Circular No. 23/2018/TT-BYT dated September 14, 2018 of the Ministry of Health on prescribing the recall and disposal of unsafe foods under the management of the Ministry of Health

CIRCULAR

Prescribing the recall and disposal of unsafe foods under the management of the Ministry of Health^[1]

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

Pursuant to the Government’s Decree No. 75/2017/ND-CP of June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Vietnam Food Administration,

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

Chapter I

GENERAL PROVISIONS

Article 1.Scope of regulation

This Circular prescribes in detail forms and 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.

Article 2.Subjects of application

This Circular applies to Vietnamese organizations and individuals, and foreign organizations and individuals in Vietnam engaged in production and trading of products specified in Article 1 of this Circular, competent agencies in charge of food safety, and other organizations and individuals involved in food safety-related activities in Vietnam.

Chapter II

FORMS AND ORDER OF RECALL

Article 3.Forms of recall

1. Voluntary recall means the recall of products willingly carried out by organizations and individuals that register for the product declaration or product self-declaration (below referred to as product owners) when detecting by themselves or receiving information about unsafe products they produce or trade, which do not fall into the cases specified in Clause 2 of this Article.

2. Compulsory recall means the recall of unsafe products by product owners under decisions issued by:

a/ Agencies receiving product self-declaration dossiers or issuing receipts of the registration of the product declaration as prescribed in Decree No. 15/2018/ND-CP of February 2, 2018, detailing a number of articles of the Law on Food Safety (below referred to as competent agencies in charge of food safety);

b/ Agencies competent to sanction food safety-related administrative violations under regulations.

Article 4.Order of voluntary recall

1. Within 24 hours after detecting or receiving information about unsafe products, if finding such products subject to recall, a product owner shall:

a/ Notify by telephone, email or other appropriate notification forms, and then notify in writing to his/her/its production and trading system (including production establishments, distribution channels, agents and stores) for intended suspension of production and trading and recall of the product;

b/ Notify in writing to provincial-level mass media and other related agencies and organizations in accordance with the law on protection of consumer rights; or notify in writing to central-level mass media for provision of information to consumers about the to-be-recalled products if the product recall is to be carried out in 2 or more provinces.

c/ Notify in writing the competent agencies in charge of food safety of the product recall;

d/ When notifying in writing the product recall, a product owner shall clearly state the names and addresses of the product owner and producer, name, packaging specifications, production lot number, date of production and expiry date, and quantity of the products, reason for the recall, list of places for gathering and receipt of the to-be-recalled products, and time of product recall.

2. Within 3 days after completing a product recall, a product owner shall send a report on product recall results, made according to the form provided in Appendix 1 to this Circular, to the competent agency in charge of food safety, and propose a form of post-recall disposal.

Article 5.Order of compulsory recall

1.Within 24 hours after finding a product subject to recall, the competent agency defined in Clause 2, Article 3 of this Circular shall issue a decision on product recall, made according to the form provided in Appendix 2 to this Circular.

2. Right after receiving a decision on product recall, a product owner shall follow the provisions of Clause 1, Article 4 of this Circular.

3. Within 3 days after completing a product recall, a product owner shall send a report on product recall results, made according to the form provided in Appendix 1 to this Circular, to the decision-issuing agency, and propose a form of post-recall disposal.

4. Upon issuing the decision on product recall, the agency competent to sanction administrative violations shall supervise the recall and notify the sanctioning to the competent agency in charge of food safety and related agencies for coordination.

Article 6.Orderofrecall in serious or emergency cases

1. In case a product owner fails to carry out or carries out incompletely the recall of unsafe products under a decision on compulsory recall issued by a competent agency or in other urgent cases specified at Point d, Clause 5, Article 55 of the Law on Food Safety, the competent agency shall issue a decision on coercive recall and organize the product recall. The decision on coercive recall must state the agency or organization in charge of coercive recall, agency or organization in charge of supervision or witness of the recall, time limit for the coercive recall, and the form of post-recall disposal.

2. After completing the recall and disposal of an unsafe product, the agency in charge of product recall and disposal shall issue a written notice to the product owner for the latter to pay recall expenses

3. A product owner shall pay expenses for recall and disposal of his/her/its products (if any) within 15 days after the agency in charge of product recall sends a notice.

Chapter III

POST-RECALL DISPOSAL OF PRODUCTS

Article 7.Forms of post-recall disposal of products

1. Recalled products shall be disposed of in one of the following forms:

a/ Correction of labeling errors: This form is applied to products having labeling errors compared to their self-declaration dossiers or dossiers of product declaration registration;

b/ Change of use purposes: This form is applied to products of inferior quality that are likely to cause harm to consumer health and cannot be used for foods but may be used for other purposes;

c/ Re-export: This form is applied to imported products of quality and safety limits not in conformity with their self-declaration dossiers or dossiers of product declaration registration or likely to cause harm to consumer health;

d/ Destruction: This form is applied to products of quality criteria or safety limits not in conformity with their self-declaration dossiers or dossiers of product declaration registration which are likely to cause harm to consumer health for which the form of change of use purpose and re-export cannot be applied under Point b or c, Clause 1 of this Article or other necessary cases specified in Article 6 of this Circular.

2. In case of product recall under Article 4 of this Circular, the product owner shall select one of the forms of post-recall disposal of products prescribed in Clause 1 of this Article.

3. In case of product recall under Article 5 of this Circular, within 3 working days after receiving a report on product recall results, the recall decision-issuing agency shall issue a written approval of the post-recall form of disposal proposed by the product owner. In case of disapproval, it shall clearly state the reason and put forth another form of post-recall disposal to be applied by the product owner.

Article 8.Reporting of post-recall product disposal results

1. In case of post-recall disposal of products under a competent agency’s decision on compulsory recall, a product owner shall complete the disposal within 3 (three) months after the competent agency issues a written approval of the disposal form proposed by the product owner.

2. For the form of correction of labeling errors:

a/ In case of voluntary recall: After correcting a labeling error, a product owner shall send a written notice that clearly states the name and quantity of products, and model of the corrected label to the competent agency in charge of food safety. After sending the notice, the product owner may circulate its/her/his products;

b/ In case of compulsory recall: After correcting a labeling error, a product owner shall send a written notice that clearly states the name and quantity of products, and model of the corrected label to the product recall decision-issuing agency. Within 3 working days after receiving the product 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. After receiving the written approval of circulation of products with corrected labeling errors from the recall decision-issuing agency, the product owner shall send a written notice of the approval to the competent agency in charge of food safety. The product owner may only circulate products after obtaining a written approval from the product recall decision-issuing agency.

3. For the form of change of use purposes:

Within 5 working days after completing the change of the use purpose of his/her/its product, a product owner shall send a written report on change of use purpose of his/her/its product that clearly states the name, quantity, time and domain of change of use purposes, enclosed with the contract and purchase and sale invoice between the product owner and buyer to the competent agency in charge of food safety or product recall decision-issuing agency. The buyer of unsafe products may only use such products for the purpose stated in the contract and reported to the competent agency in charge of food safety.

4. For the form of re-export:

Within 5 working days after completing the re-export of his/her/its product, a product owner shall send a written report on product 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 product recall decision-issuing agency.

5. For the form of destruction:

Within 5 working days after completing the product destruction, a product owner shall send a written report on product destruction that clearly states the name, quantity, time of completion of product destruction and place of destruction, enclosed with a product destruction record certified by the agency carrying out the product destruction, to the competent agency in charge of food safety or product recall decision-issuing agency.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 9.Transitional provision

For products for which receipts of regulation conformity declarations or certificates of declaration of conformity with the food safety regulations as prescribed in the Government’s Decree No. 38/2012/ND-CP of April 25, 2012, this Circular shall apply until the expiration of the time limit stated in such receipts or certificates or expiry date of products.

Article 10.Effect

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

2. To annul the following documents from the effective date of this Circular:

a/ The Minister of Health’s Circular No. 17/2016/TT-BYT of June 30, 2016, on recall and disposal of unsafe foods under the management of the Ministry of Health;

b/ The Minister of Health’s Decision No. 4930/QD-BYT of September 15, 2016, correcting the Minister of Health’s Circular No. 17/2016/TT-BYT of June 30, on recall and disposal of unsafe foods under the management of the Ministry of Health.

Article 11.Reference

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

Article 12.Organization of implementation

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

2. Directors of provincial-level Health Departments, heads of health sections, agencies in charge of food safety and related organizations and individuals shall implement this Circular.

Any problems arising in the course of implementation of this Circular should be promptly reported to the Ministry of Health (the Vietnam Food Administration) for settlement guidance.-

For the Minister of Health
Deputy Minister
NGUYEN THANH LONG

*The Appendix to this Circular is not translated.