Thông tư 23/2015/TT-BYT về Quy chuẩn kỹ thuật quốc gia đối với thuốc lá điếu do Bộ trưởng Bộ Y tế ban hành

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;

Minister of Health promulgates a Circular promulgating the National technical regulation for cigarette.

Article 1. QCVN 16-1:2015/BYT - National technical regulation for cigaretteis 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./.

QCVN 16-1:2015/BYT

NATIONAL TECHNICAL REGULATION FOR CIGARETTE

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:

2.1. Importers, manufacturers and traders of cigarettes in Vietnam.

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:

- Tar content: 16.0 (mg/total smoke volume of a single cigarette);

- 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

2.1. Nicotine content shall be determined according to TCVN 6679:2008 (ISO 10315:2000) Cigarettes - Determination of nicotine in smoke condensates - Gas chromatographic method.

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.

V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

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.

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