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THE
MINISTRY OF HEALTH OF VIETNAM
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THE SOCIALIST REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No.
51/2025/TT-BYT
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Hanoi,
December 31, 2025
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CIRCULAR
PROMULGATION OF NATIONAL TECHNICAL REGULATION FOR CIGARETTE
Pursuant to the Law on Technical
Standards and Regulations dated June 29, 2006, as amended by the Law on
Technical Standards and Regulations dated June 14, 2025;
Pursuant to the Law on
Prevention and Control of Harmful Effects of Tobacco dated June 18, 2012;
Pursuant to the Government’s
Decree No. 127/2007/ND-CP dated August 01, 2007 elaborating the Law on
Technical Standards and Regulations, as amended by the Decree No. 78/2018/ND-CP
dated May 16, 2018;
Pursuant to the Government’s
Decree No. 77/2013/ND-CP elaborating the Law on Prevention and Control of
Harmful Effects of Tobacco regarding certain measures for prevention and
control of harmful effects of tobacco;
Pursuant to the Government’s
Decree No. 42/2025/ND-CP dated February 27, 2025 defining functions, tasks,
powers and organizational structure of the Ministry of Health of Vietnam;
At the request of the Director
of Vietnam Food Administration;
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Article 1.
Promulgation of National technical regulation
The National technical regulation
for cigarette (QCVN 16-1:2025/BYT) is enclosed herewith.
Article 2.
Effect
1. This Circular comes into force
from February 14, 2026.
2. The Circular No. 23/2015/TT-BYT
dated August 20, 2015 of the Ministry of Health of Vietnam shall cease to have
effect from the effective date of this Circular.
3. The following regulations of the
Circular No. 49/2015/TT-BYT dated December 11, 2015 of the Minister of Health
are abrogated:
a) The phrase “công bố hợp quy và”
(“declaration of conformity and”) in heading of the Circular, the part of
grounds for promulgation, Article 1, heading of Chapter II and Article 10;
b) The phrase “bản công bố hợp
quy,” (“declaration of conformity form,”) in clause 1 Article 7;
c) The phrase “công bố hợp quy hoặc”
(“declaration of conformity or”) in clauses 1, 2 and 5 Article 8; clause 1
Article 9; clause 1 Article 10;
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e) The phrase “Giấy tiếp nhận bản
công bố hợp quy và” (“Certificate of submission of Declaration of Conformity
and”) in heading of Article 7;
f) The phrase “Giấy tiếp nhận bản
công bố hợp quy hoặc” (“Certificate of submission of Declaration of Conformity
or”) and the phrase “hoặc Giấy Tiếp nhận bản công bố hợp quy” (“or Certificate
of submission of Declaration of Conformity”) in Form No. 8;
g) The phrase “Giấy Tiếp nhận,”
(“Certificate of submission,”) in clause 2 Article 9;
h) The phrase “Giấy tiếp nhận hoặc”
(“Certificate of submission,”) in clause 4 Article 7; heading of Article 8;
point a), point b) clause 3 Article 8; clause 3 Article 9; clause 3 Article 10;
i) The phrase “Giấy tiếp nhận và”
(“Certificate of submission and”) in clause 3 Article 8; clause 4 Article 9;
clause 4 Article 10; clause 2 Article 16;
j) The phrase “Giấy Tiếp nhận theo
quy định tại Mẫu số 09 ban hành kèm theo Thông tư này hoặc” (“Certificate of
submission which is made using Form No. 09 enclosed herewith or”) in clause 4
Article 8;
k) Clause 1 Article 3; Article 4;
Article 5; clause 2 Article 7;
l) Form No. 01; Form No. 04; Form
No. 06; Form No. 09.
4. Clause 2 Article 6 of the
Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health
of Vietnam is abrogated.
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1. From the effective date of this
Circular, Roadmap 1 shall be applied to the maximum permitted levels of tar and
nicotine yields in the smoke of 01 cigarette, as specified in Point 1 Section
II of the National technical regulation for cigarette (QCVN 16-1:2025/BYT)
enclosed herewith.
2. From August 15, 2027, Roadmap 2
shall be applied to the maximum permitted levels of tar and nicotine yields in
the smoke of 01 cigarette, as specified in Point 1 Section II of the National
technical regulation for cigarette (QCVN 16-1:2025/BYT) enclosed herewith until
August 15, 2031.
3. From August 16, 2031, Roadmap 3
shall be applied to the maximum permitted levels of tar and nicotine yields in
the smoke of 01 cigarette, as specified in Point 1 Section II of the National
technical regulation for cigarette (QCVN 16-1:2025/BYT) enclosed herewith.
From the effective date of this
Circular, the application of a roadmap earlier than the time for application
thereof specified in clause 2 or 3 of this Article is encouraged.
Article 4.
Transition
1. Cigarette products manufactured
before the effective date of this Regulation may continue to be imported,
traded, and sold until the expiry date of such cigarette products, in
accordance with the roadmaps specified in Article 3 of this Circular.
2. Applications for registration of
the declaration of conformity submitted before the effective date of this
Regulation shall continue to be processed in accordance with regulations in
force at the time of application submission.
3. Certificates of submission of
Declaration of Conformity issued in accordance with provisions of the National
technical regulation for cigarette enclosed with the Circular No.
23/2015/TT-BYT dated August 20, 2015 of the Ministry of Health of Vietnam shall
still remain valid until the expiry dates thereon and according to the Roadmap
specified in clause 2 Article 3 of this Circular.
Article 5.
Terms of reference
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Article 6.
Responsibility for implementation
Director of Vietnam Administration
of Disease Prevention (VADP), Director of Vietnam Food Administration, heads of
Ministry of Health’s departments and affiliated units, Directors of Provincial Departments
of Health, and relevant authorities, organizations and individuals shall be
responsible for the implementation of this Circular.
Difficulties that arise during the
implementation of this document should be reported to the Ministry of Health
(via VADP) for consideration./.
PP.
MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
QCVN 16-1:2025/BYT
NATIONAL TECHNICAL REGULATION FOR CIGARETTE
(Enclosed with the Circular No. 51/2025/TT-BYT dated December 31, 2025 of the
Ministry of Health of Vietnam)
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Foreword
QCVN 16-1:2025/BYT replaces QCVN
16-1:2015/BYT - National technical regulation for cigarette.
QCVN 16-1:2025/BYT is compiled by
the Drafting Board of National technical regulation for cigarette, submitted
for approval by Vietnam Food Administration, appraised by the Ministry of
Science and Technology of Vietnam, and promulgated under the Circular No.
51/2025/TT-BYT dated December 31, 2025 by the Minister of Health.
NATIONAL
TECHNICAL REGULATION FOR CIGARETTE
I. GENERAL
PROVISIONS
1. Scope:
This Regulation deals with
technical requirements, testing and sampling methods; regulatory requirements;
responsibilities of manufacturers, traders and importers of cigarettes.
2. Regulated entities
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HS codes of cigarettes:
- Clove cigarettes: 2402.20.20
- Other: 2402.20.90.
3. Definitions
For the purposes of this Regulation,
terms herein shall be construed as follows:
3.1. “Cigarettes” refers to
products made from raw tobacco, with or without the addition of additives and
flavourings, rolled in paper to a typically cylindrical form for smoking,
whether or not equipped with a filter, and which do not require any electronic
device for use.
Where cigarettes are manufactured
using tobacco leaf substitutes, such substitutes shall not result in the
formation of additional substances harmful to human health.
3.2. “Cigarette additives” refers
to substances intentionally added during manufacturing, processing or storage
of cigarettes for the purposes of maintaining or improving their properties.
II. TECHNICAL
REQUIREMENTS
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The maximum permitted levels of tar
and nicotine yields in the smoke of 01 cigarette shall comply with the roadmaps
specified in the Table below:
Table: Roadmaps for application of
tar and nicotine yields
Roadmap
for application
Tar
yield
(mg/the
smoke of a single cigarette)
Nicotine
yield
(mg/the
smoke of a single cigarette)
Roadmap 1
16
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Roadmap 2
15
1,3
Roadmap 3
14
1,2
2. Addition of additives and
flavourings during manufacturing, trading and import of cigarettes
Manufacturers, traders and
importers of cigarettes in Vietnam shall fully declare all additives and
flavourings added to cigarettes in their declarations of conformity.
III. SAMPLING
AND TESTING METHODS
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1.1. Procedures for sampling cigarette
products for the purpose of quality inspection shall be followed in accordance
with the Circular No. 01/2024/TT-BKHCN dated January 18, 2024 of the Minister
of Science and Technology of Vietnam prescribing state inspection of quality of
goods placed on the market.
1.2. Sampling methods shall comply
with TCVN 6684 (ISO 8243) - Cigarettes - Sampling.
2. Testing methods
The satisfaction of technical
requirements laid down in this Regulation shall be determined adopting the
following testing methods:
2.1. Nicotine yield shall be
determined according to TCVN 6679 (ISO 10315) - Cigarettes - Determination of
nicotine in total particulate matter from the mainstream smoke - Gas
chromatographic method.
2.2. Tar yield shall be determined
according to TCVN 6680 (ISO 4387) - Cigarettes - Determination of total and
nicotine-free dry particulate matter using a routine analytical smoking
machine.
IV. REGULATORY
REQUIREMENTS
1. Labeling and printing of
health warnings on cigarettes
Labeling and printing of health warnings
on packages of cigarette products shall comply with provisions of the
Government’s Decree No. 43/2017/ND-CP dated April 14, 2017; the Government’s
Decree No. 111/2021/ND-CP dated December 09, 2021; the Government’s Decree No.
77/2013/ND-CP; the Joint Circular No. 05/2013/TTLT-BYT-BCT dated February 08,
2013 of the Minister of Health and the Minister of Industry and Trade, and
other relevant laws.
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2.1. Declaration of conformity
shall be based on certification results given by designated conformity
certification bodies or on the self-assessment results of manufacturers or
traders.
2.2. Certification of conformity:
a) Certification of conformity
shall comply with provisions of point a clause 1 Article 5: Method 1 (representative
sample testing) provided in Appendix II enclosed with the Circular No.
28/2012/TT-BKHCN dated December 12, 2012 of the Ministry of Science and
Technology of Vietnam and the Circular No. 02/2017/TT-BKHCN dated March 31,
2017 of the Minister of Science and Technology of Vietnam.
b) Testing for certification
purposes shall be carried out by testing laboratories designated or accredited
according to ISO/IEC 17025. The scope of designation or accreditation shall be consistent
with the requirements laid down in this Regulation.
3. Declaration of conformity
3.1. Cigarette products
manufactured, traded or imported shall be subject to declaration of conformity
in accordance with this Regulation.
3.2. Applications and procedures
for declaration of conformity shall comply with the Circular No.
28/2012/TT-BKHCN dated December 12, 2012 of the Ministry of Science and
Technology of Vietnam, the Circular No. 02/2017/TT-BKHCN dated March 31, 2017
of the Minister of Science and Technology of Vietnam, and the Circular No.
06/2020/TT-BKHCN dated December 10, 2020.
V.
RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS
Manufacturers, traders, and
importers of cigarettes shall be responsible for their products and shall
ensure that the cigarette products they manufacture, trade or import conform to
the requirements of this Regulation and other relevant laws.
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1. Vietnam Food
Administration is assigned to cooperate with Vietnam Administration of Disease
Prevention (VADP) to provide guidelines for the implementation of this
Regulation.
2. VADP is assigned to act
as a central-government focal agency in charge of organizing the implementation
of this Regulation and for proposing to the Ministry of Health of Vietnam
amendments and supplements thereto as necessary to meet regulatory
requirements.
3. Departments of Health of
provinces/central-affiliated cities are assigned to act as local-government
specialized agencies in charge of organizing the implementation of this Regulation
in accordance with clause 4, Article 17 of the Circular No. 28/2012/TT-BKHCN
dated December 12, 2012 of the Ministry of Science and Technology of Vietnam,
and point dd clause 6 Article 1 of the Circular No. 02/2017/TT-BKHCN dated
March 31, 2017 of the Ministry of Science and Technology of Vietnam, and
Article 14 of the Circular No. 06/2020/TT-BKHCN dated December 10, 2020.
4. If any legislative
documents referred to in this Regulation are amended, supplemented or
superseded, the new ones shall apply.
If any standards referred to in
this Regulation are amended, supplemented or superseded, the guidelines given
by the Ministry of Science and Technology of Vietnam shall apply.