receives the written approval of the competent authority that issued the recall decision.

3. With regard to repurposing:

After completing the repurposing, the owner shall report in writing on changes of food uses in which specifies the name, quantity, time, the new purposes, and evidence of changes to a food safety authority or the authority that issued the recall decision. The party that buys the unsafe food may only use it for the purposes reported to the food safety authority and specified in the contract.

4. With regard to re-export:

After completing the re-export, the owner of a facility shall report in writing on food re-export in which specifies the name, quantity, country of origin, re-export evidence to a food safety authority, and the authority that issued the recall decision.

5. With regard to destruction:

After completing the food destruction, the owner of a facility shall report in writing on food destruction in which specifies the name, quantity, time of completion, place of destruction, and attach a food destruction document certified by the organization that conducted the destruction to a food safety authority, and the authority that issued the recall decision.

Chapter IV

IMPLEMENTATION

Article 15. Responsibilities of specialized General Departments, Departments

Within the scope of management according to their functions and assigned duties, specialized General Departments, Departments shall take charge and cooperate with related agencies in performing the following tasks:

1. Inspect the performance of origin tracing, recall, and handling of unsafe food of facilities under their management.

2. In case of discovery through inspection or receive warnings from the importing country or other information sources about unsafe food, notify in writing to request the production, trading facility to conduct origin tracing, recall, and handling of unsafe food. The notification document shall contain the following information:

a) Name of the facility responsible for the origin tracing, recall, and handling of food;

b) Identification information of the batch/consignment that needs to be traced (if any);

c) Cause of origin tracing, recall, and handling of food after recalls (if any);

d) Scope and time limit for origin tracing, recall of food and handling of recalled products (if any);

dd) The agency responsible for the inspection of the performance of origin tracing, recall, and handling of unsafe food.

e) A notification on the compulsory recall measures; the recall in case of a serious or emergency food safety incident; the methods for handling of unsafe food, and the report on results of handling of the recalled food in accordance with Clauses 11, 12, 13, and 14 of this Circular.

3. Request the Departments of Agriculture and Rural Development, food safety management boards of the provinces to direct the affiliated specialized agency to support or directly organize the recall, handling of unsafe food in the following cases:

a) Food that is potentially harmful to the health of the community and distributed to many localities, cities;

b) Food that is potentially harmful to consumers’ health and distributed to consumers through non-traditional food distribution channels including e-commerce sites, online trading through digital platforms; online order/delivery applications; and a facility responsible for the recall has yet to be determined or such facility is unable to promptly conduct its operation in order to prevent unsafe food risks;

c) Other emergency cases where a competent authority determines that a facility is unable to recall and handle all of the unsafe food.

4. Annually or irregularly (upon request), send a report on the inspection results of the compliance with regulations on origin tracing, recall, and handling of unsafe food of facilities under the management of the Ministry of Agriculture and Rural Development (through the National Agro-Forestry-Fisheries Quality Assurance Department); propose the responsibilities of specialized management agencies and food safety assurance measures to the Ministry of Agriculture and Rural Development.

Article 16. Responsibilities of the National Agro-Forestry-Fisheries Quality Assurance Department

1. Perform duties of advisory and general recapitulation on construction; organize the implementation of regulations of the law; recapitulate reports on origin tracing, recall, and handling of unsafe food under the management of the Ministry of Agriculture and Rural Development.

2. Within the assigned scope, take charge and cooperate with related agencies in implementing regulations prescribed in Clauses 1,2, and 3 Article 15 of this Circular. Directly organize the implementation of duties of agencies prescribed in Article 15 of this Circular if the assignment of duties is unclear or the food is related to the management functions of 2 agencies or above.

3. Annually or irregularly (upon request), send a report on the inspection results of the implementation of regulations on origin tracing, recall, and handling of unsafe food nationwide; propose the responsibilities of specialized management agencies and agro-forestry food safety measures to the Ministry of Agriculture and Rural Development.

Article 17. Responsibilities of the Departments of Agriculture and Rural Development, food safety management boards of provinces and centrally affiliated cities

1. Take charge and cooperate with related agencies in inspecting the performance of origin tracing, recall, and handling of food warned to be unsafe according to warnings of agencies prescribed in Articles 15, 16 of this Circular and other information sources.

2. Organize the recall and handling of unsafe food for cases prescribed in Clause 3 Article 15 of this Circular; request organizations or individuals that produce or trade unsafe food to pay the cost for the recall and handling of food;

3. Organize the inspection of the compliance with regulations on origin tracing, recall, and handling of unsafe food of facilities under the management of the assigned administrative divisions in accordance with the professional guidelines of related General Departments, specialized departments.

4. Annually or upon request, report the inspection results of the operations of origin tracing, recall, and handling of unsafe food under the management of the local administrative divisions.

Article 18. Responsibilities of facilities

1. Establish and maintain an origin tracing system, store information to serve origin tracing purposes in accordance with regulations prescribed in Article 5, Article 6, and establish unsafe food recall procedures in accordance with regulations prescribed in Article 8 of this Circular.

2. Organize the investigation into causes of unsafe food; establish and perform necessary measures to fix or prevent similar cases.

3. When discovering the food (traded or produced) is unsafe, or when notified in writing by agencies prescribed in Articles 15, 16, and 17 of this Circular, conduct the origin tracing, recall, and handling of unsafe food in accordance with regulations of this Circular within the time limit decided by the competent state authority. If the recall is not completed within the time limit, a coercive recall decision will be issued in accordance with the law.

4. Comply with requests of the competent authority on the origin tracing, recall, and handling of unsafe food; comply with the decision to punish financial violations (if any); handle unsafe food in accordance with regulations prescribed in Article 13; report on the handling results of food after recalls in accordance with regulations prescribed in Article 14 of this Circular.

5. Pay every cost of the recall and handling of the unsafe food they produce or trade.

6. Apply technical measures to the origin tracing system; improve the connectivity of information to serve origin tracing by related parties.

Chapter V

IMPLEMENTATION PROVISIONS

Article 19. Transitional provisions

1. If unsafe fishery food is discovered and handled before this Circular comes into force, apply regulations in Circular No. 03/2011/TT-BNNPTNT dated January 21, 2011 of the Minister of the Ministry of Agriculture and Rural Development on origin tracing and recall of fishery products failing to meet food quality and safety requirements.

2. If unsafe agro-forestry food is discovered and handled before this Circular comes into force, apply regulations in Circular No. 74/2011/TT-BNNPTNT dated October 31, 2011 of the Minister of the Ministry of Agriculture and Rural Development on origin tracing, recall, and handling of unsafe agro-forestry food under the management of the Ministry of Agriculture and Rural Development.

Article 20. Entry into force

1. This Circular comes into force as of February 2, 2022

2. The following documents and regulations shall expire from the date this Circular comes into force:

a) Circular No. 03/2011/TT-BNNPTNT dated January 21, 2011 of the Minister of the Ministry of Agriculture and Rural Development on origin tracing and recall of fishery products failing to meet the food quality and safety requirements;

b) Circular No. 74/2011/TT-BNNPTNT dated October 31, 2011 of the Minister of the Ministry of Agriculture and Rural Development on origin tracing, recall, and handling of unsafe agro-forestry food under the management of the Ministry of Agriculture and Rural Development.

c) Article 7 of Circular No. 11/2017/TT-BNNPTNT dated May 29, 2017 of the Minister of the Ministry of Agriculture and Rural Development on amendments to some articles legislative documents relating to functions and tasks of units affiliated to the Ministry of Agriculture and Rural Development.

3. Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Agriculture and Rural Development for research and amendment./.

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