G/TBT/N/TPKM/517  
3 March 2023  
(23-1450) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  THE SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, 
KINMEN AND MATSU  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Health Promotion Administration, Ministry of Health and Welfare  
No.36, Tacheng St., Datong Dist., Taipei City 103205, Taiwan  
Tel: 886 -2-2522-0888 ext 618  
Fax: 886 -2-2522-0621 
E-mail: maxwell7549@hpa.gov.tw  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be in dicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  TOBACCO 
AND MANUFACTURED TOBACCO SUBSTITUTES (HS code(s): 24)  
5. Title, number of pages and language(s) of the notified document:  Regulations  of 
the Health Risk Assessment Review of Designated Tobacco Products (Draft); (5 page(s), 
in English), (4 page(s), in Chinese)  
6. Description of content:  Tobacco Hazards Prevention Act (hereinafter referred to as "this 
Act") has been promulgated and amend ed on February 15, 2023. Paragraph 1 of Article 
7 of this Act stipulates that tobacco products designated by the central competent 
authority (hereinafter referred to as "the products") shall be submitted by the 
manufacturers and/or importers to the central  competent authority for application for the 
health risk assessment review and granted by the central competent authority before 
manufacturing or importing the products. Paragraph 2 of Article 7 of this Act stipulates 
that if new health risk(s) related to the tobacco products that have been declared to the 
central competent authority is/are discovered, the central competent authority may 
designate the tobacco products as the products that shall be submitted for application for 
the health risk assessment rev iew within a specified period of time and order the recall of 
the products and suspension from manufacturing or importing the products within a 
specified period of time. If the products are not granted by the central competent 
authority under the health ri sk assessment review, the central competent authority shall 
order the recall or destruction of the products within a period of time and prohibit the 
manufacture and/or importation of the products. To provide legitimate grounds for the 
application and revie w, the Regulations of the Health Risk Assessment Review of 
Designated Tobacco Products (Draft) are stipulated in pursuant to the authorization under 
Paragraph 3 of Article 7 of this Act, and the main points are as follows:  G/TBT/N/TPKM/517  
 
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  1. The source of law for these regulations (Article 1).  
2. The obligor and time limit of and exemption from the submission of the products 
for application for the health risk assessment review (Article 2).  
3. The application form, documents and data that shall be submitted by the 
manufacturer s or importers of the products (Article 3).  
4. The methods by which the central competent authority conducts health risk 
assessment review (Article 4).  
5. The circumstances in which the application for the health risk assessment review 
shall be denied (Article 5 ). 
6. The central competent authority may require the manufacturers and/or importers 
of the products which have been granted by the central competent authority 
under the health risk assessment review to submit post -market monitoring and 
control mechanisms (Ar ticle 6).  
7. The amount of the fee for applying for the health risk assessment review is 
determined by the central competent authority (Article 7).  
8. The products that are denied under the health risk assessment review shall not 
be submitted by the same applica nt for application for the health risk assessment 
review within one year (Article 8).  
9. The application form required in these Regulations shall be promulgated by the 
central competent authority (Article 9).  
10. The central competent authority may authorize rela ted professional institutions, 
agencies, legal persons or groups to execute the tasks in these Regulations 
(Article 10).  
11. The effective date of these regulations (Article 11).  
Designated tobacco products that are made of raw materials specified in Subparagr aph 1 
of Paragraph 1 of Article 3 of Tobacco Hazards Prevention Act and the physical properties 
of the raw materials are not changed, except for cigarettes, cut tobacco, cigars, snuff and 
chewing tobacco, shall be submitted to the central competent authori ty for application for 
the health risk assessment review and be granted before being manufactured or imported.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
Tobacco Hazards Prevention Act  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  7 days from notification  G/TBT/N/TPKM/517  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO/TBT Enquiry Point  
Bureau of Standards, Metrology and Inspection  
Ministry of Economic Affairs  
No. 4, Sec. 1, Jinan Rd., Zhongzheng Dist.  
Taipei City 100 , Taiwan  
Tel: +(886 -2) 23431916  
Fax: +(886 -2) 23431804  
Email: tbtenq@bsmi.gov.tw  
https://members.wto.org/crnattachments/2023/TBT/TPKM/23_1479_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/TPKM/23_1479_00_x.pdf