Thông tư 10/2021/TT-BYT

CIRCULAR

PRESCRIBING NOMENCLATURE LIST OF AGENTS PROHIBITED FROM PRODUCTION AND BUSINESS OF HEALTH PROTECTION FOOD

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

Pursuant to the Government's Decree No. 15/2018/ND-CP dated February 2, 2018, elaborating on implementation of a number of articles of the Law on Food Safety;

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

Upon the request of the Director of Vietnam Food Administration;

The Minister of Health hereby promulgates the Circular on the Nomenclature List of agents prohibited from production and business of health protection food.

Article 1. Scope and subjects of application

1. This Circular prescribes the Nomenclature List of agents prohibited from production and business of health protection food.

2. This Circular shall apply to domestic entities and persons; foreign entities and persons in Vietnam that are involved in production and business of health protection food; entities and persons whose operations relate to health protection food in Vietnam.

Article 2. Compilation principles

1. Ensure compliance with laws and scientificity.

2. Accord with international practices and reality of food safety administration in Vietnam.

3. Punctually update and revise the Nomenclature List to meet health protection and state management requirements.

4. Ensure that agents included in the List are those likely to harm the health or life of users or those that are not food-grade.

Article 3. Nomenclature List

Agents prohibited from production and business of health protection food comprise substances included in the followings:

1. Appendix V - “List of pharmaceuticals and medicinal ingredients prohibited from import or export” to the Government’s Decree No. 54/2017/ND-CP dated May 8, 2017, elaborating on several articles and measures for implementation of the Law on Pharmacy.

2. List I – “Narcotic substances banned from healthcare and life, the use of which for analysis, testing, scientific research and criminal investigation is subject to permission by competent authorities"; List II - “Narcotic substances restricted from analysis, testing, scientific research, criminal investigation or healthcare as regulated by competent authorities"; List III – “Narcotic substances permitted in analysis, testing, scientific research, criminal investigation, healthcare and veterinary medicine as regulated by competent authorities"; List IVA – “Crucial precursors in the structure of narcotic”, annexed to the Government’s Decree No. 73/2018/ND-CP dated May 15, 2018, prescribing lists of narcotics and precursors.

3. Appendix I – “List of narcotic active ingredients” to the Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health, elaborating some Articles of the Law on Pharmacy and the Government's Decree No. 54/2017/ND-CP on drugs and medicinal ingredients subject to special control.

4. The List of Toxic Drugs and Toxic Medicinal Ingredients annexed to the Circular No. 06/2017/TT-BYT dated May 3, 2017 of the Minister of Health, promulgating the List of Toxic Drugs and Toxic Medicinal Ingredients.

5. Appendix I - “List of toxic medicinal substances of plant origin”; Appendix II – “List of toxic medicinal substances of animal origin”; Appendix III – “List of toxic medicinal substances of mineral origin” to the Circular No. 42/2017/TT-BYT dated November 13, 2o17 of the Minister of Health, issuing the Lists of toxic medicinal substances, except those with (*) that are formulated according to methods regulated by the Minister of Health under the Circular No. 30/2017/TT-BYT dated July 11, 2017, providing instructions about methods for formulation of traditional medicines and assurance of safety for production of food.

6. The List of agents included in the Appendix to this Circular.

Article 4. Entry into force

1. This Circular shall enter into force as of September 1, 2021.

2. If legislative documents used as referents herein are revised, supplemented or replaced, new versions shall be applied.

Article 5. Implementation

1. Vietnam Food Administration (Ministry of Health) shall assume the following responsibilities:

a) Preside over or cooperate with relevant entities in disseminating, guiding and implementing this Circular;

b) Directing its affiliates participating in testing of health protection food to develop test methods, invest in testing personnel and equipment to meet the requirements for testing of agents included in the list of prohibited agents regulated herein.    

2. Departments of Health, Food Safety Management Boards of provinces and centrally-affiliated cities shall be responsible for implementing this Circular while Departments of Health shall be responsible for directing Subdepartments of Food Safety and Hygiene and related units to inspect and supervise local entities and persons manufacturing and trading health protection food. 

In the course of implementation of this Circular, should there be any query or difficulty, entities, organizations and persons need to inform the Ministry of Health (Vietnam Food Administration) to seek their solutions./.