Circular No. 51/2025/TT-BYT on National Technical Regulations for Cigarettes

CIRCULAR

Issued National Technical Regulation on Cigarettes

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006, amended and supplemented by the Law on Standards and Technical Regulations dated June 14, 2025;

Pursuant to the Law on Prevention of Harmful Effects of Tobacco dated June 18, 2012;

Pursuant to Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing implementation of certain provisions of the Law on Standards and Technical Regulations, amended and supplemented by Decree No. 78/2018/NĐ-CP dated May 16, 2018;

Pursuant to Decree No. 77/2013/NĐ-CP of the Government detailing implementation of the Law on Prevention of Harmful Effects of Tobacco regarding certain measures to prevent harmful effects of tobacco;

Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Food Safety Administration;

The Minister of Health issues this Circular on the issuance of the National Technical Regulation on Cigarettes.

Article 1. Issuance of the National Technical Regulation

Attached to this Circular is the National Technical Regulation on Cigarettes (QCVN 16-1:2025/BYT).

Article 2. Effective Date

1. This Circular takes effect from February 14, 2026.

2. Circular No. 23/2015/TT-BYT dated August 20, 2015 of the Ministry of Health on "Issuance of the National Technical Regulation on Cigarettes" shall cease to be effective from the date this Circular takes effect.

3. Abolish certain provisions in Circular No. 49/2015/TT-BYT dated December 11, 2015 of the Minister of Health concerning declaration of conformity and compliance with regulations for tobacco products:

a) Remove the phrase "declaration of conformity and" in the title of the Circular, the basis for issuance, Article 1, Chapter II, and Article 10;

b) Remove the phrase "declaration of conformity," in Clause 1, Article 7;

c) Remove the phrase "declaration of conformity or" in Clauses 1, 2, and Clause 5, Article 8; Clause 1, Article 9; Clause 1, Article 10;

d) Remove the phrase "Certificate of Receipt of Declaration of Conformity (hereinafter referred to as Certificate of Receipt)," in Clause 1, Article 7;

e) Remove the phrase "Certificate of Receipt of Declaration of Conformity and" in the title of Article 7;

f) Remove the phrase "Certificate of Receipt of Declaration of Conformity or" and the phrase "or Certificate of Receipt of Declaration of Conformity" in Form No. 8;

g) Remove the phrase "Certificate of Receipt," in Clause 2, Article 9;

h) Remove the phrase "Certificate of Receipt or" in Clause 4, Article 7; the title of Article 8; point a), point b) Clause 3, Article 8; Clause 3, Article 9; Clause 3, Article 10;

i) Remove the phrase "Certificate of Receipt and" in Clause 3, Article 8; Clause 4, Article 9; Clause 4, Article 10; Clause 2, Article 16;

j) Remove the phrase "Certificate of Receipt according to Form No. 09 issued together with this Circular or" in Clause 4, Article 8;

k) Abolish Clause 1, Article 3; Article 4; Article 5; Clause 2, Article 7;

l) Abolish Form No. 01; Form No. 04; Form No. 06; Form No. 09.

4. Abolish Clause 2, Article 6 of Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health amending, supplementing, and abolishing certain legal normative documents on food safety.

Article 3. Implementation Schedule

1. From the date this Circular takes effect, implement Schedule 1 for the maximum tar and nicotine content in smoke from one cigarette as stipulated in Point 1, Section II of the National Technical Regulation on Cigarettes (QCVN 16-1:2025/BYT) attached to this Circular.

2. From August 15, 2027, implement Schedule 2 for the maximum tar and nicotine content in smoke from one cigarette as stipulated in Point 1, Section II of the National Technical Regulation on Cigarettes (QCVN 16-1:2025/BYT) attached to this Circular until August 15, 2031.

3. From August 16, 2031, implement Schedule 3 for the maximum tar and nicotine content in smoke from one cigarette as stipulated in Point 1, Section II of the National Technical Regulation on Cigarettes (QCVN 16-1:2025/BYT) attached to this Circular.

Encourage early implementation of the schedule earlier than the schedule prescribed in Clause 2 and Clause 3 of this Article from the date this Circular takes effect.

Article 4. Transitional Provisions

1. Cigarette products produced before the effective date of this Standard may continue to be imported, traded, and circulated until their expiration date according to the implementation schedule specified in Article 3 of this Circular.

2. Declarations of conformity submitted before the effective date of this Standard will continue to be processed according to the regulations at the time of submission.

3. Certificates of Receipt of Declaration of Conformity issued under the National Technical Regulation on Cigarettes promulgated by Circular No. 23/2015/TT-BYT dated August 20, 2015 of the Ministry of Health shall be implemented according to the validity period of the Certificate of Receipt of Declaration of Conformity and the implementation schedule specified in Clause 2, Article 3 of this Circular.

Article 5. Reference Provisions

In cases where legal provisions or national standards referred to in this Circular are amended or replaced, the new provisions shall apply.

Article 6. Responsibility for Implementation

The Director of the Disease Control Department, the Director of the Food Safety Department, the Heads of units under the Ministry of Health, subordinate units of the Ministry of Health; Directors of Health Departments of provinces and centrally governed cities and relevant agencies, organizations, and individuals are responsible for implementing this Circular.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to report to the Ministry of Health (Disease Control Department) for consideration and resolution./.

 

QCVN 16-1:2025/BYT

NATIONAL TECHNICAL REGULATION FOR CIGARETTES

(Attached to Circular No. 51/2025/TT-BYT dated December 31, 2025 issued by the Ministry of Health)

QCVN 16-1:2025/BYT replaces QCVN 16-1:2015/BYT National Technical Regulation for Cigarettes

Foreword

QCVN 16-1:2025/BYT was drafted by the Drafting Board for National Technical Regulation for Cigarettes, reviewed by the Food Safety Department, examined by the Ministry of Science and Technology, and promulgated by the Minister of Health together with Circular No. 51/2025/TT-BYT dated December 31, 2025.

I. GENERAL PROVISIONS

NATIONAL TECHNICAL REGULATION FOR CIGARETTES

(Attached to Circular No. 51/2025/TT-BYT dated December 31, 2025 issued by the Ministry of Health)

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

This technical regulation applies to organizations and individuals producing, trading, and importing cigarettes within the territory of Vietnam and other related organizations and individuals.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

The Harmonized System code for cigarettes is as follows:

- Cigarettes containing components from cloves (SEN): 2402.20.20

- Other types: 2402.20.90.

3. Definitions

In this technical regulation, the following terms are understood as follows:

3.1. Cigarette is a product made from tobacco raw materials, with or without additives and flavorings, rolled in paper for smoking, commonly cylindrical in shape, with or without a filter, and does not require electronic devices when used.

If a cigarette product is produced using alternative materials instead of tobacco leaves, it must ensure that no additional harmful substances are generated that are detrimental to human health.

3.2. Tobacco additive refers to substances intentionally added during the production, processing, and preservation of cigarettes to maintain or improve their characteristics.

II. TECHNICAL REQUIREMENTS

1. Requirements for maximum tar and nicotine content in smoke from one cigarette

The maximum tar and nicotine content in smoke from one cigarette is regulated according to the schedule set out in the table below:

Table: Implementation Schedule for Tar and Nicotine Content

Implementation Schedule

Organizations and individuals producing, trading, and importing cigarettes in Vietnam must fully declare additives and flavorings in the Declaration of Conformity.

III. SAMPLING AND TESTING METHODS

1. Sampling

1.1. The procedure for sampling cigarette products for quality control inspection is carried out in accordance with the guidance provided in Circular No. 01/2024/TT-BKHCN dated January 18, 2024 issued by the Minister of Science and Technology on state quality control inspections of goods circulating in the market.

1.2. The sampling method is applied according to TCVN 6684 (ISO 8243) Cigarettes - Sampling.

2. Testing Methods

The technical requirements in this technical regulation are implemented according to the testing methods specified below:

2.1. Method for determining nicotine content: carried out according to TCVN 6679 (ISO 10315) Cigarettes - Determination of Nicotine in Total Particulate Matter from Mainstream Smoke - Gas Chromatography Method.

2.2. Method for determining tar content: carried out according to TCVN 6680 (ISO 4387) Cigarettes - Determination of Total Particulate Matter and Nicotine-Free Dry Particulate Matter by Standard Analytical Smoking Machine.

IV. MANAGEMENT REQUIREMENTS

1. Labeling and health warnings on cigarette packaging

The labeling and printing of health warnings on cigarette packaging shall be carried out in accordance with the provisions of Decree No. 43/2017/ND-CP dated April 14, 2017 of the Government on product labeling; Decree No. 111/2021/ND-CP dated December 9, 2021 of the Government amending and supplementing certain articles of Decree No. 43/2017/ND-CP dated April 14, 2017 of the Government on product labeling; Decree No. 77/2013/ND-CP of the Government detailing the implementation of the Law on Prevention and Control of Harmful Effects of Tobacco on some measures to prevent and control the harmful effects of tobacco; Joint Circular No. 05/2013/TTLT-BYT-BCT dated February 8, 2013 guiding the labeling and printing of health warnings on cigarette packaging by the Minister of Health and the Minister of Industry and Trade and other relevant laws.

2. Declaration of Conformity

2.1. The declaration of conformity must be based on the certification results of conformity assessment organizations designated or on the self-assessment results of organizations and individuals producing and trading cigarettes.

2.2. Certification of Conformity:

a) The certification of conformity is carried out according to Point a Clause 1 Article 5: Method 1 (typical sample testing) stipulated in Appendix II of Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Ministry of Science and Technology on declaration of conformity and conformity assessment methods and Circular No. 02/2017/TT-BKHCN dated March 31, 2017 of the Minister of Science and Technology amending and supplementing some articles of Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology on declaration of conformity and conformity assessment methods.

b) Testing for certification purposes must be conducted by designated or recognized testing organizations in accordance with ISO/IEC 17025. The scope of designation or recognition of the testing organization must comply with the requirements stipulated in this technical regulation.

3. Declaration of Conformity

3. Announcement of conformity assessment

3.1. Cigarettes produced, traded, or imported must be declared as compliant with the requirements set forth in this Standard.

3.2. The procedures and formalities for declaring compliance shall be carried out in accordance with the provisions of Circular 28/2012/TT-BKHCN dated December 12, 2012, issued by the Ministry of Science and Technology on declaration of conformity to standards and technical regulations and methods of conformity assessment with standards and technical regulations, Circular No. 02/2017/TT-BKHCN dated March 31, 2017, issued by the Minister of Science and Technology amending and supplementing certain articles of Circular No. 28/2012/TT-BKHCN, and Circular 06/2020/TT-BKHCN dated December 10, 2020 detailing and providing implementation measures for certain articles of Decree No. 132/2008/NĐ-CP dated December 31, 2008, Decree No. 74/2018/NĐ-CP dated May 15, 2018, Decree No. 154/2018/NĐ-CP dated November 9, 2018, and Decree No. 119/2017/NĐ-CP dated November 1, 2017 of the Government.

The Ministry of Science and Technology has amended and supplemented some articles of Circular No. 28/2012/TT-BKHCN dated December 12, 2012, issued by the Minister of Science and Technology on declaration of conformity to standards and technical regulations and methods of conformity assessment with standards and technical regulations, and Circular No. 06/2020/TT-BKHCN dated December 10, 2020 detailing and providing implementation measures for certain articles of Decree No. 132/2008/NĐ-CP dated December 31, 2008, Decree No. 74/2018/NĐ-CP dated May 15, 2018, Decree No. 154/2018/NĐ-CP dated November 9, 2018, and Decree No. 119/2017/NĐ-CP dated November 1, 2017 of the Government.

V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

Organizations and individuals producing, trading, or importing cigarettes are responsible for their products, ensuring that the cigarettes they produce, trade, or import comply with the requirements set forth in this Technical Regulation and relevant laws.

VI. IMPLEMENTATION

1. The Food Safety Agency is tasked to coordinate with the Disease Control Agency to provide guidance on implementing this National Technical Regulation.

2. The Disease Control Agency is designated as the central agency to organize and implement this Technical Regulation and to propose amendments and supplements to this Technical Regulation to the Ministry of Health to ensure it meets management requirements.

3. The Department of Health of provinces/cities directly under the Central Government is the specialized agency at the local level to implement this Technical Regulation according to Clause 4, Article 17 of Circular No. 28/2012/TT-BKHCN dated December 12, 2012, issued by the Ministry of Science and Technology on declaration of conformity to standards and technical regulations and methods of conformity assessment with standards and technical regulations, and Point d of Clause 6, Article 1 of Circular No. 02/2017/TT-BKHCN dated March 31, 2017, issued by the Ministry of Science and Technology amending and supplementing certain articles of Circular No. 28/2012/TT-BKHCN, and Article 14 of Circular 06/2020/TT-BKHCN dated December 10, 2020.

4. In case the legal normative documents stipulated in this Technical Regulation are changed, supplemented, or replaced, they shall be implemented according to the new documents.

In case the standards cited in this National Technical Regulation are changed, supplemented, or replaced, they shall be implemented according to the guidance of the Ministry of Science and Technology.