THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT ________ No. 17/2021/TT-BNNPTNT | THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ________________________ Hanoi, December 20, 2021 |
CIRCULAR
On traceability, recall and disposal of unsafe food under the management of Ministry of Agriculture and Rural Development
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Pursuant to the Law on Food Safety dated June 17, 2010;
Pursuant to the Government’s Decree No. 15/2017/ND-CP dated February 17, 2017 defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;
Pursuant to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on detailing the implementation of a number of articles of the Law on Food Safety;
At the request of Director of the National Agro-Forestry-Fisheries Quality Assurance Department;
The Minister of Agriculture and Rural Development promulgates the Circular on traceability, recall and disposal of unsafe food under the management of Ministry of Agriculture and Rural Development.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Circular defines the traceability, recall and disposal of unsafe food; responsibilities of organizations and individuals engaging in the process of food production and trading under the management of Ministry of Agriculture and Rural Development.
Article 2. Subjects of application
1. This Circular applies to food producers and traders (hereinafter referred to as establishments); organizations and individuals engaging in the contents specified in Article 1 of this Circular.
2. This Circular does not apply to households and individuals producing food on a small scale for domestic use without sale in the market.
Article 3. Interpretation of terms
In this Circular, the terms below are 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. Production lot (batch) means a specific quantity of goods produced according to the same technological process and under the same production conditions within an uninterrupted period of time.
3. Lot of receipt means a quantity of materials, semi-finished products or finished products procured and received at a time by an establishment for production or trading.
4. Lot of delivery means a quantity of finished products or semi-finished products of an establishment delivered at a time to another establishment for continuation of production or trading.
5. One step back-one step forward traceability principle means an establishment’s storage of information that guarantees the identification of the previous producer or trader/production stage and the subsequent producer or trader/production stage in the process of producing and trading a traced product.
Chapter II
TRACEABILITY OF FOOD
Article 4. General requirements for traceability
1. An establishment shall establish a food traceability system on the one step back-one step forward principle to guarantee the identification and tracing of a product unit at specified stages of the process of production and trading of such food.
2. When receiving a request for food traceability, the establishment shall provide the stored information on suppliers of lot of receipt and recipients of lot of delivery, which has been stored during the production and trading process of the establishment.
3. After each stage, food must be encoded or identified in an appropriate way to enable traceability.
4. Establishments subject to grant of certificates of food safety eligibility; establishments that have been granted certification of good manufacturing practices (GMP), hazard analysis and critical control points (HACCP), food safety management system ISO 22000, IFS international food standard, British Retail Consortium (BRC) global standards for food safety, FSSC 22000 food safety system certification or equivalent certification that is still valid must establish and maintain their traceability systems specified in Article 5 and store the information about traceability defined in Article 6 of this Circular.
5. Establishments other than those defined in Clause 4 of this Article are not required to establish traceability systems but must store the minimum information for traceability specified in Clauses 1, 3 and 4 Article 6 of this Circular.
Article 5. Establishment of traceability systems
A traceability system must include the main contents as follows:
1. Scope of application of the system.
2. Procedures for encoding and identification of materials, semi-finished products and finished products throughout the entire production and trading process. The procedures for encoding must ensure retrieval of necessary information from previous production stages.
3. Procedures for recording, entering data and storing records during the production process.
4. Procedures for periodic inspection and update, amendment and supplementation of the system.
5. Procedures for traceability (implementer, content, method, implementation time).
6. Responsibility assignment.
Article 6. Storage of information about traceability
1. Minimum information to be stored for traceability at each establishment for each lot of goods produced and traded domestically:
a) For a lot of receipt: Name, address and code (if any) of supplier of the lot of receipt; time and place of delivery; information about the lot (name/type, volume, identification code);
b) For a production lot: Information about the production lot at each stage (time of production, name/type, volume, identification code of the lot/batch);
c) For a lot of delivery: Name, address and code (if any) of recipient of the lot; time and place of delivery; information about the lot (name/type, volume, identification code).
2. The minimum information to be stored for traceability at each food import establishment for each imported lot of food, including the information specified in Clause 1 of this Article and information about the producer, country of exportation.
3. The system of data management and encoding of traceability information must be stored by appropriate means to ensure convenience for lookup and minimum storage time from the date of production for food products not subject to mandatory presentation of expiration dates shall be specified as follows:
a) 06 (six) months, for fresh agricultural, forest and aquatic food;
b) 02 (two) years, for frozen and processed agricultural, forest and aquatic food.
4. For agricultural, forest and aquatic food with expiration dates, the establishment must store the information about traceability within at least 12 months from the expiration date of the lot of product.
5. Direct-to-consumer traders are not required to retain information about customers.
Article 7. Order of traceability
An establishment shall perform the traceability of unsafe food specified in Clause 1 Article 54 of the Law on Food Safety according to the following order:
1. To determine the production lot, lot of delivery subject to traceability via the stored records.
2. To synthesize and make statistics of information on food types and quantities of food of the lot of food that have been produced, imported, sold and in stock; to make a list of names and addresses of customers and food distribution agents (if any).
3. To identity the production stages relating to the production lot, lot of delivery subject to traceability.
4. To make a report on traceability results after the completion of traceability of the production lot, lot of delivery; results of recall and disposal of the unsafe food specified in Chapter III of this Circular and report on investigation of causes of unsafe food, results of application of remedial measures prescribed in Clause 2 Article 18 of this Circular.
Chapter III
RECALL AND DISPOSAL OF UNSAFE FOOD
Article 8. General requirements for recall of the unsafe food
1. The establishments specified in Clause 1 Article 2 of this Circular must formulate the procedures for recall of the unsafe food (for their lots of delivery), including the following contents:
a) To formulate plans on food recall corresponding to the establishments’ actual product production, trading and distribution activities;
b) To organize the pilot application of the plans, evaluate the effectiveness of implementation, amendment, supplementation and approval of the validity of plans on food recall;
c) To verify and evaluate annually or irregularly the effectiveness and efficiency of the approved plans on food recall.
2. Order and procedures for recall and disposal of food:
a) To receive requests for recall and disposal;
b) To assess the need for recall and disposal;
c) To formulate a recall plan (based on the approved sample plan) and submit it to the establishment leadership for approval;
d) To organize the recall in accordance with the approved plans;
dd) To apply measures to dispose the unsafe food specified in Article 13 of this Circular;
e) To make a report on results of recall and handling measures for the recalled lot of delivery and storage of records. In case the recalled good lot affects establishments in the chain of food production and trading, the establishments shall send a report to the competent agency;
g) In case the recalled lot of goods has been distributed and consumed on a large scale, it is necessary to recall quickly to minimize risks to the consumers’ health and life or the establishments are unable to recall and dispose all unsafe food, the establishments must report to competent agencies for support of organization of recall and disposal of food.
Article 9. Forms of recall of unsafe food
An establishment shall perform the recall of unsafe food specified in Clause 1 Article 55 of the Law on Food Safety according to the following forms:
1. Voluntary recall which means a recall by the food producer or trader upon detecting the unsafe food or receiving an organization or individual’s information about the unsafe food and other than those specified in Clause 2 of this Article.
2. Compulsory recall which means a recall under a decision on recall by competent state agency as specified in Articles 15, 16 and 17 of this Circular or recall under law regulations on handling of administrative violations on food safety.
Article 10. Order of voluntary recall
1. Within at most 24 hours from the time of detecting the unsafe food or receiving the information about the unsafe food, if determining that it is subject to recall, the establishment shall:
a) Notify by telephone, email or other appropriate forms, then officially notify in writing to the entire production and trading system (production establishments, distribution establishments, agents, stores) to stop the production and trading of the food subject to recall and carry out food recall;
b) Notify in writing to provincial-level mass media agencies, relevant agencies and organizations in accordance with law regulations on consumer right protection. In case the recall is conducted in two or more provinces or cities, the written notice must be sent to central-level mass media agencies to inform consumers about the food to be recalled;
c) Notify in writing the food recall to the competent agency in charge of food safety;
d) The establishment owner's written notice of food recall must clearly state: name and address of the producer; food name; packaging specifications, production lot number, date of production and expiry date; quantity of the food and reason for recall; list of places for gathering and receipt of the to-be-recalled food and time of food recall.
2. Within 03 days from the end of the recall, the establishment owner shall report the results of food recall to the competent agency in charge of food safety, using the form specified in Appendix I issued together with this Circular and the form of post-recall disposal of the food.
Article 11. Order of compulsory recall
1. Within at most 24 hours from the time of determining that the food is subject to recall, the competent agency specified in Clause 2 Article 9 of this Circular must issue a decision on recall, made using the form in Appendix II issued together with this Circular.
2. Right after receiving the decision on recall, the establishment owner shall implement Clause 1 Article 10 of this Circular.
3. Within 03 working days from the end of the compulsory recall, the establishment owner shall report the results of food recall to the competent agency issuing the decision on recall, using the form specified in Appendix I issued together with this Circular and propose the form of post-recall disposal of the food.
4. The agency competent to issue the decision on food recall shall be responsible for monitoring the recall and notifying the competent agency in charge of food safety and relevant agencies for coordination.
Article 12. Order of recall in case of serious or urgent food safety incidents
1. The competent agency shall issue a decision on enforcement of recall in cases past the prescribed time limit of recall, the establishment owner fails to recall food under the competent agency’s decision on compulsory recall under Clause 4 Article 55 of the Law on Food Safety.
2. The competent agency’s decision on enforcement of recall must clearly state the agencies or organizations in charge of the enforcement, the agencies or organizations in charge of monitoring or witnessing, time limit of enforcement and forms of disposal of food after the recall.
3. For cases where food products are likely to seriously affect the community health or in other emergency cases, the competent agency shall directly recall and dispose of them in accordance with Point d Clause 5 Article 55 of the Law on Food Safety.
4. After completion of the recall and disposal of the unsafe food, the competent agency performing the recall and disposal shall send a written notice to request their establishment owner to fulfill the obligation of recall expense payment.
5. The establishment owner shall be responsible for paying recall and disposal expenses (if any) after receiving the competent agency's written notice.
Article 13. Forms of post-recall disposal of the unsafe food
1. Correction of product flaws or labeling errors:
a) Correction of product flaws: Applies to the food which may be disposed by technical measures for food safety assurance;
b) Correction of labeling errors: Applies to the food which is not labeled in accordance with regulations.
2. Change of use purposes: Applies to the food which is unsafe, affects the customers’ health, is not used for food but may be used for other purposes after appropriate disposal.
3. Re-export: Applies to the imported food which is not safe and subject to re-export in accordance with law regulations.
4. Destruction: Applies to cases where the food’s safety limits do not conform with those stated in the dossier announced, technical regulations, regulations on food safety, affecting the customers’ health and its use purpose may not be changed or the food may not re-exported as specified in Clause 2, Clause 3 of this Article and other emergency cases defined in Article 12 of this Circular.
5. For cases of product recall prescribed in Article 10 of this Article, the establishment owner shall select to apply one of forms of post-recall disposal of products specified in Clauses 1, 2, 3 and 4 of this Article.
6. For cases of product recall prescribed in Article 11 of this Article, within 03 working days from the date of receiving the report on production recall results, the recall decision-issuing agency must issue a written approval of the form of disposal proposed by the establishment owner. In case of disagreement with the establishment owner’s proposed disposal form, the recall decision-issuing agency must issue a document, clearly stating the reason for disagreement and providing a post-recall disposal form for the establishment owner to apply.
Article 14. Report on post-recall disposal results
1. The establishment owner shall complete the post-recall disposal of food under the competent agency’s decision on compulsory recall within at most 3 months after the competent agency issues a written approval of disposal form proposed by the establishment owner.
2. For the form of correction of product flaws or labeling errors:
a) For cases of voluntary recall: After completion of correction of product flaws or labeling errors, the establishment owner shall send a written notice that clearly states the name and quantity of products, enclosed with the evidence of correction to the competent agency in charge of food safety. After sending the notice, the establishment owner may circulate the products.
b) For cases of compulsory recall: After completion of correction of product flaws or labeling errors, the establishment owner shall send a written notice that clearly states the name and quantity of products, enclosed with the evidence of correction to the food recall decision-issuing agency. Within 3 working days after receiving the establishment owner’s notice, the recall decision-issuing agency shall issue a written approval of product circulation. In case of disapproval, it shall clearly state the reason. The establishment owner may only circulate the food after obtaining a written approval of the food recall decision-issuing agency.
3. For the form of change of use purposes:
After completion of the change of use purpose of the food, the establishment owner shall send a written report on change of use purpose of the food that clearly states the name, quantity, time and domain of change of use purposes, enclosed with the evidence of change of use purposes to the competent agency in charge of food safety or food recall decision-issuing agency. The buyer of unsafe food may only use such food for the purpose reported to the competent agency in charge of food safety and stated in the contract.
4. For the form of re-export:
After completion of the re-export of the food, the establishment owner shall send a written report on food re-export that clearly states the name, quantity, country of origin and time of re-export, enclosed with the re-export dossier to the competent agency in charge of food safety and food recall decision-issuing agency.
5. For the form of destruction:
After completion of the food destruction, the establishment owner shall send a written report on food destruction that clearly states the name, quantity, time of completion of destruction and place of destruction, enclosed with a food destruction record certified by the agency carrying out the food destruction to the competent agency in charge of food safety or food recall decision-issuing agency.
Chapter IV
ORGANIZATION OF IMPLEMENTATION
Article 15. Responsibilities of Directorates and specialized Departments
Within the scope of their management according to the assigned functions and tasks, Directorates and specialized Departments shall assume the prime responsibility for, and coordinate with relevant agencies in, carrying out the following responsibilities:
1. To inspect the traceability, recall and disposal of unsafe food of establishments under their management.
2. To send a written notice to request the food producers and traders to conduct the traceability, recall and disposal of unsafe food, if detecting the unsafe food or receiving warnings of countries of importation or other information about the unsafe food after the inspection. A written notice includes the following information:
a) Name of the establishment responsible for traceability, recall and disposal of food;
b) Information to identify the lot subject to traceability (if any);
c) Reasons for traceability, recall and measures for post-recall disposal of food (if any);
d) Scope and deadline for traceability, recall and post-recall disposal of the food (if any);
dd) Agency responsible for inspecting the traceability, recall and disposal of the unsafe food.
e) Notification on the application of compulsory recall measures, recall in case of serious or urgent food safety incidents, forms of disposal of the unsafe food and report on results of post-recall disposal of the food in accordance with Articles 11, 12, 13 and 14 of this Circular.
3. To request provincial-level Departments of Agriculture and Rural Development and provincial-level Food Safety Management Boards to direct affiliated specialized agencies to support or directly organize the recall and disposal of unsafe food in the following cases:
a) Food products which are likely to seriously affect the community health and are distributed in many provinces and cities;
b) Food products which are likely to affect the customers’ health and distributed to the consumers through non-traditional food distribution channels such as: e-commerce websites; online sale via digital platforms; online ordering/delivery applications where the establishment responsible for the recall has not been identified or the establishment responsible for the recall is unable to prevent food safety risks in a timely manner;
c) Other emergency cases in which the competent agencies determine that the establishments are unable to implement the recall and disposal of all unsafe food.
4. Annually or irregularly (upon request), to send reports on inspection of the observance of regulations on traceability, recall and disposal of unsafe food of establishments under the management of the Ministry of Agriculture and Rural Development (via the National Agro-Forestry-Fisheries Quality Assurance Department); to propose the Ministry of Agriculture and Rural Development responsibilities of specialized management agencies, solutions and measures to ensure food safety.
Article 16. Responsibilities of the National Agro-Forestry-Fisheries Quality Assurance Department
1. To carry out the tasks of advising and synthesizing generally the formulation and organization of implementation of law regulations, and synthesizing reports on traceability, recall and disposal of unsafe food under the management of Ministry of Agriculture and Rural Development.
2. Within the assigned scope, to assume the prime responsibility for, and coordinate with relevant agencies in, implementing Clauses 1, 2 and 3 Article 15 of this Circular. To directly organize the implementation of the tasks of the agencies specified in Article 15 of this Circular if the management assignment is unclear or the food is relating to the management functions of 02 or more agencies.
3. Annually or irregularly, to report on results of inspection of the implementation of regulations on traceability, recall and disposal of unsafe food nationwide; to propose the Ministry of Agriculture and Rural Development responsibilities of specialized management agencies, solutions and measures to ensure agricultural and forest food safety.
Article 17. Responsibilities of Departments of Agriculture and Rural Development and Food Safety Management Boards of provinces and centrally-run cities
1. To assume the prime responsibility for, and coordinate with relevant agencies in, inspecting the traceability, recall and disposal of food warned to be unsafe according to warning information of agencies defined in Articles 15 and 16 of this Circular and from other information sources.
2. To organize the recall and disposal of unsafe food for cases specified in Clause 3 Article 15 of this Circular and request the unsafe food producers and traders to pay expenses for the recall and disposal of the food;
3. To organize the inspection of observance of regulations on traceability, recall and disposal of unsafe food of establishments managed by the localities under the decentralization in accordance with the professional guidance of relevant Directorates and specialized Departments.
4. To report on the results of inspection of traceability, recall and disposal of unsafe food under the management of the localities on an annual basis or upon request.
Article 18. Responsibilities of food producers and traders
1. To establish and maintain a system of traceability, store information to serve traceability under Articles 5 and 6 and formulate procedures for recall of unsafe food under Article 8 of this Circular.
2. To organize the investigation of causes of unsafe food, establish and implement necessary measures to remedy and to prevent similar cases.
3. When detecting their produced or traded food are not safe, or receiving a written notice from the agencies defined in Articles 15, 16 and 17 of this Circular, the establishments shall conduct the traceability, recall and disposal of the unsafe food in accordance with this Circular within the time limit decided by the competence state agencies. Past the prescribed time limit of recall, food producers and traders failing to recall food shall be coerced to do so in accordance with law regulations.
4. To observe competent agencies’ requirements on traceability, recall and disposal of unsafe food; comply with decisions on sanctioning administrative violations (if any); dispose the unsafe food under Article 13; report the results post-recall disposal of the food in accordance with Article 14 of this Circular.
5. Unsafe food producers and traders shall bear all expenses for recall and disposal of the unsafe food.
6. To apply technological solutions in the establishments’ traceability systems, increase the ability to connect information to serve the traceability of relevant parties.
Chapter V
IMPLEMENTATION PROVISIONS
Article 19. Transitional provisions
1. Unsafe fishery products that are detected and disposed before the effective date of this Circular shall continue to apply the Circular No. 03/2011/TT-BNNPTNT dated January 21, 2011 of the Minister of Agriculture and Rural Development, on traceability and recall of fishery products failing to meet food quality and safety requirements.
2. Unsafe agricultural and forest food that are detected and disposed before the effective date of this Circular shall continue to apply the Circular No. 74/2011/TT-BNNPTNT dated October 31, 2011 of the Minister of Agriculture and Rural Development, on traceability, recall and disposal of unsafe agricultural and forest food under the management of Ministry of Agriculture and Rural Development.
Article 20. Effect
1. This Circular takes effect on February 02, 2022.
2. The following documents and regulations cease to be effective from the effective date of this Circular:
a) Circular No. 03/2011/TT-BNNPTNT dated January 21, 2011 of the Minister of Agriculture and Rural Development, on traceability and recall of fishery products failing to meet food quality and safety requirements;
b) Circular No. 74/2011/TT-BNNPTNT dated October 31, 2011 of the Minister of Agriculture and Rural Development, on traceability, recall and disposal of unsafe agricultural and forest food under the management of Ministry of Agriculture and Rural Development.
c) Article 7 of the Circular No. 11/2017/TT-BNNPTNT dated May 29, 2017 of the Minister of Agriculture and Rural Development amending and supplementing a number of articles of legal documents related to functions and tasks of units under the Ministry of Agriculture and Rural Development.
3. Any difficulty arising in the course of implementation of this Circular should be promptly reported to the Ministry of Agriculture and Rural Development for study, amendment and supplementation./.
| FOR THE MINISTER THE DEPUTY MINISTER Tran Thanh Nam |
* All Appendices are not translated herein.