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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.:
23/2015/TT-BYT
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Hanoi, August 20,
2015
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CIRCULAR
PROMULGATION OF
NATIONAL TECHNICAL REGULATION FOR CIGARETTE
Pursuant to the Law on tobacco harm prevention
and control dated June 18, 2012;
Pursuant to the Law on technical regulations and
standards dated June 29, 2006;
Pursuant to the Government’s Decree No.
67/2013/ND-CP dated June 27, 2013 elaborating certain articles and providing
measures for implementation of the Law on tobacco harm prevention and control
with respect of tobacco trading;
Pursuant to the Government's Decree No.
127/2007/ND-CP dated August 01, 2007 detailing the implementation of a number
of articles of the Law on technical regulations and standards;
Pursuant to the Government’s Decree No.
63/2012/ND-CP dated August 31, 2012 defining functions, tasks, powers and
organizational structure of Ministry of Health;
At the request of the Director of Vietnam Food
Administration;
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Article 1. QCVN 16-1:2015/BYT - National
technical regulation for cigarette is enclosed herewith.
Article 2. This Circular comes into force
from November 01, 2015. The maximum allowable tar and nicotine contents
prescribed in the QCVN 16-1:2015/BYT shall prevail up to December 31, 2020
inclusively.
Decision No. 02/2007/QD-BYT dated January 15, 2007
by Minister of Health on “Regulation on hygiene and safety of tobacco products”
shall be null and void from the date of entry into force of this Circular.
Article 3. Director of Vietnam Food
Administration, heads of Ministry of Health’s departments and affiliates,
Directors of Provincial Departments of Health, and relevant agencies,
organizations and individuals shall implement this Circular./.
PP. MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
QCVN 16-1:2015/BYT
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Foreword
QCVN 16-1:2015/BYT is compiled by the Drafting
Board of National technical regulation for cigarette, submitted for approval by
the Vietnam Food Administration and promulgated under Circular No.
23/2015/TT-BYT dated August 20, 2015 by Minister of Health.
NATIONAL
TECHNICAL REGULATION FOR CIGARETTE
I. GENERAL PROVISIONS
1. Scope:
This Regulation deals with technical and regulatory
requirements regarding cigarettes.
2. Regulated entities
This Regulation applies to:
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2.2. Relevant regulatory bodies.
3. Definition
For the purposes of this Regulation, these terms
are construed as follows:
3.1. “cigarettes” refers to the products
made from unmanufactured tobacco, whether or not combined with additives,
rolled in paper to a cylindrical form for smoking, whether or not equipped with
a filter.
Cigarettes made of tobacco substitutes must not
create any substances harmful to people’s health.
3.2. “cigarette additives” refers to
substances or chemicals which are intentionally added to cigarettes during
manufacturing or storage with the aims of improving or keeping their properties
unchanged.
II. TECHNICAL
REQUIREMENTS
1. Maximum allowable limits on tar and nicotine
contents in cigarettes
The tar and nicotine contents in a single cigarette
are provided for as follows:
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- Nicotine content: 1.4 (mg/total smoke volume of a
single cigarette).
2. Addition of additives and tobacco substitutes
during manufacturing
Importers, manufacturers and traders of cigarettes
in Vietnam are responsible for submitting declarations of additives and tobacco
substitutes added during the manufacturing of cigarettes to competent
authorities.
3. Labeling requirements
Labeling and warning messages that appear on the
packaging of cigarettes must be conformable with regulations of the Joint
Circular No. 05/2013/TTLT-BYT-BCT dated February 08, 2013 by the Minister of
Health and Minister of Industry and Trade on guidance on labeling and warning
messages of tobacco products.
III. SAMPLING AND
TESTING METHODS
1. Sampling
Sampling shall be subject to the TCVN 6684:2008
(ISO 8243:2006) Cigarettes - Sampling.
2. Testing method
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2.2. Tar content shall be determined
according to TCVN 6680:2008 (ISO 4387:2000) Cigarettes - Determination of total
and nicotine-free dry particulate matter using a routine analytical smoking machine.
(These testing methods are optional. Equivalent
testing methods may be employed.)
IV. REGULATORY
REQUIREMENTS
1. Declaration of conformity
1.1. Cigarettes imported, manufactured and
sold in the domestic market must be declared conforming to requirements set out
in this Regulation.
1.2. Vietnam Food Administration shall take
charge of receiving conformity declaration documentation, issue and re–issue
Certificates of Declaration of conformity within the prescribed time limit.
1.3. Methods, processes and procedures for
declaration of conformity shall be subject to regulations on declaration of
conformity with standards/regulations and methods for conformity assessment in
the Circular No. 28/2012/TT-BKHCN dated December 12, 2012 by Minister of
Science and Technology and relevant legislative documents.
2. Inspection and actions against regulations on
cigarettes
Competent authorities shall inspect and take
actions against violations against technical and regulatory requirements in
this Regulation and relevant committed by importers, manufacturers and traders
in cigarettes.
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1. Importers, manufacturers and traders in
cigarettes must carry out procedures for conformity declaration as prescribed
herein with Vietnam Food Administration.
2. Organizations and individuals shall only
import, manufacture and trade in cigarettes after they have obtained
Certificate of Declaration of conformity from Vietnam Food Administration and
satisfied applicable law regulations.
VI. IMPLEMENTION
1. The Vietnam Food Administration shall
lead and coordinate with relevant authorities to guide and organize the
implementation of this Regulation.
2. Vietnam Food Administration, according to
its managerial duties, shall be responsible for proposing to the Ministry of
Health the amendments and supplements to this Regulation.
3. If amendments, supplements or
replacements of standards and regulations referred to in this Regulation occur,
such revisions shall govern.