Circular No. 10/2021/TT-BYT stipulates the list of prohibited substances for use in the production and business of health-promoting foods. This document applies to organizations and individuals involved in this field in Vietnam and those related parties.
적용 범위
["organizations and individuals from Vietnam", "foreign organizations and individuals in Vietnam", "organizations and individuals with activities related to health-promoting foods in Vietnam"]
핵심 사항
- "organizations and individuals" shall not use prohibited substances in the production and business of health-promoting foods according to the List prescribed in Article 3 → Article 1
- The List of Prohibited Substances includes categories of drugs, drug-making raw materials banned from importation and production; narcotic substances and their precursors; addictive drug substances; toxic drugs and toxic drug-making raw materials; medicinal herbs with toxicity from plant, animal, and mineral sources → Article 3
- The principle of building the List of Prohibited Substances must be consistent with laws and scientific bases; international practices and practical food safety management in Vietnam; timely updates to meet health protection requirements and state management → Article 2
- Substances included in the List are those capable of causing harm to the health or life of users or substances not intended for use in food → Article 2.4
- This Circular takes effect from September 1, 2021 → Article 4
🌐 이 문서의 사회적 영향
- "Citizens" are protected in terms of health when using health-promoting foods; "Enterprises" must comply with regulations on prohibited substances in the production and business of health-promoting foods.
- State management agencies have additional tools to control and monitor the use of prohibited substances in the health-promoting food industry.
❓ 자주 묻는 질문
Who does this document apply to?
It applies to organizations and individuals from Vietnam; foreign organizations and individuals in Vietnam participating in the production and business of health-promoting foods; organizations and individuals with activities related to health-promoting foods in Vietnam.
What does the List of Prohibited Substances include?
It includes categories of drugs, drug-making raw materials banned from importation and production; narcotic substances and their precursors; addictive drug substances; toxic drugs and toxic drug-making raw materials; medicinal herbs with toxicity from plant, animal, and mineral sources.
What are the principles for building the List of Prohibited Substances?
Consistent with laws and scientific bases; international practices and practical food safety management in Vietnam; timely updates to meet health protection requirements and state management.
Which substances are included in the List?
Substances capable of causing harm to the health or life of users or substances not intended for use in food.
When does this Circular take effect?
This Circular takes effect from September 1, 2021.
전문
CIRCULAR
Regulations on the List of Prohibited Substances for Use in the Production and Business of Health-Promoting Foods
thực phẩm bảo vệ sức khỏe
Pursuant to the Food Safety Law dated June 17, 2010;
Pursuant to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing certain provisions of the Food Safety Law;
Based on the review opinion in Circular No. 1731/TCTK-TTDL dated November 22, 2021 of the General Statistics Office, the Ministry of Planning and Investment;
At the proposal of the Director of the Food Safety Administration;
The Minister of Health issues this Circular regulating the List of Prohibited Substances for Use in the Production and Business of Health-Promoting Foods.
Article 1. Scope of Regulation and Applicability
Article 1. This Circular regulates the List of Prohibited Substances for Use in the Production and Business of Health-Promoting Foods.
Article 2. This Circular applies to organizations and individuals in Vietnam; foreign organizations and individuals operating in Vietnam in the production and business of health-promoting foods; and organizations and individuals engaged in activities related to health-promoting foods in Vietnam.
Article 2. Principles for Establishing the List of Prohibited Substances for Use in the Production and Business of Health-Promoting Foods
Point 1. Ensuring compliance with legal regulations and having scientific basis.
Point 2. Being consistent with international practices and the management practices of food safety in Vietnam.
Point 3. Timely updating, amending, and supplementing the List to meet the requirements of protecting public health and state management.
Point 4. Substances included in the List are those that have the potential to harm the health or lives of users or substances not intended for use in food.
Article 3. List of Prohibited Substances for Use in the Production and Business of Health-Promoting Foods
Prohibited substances for use in the production and business of health-promoting foods include substances listed in the following Lists:
Point 1. Appendix V "List of Medicines and Raw Materials for Medicines Banned from Importation and Production" issued together with Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Drug Law.
Point 2. List I "Substances Absolutely Prohibited for Use in Medicine and Social Life; Their Use in Analysis, Testing, Scientific Research, and Criminal Investigation According to Special Regulations of Competent Authorities"; List II "Substances Used Restrictedly in Analysis, Testing, Scientific Research, and Criminal Investigation or in the Medical Field According to Regulations of Competent Authorities"; List III "Substances Used in Analysis, Testing, Scientific Research, and Criminal Investigation or in the Medical and Veterinary Fields According to Regulations of Competent Authorities"; List IVA "Essential Precursors Participating in the Structure of Narcotics" issued together with Decree No. 73/2018/NĐ-CP dated May 15, 2018 of the Government detailing lists of narcotics and precursors.
Point 3. Appendix I "List of Addictive Pharmaceutical Ingredients" issued together with Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health detailing certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government regarding special controlled drugs and raw materials.
Point 4. List of Toxic Drugs and Raw Materials for Drugs issued together with Circular No. 06/2017/TT-BYT dated May 3, 2017 of the Minister of Health issuing the List of Toxic Drugs and Raw Materials for Drugs.
Point 5. Appendix I "List of Plant-Derived Toxic Herbal Ingredients"; Appendix II "List of Animal-Derived Toxic Herbal Ingredients"; Appendix III "List of Mineral-Derived Toxic Herbal Ingredients" issued together with Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Minister of Health issuing the List of Toxic Herbal Ingredients for Drugs, except for herbal ingredients marked with (*) which have been processed according to the correct processing methods prescribed by the Minister of Health in Circular No. 30/2017/TT-BYT dated July 11, 2017 guiding the processing methods of traditional herbal medicines and ensuring safety when used as food.
Point 6. Substances listed in the Appendices issued together with this Circular.
Article 4. Effective date
1. This Circular takes effect from September 1, 2021.
Clause 2. In cases where the regulatory legal documents cited in this Circular are amended, supplemented, or replaced, implementation shall be carried out according to the new document.
State-owned enterprises that have been assigned by the Ministry of Agriculture and Rural Development to conduct offshore wind power project surveys before the effective date of this Circular shall continue to implement according to the assigned documents; any new matters arising after the effective date of this Circular shall be implemented in accordance with the provisions of this Circular.
Article 3. The National Food Safety Authority (Ministry of Health) shall be responsible for:
a) Taking the lead in coordinating with relevant units to disseminate, guide, and implement this Circular;
b) Directing units involved in testing health-promoting foods to develop testing methods, invest in human resources and testing equipment to meet the requirements of testing substances listed in the prohibited substance list stipulated in this Circular.
Clause 2. Provincial Departments of Health and Food Safety Management Boards of centrally governed cities shall be responsible for organizing the implementation; the Department of Health shall direct Food Safety Supervision Agencies and related units to inspect and supervise organizations and individuals producing and trading in health-promoting foods at the local level.
During the implementation of this Circular, if there are difficulties or obstacles, they are requested to report to the Ministry of Health (National Food Safety Authority) for consideration and resolution./.
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DEPUTY MINISTER
DEPUTY MINISTER
(Signed)
Trương Quốc Cường
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